Express Pharma August 16-31, 2014

VOL. 9 NO. 20 PAGES 80

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Cover Story Lab Special Market ‘Our strategy is to develop vaccines with better protection at lower cost’ Management Idea Exchange with Dr Kenneth Thorpe, Chairman, PFCD 16-31 AUGUST 2014,` 40

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CONTENTS Vol.9 No.20 AUGUST 16-31, 2014 Chairman of the Board Viveck Goenka

Express Pharma hosts Idea Exchange with Dr Kenneth Thorpe on prevention of NCDs

MARKET

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

10

‘OUR STRATEGY IS TO DEVELOP VACCINES WITH BETTER PROTECTION AT LOWER COST’

13

SUVEN LIFE SCIENCES SECURES PRODUCT PATENTS

14

DCG(I) PLANS IT-ENABLED SYSTEM FOR FAST CT APPROVALS

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

Dr ShashankJoshi,President,Indian Diabetic Association and Dr Ratna Devi,CEO,DakshamAHealth & Education were also part of the Idea Exchange held recentlyin Mumbai | P28

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West

P18: POST EVENT

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta

P35: RESEARCH UPDATES

PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

OPPI hosts 3rd Healthcare Access Summit

MANAGEMENT

PHARMA LIFE

73

PROFILE: DR CHITRA LELE

Merck Serono initiates phase II study of Anti PD-L1 antibody in mMCC TURN TO PAGE 11 TO FIND SPECIAL DEALS

P42: VENDOR NEWS Honeywell opens seventh manufacturing facility in India

P74: CAMPUS BEAT Smriti College of Pharmaceutical Education, Indore organises workshop

30

‘WE WILL BRING SIGNIFICANT VALUE TO OUR CUSTOMERS TO HELP US GROW QUICKLY’

32

NEED FOR HEOR IN INDIA: AN OVERVIEW

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.

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EDITOR’S NOTE

The Ebola effect

T

he fear of the Ebola Virus Disease (EVD) being imported into India is worrying our Parliamentarians but besides relying on Indians returning from the affected areas to voluntarily report to immigration and also alert health authorities if they observe any of the symptoms of the disease, there is nothing much that the Government can do except hope for the best. With an estimate of around 45,000 Indians at risk in the four affected countries (Guinea, Liberia, Sierra Leone and Nigeria) the risk is quite substantial.

We have once again been caught unawares by a zoonotic disease, where the disease causing agent, here the Ebola virus, is carried by animals (fruit bats infect chimpanzees, gorillas, monkeys, forest antelopes) but enters the human population (in this case through consumption of their meat).

After the first species jump from animal to human, it doesn’t take long for the infection to assume epidemic proportions, as more humans get infected through animals or humans when they come in close contact with infected body fluids or body secretions.

The 2002 outbreak of the SARS virus and the various flu epidemics (bird/swine/horse) as well as bovine spongiform encephalopathy (BSE), commonly known as Mad Cow Disease are all examples of such zoonoses. Public health experts note that each year sees a new such infection emerge, run its course and fade out, but not before taking a death toll. According to a WHO report, as of August 6, 2014, the cumulative number of cases attributed to EVD in the affected four countries stood at 1779, including 961 deaths.

As far as cures go, in most cases, we have very few options and since these are not common disease conditions, not too many pharma companies are willing to invest in such drugs or vaccines. For example, for the current EVD, two experimental treatments have been cleared by the US FDA to treat people showing symptoms of the disease but stocks have already run low.

What can be done to encourage more companies to research cures for such disease outbreaks? Clearly, drug and vaccine research is

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There are moves to sell off brands to tide over the cash crunch while other companies are looking at reducing or abandoning manufacturing in India in favour of more accommodating countries in South East Asia

an expensive proposition and medicines for ‘poor man’ diseases like neglected tropical diseases will never be blockbusters. But as such zoonotic outbreaks prove, with increasing international travel, such diseases have no boundaries. Indeed, India too could see some cases once citizens in affected zones start returning.

Industry observers point out how the Government in India is bringing more medicines under price control as well as making rules for clinical trials more stringent. The intention is to make medicines more affordable and safer for patients. Minister of State for Chemicals & Fertilisers, Nihal Chand informed the Rajya Sabha that NPPA’s decision to cap the MRP of 108 non-scheduled formulations relating to diabetes and cardiovascular treatments led to price reduction of these drugs ranging from less than one per cent to over 79 per cent and this no doubt earned the regulator a patientfriendly aura.

But a few companies are already feeling the heat. There are moves to sell off brands to tide over the cash crunch while other companies are looking at reducing or abandoning manufacturing in India in favour of more accommodating countries in South East Asia. (See story 'Counting on research', pages 22-23 in the Lab Special section). This unfortunately will serve neither the interest of the patient, the Government or the industry.

The previous Government’s venture to make low cost medicines available to the public, through the setting up of generic drug stores or Jan Aushadhi stores (JAS), has also been proved futile.

Over one-third of these stores are lying defunct, even considering that though the government had planned to open 626 such outlets between 2008 and 2012, only 154 could be opened till March 2013.

Clearly, these options are not viable without the cooperation and inputs from a larger section of industry. It is high time that Government give a serious non-judgemental hearing to industry associations and all stakeholders work out a compromise.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘Our strategy is to develop vaccines with better protection at lower cost’ With the rotavirus and cholera vaccines programmes reaching an important milestone by this year end, Dr Davinder Gill, Chief Executive Officer, Hilleman Labs takes Viveka Roychowdhury through their strategy going forward Explain to us Hilleman Labs’ focus and strategy and how this differentiates your organisation from other R&D labs working in the same space.

The overarching strategy for Hilleman Labs as an organisation is to focus on working on developing transformational technologies for vaccine development with the public health needs of the low income countries in mind.

Focussing on coming up with a portfolio that we could deliver.

And so we asked the question: in a low income country why is it that so many children do not get to celebrate their first birthday?

And the answer is that in most cases, the reason is that the child had a serious pulmonary or diarrhoeal infection. So, we decided to build a portfolio around endemic viral diseases and develop vaccines which could impact infant mortality and reduce infant morbidity.

And so we have a programme in thermo-stable rotavirus vaccine, where we’ve made some good technical results and progress. The next goal will be to advance this programme into clinical development.

Very recently, we have added a programme to develop a high impact oral cholera vaccine with cross protection against Enterotoxigenic Escherichia coli (ETEC) diarrhoea, in collaboration with Gotovax

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AB, a biopharmaceutical company, spin off from the University of Gothenburg.

This will be at a significantly lower price than the ones currently available in the market.

As a strategy, in order for us to demonstrate impact, Hilleman Labs decided that we would focus on fixing vaccines that exist but which have not been designed for the developing world. So much of the work we are doing, whether it is the rotavirus or the cholera vaccine, is about optimising existing vaccines. This will allow us in a time span of five years to achieve proof of concept.

This is different from a strategy where we take a significant unmet need, in say, malaria, HIV, tuberculosis, or dengue and try to come up with something novel. This is a long-term strategy. Our primary goal is to demonstrate clinical proof of concept in the next three to five years.

And since both are essentially optimisation projects, where in the case of the rotavirus vaccine, it is about reformulating the current vaccine for thermostability and in the case of the cholera vaccine, it is about making it more affordable. It is about combining the manufacturing aspect with the thermostbility aspect.

So what we are hoping is to achieve accelerated clinical development studies and so to move much faster through

clinical development rather than the usual phase I, II and III stages. This is our road map and strategy for the next few years.

As a strategy, in order for us to demonstrate impact, Hilleman Labs decided that we would focus on fixing vaccines that exist but which have not been designed for the developing world

What business model are you putting in place to achieve these goals?

Hilleman Labs operates on the for-income, not-for-profit principle. At the moment, we have support from our founders, which is Merck and Wellcome Trust, but our goal is that once we have established products, we will pursue options like whether its client income, or project related collaborations, inlicensing income, etc.

And of course, down the line, once we have the products approved, some royalty income as the products move into the market.

So that is the operating model as our goal is to ultimately become financially sustainable.

But we donot think that is possible without establishing a good foundation and demonstrating that we can actually take these concepts from pre clinical to proof of concept stage.

Once we do that, there is a commercial potential to each product which is why we spent so much time picking the products/projects based on their impact on public health. These two aspects are the bedrock of our operating model.

In early July, Prime Minister Narendra Modi added four new vaccines to

India’s Universal Immunization Programme (UIP). The rationale is that the vaccines against rotavirus, rubella and polio (injectable) will expedite India’s progress on meeting the Millennium Development Goal 4 targets to reduce child mortality by two-thirds by the year 2015 and meet global polio eradication targets. The fourth vaccines, an adult vaccine against Japanese encephalitis will be introduced in districts with high levels of the disease to reduce the disease burden.

There has been some criticism that this is going to add to the cost of the programme. What are your views on this issue?

I think it is a step in the right direction because when you consider the high mortality and morbidity associated with each of these vaccines. India has large birth cohort, with around 27 million babies annually. The costs of getting these infants vaccinated, at 95 per cent coverage is already an expensive proposition.

Nonetheless, I think you have to look at the overall impact these vaccine will have in further improving child mortality and reducing child morbidity.

I think that the rotavirus and injectable polio vaccines make a lot of sense due to the heavy mortality and morbidity associate with rotavirus. India is now polio free which means that we now have to think of the post

eradication end game so the transition from the oral to the injectable polio vaccines makes a lot of sense. With respect to the rubella and the Japanese encephalitis vaccines, I think these too make a lot of sense.

Of course, it does not end there. Maybe there is an argument to be made that measles second dose coverage needs to be increased and improved. So also what about pneumococcal vaccines, given that the burden of pneumococcal diseases is also pretty high so should we

How are the vaccines being developed by Hilleman Labs superior to those already in the market?

We are looking at the

fundamental question of access and affordability. The access of vaccines is driven over and beyond by procurement costs. So you

could have, for example, a rotavirus vaccine which is made indigenously at a very low cost but if that vaccine does not have the appropriate

profile with respect to its stability, storage and distribution, then there is going to be an access problem. In a country which

In a country which is geographically so vast procurement is only going to take you so far.

You have to think about how the vaccine can be taken into the remote areas and ensure that all those pocket of population have access to that vaccine consider adding these too to the national vaccination programme? So I think it is a good start and going forward, I feel that there may be further additions to the UIP. For instance in enteric diseases like cholera where we have a programme ourselves which also tends to have a huge disease burden in India.

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EXPRESS PHARMA

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August 16-31, 2014

MARKET is geographically so vast, procurement is only going to take you so far. You have to think about how the vaccine can be taken into the remote areas and ensure that all those pocket of population have access to that vaccine.

So that is the type of technology we are working on, which allows the product to be free from cold chain storage and distribution chains from a delivery perspective.

One other area we are also working on, outside of thermostabilty, is some very unique, cheap, simple but effective delivery devices.

These are the single container closure devices which allow very easy reconstitution and easy delivery of dry formulated vaccines for oral delivery. So it is a combination of these kinds of technologies that we think will ultimately improve the access.

The other part of course is the affordability. And this is where we will look at the production cost, etc. We have quite a bit of effort in conjugate vaccines which as a class are very complex so it adds to the cost of production. I mentioned rotavirus, cholera. So we are also looking at what can we do to address the cost issues.

Also, there is only one WHO pre qualified supplier as of now of the cholera vaccine (Shanta Biotech) but with the size of the disease burden, will one supplier be enough?

So our strategy is to develop vaccines with better protection at lower cost.

Cholera is caused from enteric infection with the bacterium Vibrio cholerae primarily (~99 per cent) of the O1 serotype. By transferring a functional wbeT methyl transferase gene into the genome of an O1 Inaba strain, our partners, Gotovax AB, a University of Gothenburg spin-off biopharmaceutical company, have created a resulting ‘Hikojima’ strain that stably expresses both the Ogawa and Inaba serotype antigens on its surface; thus improving the stability and efficacy of the

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We are talking to vaccine manufacturers in India, and of course we have the unique advantage of have a good cohort of such organisation within India. And Hilleman being a global company, we are also looking at such players in the South East Asia area vaccine candidate as well as significantly reducing the cost of production. So our vaccine will provide better protection than Shanchol and yet at a price significantly lower than the Shanchol price because of our whole manufacturing strategy is to vastly improve and optimise.

So when you combine these strengths of better effectiveness, lower manufacturing cost as well as thermostability and better drug delivery, our product is superior to the existing product especially from a global stock piling perspective in cholera epidemic areas.

The products coming out of Hilleman Labs’ research pipeline are not being developed only for India and will be used in other countries with the same geographical and climatic conditions. So can you give us any time line to the launch of these products?

Both the rotavirus and cholera vaccines are in the pre-clinical stage, finishing up some toxicology studies which will be followed by animal studies. The toxicology studies should finish by the end of this year for both programmes and we would begin clinical trials next year. As both are basically optimisation studies, we are looking at accelerated clinical development, which means that in the case of the rotavirus vaccine we would look at immunological bridging studies based on sero-conversion.

In the case of the cholera vaccine, we would look at non-inferiority against existing vaccines primarily Shanchol. We think we can achieve these clinical endpoints in the 2017-18 time frame, which will then bring us to registration in our first geography, which could be India or outside of India.

Then we will expand from

there, looking at WHO pre qualification, etc.

Hilleman Labs was established in 2009, the R&D facilities were started in 2011, so its going to be almost a decade before the first product hits market.

Any learnings from this process and could it have been shortened?

This is a learning process for any kind start up/joint venture of this nature because unlike traditional biotech start ups which have a germ of an idea to convert into a product, in the case of Hilleman Labs, the vision was established, the concept put in place, the entity launched but then we had to ask what problem are we going to solve, are we the right people to solve this problem, and if we solve the problem is anyone going to care?

