Express Pharma May 16-31, 2014

VOL. 9 NO. 14 PAGES 112

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Cover Story Speeding up tri@ls Management Issues with recent changes to clinical trials’ regulations Pharma Life Re-skilling: An urgent need 16-31 MAY 2014,` 40

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CONTENTS MARKET Vol.9 No.14 MAY 16-31, 2014

11

CIPLA INVESTS IN CHASE PHARMACEUTICALS

12

INDIA REMAINS ON USTR PRIORITY WATCH LIST

13

JUBILANT BIOSYS COLLABORATES WITH ORION CORPORATION

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There is an inadequate emphasis on re-skilling and re-training in the Indian pharmaceutical industry.

However, when planned properly, re-skilling could be a major tipping point. A look at the transformation journey of five professionals | P100

HILLEMAN LABORATORIES’ TECHNOLOGY TO IMPROVE ROUTINE IMMUNISATION IN INDIA

16

CABINET CLEARS KKR’S PROPOSAL TO ACQUIRE STAKES IN TWO PHARMA COS

P20: POST EVENT

26

M&A ACTIVITY FOCUSSED ON PORTFOLIO TRANSFORMATION

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma

RE-SKILLING: AN

URGENT NEED

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

3rd Global Pharma Regulatory Summit concludes in Mumbai

MANAGEMENT

45

ISSUES WITH RECENT CHANGES TO CTS’ REGULATIONS

47

ADVANTAGES AND CHALLENGES OF AV RECORDING IN CLINICAL TRIALS

P49: RESEARCH UPDATE Novartis gains US FDA approval for Zykadia

TURN TO PAGE 13 TO FIND SPECIAL DEALS

P55: PROFILE

PHARMA ALLY/PTR

Glatt India: Leading by example

Scheduling & Coordination Rohan Thakkar

P106: APPOINTMENT

CIRCULATION Circulation Team Mohan Varadkar

Biocon appoints Dr Arun Chandavarkar as CEO and Joint MD

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‘AGILENT HAS DECIDED TO INCREASE ITS FOCUS ON THE SME BUSINESS SEGMENTS’

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

More to rules than the carrot-and-stick approach

A

fter all the posturing and speculation, United States Trade Representative’s (USTR) Special 301 Report this year did not downgrade India from the Priority Watch List to the Priority Foreign Country category. But the USTR is keeping up the pressure, by sanctioning an out-of-cycle review (OCR) later this year. India is one of 10 countries on the ‘Priority Watch List’. While 27 countries got the stick and made it to the Watch List this time, Italy and Philippines were awarded a ‘carrot’, becoming the first two to be removed from the Watch List.

Very clearly, the USTR will have an eagle’s eye on the new government on the intellectual property rights (IPR) front. Will the new government be strong enough to stand up to such carrot-and-stick tactics?

The US FDA is also accused of using 483s, warning letters and import alerts as a stick. But here the disciplinary action is supported by extensive suggestions to improve compliance, so industry is coming around to see the long-term benefits of continually upgrading manufacturing systems.

There is also increasing interaction and collaboration between the US FDA, its Indian counterpart, Central Drugs Standards Control Organization (CDSCO) and industry, which I got to see first hand on May 5 in Hyderabad. Officials of the US FDA India office, the CDSCO and the Indian Pharmaceutical Alliance (IPA), conducted the first in a series of workshops meant to get both Indian regulators and industry members up to speed with what the US regulator wants to see as evidence of compliance.

In a recorded message, Howard Sklamberg, Deputy Commissioner, US FDA Global Regulatory Operations and Policy gave hints to what the US FDA considers ‘red flags’ (like for instance, outdated manufacturing systems which would mean that automated systems inspire more confidence).

The US FDA itself is in evolution mode and two of Sklamberg's posts on the FDA Voice blog give glimpses of this process. Both posts, (dated May 9 and May 12) are about the US FDA morphing from a ‘domestically-focused regulatory agency’ to a ‘globally focused regulator’. The second post also announces a deeper collaboration with the European Commission (EC) and the European Medicines

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As with IPR,the US FDA’s intention is to ‘harmonise’ (read impose?) standards across boundaries and through its counterparts as well

Agency (EMA) to increase exchange of information.

Sklamberg’s concluding para in this post mentions ‘strengthening our mutual reliance and capitalising on our shared interests’ and says the initiative ‘signals yet another important step forward for pharmaceutical quality here in the US—and around the world.’

Thus, it is very apparent that as with IPR, the US FDA’s intention is to ‘harmonise’ (read impose?) standards across boundaries and through its counterparts as well. With the highest number of US FDA-registered plants outside the US (523 as of March this year), should India be worried that more sites in the country might face import alerts?

There are two sides to this issue: revenues and reputation. Revenues in 2013 were not hit so badly, as banned facilities accounted for around seven to eight per cent of the total exports to the US and around two per cent of the overall 2013 pharma exports from India, according to an analysis by Chennai-based India Ratings & Research (Ind-Ra).

But what really took a beating was reputation, which is infinitely more difficult to recover. And as Ind-Ra points out, these companies will also face a substantial opportunity loss on account of delayed product introductions and expenditure on corrective actions.

Of course, above both revenues and reputation is patient health and safety. If that’s compromised, everything is lost. In this issue (dated May 16-31, 2014), we are finally successful in giving a voice to patients. On our cover, we have Nidhi Shirol’s story: a teenage girl condemned to life on a ventilator as pharma companies are too wary to include her in a clinical trial.

But we also feature ‘Raj’, who is alive today because he had the courage to join a trial for a cancer drug. We also feature doctors who feel cornered between seemingly irrational rules and their moral obligation towards their patients. While the regulator is right to protect patients, confidentiality is also the fundamental right of any patient signing up for a trial.

We hope that our coverage in this issue takes the discussion forward to a conclusion acceptable to all concerned. The stick is not always the answer.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Cipla invests in Chase Pharmaceuticals To support Alzheimer’s disease drug development CIPLA ANNOUNCED its investment in Chase Pharmaceuticals Corporation, US (Chase), through its wholly-owned subsidiary, Cipla (EU), UK. Chase is an early stage drug development company, based in Washington DC. The $21 million two-phase financing will support Phase 2a and Phase 2b clinical trials for Chase’s lead drug CPC 201. The original venture funding for Chase was provided by the Brain Trust Accelerator Fund in 2010.

Commenting on the investment, Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla said, “This investment is consistent with Cipla New Ventures’ mission to build more innovationled business streams for Cipla

in the future. We want to bring affordable medicines, where we identify an unmet patient need, in a way that leverages Cipla’s formidable technology, device and development capabilities.”

Chase is focused on developing novel approaches to improve treatments for Alzheimer’s disease. It has a unique patented approach and is focused on improving the efficacy, safety and tolerability of existing Alzheimer medications.

Cipla through its impact investment unit Cipla New Ventures, is investing in the Series B round of financing as part of a syndicate, which also consists of Edmond de Rothschild Investment Partners and New Rhein Healthcare. Cipla New Ventures was set up to chart a

The $21 million two-phase financing will support Phase 2a and Phase 2b clinical trials for Chase’s lead drug CPC 201. The original venture funding for Chase was provided by the Brain Trust Accelerator Fund in 2010 trajectory in innovation around biologicals, repurposing existing safe drugs and leveraging Cipla’s enviable suite of delivery technologies through disruptive innovation around access and

affordability. It is managed by Chandru Chawla.

In addition to financing Chase, Cipla will collaborate with the company to develop the drug. If successful, Cipla

may provide low cost access to Chase’s lead drug in India and South Africa where Cipla has championed affordable access to essential and life-saving medications for decades. In India, over five million patients suffer from dementia, most of whom are afflicted with Alzheimer’s.

These numbers are expected to double by 2030. In India, the caregiver is the family and the economic and social impact is far reaching. In North America, Alzheimer’s disease affects more than over seven million patients and its impact is growing as the population ages. The disease costs the US alone $203 billion annually with projections to reach $1.2 trillion by 2050.

EP News Bureau – Mumbai

Connexios Life Sciences, Boehringer Ingelheim in pact Boehringer Ingelheim obtains global rights to CNX-012, Connexios Life Sciences’ programme on AMPK activators BANGALORE-BASED biotechnology company, Connexios Life Sciences and Boehringer Ingelheim, announced an exclusive global research collaboration agreement for AMPK agonists for the treatment of patients with Type II diabetes.

As part of the agreement, Boehringer Ingelheim obtains global rights to CNX-012, Connexios Life Sciences’ programme on AMPK activators.

The programme includes CNX570 and other compounds in

early pre-clinical development.

Boehringer Ingelheim will be responsible for all further development and commercialisation of the candidates from the AMPK programme. Further terms and financial details were not disclosed.

“As a pure research-driven organisation from India, we believe that the agreement with Boehringer Ingelheim is a big validation of both our scientific approach and capabilities as well as of our business model,” commented Suri Venkatacha-

lam, Chief Executive Officer and Founder of Connexios.

“CNX-012 is one of our flagship programmes which leverages our Network Biology approach and platform and we are pleased to be working with Boehringer Ingelheim to advance candidates from this programme. We strongly believe that the collaboration will yield best-in-class activators of this exciting but challenging target and ultimately result in better therapies for patients of Type II diabetes who also suffer from

the burden of several other cardiometabolic co-morbidities.”

“Partnering is key to our business strategy and the partnership with Boehringer Ingelheim who have shown a strong commitment to the therapeutic area of metabolic diseases is an important milestone for Connexios. With our strengths in disease biology and drug discovery, we see great complementarity between the organisations and look forward to building on this relationship in future,” added Shobha Vijayaraghavan, Vice

President, Business Development, Connexios Life Sciences.

Commenting on the agreement, Michel Pairet, Senior Vice President and Global Head of Research and Development, Boehringer Ingelheim said, “We are pleased to enter into this agreement with Connexios, a company recognised as experts in their field, which will further strengthen our discovery and development efforts in the area of cardiometabolic diseases.”

EP News Bureau – Mumbai

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MARKET

Merck receives final antitrust clearance for AZtakeover

India remains on USTR PriorityWatch List US trade body announces more in-depth investigation into India's patent laws IN THE US Trade Representative (USTR) 2014 'Special 301 Report' released on April 30, India remains on the Priority Watch List as in previous years for what the USTR considers to be inadequate protection of intellectual property.

USTR has also announced a more in-depth investigation into Indian patent law (called an Out-ofCycle Review), through which it will maintain ongoing and increased pressure on India.

Industry observers point out that India, the world’s principal producer and supplier of quality generic medicines, has in recent years repeatedly been singled out by the US government and the multinational pharmaceutical industry on grounds of insufficient enforcement of intellectual property.

An MSF release defends India's stance pointing out that what the country is do-

Industry observers point out that India has in recent years repeatedly been singled out by the US government and the multinational pharmaceutical industry on grounds of insufficient enforcement of intellectual property

ing when it seeks to limit patent evergreening (where companies file multiple patents in a bid to ever-extend monopolies), or when it authorises the sale of a generic version of an expensive patented medicine through the use of compulsory licenses, is entirely within global trade rules, and these actions save lives. Other countries are

now considering similar legislation replicating the Indian model. The US pharmaceutical industry and USTR are clearly worried and are now seeking to curb India’s influence on global patent reform efforts that have the potential to increase access to medicines for millions in need in developing countries.

Reacting to the USTR's

listing, Judit Rius Sanjuan, US Manager, Médecins Sans Frontières/Doctors Without Borders' Access Campaign, said, “The US Trade Rep is throwing every single intimidation and pressure tactic it has at its disposal at India.

This is just the latest example of how USTR is attempting to penalise India for not bowing to the endless efforts of the multinational pharma industry to severely restrict generic competition in India and world-wide.

The USTR is painting India as a rogue government, when in fact every action in India’s efforts to secure access to affordable, lifesaving medicines is fully consistent with global trade rules.

India is playing by the rules, and USTR knows it.

India’s policies have saved lives. It’s an example that should be followed, not criticised.”

MERCK HAS received Chinese antitrust clearance from the Ministry of Commerce of the People’s Republic of China (MOFCOM), meaning that the last condition relating to antitrust clearances has now been satisfied.

AZ shareholders now have until May 7 to tender their shares. With the Chinese antitrust clearance, the acceptance threshold was lowered to 75 per cent as planned. According to the UK Takeover Code, Merck can complete the transaction as soon as all conditions have been satisfied and the acceptance threshold has been reached. Apart from China, the necessary antitrust clearances in Germany, Japan, Taiwan and the US had already been granted.

“We are pleased that our constructive negotiations with MOFCOM have led to a clearance in China and that we can now swiftly complete the acquisition of AZ Electronic Materials”, said Karl-Ludwig Kley, Chairman of the Executive Board, Merck.

EP News Bureau - Mumbai

EP News Bureau-Mumbai

Glenmark gets BSE nod to merge subsidiaries with itself It has received nod for the merger of Glenmark Generics and Glenmark Access THE BOMBAY Stock Exchange (BSE) has approved the merger of Glenmark Pharmaceuticals’ two subsidiaries with the pharmaceutical company as the amalgamation does not violate securities law.

According to a PTI report, the pharma giant received nod for the merger of

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Glenmark Generics and Glenmark Access with itself, which the Glenmark Pharmaceuticals board had approved in January this year.

‘No-objection approval’ has been granted to the proposal, the BSE said a letter to Glenmark Pharmaceuticals dated May 2. Besides, the Na-

tional Stock Exchange had approved the proposed merger last month. The approval is valid for six months, during which the company will apply to the High Court for further clearance of the proposal.

Glenmark Pharmaceuticals also needs to display on website its shareholding pattern

before and after the merger.

The BSE said that it received confirmation from the company saying the scheme does not violate or override provisions of securities laws or stock exchange requirements.

“Accordingly, we do hereby convey our 'no-objection' with limited reference to those

matters having a bearing on listing /delisting/ continuous listing requirements within the provisions of the Listing Agreement, so as to enable the company to file the scheme with the High Court,” the BSE said.

EP News Bureau - Mumbai

MARKET

Jubilant Biosys collaborates with Orion Corporation The research deal is aimed at developing drug that can benefit large population of people with unmet needs in the pain management area JUBILANT BIOSYS, a Bangalore-based subsidiary of Jubilant Life Sciences, and Finland-based Orion Corporation (Orion) announced a path breaking drug discovery collaboration to discover small molecule inhibitors in neuroscience therapeutic area.

The research deal is aimed at developing drug that can benefit large population of people with unmet needs in the pain management area.

As per the terms of agreement, Jubilant’s extensive experience in drug discovery and preclinical development will be utilised by Orion to address pain management needs of Central Nervous System (CNS). Jubilant will offer integrated drug discovery services across early discovery, synthetic and medicinal chemistry including scale up and pre-clinical services. The research for the project, which has been initiated, will be undertaken primarily at state-of-theart R&D labs of Jubilant Biosys (India) and some parts at Jubilant Discovery Center, USA. Dr Subir Kumar Basak, President, Jubilant Biosys, said, “We are excited to partner with Orion to offer integrated drug discovery services. Over the past few years, we have been strengthening our therapeutic area focused discovery platform, and this partnership serves as a validation of our efforts. We are confident of offering successful results to Orion at various stages of research.”

Dr Jukka Sallinen, Head of CNS Research of Orion Pharma R&D, said; “Jubilant Biosys is widely recognised for its expertise in offering integrated services in Drug Discovery and Development Solutions and for its prodigious capabilities in Pain and Inflammation. With established ability to develop successful drugs, we consider Jubilant as our ideal partner to take forward our strategic business plans with optimum time-tomarket and accuracy.”

Jubilant will receive research

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funding from Orion for delivering Hit, Lead Generation and Optimisation milestone, accord-

ing to a pre-defined research plan. Under the royalty based alliance, Orion will provide royalty

to Jubilant and will retain ownership of the compounds developed under the collaboration

with exclusive worldwide rights.

EP News Bureau-Mumbai

MARKET

Hilleman Laboratories’ technology to help improve routine immunisation in India Thermostability technology will act as a catalyst in bridging the gap between academia and product development THE HILLEMAN Laboratories, an equal joint-venture partnership formed between Merck & Co and Wellcome Trust, announce their innovative technological intervention, thermostability to help improve coverage of the Routine Immunisation programme in India.

With the vision to achieve 95 per cent coverage of Expanded Programme of Immunisation in India which will merit 70 – 80 million doses annually, Hilleman Laboratories is bringing in innovation to act as a catalyst in bridging the gap between academia and product development by increasing the efficiency of existing vaccines with heat stable, easy to use, affordable and novel packaging features.

Commenting on the current immunisation scenario, Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories said, “With a quarter of the current birth cohort left unimmunised in the country, India severely lags behind even when compared with lesser developed nations as well as its immediate neighbours. We aim to compliment the current ecosystem and help expand the supply chain, adding scale and lowering the manufacturing cost; making the existing vaccines accessible and affordable for the unimmunised in India and other developing nations.”

According to WHO, 70 per cent of the world’s 22.6 million unimmunised children live in 12 nations; with India home to the largest chunk of 6.9 million.

According to the Immunisation Report

by UNICEF and WHO, against the 67 per cent cover in India, our neighbours boasts a much higher coverage with Sri Lanka topping the list at 97 per cent followed by Bangladesh at 95 per cent, Bhutan at 92 per cent, Pakistan at 88 per cent and Nepal at 85 per cent.

The solution to amplify this figure

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According to WHO, 70 per cent of the world’s 22.6 million unimmunised children live in 12 nations; with India home to the largest chunk of 6.9 million lies in distributing life-saving vaccines without the requirement for large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient, currently spearheaded by Hilleman Laboratories. One of the key breakthrough results the company presents is about the thermostable property of vaccines enabling it to withstand tough temperature conditions of countries in Asia and Africa.

According to a recent McKinsey & Company report, one of the key constraints of enabling deeper vaccine penetration in India is attributed to limitations in distribution, public health delivery system and supply. Distribution is hampered by an inadequate cold chain and constraint to last-mile distribution, which has limited penetration of basic vaccines to 60-70 per cent.

EP News Bureau - Mumbai

MARKET

Abbott bags award for operational excellence Clonmel, Ireland, facility is the first site in Europe to receive the prestigious Shingo Prize ABBOTT HAS been awarded the Shingo Prize, an international award for operational excellence, by the Shingo Institute at the Jon M Huntsman School of Business at Utah State University. Abbott’s vascular devices manufacturing facility in Clonmel, Ireland, received the award, recognising the site’s initiative to develop and maintain continuous improvement to achieve operational excellence.

The prize is awarded to organisations that demonstrate a culture where principles of operational excellence are deeply embedded into the thinking and behaviour of all leaders, managers and associates.

“Only the highest-performing organisations are considered for the Shingo Prize,” said Robert Miller, Executive Director, Shingo Institute. “Organisations that receive the top Shingo Prize have successfully created a culture characterised by excellence, respect, humility, the quest for perfection and flow of value to the customer. Ultimately, these are some of the best organisations in the world.”

Abbott’s Clonmel facility is a centre of excellence in the manufacturing of medical devices used to treat people with vascular diseases, including heart diseases, in more than 100 countries around the world. By adopting the Shingo model of operational excellence and continued improvement, the team at Abbott further developed and strengthened its long-term vision and strategy, discovered the most effective ways to foster collaboration among employees, and identified opportunities to enhance the way the company manufactures medical devices. As a result, the Clonmel site has achieved significant increases in productivity, while maintaining the highest standards of quality as it brings innovative medical technologies to the market.

“Abbott’s dedication to excellence is a driving force across all functions and

The prize is awarded that demonstrate a culture where principles of operational excellence are deeply embedded into the thinking and behaviour of all leaders roles, and is central to our development of innovative business solutions so that we can continue to deliver world-class products to our customers,” said Chuck Foltz, Senior Vice President, vascular, Abbott.

“Receiving the top Shingo Prize for our manufacturing facility in Clonmel is a testament to the deep commitment of our employees and to our ongoing focus on serving the people who benefit from our products.”

The Shingo Prize, established in 1988, is named after Japanese industrial engineer Shigeo Shingo, who distinguished himself as one of the world’s thought leaders in concepts, management systems and improvement techniques.

The Shingo Prize began as a way to recognise and inspire excellence in manufacturing but has grown to serve as the global standard for enterprise excellence. The prize is open to organisations across all industries and sectors globally.

EP News Bureau – Mumbai

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MARKET

Cabinet clears KKR’s proposal to acquire stakes in two pharma companies The two deals are estimated to be worth ` 1,434 crores THE GOVERNMENT cleared private equity major KKR’s proposal to acquire stakes in two pharmaceutical companies in deals worth over ` 1,400 crores, including 38 per cent stake buy in Gland Pharma. The two deals are estimated to be worth `1,434 crores, sources said.

In the first proposal, the Cabinet, in its last meeting under the leadership of Prime Minister Manmohan Singh, cleared KKR's acquisition of stake in Hyderabadbased Gland Pharma through a combination of primary investment into the company and share purchase from EILSF, an existing investor. The private equity major is to snap up 37.98 per cent stake in Gland Pharma. Besides, the Cabinet gave its nod for another proposal where KKR would acquire 24.9 per cent stake in Gland Celsus Bio Chemicals.

In January, fair trade watchdog Competition Commission of India approved the deals. KKR, Gland Pharma and Gland Celsus had entered into the share purchase agreements on November 27 last year. KKR had also entered into a shareholders’ agreement with the promoters of Gland Pharma and EILSF Co-Invest I LLC, an existing private equity investor in Gland Pharma.

PVN Raju Founder-Chair-

The private equity major is to snap up 37.98 per cent stake in Gland Pharma.

Besides, the Cabinet gave its nod for another proposal where KKR would acquire 24.9 per cent stake in Gland Celsus Bio Chemicals man, Gland Pharma said, “Gland Pharma is at an important juncture in its evolution where we have proven our sterile manufacturing capabilities, established ourselves as a high-quality manufacturer of complicated injectables products and achieved a

track-record of strong financial performance. Our partnership with KKR will help us in our next phase of growth as we look to materially expand our manufacturing capacities and invest more in our development work with the goal of expanding our product registrations.”

Raju said, “We thank the Vetter family of Ravensburg, Germany, who are investors in Gland Pharma, for inspiring Gland Pharma in the niche field of pre-filled syringes. Vetter Pharma, owned by the Vetter family, enjoys a pre-eminent position globally in the field of prefilled syringe technology.”

Dr Ravi Penmetsa, Vice Chairman and Managing Director, Gland Pharma mentioned, “In addition to securing growth capital, we look forward to leveraging KKR’s global network of relationships to help enter new markets.”

Sanjay Nayar, Chief Executive, KKR India highlighted, “Gland Pharma has a track record of strong financial performance as well as long-standing relationships with Indian and international pharmaceutical companies and we believe there is significant potential for it to grow these partnerships even further.

EP News Bureau - Mumbai

Novartis granted injunctions against four other generic makers over Galvus Novartis filed an RTI with the DCGI seeking information regarding regulatory approvals issued for Vildagliptin NOVARTIS HAS obtained Quia timet injunctions against four other generic companies: Glenmark generics, Bajaj Healthcare, Cadila Healthcare and Alembic Pharmaceuticals thus preventing them from launching generic versions of its blockbuster anti-diabetic drug Galvus (Vildagliptin).

Analysing these injunction orders, a blogpost on Spicy IP points out that in each of these orders Justice Sanjeev Sachdeva found that that plaintiff has made out a strong prima facie and that balance of convenience is also in favour of plaintiff (Novartis) and in case, the ad-interim injunction is not granted, the plaintiff shall suffer and irreparable loss and injury.

The fact that Novartis had obtained similar quiatimet injunctions from the Delhi High Court against two other drug-makers (Wockhardt and Biocon) over the alleged infringement of

Vildagliptin in March, is an indication that it is taking all measures possible to safeguard the anti-diabetic drug against competition.

India with over 63 million diabetics represents the world’s second largest diabetes population after China.

The Indian population that had faced under nutrition for a long time is now exposed to over nutrition and sedentary lifestyles. Coupled with a bad nutritional history and the fact that Indians are genetically more vulnerable to diabetes compared to other population groups, India’s struggle with diabetes is expected to be one of the biggest epidemics the country has ever witnessed. This explains the increasing number of generic majors seeking regulatory approvals for manufacture of Vildagliptin, and the increasing interest in the anti-diabetic drug market.

EP News Bureau - Mumbai

MARKET PRE EVENT

UBM India to host PharmaLytica 2014 in Bangalore Will see congregation of 100 plus exhibitors UBM INDIA will host PharmaLytica 2014 in Bangalore from September 25-27, 2014. PharmaLytica 2014 will be a combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods. It is a platform connecting the pharmaceutical community with outsourcing solution providers, including clinical trials, contract research, custom manufacturing, biotech, IT and analytical services.

PharmaLytica 2014 will

The event will see R&D heads and decision makers from pharma, contract research, clinical trials, and biotechnology spread over 2,000 sq mt featuring over 100 plus exhibitors. The event will be supported by Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA). Also, India Pharmaceutical Association (IPA), Confederation of Indian Pharmaceutical Industry (CiPi) and Association of Contract Research Organization (ACRO) will support the event.

The event will see a congregation of R&D heads and decision makers from pharmaceuticals, contract research, clinical trials, and biotechnology all under one roof. Along with the exhibition, the event will have a conference where innovation and expertise will be showcased.

EP News Bureau-Mumbai

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INSPECTION TO PERFECTION! Visit us in DĂźsseldorf, Germany 08 -14 May 2014 | hall 16, stand A25

Redesign of Seidenader CS inspection machine High-tech inspection tailored to your needs and put onto our smallest machine plattform: This is German state-of-the-art technology at best price!

Ensure the quality of your liquid or freeze-dried products by checking vials and ampules on the new Seidenader CS inspection machine!

For further info please contact our local partner: www.salesworthsynergies.com or check www.seidenader.de

MARKET POST EVENT

IDMAorganises conference on ‘Current Challenges & Opportunities in Pharma Marketing More than 50 participants from across the industry attended the day-long conference

Usha Sharma Mumbai THE INDIAN Drug Manufactures' Association's (IDMA) Marketing and MSME Sub-committees recently organised a day-long conference on ‘Current Challenges and Opportunities in Pharma Marketing' in Mumbai.

