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FOREWORD Being a most active sector of the global economy, life sciences is thriving with opportunities and growth, powered by innovation, scope and profound expertise. Asia and more specifically India are well poised to become a power house for the global life sciences sector. The Indian life sciences industry is on the threshold of entering a New Era of growth and positivity, promising extraordinary growth and an innovation driven bioeconomy. However, the big question remains whether the life sciences industry is prepared to exploit this evolving environment and capitalize on the big opportunity? The 12th BioAsia brought together the global industry leaders, researchers, policy makers, innovators, and investors together on one platform to discuss the new opportunities in the transition. Witnessing participation from about 1300 delegates representing over 500 organizations and 450 visitors from 50 Countries, the event had a great reception from the life sciences community and the feedback received has been overwhelming. Besides, over 900 business partnering meetings were realized during the event. Through this post event report, we intend to bring to you the highlights of BioAsia 2015 event including the session deliberations, satellite events, participant facts & figures, media coverage, feedbacks & comments, etc. Please do contact us at info@bioasia.in for any additional information.

Warm Regards, Team BioAsia


Sponsors

While the success of BioAsia 2015 can certainly be attributed to its focused content, dynamic platform structure and its inherent ability to connect and optimize opportunities, it was ably supported and complimented by its sponsors; bodies of individual esteem and repute each of whom are irrevocably contributors to this global event.

Sponsors Country Partner

Associate Country Partner

State Partners

Industry Co-Hosts

Corporate Sponsors

Conference Sponsors Information Technology Electronics and Communications Department

Tourism Partner

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Supporting Organizations & Media Partners

Supporting Organizations

HOCHIMINH CITY

SOUTH INDIA BSICC BRITISH COUNCIL OF COMMERCE

Association of Diagnostics Manufacturers of India

Media Partners

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At a Glance

Introduction.................................................... 7 International Advisory Board......................... 8 Organizing Committee................................... 9 Participant Profile......................................... 10 Ceremonies.................................................. 11 Awards......................................................... 13 Keynote Lectures......................................... 17 CEO Conclave............................................. 23 Conferences................................................. 29 Satellite Events............................................. 75 Media Coverage........................................... 85 Feedback and Comments........................... 89

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Introduction Introduction

The global life sciences industry is undergoing an unprecedented transformation. With cost containment measures by the government and moves to cut health expenditures across continents, the pressure on global drug industry to reap more from less is palpable. As one step typically seen, the industry has more than embraced partnerships, eased out of noncore and grown into specialized segments. As an emerging model in the hunt for molecules and cutting down on cost of development, local innovations is gaining importance. The market focus for Big Pharma has simultaneously shifted to developing economies, most distinctly visible in Asian countries like India and China. Regardless of the shortcomings of a tough regulatory and aggressive price control regime, global companies are seen working around the system with new access and financing models than abandoning these markets. The Indian life sciences industry is on the threshold of entering a New Era of growth and positivity, promising extraordinary growth and an innovation driven bioeconomy. However, the big question remains whether the life sciences industry is prepared to exploit this evolving environment and capitalize on the big opportunity? BioAsia 2015 - the twelfth edition of the widely attended annual convention, brought together the global industry leaders, researchers, policy makers, innovators, and investors together on one platform to discuss the new opportunities in the transition. BioAsia 2015, as a unique meeting platform of leaders from across the industry, offered participants, the right opportunities to catch the right notes and develop strategies to succeed in emerging markets like India.