Answering those questions unfortunately took longer than we estimated. Crafting that strategy and deciding what is going to be practical

for us took time but now that’s in place and we are at the implementing stage.

I think any research activity takes a long time to decide the approach, etc.

There is no short cut or formula for that. Especially when you have to pay attention to not just clinical proof of concept but also to the process. Ultimately we need to have a very robust factory ready process because we need to meet very stringent regulations. In fact I would argue that given these factors, eight to nine years is a relatively short period of time. What’s really crucial for us is execution of our strategy. We need to move fast, execute flawlessly but we also need to keep in mind that we are going to need a lot of help. We are talking to companies to help us in clinical development and some of the manufacturing issues, given that Hilleman Labs ourselves are not going to be doing the commercial manufacturing ourselves. All those conversations are happening in parallel.

What are the kind of companies you are talking to at this stage?

We are talking to vaccine manufacturers in India, and of course we have the unique advantage of have a good cohort of such organisations within India. And Hilleman Labs being a global company, we are also looking at such players in the South East Asia area. We began these conversations a year or so ago and now we are narrowing them down. We are hoping that as the rotavirus and cholera vaccine programmes progress, we will take these talks to the next level. We will have to decide who will be our clinical development partner, and then our manufacturing partner. In what geography will we do the manufacturing?

And how does that align with some of the early registrations that we will seek in those geographies? We hope to make these decisions soon. viveka.r@expressindia.com

MARKET COMPANY WATCH

Suven Life Sciences secures product patents Patents from Australia and Eurasia correspond to the NCEs for the treatment of disorders associated with neurodegenerative diseases SUVEN LIFE Sciences has received grant of one product patent from Australia (2010337836) and one product patent from Eurasia (019496) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2030 and 2029 respectively. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia.

Suven has a total of 18 granted patents from Australia and 12 product patents from Eurasia. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at phase-I or phase-II. “We are pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,” says Venkat Jasti, Chief Executive Officer, Suven.

EP News Bureau – Mumbai

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FULL ATTENTION TO THE TINIEST DETAIL. A big machine with some great details.

The CP400 marks a milestone in packaging technology: in 1993 it was the world’s first machine in which the classic vertical shaft was replaced by servo-motor drive of all functional units. After some 20 years of ongoing development, the CP400 has reached a unique degree of maturity; its exemplary GMP design guarantees maximum production security.

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

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MARKET

DCG(I) plans IT-enabled system for fast CTapprovals Seeks stakeholders' suggestions/comments within three weeks Usha Sharma Mumbai AS PER Minister of Health and Family Welfare Dr Harsh Vardhan's recommendations, Central Drugs Standard Control Organization (CDSCO) has proposed to create an information technology (IT)-enabled system for conducting clinical trials in India.

The endeavour is to enable complete transparency and accountability in the functioning of CDSCO. The CDSCO has issued a notice to all stakeholders on creating an IT enabled system for online submission of various information on clinical trials yesterday (July 28) and has invited suggestions/comments within three weeks time to the office of Drugs Controller General (India) (DCG(I)).

This was one of the recommendations of the expert committee chaired by Prof Ranjit Roy Chaudhary which suggested the use of IT during all stages of clinical trials to ensure transparency and faster dissemination of information among stakeholders, including the gen-

In the first phase, CDSCO proposes to create an IT-enabled system for online submission of various information on clinical trials to streamline the process of approval eral public.

It has accordingly been decided that the latest technology and modern tools need to be adopted by CDSCO to discharge duties including grant of approvals/ licences, enforcement etc.

Dr GN Singh, DCG (I) said, “As per direction from the new Government, we are working to bring complete transparency in the clinical trial system. It will provide complete information to laypeople related to the progress of clinical trials across India and also plug the current gaps which exists in the clinical trial approval system.”

According to sources within the CDSCO office, complete IT

implementation will cost around `150 crores. It is amenable to consider tailor-made solutions for clinical trial activities. It has planned to invest in a phase-wise manner, with the first phase requiring an investment of around ` 50 lakhs.

In the first phase, CDSCO proposes to create an IT-enabled system for online submission of various information on clinical trials to streamline the process of approval, maintaining a comprehensive database and monitoring of clinical trials for ensuring the protection of the rights, safety and well being of trial subjects and authenticity of the data generated.

The notice requires that all

information related to sponsor/CROs, investigators ethics committees (ECs) and patients should be captured through online means in an organised manner. On the proposed IT-enabled system, a sponsor /applicant needs to submit the information related to clinical trial to DCG (I), which will have full title of the trial, sponsor’s protocol code number, name or abbreviated title of the trial. The notice also has three annexures which detail the information required to be uploaded by the various stakeholders Seeking the cooperation of the CRO industry, DCG (I) has requested CROs to share feedback/ comments so that they can simultaneously brief the National Informatics Centre (NIC) on industry requirements. “I am sure we will be able to speed up the clinical trial approval process by approximately 60 per cent and all issues related to delay in approval process will get resolved efficiently,” adds Singh.

franchise in Brazil, once it achieves regulatory approval.

Cipher’s isotretinoin product is a novel formulation of isotretinoin, which is used in the treatment of severe recalcitrant nodular acne. Isotretinoin is the most effective severe acne therapy available to teenagers who suffer from acne. The product is marketed in the United States by Ranbaxy as Absorica.

CIPLA EUROPE (Cipla) and BioQuiddity have entered into a commercial collaboration, covering the territory of the European Union and certain other European countries, for BioQuiddity’s OneDose ReadyfusOR in regional anaesthetic applications for post-surgical pain management.

Cipla intends to launch the CE Marked OneDose ReadyfusOR pre-filled with Ropivacaine under its own label into the German market late this year. The ready-to-use infusion systems are non-electric, ambulatory, and should enable seamless transition between sites of care.

“Cipla is an excellent strategic partner for BioQuiddity and our pre-filled ready-to-use post-surgical pain product candidates,” said Joshua Kriesel, President and Chief Executive Officer, BioQuiddity.

“Cipla’s strong commercial record puts them in an outstanding position to detail the OneDose ReadyfusOR’s safety, sterility, and ease of use value proposition objectives.”

“We are thrilled to be BioQuiddity’s European commercial partner for the OneDose ReadyfusOR”, said Frank Pieters, Head, Cipla Europe.

“Cipla believes that this postsurgical pain product candidate presents a unique opportunity to provide an easy to use, well-tolerated, and efficient regional anaesthesia system that could make savings for healthcare providers and patients.”

EP News Bureau – Mumbai

EP News Bureau – Mumbai

u.sharma@expressindia.com

Ranbaxy and Cipher sign agreement To sell and distribute Cipher’s isotretinoin capsules in Brazil RANBAXY LABORATORIES has signed a licensing agreement with Cipher Pharmaceuticals to exclusively market, sell and distribute Cipher’s isotretinoin capsules in Brazil.

The agreement extends the current relationship with Cipher, under which Ranbaxy is marketing and distributing Cipher’s isotretinoin product in the US under the brand Absorica.

Under the terms of the agreement, Cipher will receive

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an upfront payment and is eligible for additional pre-commercial milestone payments.

Cipher will be supplying the product and Ranbaxy will be responsible for gaining regulatory approval of the product in Brazil.

Commenting on the partnership, Sanjeev I Dani, Executive Vice President and Head, Global Strategy, Ranbaxy said, “We are pleased to take this novel formulation of isotretinoin to the additional

large market of Brazil. I am sure it would prove to be a valuable option for dermatologists and patients who suffer from severe recalcitrant nodular acne. We will utilise our strong front-end capabilities in making this product available in Brazil.”

Ranbaxy plans to promote the product through a brand dermatology division in Brazil.

The isotretinoin formulation is expected to be a flagship product in Ranbaxy’s dermatology

Cipla partners with BioQuiddity

MARKET

GVK BIO launches brand CLINOGENT Glenmark plans To offer bioequivalence studies for generic pharma and facility in the US late phase patient-based clinical studies for researchThe facility will manufacture oral solids, injectables and topicals

based companies GVK BIOSCIENCES has unveiled a new brand CLINOGENT in the clinical development industry.

CLINOGENT provides endto-end clinical development services. From offering bioequivalence studies for generic pharma and late phase patient-based clinical studies for research-based companies, CLINOGENT brings expertise in delivering solutions to complex data analysis and medical communication problems to customer’s the world over.

CLINOGENT will endeavour to provide innovative solutions to all the clinical and scientific challenges that

CLINOGENT will endeavour to provide solutions to all the clinical and scientific challenges that their customers face in the business

their customers face in the business.

Manni Kantipudi, Chief Executive Officer, GVK BIO said, “CLINOGENT will be a unique clinical development service provider from India, as it will be able to address the clinical needs of both innovator bio-pharmaceutical and generics companies world-wide. I am confident this step will bring greater focus on delivering innovative and intelligent solutions and will make significant contributions in the clinical development value chain of our customers.”

EP News Bureau – Mumbai

GLENMARK PHARMACEUTICALS plans to set up a new manufacturing facility in Monroe Corporate Centre, North Carolina, US. The facility will be spread over 100,000 sq feet and the company will first begin work on an oral solid unit and thereafter set up manufacturing units for injectables and topicals.

Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals said, “The US is a key strategic market for Glenmark and it is important for us to have a manufacturing base here to serve our growing business in the coun-

try. Over the next five years, we will make significant investments in this proposed facility and set up three units which will produce oral solids, injectables and topicals,” he added.

The company expects to start manufacturing activity by the end of the current financial year FY 2014 – 15. This facility is dedicated only for the US market and is Glenmark’s first manufacturing facility in North America adding to its list of 14 plants in four countries – India, Brazil, Argentina and Czech Republic.

EP News Bureau – Mumbai

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Registered Office Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identification Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

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MARKET DEAL TRACKER

Expansion into new geographical markets drives M&A activity in pharma sector M&A ACTIVITY in the pharmaceutical sector was focused on geographical expansion to create additional growth opportunities. In line with the above trend, Mylan agreed to acquire the non-US developed markets speciality and branded generics business of Abbott Laboratories, a US-based pharmaceutical and healthcare products company, for approximately $5.3 billion.

This acquisition will further diversify Mylan’s business and strengthen its commercial platform outside the US, building

FIGURE: M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

Source:

FIGURE: VENTURE FINANCING TREND ANALYSIS

Source:

TOP M&A DEALS (JUL 2014) Rank

Date

Target

Acquirer

Deal value ($m)

1

07/18/14

Shire plc (IE)

AbbVie, Inc. (US)

54659.8

2

07/14/14

Abbott Laboratories - Generics Business

Mylan, Inc. (US)

5300

3

07/31/14

Rottapharm SpA (IT)

Meda AB (SE)

3084.67

4

07/01/14

Seragon Pharmaceuticals, Inc. (US)

Genentech, Inc. (US)

1725

5

07/30/14

Baxter International, Inc. - Commercial Vaccines Business (AT)

Pfizer, Inc. (US)

635

6

07/11/14

Archimedes Pharma Limited (UK)

ProStrakan Group plc (UK)

387.95

7

07/16/14

InnoPharma, LLC (US)

Pfizer, Inc. (US)

360

8

07/28/14

Penn Pharmaceutical Services Limited (UK)

Packaging Coordinators, Inc. (US)

215.65

9

07/02/14

Aciex Therapeutics, Inc. (US)

NicOx S.A. (FR)

120

10

07/14/14

Phlexglobal, Ltd. (UK)

Bridgepoint Development Capital (UK)

71.92

Source:

TOP VENTURE FINANCING DEALS (JUL 2014) Rank

Date

Target

Investors

Deal value ($m)

1

07/28/14

PaxVax, Inc. (US)

Pharmakon Advisors, LP; Undisclosed Investors

62

2

07/30/14

Cold Genesys, Inc. (US)

Ally Bridge Group (UK)

13.57

3

07/16/14

Virobay, Inc. (US)

Perceptive Advisors LLC; TPG Biotechnology Partners, LP; Alta Partners; Sutter Hill Ventures; AbbVie, Inc.

8

4

07/15/14

amcure GmbH (DE)

LBBWVenture Capital GmbH; KfW Group (Kreditanstalt fur Wiederaufbau); MGB Mittelstandische Beteiligungsgesellschaft Baden-Wurttemberg GmbH (MBG medium-sized investment company Baden – Wurttemberg); BioM AG; S-Kap Beteiligungen Pforzheim; Undisclosed Investors

6.81

5

07/14/14

Xagenic, Inc. (CA)

BDC Capital; Undisclosed Investors

5.12

Source:

16

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MARKET new opportunities for growth and additional sales channels in the acquired markets. This enhanced commercial platform will help Mylan drive the continued expansion of EpiPen(R) Auto-Injector globally and enable it to more effectively launch important growth drivers, such as respiratory and biologics.

In addition, the transaction also provides Mylan with reach in the physician and patient channels in the acquired markets, complementing its reach in pharmacies.

In another key deal, Meda agreed to acquire Rottapharm, an Italy-based consumer healthcare focused branded speciality pharma company, for $3.08 billion. Rottapharm’s presence, with its own sales forces, in Southeast Asia is particularly complementary to Meda, providing additional opportunities to sell Meda’s products in new geographic markets.

This transaction would increase Meda’s consumer healthcare presence and provide a diverse portfolio of brands such as: Dona(R), Saugella(R), ArmoLIPID(R), and Legalon(R).

M&A activity in the pharma sector increased in volume and value terms, when compared to the average of the previous six months’ (Jan 2014 – Jun 2014).