The conference provided a platform to the pharmaceutical executives to understand the issues and opportunities that exist in pharma marketing.

The organiser committee of the conference invited key faces from the Indian pharma industry who are experts in their respective arenas. The day-long conference witnessed speakers like Narayan B Gad, Director, Gadtech, Salil Kallianpur, Commercial Head CVM Virology, Oncology

Speakers at the event

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and Biosimilars, GlaxoSmithKline, Atul Hadap, SBU Head, Ranbaxy Laboratories, Priti Mohile, Managing Director, MediaMedic Communications, Nandakumar Shetty, GM Marketing, Cachet Pharmaceuticals, Dr Sanjoy Mitra, Managing Director, Strategic Marketing Solutions and Research Centre (SMSRC) and Dr RK Sanghavi, Clinician and Consultant Healthcare Neuromarketing. The conference comprised more than 50 participants.

Vinay Pinto, Chairman, IDMA Marketing Subcommittee inaugurated the conference, which was followed by various sessions. Gad explained the importance of training programmes for marketing representatives (MRs) and elaborated on how this training helps them to have

MARKET non-negative attitudes. He highlighted the need and importance of having a positive approach, communicating well and delivering the message in an appropriate manner to his/her doctors as it might help MRs to build a better rapport with the doctors.

Kallianpur, (in his individual capacity), presented various aspects of progress in pharma sales and marketing. He pointed out that multinational pharma companies spend more on research and development whereas domestic pharma companies believe in spending more on different M’s (marketing, management etc.) than in R&D. He emphasised that the approach and attitude should be transactional and not emotional. He justified his stance by giving Lipitor's example and said that soon after patent expiry of Lipitor, its generics came into the market and doc-

tors chose the generics over the branded product. He also said that in today's scenario, key challenges for pharma companies are price, innovation and value.

Kallianpur raised a valid point during the conference and said that none of the pharma companies have their patients' data and none of their products have been developed based on the requirements of the diseases from the company's previous drugs data registry. He urged pharma companies to work in this area and generate data to re-use it for developing new molecules. He stated that only then we can say that there is an innovation drive.

“I feel nothing has changed in the pharma industry. The industry has remained the same as it was 40 years before,” opined Kallianpur.

Pharma companies spend

Participants during the conference

considerable amount on marketing and brand building activities. Pharma companies need to decide where they should allocate their budget for such activities. Hadap emphasised, “Key opinion leaders (KOL) cannot be held responsible for business. They are only for influence/endorsement

whereas key business leaders (KBLs) are responsible for the business. So before venturing into a new market or business, pharma companies need to identify the KOLs and then accordingly decide where pharma companies have to allocate the KOL budget.“ He stressed the point that

KOL should be a part of the marketing budget in pharma companies and marketing is a part of KOL engagement. He said that KOL engagements help companies to grow their brands and that's why KOL budget should be part of the promo budget. Moving forward, he suggested cutting down the budget on giving literature, table products and samples. He urged to pharma companies to spend these amounts on KOLs which will give a long term benefit.

Shetty shared insights about the exercise followed in the pharma companies. He pointed out how pharma companies fail after launching a product /division. He rightly pointed out that launches should be based on analysis not on just instincts. The conference ended with a round table discussion and a Q&A session. u.sharma@expressindia.com

EXPRESS PHARMA

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May 16-31, 2014

MARKET POST EVENT

3rd Global Pharma Regulatory Summit concludes in Mumbai Experts from overseas and India discuss regulatory issues related to different pharma markets CPHI AND UBM recently organised a three-day Global Pharma Regulatory Summit (GPRS) in Mumbai.

The day first saw experts from India and overseas discussing the regulatory issues related to the US market.

Dr Sumit Sen, Chemist (Instrument Specialist), US FDA, talked about analytical methodologies on reducing and controlling metallic and elemental impurities and its regulatory implications.

Frances M Zipp, President, Lachman Consultants, spoke about stability guidelines for Abbreviated New Drug Applications (ANDAs).

She also narrated process validation guidelines-general principles and practices. Zipp gave an overview of 2013 US FDA guidelines during her presentation.

Devendra Kamat, Deputy General Manager, Pharma, ThermoFisher Scientific, talked about

the ways of achieving more productivity through processes in lieu with compliance. He explained how technology can be used to preserve time, money and other resources.

Day two focused on Europe.

Lachman Consultant President, Frances Zipp giving an overview on US FDA regualtions

(From left) Dr Sumit Sen - US FDA, Brijesh Patel Former MHRA, Frances Zipp - Lachman Consultant, Anjana Agarwal- MHRA

20 EXPRESS PHARMA May 16-31, 2014

MARKET

Dr Sumit Sen, Chemist (Instrument Specialist), US FDA talks about the elemental impurities guidelines of the US FDA

Dr Anjana Aggarwal, Senior Pharmaceutical Assessor, MHRA, explained the strategies to support the implementation of the variations guidelines in European procedures.

Aggarwal's presentation included sub-points like regulatory overview, types of variations, variation classification system, grouping and work

Former MHRA Sr Assessor, Brijesh Patel talks on the criticality of QbD guidelines

sharing, MHRA experience and strategy for submissions.

Dr Vandana Jolad Shivangi’s topic of discussion was procedure for reporting of GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP). Shivangi is a pharma consultant.

Day three was dedicated to

India where Kedar Suvarnapathaki, Head Regulatory, Boehringer Ingelheim India, reveal various aspects related to clinical trial sector in India.

He briefed the audience about changing clinical trial guidelines, compensation guidelines and audio visual consenting.

Vandana Gupta, Senior

Anjana Aggarwal, Senior Pharmaceutical Assessor, MHRA talks on the regulatory and procedural guidelines

Regulatory, Ranbaxy gave a perspective about regulatory framework, procedures and requirement in Latin America.

Bharti Ramesh, Director, Integrated Global Regulatory Services, talked about harmonisation of guidelines in the Association of Southeast Asian Nations (ASEAN).

These guidelines included

points like existing pharma requirement and regulations implemented by each ASEAN country, comparative analysis of product registration requirements in ASEAN member countries and open discussion on technical dossier requirement for product registration for ASEAN. EP News Bureau-Mumbai

EXPRESS PHARMA

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May 16-31, 2014

MARKET POST EVENT th

7 International Conference of SAC-ACCP held in Mumbai The theme for this year's conference was translational research

TH

THE 7 International Annual Conference of the South Asian Chapter of American College of Clinical Pharmacology (SAC-ACCP) was recently held in Mumbai. The conference and pre-conference workshops were co-hosted by the National Institute for Research in Reproductive Health (NIRRH), Indian Council of Medical Research (ICMR), GS Medical College, KEM Hospital, ESI-PGIMSR MGM Hospital and Maharashtra University of Health Sciences, Nashik MUHS. The theme of the conference was translational research.

The conference was inaugurated by Dr Anil Kakodkar, DAE Homi Bhabha

22 EXPRESS PHARMA May 16-31, 2014

Chair Professor and former Chairman of Atomic Energy Commission and Dr VM Katoch Secretary, Department of Health Research, and Director General, ICMR. This year, two pre-conference

MARKET workshops were also organised.

Dr Stella Blackburn and Priya Bahri of ENCePP/EMA; Dr Rakhi Dhawan of NIMR and Dr Robin Ferner, Professor, Clincial Pharmacology, Birmingham, UK took part in the pharmacoepidemiology workshop. Workshop on Modeling and Simulation to support drug development decisions was organised by Dr Pravin Jadhav from Merck, US and his team.

Dr Renu Swarup from the Department of Biotechnology, Govt of India; Dr Samadhanam, Former Director, Department of Science and Technology, Govt of India and Dr Sarala Balachandran from CSIR spoke about the Government initiatives in India.

Dr Mike Conlon from University of Florida spoke about NIH USA initiative and the clinical and translational science institute at the University of Florida.

Dr JN Varma, researcher entrepreneur, spoke about his experience in marketing the liposomal amphotericin drug developed

by Dr BK Bacchawat, Dr NA Kshirsagar and others at the Department of Biochemistry, Delhi University and GS Medical College, KEM Hospital Mumbai. Dr Utkarsh Palnitkar discussed the view points of investors and the financial implication of translational research.

Dr Prasad Kulkarni elaborated on issues in taking products like vaccines to large population for public health.

National and international experts like Dr Rinti Banerjee (IIT Mumbai), Dr Shanti Nair (Amruta institute, Thiruvananthapuram), Dr Padma Devarajan (ICT Mumbai), Dr Gerd Arnold (Germany), Dr Mohan Raizada (US), Dr Vinayak Shenoy (US), and Dr Marcus Homepash (US) spoke about issues in product development, drug delivery systems and testing for nutraceuticals, leukaemia etc..

Dr RD Lele released a book titled 'Emerging Trends in Phytopharmaceuticals', edited by Dr Priyanka Ingle Jadhav, Dr Manoj Jadhav and Dr Kshirsagar.

A pre-conference workshop on pharmacoepidemiology was conducted by Dr Kshirsagar.

She elaborated on the need for systematic review of data from India to help take policy and

EXPRESS PHARMA

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May 16-31, 2014

regulatory decisions nationally, and for drug therapeutics committees and individual patients locally. National registries were discussed by Dr Dhawan, Dr Abhimanyu Panda, Dr Narayani and Dr Harshad Devarbhavi.

Regulatory requirements were discussed by Dr Priya Bahri from EMA and Dr YK

Gupta, Head, Department of Pharmacology and spokesperson, AIIMS from India. Dr Ferner and Dr Bahri discussed on how to take decisions with inadequate data.

Dr Chandrahas Sahajwalla from US FDA and Dr Lokesh Jain were present at the valedictory function where

students were given best poster and best oral paper awards for clinical research, and preclinical studies and drug delivery systems. Dr Mrudula Phadke, former Vice Chancellor guided the students with her inspiring talk.

EP News Bureau-Mumbai

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EVENT BRIEF MAY-JULY 2014 16

Seminar on Managing Risks for Quality Compliance 2014

SEMINAR ON MANAGING RISKS FOR QUALITY COMPLIANCE 2014 Date: May 16, 2014 Venue: Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Technical Subcommittee will organise a seminar on Managing Risks for Quality Compliance 2014. Experts in technology, quality assurance, regulatory affairs, engineering, production and packaging spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

Dr K Bangarurajan, Deputy Drugs Controller (India), CDSCO West Zone (Mumbai) will give the keynote address on ‘QRM Requirements of WHO’; Bharat Doshi, Pharmaceutical Consultant, will peak on ‘Risk Free Facility Design for efficient QRM’; SM Mudda, Executive Director, Technical & Operations- Micro Labs will speak on Managing Operational Risks for Quality Products; R Raghunandanan, Pharmaceutical Consultant, will speak about ‘Managing Risks in Quality of Aseptic Operations’; RR Tuljapurkar, Vice President, Quality Assurance, Zydus Cadila, will speak on ‘Controlling Risks in Quality Control’; R Dadich, Vice President,Corporate Quality, IPCA Laboratories will speak on 'Quality Materials for Quality ProductsControlling Risks.’

The seminar is designed to cater to all those involved in pharmaceutical industry, bio-pharmaceutical industry, academic institutions; business consulting companies, facility design and materials management.

Contact details Indian Drug Manufacturers’ Association 102B, A Wing,Poonam Chambers, Dr Annie Besant Road, Worli, Mumbai – 400018 Tel: +91-22-24944624/ 24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Web: www.idma-assn.org

SEMINAR ON ION CHROMATOGRAPHY Date: May 21, 2014 Venue: SIES Institute of Chromatography and Spectroscopy Auditorium, Sri Chandrasekarendra Saraswathi

24 EXPRESS PHARMA May 16-31, 2014

21

Seminar on Ion Chromatography

Vidyapuram, Plot 1-E, Sector V, Nerul, Navi Mumbai-400706 Summary: Chromatographic Society of India will host a seminar programme on Ion Chromatography and water purification at the SIES Institute of Chromatography and Spectroscopy. The one-day seminar with live demo will be free and is being sponsored by Metrohm, a leading manufacturer of Ion Chromatographs and other laboratory equipment.

Contact details email: info@chromsocindia.org, info@metrohm.in

CONTRACT MANUFACTURING 2014 Date: July 11, 2014 Venue: Hotel Hilton, Sahar, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Contract Manufacturing Subcommittee will organise the 1st conference on Contract Manufacturing 2014. The main theme of this conference is ‘360 degrees of Contract Manufacturing.’

Eminent experts in contract manufacturing, research, and regulatory spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

Contact details Indian Drug Manufacturers’ Association 102 - B, ‘A’ Wing, Poonam Chambers Dr Annie Besant Road, Worli Mumbai – 400018 Tel: +91-22-24944624/24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Website: www.idma-assn.org

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: Amrita Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference which aims to make a ‘industry-scientists-academics’ collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics re-

EVENT BRIEF lated to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/ researchers/ students and professionals from academia and industries from all over the country and abroad. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

ing, biotech, IT and analytical services. PharmaLytica 2014 will spread over 2,000 sq mt featuring over 100 plus exhibitors. The event will be supported by

Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA). Also, India Pharmaceutical Association (IPA), Confederation of

Indian Pharmaceutical Industry (CiPi) and Association of Contract Research Organization (ACRO) will support the event.

Contact details Rahul Deshpande Sr. Manager - Projects E: rahul.deshpande@ubm.com T: +91 22 61727165 | M: +91 98209 02476

Contact details Dr PK Krishnan Namboori Asso. Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014 Computational Chemistry Group (CCG) Computational Engineering and Networking AMRITA Vishwa Vidyapeetham-Amrita University Amritanagar, Coimbatore - 641 112 Tel: (0422) 2685000 (Extn: 5592) Email: aicadd_2014 @cb.amrita.edu / aicadd2014 @gmail.com Website: http://www.amritaccg.inConference URL: http://www.amritaccg.in /aicadd2014

PHARMALYTICA 2014 Date: September 25-27, 2014 Venue: BIEC, Bangalore Summary: UBM India will host PharmaLytica 2014 in Bangalore from September 25-27, 2014. PharmaLytica 2014 will be a combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods. It is a platform connecting the pharmaceutical community with outsourcing solution providers, including clinical trials, contract research, custom manufactur-

EXPRESS PHARMA

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May 16-31, 2014

MARKET DEALTRACKER

M&A activity focussed on portfolio transformation Indian pharma sector witnessed one deal in April 2014, against the average of 0.8 deals over the previous six months In the third transaction, Novartis and GSK agreed to create a leading consumer healthcare business through a joint venture between Novartis OTC and GSK Consumer Healthcare. GSK will have a 63.5 per cent equity interest in the joint venture company, while the remaining 36.5 per cent interest will be held by Novartis. GSK will assume control of Novartis’ OTC manufacturing

network. This includes Novartis’ facility in Lincoln, Nebraska.

M&A activity in the pharma sector increased in volume and value terms, when compared to the average of the previous six months (October 2013 – March 2014). According to Datamonitor's Medtrack database, the pharma sector recorded 32 M&A transactions in April 2014, against the previous six months’

M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

VENTURE FINANCING TREND ANALYSIS

1 9

12

17

6 1 4

5

13

2 1

9

8

13

1

4

10

9 20

14

24

17

16

12

% &

!

4

8

1 8 23

12

average of 32.6 transactions. In value terms, the sector recorded deals worth $41.9 billion, against the previous six months’ average of $9.3 billion.

The Indian pharma sector witnessed one deal during April 2014, against the average of 0.8 deals over the previous six months, in which Sun Pharmaceutical Industries agreed to acquire Ranbaxy Laboratories, an

" # $

Source:

1

2 6

1 4

10

1 9

10

" #

$

( )

2 1 9

4

15

%# & #'#

Source:

TOP M&A DEALS (APR 2014) Rank

Date

Target

Acquirer

Deal value ($m)

1

Apr 22, 2014

GlaxoSmithKline plc - Oncology Business (GB)

Novartis AG (CH)

16,000.00

2

Apr 22, 2014

Novartis AG - Vaccines Business (CH)

GlaxoSmithKline plc (GB)

7,050.00

3

Apr 07, 2014

Questcor Pharmaceuticals, Inc. (US)

Mallinckrodt, Inc. (US)

5,600.00

4

Apr 22, 2014

Novartis Animal Health, Inc. (CH)

Eli Lilly and Company (US)

5,400.00

5

Apr 06, 2014

Ranbaxy Laboratories Limited (IN)

Sun Pharmaceutical Industries Limited (IN)

4,000.00

6

Apr 28, 2014

Furiex Pharmaceuticals, Inc. (US)

Forest Laboratories, Inc. (US)

1,100.00

7

Apr 25, 2014

Insight Pharmaceuticals Corp. (US)

Prestige Brands Holdings, Inc. (US)

750.00

8

Apr 29, 2014

iPierian, Inc. (US)

Bristol-Myers Squibb Company (US)

725.00

9

Apr 24, 2014

Andromeda Biotech, Ltd. (IL)

Hyperion Therapeutics, Inc. (US)

570.51

10

Apr 01, 2014

Intarcia Therapeutics, Inc. (US)

RA Capital Management, LLC; Farallon Capital Management,L.L.C.; Foresite Capital Management, LLC; Fred Alger Management, Inc. (Alger); New Leaf Venture Partners; Quilvest Ventures; New Enterprise Associates, Inc. (NEA); Venrock; The Baupost Group, LLC; Franklin Templeton, LLC

200

Source:

26 EXPRESS PHARMA May 16-31, 2014

position in global vaccines business. The addition of Novartis’ Bexsero and MenABCWY will strengthen the breadth of GSK’s portfolio, notably in meningitis.

Besides, it would also strengthen GSK’s manufacturing network and increase overall capacity, notably with the addition of Novartis’ secondary packaging and supply facilities in Rosia, Italy and Marburg, Germany.

PORTFOLIO TRANSFORMATION through asset swapping was the core focus of companies M&A activity, in the month of April, 2014. In line with the above trend, Switzerlandbased Novartis, announced a three-part portfolio transformation transaction with GlaxoSmithKline (GSK), a UK-based healthcare company, to exchange certain assets.

As part of the above, the first transaction involves Novartis agreeing to acquire oncology products of GSK for approximately $16 billion. This acquisition will allow Novartis to strengthen its oncology business with new therapies. The addition of GSK’s products would expand Novartis' position in targeted therapies and small molecules.

In the second transaction, GSK agreed to acquire the vaccines business (excluding influenza vaccines) of Novartis for approximately $7.05 billion. This acquisition will improve GSK’s

MARKET TOP VENTURE FINANCING DEALS (APR 2014) Rank

Date

Target

Investors

Deal value ($m)

1

Apr 07, 2014

Adaptive Biotechnologies Corporation (US)

Viking Global Investors LP (US)

100.00

2

Apr 10, 2014

NuCana BioMed Limited (GB)

Sofinnova Ventures, Inc.; Sofinnova Partners; Morningside Venture Investments, Ltd.; Alida Capital International Ltd; Scottish Investment Bank

57.00

3

Apr 22, 2014

Avalanche Biotechnologies, Inc. (US)

Venrock; Deerfield Management Company; Adage Capital Management, L.P.; Redmile Group; Rockspring Capital; Sabby Capital; Cowen and Company, LLC; Undisclosed Investors

55.00

4

Apr 22, 2014

Principia Biopharma, Inc. (US)

Sofinnova Ventures, Inc.; Morgenthaler Ventures; New Leaf Venture Partners; OrbiMed Advisors, LLC; SR One; Mission Bay Capital, LLC; Undisclosed Investors

50.00

5

Apr 28, 2014

Kite Pharma, Inc. (US)

Undisclosed Investors

50.00

Source:

India-based pharmaceutical company, for approximately $4 billion. This acquisition provides Sun Pharmaceuticals with a strong complementary platform in high-growth emerging markets.Companies in the pharma sector raised $603.7 million during Apr 2014, against the previous six months’ average of $278

million. In terms of volume, the sector recorded 20 venture funded deals, when compared to the previous six months’ average of 18.5 transactions.

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on

companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc.

Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key

insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

Definitions 1.Deal value trend is based on transactions where associate values have been disclosed.

2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits.

For more information, visit us at www.medtrack.com

EXPRESS PHARMA

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May 16-31, 2014

cover )

15 year-old Nidhi Shirol, who has Pompe Disease, receives life saving enzyme replacement therapy free of cost, but cannot be part of global clinical trials that could give her a ventilator-free life. The implications of the decision for this community of patients are truly grave; should they be denied the rare chance of an uncompromised life? This is her story as related by her father Prasanna Shirol

28 EXPRESS PHARMA May 16-31, 2014

(

PUTTING CANCER ON TRIAL| 32

CONSENTBY CAMERA: WHEN VISUALS DON’TTELLTHE FULLSTORY| 34

SPEEDING UP TRI@LS| 38

THE MAIN FOCUS

PATIENT RECRUITMENT: APARALYSED PROCESS?| 40

MYDOCTOR HERO|44

EXPRESS PHARMA

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May 16-31, 2014

cover )

W

hen Nidhi was around three to four months old, she began to suffer from frequent liver related problems and pneumonia.

As time passed, we realised that the expected milestones for infants were not being met by our daughter. At the age of one year she was not able to sit up, she did not stand and was not able to sit up.

We were staying in Hubli.

Karnataka at that time. When Nidhi turned two and a half years, we brought her to National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore to see a neurologist. Her biopsy results revealed that she had Glycogen Storage Disorder Type2 – a muscle degenerative disorder. There was no treatment for her disease. We were told that her illness was progressive in nature and by the age of 10 or 12 years, she would completely collapse.

The world collapsed around us. We were heartbroken. In desperation we took her to many doctors and religious seers. Her pneumonia breakouts continued. In early 2007 we found a doctor in Davangere, Karnataka, who worked on our case for months together. It was here that she was diagnosed with Pompe Disease. We were told that there was a new drug released in the US but it was costly and was not available at that point of time.

In September 2007, Nidhi fell very ill again and was put onto a ventilator in a hospital in Davangere. She was on a ventilator for a week but showed no signs of improvement. It was a serious breakout of pneumonia. While normal people usually cough and remove the phlegm from their lungs, Nidhi’s muscles were so weak that she could not even

30 EXPRESS PHARMA May 16-31, 2014

Nidhi Shirol with her parents

cough. As a result the phlegm remained in her lungs. The doctor there was unable to treat her further.

I would not give up that easily. We arranged for an ambulance and brought her to Manipal Hospital in Bangalore. A miraculous event occurred on the way from Davangere to Bangalore. Due to the constant jerks and bumps while travelling on the road, her lungs automatically pushed out the phlegm.

When we brought her to Manipal Hospital, they were easily able to suction out the phlegm and her lungs cleared. She continued to be on a ventilator in the ICU. It is very depressing for a small child to be in the ICU for so long. She was otherwise perfectly normal except that she needed ventilator support. A lot of children get worse being isolated in the ICU ward. After repeated requests, the hospital allowed us inside the ward. This was a big relief for all of us and she was also allowed to watch movies on TV/video.

At that time, the doctor suggested that we do a tracheotomy and insert a tube directly into her lungs. This allowed her to have a normal intake of food.

However she lost her ability to speak properly but we had no choice. She was then shifted from the ICU. Since Nidhi now needed a ventilator constantly, we decided to invest in a ventilator and other ICU equipment to be set up at home for `10 lakhs. I even took a house opposite Manipal Hospital so that for any emergency we could take her there immediately. We tried to procure the medicine from abroad but it was too expensive.

I then contacted the Pompe Association for support. In Janu-

Many guidelines and regulations have been introduced to safeguard Indian patients and regulatory agencies are continuously working to address these issues. Still there are a lot of ambiguity present which is leading the industry no where ary 2008, Genzyme developed an Enzyme Replacement Therapy (ERT) drug. It was an injection which needed to be taken every 15 days. For a body weight of 20 kg, injections worth `70 lakhs approximately, per annum are needed. This drug stops further deterioration of the muscle.

By God’s grace and due to our association with the Pompe Association, Genzyme has made this drug available free of cost for my daughter.

This is a big relief for us.

However, because she was put on this drug too late, there are parts of her body that have already suffered damage. For example, early last year, her spine gave away completely and she could not even sit in an upright position. Doctors had to do scoliosis surgery and insert rods down her spine to support her back.

She is paralysed from the waist down and needs constant attention 24x7. My wife is her constant companion. She gets up two to three times at night to move Nidhi to a different position as she cannot move by herself.

We try and keep her as comfortable as possible but she knows that all her life she will

need constant support. We take her out for movies and long drives and check in advance at the theatre to see if they have a proper socket so that we can connect the ventilator for the time spent watching the movie.

While the Genzyme drug is a life saver and has helped arrest further deterioration of her condition, I wish that there was some medication available that could repair the damage that has already happened ... that could somehow revive and bring strength back to her muscles so that she can perform her normal body functions by herself.

I believe that there are a few companies companies in the US in various stages of clinical trial that are testing alternate therapies like gene therapy that could give Pompe patients the ability to lead a ventilator-free life and bring considerable improvement to different forms of Pompe disease. I would like my daughter to participate in these trials. However due to the uncertain conditions in India, foreign companies are hesitant to conduct research here. Many patients like my daughter are deprived of these life saving treatments which is a tragedy.

As a father, it is my mission to ensure that I do my very best for my daughter. I have contacted almost every such company in the US as well as every doctor whether in India or abroad who are treating this disease. My dream for my daughter is to just see her be able to do things by herself so that she gets some chance at leading a normal life.

(Based on his family's personal experience of caring for his daughter, Prasanna Shirol has helped create parent support groups. In October 2008, he started the Lysosomal Storage Disorders Support Society (LSDSS), along with other LSD parents, the country's first national level parent support group for a rare disease of the same name.

It was instrumental in the observation of Rare Disease Day for the first time in India on a national scale to create awareness and is today advocated with more than 10 state governments and the Central Government.