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International Advisory Board

Chairman: Dr. Ajit Shetty

Corporate Vice President Global Operations, Johnson & Johnson USA (retd.), Chairman Emeritus, Janssen Pharmaceutica, Belgium

Members: Dr. Alfredo Aguilar

Chairman, Task Force on Bioeconomy, European Federation of Biotech; Former Head of Unit, European Commission, Research Directorate General - Biotechnology, Agriculture and Food Research, Belgium

Ms. Asha Bhavsar

Associate Principal Scientist, Analytical/Stability R&D, Merck Consumer Care, USA

Mr. George Bickerstaff

Founder and Executive Chairman, The Global Leaders; Former CFO, Novartis, Switzerland

Ms. Helen Karuso

Principal, Regenerate Capital, Washington D.C., USA

Dr. Makarand S Jawadekar Former Director, Pfizer, USA

Dr. Ravi Kiron

Chief Business Officer, KineMed, Inc., USA

Dr. Robert Naismith

Chairman, JUJAMA, Inc., USA

Dr. Sang-Ki Rhee

Executive Director, SCH Center for BioPharmaceutical Research and Human Resources Development, Soon Chun Hyang (SCH) University, South Korea

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Organizing Committee

Chairman: Dr. K V Raghavan

Scientist Emeritus and Former Director, Indian Institute of Chemical Technology, Hyderabad.

Members: Mr. K. Pradeep Chandra IAS

Mr. Jayesh Ranjan IAS

Special Chief Secretary to Govt. of Telangana and Commissioner for Industrial Promotion, Industries and Commerce Dept, Hyderabad (Ex-Officio)

Vice Chairman & Managing Director, Telangana State Industrial and Infrastructure Corporation, Government of Telangana, Hyderabad (Ex-Officio)

Dr. T Madhan Mohan

Dr. Vijay Kumar Kutala

Advisor, Department of Biotechnology, Government of India

Dr. P V Appaji

Director General, Pharmaceutical Export Promotion Council, Government of India

Dr. Ahmed Kamal

Project Director, National Institute of Pharmaceutical Education & Research (NIPER)

Dr. GVJA Harshvardhan

Director, Bharat Biotech International Ltd., Hyderabad

Mr. P. Gopal Krishnan

Director & Principal Consultant, Stabaka Consulting Pvt. Ltd., Hyderabad

Mr. Saurabh Garg

Associate Director - Business Operation & Management, Nektar Therapeutics, Hyderabad

Secretary General, FABA and Additional Professor of Biochemistry, Dept. of Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences [NIMS], Hyderabad

Mr. CSN Murthy

Chief Executive Officer, Aurigene, Hyderabad

Dr. Subir Basak

President - Global Drug Discovery, Jubilant Lifesciences, India

Mr. Sujay Shetty

Executive Director & India Leader, Pharma, Life Sciences & Medical Devices, PricewaterhouseCoopers India, Mumbai

Mr. Anuj Kapoor

Founder and Managing Director, StratCap Corporate Advisors LLP, Hyderabad

Mr. Amritanshu Roy

Senior Associate Director – India, US Based REIT, Hyderabad

Convener: Mr. Shakthi M. Nagappan

Executive Secretary, FABA and Technology Development Professional, International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), Hyderabad – Chief Executive Officer, BioAsia

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Participant Profile

The number of delegates registered for the event was over 1300. In addition, over 450 visitors attended the 3 dayglobal biobusiness event. Thailand participated as the Country Partner, UK participated as the Associate Country Partner while States of Kerala, Karnataka and Uttar Pradesh participated as State Partners and over 50 countries took part in BioAsia 2015 with major delegations from Thailand, UK, USA, China, Russia, Belgium, Singapore, Hungary, Kazakhstan Ecuador and Vietnam. The International Tradeshow at BioAsia 2015 attracted about 85 companies from across the globe.