According to Datamonitor's Medtrack database, the pharma sector recorded 33 M&A transactions in July 2014, against the previous six months’ average of 30.6 transactions.

In value terms, the sector recorded deals worth $66.7 billion, against the previous six months’ average of $16.4 billion.

The Indian pharma sector witnessed two deals in Jul 2014, against the average of 0.6 deals over the previous six months.

Notable among them is Strides Arcolab’s acquisition of majority stake in India branded generics business of Bafna Pharmaceuticals for $8 million.

This acquisition would strengthen the women and child care portfolio of Strides’ branded generics business and provide necessary impetus to its domestic branded generics business. The transaction would strengthen Strides’ reach to newer markets with a wider portfolio of products.

EXPRESS PHARMA

Venture funding Companies in the pharma sector raised $106.1 million during July 2014, against the previous six months’ average of $260.4 million. In terms of volume, the sector recorded 13 venture funded deals, when compared to the previous six months’ average of 13.8 transactions.

Part III: 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.

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

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.

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August 16-31, 2014

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MARKET POST EVENT

OPPI hosts 3 Healthcare Access Summit rd

Focuses on collaboration to achieve universal healthcare access in India THE ORGANISATION of Pharmaceutical Producers of India (OPPI) recently organised its third Healthcare Access Summit in Mumbai. At this summit, leaders from the pharmaceutical industry, healthcare policy experts, consumer activists and other distinguished professionals focused on the importance of partnerships in achieving affordable healthcare access for all.

Global best practices in healthcare access were shared and discussions revolved around better standards in healthcare and wellness.

“Understanding the challenge is critical to achieving Universal Healthcare Access and finding sustainable solutions. Government needs to lead the way in collaborating with the industry and all stakeholders. We need holistic solutions and all the stakeholders will have a role to play, the pharma industry is willing to step forward and do its part,”

18

EXPRESS PHARMA

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(L to R) Sanjeev Navangul, Managing Director- Janssen India, J&J; Ranjana Smetacek, Director General, OPPI, Shailesh Ayyangar, President, OPPI and Managing Director, India and Vice President- South Asia- Sanofi; DR Mehta, Founder and Chief Patron, Bhagwan Mahaveer Viklang Sahayata Samiti; Sudarshan Jain, Vice President OPPI Access & Affordability Working Group and Managing Director, Healthcare Solutions, Abbott Healthcare

said Ranjana Smetacek, Director General, OPPI, in her welcome address.

Dr Shailesh Ayyangar, Pres-

ident, OPPI, and Managing Director, India and Vice President, South Asia, Sanofi added, “The pharma industry is more

than willing to partner with the Government to achieve the vision of healthcare access for all.

Focus on human resource aug-

mentation, last-mile availability of medicines and stronger healthcare distribution will catalyse access to healthcare.”

Pankaj Patel, Chairman and Managing Director, Cadila Healthcare, in his discussion, pointed out that healthcare in the country presently seems to be ‘nobody’s baby’.

He added, “Effective access to healthcare can be achieved only with a stable healthcare policy which will address all the critical dimensions. Government needs to encourage innovation and clinical research that will provide access to modern medicines.”

DR Mehta, the Founder and Chief Patron, Bhagwan Mahaveer Viklang Sahayata Samiti (BMVSS) was the recipient of the first OPPI Healthcare Access Award 2014 for the exemplary work done for the rehabilitation of the physically disabled.

EP News Bureau – Mumbai

EVENT BRIEF SEPTEMBER -OCTOBER 2014 25

PharmaLytica 2014

PHARMALYTICA 2014 Date: September 25-27, 2014 Venue: BIEC, Bangalore Summary: UBM India will host PharmaLytica 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. 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

16

Association of Contract Research Organisation (ACRO) will support the event.

Contact details Rahul Deshpande Sr. Manager - Projects Tel: +91 22 61727165 Mob: +91 98209 02476 Email: rahul.deshpande @ubm.com TH

DIA’S 9 ANNUAL CONFERENCE Date: October 16-18, 2014 Venue: Mumbai Summary: The theme of the meeting is ‘The Future of Indian Healthcare: Patients, Ac-

th

DIA’s 9 Annual Conference

cess and Innovation.’ The programme committee members are Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals Europe, United Kingdom, Madhur Gupta, Technical Officer - Pharmaceuticals, WHO, India, Prof Ranjit Roy Chaudhury, Chairman, Task Force for Clinical Research, Apollo Hospitals Group.

Speakers who will take part in the conference are MK Bhan, Former Secretary, Department of Biotechnology (DBT), Government of India, Vikas Mohan Sharma, Senior Director, Medical Ethics & Research Office of CMO, Quin-

tiles Technologies India, Bhasker Iyer, Divisional Vice President, India Commercial Operations, Abbott Healthcare, Urmila Thatte, Director, FERCI, Prof and Head, Deptartment of Clinical Pharmacology, KEM Hospital, Satish Chandra, Senior Specialist and Head Clinical Research, TAWAM Hospital (associate of John Hopkins), United Arab Emirates, YK Gupta, Prof & Head, Department of Pharmacology, All India Institute of Medical Sciences, Pooja Sharma, Patient Advocacy Groups, CANKIDS, India, Ajoy Roy, Senior Medical Director and Head Medical Affairs, Parexel, Vivek Ahuja, Director,

PATH, Adnan Mahmood, Director- Medical Safety & Clinical Development, Global Patient Safety, UK, Mira Shiva Founder, Health Action International Asia Pacific, Mira Shiva, Founder, Health Action International Asia Pacific, Vikas Ahuja, President, The Delhi Network of Positive People, Ketho Angami, Executive Member, HepCoN. Contact details Drug Information Association A-303, Wellington Business Park - I, Marol, Andheri Kurla Road Andheri (East) Mumbai - 400 059 Tel: +91.22.67417625 Website: www.diahome.org

Medica Instrument Mfg Co sales@medicainstrument.com

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cover )

LAB SPECIAL

Indian pharmaceutical companies are putting extra efforts into researchled innovation. But they feel their efforts deserve more attention and incentives from the Government

BY USHA SHARMA According to a report from the India Brand Equity Foundation, India is among the top five emerging pharma markets across the globe and has grown at an estimated compound annual growth rate (CAGR) of 13 per cent during FY 2009–2013. In fact, the domestic pharma industry in India has been growing faster than the average CAGR of emerging markets, clocking a CAGR of over 14.5 per cent for the past four years.

In the past few years, Indian companies are investing a

C O U N T I N G

O N

RESEARCH considerable part of these earnings on research and development (R&D) towards building strong product pipelines. Dr Manu Chaudhary, Joint Managing Director, Venus Remedies, and Director, Research, Venus Medicine Research Centre observes the new trend in the pharma sector and says, “The trend in Indian pharma is shifting from process patent-based research to innovative solution-based research." She admits that global acceptance of this research will take time.

Market forces justify the need for innovation-led drugs science. Bhavin M Mehta, Director, Kilitch Drugs simplifies the necessity to invest in scaling up research pipelines and says, “It has become necessary for pharma companies to invest in the technology pipeline of discovery research which will help them to sustain in the market with new products time to time.”

Opportunities knocking at door By 2016-17 most of today's branded drugs will be off patent and foreseeing these opportunities, Indian pharma companies are planning to launch various drugs across the globe. Chaudhary explains, “The Indian pharma companies are going all out to launch various generic drugs across the globe. The first generic is the key and the one who has the best R&D capabilities and expertise will be the one to lead the show.”

Domestic pharma companies have proven capabilities in branded generics and are now focusing on the development of innovative drugs. To meet global requirements, many Indian pharma companies have a strong product pipeline for both the domestic as well as for the international markets which are in different stages of the development process.

Analysing the potential of Indian pharma companies to deliver better medicines to the world at an affordable cost, Aditi Kare-Panandikar, Managing Director, Indoco Remedies avers, “The Indian pharma industry is highly fragmented and R&D can create a good

20 EXPRESS PHARMA August 16-31, 2014

( measure of differentiation and distinction to companies. Only those companies which spend substantial amount on research activities will have products ready as per the market requirements, fuelling a sustainable growth.”

“India’s large talent pool and cost effective strategies have helped pharma giants to cut short budgets involved in pipeline projects. On the other hand, small companies coming up with innovative technology pipelines are becoming outsourced partners for giants in generating IP for newer molecules,” Mehta highlights.

filing to go after the First to File (FTF) opportunity. However, for the other companies, the opportunity to manufacture for leading pharma players globally, in itself is a great opportunity.”

Challenges Over the last one and half years, the Indian pharma industry's image has been somewhat sullied in the global pharma market. Manufacturing facilities of

THE MAIN FOCUS

Indian pharma companies have been under the US FDA scanner while drugs manufactured in India and exported to other countries have been labelled as 'sub-standard' or spurious.

Besides facing increased scrutiny from global regulators, pharma companies are facing the heat on home ground as well.

Delays in the approval process have also negatively impacted

Strategies Indian pharma companies are investing considerably on its R&D projects. As per data available, R&D investments in India have grown from `347 crores ($ 52.5 million) in 2000 to ` 4,276 crores ($ 646.5 million) by 2010.

Of which, nearly 80 per cent is accounted for by the domestic companies while the remaining 20 per cent comes from foreign companies. It is the result of pharma outsourcing to the Indian market which is constantly growing at a CAGR of 62 per cent over an eight-year period.

Chaudhary spells out, “Research is the key driver for any industry to be competitive. In a country like India which has a vast talent pool of intellect, an encouraging research environment can bring laurels to the country. There is nothing which India cannot do or deliver to the world either in new drug development, contract research or joint research. These new avenues hold great potential and a promising future lies ahead.”

Kare-Panandikar feels, “For almost a decade now, Indian companies have shown a very good understanding for early product selection, process chemistry, patent challenge and market entry strategies. These are needed to take advantage of being early entrants in the generic space. And the generisizing of several products in the developed markets produces a good opportunity for the Indian pharma companies. Many have a distinct advantage of early

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cover ) As pharma and healthcare industry go hand in hand, grants to Government hospitals to conduct investigator initiated studies by centre will be a big assistance to industry Dr Manu Chaudhary, Joint Managing Director, Venus Remedies, and Director, Research, Venus Medicine Research Centre

India’s large talent pool and cost effective strategies have helped pharma giants to cut short budgets involved in pipeline projects Bhavin M Mehta, Director, Kilitch Drugs

Uncertainty in the pricing policies is becoming a major challenge for the industry Aditi Kare-Panandikar, Managing Director, Indoco Remedies

22 EXPRESS PHARMA August 16-31, 2014

most companies' commitment timelines and the recent efforts to bring more medicines under price control are further agitating the industry.

As Kare-Panandikar points out, “Uncertainty in the pricing policies is becoming a major challenge for the industry. The recent announcement by the NPPA, reducing the prices of products not covered under National List of Essential Medicines (NLEM), has come as a surprise. The regulatory framework in the country clearly needs to orient itself for the speedy development of the pharma industry.”

“Due to lack of clarity, most of the clearances are delayed, especially new drug approval, R&D test licenses, import/ export licenses, etc. The customer focus is lost, leading to delays in product approvals in the domestic markets and custom clearances of imports/ exports, which is highly detrimental to the growth of any company,” Kare-Panandikar emphasises.

And the fallout may not be exactly what the government expected. Chaudhary comments, “This (regulatory delay and increasing price control) is one of the reasons why many pharma companies may exit or sell few of their brands to remain in the race.“ Even more worrisome than brands being sold, is the fact that many of these companies have started looking at overseas options where doing business will be smoother. As Chaudhary says, “The slowdown in clinical R&D, patent processes and delayed regulatory approvals are pushing a lot of Indian pharma companies to think of shifting their operations to South-East Asia. In pharma nothing can be launched without human clinical trials and though the new laws imposed on the industry were intended to streamline processes, some of them proved to be hasty decisions. Awareness among various stakeholders, government support and a conducive healthy atmosphere for creating a research ecology are the only means to tackle it.”

LAB SPECIAL

Survival model The industry is trying to overcome these challenges with a long list of measures but this is only possible if companies have strong research pipelines.

Sharing her mantra for sustainable growth and to encourage pharma companies devoted to building an R&D community, Chaudhary says, “R&D is the key to survival because the world runs on the 'survival of the fittest' theory. In a cut throat competitive environment, with ever rising pressure on margins of generic products, moving to research is the only option to keep growth alive.”

Kare-Panandikar feels the stringent regulatory approval process is an opportunity as it helps the company to continuously upgrade itself to a high technical competency. She speaks on how challenges can be converted into opportunities and says, “We are expanding and investing in our regulatory and quality teams to stay abreast with the new guidelines issued by the regulatory authorities globally.”

Chaudhary's message will certainly encourage the community as she says, “R&D is a

very satisfying work to show your creativity, a sense of responsibility towards society, a feeling of pride for the achievements and a continuous motivational factor to move ahead.”

Mehta explains, “Molecules worth $250 billion are going off patent. Although the generic industry will benefit in the short term, it will also see a slowdown in revenue growth after 2015 because fewer blockbusters will be coming off patent for them to replicate, hence the time is ripe for pharma companies to invest in R&D in order to benefit in the long run.”

Kare-Panandikar's statement reflects through her action. The company has expanded its R&D facility from a 200 sq ft area created in 1993 in Rabale, to a state-of-the-art R&D facility covering 100,000 sq ft area, employing 200 scientists. “We are planning to further expand R&D activities in Goa,” she informs.

Indoco Remdies encourages R&D activities by involving the core team in strategy planning so that they have a long-term perspective, are aware of the market needs and are prompted to come out with

innovative ideas. This ensures a continuous pipeline of new products and improvement in the existing ones.