Besides being the Founder Member & Founder President of LSDSS, he is the President, of Pompe Foundation, which he started in April 2011.

He is also a founder member of Organisation for Rare Disease India (ORDI) which was started in January 2014, as a voluntary nonprofit organisation founded to represent the collective voice and needs of the rare disease patients and stakeholders in India. ORDI aims to address the unmet needs and create opportunities that benefit rare disease patients in India.

Based on their experience and extensive feedback from the Indian rare disease community, ORDI has identified several urgent action items for the benefit of patients of rare diseases in India. He is also Regional Manager-Clinical Business, Strand Life Sciences).

cover ) PUTTING CANCER ON TRIAL Clinical trials are sometimes the only option for cancer patients to access newer drugs when standard treatment has been exhausted. Express Pharma presents three perspectives: a patient, a caregiver and an oncologist

‘Patients have to develop the courage to fight the disease and take a chance’ Lets call him Raj. A sprightly 72-year-old, one of the many patients for whom big hospitals in the city represent the last chance of a cure. Raj was detected with lung cancer, in the fourth stage, in September 2011. Today his cancer is controlled. His zest for life remains intact; enthusiasm and wit defy his age and medical records. Against all odds, he has survived more than 30 months when the average life of a patient with his is 8-10 months?

This is Raj’s story

I

came to one of the country’s largest hospitals, known for treatment of cancer patients, in September 2011 after I was diagnosed with stage 4 lung cancer. According to the doctors, the disease was so advanced that I had only nine to 10 months to live. Hearing this, my family members broke down and there were many tears shed, as no one expected me to survive.

But I have trained myself not to fear death. So when I was told of a new drug, being tried on a few patients like me, which might be also effective on my cancer and could prolong my life, I decided to take a chance.

My doctors informed me about the new medicine,

32 EXPRESS PHARMA May 16-31, 2014

explaining the number of times I would have to come to the hospital to take it, the possible side effects, and how it might prolong my life.

After discussing with my family, I decided to join the trial and signed the informed consent forms.

The trial started in (month, year). Almost a year, after two doses, the doctors give me the good news. They explained to me that my tumour had responded to the treatment. As my cancer was diagnosed in stage 4, I understand I can never completely recover from it, but the medication helped in reducing the cancer cells and containing it.

For the past six months, I have been coming for my regular check ups and post recov-

My advice to other patients faced with the same choice, is that they have to develop the courage; to fight the disease and take a chance. Courage cannot come from a medicine; that has to come from within. They should not be afraid of death.

This is vital for a cancer patient.

The mind has to believe that cancer can be fought ery drugs. I can do my daily exercises regularly and feel strong enough to carry two

men on my shoulders!

I do not know what is happening within my body but I

trust my doctors; they are the experts. What I do know is that I feel healthy enough to live till I am 90!

My advice to other patients faced with the same choice, is that they have to develop the courage; to fight the disease and take a chance.

Courage cannot come from a medicine; that has to come from within. They should not be afraid of death. This is vital for a cancer patient. The mind has to believe that cancer can be fought. And secondly, I have faith in process followed at the hospital and my doctors. I believe that they have done their best and therefore I encourage more patients to participate in such studies.

(As narrated to Viveka Roychowdhury)

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Clinical trials are one wayto ensure that newer drugs are available or accessible to more patients

I am glad mymother could benefit from a clinical trial A daughter relives the story of her mother, who was diagnosed breast cancer type Her2+ve, in the fourth stage but is today cancer free, after she was able to access treatment and benefit from a clinical trial

I

t was in May 2012 that my mother was diagnosed with cancer. My mother stays in Mysore and in early 2012, at the age of 59, was diagnosed with diabetes. When we went to visit her in May, she looked considerably weak and complained of a persistent cough. She also mentioned that she felt a lump in her breast.

I was concerned as my mother-in-law had also gone through a similar experience. I brought her with me to Bangalore. My husband runs a diagnostic centre, so we did an initial X-ray, in which secondary cancer cells were detected in her lungs.

We immediately took her to Dr P P Bapsy, Senior Consultant – Medical Oncologist, at Apollo Hospital, who had also treated my mother-in-law. We had complete trust in her diagnosis and treatment as she had cured my mother-in-law.

The test results indicated that my mother had breast cancer Type Her2+ve. She was in

the fourth stage and the cancer had spread completely to her lungs. It could not be operated upon. We were very worried and anxious for my mother’s health and her life.

That was when Dr Bapsy mentioned that there was a trial going on for Her2+ve and suggested that my mother might want to consider participating in the trial. We were desperate for a cure. So we discussed this with my mother and my younger brother and sister. Dr Bapsy explained the Informed Consent Process and the pros and cons of the trial. She gave us an information sheet which explained in detail the benefits and the side effects of the trial. She explained everything to my mother and took time to discuss the process in detail. She then gave us the information to take home and read thoroughly and discuss it with the family. We took a few days to understand everything after which we were convinced that this was the best way forward.

We then enrolled my mother

for the trial.

The trial consisted of injection and chemotherapy in regular intervals of 21 days. After four cycles, a CT scan was done which showed that the cancer cells were in remission. We were so happy to hear this. After the eight sitting, the end of the trial, a PET scan was done at the Bangalore Institute of Oncology which showed that her tumour had almost gone and her lungs had cleared.

We were overjoyed to hear this. Dr Bapsy then advised us that in order for my mother to be completely cancer free, she would need to continue the HER2+ve treatment which was currently available in the market. This was supplemented along with hormone therapy.

My mother is now cancer free since March and is only on maintenance hormone therapy and calcium tablets. She is getting healthier every day. I am so glad that my mother was able to access this treatment and benefit from a clinical trial.

C

linical trials are very important for patient care, apart from the development of newer drugs and science.

There is enough data to prove that the best care you can get is on a clinical trial. I recommend that people should read the The National Comprehensive Cancer Network (NCCN) site: www.nccn.org to get more information.

But when I say this, I mean a properly run clinical trial.

There are enough checks and balances built into the process to make it as transparent as possible. For instance, if a trial is ethics committee- approved, if it listed on clinicaltrials.gov, approved by the Drug Controller General (India) then one can be reasonably reassured that it is a good clinical trial. In addition, the patient will need to go through the informed consent process, and then after understanding the process, decide regarding participation in the study.

Now in the Indian context, not only does the care of the patient improve during the clinical trial, but it also leads to access to many drugs which are not yet available in India.

Clinical trials are one way to ensure that newer drugs are available or accessible to more patients. Every week I encounter patients who have no option because they have exhausted the standard treatment and its not effective. If there are no clinical trials, they have no more options left even

Dr Kumar Prabhash, Associate Professor and Medical Oncologist, Tata Memorial Hospital, Mumbai

though these may be available to patients in the western world. So my message to patients is that if they are eligible to participate in a clinical trial, the chance of benefit is more than the chance of harm.

My message to clinicians, both in government as well as private hospitals, is that there should be as many more clinicians participating in clinical trials. Apart from conducting trials sponsored by pharma companies, we should also be doing much more investigatordriven trials where we bring up many questions which a pharma company may not be interested in, but which are important for our patients' health. And my message to pharma companies is that they should do as many clinical trials as possible in our country in spite of the current situation.

They should be positive and hope that things will improve.

(As narrated to Viveka Roychowdhury)

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cover ) CONSENTBYCAMERA:

WHEN VISUALS DON’TTELLTHE FULL STORY The regulator has mandated AV consents as superior to the written process in terms of generating more tamper-proof evidence and protecting patients, but has this objective been fulfilled? By Viveka Roychowdhury

T

he informed consent process is one example of how regulators have made checks and balances a part of the clinical trial process. Performed properly, this is a rigorous process in which doctors first explain to the patient why they are suggesting that they participate in the trial, what are the benefits expected and what can go wrong. A patient can go through many sittings to clarify doubts, before enrolling as part of the trial by signing the informed consent form, which states that they have agreed to participate in the trial and are aware of the pros and cons of the trial.

One of the amendments

34 EXPRESS PHARMA May 16-31, 2014

made to the regulations governing the conduct of clinical trials in India, which came into effect from January 2014, mandates audio visual (AV) recording of the informed consent process of all patients agreeing to participate in a clinical trial.

Investigators have reported that the newly mandated AV consenting process (also known as consent on camera) has thrown up a range of practical and ethical issues and is being debated globally as well.

Express Pharma spoke to a number of doctors who are also investigators on clinical trials. The overall reaction was that the theory behind the mandate of AV consent was sound; putting it into practice was the tricky part. The reactions of patients may vary depending on the disease condition as well as many other variables. The regulator has mandated AV consents as

superior to the written process in terms of generating more tamper-proof evidence and protecting the patient that consent was properly taken, but has this objective been fulfilled?

Consent over multiple sittings poses practical challenge For Dr Paramesh, a diabetologist at Bangalore Diabetic Center who has a decade of experience with clinical trials and has already done close to 50 AV consents, the loss of confidentiality of the patient is the main concern. As opposed to the previous practice of explaining the details of the trial verbally, documenting the queries made by the patient as well as the answers given, and then taking the person's signature on the informed consent form, the new dispensation requires the entire process

The new guidelines have discouraged principal investigators from participating in trials. The higher authorities should try something else which is satisfying to all: the regulator, the doctor as well as the patient Dr Sarvajeet Pal, Consultant Rheumatologist, Apollo Hospital, Hyderabad

to be recorded.

Even though the patients are enrolling on a trial for their benefit as well as that of medical science, they draw the line at any loss of privacy. Dr Paramesh says that patients start having second thoughts when they realise that there may be a possibility that their details will be seen by people other than their doctors (i.e. members of ethics committees as they review the study etc) who may know them or their families.

Enrolling on a trial is still not considered the done thing and there is worry about how it may be perceived by peers and family friends. The unease is multiplied several fold with patients who have diseases like tuberculosis, HIV/AIDS or cancer where the social stigma is considerable. Dr Paramesh reasons that the drop out rate with such patients will be even

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We have to look at the number of deaths versus those prevented. There are enough check and balances to stop the trial if there are too many deaths or adverse reactions Dr Paramesh, Diabetologist, Bangalore Diabetic Center

higher due to the AV consenting decree.

Dr Paramesh points out that the informed consent process may not happen in one sitting, and could be spread over weeks or even months of multiple sittings.

Compiling these recordings into a single AV recording could be cumbersome, as is the problem of storage of CDs: how to store, how long and where. In addition, he says that there may be technical glitches during the AV consent process. For instance, the camera may malfunction, etc which could create doubt that there was an abuse of the process. He recalled a case where the patient received a call during the consent process and the entire one sided conversation was recorded as part of the AV consent process! The doctor could not stop the camera

AV consent will increase transparency and may be good in the long term but it will strain the doctorpatient rapport Dr Chirag D Bhatt, Vitreo Retinal Consultant, Susrut Eye Foundation and Research Center, Kolkata

as it would mean repeating the entire consent process again and the patient might have just backed out.

Even though it makes the process more tedious and fraught with practical difficulties, Dr Paramesh concedes that he does see the benefits of having an AV consent process, as it is proof that all the steps were followed in case there is a problem later. AV consenting could be restricted to selected cases, for example, when the patient is not mentally fit to give consent, or when children need to be consented.

He raises another point: consent for surgical procedures has been part of medical practice and has been not brought under the AV consent mandate. The main concern according to him, is the occurrence of deaths during trials, but deciding if it was due to the trial, merely during the trial or related to the investigational drug? He

points out that even the polio vaccine still causes adverse reactions in some cases but this has not stopped our national polio vaccination programmes.

Thus he believes, “We have to look at the number of deaths versus those prevented. There are enough check and balances to stop the trial if there are too many deaths or adverse reactions.�

He also busts two myths.

One, that India is a hub of clinical trials. He points out that as per clinicaltrials.gov, India has only two per cent of global trials. Secondly, contradictory to the popular image of only poor people signing up for trials, volunteers on his trials included a lawyer, a doctor and even an Assistant Commissioner of Police. People from all strata of society want to contribute to new drug development

Patients help patients. Today all of us have access to better and newer treatments because of patients who have participated in clinical trials. Thus, we all are beneficiaries of clinical research Suneela Thatte, President, Indian Society for Clinical Research (ISCR)

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cover ) and have faith in the doctor.

Eroding the doctorpatient bond Today, the doctor too is not above suspicion. The impact of adverse media coverage can be gauged by the fact that public ire, which was previously directed at organisations (sponsors and hospitals which are the sites for these studies) is now also viewing doctors with suspicion.

Take Dr Sarvajeet Pal, a consultant rheumatologist at Apollo Hospital, Hyderabad.

80 per cent of his patients are female, and the AV consent process makes them very uneasy; more so if their religion requires them to wear the burqa (Muslim) or the head veil/ghunghat. He reasons that he cannot ask these women to go against their religious/social norms and unveil for the AV consent process.

Dr Pal also opines that the DCGI's move to cancel trials held in clinics was unwarranted. Most investigatordriven trials are in fact conducted by individual doctors in their clinics. Rather than cancelling all such trials, he suggests that the regulator should check clinics to see if they are suitable and then allow or stop a trial. His reasoning is that smaller trials which do not require hospitalisation should be allowed to be conducted in clinics as the quality of treatment is the same, whether conducted at clinics or hospitals.

In fact in a larger hospital, the crowds and procedures may discourage patient enrolment.

The AV consent issue has strained the doctor-patient bond to such an extent that investigators themselves are reconsidering their participation in clinical trials. Even though he has been associated with clinical trials for six to seven years, he says that today principal investigators in India are ‘frustrated.’

“The new guidelines have discouraged principal investigators from participating in trials,” he says. “Uneducated people are more suspicious, though educated people too

36 EXPRESS PHARMA May 16-31, 2014

'CLINICAL TRIALS HAS TAKEN A BEATING IN INDIA BUTWE ARE GOING TO RISE AGAIN'

P

admashree Prof. Ranjit Roy Chaudhury, Chairman, Task Force for Research, Apollo Hospitals Group agrees that clinical trials has taken a beating in India but we are going to rise again, with ethical, transparent and efficient clinical trials all over the country supervised by ethics committees and a system of accreditation. “We cannot do clinical trials unless the centres are accredited, unless the principal investigator is accredited, and unless the ethics committee is accredited. When these fall in line, we will become a forerunner in the world,” he says.

As Chairman of the six-member Expert Committee for Reforms in Drug Regulation and Clinical Trials set up by the MoHFW, Govt of India last year Prof Roy Chaudhury has included recommendations to this effect and in fact the industry has been protesting the regularisation of all these practices,

saying that some of them are not planned out well.

Prof Roy Chaudhury's message to patients is equally important: that they must be alert, should not hesitate to ask questions and find all all they can about the place where the trial is being conducted. They must feel empowered enough to find out at least if the centres where they are planning to be clinical trial subjects have accreditation and if the ethics committee at the centre is functioning properly and has a good track record. If this is the case, if they are reasonably assured that the centre, the investigator and the ethics committee is good, then is there is nothing wrong in the conduct of the trial. If they do not understand anything on the informed consent form or on the patient information sheet, like technical terms, they should ask the ethics committee members for clarification.

Prof Ranjit Roy Chaudhury Chairman, Task Force for Research, Apollo Hospitals Group

object to the procedure. They do not understand about regulations; all they see is their doctor switching on a camera. The DCGI should probably send a person to do the recording then they may believe us when we say that it is part of new rules. Today it is the doctor who is being blamed. We are being forced to follow protocol.

The higher authorities should try something else which is satisfying to all: the regulator, the doctor as well as the patient.”

When faced with no choice It is becoming more obvious that the reaction to the AV consenting process varies according to the disease condition and the seriousness of the condition. Cancer patients who have exhausted all available treatment and for whom clinical trials could be the last hope to prolong their life span, may have no choice but to allow a video recording.

But oncologists report that even when faced with no alternative, quite a few patients who would have previously signed on might be put off.

Cancer patients have to cope with the trauma of changed appearance (hair loss, etc due to chemotherapy) and this leads to an aversion to being photographed, much less being videographed. To top it, the doctor is unable to share the AV recording, in the way that he could allow the patient to take home the informed consent forms so that the patient could discuss them with family members.

“AV recording is seen as the doctor not being as transparent as before,” says Dr Srinivasan, a clinical oncologist, at Dr Kamakshi Memorial Hospital, Chennai. He thus feels that by being bound to follow the AV consent process, the doctor may be indirectly denying them the freedom to participate in a trial and in turn denying them life. He does concede that there may have been some cases where the informed consent process was not being done properly but reasons that

( the whole fraternity cannot be penalise for the wrongdoings of a few. He suggests that cancer trials should be exempt from the AV consent process for this reason.

Dr Srinivasan points out that AV consent is not mandatory in western countries like the US and in fact, there is a lot of encouragement for conducting clinical trials. It is only in India that clinical trials have not been projected in the right perspective, he points out.

Dr Chirag D Bhatt, a vitreo retinal consultant at Susrut Eye Foundation and Research Center, Kolkata does not face as much back lash to the AV consenting process from his patients, probably because eye diseases are not associated with any social sigma nor are accompanied by major disfigurement. “AV consent will increase transparency and may be good in the long term but it will strain the doctor -patient rapport,” is his assessment.

He explains that not all patients may be educated enough to understand so doctors have to then spend more time on the consent process. Patients may become camera conscious, and may appear stiff, give short abrupt replies which may appear unnatural to a reviewer.

He expresses hope that this will change in time.

When companies sign on doctors for trials, they prefer those with a heavy patient load

AV recording is seen as the doctor not being as transparent as before Dr Srinivasan, Clinical Oncologist, Dr Kamakshi Memorial Hospital, Chennai

but these doctors may not have the time, especially if AV consent adds to the patient recruitment time. Clinical trials require a different mindset, and skills like record maintenance etc but Dr Bhatt reckons that doctors like him need to be part of clinical trials as its their contribution to science.

Going by the experience of these doctors, the AV consent process seems to be in direct contradiction of the tenets of the Hippocratic oath, where all doctors are duty bound to do no harm, keep their patients' well being paramount and above all, maintain strict confidentiality.

Commenting on the overall scenario, Suneela Thatte, President, Indian Society for

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When companies sign on doctors for trials, they prefer those with a heavy patient load but these doctors may not have the time, especially if AV consent adds to the patient recruitment time. Clinical trials require a different mindset, and skills like record maintenance etc Clinical Research (ISCR) points out, “Patients help patients. Today all of us have access to better and newer treatments because of patients who have participated in clinical trials. Thus, we all are beneficiaries of clinical research. Yet it is unfortunate that the progress of clinical research in India has been stalled by several extraneous factors denying patients the opportunity to participate in and benefit from ongoing clinical research. The impact of this on patients is huge. A slowdown in clinical research in the country means little or no access to newer and better medicines for our patients and a rising disease burden.”

This is the reason why ISCR has chosen 'Patients

First' as the theme for this year's International Clinical Trials Day which falls on May 20th. This day commemorates the world's first controlled clinical trial on a group of sailors suffering from scurvy, conducted in 1747, by Dr James Lind, a Scottish physician.

Through their participation in the study, the sailors contributed to the discovery that Vitamin C was an effective treatment for scurvy. Thatte also appealed to the media, saying that it had the potential to play an transformational role in highlighting the value of clinical research and creating confidence about participating in clinical research amongst the public at large.

A research paper authored

by Niranjan G Kulkarni, Jeroze J Dalal, and Tejashree N Kulkarni, titled ‘Audio-video recording of informed consent process: Boon or bane’ provides both sides of the debate. Published in Perspectives of Clinical Research, Jan-March 2014, the authors make the point that while AV recording of the consent process will definitely help to record the actual consent process, ascertaining that the participant has voluntarily consented still remains debatable.

They also point out that until expectations of regulators from the AV recording are crystal clear, the records may work as double-edged sword for the investigators and sponsors, because AV recordings once made becomes an irreversible process and mistakes made by the investigator would be difficult to be corrected and can be misused. Even with these challenges, the authors conclude saying that is their highest priority to reassure the government and community at large about standards adopted by the industry and AV recording would be a very positive step ahead to build trust and confidence in the clinical research.

Thus the industry is willing to implement amendments aimed at patient safety, but the regulator will need to decide if the purpose is truly being served? viveka.r@expressindia.com

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Speeding up tri@ls Patients have so far been recruited for trials by sponsors or CROs. However, the social media bandwagon offers an interesting alternative with its patient-centric approach.

Shalini Gupta reports

C

linical trials play a crucial part in ensuring that a drug comes to market and even more so towards affirming the safety and efficacy of the drug in question on the people it would impact the most - the patients. Even as the industry is going through its own set of trials and tribulations, the patient remains both the end user as well as at the core of the strategy. It then helps to understand how to enhance patient involvement in the process and utilise this towards making trials successful.

Tapping users, upping enrollment It was perhaps with this in mind that a team of cardiologists, led by Dr Sharonne Hayes at Mayo Clinic turned to patient-run websites dedicated to heart conditions in order to recruit survivors of SCAD (spontaneous coronary artery dissection, a heart condition which affects fewer than 200,000 Americans annually).

The novel recruitment method helped researchers assemble “large and demographically di-

38 EXPRESS PHARMA May 16-31, 2014

verse patient groups more quickly and inexpensively than they could using traditional outreach methods,” the study noted. 18 participants lined up in less than one week, six more than those eligible to participate in the 12-person pilot.

The Internet might have brought the world closer, but challenges remain still. A 2011 Pew Internet report titled “The Social Life of Health Information” found that 62 per cent of Internet users and 46 per cent of adults use social media. While the number of users has increased to 85 per cent in 2013 with 72 per cent of those using social media to access health information, enrollment figures by Cutting Edge Information reveal that an estimated 80 per cent of trials fail to meet enrollment timelines, with half of them enrolling one or no patients.

Ashish Dutt, Director and COO, Bioquest Solutions cites an instance of assisting a Europe based company for a trial of a drug which got stuck in Singapore, with one of the major reason being the non availability of patients. Social media then plays an undeniably important role in reaching to the patient and engaging them in the process. “This can be done either by seeking to acquire people to easily penetrate patient community or

going one step further by engaging a patient enrolled in a trial,” he adds.

Sponsors and CROs have been traditionally using physician referrals and mass media advertising to reach and solicit patients, however, enrollment figures remain low.

“With almost one third of clinical trial budgets spent for patient recruitment, cost is not the only prohibitive factor.

There is a logistical challenge as well. Many clinical trials are delayed due to lack of enrollment, and increasingly pharmaceutical companies need to look beyond traditional methods of patient recruitment, exploring new avenues and potentially lowering cost while still increasing clinical trial participation,” pitches in Ruchi Dass, Founder and CEO, HealthCursor Consulting. Quintiles took a lead by launching Mediguard, which provides free medication safety monitoring to 2.6 million registered users worldwide as of today. The mediguard app launched earlier this year provides users information about potential adverse reactions from multiple medicines and a pill reminder which can be set for hourly, daily or weekly alerts.

Clinical research.com, another initiative from the company provides social network-

ing opportunities and information about clinical trials to 2,50,000 registered patients.

Dass cites an example of Vancouver-based company Qu Biologics which recently harnessed social media to recruit patients and successfully get a lead for a phase I/II trial of its novel site

( specific immunomodulation treatment for Crohn’s disease- QBECO SSI. The company has a dedicated Twitter account @QuCrohnsTrial, along with a similarly focused Facebook page which share information about the trial as well as general information on Crohn's disease. Launched in August 2012, the Twitter account has notched up more than 1,000 tweets, rising above the trend of new accounts starting well but quickly falling into disuse.

Strategising and crafting the blueprint The landscape in India is yet to warm up to the idea. “There is a lot of information on clinical trials in the public domain with websites such as ctri.nic.in and clinicaltrials.gov which provide details on trials being conducted and can be accessed by anyone. Is that not social media?” argues Sauren Das, Executive Director, Excell Life Sciences.

He does accept that Twitter and Facebook are not being utilised as much in India as they are to this effect in the West. Perhaps this has to do with the fact that it is not difficult to find patients in India.

“Evidence-based informational websites like Centerwatch are doing really good in India as well. A leading source of clinical trials information for both clinical research professionals and patients, CenterWatch currently has one of the largest databases of clinical trials with listings in 20+ therapeutic areas representing more than 650 medical conditions in 58 countries,” chips in Dass.

However, just having a social media presence is not enough. The Mayo Clinic study helps us understand that certain key factors are necessary for a successful outcome. These include a positive brand association allaying any fears

There is a lot of information on clinical trials in the public domain with websites such as ctri.nic.in and clinicaltrials.gov which provide details on trials being conducted and can be accessed by anyone.

Is that not social media?

Sauren Das Executive Director, Excell Life Sciences

of the study not being genuine, a motivated patient population organised as a online forum coupled with a disease/condition that is unique(SCAD), favourable patient demographics relative to the study and no geographic constraints.

Designing such a campaign thus is much more than placing an ad on social

media, it requires a continous dialogue and strategy monitoring. Online forums are a great platform to recruit study patients. They allow potential patients and their loved ones to access information and connect with others in similar situations as well as keep the conversation going by creating a place where people who applied but didn't qualify for a trial aren't left feeling abandoned and may remain open for a different trial. In turn, this continues to build upon a targeted pool of potential participants that may be needed in the future.

Dass offers a few tips to help get the most out of social media. “The key to successfully leveraging your social media networks is identifying the studies’ core variables to help decrease the chance of running into problems, such as frustration or wasted recruitment budgets, because like any tool, social media is only as useful as the appropriateness of its application. Another important aspect is the quality of communication. To engage potential patients and their families or advocates, information about clinical trials must be translated in a way that is easy for the average, non-medical person to understand,” she says. For

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instance removing medical jargon (instead of using the term hypertension, just use high blood pressure), breaking down complex concepts and putting a human face to the study.