BioAsia 2015 Participants

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Ceremonies

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Ceremonies

Welcome Reception With New Era of Lifesciences as a theme, BioAsia 2015 kick-started its highly anticipated three-day conference on February 2, 2015, at the Hyderabad International Convention Center in Hyderabad. The first day of the event showcased a biopark visit in the morning which was followed by a Welcome Reception in the evening. The Chief Guest at the reception was Shri Juppaly Krishna Rao, Honorable Minister for Industries & Commerce, Government of Telangana. The dignitaries present at the function include: •• Mr. Andrew McAllister, Hon’ble British Deputy High Commissioner, UK •• Shri Pradeep K Chandra IAS, Special Chief Secretary, Industries & Commerce Department, Government of Telangana •• Mr. Somchai Tiamboonprasert, Deputy Permanent Secretary, Ministry of Science & Technology, Thailand •• Shri Jayesh Ranjan IAS, Commissioner of Industries, Government of Telangana and VC & MD, Telangana State Industrial Infrastructure Corporation •• Mr. Thabang Bambo, Deputy Director, Ministry of Science & Technology, South Africa •• Dr. Ajit Shetty, Corporate Vice President Global Operations, Johnson & Johnson USA (retd.), Chairman Emeritus, Janssen Pharmaceutica, Belgium & Chairman, BioAsia International Advisory Board •• Dr. KV Raghavan, Scientist Emeritus and Former Director, Indian Institute of Chemical Technology, Hyderabad & Chairman, BioAsia Organizing Committee, India •• Dr. PV Appaji, Director General, Pharmaceutical Export Promotion Council, Government of India During the reception, Hon’ble Shri Jupally Krishna Rao, highlighted in his speech that Biotechnology has immense scope both in terms of employment and entrepreneurship and is shaping the rapidly developing Indian economy. He also added that the lifesciences sector has been identified as a trust area for investment by the government. The Welcome Reception also featured the release of the Lifesciences Policy for the State of Telangana by the Chief Guest in presence of the dignitaries. The reception was followed by a classical musical performance and a networking dinner.

Participants During Welcome Reception

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Classical Music Performance


Awards

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Awards

Genome Valley Excellence Award “Genome Valley Excellence Award” was introduced to recognize and honour eminent individuals and organizations for their exceptional contribution to Lifesciences Research & Industry. The State Government had instituted the “Genome Valley Excellence Award” during its first BioAsia 2004 and being continued in every edition of BioAsia. This year’s Genome Valley Excellence Awards were presented to – Prof. Mark Caulfield of the William Harvey Research Institute, UK in light of his •• Exemplary contributions to the genomic research that led discovery of over 70 genes for blood pressure and other cardiovascular disorders. •• Extraordinary leadership at William Harvey Research Institute, making itone of the leading pharmacological institutes in Europe with over 90% of the research being externally rated as world-leading or internationally excellent •• Vision and efforts to create the Barts and London Genome Centre which supports over 40 programmes of research as of 2015

Nektar Therapeutics in light of it’s •• Progressive contributions in the area of biopharmaceutical research and innovation through development of much needed therapies - pain, cancer & infectious diseases. •• Leadership and proven excellence in bringing drugs across multiple therapeutic areas with enhanced benefits for patients, by utilizing its established polymer conjugation technology platform. •• Vision, focus and commitment toward research and development for improved patient health and quality of living.

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Awards

FABA Special Award In order to recognize and honour eminent personalities for their longtime contributions to Biotechnology and Lifesciences sector, FABA instituted the “FABA Special Award” in BioAsia 2010. This year’s FABA Special Awards were presented to –

Dr. Dennis Gillings, Executive Chairman, Quintiles Inc., USA

Dr. Cyrus Poonawala, Chairman & Managing Director, Serum Institute of India Ltd., India. Award received by Dr. Cyrus Poonawala’s daughter-in-law, Mrs. Natasha Poonawala

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Awards

BioAsia Innovation Award INR 1 Lakh Cash Prize, Memento and Citation awarded to Mr. Soumitra Ghosh from the Department of Microbiology and Cell Biology, Indian Institute of Science, Bangalore for his project “Nucleoid-Associated Protein HU: A Novel Target For AntiTuberculosis Drug Development” and to Mr. Rahul Shubhra Mandal from the National Institute of Cholera and Enteric Diseases for his project “Bacterial Lysr-Type Transcriptional Regulators (Lttrs) As Novel Targets For Broad-Spectrum Therapy Against Infections”