Better approach There is a need to bridge the gap between industry and academia but unfortunately not too many efforts have been taken on this front. Pharma companies need to work closely with academia for better research output. Over a period of time the sector has been rattled by various reasons. Chaudhary analyses, “The challenges being faced by research companies include lack of funding for research as investor sentiment in India is not pro research, lack of specialised infrastructure because each company cannot invest in costly instruments and there is need for Central Instrumentation Labs (CIL) in the acadamic set up to support companies. Further, the approach at the academia level needs to be changed for industry-academic collaborations to come up with some economic solutions for industry.”

In India, companies like Kilitch Drugs have already taken a step ahead by investing

( in promising small start up companies. This helps in working closely with them in leveraging the company's growth. Mehta reveals, “We have been encouraging R&D activities every year by investing in small/start-up companies who have the capability to bring innovation in the pharma market. In 2013, we invested in a start-up “Novo Informatics” based in Indian Institute of Technology Delhi. Their expertise in computational drug discovery helped them to collaborate with pharma companies and academic units globally to discover new chemical entities.”

must be special recognition and incentive for intellectual wealth creation. As pharma and health-

care industry go hand in hand, grants to Government hospitals to conduct investigator initiated

THE MAIN FOCUS

studies by centre will be a big assistance to industry.” She sums up, “We plan to meet the Prime

Minister directly if he gives us an opportunity to listen to us.” u.sharma@expressindia.com

Aspiration for next level The Indian pharma industry has been in the limelight recently for all the wrong reasons. The industry is trying to communicate their side of the story to the Government but there has not been too much response. The industry had really high hopes from the Union Budget 2014-15, but unfortunately, it did not meet their expectations.

Stakeholders feel that to combat these prevailing issues, industry needs more attention from the Government. Chaudhary suggests, “The centre must create a healthy ecosystem and environment for research, especially with respect to funding by venture capitalists, private equity players along with an industry-academy collaboration for low cost research. There must be a change in academic study design to ensure that at least 50 per cent of the project work done by students in universities at M.Pharm/Ph.D/MD levels must be industry-sponsored.

This will not only bring industry and academy closer but will also fetch good talent pool and low cost research to industry.”

Kare-Panandikar too puts forwards her wishes and says, “The research-based pharma companies will need speedy issuance of licenses to conduct bio-studies, clinical trials, import of innovator product samples and hassle-free custom clearances of imports and exports.

We plan to raise these issues with the Government through industry associations.”

Chaudhary suggests, “There

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cover )

SAFETY FOR

SUCCESS Ensuring safety norms are followed in laboratories is one of the crucial criteria for pharmaceutical companies to bag a Good Laboratory Practice (GLP) stamp of approval.

But there are many lessons lab operators still need to learn to achieve this feat

BY SACHIN JAGDALE

24 EXPRESS PHARMA August 16-31, 2014

LAB SPECIAL

(

THE MAIN FOCUS

A

ny pharmaceutical company is only as good as its last blockbuster, or rather as good as is being researched and tested in its R&D labs. The laboratory, whether R&D or QC, is thus at the heart of the success of a pharma company; nay the entire industry. From such labs, emerge best selling medicines. Such labs also test every batch of medicines going into the market. Pharma companies accordingly invest a sizable chunk of their capex to buy the latest high tech

India is at par with global standards when it comes to practicing safety. It is done as per the EHS guidelines Surendra Chavan, Founder and CTO, Quantimmune Solutions

equipment, hire the best talent and put in place safety and security measures to protect its people and the data generated.

Creating a lab is one thing, running it as per regulations and getting it certified is a different task altogether. One important factor is maintaining a safe environment in these laboratories and this aspect is globally governed by Environmental, Health and Safety (EHS), Occupational Safety and Health Act (OSHA) guidelines.

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August 16-31, 2014

cover ) India follows the same guidelines.

Speaking about the trends in lab safety, Surendra Chavan, Founder and CTO, Quantimmune Solutions, a Mumbaibased CRO says, "Staff undergo safety trainings at regular intervals which involves fire-fighting, spillage control etc. Mock drills are conducted. Alarm systems have been installed and people are trained to respond to the same.

Similarly designated individuals act as safety co-ordinators who become a link between the lab staff and the EHS department. Personal Protective Equipment (PPE) which includes mask, gloves, goggles etc. are worn by staff while working in the lab."

Salil Sansare, Director, Labguard India, a leading manufacturer of safety features like fume hoods and laboratory furniture, which also offers lab design services, provides more details on how pharma companies can meet lab safety standards. According to him, labs are designed in an ergonomic manner so that material and man movements are free. Separate chemical storages are defined. An adequate number of eye wash stations and safety showers are installed in the lab to handle emergencies. Their locations in the lab are also carefully decided based on workflow patterns.

Sansare describes many steps taken to ensure lab safety.

"Lab users need to check the norms to use flameproof electrical fittings. Good level of efforts are made to ensure that labs are electrically safe," informs Sansare. Flameproof electrical fittings are important as in the last few years quite a few mishaps were reported in pharma plants across India.

Some of these incidences were suspected to be the outcomes of electrical short circuits.

Sansare adds, "Lab ventilation is also given a lot of importance. More and more labs are well ventilated or even air conditioned. VAV systems are integrated into the lab’s heating, ventilation, and air conditioning (HVAC) system to achieve

26 EXPRESS PHARMA August 16-31, 2014

comfort and safety in the lab. Fume hood performance tests are carried out as per ASHRAE-110:1995 or EN-14175:2003 standard to ensure that the fume hoods are safe to use and not merely a ventilated box."

Employee, a risk carrier Laboratory staff is perhaps the most mobile object in any lab. Disease carrying individuals can spread disease causing bacteria to different parts of the lab.

So they can also be classified as a risk factor to the laboratory.

“Laboratory management should take the health and safety of employees into account. As per GLP norms, all laboratory persons should have annual medical examination to know their physical fitness /health status. An individual who has an illness/disease which may adversely affect the quality and integrity of the study should be excluded from direct contact with test systems and from test and control articles until full recovery from that illness/disease. After a medical fitness test approval is obtained, he/she can again perform regular laboratory work. It can be certainly classified under a safety risk to the lab,” opines Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals.

Experiments that involve animals are at higher risks due to the staff that has health issues. There are chances of zoonotic disease, which are transmissible between animals and man. Intox Laboratories perform toxicological studies and lab animals are integral part of their regular studies.

Dr Mukul Pore, Director, Intox Laboratories, says, “If any person working with animals is found

LAB SPECIAL

The labs are designed in an ergonomic manner so that material and man movements are free Salil Sansare, Director, Labguard India

As per the GLP norms, all laboratories and organisations carrying out testing, calibration, validation in India have to adhere to Schedule L 1 guidelines Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals

An appropriate immunisation (vaccination) schedule should be adopted for people working with animals Dr Mukul Pore, Director, Intox Laboratories

to have any communicable disease (zoonotic disease) which would affect the studies and other individuals working in the facility, he/she shall not be allowed to work in the animal house. The management should organise medical check ups of all the staff and workers at the time of joining and at least once a year. This examination should be conducted by a registered medical practitioner.”

While talking about more safety precautions that are to be taken while working in the animal labs, Pore informs, “Potential hazards while working with animals include zoonoses, chemical, biologic and physical hazards (e.g. radiation and allergies). Personnel working in the animal house or laboratory should be trained for zoonoses, unusual conditions or agents that might be part of experimental procedures (e.g. use of human tissue in immunocompromised animals), handling of waste material, personal hygiene etc. Researchers should be instructed (enforced) to use Personal Protective Equipments (protective clothing, gloves, masks, face shields, head cover, coats, shoes or shoe covers) to avoid exposure to urine, faeces, and allergenic agents associated with animal subjects. Outer garments worn in the animal rooms should not be worn outside the animal facility. An appropriate immunisation (vaccination) schedule should be adopted for people working with animals. It is important to immunise animal care personnel against tetanus, rabies (if working with species like dogs, primates etc) or hepatitis B virus (if working with human blood or human tissues).”

Chavan says, “People working in the lab periodically undergo medical and or physical evaluation and

based upon the clean bill of health they are allowed to work in the lab.”

Safety audits Irrespective of the purpose and size, regular examination of safety measurements at the lab is recommended by concerned authorities. Every lab has to perform safety audits as directed by the domestic and international norms.

Dahatonde informs, “The GLP guidance and norms, based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP has now become a national system for GLP compliance monitoring and for recognition/certification of test facilities/ laboratories engaged in conducting safety studies, concerned with the effect of chemicals/pharma products on human health and environment. As per the GLP norms, all laboratories and organisations carrying out testing, calibration, validation in India have to adhere to Schedule L 1 guidelines. Global regulatory norms are based on OECD guidelines. As per guidelines, the period of safety audit is once in a year by external experts and internal audit as per planned schedule.”

He adds, “The GLP accredited lab should have qualified safety personnel to maintain and to implement documented safety system. The safety personnel should prepare a schedule for technical audit of the laboratory by an expert. Internal safety audits should be done to assure the safety measure with appropriate checklist, to verify that the operations continue to comply with the requirements of safety system and regulatory authorities. It also needs periodic checking of all safety equipment and accessories along with annual service contracts with the safety equipment suppliers to ensure the performance of the equipment.”

According to Chavan, safety audits are based upon the Standard Operating Procedure (SOP) adopted by the company, keeping global practices in mind.

( Training matters According to the industry experts, despite well defined safety norms for labs, reports of untoward incidences are not uncommon. There is also consensus on the fact that only properly trained staff can ensure safety at labs. Use of different types of chemicals, different animal species, radiological materials, different types of gases is quite common in all kinds of labs. As these material are sensitive in nature and lack of knowledge in handling them is asking for trouble. “Researchers are provided with extensive training for handling animals safely to avoid bites and to minimise experimenter-induced stress in the animals,� points out Pore, who is closely associated with ex-

with global standards when it comes to practicing safety. It is done as per the EHS

guidelines. In the coming years experiments in labs are going to get more complex. However,

THE MAIN FOCUS

on the positive side, technological advances taking place simultaneously are going to

fulfill newly generated safety related requirements as well. sachin.jagdale@expressindia.com

According to the industry experts, despite well defined safety norms for labs, reports of untoward incidences are not uncommon periments related to animals.

The employees need knowledge of handling safety related emergencies during working in the lab. They are educated by frequent training programmes by safety experts, which includes handling cylinders of compressed gases relevant colour identification codes. Additionally they are educated in the first aid techniques, emergency care and use of antidotes and use of firefighting equipment including fire extinguishers, fire blankets and gas masks.

Though always criticised for safety measures at the labs, according to Chavan, who has extensively worked in an overseas lab environment, India is at par

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MANAGEMENT

Express Pharma hosts Idea Exchange with Dr Kenneth Thorpe on prevention of NCDs Dr Shashank Joshi, President, Indian Diabetic Association and Dr Ratna Devi, CEO, DakshamA Health & Education were also part of the Idea Exchange held recently in Mumbai

W

ith non-communicable diseases (NCDs) like asthma, arthritis, cancer, diabetes and heart disease taking more than 36 million lives each year, they have emerged as one of the biggest threats to India’s health. They pose a double menace as NCDs not only affect the quality of life but also drive up healthcare costs thereby hindering healthcare access and affordability.

Express Pharma & Express Healthcare, Indian Express Group publications conducted an Idea Exchange with Dr Kenneth Thorpe, Chairman of the Partnership to Fight Chronic Disease (PFCD) to delve more into this situation and mull on effective measures that need to be implemented to tackle the growing threat of NCDs in India.

Thorpe was joined by Dr Shashank Joshi, President, Indian Diabetic Association and Dr Ratna Devi, Chief Executive Officer, DakshamA Health and Education.

Viveka Roychowdhury, Editor of Express Pharma and Express Healthcare, moderated the session which offered perspectives from three major stakeholders i.e. policy expert, clinician and a patient/NGO to the questions posed by her and the audience.

Thorpe stressed on the gravity of the situation as far as NCDs are concerned and said, “The magnitude of the problem of chronic diseases/NCDs in India is substantially growing. To fill the gap between what’s needed in terms of system delivery and patient treatment, I think there is a growing interest in

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(L-R) Dr Ratna Devi, CEO, DakshamA Health and Education, Dr Kenneth Thorpe, Chairman of the Partnership to Fight Chronic Disease (PFCD) and Dr Shashank Joshi, President, Indian Diabetic Association

coming up with a blueprint or a comprehensive healthcare reform framework that really focuses on three issues i.e. how to do a better job in preventing the growth of chronic diseases, how to increase the disease detection rate and building a primary care, chain-based care management system.”

Joshi, a strong advocate of prevention and early diagnosis to stop the advent of chronic diseases said, “Chronic diseases are a common threat because of fundamentally sedentary work habits, improper diets and probably some genetic transformation. Hence, NCDs should be a common goal/theme and deliverables must be achieved by health-

care workers. We are one of the largest exporters of doctors and healthcare workers across the world. Yet, healthcare (in India) is grossly understaffed. We have one of the worst doctor to patient ratios.

But, the bigger challenge in prevention is actually looking at pre-disease (hidden disease) and that burden is very large. It needs a political will and individual will to make a change. We are not yet empowering either our policy makers or our individuals to make that change. That needs to happen. It has to be a movement. Until we are able to crystallise the movement, we will not be able make a dent on our numbers.”