Dutt feels that safety might be a concern for patients who’d rather prefer to go to the doctor. “CROs and IT companies need to play a proactive role to make this happen. There is a need to make it patient centric, so that patients enrolled in a trial feel a sense of ownership,” he says. Das also echoes cautious optimism. “While it is a cost effective strategy to reach out to the masses and spread awareness across a wide geography, the flip side is that only the tech savvy ones who have access to the Internet or television can participate. Retention can be an issue since patients coming via this medium are from far off places which may in turn lead to a much larger enquiry coming in from all ends on hearing/seeing the news in the media,” he cautions. In the end, social media for patient recruitment remains a challenge, one that might be formidable but equally rewarding should it be tailored strategically. shalini.g@expressindia.com

The Mayo Clinic study helps us understand that certain key factors are necessary for a successful outcome. These include a positive brand association allaying any fears of the study not being genuine, a motivated patient population organised as a online forum coupled with a disease/condition that is unique (SCAD), favourable patient demographics relative to the study and no geographic constraints

CROs and IT companies need to play a proactive role to make this happen. There is a need to make it patient centric, so that patients enrolled in a trial feel a sense of ownership Ashish Dutt, Director, COO Bioquest Solutions

The key to successfully leveraging your social media networks is identifying the studies’ core variables to help decrease the chance of running into problems, such as frustration or wasted recruitment budgets, because like any tool, social media is only as useful as the appropriateness of its application Ruchi Dass, Founder, CEO, Healthcursor Consulting

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cover ) PATIENT RECRUITMENT:

A paralysed process?

Despite enormous patient pool availability at low cost, CROs are still battling with issues in patient recruitment for clinical trials. Are regulatory changes also responsible for issues associated with it? Usha Sharma analyses

I

ndia has the dubious advantage of having a varied patient pool, ranging from different types and severity of diseases like diabetes, hypertension and cancer caused a result of lifestyle choices, to tropical like malaria, kalaazar and H1N1 influenza virus as well as diseases of viral origin like HIV, hepatitis etc.

This has long served the cause of clinical trials in the country since pharmaceutical companies get the requisite volunteer mix for testing their drugs. Dr (Prof ) YK Gupta, Head, Department of Pharmacology and spokesperson of AIIMS informs, “One can get subjects in adequate numbers to evaluate new molecules sensitive as well as resistance to conventional medications needed for chloroquine resistant malaria, MDR and XDR tuberculosis and resistant staphylococcus.

Treatment naive patients are also relatively more as compared to developed world.�

Yet, the recruitment process for the trials has become a bone of contention in the progress of clinical trials

40 EXPRESS PHARMA May 16-31, 2014

sector.

According to Centerwatch survey, 70 per cent of all trials are delayed by one to six months owing to patient recruitment issues.

80 per cent of clinical trials conducted globally are delayed due to slow patient recruitment process. India

too is facing this problem and the industry feels that patient recruitment, which accounts for almost one third of the time and drug development budget, has gradually become a critical bottleneck in the Indian clinical research arena.

Recruitment process in clinical trials Laws have been formed to ensure that patients volunteering for clinical trials are protected. It is mandated that the recruitment of subjects in any trial has to be as per the guidelines of Indian good clinical

practice (GCP) and informed consent of the volunteers. In the true sense, 'informed consent' has to be 'understood consent' of the patient. It has to be in the language that is easily understood by the patient so that he can take a decision after being fully aware

(

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Growth of clinical trials sector can happen only by following strict ethical guidelines, strong regulatory oversight and action on those who violate it. India needs to make her own guidelines, regulations which addresses the ethical milieu sociocultural and economic conditions on our own country.

There are no real challenges to patient recruitment. However the introduction of the audiovisually record system in the informed consent process, has posed some challenge wherein some patients have started showing lack of willingness to participate in CTs as they feel it is an invasion of their privacy

Dr (Prof) YK Gupta,

Dr Viraj Suvarna

Head, Department of Pharmacology and Spokesperson, AIIMS

Medical Director, Boehringer Ingelheim India

of the benefits and risks involved in the trial.

“The recruitment process in clinical trials is quite straightforward. Patients who volunteer to participate are taken through a robust informed consent process.

This is done in local language as appropriate. Once this is complete, patients sign an informed consent document to indicate they have fully understood the requirements of the study. It is imperative that patients are only enrolled in a study if they meet the criteria and they understand the potential risks and benefits. For certain patients groups, such as children, consent is provided by a designated parent or guardian,” informs Dr Shoibal Mukherjee, Chief Medical Officer, Quintiles India and Head, Asia Medical Sciences Group.

Gupta reiterates Mukherjee's views and further elaborates, “Special precaution needs to be taken if the patient is not competent to take a decision, say due to psychiatric illness, in the case of children, unconscious patients etc. Assent or consent in the presence of competent witness is required in such instances. In case of specific

diseases, the patient is screened on the basis of specific needs to meet the inclusion and exclusion criteria.

The placebo must not be used in place of standard care treatment however adding it to standard treatment and care can be permitted.”

Loopholes and challenges While the guidelines are in place they have not been effectively implemented.

Therefore, India's rise as a clinical trial hub as been severely curtailed and aspersions have been cast on the safety and ethicality of the trials being conducted in the country. The laws and regulations enforced have also not proven fool-proof and given rise to further complications, making the patient recruitment even more complex. As a result, over a period of time the total number of clinical trials being conducted in India dropped significantly and pharma firms started looking at other South East Asian countries for their requirements.

According to the Tufts Center for the Study of Drug Development has reported that about 30 per cent of

Principal Investigators (PIs) under-enrol in a given trial, and about 20 per cent fail to enrol a single patient. Patient recruitment process for clinical trials in India is also mired in controversies and challenges. Dr Arun Bhatt, President Clininvent Research talks about the traditional recruitment pattern followed in the industry, “Most trials in India are conducted at public hospitals; these are attractive to sponsors because they have a large number of treatmentnaïve subjects. There is a lack of focus on important research priorities, such as the creation of databases on subjects. As most Indian sites lack patient databases, it becomes difficult for them to identify suitable subjects rapidly. However, the large patient loads at these hospitals make big demands on the physicians’ time, which becomes a recruitment barrier in conducting clinical trials.”

The unwillingness and ignorance of the patients also hinder the recruitment process. Nimita Limaye, Vice President, CDM, Medical Writing and Risk Based Monitoring, Tata Consultancy Services (in her

individual capacity) explains, "It has been reported that upto 70 per cent of eligible patients choose not to participate. Reasons in India are multi-fold – negative publicity, the fear of side-effects, too much travel time, lack of awareness of the ongoing trials and their significance, or the patients are already enrolled on other trials, limited access of the clinical site to the target patient population also the scarcity of time of qualified and motivated investigators support patient recruitment. Inclusion, exclusion criteria are also often very stringent, thus impacting recruitment.” She says, “Ongoing regulatory changes resulting in delays in regulatory approvals are also significantly impacting the interest in conducting clinical trials in India. While a vast treatment naïve, therapeutically diverse patient pool still exists, even Indian companies such as Biocon, Piramal and Lupin are conducting some of their trials overseas resulting in a direct increase in drug costs.”

Gupta feels that the biggest challenge for all stakeholders of clinical research is creating confidence in the patients, public, and

Indian hospitals have to invest in training of the investigators/staff in science, ethics and regulation governing clinical research, create computerised patient databases, and develop research infrastructure to improve overall conduct of clinical trials including recruitment of patients.

Dr Arun Bhatt, President, Clininvent Research

Those who do not wish to be filmed should be able to waive this right and still be allowed to participate in the trial as long as the informed consent process is well managed and documented in other way Dr Shoibal Mukherjee, Chief Medical Officer, Quintiles India and Head, Asia Medical Sciences Group

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cover ) I suggest there should be a provision for taking a waiver from the DCGI. At the same time the AV recording should be only mentioning the drug name, subject’s name and his willingness to participate. otherwise it takes away about an hour of recording Kiran Marthak, Member of Board of Director and Global Head of Clinical Development, Lambda Therapeutic Research

Patient selection for different therapeutic areas depends upon the study complexity and the core study objectives Nimita Limaye, Vice President, CDM, Medical Writing and Risk Based Monitoring, Tata Consultancy Services

42 EXPRESS PHARMA May 16-31, 2014

even the parliamentarians.

Mukherjee also feels, “Patients in India have a very low level of awareness of research practices and clinical trials, and do not specifically seek out clinical trials unlike in more developed countries.” He adds, “For many disease categories, patients travel long distances to receive care at a reputed institution and it may not be possible for the patient to visit the site repeatedly to meet requirements of the study protocol. Such patients should not be recruited for a trial. Each of these factors leads to challenges in patient recruitment.”

Limaye also highlights that the complexity of the diseases and its procedures can also give rise to challenges while selecting the patient profile for the study, “Patient selection for different therapeutic areas depends upon the study complexity and the core study objectives. Oncology for example, is a relatively more complex therapeutic area in terms of endpoints, role of comparator drugs and adverse events reporting. Thus patient recruitment is not easy in the case of oncology trials. Targeted approaches help maintain demographic homogeneity. Recruitment is not a challenge only in the case of critical diseases such as AIDS, but also for more routine ones like diabetes and heart ailments. While India has a large patient pool, there is shortage of centralised databases of patient profiles, and high recruiting sites, add to the challenges.”

Apurva Shah, Co-founder and Group Managing Director, Veeda Clinical Research opines, “Slow recruitment or inadequate retention of trial subjects continues to be the leading cause of study delays.

A vast majority of eligible candidates are either unaware of available trials or have a poor perception of clinical research.”

Shah reveals, “About 80 per cent of the clinical trials

Centerwatch survey says 70 per cent of all trials are delayed by one to six months owing to patient recruitment issues. 80 per cent of clinical trials conducted globally are delayed due to slow patient recruitment process

do not complete on time.

Though recruitment is not a problem in India, patient retention is.”

AV consent: Problem or panacea?

The Supreme Court's recent mandate is that an audio visual (AV) recordingshould be made of the informed consent from patients for participation in clinical trials. The order aims to ensure that the subject volunteering for a clinical trial is made aware of all the pros and cons of the study.

However, this move has spurred several debates and arguments. Many believe that it would cause further problems in patient recruitment and deter those who want to conduct clinical trials in India.

Dr Viraj Suvarna, Medical Director, Boehringer Ingelheim India feels, “There are no real challenges to patient recruitment. However, the introduction of the audio-visual record system in the informed consent process has posed some challenges wherein some patients have started showing lack of willingness to participate in clinical trials as they feel it is an invasion of their privacy.”

Dr Anil Pareek, President – Medical Affairs & Clinical Research, Ipca Laboratories emphasises, “Motive of the regulators behind having AV recording of IC process was right. However, regulators

should have studied the implications of recommended changes and practical feasibility in much detail before implementing it. Again the guidelines are not exhaustive and clear on how to meet the regulators expectations.” He analyses, “With this guideline, it is becoming difficult for the sponsors to convince investigators because some have started exploiting the sponsors by asking more money despite receiving the necessary infrastructure for AV recording. Moreover, investigators are also facing a challenge in convincing the patients to agree for AV recording, which may further affect patient participation in clinical trials. Ultimately, because of this poor participation, patients may be deprived of benefits of new drugs. Regulators should check/study the best practices adopted by more developed regulators world over to ensure authenticity of informed consent process.”

Limaye raises her concern and insists, “AV consenting, while a good measure, may not be very practical, especially in the Indian scenario, there may also be patient data privacy issues and cultural sensitivities that need to be addressed. In addition, to the best of my knowledge, while this has been recommended by the FDA, this is not mandated anywhere else in the world. Many steps are being taken in the right

direction for curbing unethical practices and ensuring patient safety and these should contribute to restoring patient confidence.”

Mukherjee opines, “Patients should be informed of their right to have the consent process video-recorded.

However, those who do not wish to be filmed should be able to waive this right and still be allowed to participate in the trial as long as the informed consent process is well managed and documented in other ways.”

Kiran Marthak, Member of Board of Director and Global Head of Clinical Development, Lambda Therapeutic Research feels, “There are many females who have enrolled themselves for the HIV and TB trials and do not wish to be filmed. It has reduced the enrollment by 50 per cent. I suggest there should be a provision for taking a waiver from the DCGI. At the same time, the AV recording should be only mentioning the drug name, subject’s name and his willingness to participate, otherwise it takes away about an hour of recording. It is difficult for the investigator to spend so much time and he starts immediately feeling that there should be an option of removal of the rule about AV recording.”

Gupta too opines, “The amendments in rules to address these issues and some clarifications about the procedures need to be clarified.

The ethics committees should be empowered to relax AV rule after due consideration in such specific situations. As the basic philosophy of the Government order is to ensure that the enough effort has gone to make the trial subject fully understood the risks and the benefits involved in the trial, AV recording is the ideal thing. However, there are certain situations where this will be logistically difficult for e.g. women following purdah/burkha system, trials of HIV, sexually transmitted

( diseases, certain contraceptive trials, conditions of acute emergency etc.”

The final verdict on whether SC’s new dictate would aid or cause further detriment to the clinical trials industry in India is yet to come.

Need for change in regulations So, what needs to be done to mitigate the challenges in patient recruitment and revive the growth of the clinical trials sector of India? Industry experts believe that reforms in the regulatory scenario is essential to bring in a positive change. Limaye feels that there needs to be a focused effort towards nurturing a healthy relationship between the stakeholders and ensuring that the investigators have access to the right patient pool, do not have conflicting trials, are well trained and are motivated.

Gupta opines that the growth of clinical trials sector can happen only by following strict ethical guidelines, strong regulatory oversight and action on those who violate it. He says, “India needs to make her own guidelines, regulations which addresses the ethical milieu sociocultural and economic conditions on our own country. For ensuring the adherence and enforcement of the guidelines, strong oversight mechanism is must.”

Mukherjee also presents his views, “At present the threats to the viability of clinical research in India are from ill conceived, difficult to implement regulations and the slow pace of regulatory decision-making that has led to international sponsors curtailing research initiatives in the country. At the same time local sponsors are having to undertake clinical development activities outside the country at great additional expense.” He points out, “India has the highest disease burden in the world and many patients do not have access to standard care.

Over a period of time the total number of clinical trials being conducted in India dropped significantly and pharma firms started looking at other South East Asian countries for their requirements

Clinical trials provide the opportunity for patients to benefit from a high standard of patient care mandated by the study protocol. Unfortunately, current policy initiatives are driving sponsors away from India. With studies not being initiated, patients are being denied the opportunity to participate and benefit from clinical trials.”

The way forward While it is essential to bring in regulatory changes, experts believe that several other steps also need to be taken to bring back growth to the clinical research arena.

Some of them are: ◗ Better accessibility to resources In other countries, government agencies make information about clinical trials freely available to patients through websites and other information channels. In the US, the Food and Drugs Administration’s websites are a good example of this, but there are many other public sources of information such as the US National Institutes of Health, the US National Cancer Institute, and many university and research institution websites. However, that's not the scene in India. Mukherjee discloses, “Regrettably, such information is not made easily available by the Indian regulatory agencies or research institutions, although the Department of Health Research, Ministry of Health

and Family Welfare has taken some initiatives in this direction. And I feel the media can also help patients in this regard.”

In an attempt to bring better transparency, the details of ongoing trials in India are now listed on the clinical trial registry of India (www.ctri.nic.in) which has resulted in increasing visibility.

Though there is no facility for volunteers to register on this site. Commenting on timely corrections and updation for a better accessibility in the clinical trial process, Limaye mentions, “The importance of clinical trials is to be made apparent to patients, and along with this many things need course correction, the right checks and balances are being laid out and patients, especially those who have no means of availing of existing therapies, should be made aware of the positive benefits of clinical trials.” ◗ Encouraging innovation Pareek says, “No doubt regulatory changes are made to strengthen the systems and regulations and to bring transparency in conducting clinical studies.

Such changes will definitely discourage malpractices.

But the bigger picture lies ahead when Indian pharma companies will conduct clinical trials not just as a regulatory ritual but to develop their indigenous innovations/ideas. If majority of Indian companies start doing this then India will be exploring its potential talent

THE MAIN FOCUS

in the true sense.” ◗ Strategising for progress The right approach and strategy are essential in clinical trials. Suvarna says, “Based on the study protocol and therapeutic area there could be slight differences in the approach. The system begins with careful selection of the right investigator, training of the investigator and team, and continuous oversight/regular monitoring, to ensure the right patients are recruited. The study is done only if it meets current unmet medical need of Indian patients, benefit is more than risk, and the new drug has the potential of being a significant advance over current standard of care.· Marthak stresses on the procedures depending upon complexity of a disease, “There are different strategies for different indications. e.g. oncology patients also need assurance for continuing the chemotherapy along with marketed product. HIV patients need confidentiality and also the right combination of drugs. TB patients need confidentiality and also additional nutritional support. If their needs are taken care of the patients do participate in clinical trials.” ◗ Invest in training Bhatt suggests, “Indian hospitals have to invest in training of the investigators/staff in science, ethics and regulation governing clinical research, create computerised patient databases, and develop research infrastructure to improve overall conduct of clinical trials including recruitment of patients.”

Conclusion If implemented, these recommendations would resolve the issues plaguing the footsteps of the clinical trials segment in India, including patient recruitment, and help to retrieve the country's reputation as a clinical trial hub.

About 80 per cent of the clinical trials do not complete on time. Though recruitment is not a problem in India, patient retention is Apurva Shah, Co-founder and Group Managing Director, Veeda Clinical Research

Motive of the regulators behind having AV recording of IC process was right. However, regulators should have studied the implications of recommended changes and practical feasibility in much detail before implementing it.

Again the guidelines are not exhaustive and clear on how to meet the regulators expectations Dr Anil Pareek, President – Medical Affairs & Clinical Research, Ipca Laboratories

u.sharma@expressindia.com

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cover )

T

MYDOCTOR HERO The issue of post trial access to investigational drugs has not seen as much debate in India.

Express Pharma presents the experience of Dr Cecil Ross, Professor of Medicine and Hematology at St Johns Medical College Hospital Bangalore, who, along with other investigators, succeeded in securing post trial access for their patients

44 EXPRESS PHARMA May 16-31, 2014

he ICMR Ethical Guidelines for Biomedical Research on Human Participants refers to Helsinki Declaration of 2000 and recommends that whenever possible the ethics committee should consider a post trial access arrangement in the a priori agreement. Only recently, Indian regulators have started asking companies to give an undertaking to ensure posttrial access, free of cost for subjects who benefit clinically.

But there are opinions on both sides of the debate. Most investigators are in favour of post trial access because they would like their patients to continue to benefit from the investigational drug if their health parameters have improved during the trial.

However, sponsors are wary of giving access immediately on trial completion because there is approximately a time gap of a year between completion of the trial and the availability of trial results and sponsors would not like to give access to what is in essence still an unproven compound.

It also presents an ethical dilemma because considering the socio-economic realities of India, post trial access could be construed as undue incentive/exploitation of clinical trial participants. Globally, the debate on post trial access ranges from the medico-legal (morality, legality) to more prosaic aspects (feasibility and practicality.)

Dr Cecil Ross, Professor of Medicine and Hematology at St Johns Medical College Hospital Bangalore was faced with this choice, when he recruited some of his patients to a global multi centre study to study a new injection meant for haemophilia patients.

Haemophilia patients suffer from a genetic defect, due to which their blood does not clot.

Hence they bleed spontaneously. This condition has no cure, and their only recourse is regular replacement of clotting factor concentrates. This injection gives them relief for eight hours only and costs `10,000.

Thus these patients end up spending upto ` 2.5 lakh every year on injections to keep their bleeding under check.

The new injection on trial was a major boon for patients as it needed a once-a-week dosage, and thus improved quality of life to a large extent. If this medication works, haemophilic patients across the world will benefit immensely, given that the age of these patients range from toddlers to 25 years. Children

Haemophilia patients suffer from a genetic defect, due to which their blood does not clot will get a chance to have as normal a life as possible, while young adults can access a world of opportunities.

If found efficacious and safe, post the clinical trial and in order for the haemophilia patient to continue receiving treatment, the investigators negotiated with the sponsoring company that the patients would continue to get the same medication in the post trial stage, till such a time as the drug is officially approved and marketed in India.

They did this to ensure that the company would then consider seriously marketing the drug in India, at reasonable rates after the approvals are done.

And also the patient would continue to get access to the superior quality medication, so that he is not left high and dry after the trial.

MANAGEMENT INSIGHT

Issues with recent changes to clinical trials’regulations Bhavik Narsana, Partner, Sameer Sah, Principal Associate and Arijeet Mukherjee, Associate, Khaitan & Co aim to identify the recent changes to the legal framework and issues relating to informed consent, SAE reporting and compensation for clinical trials in India TO DEVELOP a new drug, it is sine qua non that clinical research must be carried out.

Clinical research is a fundamental building block of innovation in the field of science and medicine. It is fair to say that India was looked at as one of the potential top destinations worldwide to carry out clinical research.

However, in the last couple of years, on account of issues raised by NGOs and patient welfare organisations, the Supreme Court of India1 had to intervene and the Indian government has introduced various measures to regulate the clinical research industry in India. The Central Drug Standards Control Organisation (CDSCO) had also established an expert committee under the chairmanship of Prof Ranjit Roy Chaudhury to formulate a policy and guidelines on clinical trials and this report was submitted in 2013. Presently, this report is under consideration by the Government of 2 India.

The new measures have attracted a mixed response and based on information in public domain, have led to quite a few pharmaceutical companies moving their clinical research programmes out of India. In this Article, we aim to identify the recent changes to the legal framework and issues relating to: (a) informed consent; (b) SAE reporting; and (c) compensation for clinical trials in India.

Informed consent in clinical trials Clinical trials in India are regulated by the Drugs and Cosmetics Act, 1940 (Act).

The Drugs and Cosmetics Rules, 1945 (Rules) formulated under the Act provide detailed provisions for regulating clinical trials in India.

The Rules define ‘clinical trials’ as systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and/or efficacy of the new drug. 3 The Rules provide for various requirements that have to be satisfied prior to conducting any clinical trials.

These include requirements related to informed consent and specify the format of the consent to be obtained along with details to be specified therein.

In June 2013, the Government released draft rules proposing to make audio visual (AV) recording mandatory.

Eventually, in October 2013, the Supreme Court ordered that AV recording must be made mandatory for all consent recording and this was followed by an order from Drugs Controller General (India) on November 19, 2013 requiring the AV recording of the informed consent process of each trial subject, including the procedure of providing

information to the subject and the subject’s understanding of such consent. CDSCO released Draft Guidelines on Audio-Visual Recording of Informed Consent Process in Clinical Trial dated January 9, 2014 (Draft Guidelines) which provides for the procedure for the AV recording.

The salient aspects of the procedure include: ■ Explaining the research process, time duration, benefits, reasonably foreseeable risks, etc., in a language that is non-technical and understandable to the study subjects, this also includes appraising the subject of alternate therapies available to him / her, and also explaining to the subject that there could be certain unforeseeable risks that the subject could encounter in the process.

■ The investigator has to identify the protocol, the subject/legally acceptable representative/impartial witness (as the case may be) and the language understood by such person. If the investigator does not know the language, a member of the study team who understands the language, would have to become the interpreter.

The introduction of compulsory AV recording has received a mixed response from the pharma industry and the scientific community. While there are some apparent advantages of such recording, there are numerous logistical

and other implementation issues which may impede the attainment of the legislative intent. These logistical and implementation issues inter alia include: ■ Investigators have been reported to state that volunteers are weary of being filmed while discussing details pertaining to their ill health.

This arises on account of several factors including fear of leakage misuse or tampering of the recordings.

■ It appears that certain subjects are uncomfortable on account of socio-religious factors or on account of an apprehension of physical ill-appearance from being recorded.

■ Given the conservative nature of Indian society, it is possible that women may not be comfortable being videographed, and if they agree, they may request the presence of a male member of their family which may defeat the purpose of ensuring that the subject is herself aware of the risk, etc., associated thereof.

■ There is a social stigma associated with certain diseases (including leprosy, STDs such as AIDS, etc.) and subjects may not be comfortable being video graphed.

■ The order applies to all clinical trials. Therefore, AV recording of field study also becomes mandatory, which may be difficult considering that the Draft Guidelines require the AV recording to be

BHAVIK NARSANA, Partner, Khaitan & Co

SAMEER SAH, Principal Associate, Khaitan & Co

ARIJEET MUKHERJEE, Associate, Khaitan & Co

conducted in a room conducive to recording of disturbance-free audio and video of the consent process.

Bearing in mind the larger picture, the regulation appears to be slightly lopsided.

The AV recording is intended to achieve two purposes: (i) ensuring that the subjects are orally explained the potential risks and other details pertaining to the study as opposed to the subjects simply signing a lengthy standardised form carrying all these details, and (ii) enforcing implementation as AV recordings would be available for future scrutiny as well. From what is apparent, industry sources do not sense an issue with discussing risks, etc., with subjects. Rather, this would probably be in the interests of both the patients as well as the investigators.

The concern is on the recordings. Therefore, considering the issues associated with the AV recording, an alternate option that could be considered would be an investigator administering the information to provide sworn affidavits that the process has been duly completed.

Nevertheless, given the fact that there is a Supreme Court order mandating such AV recording, it is unlikely that such AV recording can be removed as a

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MANAGEMENT requirement unless the Supreme Court withdraws the order. Hopefully, once empirical data is available regarding the difficulties being faced, the Government may understand the issues and petition the Supreme Court again.

SAE reporting and compensation The Rules were amended in January 2013 to provide for obligations concerning reporting of ‘special adverse events’ (SAEs) and to provide for compensation in case of injury or death of a subject during a clinical trial. The Ministry of Health and Family Welfare has also issued certain draft rules for public comments by a notification dated 24 April 2014 (Draft Rules).

SAE reporting In relation to SAE reporting, investigators are required to report SAEs within 24 hours of occurrence, and sponsors are required to report them within 10 calendars days of occurrence. Industry participants have reacted to the timelines as being very tight, especially considering that these are linked to occurrence and not knowledge. As per the Draft Rules, the investigator has been provided the opportunity to explain the reasons for the delay to the satisfaction of the licensing authority. Further, for sponsors to report the SAE, the time period is proposed to be increased from 10 calendar days to 14 calendars days of occurrence. However, as the linkage to the occurrence as opposed to knowledge of occurrence has been retained, it is unclear whether this would solve the issues being raised by industry participants.