BioAsia Young Minds Award INR 50,000 Cash Prize, Memento and Citation awarded to Ms. Rakshanya Sekar from Kendriya Vidyala, for her project “Pattom Smart Disposal Bin”

In partnership with


BioAsia 2015 Keynote Lectures

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Keynote Lectures

Professor Mark Caulfield, Director, Genomics England and William Harvey Research Institute, UK

Professor Caulfield, delivered the keynote address on the 100,000 Genome Project. He elaborated on genomic sequencing as a technique that can be used in diagnostics as well as in priming therapeutic innovations that are ready to be translated into clinics. He spoke about how it can help identify causes of diseases, thus helping discover responsible pathways, either causative or collateral, for development of the disease. He also gave examples of certain pathways from institute researches that can be considered for priming therapeutic innovations. He explained how genomic sequencing is an opportunistic field using positive results as evidences from various projects undertaken by the research institute. He also said that because of the rare possibility of new drug development through the usage of physiology and pharmacology (as majority of the available targets in those areas have already been used), genetics as a field can help with the way forward. This was followed by an elaborate presentation explaining the project, which is one of the largest genomic medicine transmission program taken up by National Health Services, UK. The programme aimed to sequence, as much as possible, the whole genomes of the patients with rare inherited diseases and includes some of the more common diseases. However, all the disease being studied had residual diagnostic unmet needs. Since only half of 7,000 such diseases have genomic diagnosis, he said that there was a huge opportunity to discover new diagnostics and thus, new therapeutic innovations. He ended the presentation by talking about multi-omics saying that going forward, not just whole genomes but multi-omics will be needed. Since multi-omics will require a range of samples for the study, collaboration between research and industry is essential to reduce the time to market for a drug.

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Keynote Lectures

Dr. Dennis Gillings, Executive Chairman, Quintiles, USA

Dr. Gilliangs began his address by stating that he is a huge fan of India and has been doing business here since 1996. Quintiles has around 33,000 employees worldwide, 15% of whom are in India. Hence, he has always been most supportive of commercial and corporate efforts in India to expand business. He thinks Quintiles, the company that he founded, has paved the way for the pharma industry to innovate with young innovators and small and medium-sized companies and has eliminated the entry barriers to the pharma industry. Almost 30 years ago, it was almost impossible to become a major pharmaceutical company without building huge investment in infrastructure, which then became huge barrier for entry. He added that without sourcing and development of skills that enable the complexity of drug development, they navigated regulations across the world, which is transforming the biopharma sector. The opportunity for innovation in India, and especially Hyderabad, is profound. Hopefully, that innovation will be pursued in-depth and bring much success in life sciences locally and throughout India. He said that the most important trend is IT and the ability to generate computing power. New law is being introduced in medicine, molecular biology and genetics. With the amount of information doubling every 18 months, new knowledge is being created and is having a profound impact on the biopharma sector. This means that every drug present today will be replaced by a much more targeted drug. A targeted drug does only what it’s supposed to do and does not have other side effects. The term which best encapsulated this new medicine is precision medicine; it also goes under the name of personalized medicine. It’s the medicine that follows the model of ‘one size fits all’. It’s the medicine where the underlying disease is conquered rather than just the symptoms. He called this era to be an era of opportunity and the era of the internet, which has made a profound impact on IT and data because of opportunity in knowledge and connectivity created. Molecular medicine and genetics are underpinning everything that’s happening inside the human being biologically and this is clearly going to create an enormous opportunity for those with the knowledge base that can grasp them. At the same time, clinical trials are becoming deeper and more complex. Quintiles has built a large back office in India, including data and software, which is the strength of India. They run much of their global operations with data systems and software that run in India. They run all the clinical services through this back office, with the global project management, clinical sites services and safety and documentation of safety are run by systems in India. He made a strong appeal to the audience saying that quality assurance is a huge part of innovation. Regulatory agencies around the world are very dogmatic about high quality. If quality is pursued to the utmost there will be success in innovation of life sciences. Historically, India has not made major investments in basic research, India’s contribution to the life sciences industry is mostly in manufacturing generics, which is a profound cost-cutting contribution, so that the product is not only invented but also becomes cost effective. Hyderabad depicts the other side of India, which is truly innovative. Without innovation there will not be new things to manufacture and new products to make generics. All stakeholders of the BioAsia event should be applauded in taking these steps to facilitate greater innovation in the country. India is home to 17% of the global population and 20% of the worldwide disease according to WHO estimates. In clinical trials, we just have a 1.5% share. This movement of innovation moving into clinical research needs more focus. It is important