Ratna was emphatic that

unless people understood the gravity of the situation and became more pro-active in maintaining their own health, it would be difficult to curb NCDs. Giving the example of the HIV campaign where patients themselves formed peer groups, got themselves tested and helped remove the stigma associated with the disease, she said, “In the NCD segment this kind of movement is yet to start. Though there are a few organisations that are working in particular areas, especially the cancer groups where there is a lot of advocacy, awareness is being generated and enrollment has happened so people are coming forward to seek treatment, it is still at a very

nascent stage. Lot of work needs to be done to get people mobilised to work together and become aware so that they start working towards prevention and manage their health by themselves.”

Thorpe also spoke on successful programmes implemented in the US to curb smoking and effective diabetes management programmes implemented in several countries like Finland and China, as examples of initiatives that can be emulated in India to deal with NCDs. The three speakers also gave their recommendations on the measures that need to be implemented by the Government to curb NCDs in India.

IDEA EXCHANGE: RECOMMENDATIONS

DR KENNETH THORPE

DR SHASHANK JOSHI

DR RATNA DEVI

Dr Thorpe emphasised on the need to develop a national framework or road-map for driving the kind of reforms that will really prevent the growth in NCDs, do a better job of early detection and then manage and work with patients to do that.

His first recommendation was to recognise the power of partnerships. Pointing out that the magnitude of this problem is quite substantial, he said that the Government is not going to solve this by itself.

So, patients, providers, employers and employees, should work collaboratively as part of their process.

He also suggested finding ways to unleash an extraordinary amount of entrepreneurship and innovation, which in his opinion is already here in India. He said, in many sectors of the Find ways to Indian economy there has unleash an been a lot of innovation in extraordinary international leadership amount of and entrepreneurship and entrepreneurship advised harnessing it to and innovation to prevent disease or make it a part of the reform process, and coming up for delivery with innovative ways to presystem reforms vent disease or for delivery system reforms.

He highlighted that India spends a real low amount of money on healthcare and the bulk of it is paid out of pocket. Hence, as part of the framework discussion, there should be a debate on the role of private insurance and examine whether the kind of private insurance that currently exists in the market makes any sense in terms of treatment of the chronically ill patients. He said that probably there is a big gap between what the insurance covers and what is really needed to provide healthcare services which are clinically effective to chronically ill patients. So, if one can get more money from the private sector then it is an opportunity for the Government sector to increase their commitment towards those at the lower end of income distribution and come up with a national framework for public health infrastructure which can be initially adopted at the state-level.

He says that a road-map which gauges the wide variety of stakeholders i.e. insurance groups, provider groups, patient advocacy groups, employers, and takes the best of the best will lead to a lot of good thinking. Then there will be people, who are some of the best, sitting at the table trying to solve the problem.

Dr Joshi pointed out that we need to recognise that NCDs are an epidemic in India and our healthcare professionals, especially the Health Ministry needs to recognise that we should not be in NCD-denial mode. He mentioned that while a tobacco control programme and smoking-cessation has just come in place, we also need to ban and tax fast foods very aggressively because by breaking our ancestral habits and embracing such foods, as well as becoming physically inactive, we are seeing an increasing incidence of hypertension, diabetes or heart disease as well as stress and depression.

Besides aggressively tackling NCDs at each stage, from predisease to the end stage, Joshi believes we need to empower Though the Food our patients. Therefore we Security Bill need to have more nutripassed by the tionists, more counselors, previous more support systems in Government will place as well as peer give cereal groups. security, not He also mentioned that providing protein though the Food Security will make Bill passed by the previous beneficiaries Government will give cediabetic real security, not providing protein will make beneficiaries diabetic. We need a movement to generate awareness on these issues, said Joshi.

Dr Devi’s first recommendation is to recognise patients as a very strong voice that can contribute very positively at different levels.

The second one is to empower them with the right amount of knowledge and the tools. There is a lot of information available but how to understand that at an individual level to be able to connect or correlate to the disease condition or the disease syndrome that the patient has, is very difficult. She feels that is the reason why we hear a lot of stuff but we do not really imbibe or understand what exactly it is trying to convey.

So, Dr Devi wants to empower them with the right knowledge and the right tools. She clarifies, that there are a lot of diagIt is very difficult nostic kits and home made in the current kits available in the market situation because but again how easy are they our health system to use, how comfortable are is over burdened people really buying the so that kind of stuff because one may buy space just does an instrument but the paranot exist phernalia that goes with it is sometimes is not available. So empower the patients so that they are able to use the tools with the right knowledge and the right information.

Thirdly, make the patients responsible for their own disease outcomes, manage their own disease in a way that they feel happy at the end of a certain period that they have achieved the targets they set for themselves. She mentioned that it is very difficult in the current situation because our health system is over burdened so that kind of space just does not exist. Counselors from amongst the patients or caregivers can come forward and do the work for them.

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In her closing remarks Roychowdhury thanked the speakers for their insights and said it is to be hoped that such debates will pave the way for effective policies and strategies which would help in bringing down the numbers of NCD incidence in the country.

EP News Bureau-Mumbai

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MANAGEMENT I N T E R V I E W

‘We will bring significant value to our customers to help us grow quickly’ GVK Biosciences has recently unveiled a new brand Clinogent in the clinical development industry. Its distinctive approach comes from the fact that it provides end-to-end clinical development services. Chetan Tamhankar, Senior Vice President, Clinical Development, Clinogent reveals the company's plans to Usha Sharma Why did GVK BIO introduce Clinogent as a separate division of the company as a clinical development solution at a time when the CRO industry in India is in a state of upheaval?

Though the Indian industry is going through some challenging times, we believe it is the right opportunity to invest now as the time will change for better in the coming months.

We have invested during the downturn so that we are ready to grab the opportunity on the upturn.

By integrating our clinical pharmacology and late phase clinical trial (CT) units under one brand identity, we have created an integrated service offering that will differentiate itself with intelligent and innovative

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solutions for our customers.

There are a number of domestic as well as multinational CROs in India. How can Clinogent compete with them and what strategies have you chalked out?

There are Bioavailability and Bioequivalence (BA/BE) CROs apart from late phase CROs. None of the other CROs have integrated offering that is as mature as Clinogent. With our clinical pharmacology offering for generic companies, late phase trials for researchbased companies and stateof-the-art data, statistics and medical communication solutions, we offer an integrated and differentiated solution and hence are confident that we will be able

to compete well with other CROs. We are also working on creating new solution offerings that are innovative and integrated for our customers.

The Indian CRO industry has seen regulatory reforms in the last one and half years. According to you, are these reforms rational?

How will they impact the industry’s growth? Will they act as a key for success or will they mark the start of a downward spiral?

Yes. Robust scientific and ethical review and approval process, ensuring patient/subject rights are protected, making sure that patient/subject is fully informed about what to expect when he/she agrees to participate in a trial and

taking care of patient if he/she has experienced injury/illness due to participation in study. All these reforms and regulatory changes are rational and in the right direction. The concern was lack of clarity, and extended delays in decision making. We are optimistic that if now the new Government moves ahead with proper decision making quickly and with clarity, it will act as key to success for the industry.

By what percentage has the clinical trial approval rate decreased in the last twothree years? What impact has this had on your company's growth?

The approval rate of BA/BE studies for generic products did not decrease,

MANAGEMENT however, for new drugs approval, the rates were dramatically impacted in 2013. Approval rate dropped over 90 per cent in 2013 as compared to previous year, which has of course impacted the industry significantly.

The company has announced that it will carry out studies for both large and small molecules. How will this differentiate Clinogent from other companies?

It is estimated that six of top 10 blockbuster drugs will be biologics in coming years and it is necessary for CROs to align their offering to meet this market demand.

Expertise in large molecules that are primarily biologics

It is estimated that six of top 10 blockbuster drugs will be biologics in coming years and it is necessary for CROs to align their offering to meet this market demand. Expertise in large molecules that are primarily biologics will help position correctly to meet the market expectations will help us position correctly to meet the market expectations.

Europe and Asia as well. India of course remains a crucial market for us.

Do you think Turkey is a key market for Clinogent?

Which other markets can be tapped?

Turkey is as important an market as other markets for us. We are focusing on the US,

How will your industry experience leverage the company to grow much faster?

GVK BIO has over 10 years of experience in servicing our customers

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across the range of service offerings. I am sure we will bring significant value to our customers to help us grow quickly through our innovative service offering.

Presently, how many research sites do you have and what are your future plans?

We have two clinics (Ahmedabad and Hyderabad for clinical pharmacology studies) and have access to over 300 investigator sites across India, Bangladesh, Nepal and Sri Lanka for late phase trials.

Tell us about the company’s short and long-term plans We are evaluating various options and it is difficult to specify as of now. We will invest in expanding bioanalytical facility at Ahmedabad and expand and strengthen our data, statistics and medical communication services further. These are near term steps. We are still working on our long-term plans. u.sharma@expressindia.com

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MANAGEMENT INSIGHT

Need for HEOR in India: An overview

DR AMIT DANG, Founder and Chief Executive Officer, MarksMan Healthcare Solutions

Dr Amit Dang,Founder and CEO,MarksMan Healthcare Solutions elaborates on concepts like HEOR,HTA, pharmacoeconomics,and gives insights on their role and challenges in the Indian context HEALTH ECONOMICS and Outcomes Research (HEOR) and Health Technology Assessment (HTA), though quite popular in the healthcare sectors of developed nations such as the US and European countries, are relatively new terms in the Indian healthcare sector.

Put in simple terms, Health Economics is the application of principles of economics in the field of health and healthcare delivery systems to prioritise the needs of the general public based on cost effectiveness. By health economic evaluation, we attempt to provide ‘Value for Money’ in healthcare systems.

This is done by ensuring cost-effectiveness in addition to clinical effectiveness of a given healthcare system or technology.

On the other hand, outcomes research is the analysis of endresults of any healthcare practice or intervention. These endresults may include mortality, clinical efficiency, patient satisfaction, doctor satisfaction, economic burden, social/ cultural/ societal impact, etc. Outcomes research takes into account patients’ experiences, preferences and values. It attempts to provide practical and real-world evidence for the effectiveness of various health technologies.

Two related terms are pharmacoeconomics (PE) and HTA. Pharmacoeconomics is a branch of health economics which evaluates clinical, economic and humanistic aspects of a pharmaceutical product. It provides valuable information to the healthcare decision makers,

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healthcare providers and patients for the purpose of optimal allocation of healthcare resources.

HTA on the other hand is a process of critically assessing various properties of any medical technology used in healthcare and intends to act as a bridge between evidence and policy-making.

Though all these terms appear as same, but we can broadly say that PE and HTA are the subsets of HEOR. While PE is primarily concerned with the economic analysis of a pharma product, HTA has a wider coverage and includes any health technology, and the assessment includes economic as well as other practical aspects of the health technology in question.

Pharmacoeconomics Out of these different terms that have been introduced in the previous section, the term that is perhaps the best known in the Indian context is pharmacoeconomics. In pharmacoeconomics, we compare the ‘value’ of one drug or drug schedule with another.

The concept of ‘Costs’ and ‘Consequences’ Two most basic terminologies in pharmacoeconomics are ‘cost’ and ‘consequences’. Put in plain terms, in pharmacoeconomics, all types of inputs in any healthcare intervention are termed as costs (expressed in monetary terms), and all forms of outputs are termed as consequences of

the intervention (expressed in terms of monetary value, efficacy of the intervention, or enhancement of the quality of life of the individual).

The costs may be direct, indirect and intangible. ❑Direct costs include the costs of all resources consumed during the course of providing the intervention to the patient, as well as any consequences of the intervention (such as adverse events). They can be broadly categorised into: ● Medical costs: Include costs which are directly related to the medical services, such as physician’s consulting fees, costs incurred for diagnosis, and costs for treatment including medicines and surgical costs

● Non-medical costs: Include non-medical costs which are directly due to the illness, such as transportation, parking, outside food consumption, child care etc. ❑Indirect costs are those which are associated with the reductions in individual productivity due to the illness, disability or death. These include costs due to sickness absenteeism, unpaid assistance from family member, etc. ❑Intangible costs are costs due to pain and sufferings, which

cannot be measured The various types of consequences considered in pharmacoeconomics are: ❑Direct monetary benefits ❑Effectiveness of the therapy.

E.g., number of years of life saved, duration of hospitalisation avoided, complication-free episodes, etc. ❑Utility: A utility is a Quantified preference for a specified health state. Utilities are usually expressed using scales of zero to

MANAGEMENT one. E.g., QALY (Quality-adjusted life year), HALY (Healthadjusted life year) etc.

The concept of ‘Perspectives’ and its importance in pharmacoeconomic analyses Another basic and important concept in pharmacoeconomics is ‘perspectives’. It indicates the viewpoint from which a pharmacoeconomic study is to be conducted and interpreted. With changing perspective, the need to do the pharmacoeconomic evaluation and the expected desirable outcome also changes significantly.

For example, from the perspective of a medical scientist involved in medical research, the most desirable outcome with a new health technology is its clinical effectiveness. But, from the perspective of a patient, all possible types of costs to the individual, due to the new health tech-

nology, should also be counted in addition to its effectiveness.

When the perspective of a hospital administrator is considered, the costs and consequences of all the patients attending the particular hospital should be taken into account and decision that benefits the majority of the patients are to be taken. The implications are larger from the perspective of the society and even larger when the national perspective is considered. Economic analyses should take the widest possible perspective in order to maximise their value to a large number of people as a basis for healthcare decision-making. This is also the reason why whenever the Government wants to do a pharmacoeconomic evaluation, it gives the most importance to the societal and the national perspective.

Need of pharmacoeconomics in healthcare system

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Pharmacoeconomic analysis helps the decision makers of a healthcare system to optimise the resources in health Pharmacotherapy decisions traditionally depended solely on clinical outcomes like safety and efficacy, but pharmacoeconomics teaches us that there are three basic outcomes to be con-

sidered: clinical, economic, and humanistic in drug therapy.