Medical management The Rules provide for expenses related to medical management of the subject and for separate compensation in the case of injury and / or death. The obligation to provide free medical management applies to any injuries sustained during the clinical trial, whether or not these are related to the clinical trial. It

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remains questionable whether the medical expenses should be provided only for injuries related to the clinical trial, or for all injuries sustained by the subject whether or not sustained in the process of the clinical trial. The Draft Rules seek to amend the Rules, and while they retain the right of the subject to receive medical treatment until it is established that the injury is not related to the clinical trial, it has still not been clarified as to who would decide whether the injury is related to the trial (whether it would be the investigator or the ethics committee). Theoretically, however, non-trial related injuries will be excluded from the ambit of receipt of free medical assistance once this is established.

Further, it is not really clear whether the sponsors could consider medical insurance for the subjects given their existing ailments and the fact that they would be participating in such research.

Compensation With respect to financial compensation available to subjects suffering from clinical trial related injuries, the Draft Rules have sought to create degrees of injuries and the commensurate financial compensation thereof. At the outset, the Draft Rules categorise the injuries as permanent and non-permanent; in case of injury of non-permanent nature, the compensation will be quantified proportionate to the nature of the non-permanent

injury, loss of wages and transportation.

Under the Rules, the primary responsibility of the compensation lies on the sponsor. Further, the liability of the sponsor is attracted even in cases where there is negligence, etc., by the investigator. To this some sponsors had claimed that compensation for certain instances such as therapeutic failure, adverse effects due to concomitant medication, and placebo related issues, violated principles of clinical legal research.

Taking these points into consideration, under the Draft Rules, injuries or death occurring due to therapeutic failure or placebo related issues can be claimed for compensation, only if it is established that standard care, even though available, was not provided to the subject as per the clinical trial protocol.

The Independent Expert Committee constituted for examination of SAE of deaths had suggested a compensation formula. The formula takes into account a factor that varies with the age of the subject and is based on the Workmen Compensation Act, 1923. It also takes into account a risk factor based on the risk associated with the subject (the lowest multiple being for terminally ill patients and the highest multiple being for healthy volunteers having little or no risk). Further, for patients where the expected mortality is 90 per cent or more within 30 days, a fixed amount of ` 2,00,000 should be given.

A separate committee was constituted for clinical trial related injury (other than death) and this was published by the CDSCO on May 1, 2014 seeking comments by May 16, 2014. The committee has recommended using the formula for death related compensation and discounting it by 80 per cent and 50 per cent, respectively, in the case of SAE leading to permanent disability or a congenital defect. For SAEs that lead to life threatening diseases or where SAEs are reversible, the compensation would be linked to the number of days when the subject is affected by the condition.

From a broader perspective, these stipulations have the potential to increase costs for sponsors. Further, there is some potential for misuse in these provisions (for instance, injuries caused to subjects which are unrelated to the clinical trials would also be covered by the medical management provision). Considering that clinical research forms a part of the costs associated with drug development, sponsors are likely to want to understand their maximum bottomline exposure. Hopefully, the Government will work towards striking a balance between patient welfare and the sponsors’ commercial requirements.

Conclusion The Indian clinical research industry is a very important part of the Indian pharma industry and market, and also has the potential to

provide independent economic support to the country.

The Government of India has time and again raised a concern for the sale and supply of essential medicines in India at affordable pricing and this has manifested in various results, including, the introduction of a new pricing regime in 2013, granting of compulsory licenses for patented products that are not available in a sustainable manner to the Government. To that extent, drugs would be introduced in India either by domestic manufacturers or by foreign manufacturers. Historically, the CDSCO has been known to approve drugs without the submission of clinical data, but this is a practice that was frowned upon by the Standing Committee of the Ministry of Health and Family Welfare in its scathing report on the functioning of the CDSCO submitted to the Rajya Sabha in 2012. Therefore, the CDSCO is now bound to increasingly insist on clinical data.

This by itself translates into a tremendous need and opportunity for the clinical research industry in India to be robust.

Apart from this, where Indian subjects participate in global studies, this represents an economic opportunity for the subjects as well as the Indian contract research organisations. Therefore, understandably, industry participants have reason to look forward to the authorities to strike a balance between robust regulation and operational flexibility.

The Draft Rules suggest a step is being taken in the direction of balancing interests, but the industry participants definitely expect more.

(The views of the authors are personal and should not be attributed to the firm.)

References 1. Swasthya Adhikar Manch, Indore & Anr v. Ministry of Health & Family Welfare & Ors, Hon’ble Supreme Court of India, W.P. (C) No 33/2012.

2. http://www.cdsco.nic.in/ writereaddata/ Report_of_Dr_Ranjit_ Roy.pdf 3. Rule 122-DAA of the Drugs and Cosmetics Rules, 1945

MANAGEMENT INSIGHT

Advantages and challenges of AVrecording in clinical trials

DR YK GUPTA, Head Department of Pharmacology and Spokesperson AIIMS

Dr YK Gupta, Head Department of Pharmacology and Spokesperson AIIMS, and Lt Col (Dr) Prafull Mohan, Senior Resident, Department of Pharmacology,AIIMS, New Delhi, give an insight on the pros and cons of the Supreme Court order mandating audio visual recorded as well as written informed consent

LT COL (DR) PRAFULL MOHAN, Senior Resident, Department of Pharmacology, AIIMS, New Delhi

IN THE last couple of years in India, concerns have been raised by the public and the Parliament about the lack of ethical oversight and recruitment of vulnerable subjects into clinical trials without undertaking proper informed consent, which is a legal, as well as ethical requirement of research in human beings.

Even though it is mandatory under Schedule Y of the Drugs and Cosmetics Rules 1945 to obtain a freely given informed, written consent from study subject before he/she is enrolled in a clinical trial, in the absence of audio/video proof, there have been complaints about misuse of this provision by the pharma companies and CROs who are engaged in clinical trials. There were reports that many a time the informed consent was taken from the participating subjects without informing them about the pros and cons of the trial.

It is the duty of the investigators to adequately inform the trial subjects about the essential elements of the study and that of the drug to be administered.

The trial subjects should be made fully aware that the drug is a new drug and it is being administered for the first time; its therapeutic efficacy and adverse effects have not yet been well documented. The research subject should also give his consent stating that he has understood the information provided by the investigator with respect to the study and his

participation in the trial is voluntary. Incidentally, the informed consent which should truly mean ‘understood consent’ has been found lacking in the later and in spirit at many occasions. In our opinion, the word informed consent should be replaced by ‘understood consent’.

Some important factors that compromise the quality of the informed consent process

are poorly comprehensible language in the participant information sheet, its erratic translation in vernacular language, partial disclosure of information, lackadaisical back translations and inadequate time provided to the prospective participant to take a truly informed decision.

Various ethical issues concerning conduct of clinical

trials, including informed consent process, has drawn the attention of the print and electronic media. Health sector NGOs have been at the forefront of raising this sensitive issue.

In the case writ petition (W.P.) (C) No. 33/2012 of Swasthya Adhikar Manch, Indore & Anr Vs. Ministry of Health and Family Welfare &Ors. with WP(C) No. 779/2012

regarding clinical trials, the Supreme Court has passed an order dated 21.10.2013. As per the said order, with respect to five global clinical trials for which approval was given by CDSCO after 01.01.2013 till 31.08.2013, before the clinical trials are conducted, appropriate provision shall be made or administrative direction shall be issued which ensures that

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MANAGEMENT audio- visual recording of the informed consent process of the participants is done and the documentation is preserved, adhering to the principles of confidentiality.

In light of the above order by the Supreme court, CDSCO vide F. No. GCT/20/SC/Clin./2013 DCG1 dated 19.11.2013 issued direction that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual (AV) recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required while adhering to the principles of confidentiality.

To facilitate and guide the implementation of draft notification, the SC’s order and its own office order, CDSCO issued ‘Draft guidelines on audio-visual recording of informed consent process in clinical trial’ dated Jan 9, 2014. This document provides guidelines to stakeholders on audio-visual recording of informed consent process in clinical trial as per the above direction.

Advantages of the AV recording of the informed consent of clinical trial: ❑ This gives emphasis on both the process as well as content of consent recording. It ensures that the participant has consented to participate in the trial after due deliberation. ❑ There will be more transparency of the informed consent process ensuring that it has actually taken place and the process has been done in a fair and unbiased manner. ❑ It proves that all the components of the informed consent have been covered. ❑ It safeguards stakeholders. It ensures that all the pertinent information has been provided by the investigator and there will be irrefutable evidence that the information has been passed in case of any dispute in future, especially in the case of vulnerable groups such as illiterate persons, pregnant women, children, elderly, tribal population and mentally challenged persons. ❑ Electronic data will occupy less space for storage and will

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AV recording of clinical trial consent will help reassure the regulatory authority and community about the practice of clinical trial standards and ethics in letter and spirit but grey areas and challenges in execution need to addressed be durable. ❑ Will increase confidence of trial participant and society at large in the entire clinical trial activity.

Challenges of AV recording of informed consent process in clinical trials ❑ Infrastructure and personnel/AV recording sites: There are 650 plus ethics committees (overseeing at least as many trial sites) in the country. Many trial sites may not have sufficient infrastructure such as a dedicated room with no background noise for AV recording.

A designated videographer may also not be there. Personnel with basic knowledge and skills of recording need to be permitted to undertake AV recording after adequate competence training has been given to them. ❑ Time: Informed consent is not an event, it is a process which may sometime take several hours spread over many days.

Participant may come back with some questions after consulting his/her family members and therefore informed consent process may be interrupted in between. ❑ In some situations, urgency of the enrolment may not permit the video recording e.g. trial of drugs for stroke, for post head injury intervention etc. There should be some provision for granting relaxation of AV recording by the EC on a case-to-case basis, provided adequate rationale is available for the same. ❑ Reluctance of prospective participants to undergo video recording: India is a country with diverse social, cultural and religious background. Some participants such as those belonging to rural areas, ladies practicing purdah or ghunghat may be reluctant to get videographed. Participants suffering from some specific diseases

such as Hep C, HIV, leprosy, TB may hesitate to subject themselves to AV recording due to the attached/perceived social stigma. ❑ Videography, while ensuring robustness of the informed consent process, may act as a deterrent and prevent some participants from discussing certain sensitive issues (such as contraception) over camera. ❑ Legally authorised representatives (LAR) of participants such as those of minors, illiterate persons, suffering from psychiatric illnesses will also need to be included in videography. ❑ Data storage and risk of tampering: While electronic storage of data offers advantages in terms of longer shelf life and lesser space requirements, it also poses certain challenges.

This data can be copied or deleted easily by anyone.

The issue of AV recording of informed consent process has been widely debated by all stakeholders involved in clinical research in India .

The Indian Society for Clinical Research (ISCR), an association of professionals involved in clinical trials, said that lack of guidance and direction on operational and logistical issues of managing the AV recording process like the kind of equipment to be used, the quality aspects of AV recordings and where and how information should be stored could leave room for ambiguity and inconsistencies in execution thereby defeating the very purpose of these guidelines and instructions.

More clarity is required on the following issues: a) How to protect and maintain confidentiality of patients in an AV context and what processes need to be followed in instances where, for religious and socio-cultural reasons,

patients might not want to be videographed? b) Who bears the overall responsibility of AV recording, if and how should the ethics committee monitor the AV process and what is the broad purpose of doing AV recording? c) Should the participants be provided with a copy of the recordings as this can increase participant confidence in the informed consent process and the study itself? d) Is re-recording needed for protocol amendments requiring reconsent? In some situation the protocol may be amended because of addition of any investigational procedure, deletion of some investigation, change in rescue medication and also altered risk assessment in view of the recent information. Will the re-consenting in such cases need to be done on AV recording. Though logically yes, but some believe it is a minor change and AV recording can be avoided considering the logistics involved. e) Is editing of the AV recording permitted? AV recording often require editing for making it crisp, short and relevant. However, editing may have the risk of accidental or intentional deletion of a strategically important component of the consenting process. For e.g. the participant may be asking whether any adverse event is associated with the intervention or not. This may be answered in the negative to ensure the person’s participation and then that part of the video may be edited out. This may be disastrous for interventions such as cardiac stents, anti-coagulants etc. On the other hand, if editing is not allowed, then does the EC or any other authority such as CDSCO have the expertise and the time to analyse whether editing has been done or not. f) If the AV recording is not

edited then the duration of the video may be too long.

It is imperative that clear guidelines be formulated to specify the following: a) The device to be used for recording – in the notification it has only been mentioned that sufficient quality of video and audio should be ensured.

Though some mobile phones may be equipped with a good quality camera, can they be used? With mobiles there is a confidentiality issue, since mobile phones are more susceptible to inadvertent transfer of data. b) Specific protocols to be followed for identifying, archiving (password protection), access control (to the PI, or sponsor or the EC) and creating secure backups for the AV recordings. c) To ensure the standards required, it is desirable to specify minimum standards such as megapixels, distance between the camera and participant etc AV recording of clinical trial consenting will undoubtedly help reassure the regulatory authority and the community about the practice of clinical trial standards and ethics in letter and spirit thereby re-establishing society’s faith in clinical research. But, due to grey areas and challenges in execution of mandated AV recording, there is a case of revising the issue of AV recording There is a need to look at the following alternatives: ❑ Restriction of AV recording of informed consent process to only those trials which include participants from the vulnerable population or to trials in specific disease conditions. ❑ E-Consent may be an alternate solution. We may soon have a technology in place for e-Consent by using iPads. There is already a solution available internationally.

The decreased confidence of the public and Parliament in the informed consent process in India resulted in a corrective step in the form of AV recording of informed consent of all trials.

Evidence and logic-based deliberations are required for correcting the largely perceived over correction.

RESEARCH RESEARCH UPDATE

Novartis gains US FDA approval for Zykadia Zykadia (ceritinib) demonstrates an overall response rate of 54.6 per cent in patients with ALK+ metastatic NSCLC

Abbott’s test may identify infections faster Barcelona, Spain

Basel US FOOD and Drug Administration (US FDA) has approved Novartis’ Zykadia (ceritinib, previously known as LDK378) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib[1]. The approval of Zykadia addresses an unmet medical need for patients with this type of lung cancer who have progressed on prior therapy.

“Zykadia represents an important treatment option for ALK+ NSCLC patients who relapse after starting initial therapy with crizotinib,” said lead investigator Alice T Shaw, MD, Massachusetts General Hospital Cancer Center, Boston.

“This approval will affect the way we manage and monitor patients with this type of lung cancer, as we will now be able to offer them the opportunity for continued treatment response with a new ALK inhibitor.”

Lung cancer is the leading cause of cancer death worldwide. The most common type of lung cancer is NSCLC, accounting for 85-90 per cent of all cases[3]. Of those, two to seven per cent are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells and can be identified by a molecular test of the cancer tumour[2].

Despite significant treatment advances for patients with

[1] Zykadia(TM) (ceritinib) Prescribing Information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; April 2014.

[2] National Comprehensive Cancer Network (NCCN).

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer. NCCN 2014 3:1-148.

[3] American Cancer Society.

Lung Cancer - Non-Small Cell Detailed Guide. Available at: http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-smallcell-lung-cancer-what-is-non-s mall-cell-lung-cancer. Accessed on March 31, 2014.

[4] Lin E, Li L, Guan Y, et al.

Exon Array Profiling Detects EML4-ALK Fusion in Breast, Colorectal, and Non-Small Cell Lung Cancers. Mol Cancer Res. 2009;7(9):1466-1476.

[5] Shaw A, et al. Targeting Anaplastic Lymphoma Kinase in Lung Cancer. Clin Cancer Res 2011;17:2081-2086.

ABBOTT ANNOUNCED initial results that suggest its innovative testing platform, known as IRIDICA (currently in development), produces results consistent with the current standard of care in just hours. Currently, the diagnosis of serious infections, such as sepsis or pneumonia, can often take several days. The data from the RApid Diagnosis of Infections in the CriticAlly IlL (RADICAL) study promises to provide new hope for critically ill patients with infections and potentially change the way infections are diagnosed around the world.

Principal investigators for RADICAL retrospectively analysed samples from more than 180 critically ill patients with suspected severe infections from the UK, France, Belgium, Poland, Switzerland and Germany, to compare the results of Abbott's technology to culture, the current standard of care. After reviewing the interim data set, independent physicians on an adjudication panel reported they would have prescribed a different course of treatment in more than 50 per cent of the cases evaluated.

“Every minute can count when diagnosing and treating serious infections,” study author Jean-Louis Vincent, Professor of Intensive Care, Universite Libre de Bruxelles and the Head of the Department of Intensive Care, Erasme University Hospital, said. “The interim RADICAL results provide increasing evidence that Abbott’s platform may be used for critically ill patients with infections to quickly identify microorganisms before lab cultures can detect similar results.”

EP News Bureau-Mumbai

EP News Bureau-Mumbai

Zykadia is one of the first medicines to be approved following FDA Breakthrough Therapy designation, which was received in March 2013 due to the significance of results observed in the pivotal trial and the serious and life-threatening nature of ALK+ NSCLC. Additional regulatory submissions for Zykadia are underway worldwide, with an application currently filed in the European Union.

References

ALK+ NSCLC, disease progression is often inevitable and more options are needed. The approval of Zykadia is based on a pivotal trial that included 163 patients with metastatic ALK+ NSCLC who progressed on or were intolerant to treatment with crizotinib. The most common sites of metastases in the patient population studied were brain (60 per cent), liver (42 per cent) and bone (42 per cent)[1].

Among previously-treated patients, Zykadia achieved an overall response rate (ORR) of 54.6 per cent [95 per cent CI, 47-62 per cent] and a median duration of response (DOR) of 7.4 months [95 per cent CI, 5.410.1 months][1]. The most common adverse reactions (incidence of at least 25 per cent) were diarrhoea, nausea, elevated transaminases, vomiting, abdominal pain, fatigue,

decreased appetite and constipation[1].

“The approval of Zykadia less than three and a half years after the first patient entered our clinical trial exemplifies what is possible with a highly focused approach to drug development and strong collaboration,” said Alessandro Riva, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs. “The dedication of clinical investigators, patients, the FDA and others has enabled us to bring this medicine to patients in need as swiftly as possible.”

Zykadia is an oral, selective inhibitor of ALK, an important therapeutic target in lung cancer. ALK is a gene that can fuse with other genes to form an aberrant ‘fusion protein’ that promotes the development and growth of cancer cells[4],[5].

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RESEARCH

US FDAapproves Zontivity tabs To reduce the risk of heart attacks and stroke in high-risk patients THE US Food and Drug Administration approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs. Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It is an anti-platelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke.

Like other drugs that inhibit blood clotting, Zontivity increases the risk of bleeding, including life-threatening and fatal bleeding. Bleeding is the most commonly reported adverse reaction in people taking Zontivity. The drug’s prescribing information (label) includes a Boxed Warning to alert health care professionals about this risk. Zontivity must not be used in people who have had a stroke, transient ischemic attack (TIA), or bleeding in the head, because the risk of bleed-

ing in the head is too great.

“In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death. In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5 per cent to 7.9 per cent over a 3-year period – about 0.5 per cent per year,” said Ellis Unger, Director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.

Health care professionals should inform patients that they may bleed and bruise more easily when taking Zontivity.

Patients should report to their health care professional any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine. Zontivity will be dispensed with an FDAapproved patient Medication Guide that provides instructions for its use and important safety information.

In a clinical trial with over 25,000 participants, Zontivity,

Incorrect biopsyresults cloud Nymox Pharma prostate cancer study

added to other anti-platelet agents (generally aspirin and clopidogrel), reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart (coronary revascularisation) when compared to an inactive pill (placebo). Zontivity is made by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. of Whitehouse Station, N.J.

NYMOX PHARMACEUTICAL Corp said its experimental prostate cancer drug reduced the progression of cancer in patients, but it could not determine if the study succeeded in meeting pre-determined goals due to a high rate of incorrect biopsies. In the mid-stage study, patients receiving a single injection of the drug, NX-1207, had less cancer progression in the treated area than in untreated patients.

The main goal of the trial was to show a significantly higher number of patients with undetectable prostate cancer after 45 days of treatment, compared to untreated patients.

However, the company was unable to assess the drug's benefit because of a high percentage of false negative biopsies a result suggesting there is no cancer present when it actually is in the untreated patients’ group..

EP News Bureau-Mumbai

Reuters

Scientists invent new letters for the alphabet of life New York SCIENTISTS HAVE taken the first steps toward writing the blueprint of life in an alphabet unknown to nature, they reported online in the journal Nature.

Until now, biologists who synthesise DNA in the lab have used the same molecules called bases that are found in nature. But Floyd Romesberg of the Scripps Research Institute in La Jolla, California, and colleagues not

50 EXPRESS PHARMA May 16-31, 2014

only created two new bases, but also inserted them into a singlecell organism and found that the invented bases replicate like natural DNA, though more slowly.

The scientists reported that they got the organisms, the common bacteria E coli, to replicate about 24 times over the course of 15 hours. The accomplishment ‘redefines this fundamental feature of life,’ wrote biologists Ross Thyer and Jared Ellefson of the University of Texas, Austin, in a commentary in Nature on. The

booming field of synthetic biology holds promises for creating new antibiotics and other drugs.

It has also raised concerns scientists are in some way "playing God" by creating living things that could escape from labs into the outside world where they have no natural predators and nothing to check their spread.

In the current experiment, the scientists took pains to make that impossible, according to their paper. The new bases are not found in the natural environ-

ment, Romesberg and his colleagues said, so even if organisms with manmade DNA were to escape from the lab they could not survive, let alone infect other organisms. In nature, DNA's bases, designated A, T, C, and G, pair up. A pairs with T and C with G, forming what looks like steps in a winding staircase - the double helix that is the DNA molecule. Bases determine what amino acids a particular strand of DNA codes for, and therefore what proteins (long strings of

amino acids) are produced.

So far, the synthetic bases, which Romesberg's team call X and Y, do not code for any amino acids, the scientists reported.

But in principle they or other manmade bases could. Much as th adding a 27 and 28th letter to the English alphabet would allow more words to be created, so adding X and Y to the natural DNA bases would allow new amino acids and proteins to be created.

Reuters

RESEARCH

Scientists find MERS virus antibodies

FDAokays start of BrainStorm stem cell trial

Discovery marks a step towards developing treatments for the often fatal disease

London SCIENTISTS HAVE found natural human antibodies to the newly-emerging Middle East Respiratory Syndrome (MERS) virus and say their discovery marks a step towards developing treatments for the often fatal disease. MERS, a SARS-like viral disease first detected in 2012 that has caused outbreaks in the Middle East and sporadic cases around the world, has raised international alarm in recent weeks with a surge in infections and deaths in Saudi Arabia.

Saudi officials confirmed 26 more MERS cases and 10 deaths at the weekend, bringing the toll in the kingdom alone to 339 confirmed cases, of which 102 have been fatal. There is currently no cure or vaccine for MERS a severe respiratory disease which causes cough, fever, shortness of breath, and can lead to pneumonia and kidney failure. But in studies published in two leading scientific journals , scientists from the US, China and Hong Kong said they had found several so-called neutralising antibodies that were able to prevent a key part of the virus from attaching to receptors that allow it to infect human cells.

Antibodies are proteins made by the immune system that recognise foreign viruses and bacteria. A neutralising antibody is one that not only recognizes a specific virus but also prevents it from infecting host cells, eventually meaning the infection is cleared from the person or animal. In one study in the Science Translational Medicine journal, a Chinese-led team found that two antibodies, called MERS-4 and MERS-27, were able to block cells in a lab dish from becoming infected

with the MERS virus.

“While early, the results hint that these antibodies, especially used in combination, could be promising candidates for interventions against MERS,” the scientists said. In a second study in the Proceedings of the National Academy of Sciences (PNAS) journal, a team from the US said their discovery of a panel of seven neutralising antibodies offered the long-term possibility that either a vaccine or treatments could be developed to fight MERS. The vast majority of MERS cases have been in Saudi Arabia and other countries in the Middle East, but the discovery of

sporadic cases in Britain, Greece, France, Italy, Malaysia and other countries have raised concerns about the potential global spread of the disease by infected airline passengers.

Although the disease has not yet been seen in North America, "the chance of someone infected with MERS landing on US shores is possible," said Wayne Marasco, an infectious disease expert at the Dana-Farber Cancer Institute who led the PNAS study. Scientists are not yet clear precisely how the MERS virus is transmitted to people, but it has been found in bats and camels, and many experts say camels are the most

likely animal reservoir from which humans are becoming infected. The virus is similar to the one that caused Severe Acute Respiratory Syndrome (SARS) which emerged in China in 2002/2003 and killed some 800 people - around a tenth of those it infected.

The World Health Organization has said it is "concerned" about the rising number of MERS infections in Saudi Arabia. The United Nations health agency said it plans to send a team of international experts to the kingdom this week to help investigate the outbreak.

Reuters

BRAINSTORM CELL Therapeutics said the US Food and Drug Administration (US FDA) approved the start of a midstage clinical trial of its adult stem cell treatment for patients with amyotrophic lateral sclerosis (ALS).

The Phase II trial will be launched initially at Massachusetts General Hospital in Boston and the University of Massachusetts Memorial Hospital in Worcester. Dana-Farber Cancer Institute's Connell O’Reilly Cell Manipulation Core Facility will manufacture BrainStorm’s NurOwn cells for these two clinical sites. The trial will also be conducted at the Mayo Clinic, the Israel-based company said.

The trials are expected to start soon.

"Today’s announcement represents the most significant milestone BrainStorm has achieved to date," the company's president, Chaim Lebovits, said. This trial will be the first Phase II double-blinded stem cell study to be conducted for ALS, he added. ALS, also known as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.

BrainStorm's Phase II trial is designed to evaluate the safety and efficacy of transplantation of the stem cells in 48 ALS patients. The cells will be administered via intramuscular and intrathecal injection.

Patients will be followed monthly for three months before transplantation and for six months following transplantation. Earlier clinical trials have shown that treatment with NurOwn cells was well tolerated and safe.

Reuters

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RESEARCH

Scientists discover new rare genetic brain disorder INTERNATIONAL TEAMS of researchers using advanced gene sequencing technology have uncovered a single genetic mutation responsible for a rare brain disorder that may have stricken families in Turkey for some 400 years.

The discovery of this genetic disorder, reported in two papers in the journal Cell, demonstrates the growing power of new tools to uncover the causes of diseases that previously stumped doctors.

Besides bringing relief to affected families, who can now go through prenatal genetic testing in order to have children without the disorder, the discovery helps lend insight into more common neurodegenerative disorders, such as ALS, also known as Lou Gehrig's disease, the researchers said.

The reports come from two independent teams of scientists, one led by researchers at Baylor College of Medicine and the Austrian Academy of Sciences, and the other by Yale University, the University of California, San Diego, and the Academic Medical Center in the Netherlands. Both focused on families in Eastern Turkey where marriage between close relatives, such as first cousins, is common. Geneticists call these consanguineous marriages. In this population, the researchers focused specifically on families whose children had unexplained neurological disorders that likely resulted from genetic defects.

Both teams identified a new neurological disorder arising from a single genetic variant called CLP1. Children born with this disorder inherit two defective copies of this gene, which plays a critical role in the health of nerve cells. Babies with the disorder have small and malformed brains,

52 EXPRESS PHARMA May 16-31, 2014

they develop progressive muscle weakness, they do not speak and they are increasingly prone to seizures.

Dr Ender Karaca, a postdoctoral associate in the department of molecular and human genetics at Baylor, first encountered the disorder in 2006 and 2007 during his residency training as a clinical geneticist in Turkey. "We followed them for years," said Karaca, a lead author on one of the papers. Karaca said he and his colleagues performed some basic genetic tests on the families but to no avail.

He presented these cases at a genetics conference in Istanbul in 2010, where he caught the attention of Dr James Lupski, who leads the Center for Mendelian Genomics at Baylor, a joint program with the Johns Hopkins University School of Medicine funded by the National Human Genome Re-

search Institute (NHGRI). The center is focused on finding and recruiting thousands of patients and families with undiagnosed disease likely caused by single-gene defects known as Mendelian disorders.

Lupski recruited Karaca into his program at Baylor, where the team continued to work on identifying more cases. A broad genetic test known as exome sequencing, which looks at all of the protein-making genes representing about one per cent of the genetic code, eventually identified five families with similar characteristics and the same CLP1 mutation.

Researchers needed confirmation in lab tests that the defect could cause the neurological problems seen in the families. That came at a meeting in Vienna, when Dr Richard Gibbs, director of Baylor's Human Genome Sequenc-

ing Center, presented the gene as part of a list of suspected disease-causing variants.

In the audience was Dr Josef Penninger of the Austrian Academy of Sciences in Vienna, whose lab had been working on a model of this same genetic variant in mice.

Both the mice and the people with the genetic defect shared similar characteristics.

Further experiments by the Vienna team showed the mutant copies of the CLP1 gene affected the survival of key cells in the brain stem of the mice.

"We had patients with an interesting phenotype (symptoms) and a novel gene but no evidence from the lab that these mutations are diseasecausing. They had a model organism, a mouse, but they didn't have evidence that it affected people. It was a perfect storm," said Baylor ge-

neticist Dr Wojciech Wiszniewski, author of another study. As the Baylor-led researchers were working on the problem, collaborators at the Yale Center for Mendelian Genomics, another of the government-funded Centers for Mendelian Genomics, were sequencing families in Turkey under the direction of Dr Murat Gunel, a professor of genetics and neurobiology at Yale.

Gunel and colleague Dr Joseph Gleeson at University of California, San Diego, have been focusing on understanding the fundamental mechanisms of how the human brain develops. Gunel had been collecting DNA samples from children affected with neurodevelopmental brain problems. The team did exome sequencing on more than 2,000 samples, and they, too, turned up a disorder linked with the CLP1 gene. Further investigation of the genetic data suggested that all of the cases they identified among four, unrelated families were linked with a single, spontaneous mutation in the CLP1 gene that occurred 16 generations, or about 400 years ago.

Gunel, who received his medical degree in Istanbul, said the high rates of marriages between closely related people in Turkey and the Middle East lead to these rare disorders as affected children inherit mutations in the same gene from both of their parents. Without such marriages, children are very unlikely to inherit two mutations in the same gene. The Yale paper credits Lupski at Baylor for sharing some of his unpublished findings. Gibbs said the whole effort is an "good example of communication-driven discovery."

Reuters

PHARMA ALLY SPOTLIGHT

DSM Vadodara – a new life Royal DSM recently inaugurated its 14th Fortitech premixes plant in Vadodara, Gujarat, a first-ofits-kind facility in India. It is designed to cater to the needs of various segments of the company’s client base with the Fortitech technology under a single roof. Usha Sharma takes a tour round DUTCH-BASED, Royal DSM, a global science-based company active in health, nutrition and materials also has its unique competencies in life sciences and materials sciences. Seeing the tremendous growth opportunities in nutraceutical, food, beverages and dietary supplement markets in India, it recently inaugurated its 14th Fortitech premixes plant in Vadodara, Gujarat with an investment of over $10 million. The facility is spread across 5,000 sq mt and the commercial productions is expected to begin from May 2014.

Strengthening Indian presence For multinational investors, Gujarat is becoming a lucrative and preferred destination to invest in various projects which motivated DSM to set up its 14 th Fortitech premixes facility in the state. Commenting on the Indian investment, Brian Wilcox, Global Vice President – Fortitech Premixes, DSM Nutirtional Products, Human Nutrition and Health said, “DSM is a B2B company and we provide complete solutions to our customers. For us, India is a fast growing market and has a record of achieving double digit growth consistently. We realised that India has a better business opportunity for us and we have not invested in this market. And analysing the business potential we felt the urge to set up the plant in Vadodara.”

Highlighting the optimal benefits of having a facility in Vadodara Wilcox said, “Vadodara has easy access to the ports of Nhava Sheva and

(L to R): Brian Wilcox, Global VP, Fortitech Premixes; Bharath Sesha, President, DSM; Rick Greubel, President, Human Nutrition & Health; Advait Pandit, Business Director, HNH and Peter Nuboer, Vice President, APAC, HNH

Kandla, as well as the industrial corridor of Delhi and Mumbai. Many of our customers have their facilities in Vadodara. Few of our clients like Abbott, Amul, Nestle etc. have their manufacturing facilities near our newly built plant. We feel that with the help of the new facility we will be in a position to meet our clients’ requirements more efficiently and this facility will accelerate growth opportunities to serve our global customers from India.”

The company has appointed 29 full-time people for Fortitech premixes plant in Vadodara for streamlining the work-flow of the facility. The

facility will also be supported by a team of account managers and marketing managers along with a dedicated technical and regulatory manager. Moreover, a regional business development team in Malaysia and an upcoming innovation centre in Singapore shall support the plant team with their global expertise.

Bringing Fortitech to Vadodara In December 2012, the company acquired Schenectady, New York-based Fortitech for a total enterprise value of $634 million. The acquisition of Fortitech accelerated DSM’s strategy to be-

come a full solutions provider in food ingredient blends. It helped expand DSM’s value chain presence, while adding additional capabilities to its business. DSM Team in India stated, “With Fortitech and its workforce, DSM has a capability to deliver customised food ingredient premixes and blends to our customers while at the same time strengthening our international footprint.”

The new facility has a capability to cater to the company’s Asia-Pacific requirements i.e. India, Malaysia, Singapore with its teams split between Delhi and Mumbai, as well as a business develop-

ment group, based in Malaysia and an upcoming Nutrition Innovation Centre in Singapore.

Bharath R Shesha, President, DSM India said, “India is on the verge of an explosion in the area of nutraceutical products. The nutra sector requires revolving spirit and awareness and I am confident that our new facility will help us cater to our customers’ requirements in a better way.

This is a one-stop source for food, beverage, nutraceutical and pharma manufacturers and the company is looking for fortification as a way to differentiate their products from their competition.”

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PHARMA ALLY As per available information in the public domain, fullfledged production of this facility was set to commence in June 2013. Commenting on the delay in the commissioning process of this facility, Shesha said, “Fortitech – DSM acquisition occurred after we finalised building of the facility in Vadodara. At a time when we were in the midst of facility completion, Fortitech – DSM deal was concluded successfully. And post the deal DSM management decided to make this facility as the 14 th Fortitech prefix plant of DSM. And immediately we revised the entire design process of this facility following Fortitech requirements. A few months back the construction work of this facility got finished and we have shifted almost all the equipment of the Fortitech Denmark to this facility which is a speciality of this plant. And that's how the project got delayed for nearly 10 months.”

DSM plant at GIDC, Savli Vadodara

For the new facility, the company has applied for the Food Safety and Standards Authority of India (FSSAI) manufacturing license and expects to receive it soon. Apart from this, the facility will also have ISO 9001: 2008 – Quality Management System certification

Technologically driven The company roughly spends about five per cent on research and development. It has built a state-of-the-art lab and production facilities at the Fortitech premixes plant at Vadodara which is similar to other global labs of DSM. The company has a fully automated process to avoid any human hazards, except for the vessel discharge process.

Presently, it has a single discharge room facility and plans to increase it in the future depending on its necessity. It also has special rooms for charging and discharging of big sized vessels and mixing different batch sizes.

The company is uniquely positioned with its backward integration in the space of vitamins and carotenoids as well as Fortitech technology. “With this facility, we can now handle a portfolio of 1400 ingredients for blending. Ingredients manufactured by DSM will continue to come from our facilities in Europe and the US. DSM is currently sources certain third party ingredients like minerals from India. For our global requirements the

54 EXPRESS PHARMA May 16-31, 2014

same approved sources will supply to the newest Fortitech facility in Vadodara,” informs a team member of DSM. At present, the company outsources raw materials, mainly from Singapore.

Regulatory compliance For the new facility, the company has applied for the Food Safety and Standards Authority of India (FSSAI) manufacturing license and expects to receive it soon. Apart from this, the facility will also have ISO 9001: 2008 – Quality Management System certification. It is also expecting few more approvals for this plant such as FSSC 22000: 2010, ISO 14000: 2004, HACCP, GMP as well as Halal & Kosher certifications in the near future.

Richard (Rick) Greubel, President, Human Nutrition and Health, DSM Nutritional Products shared, “We are delighted to start our new Fortitech premixes plant in Vadodara. All Fortitech premixes adhere to the criteria set forth in our ‘Quality for Life programme’, which represents our unwavering commitment

to quality, reliability, traceability and sustainability. As one of the fastest growing economies in the world, we believe that this facility in India will add to DSM’s overall growth and profitability. By expanding our presence, we aim to deliver more value to our Indian and South Asian customers.”

Indo-Dutch partnership The company informed that the Fortitech premix plant is the latest addition and a perfect example of their investment in Indian market. A key element of DSM’s growth strategy has been to broaden its international presence to capture opportunities in high growth economies such as Brazil, Russia, India and China, said a team member of DSM. The share of sales in high growth economies as a portion of DSM’s total sales has increased significantly in the recent years, and accounted for around 39 per cent in 2013. It is DSM's aim to increase this share to about 45 per cent by 2015.

Speaking at the inauguration ceremony, Alphonsus Stoelinga, The Am-

bassador of the Kingdom of the Netherlands said, “India and the Netherlands are very important economic partners for each other. India is the fifth largest source of Foreign Direct Investment (FDI) in the Netherlands and vice. This plant is a perfect example of Dutch FDI in India. But there is more to it: Royal DSM is recognised for its global leadership in initiatives related to food security, preventing hidden hunger and promoting sustainable development in high growth economies. The new Fortitech Premixes plant in Vadodara is testimony of its commitment to develop and deliver innovative nutrition solutions to the South Asian market,” he further added.

The DSM team remarked, “As one of the fastest growing economies in the world, we believe that India offers a tremendous opportunity for food, beverage and dietary supplement manufacturers.

Our new site in Vadodara brings industry leading innovation capabilities and access to the broadest portfolio of nutritional ingredients to the

Indian subcontinent. With this investment we have increased our commitment to our customers and have accelerated our growth plans in the region.”

Wilcox informed, “Growing economies, such as India, offer tremendous opportunities for Fortitech Premixes. The fast-paced lifestyles of today’s consumers mean that proper diet and nutrition are not always within easy reach on a daily basis. We have a long and successful history of working with food and beverage manufacturers to create fortified products that have a tremendous appeal to consumers. We are looking forward to continuing that tradition with our operations here in Vadodara. The talented workforce we have on hand here can only guarantee our success.”

Commenting on the benefits of the newly commissioned facility, Shesha said, “Our new Fortitech premixes site brings industry leading innovation capabilities and access to the broadest portfolio of nutritional ingredients to the Indian subcontinent. Also, we believe that currently there are no manufacturers in India which have integration nutrition solution capabilities for micronutrient mixes like DSM. Therefore, with this investment, we aim to increase the commitment to our customers and accelerate our growth plans in India.”

Set to grow DSM has a long list of clients globally, including Merck, GSK, Bayer and Pfizer. The company does business worth $4 billion globally which is split between animal and human nutrition and personal care segments. Out of the total, 45 per cent business comes from the human nutrition segment. The company is targeting double digit growth. It has active pipelines for merger and acquisitions.

The company is eyeing to establish its active presence in Pakistan, Nepal and Bangladesh. u.sharma@expressindia.com

PHARMA ALLY PROFILE

Glatt India: Leading by example From humble beginnings in technologies for the pharma industry coupled with an uncompromising stance on quality to deliver the best to its customers, Glatt India Pharma Engineering is constantly setting new milestones for itself. Shalini Gupta reports IN 1954, Werner Glatt laid down the foundation of Glatt in Binzen Germany, and five years later in 1959, pioneered the design and manufacture of their first fluid bed machine for the pharmaceutical industry. His aim to continuously improve the state-of- the-art and his credo of having only satisfied customers is the reason that today the company proudly boasts of 1800 employees, 20 subsidiaries and various sales representatives worldwide alongwith a presence in the food, feed and fine chemical industry verticals as well. It has a global presence with offices in the US, the UK, Russia, India and Switzerland.

The company is divided into four business units(BUs)- 1) process technology and equipment 2)product development and contract manufacturing 3) process and plant engineering validation/qualification including process technology and equipment 4) contract manufacturing. While all of them are growing at a steady rate, the pharma equipment manufacturing unit i.e. BU I is the highest grossing unit followed by BU III. The reason is simple- sales of pharma equipment is far greater than non-pharma equipment.

(From Lto R) Anuvrat Singal, Reinhard Boeber, Jay Novak and Bernd Kreyer at the Glatt India office in Delhi

From strength to strength Glatt (India) Pharma Engineering, part of the third business unit, recently inaugurated its second office in New Delhi (the first one being in Mumbai).

Having started operations in India in 2008, it specialises in the provision of consulting, engineering and plant supplies and services exclusively to the biopharma and pharma industry and has completed 10 projects

I believe this set up in India has the potential to be in the top if not the top pharma engineering consultancy, it is just a matter of time. We have a strong team of engineers who are able to work alongside their German counterparts and give excellent results.

I hope that this set up will contribute a substantial amount to the revenue of Glatt Engineering globally few years down the line Reinhard Boeber Managing Director, Glatt

Uwe Hรถhn, Thuringian Minister for Economy, Labour and Technology inaugurating the Delhi office alongwith Reinhard Boeber

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We are going to come up with our process technology on continuous fluid bed technology for the chemical and the food industry. Even the pharma sector is looking into the field of continuous technologies

We are focussed on CIS, Russia, Middle East, Asia and Africa. We believe we have a competitive edge in these markets with an Indo-German collaboration offering the best of technology at an affordable price to our clients

Anuvrat Singal

Bernd Kreyer

General Manager, Glatt (India) Pharma Engineering

Head of Pharma Engineering, Glatt Ingenieurtechnik

so far. The company is currently working on three projects in Algeria, Angola and Saudi Arabia.

Having an office in India, gives the company close proximity to its clients in Asia and better serve emerging economies. It makes business sense given that most MNC’s now have facilities in the country.

Chips in Bernd Kreyer, Head of Pharma Engineering, Glatt Ingenieurtechnik, “We are focussed on CIS, Russia, the Middle East, Asia and Africa. We believe that we have a competitive edge in these markets with an Indo-German collaboration offering the best of technology at an affordable price to our clients.

We have to be flexible and look at the big picture, instead of concentrating on a few markets.” He cites how Egypt, was a big market for the company but is down after the Arab Spring. He is optimistic about Iran, which looks to be a promising market down the lane.

The Delhi office currently serves India, Bangladesh, the Middle East and African markets. It recently bagged a green field project in Saudi Arabia with a total project CAPEX worth 70 million euros for which its services and equipment will be worth five million euros. The facility will include an oral dosage block and sterile block.

The project is scheduled to be completed by the first quarter of 2015. Apart from this, the company is also working on two other projects in Algeria and Angola. “India operations are a drop in the ocean but we intend to grow in double digits going further. I believe this set up in India has the potential to be a market leader, if not the leading Pharma Engineering consultancy – it is just a matter of time.

56 EXPRESS PHARMA May 16-31, 2014

Pune factory

We look forward to penetrating countries like Indonesia, Vietnam and certain African nations from this Indian set up,” says Anuvrat Singal, General Manager, Glatt (India) Pharma Engineering.

In many emerging economies (for pharma) the trend is to go for oral solids as the first step and once the customer has absorbed the pharma requirements, do they venture into the liquid i.e. biotech world. Glatt has so far been able to maintain 50:50 share in solid and liquid projects, be it vaccines, insulin, blood plasma, tablets, capsules, inhalers, ointments etc. A German project director as rule of thumb on all projects ensures the transfer of know-how from Germany to India and in turn to its customers. However, India undeniably remains a price sensitive market with competition from global engineering consultants, as well as domestic small companies. Glatt is clear about its stand on the issue. “Everyone in the world wants to reduce cost, but Glatt will never cut corners and jeopardise the health of the patient in order to save costs for the customer,” Singal emphasises.

Committed to quality The parent company is credited with more than 250 turnkey projects executed worldwide (BUIII), with extensive experience in designing and setting up manufacturing plants, laboratories and R&D units around the globe. With Good Manufacturing Practices(GMP) at the heart of a drug manufacturing facility, guidelines from FDA, ISPE and Glatt quality manuals are followed along with local country specific guidelines to ensure standards are met. Keeping the patient at the heart, the strategy is to work inside out, keeping the man and material flow in view while designing the facility along with addressing the health, safety and environment issues from the very beginning of the project.

Year 2013 not only saw Glatt Engineering set up a liasion office in Mumbai but also an entity in Pune which comes under the equipment manufacturing division and is now fully functional to cater to local as well as other global markets. There are 12 plus engineers in the Mumbai office, jointly shared by Pune, trained at the company's labs in Germany. With an equal num-

ber and more joining them at the Delhi office, it is expected that there would be a team of 25-30 engineers by the end of this year.

“We are building our own technology centre in Pune to help customers touch, feel and work on our technology and hopefully buy it by providing engineering services for pharma, food, feed and chemical. This office will help Glatt penetrate markets which we haven’t entered into so far. It will become the jewel in our crown,” Singal envisions.

Import bans imposed by the US FDA on certain Indian pharma companies on account of non-compliance with GMP norms might have tainted the market, however, Singal is hopeful that India will soon recover and rise above its mistakes. “We see a huge potential in this market and double digit growth,” he chips in. Conversely, he feels that this has much rather led to customers focusing more on quality and working alongside Glatt to design a world class facility. “The drug manufacturers along with consultants like Glatt Engineering have to keep track of all GMP + GEP (Good engi-

neering practices) etc. in order to provide state-of-the-art solutions to customers and to try and future proof their facilities,” he stresses. The recent spate of M&As might have reduced the client base for Glatt but he believes that it has helped customers get more conscious about quality.

Since January this year, Glatt (India) Pharma Engineering has expanded its ambit beyond pharma and biotech projects into food, feed and fine chemicals in line with its vision to be the topmost engineering consultancy in India. “We are going to come up with our process technology on continuous fluid bed technology for the chemical and the food industry. Even the pharma sector is looking into the field of continuous technologies,” says Singal. The technology is in great demand and is going to be a major leap forward with most MNCs looking to upgrade it.

Most industries currently work in the batch process (production in kgs), whereas continuous fluid bed technology helps achieve a higher capacity(production in tonnes). Although the upfront cost might be high but in the long term, it is a cost saving procedure. And finally as the growth in developed markets will slow down over the next decade, emerging markets (like BRICA nations Brazil/ Russia/ India/ China/ Africa) and those beyond BRICA will spearhead growth within these markets. Off patent products, increase in middle class spending on health and government policies will further fuel this. “Glatt plans to focus on these markets and establish itself as the leader in the due course of time,” concludes Singal. shalini.g@expressindia.com

PHARMA ALLY I N T E R V I E W

‘Massive growth of pharma machinery and packaging industry is expected’ Rajesh Shah, President, Indian Pharma Machinery Manufacturers Association (IPMMA), speaks on the highlights of Pharma Pro & Pack Expo 2014 and their advantages to Indian and global exhibitors, in a discussion with Sachin Jagdale

What will be the key features of Pharma Pro & Pack Expo 2014?

The second edition of Indian Pharma Machinery Manufacturers Association’s (IPMMA) initiative, Pharma Pro & Pack Expo 2014, is all set to go and it is going to be a milestone event. It is being supported by more than 14 national and international associations. Since the first edition of Pharma Pro & Pack expo 2013 received an outstanding response, expectations of the whole pharma industry is very high in the second edition and it is being highly awaited and most promising pharma manufacturing exhibition.

More than 480 pharma manufacturing companies from 18 countries will participate in Pharma Pro & Pack Expo 2014 and IPHEX 2014. One of the most fascinating features of Pharma Pro & Pack Expo 2014 is that there are more than 20,000 potential buyers including more than 1400 buyers from 140 countries who will mark their presence in both the twin exhibitions, which is truly outstanding.

How will the Pharma Pro & Pack Expo 2014 be different from the other events?

It is the only exhibition where even the smallest entrepreneurs of pharma and packaging machinery can participate along with the other industry giants. A unique business platform opens the door of opportunities to do business across the globe for all

the exhibiting companies, regardless of their scale.

Without Pharma Pro & Pack Expo 2014, they would not dream to explore business across the geographical boundaries.

Moreover, some key decision makers of the pharma industry have joined the exhibition advisory board of Pharma Pro & Pack Expo 2014, Mumbai Exhibition, to provide valuable guidelines and make the visit more meaningful to every single visitor attending the exhibition.

Have you made any special arrangements/provisions for the Indian exhibitors?

Indian exhibitors are going to be benefited to a large extent from this exhibition. The exhibition will provide equal opportunities to the smallest technocrat and big pharma companies who will participate to gain maximum benefit through business networking.

The activities undertaken to promote the exhibition will directly benefit the exhibiting companies as they will see a large pool of potential clients coming to them. A special exhibitor module has been prepared to facilitate their clients. With the help of the module, exhibitors can register their potential clients by themselves and automated e-badges as well as an SMS alert goes to the registered clients. Visitors can get the printouts of e-badges while visiting the exhibition.

What is the total number of

More than 480 pharma manufacturing companies from 18 countries will participate in Pharma Pro & Pack Expo 2014 and IPHEX 2014

confirmed participants?

What is the percentage of foreign exhibitors?

More than 200 exhibiting companies are participating in Pharma Pro & Pack Expo 2014 and out of the total exhibitors around 10 per cent of international companies will take part in the event.

Currently the majority of exhibitors are from India.

However, representatives from their principal companies across the world are likely to be present at Pharma Pro & Pack Expo 2014. We are sure that the next edition of Pharma Pro & Pack Expo 2015 will have more number of international participants as this exhibition is getting strong roots in all parts of the world.

What efforts have been taken to provide the foreign exhibitors with an international experience at the venue?

It is an international exhibition on total pharma manufacturing technologies.

Emphasis is always given to make the exhibition a truly international one. There are more than 20,000 buyers out of which 1400 buyers are from 140 countries which shows that the international exhibitors who participate in Pharma Pro & Pack Expo 2014 are provided with an international environment where they can expect their prospective clients from different regions of the world like Asia, Africa, Latin America, Europe etc.

International standard facilities and services are provided at

Pharma Pro & Pack Expo 2014 and IPHEX 2014 which makes international exhibitors feel very comfortable during the entire exhibition.

With a few exceptions, Indian companies have mainly remained followers of technologies developed by overseas companies. What needs to be done to make Indian companies self reliant in terms of technology?

It’s no exaggeration to say that the Indian pharma machinery manufacturers used to depend upon imported technologies in the early 70s due to lack of funds, initiative and technological advancements. But today, massive future growth of the pharma machinery and packaging industry is expected as the industry is growing at a steady rate of 1520 per cent. Unlike earlier days, now Indian pharma and machinery manufacturers have been able to take advantage of cutting edge technologies. Due to the enormous growth of the Indian pharma machinery industry, there are more than 700 units today that supply machines to the pharma industry in India and worldwide.

However, to sustain in the competition, more emphasis should be given on research and development. Moreover, to be self reliant, technological development is a must. This can also help offer cost effective solutions to the industry. sachin.jagdale@expressindia.com

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‘Agilent has decided to increase its focus on the SME business segments’ In September last year, Agilent announced its plans to separate into two industry-leading public companies, one in life sciences, diagnostics and applied markets (LDA) that will retain the Agilent name, and the other in the electronic measurement businesses that has been named Keysight Technologies. Shalini Gupta finds out more about the India strategy in an interview with P Siva Kumar, Country Manager, LDA, Agilent Technologies India

What have been the revenues of the LSCA (India) division for 2013? By how much have they increased over the past year? How much does the LSCA (India) division contribute to the global pie?

By how much has this increased in the last few years?

Agilent has been able to show a significantly better performance in 2013. As an organisation, we have grown the business much beyond anticipation and market expectation. The growth has surpassed the average market growth rate for the markets we address. India, as a geographical market unit, contributes approximately three per cent of total Agilent worldwide (LSCA). The growth of business over the years has been quite significant and satisfactory even under tough and turbulent market conditions.