Pharmacoeconomic analysis helps the decision makers of a healthcare system (e.g., clinicians, hospital administrators, health insurance providers, or the government) to optimise the resources in health. Burdened by the limited nature of resources, the decision makers face the problem of balancing the healthcare needs of a few patients with the healthcare needs of the larger society. In this background, pharmacoeconomic analysis provides means for assessing costs and consequences of all the available alternate pharma products.

With the boom in the pharma industry, many drugs belonging to the same class have been made available to the prescriber.

Further, different brands of the same drug are often at the disposal of the prescriber. Though

this situation improves the choice for the prescriber, it also brings in confusion as to which brand should be chosen.

At a higher level, a similar dilemma is will be faced by a hospital, Government, or an insurance company, when an introduction of a health scheme or a health insurance scheme is being contemplated. The hospital/ insurance company/ government will be interested to know whether the new drug/ device/ procedure, which is usually more expensive than the established drug/ device/ procedure, is significantly beneficial to the patient, and at the same time economically viable.

In either of these scenarios, pharmacoeconomics plays a very crucial role in helping with the correct choice of healthcare delivery systems.

Pharmacoeconomics also plays a vital role for the

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MANAGEMENT pharmaceutical industry by providing inputs for fixing the price of a new drug, and for re-fixing the price of an existing drug in the context of another similar drug of a rival pharmaceutical industry entering the market.

Pharmacoeconomics in India Pharmacoeconomics is not well established in India. There are very few, if any, quality papers dealing with pharmacoeconomics from the Indian context.

There are no uniform guidelines for performing PE studies in India, and the researchers who plan to conduct such studies most often rely on guidelines used in the US or European countries which do not suit the Indian situation entirely. Further, there is a dearth of qualified professionals as well as institutions which offer quality education, in the field of pharmacoeconomics.

The Indian chapter of International Society for Pharmacoeconomics and Outcomes Research (ISPOR) was established in May 2006, and is the information centre for all the pharmacoeconomic-related activities in India. The Indian chapter of ISPOR has drafted the proposed pharmacoeconomic guidelines for India, with the objective of initiating India-specific pharmacoeconomics research. Despite this, the full potential of pharmacoeconomics is yet to be realised in India.

Health Technology Assessment (HTA) Health Technology Assessment (HTA) is a process of critical assessment (examining and reporting) of various properties of any ‘medical technology’ used in healthcare. The term ‘medical technology’ includes any technology, procedure or intervention related to the healthcare management of the patient, such as diagnostic equipment, diagnostic tests, novel drug or drug schedule, device, surgical technique, surgical materials, etc.

The properties of the ‘medical technology’ considered while doing HTA may include its safety and efficacy, indications for use, feasibility, its cost and cost-effectiveness, its outcomes, and its short-term and longterm consequences (social,

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India remains one of the few major countries in the world that does not have a formal HTA programme economic, ethical, legal and political). Both direct/ intended as well as indirect/ unintended consequences are considered.

Need for HTA in healthcare system The primary objective of HTA is to provide ‘Value for money’ for the patients.

HTA comes into picture whenever a new healthcare technology is made available in a healthcare set-up, and a decision is to be made between the new technology and the alreadyexisting technology.

HTA seeks to answer two major questions: (a) How do the health outcomes of the new technology compare with the established alternatives? (i.e. clinical effectiveness) and (b) Are the clinical improvements seen with the novel technology commensurate with the additional costs due to the technology?(i.e. cost-effectiveness).

A health technology which has a good evidence of effectiveness in literature may fare poorly when introduced in a healthcare set-up due to some unexpected adversity (such as high cost, unacceptable levels of side effects, or unexplained hurdles in the social, cultural, or societal front).

This will result in tremendous loss, both monetary and otherwise, for the healthcare providers, patients, and the policy-makers. A properly done HTA will predict whether or not a health technology intended to be introduced in a hospital or society will result in a favourable riskbenefit profile. Thus, HTA is expected to act as a bridge between evidence and policy-making.

Key stakeholders in HTA The key stakeholders in HTA are: ❑ Healthcare policy makers: Those involved in funding, planning, purchasing and investing in healthcare ❑ Healthcare providers: Responsible for the administration of the health technology ❑ Patients: The recipients of the health technology ❑ Pharmaceutical industry: Manufactures the health technology ❑ Government: Decides upon the health technologies to be introduced in its public health plans and schemes ❑ Insurance companies: To seek justifications and make decisions for including new technologies under various insurance schemes HTA in India The poor public healthcare delivery in India and the virtual absence of health insurance schemes has resulted in increasing reliance on private health sector. As a result, the current model in the Indian healthcare system relies on most of healthcare expenditure being borne out of pocket (OOP) by the patient. There is no control over what tests the practitioner can order and what drugs the patient can be prescribed; the deciding authority rests with the practitioner.

In this background, increasing and often illogical ordering of diagnostic tests and the irrational prescription of unwanted medicines often results in catastrophic payments (a scenario where the healthcare expenditure in a household exceeds 10-20 per cent of the total

household income); India’s catastrophic payments prevalence is amongst the highest in Asia.

If, the scenario of OOP spending for healthcare needs in India is replaced by a system where all individuals are covered by some form of health insurance (either Government or private), the entire equation undergoes a drastic change.

Since the payment for the healthcare services comes from the Government and insurance companies, accountability will be brought into all aspects of healthcare system, including diagnostics and prescription of drugs. More significantly, the onus will be on the pharma companies and manufacturers of healthcare chemicals and devices to convince the Government and insurance companies that their product is indeed different and unique in comparison with the existing ones.

If this scenario becomes a reality, since the Government and insurance companies are expected to cater to the whole society and not just to a few patients, they will be expected to take decisions with due importance given to all aspects of the health technology being considered (including the effectiveness, costs, risks, and social, cultural, legal, ethical and societal impacts). The only tool that can provide all these information is HTA. Major hurdles for introducing HTA in the Indian healthcare system Though the idea of HTA is lingering (The High Level Expert Group report on Universal Health Coverage by the Planning Commission of India has

highlighted the need for using economic evidence for policymaking in India), unfortunately India lacks a commendable HTA programme. While the importance of HTA has been fully appreciated and has been fully utilised for framing healthcare policies in developed countries of the world, India remains one of the few major countries in the world that does not have a formal HTA programme. Further, there is a lack of qualified HTA personnel in India, or courses which impart quality HTA education in India.

Though there is no formal national HTA programme in India, there have been isolated attempts by a few groups in the direction. For example, NICE International (UK), SIGNET initiative (Singapore), ISPORIndian chapter, HTA International, and PHFI have all organised workshops and conferences in order to provide sensitisation in the branch of HTA to Indian policy makers and senior clinicians.

The way forward For the approval of a new drug in India, the Drug Controller General (India) (DCGI) requires only clinical data, and not economic data. This, it becomes important to sensitise the policy makers and senior politicians about the need for HTA in India.

HTA is a complex science, and guidelines need to be formulated. In this direction, the Indian chapter of ISPOR has already drafted the proposed pharmacoeconomic guidelines for India. Most of the existing guidelines and protocols in HTA and HEOR have been developed in the western world.

While devising similar guidelines for India, due care has to be given to the prevalent socioeconomic situations, healthcare systems, medical practices, cultures and values systems in India which are significantly different from those in the western world.

Further, it is also important to realise that there is a dearth of adequately qualified authority in the field of HTA in India and hence, related talent development is the need of the hour.

RESEARCH RESEARCH UPDATES

Merck Serono initiates phase II study of AntiPD-L1 antibody in mMCC mMCC is a rare and aggressive skin cancer lacking effective treatments MERCK SERONO has initiated an international phase II study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). This multicentre, single-arm, open-label study is being conducted in patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive type of skin tumour,1,2 who have previously received one line of chemotherapy.

It is expected to recruit 84 patients across Asia Pacific, Australia, Europe and North America. The primary endpoint of the study is overall response.

The PD-L1/PD-1 pathway is implicated as a major mechanism by which tumours evade elimination by the immune system.3 The PD-L1 molecule is expressed in many cancer types, including mMCC.3,4 MSB0010718C, which blocks the interaction of PD-L1 with its receptor PD- 1, may have the potential to restore effective anti-tumour T-cell responses and thereby to inhibit tumour growth.

Immune mechanisms are implicated in the pathogenesis of MCC, with an increased risk observed in immunosuppressed individuals.5 MCC also is associated with the presence of the Merkel cell polyomavirus, which may have a role in tumor formation.6 Globally, the incidence of MCC is increasing, and outcomes for patients with this disease are poor.1,2 Therefore, new treatment approaches are required to improve the outcome of patients with this type of cancer.

“We believe that modulating the immune system by targeting PD-L1 represents a promising new approach in the treatment of this aggressive cancer, especially considering that many of the predisposing factors for mMCC seem to be related to functional disruptions of the immune system,” said Helen Sabzevari, Senior Vice President of Immuno-Oncol-

ogy, Merck Serono. “Our anti-PD-L1 compound may present a potential new approach for the treatment of mMCC patients.”

In addition to this new study in mMCC, MSB0010718C is currently being explored in a phase I clinical trial for the treatment of solid tumours. The study aims to recruit 590 patients and has enrolled 422 patients to date. On June 1, 2014, Merck Serono presented initial data from this dose escalation study in solid tumours at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago.7 This study is currently recruiting patients into expansion cohorts in seven cancer types: castrate-resistant prostate cancer, colorectal cancer, gastric/gastroesophageal cancer, melanoma, metastatic breast cancer, non-small cell lung cancer and ovarian cancer.

References 1. Hughes MP, et al. Curr Dermatol Rep 2014;3:46–53.

2. Kaae J, et al. J Natl Cancer Inst 2010;102(11):793–801.

3. Lipson EJ, et al. Cancer Immunol Res 2013;1(1):54-63.

4. McDermott DF and Atkins MB. Cancer Med 2013; 2(5):662–73.

5. Bhatia S, et al. Curr Oncol Rep 2011;13(6):488-97.

6.

Feng H, et al.

Science 2008;319(5866):1096–100.

7. Heery CR, et al. J Clin Oncol 2014;32:5(Suppl.) Abstract No. 3064.

EP News Bureau Mumbai

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RESEARCH

Central memoryTcells shows all traits of adult tissue stem cells These cells can generate diverse offspring that can reconstitute ‘tissue’ function RESEARCHERS IN Germany and the US have proven for the first time that specific individual cells of the immune system, termed central memory T cells, have all the essential characteristics of adult tissue stem cells. Such cells are capable of perpetuating themselves indefinitely as well as generating diverse offspring that can reconstitute 'tissue' function. These findings indicate that it should be possible to fully restore specific immunity to pathogens in patients with a compromised immune system by substitution of small numbers of central memory T cells. The results, published in the journal Immunity, highlight the therapeutic promise of ‘stemness’ in T cells.

The immune system has evolved to recognise and respond to threats to health, and to provide life-long memory that prevents recurrent disease. A detailed understanding of the mechanism underlying immunologic memory, however, has remained elusive.

Since 2001, various lines of research have converged to support the hypothesis that the persistence of immune memory arises from a reservoir of immune cells with stem-celllike potential. Until now, there was no conclusive evidence, largely because experiments could only be carried out on populations of cells. This first strict test of the stem cell hypothesis of immune memory was based on mapping the fates of individual T cells and their descendants over several generations.

That experimental capability was developed through a long-term collaboration, focused on clinical cell processing and purification, between researchers based in Munich and Seattle. Since 2009, the

36 EXPRESS PHARMA August 16-31, 2014

groups of Prof Dirk Busch at the Technische Universität München (TUM) and Stanley Riddell at the Fred Hutchinson Cancer Research Centre have combined their technological and clinical expertise under the auspices of the TUM Institute for Advanced Study. The University of Heidelberg, the University of Düsseldorf, the Helmholtz Center Munich, the German Cancer Research Center (DKFZ), and the National Center for Infection Research (DZIF) also contributed to the present study.

After generating an immune response in laboratory animals, TUM researchers Patricia Graef and Veit Buchholz separated complex ‘killer’ T cell populations enlisted to fight the immediate or recurring infection. Within these cell populations, they then identified subgroups and proceeded with a series of single-cell adoptive transfer experiments, in which the aftermath of immune responses could be analysed in detail. Here the

ability to identify and characterise the descendants of individual T cells through several generations was crucial.

The researchers first established that a high potential for expansion and differentiation in a defined subpopulation, called ‘central memory T cells,’ does not depend exclusively on any special source such as bone marrow, lymph nodes, or spleen. This supported but did not yet prove the idea that certain central memory T cells are, effectively, adult stem cells.

Further experiments, using and comparing both memory T cells and so-called naive T cells – that is, mature immune cells that have not yet encountered their antigen – enabled the scientists to home in on stem-cell-like characteristics and eliminate other possible explanations.

Step by step, the results strengthened the case that the persistence of immune memory depends on the ‘stemness’ of the sub-population of T cells termed central memory T

Information on transcranial ultrasound therapy revealed

cells. Individual central memory T cells proved to be ‘multipotent’, meaning that they can generate diverse types of offspring to fight an infection and to remember the antagonist.

Further, these individual T cells self-renew into secondary memory T cells that are, again, multipotent at the single-cell level. And finally, individual descendants of secondary memory T cells are capable of fully restoring the capacity for a normal immune response.

One implication is that future immune-based therapies for cancers and other diseases might get effective results from adoptive transfer of small numbers of individual T cells.