What have been the growth drivers in the past few years?

How have they changed?

Over the last few years, Agilent has shown a consistently upward trend as far as the market penetration and growth is concerned. The major drivers for the business

58 EXPRESS PHARMA May 16-31, 2014

growth have been the focus on a solution- centric approach to target customers, coverage and business discipline to overcome the macroeconomic situation.

However, I strongly feel that each of the companies have grown by tweaking the way the business is done rather than working on specific growth drivers – especially in analytical industry since the technology has not changed significantly.

Within the LSCA division, which verticals have been growth leaders? What reasons would you attribute to the same?

We have been able to grow the business uniformly across our various product lines and the market segments we operate in. With the acquisition of Varian few years ago, Agilent has the entire portfolio of Spectroscopy under its product portfolio and we have been able to gain significant market share in this segment across markets.

In terms of markets, with the government increasing its emphasis on food testing to implement the food law, the opportunities in this segment are quite encouraging. Owing to this, Agilent has been able to register significant gains in this market segment. As far as the

challenges are concerned, food testing market is becoming more and more dependent on Government funding and this leads to uncertainty of release of funds and hence delays the procurement. Apart from this, Agilent continues to focus on the pharma, biopharma and material science markets.

We have been able to grow the business uniformly across our various product lines

Which products registered the highest sales in the pharma sector in 2013? What new products were launched in 2013?

For any analytical instrument company, a major chunk of business volume comes from Liquid Chromatography (LC); in line with this trend, Agilent has been able to perform extremely well in this segment. While there were a few product launches in Spectroscopy in 2013, including the revolutionary ‘Universal Measurement Solution’ but a number of products, relevant to the pharma market, were launched in early 2014. The new product introduction included industry leading 7900 ICP-MS, which find major applications in elemental analysis in pharma and clinical markets. We are expecting few more introductions for pharma

applications in the coming months.

The last year has seen the industry beset by regulatory, pricing, IP and other such challenges. How have these impacted business for suppliers such as yours?

2013 has been a year of challenges with the macroeconomic situation in the country, the depreciation of Indian currency and the political scenario adding to the fray. These challenges have put pressure on the overall business objectives of the organisation. However, with consistent focus on customer support and development of market-specific applications we have been able to overcome these difficulties. The depreciating India rupee against the US dollar led to decreased profitability which was partially mitigated through discipline and prudence in expense management.

What are the challenges of operating in the Indian market? Have these eased out over the years? At the same time what new opportunities are being created since pharma is an industry in transition?

India continues to be a challenging market. Some of the factors particularly specific to analytical industry are poor payment behaviour, niche customer base and extremely stringent requirement and product specifications in tenders. All these factors have a significant commercial effect on our business and demand generation. The dynamic changes in funding for government institutions is another major challenge and the product purchase requests from this market segment are showing a downward trend. In order to confront these challenges Agilent has decided to increase its focus on the SME business segments.

These have been untapped since most of the companies have been getting substantial chunk of their business from the established large pharma companies. However, with the economy on the downward spiral and stringent measures to improve productivity in

these big companies, the procurement has slowed down. This has lead to looking for opportunities beyond and this is yielding positive results.

While as a company you cater to the industry, what percentage of the revenues comes from the academia (research labs, government institutions)? Has this increased over the years?

Agilent has been focusing on academia and research for quite some time now and due to this we have been able to enhance our contribution and market hold in this sector.

Greater emphasis is being given to target business requirements that are initiated through tenders. The idea is to be there (with the customer) from the beginning. In contrast to institutions in the western countries, the academic and research institution in India are mostly government funded.

Due to this reason, their terms and conditions can be quite demanding and can affect the

Training is a major focus initiative for Agilent and we constantly invest in the development of training infrastructure and skillbuilding of our employees. We have two major centres of excellence in Bangalore and Manesar

2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9710022999 Fax: 044- 28543035 Email id: yuvaraj.murali@expressindia.com HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express Ltd Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com

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profitability of the deal.

instruments being sold.

What drives innovation at Agilent? What unmet needs of the life sciences and pharma industry are yet to be realised/ being worked at the R&D level?

In Agilent, the investment in research and development is purely based on customer needs and demands. A major focus is laid on providing the customer solutions through market specific applications.

This is clearly demonstrated through the investment in life sciences research centre in Bangalore. With the technology not changing much in the analytical industry, the need of the hour is to identify more number of molecules and new entities for analysis. This could be supported only by robust applications support and method development.

Hence, it is important that the focus is made through solution needed by the customer rather than providing higher specifications of the

What is the focus on training at Agilent?

Training is a major focus initiative for Agilent and we constantly invest in the development of training infrastructure and skillbuilding of our employees. We have two major centres of excellence situated in Bangalore and Manesar, Haryana. Our marketing team also makes regular investments in building the user’s knowledge and awareness about our products through workshops, training programs and on-site customer events.

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What is going to be the focus for the LSCA division in 2014?

The focus area for 2014 is to expand the business geographically and vertically, enabling Agilent to reach newer geographies and SME segments and get ‘profitable growth’ for the company. shalini.g@expressindia.com

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PHARMA ALLY VENDOR NEWS

Industry must drive process improvements to meet growing global demand: CPhI Improved process efficiency, with modern manufacturing techniques could save billions and increase profits, improve quality and open up sales in developing markets CPHI WORLDWIDE, part of UBM Live’s Pharmaceutical Portfolio, has announced the findings of its Pharma Insights report on manufacturing. Overall the report indicates that the industry is aware of the need to continue to improve manufacturing practices, processes and efficiencies to dive down costs and improve profits and drug quality. However, the report warns that industry must more actively take the lead if we are to see these vital changes driven through- currently, the inertia of the existing model is impeding innovation and preventing wide spread adoption.

CPhI adds that most of the sector now states that they are utilising continuous process improvements to drive efficiency savings, but more could be done to revolutionise practices. CPhI findings show that 26 per cent are using ‘statistical process control’, 21 per cent using ‘process capability analysis’, 16 per cent QbD, 12 per cent ‘six sigma’ and 11 per cent using both ‘lean/kaizen’ and ‘PAT’. Furthermore, many are building for the future and making essential upgrades to existing equipment with 70 per cent actively investing in manufacturing.

In the medium to long term, we should see a crosspollination of process im-

60 EXPRESS PHARMA May 16-31, 2014

In terms of the industry’s economic strength, the findings show that the sector is in good health with 59 per cent planning to increase headcount this year and only four per cent planning reductions. In outsourcing we continue to see increases with 41 per cent outsourcing more of their manufacturing

provements from generics (where costs savings can still be made) though CMOs and ultimately into big pharma’s patented products. The advantage here is that lower cost patented products would open huge new markets, whilst reducing the attractiveness of counterfeits.

For cost savings to be made, however, the report clearly states further improvements must come from the industry itself and not the regulator, as this will only increase costs.

Girish Malhotra, CPhI panel member and President EPCOT International said, “Not much will change in the current processes as the needed regulatory approval will come in the way of any improvement of existing

processes. Success to exceed regulations will only come from process inception stage along with command of the process as they become commercial. ‘Process centricity’ has to overtake the current ‘regulation centricity’ if pharma wants to see cost reductions in new and existing processes.”

In terms of the industry’s economic strength, the findings show the sector is in good health with 59 per cent planning to increase headcount this year and only four per cent planning reductions. In outsourcing we continue to see increases with 41 per cent outsourcing more of their manufacturing. Going forward, if manufacturers want to improve product quality, they must find a supplier that

aligns with their own GMP compliance expectation.

Additionally, nearly 50 per cent of the industry stated they introduced more than three products last year, with a further 41 per cent adding one to three products.

The biggest manufacturing goals are to ‘increase efficiencies’ and ‘safety’ and already 89 per cent are testing raw material sourced- with ‘compendial testing’ by far the most favoured method (81 per cent).

Chris Kilbee, Group Director, CPhI Pharma Portfolio said, “With the majority of the industry now committed to process improvements and increased product quality the next few years will hopefully see more new manufacturing methods coming to market,

with tighter process controls these should ultimately reduce costs and increase profits for the industry.”

CPhI believes that if one major pharma company starts reaping the benefits of implementing process perfection from initial development to commercialisation others will follow. Drawing all these findings together the report concludes that the industry has made great strides and with new efficient techniques drugs should be more available globally at reduced cost, enabling developing countries increased access.

Kilbee added, “The desire to modernise processes across the industry is clearly there and taking a long-term view we can see that the way we conduct development work right through to commercialisation has the chance to revolutionise the business model. Patented products will be opened up to a wider number of the globe’s seven billion inhabitants, which is a real human goal, but also one that will see the industry become more sustainable and increase profits. I believe that with these commitments we see a situation where industry actively drives improvements and takes these new methods to the regulator- cost savings and improved quality should go hand in hand.”

EP News Bureau - Mumbai

PHARMA ALLY

Aptar Pharma celebrates Colorcon invests in its Goa facility World Asthma Day Releases new scientific publication following its recent Inhaler Adherence round table organised in Paris

The plant is one of six Colorcon manufacturing plants dedicated to film coatings

APTAR PHARMA, global solution provider of innovative and proven aerosol, injection and spray delivery systems for biotech, healthcare and pharmaceutical products, has presented a new scientific publication, following its recent Inhaler Adherence round table organised in Paris, France. The theme of this roundtable was ‘Inhaler Adherence, Exploring Key Factors.’

Aptar Pharma recently welcomed a panel of five eminent key opinion leaders specialising in inhaler adherence, from France and the UK. They were Beverley Bostock, Nurse Practitioner, Clinical Lead, Warwickshire, UK; Dr Nayna Govind, NG Pharma Consulting, UK; Dr Kevin Gruffydd-Jones, GP, RCGP Respiratory Clinical Lead, Wiltshire, UK; Christine Loveridge, Respiratory Clinical Lead, Education for Health, UK and Nicolas Roche, Head of Pulmonary Service, Central Paris University Hospital, France.

During the one-day meeting, which focused on inhaler adherence, the key opinion leaders shared their knowledge and debated a number of topics, including: current guidance with regard to therapy/inhaler prescribing, specific healthcare professional and patient issues with inhaler devices and unmet needs, potential avenues for making more adherencefriendly inhalers, healthcare costs, reimbursement and emerging therapies.

Participants looked at the process of prescribing inhalers for the treatment of asthma and COPD, which was seen to be a complex issue. Although detailed industry guidance exists to help select the correct therapeutic class of drug, there are a number of factors related to the patient’s capabilities that must

COLORCON HAS completed a major expansion of capacity at its South Asia production facility in Verna, Goa. The investment in incremental manufacturing capacity is evidence of Colorcon’s ongoing commitment to the Indian pharmaceutical and nutraceutical industries. The Goa plant is one of six Colorcon manufacturing plants dedicated to film coatings.

These plants are strategically located close to key customer centres in India, China, Europe, North America and Japan.

Subodh Priolkar, Regional Managing Director for South Asia, Colorcon said the investment would enable Colorcon to continue to meet the needs of its customers through security of supply and short lead times. “Having been established in the region for over 30 years, Colorcon is proud to be the supplier of choice for film coatings and excipients to the pharmaceutical industry in India and South Asia. We are excited about the plant expansion and are well positioned to continue supporting the growth of our customers in the region. Our customers value our commitment to the region and our ability to support them throughout the entire product lifecycle, from the product design stage to production with services like tablet design, technical and regulatory support.”

Martti Hedman, Chief Executive Officer, Colorcon said “India is one of the fastest growing pharma markets due to improving standard of living, easier access to western medicine and increase of lifestyle diseases. India is also the most important produc-

Participants noted that healthcare providers and pharma companies may need to collaborate on the issue of reconciling the ‘increased costs’ associated with developing more patient adherent devices and products with the target of reducing healthcare costs also be considered. These include age, coordination skills, inhalation capacity and patient preferences. Selecting the actual device type depends on the therapeutic class of drug, the cost, and whether to use innovator or generic products. The participants noted that the selection of the inhaler device type is at least as important as the type of therapy chosen.

The participants then discussed what happens once the inhaler is selected. When a patient consults a physician about a new inhaler, it is unlikely that much time can be spent on instructions for use. Consulting a respiratory nurse practitioner for instructions for use is seen as best practice, with follow-up sessions to check on correct use.

The diversity of inhaler devices on the market is also seen as a challenge. This is perceived as a specific issue for DPIs, which may have very different modes of operation, with some patients having separate inhalers for asthma relief and asthma control, each providing a different patient experience.

Looking to the future, the participants saw promise for better adherence in active mon-

itoring and feedback, using smart devices. A new generation of e-devices will be potentially able to communicate with future tele-health systems. In a study in the UK, reminders and incentives to use the inhaler proved capable of reducing costs by over 20 per cent and emergency admissions to hospital by 50 per cent.

Participants noted that healthcare providers and pharmaceutical companies may need to collaborate on the issue of reconciling the ‘increased costs’ associated with developing more patient adherent devices and products with the target of reducing overall healthcare costs.

“It was agreed by all the participants in this roundtable that inhaler non-adherence is a real issue in asthma and COPD therapy. Discussions identified a number of issues that impact non-adherence and looked at ways of addressing these issues, in both the short and long term,” said Chris Baron, Associate Director, Business Development, Aptar Pharma Prescription Division.

EP News Bureau - Mumbai

The Goa site operates under schedule M of the Indian FDA and IPEC guidelines, with Colorcon accredited to the latest ISO 9001 standard tion cluster of generic medicines for global markets. Colorcon is investing heavily in India to support its customers during both development and manufacture. Speed to market, cost to produce and consistently high product quality are our customers’ strategic objectives. Colorcon continues to work relentlessly to help our customers to meet these objectives better than any other supplier.”

The Goa site operates under schedule M of the Indian FDA and IPEC guidelines, with Colorcon accredited to the latest ISO 9001 standard.

Colorcon provides industry leading film coatings, modified release technologies, functional excipients and tablet design services to the pharma industry. Its products meet the highest standards for quality, efficiency and safety.

EP News Bureau – Mumbai

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PHARMA ALLY

Waters Corporation unveils NuGenesis Lab Management System Powerful alternative to LIMS offers seamless lab-to-business connection for science-driven organisations WATERS CORPORATION has launched the NuGenesis Lab Management System, a unique and powerful alternative to a traditional Laboratory Information Management System (LIMS) with advances that enable deeper insight into scientific challenges, accelerated decision-making, better business results, and compliance with government regulations.

The NuGenesis Lab Management System offers high impact functionality with a high degree of flexibility. New advances include NuGenesis

SampleShare, an optional, secure web-client for sample submissions and results management; NuGenesis Stability, a complete stability protocol management and testing solution to facilitate a consistent regimented workflow across lab operations; NuGenesis Connectors, a bi-directional link between lab systems and business applications; and Paradigm Scientific Search, a fully integrated scientific search solution for text, documents and science objects.

Uniquely combining synergistic data, workflow and sam-

The NuGenesis Lab Management System offers high impact functionality with a high degree of flexibility

ple management capabilities to support the entire product lifecycle from discovery through manufacturing, the NuGenesis Lab Management System is a user-centric platform that encompasses a Scientific Data Management System (SDMS), Electronic Laboratory Notebook (ELN) and Laboratory Execution System (LES).

“The NuGenesis Lab Management System is more comprehensive than anything in its class, combining new improvements with key existing capabilities, minus the complex, costly and time-consuming lim-

itations associated with traditional LIMS,” said Garrett Mullen, Senior Product Marketing Manager, Laboratory Management Informatics, Waters Corporation.

The NuGenesis Lab Management System enables science-driven chemical, environmental, food and beverage, and pharma companies to connect and communicate across their laboratory operations, and maximise consistency and efficiency across products, labs and countries.

EP News Bureau – Mumbai

PMMI addresses top trends in robotics, traceability and retail ready packaging at Interpack PMMI has launched, Top101Innovators.com, an online platform where Interpack attendees can identify and locate these companies at the show PMMI, THE association for packaging and processing technologies, recently addressed top trends in robotics, traceability and retail ready packaging at Interpack.

According to PMMI’s recent study on robots usage and trends, robots are projected to be used for 27 per cent of primary packaging for medical devices by 2018, compared to just three per cent in 2013. For pharmaceuticals, robots are expected to handle 34 per cent of primary packaging operations, up from 21 per cent in 2013.

With global spending on medicines forecast to grow at three to five per cent CAGR

62 EXPRESS PHARMA May 16-31, 2014

With global spending on medicines forecast to grow at three to five per cent CAGR over the next five years, PMMI is helping industry players discover the solutions they need to advance over the next five years, PMMI is helping industry players discover the solutions they need to advance. The association has 185 member companies showcasing world-class processing and packaging innovations at Interpack.

To make it easier for Interpack attendees to connect with

these technology providers, PMMI has launched, Top101Innovators.com, an online platform where interpack attendees can identify and locate these companies at the show.

The website links to each company’s portal on pharmaexpo.com to deliver more information on the tech-

nologies they will bring to Pharma EXPO (November 2-5; McCormick Place, Chicago, IL) later this year. The new show is co-located with PACK EXPO International 2014 and co-produced by PMMI and ISPE, the International Society for Pharmaceutical Engineering, and will serve as platform for

discovering processing and packaging innovation and insights for the pharmaceutical, nutraceutical, medical device and biotech industries.

“As North America’s pharmaceutical industry emerges from a challenging period, manufacturers are gearing up to capitalise on opportunities for growth, but still face many hurdles,” says Charles D Yuska, President and Chief Executive Officer, PMMI. “A complex regulatory environment, persistent counterfeiters and growing demand make it necessary for pharma companies to advance.”

EP News Bureau – Mumbai

PHARMA ALLY PRODUCTS

Jay Instruments & Systems launches Lab Spray Dryer JAY INSTRUMENTS & Systems Ltd (JISL) has launched Lab Spray Dryer.

Many products are preferentially used in solid form.

This simplifies storage and measurement and it may be essential for the application for which the product is to be used. Spray drying is a speedy, time saving and gentle method of obtaining even the smallest quantities of substance in power form.

The very short residence times and the cooling effect-resulting from evaporation make it possible to process even temperature sensitive products in a gentle manner. If the use of or-

ganic solvents is involved, the thermal load is reduced to a minimum.

Not only does the Lab Spray Dryer make it possible to obtain power directly from a solution but many other processes can also be completed in a single stage: ◗ Modification of particle size ◗ Agglomeration of nanoparticles ◗ Drying suspensions ◗ Particle Coating ◗ Immobilisation of liquids and solid materials in a matrix ◗ Manufactures of microcapsules

Weather the requirement is gentle drying of natural product, dyestuffs, the isolation of highly effective pharmaceuticals active agents, or the micro encapsulation of aromas, the Lab Spray Dryer is an ideal choice for such application.

Contact details: M/s Jay Instruments & Systems E-16, Everest Building, Tardeo Road, Mumbai – 400 034.

Tel: 0- 90042 79992.

Website: www.jayinst.com email: marketing@ jayinst.com

Uson unveils Raptor OVER FIFTY years after pioneering automated leak testing, Uson is still introducing innovative new products with first-of-kind features.

The Raptor single channel pressure decay leak tester is the company’s latest addition to a comprehensive line of leak detection instruments, equipment and automation systems.

Raptor is a compact bench-top leak tester with built-in touch screen colour display. It is programmable by a Uson App via an Apple or Android smart device tablet or phone. The user interface displays pressure plot, countdown timers, step results, coupling outputs and the current test pressure, keeping the operator in-

64 EXPRESS PHARMA May 16-31, 2014

formed of test status throughout the cycle.

Technological advancement doesn’t stop with the HMI. Inside the tester is Uson’s compact high performance Stallion valve manifold block. Tested to 50,000,000 cycles, the Stallion valve block features self-

cleaning valves and individual valve port control for maximum performance and reliability.

The new leak tester is available in five pressure ranges from vacuum to 150psi, sufficient to cover most common air decay leak tests with resolution to

0.001psi. Ten discrete digital inputs and outputs (I/O) permit automation via PLC or computer interface, with data collection via USB or Ethernet.

Raptor’s ten on-board programmes provide versatility for testing many different types of parts. It is has a small footprint and is lightweight at only 10.5 lbs. allowing for a good smart fit into in a wide range of applications and markets.

Contact details Mikro Innotech India 44/10, Narhe Industrial Estate, Adj. Darshana Properties Pune-411041 Ph:08308802307 web: www.mikroindia.com

Laboratory refrigerators from Cole-Parmer COLE-PARMER offers laboratory refrigerators, a reliable storage of high value and critical samples.

These refrigerators operate with stable temperatures and are developed for the consistent storage of samples.

With sleek design, large storage capacity and a concealed thermostat, it is the first choice for most of the applications in pharmaceuticals, laboratories and universities.

The refrigerators are equipped with external digital temperature display and fully electronic temperature control that ensures a correct set temperature between +2°C to +8°C and are developed for the consistent storage of samples. The refrigerators have large control panel. Its large display provides an easy view of the current cabinet temperature. You can view temperature history with the illustrative graph chart that can be generated on the screen. Temperature data can also be downloaded with the USB data logging system.

The tall and streamlined design makes the refrigerator fit easily into any room and setup. Mobility is, in addition, enhanced by the castors, which makes positioning and re-positioning effortless and is equipped with an ergonomic door handle for better grip and LED lighting for clear viewing of contents.

Typical applications of these refrigerators are storage of reagents, chromatography equipment and samples, biological / BOD (biochemical oxygen demand) samples, culture media, vaccines, and academic research labs/biotech labs/pharmaceutical labs/certain clinical labs.

Contact details Tel: 022-67162229/53 e-mail response@coleparmer.in website: www.coleparmer.in.

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We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Digestive Aids Papain Pepsin

Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules 66

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Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

Top Tank / Reactor Sampler

Flush Bottom valve

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EXPRESS PHARMA AVAILABLE DIRECTLY FROM THE MANUFACTURER AT HIGHLY COMPETITIVE PRICES < Ortho / Para Anisic Acid < Ortho / Para Cyano Phenol < 2 – Ethoxy Benzoic Acid < 1 / 6 – Hydroxy – 2 – Napthoic Acid < 3 / 4 / 5 – Methyl Salicylic Acid & Ester < 3 / 4 / 5 – Chloro Salicylic Acid < 3 / 4 / 5 – Amino Salicylic Acid < 6 – Methoxy – Naphthaldehyde < All types of Paraben & Mixtures thereof.

AN ISO 9001 : 2008 & 14001: 2004 COMPANY OUR PRODUCTS ARE STAR K-KOSHER & HALAL CERTIFIED

3A, Barodawala Mansion, 81, Dr. A.B. Road, Worli, Mumbai-400018.

Tel : +91-22- 43625500 Fax : +91-22-24974886 E-Mail : gujorg@gujaratorganics.com Web : www.gujaratorganics.com

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Creative and

reliable

?

DC formulation Yes â&#x20AC;&#x201C; with Roquette Our directly-compressible polyols, such as mannitol DC and, now also, sorbitol DC, xylitol DC and maltitol DC, offer the flexibility you need for formulations that open up markets.

Aroma. Texture. Sweetness.

Whatever it takes, Roquette gives you the keys to creativity and reliability.

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

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6,/,&21(6 Peroxide Cured

Braided

Platinum Cured

Ring

Tri Clover

Septa

Washer

Cork

Gripper

Flush Bottom

Profile

Butterfly

86 )'$ UHJXODWLRQV &)5 IRU FRQWDFW ZLWK IRRG 863 FODVV 9, UHTXLUHPHQWV (XURSHDQ 3KDUPDFRSRHLD $QLPDO GHULYDWLYH IUHH

DMF No. 26710 Certified Cleanroom

205 & 206 Hill View Industrial Premises, Amrut Nagar, Ghatkopar (W), Mumbai - 400 086, India.

Tel.#:022-2500 4576 Fax #:022-2847 5722 E-mail :sales@mksilicone.com 70

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Blue Heaven

M. K. Silicone Products Pvt. Ltd.

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TABLET GRINDER RM 200

If you are looking for a grinder for reliabe and reproducible sample preparation of pharmaceutical materials, look no further than RETSCH. n Mixing and homogenization of powders and pastes n Gentle grinding down to <10 microns, dry and wet n Ideal for the preparation of homeopathic medicine n Cryogenic grinding of frozen yeast cells (‘noodles’) possible n Mortars and pestles in 7 different materials n Easy to use and clean

Mortar Grinder RM 200 www.retsch.com/rm200

www.retsch.com VERDER SCIENTIFIC PRIVATE LIMITED | 1-2-45/1, 2nd Floor, Street No: 2 Kakatiya Nagar Colony, Habsiguda | 500 007 Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: info@verder-scientific.co.in

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ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

Quality in our genes…

!"#$%&%'($%)# )& +"'),-%#(#$ .+)$"%#/ (/ ."+ 012 31415.(6"7 8"/$"+# -9)$7 2".$%!" ,(..%#6: ;#(9</%/ )& .+)$"%# %,.=+%$%"/ %# +"'),-%#(#$ .+".(+($%)#/ >"#" ?=(#$%&%'($%)# -< @A52B@ C9"'$+).D)+"/%/ /</$",/ E)9"'=9(+ /%F" !"$"+,%#($%)# 31CB: B9%#%'(9 -%)'D",%/$+< (#(9</%/ G".(+%# 7C#)H(.(+%#7 G=,(# 1"+=, ;9-=,%# (#(9</%/

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BIOSIMILAR TESTING

SERVICES Formulation Development Microbiological Studies Biological Studies Pre Clinical Studies Analytical Research Bio-equivalence Studies Clinical Trials Dossier Preparation

ACCREDITATIONS USFDA registered cGMP control testing laboratory DSIR approved R & D Centre Drugs Controller General of India (DCGI) NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical Recognized by Bureau of Indian Standards Drugs Control Administration (A.P) Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC)

4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

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m-VROC is the leading small sample viscometer in biopharmaceutical applications used routinely by the leading biopharmaceutical companies at multiple locations globally. m-VROC is the ultimate viscometer for small sample protein therapeutics as little as 20 microliter and high shear rate viscosity measurement up to 1,400,000 s -1.

m-VROC Overview : Accuracy: 2% of readings Repeatability: 0.5% of the range Viscosity range: 0.2 ~ 100,000 m-Pas Shear rate range: 0.5 ~ 1,400,000 s -1 Sample volume: 20 microliter +

Specification : : Accurate, Precise and top-of-the-line viscometer for R&D application : : 20 μl Repeatability Min sample volume : : 1 Maximum shear rate, s-1 0.5 ~ 1,400,000 Temperature sensor : : 2 Viscosity range, mPa-s (cP) 0.2 ~ 100,000 Software : : Temperature range* 4~70 oC Non-Newtonians ? : No Portable Temperature sweep : : : Accuracy 2% of Reading Shear rate sweep Description

ROSALINA

Advanced Radiotherapy

PRESENCE:

76

MUMBAI

May 16-31, 2014

S

DELHI

S

BANGALORE

S

KOLKATA

S

CHENNAI

S

AHMEDABAD

S

PUNE

S

0.5% of full scale Built-in Included Yes Yes Yes

127, Bussa Udyog Bhavan, Tokershi Jivraj Road, Sewri Mumbai - 400 015. INDIA Tel: 91 22 24166630 / 24173493 Fax: 91 22 66627766 E-mail support@rosalina.in www.rosalina.in

HYDERABAD

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For your Pharma export consignments, to assist you with your Good Distribution Practices (GDP) A Single Use Sub Zero to Low Temperature Monitoring Device

+

=

ASSURED & ACCURATE TEMPERATURE MONITORING

•

Easy to use Single Use sub zero to low temperature data logger. Just activate and toss it inside the box containing the export consignment

•

Accurately monitors sub zero to low temperatures

•

Starts logging temperatures at set intervals as soon as it is activated

•

Can log as many as 6000 readings in transit

•

Excellent battery life depending on the Transaction Days set and the frequency of temperature logging ie the intervals

•

Allows a number of parameters to be set by the user e.g. Transaction Days, Lower and Higher TTI Time, Min and Max Alarm Limits, Start Delay, etc...

•

Logged data can be downloaded by the importer when the consignment reaches them

•

The same data can be uploaded by them to the Enviro website, with a unique device ID, which in turn can be accessed by the exporter

•

Report and Graph with Mean Kinetic Temperature (MKT) calculation in 21 CFR part 11 compliant PDF format

•

Report and Graph with Time Temperature Integration (TTI) calculation, as per USP Chapter 1118

Enviro also offers effective solutions for the monitoring of environmental parameters, suitable for Pharma Clean Rooms and Warehouses.

Enviro Technologies for Accurate, Tamper Proof and therefore Authentic and Reliable monitoring of environmental parameters and analytical reports.

Enviro Technologies 308, Puranik Capitol, Opp Hyper city mall, Ghodbunder Road, Kasarvadavali, Thane (W) 400 607 Tel: +91 - 22 – 64646500 Website: www.enviroworld.in E-mail: enquiry@enviroworld.in

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PHARMA LIFE

RE-SKILLING: AN

URGENT NEED

There is an inadequate emphasis on re-skilling and re-training in the Indian pharmaceutical industry.

However, when planned properly, re-skilling could be a major tipping point. A look at the transformation journey of five professionals

By Usha Sharma

100 EXPRESS PHARMA May 16-31, 2014

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PHARMA LIFE

â&#x20AC;&#x2DC;I value exp erience over qualificationâ&#x20AC;&#x2122;

L

earning, of course, need to be a continuous process not only for better earning, but also for quality of life and healthy living. In todayâ&#x20AC;&#x2122;s technologically evolving global and local scenario, honing and updating to keep in pace with changing times has become extremely important. In a knowledgedriven sector like life sciences and pharmaceuticals, 'knowledge' cannot be made obsolete by technology. Knowledge is the foundation on which technology builds and from where technology evolves. Obsolete technologies are embedded in the knowledge base. Improvements whether micro or macro, whether incremental or disruptive, teaches to overcome the weaknesses, short comings or failures of earlier technologies in the knowledge basket, which helps the progression of scientific solutions on a perpetual basis. Knowledge enrichment with new teachings, new learning and evolving innovative technologies are imperative for career progress.

Roots for re-skilling and re-training It is indeed unfortunate that there is inadequate emphasis on re-skilling and retraining in India or even elsewhere. In the pharma industry such updating in knowledge, in all fields for professionals, is absolutely essential. Imagine the medical practitioners of yesteryears, who were compounding their medicines and not using any device beyond the stethoscope while practicing, compared to current facilities in modern hospitals. Fortunately, top hospitals and medical institutions do have programmes for re-training and skills upgradation. In the US and many other countries 'retail pharmacy' is the most lucrative career for pharmacists. With the current trend of harmonised enforcement of prescription of scheduled

102 EXPRESS PHARMA May 16-31, 2014

drugs and restrictions of medical profession and hopefully on medical representatives too as in the case of chemists and druggists by the Competition Commission, increasing shift to retail pharmacy and hospital pharmacy could be new doors opening up, eventually.

Turning point After my Ph.D from National Chemicals Laboratory, Pune in the early sixties and post-doctoral stint in IIT, Powai, I joined a small scale family-owned Indian pharma company in the late 60s. Unlike many successful CEOs, I did not (have to) start from the bottom rung. But starting work in a truly small scale pharma company, provided all round training opportunities.

However, I realised my weaknesses early. Being a pure research scientist, I was more of a misfit in the ground level management challenges. Realising this, I opted for two management diploma courses from Jamnalal Bajaj Institute, the premium management institute of the 70s, in operations and marketing.

However, since my opportunities in the small scale family-owned pharma company being limited, I took active role in the pharma industry association, IDMA and the government-supported export promotion council, Chemexcil (and later Pharmexcil). The long and continued association with IDMA, BDMA and Chemexcil, Pharmexcil and other public organisations helped me to understand the problems of the pharma industry and work to resolve them and provide impetus to the quality and international trade especially through promotional visits to a very large number of both developed, developing as well as least developed countries. Having actively participated in the debates and discussions on Uruguay Round, Dunkel Draft, Amendments to the

In the pharma industry updating in knowledge, in all fields for professionals is absolutely essential Gopakumar G Nair Chief Executive Officer Gopakumar Nair Associates

With the current trend of harmonised enforcement of prescription of scheduled drugs, increasing shift to retail pharmacy and hospital pharmacy could be new doors opening up, eventually (Indian) Patents Act, 1970, I was shocked to take note of two alarming trends. India had very few resource persons on Intellectual Property laws and the emerging harmonised TRIPs-based Patent law amendments including EMRs and product patents.

There was an increasing demand and need for intensive participation in policy making in pharma-related IP laws.

Secondly, the harmonisation and globalisation of the 90s were giving clear signals, more red in colour, for technopreneurs (I had become one by the 90s) who did not have deep pockets or were no financial wizards like Dilip Shanghvi. Taking note of

these challenges, I plunged myself into a re-training and re-skilling initiative and action plan. My ex-colleague, Arun Kumar of Strides Arcolab came forward as a saviour to take over my public limited speciality chemical pharma company, Bombay Drugs & Pharmas. Self-assessment and swot analysis consequent to 'Shiv Khera' and Landmark Forum helped. Soon after my stint as the President of IDMA, I joined the first batch of IIPS (Institute of Intellectual Property Studies and took a Diploma in Patent Law & Practice. The exemplary facilities, that IIPS offered, helped me to learn WTO, TRIPs, various nuances of in-

tellectual properties including International IP and patent laws. Further, the best available faculties in IIPS helped me immensely to learn the changing rules of the game.

The intensity and commitment to learn (at post-60) was kindled because of the realisation that we need to re-skill ourselves with the emergence of WTO/TRIPs and the immense pressures and turbulence the nation faced.

My self-transformation, post re-skilling after 60 years was probably taken note and I was offered the post of Dean of IIPS, Hyderabad. Around the same time, I became a Registered Patent Agent as well as Registered Trade Mark agent. Distinguished pharma leaders such as from Cipla, Ipca, USV, Lyka and many others approached me for support in their patenting operations. At this juncture, the need for formal legal training was felt by me for providing quality service to our (by this time, I set up Gopakumar Nair Associates) clients. However, I was too busy initially without support of a team.

Once a team of professionals was put in place, I completed LLB (IP laws) and became a Bar Council Member. Having realised the need for re-training and re-skilling in the fast paced and constantly changing legal and technological environment, our firm, Gopakumar Nair Associates, set up an in-house training facility GNA Patent Gurukul, which conducted seven batches of diploma courses in IP in Mumbai and made available IP trained professionals to pharma and allied (as well as other fields) companies. For the first time in the country (probably elsewhere too), we set up EWYL (registered trademark) programme, 'Earn While You Learn' which was a grand success.

We formalised this programme, thereafter, in our Continued on Page 105

PHARMA LIFE

‘Right blend of qualifications and ‘Life should be driven experience is the need of hour’ bya passion to learn’ Knowledge-driven industry The pharmaceutical science is an applied science and therefore obviously is driven by the enhancements in basic sciences. On the consumer interface, the pharma industry constantly endeavours to developments which are patient friendly, as well as meeting the challenges of diseases and ailments emerging out of life style changes, environmental changes which includes the impact and issues from drug induced diseases as well as drug resistance etc.

Thus the pharma industry is essentially knowledge driven and obviously survives on the effectiveness of re-skilling and re-training master plans and protocols.

Building the vision My initial academic qualification was Masters in Pharmacy, while during the professional span I have completed Ph.D in pharmaceutics. The primary stimulus was to keep myself updated with advances in research in the field of pharmaceutics. Being a regulator, the challenge is to cope up with the readiness of forensic cognizance of new drugs, new drug delivery systems and even supporting the post marketing pharmacovigilance. Thus the higher platform of formal education was an approach to extend the network of regulators with academicians, research scientists apart from building the vision and strategic approach to my tasks.

Experience qualification Experience provides an insight into the application of basic knowledge which is acquired by qualification and training. It is thus the art of applying the scientific tools

Sharpening one’s axe

The hunger for knowledge and being a student for life time is the best way to approach towards career challenges and techniques that matters.

The right blend of qualifications and experience is the need of hour.

The general view on this is not much different. Beyond the qualification and experience the value of leadership attitudes, initiative and innovative approach, technology friendliness and many such other personality traits are critical for professional success. An added degree does support upward movement of career although it was not primarily a requirement to move up the ladder. Yes, I have added value to my current position more so in terms of recognition for challenging assignments and tasks.

Focus more on why over how The hunger for knowledge and being a student for life time is the best way to approach towards career challenges. There is always a better, smarter and more efficient way of achieving the task over the way it is being achieved and hence one must

I think that is absolutely essential. Technology is evolving very rapidly today and it is all the more essential to keep sharpening one’s axe. Or become redundant.

Achieving credentials

Dr HG Koshia Commissioner, Food & Drugs Control Administration, Gujarat

have an open mind to learn, as well as de-learn and focus more on why over how.

Support re-skilling ambitions Pharma companies can support re-skilling ambitions by way of many conventional and modern training tools.

Apart from encouraging working professionals for distant learning courses, part time university courses, there are tools like web seminars, memberships to certain industry specific groups etc.

Internal job-specific brain training sessions and group exercises can be of great value to the professionals to show case their hidden abilities and in turn offer higher contributions to the organisations they work for.

Job enrichment by way of enhancing skills and knowledge through formal training is a highly rewarding retention strategy.

Pharma companies have been very agile on the aspect of knowledge updates and have been increasingly spending on this.

Apart from my doctorate, earlier on I pursued an Adv Dip in French – but that is because I love languages as much as I love science. Along the way, I did an Advance Diploma in Management, got trained as a Black Belt in Lean Six Sigma, became the first from India to do the CCDM certification, and did multiple other courses along the way.

The primary stimulus has

Technology today is making learning opportunities accessible at a global scale

been an interest to learn new things, coupled with the need to remain state of the art and to achieve the highest professional credentials in whatever I do.

Experience over qualification I value both, though I would respect experience more. I would also tend to believe that that is the general view as well.

Just additional degrees don’t help. But yes, additional certifications from professional associations/ reputed institutes do build credibility. Finally, demonstrating how you have applied

what you have learned is what makes the difference.

Transition period I think at a junior level it is more about technical skills, and as one moves up it is more about behavioural skills. But upskilling in every respect is important and I do not believe that one can ever stop learning. Life should be driven by a deep passion to learn. While technology is evolving really fast, technology today is making learning opportunities accessible at a global scale.

Advice Definitely upskill on an ongoing basis and never ever stop learning. Seek high professional

Nimita Limaye Vice President, CDM, Medical Writing and Risk Based Monitoring, Tata Consultancy Services

standards – you should be able to stand shoulder to shoulder with the best in the world.

Re-skilling ambitions First, carry out career planning exercises which are often lacking, even in large organisations. Based on the proposed growth plan, identify needs for upskilling. Pharma companies do invest, especially on their key retains and to that extent it does serve as a retention strategy. More investment is clearly required, but along with that the ROI needs to be monitored as well.

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PHARMA LIFE

‘Add qualifications at young age’

‘The aim should be to add at least one newskill set everyyear’

Knowledge sharing

Importance of re-skilling / re-training

Pharma industry is a knowledge-based industry and it is evolving very rapidly. The dynamic nature of the industry requires you to continuously reskill and re-train oneself to align with the newer technologies, regulatory requirements and market realties. Infact, the entire organisation has to go through continuous training and development activities. The best

Qualification has its own advantages mainly at the entry point and enables you to imbibe the experiences faster

way of re-skilling is also by sharing the knowledge and information with your colleagues, subordinates and peers.

Transforming to the times Besides the initial academic qualification, after about 20 years work experience, I had an opportunity to qualify for the Global Advanced Management Programme conducted jointly by the Indian School Of Business Hyderabad and The Kellogg Business School Chicago.

This programme changed my perspective to a large extent and encouraged me to take leadership initiative since the organisation was undergoing a con-

104 EXPRESS PHARMA May 16-31, 2014

stant transformation. The primary stimulus really came from our Chairman, Suresh G Kare, who wanted to groom me for higher positions, step by step.

This also gave me the confidence and I accordingly took keen interest in further adding to my academic qualifications.

Value addition I value experience over qualification. However, qualification

A strong academic background can help a candidate land a good job in the pharma industry, however, re-skilling and re-training is essential for the individual’s growth in an organisation. Rapid scientific advances in the pharma industry also mean a person needs re-skilling, and often upskilling, to build the kind of expertise needed to avail of current and future job opportunities in this sector.

Growth path

Sundeep Bambolkar Joint Managing Director, Indoco Remedies

also has its own advantages mainly at the entry point and enables you to imbibe the experiences faster. I feel, at every point of time a person has to be elevated from his/her position, he/she should be armed with an additional qualification. It is important that the person takes keen initiative in keeping himself abreast of the latest developments in the field. I secured a MBA degree after having worked for about five years with the organisation. This definitely gave me a system-oriented and a structured approach towards corporate life.

Continued on Page 105

I am an M.Tech in Biochemical Engineering and Biotechnology from IIT, Delhi. As cGMP training is very important for pharma professionals, in the initial part of my career, I did a course on ‘cGMP in pharma industry’ conducted by Purdue University, US, in 2004.

As I moved up the corporate ladder, I needed more management expertise and enrolled for the ‘Global Advanced Management Program,’ conducted by the Indian School of Business, Hyderabad and the Kellogg School of Management, US, in 2008.

Aim to excel As I have said earlier, strong academic qualifications from a reputed university can give an individual the initial break in the pharma industry, but will not guarantee career growth. It is the quality of work that an individual delivers that is paramount in deciding his or her career trajectory. In the 22 years that I have spent in the pharma industry, I have had experience across projects, production, operations and business management. And it has always been with the aim of excelling in my work that I have added to my qualifications and training.

Learning is a continuous process and an individual should assess what new skills he or she has picked up over the year

Prasad BSV Vice-President and Business Unit Head, Small Molecule API, Biocon

Transition

Retain top talent

Training on General Management and Finance for executives with a non-finance background are always helpful during the transition to senior management positions. In addition, personality development programmes can also help an individual become a better manager. I attended a personality development programme conducted by Dale Carnegie in 2006.

All good companies have competent Learning and Development (L&D) teams as part of their HR functions with defined budgets for these L&D activities. Biocon has L&D activities that aim to identify and address specific L&D needs arising out of business priorities. It also conducts various classroom training programmes to improve the behavioural skills of employees. Biocon also nominates employees to attend external conferences, both in India and abroad, to help them update their knowledge of the latest developments in various scientific fields. Moreover, leadership development initiatives aimed at building and developing leadership competencies among Biocon’s senior leaders are also implemented on a regular basis.

Such activities have helped Biocon retain top talent, as well as emerge as one of the Top 10 Biotech and Pharma Employers in 2013, according to a ranking by a science magazine.

Assess new skills Learning is a continuous process and an individual should assess what new skills he or she has picked up over the course of a year. Don’t allow the daily routine and work pressures to bog you down. The aim should be to add at least one new skill set every year, which can directly add value to your career. Also, improving one’s emotional intelligence can make the crucial difference between a 'good employee' and a 'great achiever.'

PHARMA LIFE Continued from Page 102

Continued from Page 104

Gopakumar G Nair, CEO Gopakumar Nair Associates

Sundeep Bambolkar, Joint Managing Director, Indoco Remedies

'I value experience... organisation. Almost all our associates and employees have taken (continues to take) benefit of our policy of liberally allowing one and all to learn while working. Most technically qualified associates in the field of pharma, bio, electronics, engineering and others have either done LLB and LLM or are continuing their global training even now. A few are doing post-graduation such as M.Sc. in their fields. This policy has immensely helped to strengthen the skills of our organisation and the quality of service to our clients.

Presently, we have started franchise operations for Patent Gurukul in other cities such as Chennai, Pune, Nasik and others. We have recently concluded a Patent Gurukul batch in Pune jointly with DY Patil group.

Passion for learning I value experience over qualification, if the person is willing to learn on the job with passion, commitment and common sense. I have come across highly qualified ‘misfits’ who have learned only to moderately 'earn', with no passion. I have personally seen least educated persons with passion to learn and with commitment on the job, excelling themselves in their contribution to the organisation and value addition to themselves. If there is a 'will to learn', I value experience (70 per cent) over qualification (30 per cent). Unfortunately, in India, a person is valued for all the wrong reasons and hence one has to meet the 'minimum expectations of qualification', which the job demands. Added degrees do help to enter but not to stay put. Passion and commitment to deliver excellence is far more valuable than glamorous qualifications for

‘Add qualifications...

Quality trainers and teachers are the need of the hour in the pharma industry. Quality and excellence should not take a back seat while focusing on quantity whether in education and training or in pharma APIs and dosage forms moving up the career ladder.

My Ph.D or other qualifications did give me a technical foundation and scientific discipline. But what I 'learned' (post-sixty years of age) in my current avatar, as an IP professional, through my IP practice, is multiple times valuable compared to my educational qualifications.

Tailor-made training programmes Management course were the most popular in the 70s to 90s. Currently, specialised and focused training programmes are most valued.

Training programmes need to be tailor-made to meet one’s own career and professional requirements. There is, however, no doubt that training and re-training, including on the job, is undoubtedly of immense importance in career growth and development. A SWOT analysis on oneself is strongly recommended prior to choosing the course as well as the career.

Quality excellence In the current context, al the junior and middle level professionals in pharma and life science industry need to wake up and take note of the

need for building 'excellence' as a way of life and culture.

All eyes, all over the world are on India pharma industry, its deliveries in quality, quantity, innovation content and reputation. Lately, whether due to poor quality culture or due to sabotage in changing ownership environment, Indian pharma has received some negative attention, probably created by intent, in some cases. We need to reverse this. In pharma education, unfortunately, of late, there is too much reliance on quantity than quality. We need to shift the emphasis more intensively on 'quality excellence'.

This is all the more essential in the context of 'Competitive Intelligence', 'Contextual Intelligence' and 'Conceptual Intelligence' in vogue today.

Quality trainers and teachers are the need of the hour in the pharma industry.

Quality and excellence should not take a back seat while focusing on quantity whether in education and training or in pharma APIs and dosage forms. India needs to perform the duties that Article 51(A) (h) of Constitution of India demands 'to develop the scientific temper, humanism and the spirit of

inquiry and reform.'

Indian professionals should constantly and continuously contribute to innovative ideas and must be in 'open dialogue' mode with the management in the pursuit of excellence. The pharma managements must also re-align (few visionaries are doing it already and seeing the successful results of excellence) to train and retain their resource people and keep them motivated and provide them a sense of belonging and ownership.

Pharma professionals should never be tempted to fall prey for the US policy of encouraging whistle blowers. Errors or mistakes must be corrected, eliminated and 'nipped in the bud', rather than reserved for receiving personal rewards. We owe it to our nation and our pharma industry to make us proud as a source of excellence in pharma quality and efficacy.

The new generation must position themselves for contributing this goal.

Support re-skilling ambitions Every successful pharma management and pharma industry leader realises the need for re-training and reskilling on the job. This is not only a good retention strategy but also a means of providing strong foundation for excellence through motivation, commitment and sense of belonging. Just like the saying that 'conformance is cheaper than non-conformance' in pharma, re-training or re-skilling or providing 'earn while you learn' or more aptly 'learn while you earn' should not be considered as an expense or spending, but should only be looked as an 'investment on excellence' which will pay rich dividends in the long term.

Adding appropriate qualifications In anticipation of the growth in the organisational hierarchy, a person must prepare himself by adding appropriate qualifications from time to time, e.g., depending upon the area of specialisation a person can add qualifications in the fields like intellectual property rights (IPR), analytical research, regulatory

We run various development initiatives specifically designed for each age group and skill levels requirements, international business etc. Once you reach the higher orbit, then you hardly have time left to add to your qualifications and then the experience alone matters. Therefore, make sure that you add enough qualifications at the young age which will put you on a faster growth track.

Initiatives At Indoco we definitely use re-skilling as one of the retention strategies. We run various development initiatives (training programmes) specifically designed for each age group and skill levels. We also have a very active mentoring programme in the organisation which has helped the organisation in people retention and these will be instrumental in driving the company’s growth in future. We do not spend extraordinary high amount, but spend good quality time for these initiatives, which is well appreciated among the employees. u.sharma@expressindia.com

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PHARMA LIFE APPOINTMENTS

Biocon appoints Dr Arun Chandavarkar as CEO and Joint MD Chandavarkar has been the Chief Operating Officer of Biocon since 2006 BIOCON HAS approved the induction of Dr Arun Chandavarkar to the board of Biocon. He has also been appointed as Chief Executive Officer and Joint Managing Director.

Welcoming Chandavarkar on the Board, Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon, said, “I am happy to have Chandavarkar join the Board of Directors and take on the mantle of Chief Executive Officer and Joint Managing Director. He has been a core member of the leadership team at Biocon and has worked very closely with me over the last 24 years. He has played a pivotal role in the evolution of Biocon and I am confident that, in his new role, he will build immense

value for Biocon and its stakeholders.”

Chandavarkar said, “I am delighted and honoured to join the Board of Biocon.

These are exciting times and I look forward to steering the company to the next level.”

He has a B Tech from IIT, Bombay and earned his Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology, Cambridge, USA. Chandavarkar has been the Chief Operating Officer of Biocon since 2006. He joined Biocon as General Manager – Operations in 1990. Under his leadership, Biocon has established expertise in diverse technology platforms spanning microbial fermentation, cell culture, chemical synthesis and purification to develop a wide range of products from speciality enzymes to active pharmaceutical ingredients to recombinant therapeutic proteins.

EP News Bureau-Mumbai

Theresa Stevens joins Lupin as Chief Corporate Development Officer Has over 27 years of experience in the pharmaceutical and biotech sector LUPIN ANNOUNCED the appointment of Theresa Stevens as Chief Corporate Development Officer for its global operations.

Stevens will assume full responsibility for global merger and acquisitions and speciality business strategy. Prior to joining Lupin, she was with Aptalis pharma as the chief corporate development officer responsible for Mergers and Acquisitions (M&A), Strategy and Global Business Development.

Before Aptalis, Stevens was in Novartis for more than nine years and held positions of increasing responsibility including head, Global BD&L for General Medicines, executive director and head, Global BD&L for Respiratory and Dermatology Business Units and head US Business Development and Licensing, life cycle management and generic brand strategies.

She has a Masters Degree in Biochemistry from University of Maryland and is a Juris Doctor (J.D) from the Widener Univer-

sity School of Law, Wilmington, Delaware. She started her career as a research scientist at Dupont and has practiced Corporate Law at Pennie and Edmonds (Jones Day). Having worked with Aptalis and Novartis, Stevens has over 27 years of experience in the Pharmaceutical and Biotech sector with significant experience in managing strategy, corporate development, M&A and licensing.

Marcus Kuhnert joins Merck as Group CFO Kuhnert to join Merck Executive Board on August 1, 2014 THE BOARD of Partners of E Merck has appointed Marcus Kuhnert as Group Chief Financial Officer of pharmaceuticals and chemicals company Merck. Kuhnert will become a member of Merck’s Executive Board with unlimited personal liability as of August 1, 2014.

106 EXPRESS PHARMA May 16-31, 2014

Marcus Kuhnert has been the CFO of Henkel’s Laundry & Home Care business unit since 2010.

With around 9.000 employees, the business unit generates annual sales of € 4.6 billion.

Marcus Kuhnert following his studies at the Technical

University of Darmstadt, Germany, where he earned a combined master’s degree in business administration and mechanical engineering and a Ph.D. at the Institute for Finance and Controlling, he started his career as Corporate Controller at Henkel in 1999, moved to Investor

Relations and as of 2003 headed Group Financial Statements & Subsidiary Controlling. At Merck, Kuhnert will succeed Matthias Zachert, who assumed the role of Chief Executive Officer of Lanxess on April 1.

EP News Bureau-Mumbai

EP News Bureau-Mumbai

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