“In principle, one individual T cell can be enough to transfer effective and long-lasting protective immunity for a defined pathogen or tumour antigen to a patient,” says Dirk Busch, Director of the Institute for Medicial Microbiology, Immunology and Hygiene, TUM.

A RECENT study completed at the University of Eastern Finland provides new information on the limitations and potential new directions for the future development of transcranial ultrasound therapy. Active research is taking place in the field of transcranial ultrasound therapy, which in the future can potentially be applied to the treatment of brain tumours and targeted drug delivery.

The therapy modality has already been successfully applied to the treatment of neuropathic pain disorder and essential tremors. The benefits of transcranial ultrasound therapy include minimal invasiveness, as the treatment is delivered to the brain by transmitting ultrasound through the intact skull of the patient. The study focuses on two issues that may potentially limit the applicability of transcranial ultrasound: skull-base heating and formation of standing-waves.

As the ultrasound beam encounters the skull bone, part of the beam’s energy is transferred into the skull as heat. In the study, it was found that the heating of the skullbase during transcranial ultrasound therapy can result in hazardous temperature elevations when the sonications are performed close to the skull-base. Three new methods to counteract this potentially hazardous phenomenon were developed in the study.

Standing waves, on the other hand, are formed in the ultrasound field when waves reflect from the surface of the skull bone. During transcranial ultrasound therapy, the ultrasound amplitude can reach higher levels than intended if these reflections are not taken into account during the initial treatment planning. The study found that the formation of standing waves is greatly reduced when specifically designed large-area ultrasound transducers are used.

EP News Bureau Mumbai

EP News Bureau Mumbai

RESEARCH

US FDAapproves Imbruvica for chronic lymphocytic leukemia Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide THE US Food and Drug Administration (US FDA) expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.

The US FDA is also approving new labelling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug’s clinical benefit.

A type of non-Hodgkin lymphoma, CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,720 Americans will be diagnosed and 4,600 will die from CLL in 2014. Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide.

“We continue to see advances in the availability of therapies to treat chronic lymphocytic leukemia, especially for difficult-to-treat patient populations,” said Richard Pazdur, Director of the Office of Haematology and Oncology Products, FDA’s Center for Drug Evaluation and Research. “Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation, reflecting the promise of the breakthrough therapy designation programme and demonstrating the FDA’s commitment to working cooperatively with companies to expedite the development, review and approval of these important new drugs.”

The other three drugs approved to treat CLL that received breakthrough designations are Gazyva (obinutuzumab) in November 2013, Arzerra (ofatumumab) in April 2014 and Zydelig (idelalisib) in July 2014. Imbru-

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vica’s application for accelerated approval to treat CLL did not receive breakthrough therapy designation.

The approval actions for Imbruvica are based on a clinical study of 391 previously treated participants, 127 of whom had CLL with 17p deletion. Participants were randomly assigned to receive Imbruvica or Arzerra until disease progression or side effects became intolerable. The trial was stopped early for efficacy after a pre-planned interim analysis showed Imbruvica-treated participants experienced a 78 per cent reduction in risk of disease progression or death (progression-free survival). Results also showed a 57 per cent reduction in risk of death (overall survival) in participants treated with Imbruvica. Of the 127 participants who had CLL with 17p deletion, those treated with Imbruvica experienced a 75 per cent reduction in risk of disease progression or death.

The most common side effects associated with Imbruvica observed in the clinical study include low levels of platelets in the blood (thrombocytopenia), a decrease in infection-fighting white blood cells called neutrophils (neutropenia), diarrhoea, low red blood cells (anaemia), fatigue, pain in the muscles and bones (musculoskeletal pain), upper respiratory tract infection, rash, nausea and fever (pyrexia).

Imbruvica is co-marketed by Pharmacyclics, based in Sunnyvale, Calif., and Janssen Biotech, based in Horsham, Penn.

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EP News Bureau Mumbai

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RESEARCH

IsoRay’s Cesium-131 Isotope shows excellent results in treating metastatic brain cancer IsoRay’s cancer fighting products diminish the ability of the tumour to recur, resulting in important benefits for patients in longevity ISORAY, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, announced the publication of the first major peer reviewed study showing superior results using IsoRay’s Cesium-131 seeds in the treatment of metastatic brain cancer.

Dwight Babcock, Chief Executive Officer, IsoRay commented, “We are excited to have growing evidence that Cesium-131 isotope seeds continue to perform so well against aggressive cancers throughout the body and specifically now metastatic brain cancer. We believe our marketing efforts will be enhanced by teaming up with medical industry thought leaders as they seek better solutions and outcomes for their patients. As we continue to develop our product offerings internally with support from industry leaders, our message is clear and the medical community is becoming increasingly aware of the innovative alternative our Cesium-131 products offer to cancer patients.”

Dr A Gabriella Wernicke, Radiation Oncologist and Dr Theodore H Schwartz, Neurosurgeon, with Weill Cornell, were two of the co-authors of the publication, which stated, “The use of post resection permanent Cesium-131 brachytherapy resulted in no local recurrences and no radiation necrosis.”

The study followed 24 patients enrolled between 2010 and 2012, with a median 19.3 month follow-up period. Each patient had stranded Cesium-

38 EXPRESS PHARMA August 16-31, 2014

131 seeds implanted at the resection of a brain metastasis.

During the follow-up period, study participants had 100 per cent local (resection cavity) freedom from progression (FFP) and 93.8 per cent one-year regional FFP. While patients with metastatic brain cancer experience significant hazards to survival (overall one-year survival rate in this study was 50 per cent), the excellent local control of the surgically removed and Cesium-131 treated brain tumour, along with the lack of significant complications and the improved quality of life compared to other radiation therapy approaches, represents an important step forward in managing these difficult cases.

Babcock said, “Commercialisation requires published studies, like this one, that are peer reviewed, providing patients and family members with new insights into technological advances being made to treat these dreaded diseases. Leaders in the medical arena recognise and rely on the reported results in such publications, providing a means to stay abreast of these new and powerful weapons now available in the battle against cancer. As with this latest publication on metastatic brain cancers, I believe Cesium-131 is now a proven solution that can meet patient needs.”

IsoRay’s various products, including Cesium-131 seeds, sutured seeds, stranded

Leading pharma firms in tie up with MRC

mesh and the GliaSite� radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumour removal or by placing seeds within the prostate.

The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay’s cancer fighting products diminish the ability of the tumour to recur, resulting in important benefits for patients in longevity as well as quality of life.

A GROUP of seven leading drugmakers has agreed to share an array of neglected experimental medicines with British academic researchers in the latest example of the deepening ties between industry and external scientists.

Vince Cable, British Business Minister recently announced the new partnership between the Medical Research Council (MRC) and the companies, under which the researchers will gain access to ‘deprioritised’ pharmaceutical compounds.

Often these compounds have been dropped from development because they are not sufficiently effective against a particular condition, but they may still be useful against other diseases with shared biological pathways.

AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer, Takeda and UCB have all signed up to the scheme, which builds on the success of an earlier two-way programme between AstraZeneca and the MRC. One project under that original 2011 programme involves a drug designed originally to treat acid reflux disease that has now been utilised as a treatment for chronic cough and is being tested in clinical trials.

While drugmakers have traditionally been reluctant to share their compounds, there is a growing recognition that outside experts may be able to unlock value by taking a different approach, resulting in shared profits between companies and academic institutions.

EP News Bureau Mumbai

Reuters

RESEARCH

Gene therapy creates ‘biological pacemaker’cells for heart The researchers envision using the procedure initially will help people with heart rhythm disorders who cannot use a pacemaker RESEARCHERS HAVE succeeded in turning ordinary cardiac muscle cells into specialised ones that deliver a steady heartbeat using a gene therapy procedure they predict could become an alternative to implanted electronic pacemakers.

A study published on Wednesday involved pigs with a condition called heart block that makes their hearts beat too slowly. By injecting a human gene into a tiny region of the heart's pumping chambers roughly the size of a peppercorn, the researchers reprogrammed heart muscle cells into a type of cell that emits electrical impulses to drive the beating heart.

In doing so, cardiologists at Cedars-Sinai Heart Institute in Los Angeles created 'biological pacemaker' cells that restored a normal heart rate in the pigs.

The procedure achieved the same result as implanting an

electronic pacemaker that sends electrical pulses to the heart if it beats too slowly or skips a beat.

“This development heralds a new era of gene therapy where genes are used not only to correct a deficiency disorder but actually to convert one type of cell into another to treat disease,” Dr Eduardo Marbán, Director, Cedars-Sinai Heart Institute and leader of the research team, told reporters.

The researchers noted that pig hearts are very similar to human hearts. Dr Eugenio Cingolani, Director of the institute's Cardiogenetics-Familial Arrhythmia Clinic, said, “If all goes well" in further animal studies examining the procedure's longterm effectiveness and safety, we hope to be able to begin trials in humans within three years.”

The researchers envision using the procedure initially to help people with heart rhythm

disorders who cannot use a pacemaker because of devicerelated complications like an infection or in fetuses in the womb with congenital heart block.

Such foetuses cannot have a pacemaker implanted and risk severe heart failure often result-

ing in stillbirth. The researchers hope to develop an injectionbased treatment to deliver the gene therapy to these developing babies.

They said down the road the procedure might be used in a broader patient population as a

realistic alternative to the pacemaker. Marbán said about two per cent of pacemakers lead to an infection requiring treatment. In the US alone, about 300,000 people get pacemakers annually.

Using a minimally invasive catheter procedure, the researchers injected pigs that had complete heart block with a gene called TBX18 that is responsible for a protein that makes the heart keep the right rhythm. On the second day after the gene was injected, the pigs developed a faster, more normal heartbeat that lasted for the rest of the 14-day experiment.

The researchers used a common type of virus called an adenovirus to introduce the gene into the pigs but expressed confidence the virus poses minimal risk. The research appears in the journal Science Translational Medicine.

Reuters

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

40 EXPRESS PHARMA August 16-31, 2014

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express Limited, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

PHARMA ALLY I N T E R V I E W

‘Stricter regulations means more opportunity to help our customers’ With FDA urging pharmaceutical companies to move from GMP compliance to a focus on product and process quality, there will be a demand for better methods and tools for process development, validation and control. Sameer Gandhi, Managing Director, Omron Automation, India, talks to Shalini Gupta about the company’s plans in the automation space

How is the current environment for automation in pharma?

With the pharmaceutical industry doing well in India, automation level is going to grow. New FDA regulations will be an impetus to the industry to invest more in automation. New rules on track and trace and serialisation require automation so its good news for automation industry, not only for new machines but also for old ones. Of all the sectors automation finds use in, the requirement by design in pharma is more stringent because here we are dealing with the lives of patients. So the accuracy and liability factor is very high.

How is automation helping companies be energy efficient?

When we look at energy reduction or optimisation, it is not about how less do you consume for a given amount of time. We need to look at how much did you produce with a given amount of energy and what does that include. Does that include reducing wastage, increasing throughput, increasing the right quality of? That is where precise automation solutions come in: like PID loops for temperature control, camera systems for reading barcodes and OCRs that work on high speeds, cameras which can detect foreign particles in medicines

New FDA regulations will be an impetus to the industry to invest more in automation.

New rules on track and trace and serialisation require automation so its good news for automation industry, not only for new machines but also for old ones (absence and presence detectors). Track and trace means that both detection and recording needs to be done. That again can be done at very high speeds. All these technologies from Omron help companies to increase throughput.

How do you see the move towards stringent regulations?

Stricter regulations means more opportunity to help our customers, with better and more secure automation systems. For example, cameras have been around since 1980s, but the image detection has changed.

Earlier we could only detect whether the label is there or not. Now we can read the dates and do an OCR and then decide what is getting

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printed is correct or not.

Industry requirements are changing and hence it spurs us to do a value addition on the products. Safety was all about presence detection earlier, but in high speed machines today we have improvised to safety scanners, which work at varying speeds. In track and trace, as the data is captured on every bottle (the unique 3D code printed) it gets recorded on a relational database. Our new PLC systems can directly transfer the data to the RDBMS/ ERP/SQL server. There is no intervening layer. So we are trying to simplify and reduce the no of layers involved. Less complexity, lesser chances of failure.

How have you been

innovating and what trends do you see going forward?

Everytime a customer comes to us with a new requirement, it gives us the impetus to innovate. For eg, we are working with a client who makes machines to manufacture capsules. The requirement is that sometimes capsules crack.

They want us to detect the cracks while manufacturing.

We launched Scara robotpick and place robots and are seeing a good response for them from the industry. In the immediate future robotisation would be a trend. With an increasing demand, machine speeds will increase, making some functions unsafe or impossible for human beings, hence the shift to robots.

In the future, the trend is going to be towards wireless

devices. We’ll see more and sensors which are unconnected, basically powered using ambient energy such as vibration, heat or light. Such wire free devices won’t even need power supply or batteries.

They can be in remote locations, where wiring would be very cumbersome.

Tell us about the new automation centre launched in Mumbai.

This is the first such centre in India and the fifth in the world and indicates the strategic position India holds in Omron’s business plans.

Here customers can experience our products as we offer live demo of our products. We have a vision lab and test samples for our customers depending on their requirements. This is a unique concept where we can simulate the applications for customers. It cuts down their development time for a new machine, as well as if they want to make some iterations in an existing machine. We have a connectivity lab.

Multiple devices from multiple vendors need to communicate with other which can be a challenge.

Before going to the field, we can test this out in the labs, develop a software, so that during commissioning it doesn’t cost the customer time. shalini.g@expressindia.com

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PHARMA ALLY POST EVENT

HEL/Skytech joint seminar discuss on QbD regulations Seminar in Hyderabad and Bangalore attended by process engineers, chemists and managers from pharmaceutical companies HEL/SKYTECH jointly organised a seminar recently in Hyderabad and Bangalore. Discussions were held on the topic ‘Using DOE in Combination with Parallel Reactor Platforms QbD perspective as per US FDA regulation’. The seminars in Hyderabad and Bangalore were attended by process engineers, chemists and managers from pharmaceutical companies.

Dr Jasbir Singh, Chief Executive Officer, HEL Group presented various case studies and data with respect to DOE and parallel reactor systems for different processes like crystallisation and hydrogenation and how it helped in enhancing the product yield during the development stages in R&D. The importance of QbD regulation from process

optimisation and risk management was presented by D Malviya, Country Manager, along with the benefits obtained by the innovator company with QbD duly implemented and how generics companies will be required to implement QbD from regulatory point of view.

EP News Bureau - Mumbai

VENDOR NEWS

Honeywell opens seventh manufacturing facility in India HONEYWELL HAS launched its seventh manufacturing facility in India. The 75,000 sq ft facility has been built for Honeywell Automation India Limited (HAIL) and will significantly expand Honeywell’s manufacturing capabilities in the country. Honeywell now has seven state-ofthe-art manufacturing facilities and five technology development and engineering centres in India with ~2 million sq ft of combined built-up area.

“The Pune facility is the second manufacturing location we have built in India this year alone, demonstrating Honeywell’s continued commitment to India,” said Thomas A Szlosek, Senior Vice President and Chief Financial Officer, Honeywell International.

“Honeywell already has a significant presence in Maharashtra with its automation and turbocharger manufacturing facilities based in Pune, built with an investment of around `500 crores. It provides full time employment to nearly 3,000 people in the state, besides indirect employment and livelihood generation through ancillary industries,” said Anant Maheshwari, President, Honeywell India.

The new facility will integrate manufacturing, factory testing, quality control and advanced manufacturing engineering for Honeywell’s automation business in India. It will provide a full suite of process solutions, which comprehensively deployed, can improve efficiencies for industries by up to 30 per cent. It will

(L-R) Thomas A Szlosek, Senior Vice President and Chief Financial Officer, Honeywell, Anant Maheshwari, President, Honeywell and Vikas Chadha, Managing Director, HAIL

serve all major process industries such as refining, oil and gas, pulp and paper, power generation, chemicals, life sciences, and metals, minerals and mining.

Honeywell’s flagship solution –

the Experion Process Knowledge System, a range of pressure and temperature transmitters, and process safety systems, are some key products from the process solutions portfolio that

will be manufactured here.

Sensing and control products manufactured here will offer precision, repeatability and durability for OEM and industrial applications spanning aerospace and defence, medical, transportation, and test and measurement markets. Key products include shifters, pressure switches, limit switches, position sensors, speed sensors, and hour meters.

“Consolidating manufacturing in one location will create efficiencies and improve productivity for us. It will enable businesses to share expertise and training capabilities as well,” said Vikas Chadha, Managing Director, HAIL. EP News Bureau – Mumbai

42 EXPRESS PHARMA August 16-31, 2014

August 16-31, 2014

PHARMA ALLY

Schreiner MediPharm receives ‘Leo Best Supplier Award 2013’ LEO PHARMA’S production site at Vernouillet, France, awarded the ‘Leo Best Supplier Award 2013’ to Schreiner MediPharm for its outstanding performance. Schreiner MediPharm supplies the internationally active pharmaceutical company with needle-trap, which is applied to heparin syringes to protect from needlestick injuries.

“We are happy that the cooperative partnership is reinforced by the award.

This prize honours us and motivates us to continue optimising our processes in the future,” said Rainer Alberth, Senior Sales Director, Schreiner MediPharm.

Doriane Moulard and Benoit Joseph Bezine, purchasers at Leo Pharma, pre-

sented the Supplier of the Year Award to the team from Schreiner MediPharm.

EP News Bureau – Mumbai

Waters acquires REIMS Technology Waters’ experience with REIMS technology stems from a three-year collaboration among Waters, MediMass and Imperial College London focused on advancing REIMS WATERS CORPORATION has acquired Rapid Evaporative Ionization Mass Spectrometry (REIMS) technology from MediMass. The REIMS technology represents substantially all of the assets of MediMass and includes patent applications, software, databases and REIMS expertise.

Rohit Khanna, Vice-President, Worldwide Marketing and Informatics, Waters Division said, “This technology acquisition along with our recent agreement with Prosolia, for the exclusive rights to Desorption Electrospray Ionization (DESI) technology in clinical applications are key components in our burgeoning heath sciences initiative.”

REIMS is the enabling technology for the ‘Intelligent Knife’ or ‘iKnife,’ a device in the conceptual stages of development that could potentially be used for real-time diagnostics in surgery. Waters

is committed to exploring the viability of this application in accordance with all applicable regulatory requirements. To date, no regulatory approvals have been sought for this device.

Waters’ experience with REIMS technology stems from a three-year collaboration among Waters, MediMass and Imperial College London focused on advancing REIMS. The goal of this relationship has been and continues to be advancing REIMS technology capabilities for health science applications.

REIMS is an ionisation technique that can be used as a source for direct analysis of samples by mass spectrometry. To date, REIMS technology has shown the ability to bring ambient ionisation sampling into real world applications such as food safety, microbiology and clinical diagnostic applications.

EP News Bureau – Mumbai

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PHARMA ALLY PRODUCTS

Phenomenex launches Phenova CRM for environmental laboratories PHENOMENEX HAS launched Phenova Certified Reference Materials (CRMs) – a comprehensive line of ISO/IEC 17025- and ISO Guide 34compliant standards for the calibration of analytical equipment and quantitation of analytical measurements for environmental testing.

Sold and distributed exclusively by Phenomenex, Phenova CRMs are manufactured by Phenova, an established environmental proficiency-testing (PT) provider. Phenova brings the same precision to its CRM manufacturing process, underlined with the same methodical quality commitment that has been proven successful in

fortify the company’s entry into the CRM market such as a free sample programme, multiple lot inventory, a dedicated technical support team, and a novel packaging configuration that delivers on safety, unique labelling, and organisation.

Phenova CRMs complement Phenomenex’s portfolio of GC and LC products and accessories specialised for the environmental industry and are currently available in the US and Canada.

manufacturing PT standards.

Additionally, Phenova CRMs deliver lot-to-lot consistency with the verification of each lot to both

internal and independent CRM materials. This ultimately provides a competitive product that allows customers to extend their initial calibrations

and increase throughput between calibration events.

As the distributor, Phenomenex has implemented a series of added benefits to

Contact details Jennifer Dahlgren, Dahlgren Communications Phone: (530) 263-6817 E-mail: dahlgrenpr@ comcast.net

CPC launches integrated single-use sterile and sip connector COLDER PRODUCTS Company CPC) has launched AseptiQuik STC connector for use on biopharmaceutical processes using a hybrid combination of stainless equipment and single-use systems.

The combined AseptiQuik sterile connector and Steam-Thru II SIP connector will give Indian biopharmaceutical manufacturers increased flexibility in process design and plant configuration, lowering overall production costs and reducing time to market.

The union of the two connectors into a single unit via sanitary clamp creates a combination product that allows an AseptiQuik sterile connection to be steamed-in-

44 EXPRESS PHARMA August 16-31, 2014

AseptiQuik half without having to wait 30-60 minutes for SIP prior to feed or harvest. The AseptiQuik STC connectors are offered in both a standard version for gamma sterilization and a high temperature (HT) version for autoclave sterilization.

CPC’s bioprocessing connections are manufactured in an ISO Class 7 certified cleanroom and met USP Class VI and ADCF requirements.

place (SIP) on to stainless equipment. After the SIP cycle, a wide range of single-use systems can be connected to the AseptiQuik STC, presenting Indian

manufacturers with even greater flexibility for hybrid stainless steel and single-use processing.

The AseptiQuik STC connector can be mounted

directly to the stainless steel vessel via either a ¾” or 1-½” sanitary termination. The SIP process can be done in advance, allowing a quick and easy sterile connection to the

Contact details Pavan Urs M Regional Sales Manager, India CPC Tel: +91 80 40 689 689 pavan.urs@ cpcworldwide.com Web: cpcworldwide.com

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

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UBM India the organizer of CPhI & PMEC - South Asia's biggest and most comprehensive Pharma event

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25 - 27 September 2014

Bangalore International Exhibition Centre, Bengaluru, India

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PHARMA LIFE PROFILE

Inspiring others Change leaders in any industry bring new paradigm shifts into the way it functions.

Dr Chitra Lele leads by example. A profile by Express Pharma DR CHITRA LELE, Chief Scientific Officer, Sciformix Corporation has been named in the top 100 most inspiring people in the life sciences industry by an international magazine. She was selected from distinguished nominees representing a broad cross section of life science sectors based on affecting positive changes within their companies and the industry at large.

Currently serving as Chief Scientific Officer at Sciformix Corporation, she has been a part of the company leadership from its inception and has over 20 years of experience in the lifescience industry.

Lele has been recognised for her ability to view industry trends as challenges not burdens, and as opportunities not obstacles. She has also been commended for her passion and conviction for the industry; her ability to innovate and think outside of the box and develop breakthrough strategies, products, and services; for pioneering new paths and lifting her company to new heights.

Prior to her stint with Sciformix, she worked as Executive Director responsible for Indian operations of Pfizer Global R&D. Leading the biometrics department for Pfizer, she was notable to grow it to a staff of 400 personnel as well as helped develop an outsourcing strategy for clinical data management in India, strategising and implementing a new model for partnering with Contract Research Organisations (CROâ&#x20AC;&#x2122;s).

These initiatives have been credited with increased capacity building in the Indian CRO industry, leading to large scale offshoring of biometrics and medical writing in a functional service provider model from cost-effective locations, with

Dr Lele has been recognised for her ability to view industry trends as challenges not burdens, and as opportunities not obstacles. She has also been commended for her passion and conviction for the industry; her ability to innovate and think outside of the box and develop breakthrough strategies, products and services several pharma companies taking advantage of the new talent pool. She has been a pioneer in operationalising a globally distributed model to support design, analysis, and reporting of clinical trials.

She is especially passionate about bringing up the next generation of scientists, by working simultaneously as a visiting faculty member in a reputed University in India, developing and teaching new masters level courses. She is among the founding members of the Academy for

To subscribe: bpd.subscription@expressindia.com

Clinical Excellence (the first institute in India to provide clinical research related education) as well as the Indian Association for Statistics in Clinical Trials (to provide a platform for the statisticians and programmers to share and learn). She holds a PhD in Statistics from Stanford University, with prior experience working as a biostatistician in cancer epidemiology at both Stanford and the University of California.

Lele has been instrumental in setting up and establishing

Sciformix Corporation in all respects, from the management of operations and delivery, to strategising the organisational path and trajectory, growing the business; laying down the foundations of the organisation which has been conducive to its growth. She has chartered the path of Sciformix by determining services to focus on across a number of industry segments, the geographies to grow in, partnership models suited for each service line and the conceptualisation of new solutions and offer-

ings. She has nurtured her entrepreneurial spirit in continuing the growth and success of Sciformix.

Since Sciformix is an outsourcing partner, she believes that the company is particularly impacted by industry trends for outsourcing domain-intensive activities. However, the fact that many more companies, not just the large global ones, are open to working with partners in a globally distributed manner and consider many areas that were previously taboo for outsourcing is a favourable development. â&#x20AC;&#x153;Some of the large companies which have years of experience in working with offshore partners, are re-evaluating their strategy based on their experience and are getting into deep relationships with large fullservice CROs or want a stronger onshore presence of the vendor, which is disadvantageous for Sciformix, but at the same time, there are some who want to move to a two-vendor strategy and are interested in the second vendor being more specialised, like Sciformix,â&#x20AC;? she is quoted as saying.

In a nutshell, the focus on quality and compliance has increased substantially. Companies have acknowledged the growing commercial relevance of the emerging markets which are now seeing more action from the industry.

A staunch believer in education for the underpriveleged and affordable healthcare, she is confident that personalised medicine will soon become a reality.

She also believes that the increased importance of and availability of Big Data, in the areas of safety and effectiveness of medicines, will influence and shape the path of companies such as the one she leads.

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PHARMA LIFE CAMPUS BEAT

Smriti College of Pharmaceutical Education,Indore organises workshop ‘Hands on training in HPLC’ was sponsored by IPA INDIAN PHARMACEUTICAL Association (IPA) recently sponsored a one-day workshop on ‘Hands on training in HPLC’ at Smriti College of Pharmaceutical Education, Indore. Twenty delegates from industry and institute participated to have a firsthand experience on handling of HPLC. Dr Sanjay Jain, Director, Smriti College of Pharmaceutical Education, Indore, welcomed

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the delegates and briefed about the need of such workshop in the current scenario.

The technical session were presided over by Dr AG Hariharan, HOD Pharmaceutics, Smriti College of Pharmaceutical Education, Indore and Sudhkar CK, Assistant Prof Department of Pharmaceutics, Smriti College of Pharmaceutical Education, Indore who presented the basic concepts

Twenty delegates from industry and institute participated to have a firsthand experience on handling of HPLC of HPLC and briefed about the various softwares used for functioning of HPLC. Joining

them Niharika Gokhale and Jacky Dumbwani gave practical demonstration of HPLC

working.

In the valedictory session, certificates were distributed by the convenor Dr Neelesh Malviya. Co-coordinator of workshop Rakesh Barik conveyed the vote of thanks.

The public relations team of the institute said that such workshops will be held in the near future too.

EP News Bureau-Mumbai

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