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Keynote Lectures

to note that the countries on the cutting edge of the medicine are also on the cutting edge of the clinical research. He cited the example of Japan, which is bringing in more clinical research by foreign companies in recent years as the approval of its own products and keeping Japanese medicine on the cutting edge was facing limitations. Notable research and development advances are being made in life sciences in India, and the rotavirus vaccine is just one such example Quintiles is proud to be involved in this process. This is indeed an innovative product and illustrates the investments taking place in India and what it can produce. India’s strength in IT and software is significant here as we are moving to the big data world, which is becoming much more evidence based. Drug development, therapeutic evaluation, patient care and health policy, all will become more evidence based in the future. He believes that there is a strong linkage between IT, big data and infrastructure and, ultimately, life sciences and what they provide to the public at large. He said the Hyderabad knowledge park is modeled to some extent on the knowledge park in North Carolina, where biotech and IT are two knowledge-based industries to replace historical industries like tobacco, furniture and textiles. Hence, one can see lot of evidence to support the direction being taken. Significant innovation in life science is linked to entrepreneurism. Sharing his learning as an entrepreneur, he said first you have to believe in your idea, because lot of people will say it’s nonsense. But to pursue that further takes lot of courage. Every idea will face challenges and many times you will think it is dead but it requires inner strength to move ahead. Next, entrepreneurs have to show strong leadership in particular to promote loyalty of their own people and organisation. They can then build a strong motivated workforce. They should also know when to talk as they have to push their ideas against the adversity but sometime they should also know when to listen as they may not know all the details and always e right. But knowing when to talk and when to listen is indeed a challenge and critical to the ultimate success of an entrepreneur. It’s also necessary to raise money when you can and not just raise it when you need it. So he advised that when you see an opportunity to raise money, you should raise money even if it calls for diluting your stake in the ownership. This he feels is better than going bankrupt. And he advised entrepreneurs to not be afraid to hire good people, even if they are better than them. He thinks that the best people hire better people beneath them. Focus on your business vision as it’s very easy to get distracted. As new knowledge is coming at an enormous pace, stay focused on what you are inventing without ignoring the new knowledge. This focus requires lot of discipline which will make you win in the end. It’s also important to know broader aspects of business and as they have become exceedingly complex, be it legal, accounting, financial, management and while developing incentive systems. So entrepreneurs have to either go back to school or bring someone on board that has expertise and trust them. Invention alone will not bring about success; it’s accumulation of all the things that will make it a success. Create excitement about the business that will motivate you. He concluded by saying that he is a strong supporter of regulatory environment changes, which will enable innovation moving to clinical research or translational research into clinical and into the patient. He looks India to be very strong here. If it’s good for patients, it’s good for the life sciences. You should always go back and see if it’s good for patients while making decisions in this business. No one can go alone and no one is too big, and Quintiles is looking to partner with all key stakeholders. Quintile has invested for more than 20 years in growth in Asia. India is a major country in Asia, and the economics and demographics of India bode well for life sciences to be successful as long they generate quality and cost improvements in healthcare systems.

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Keynote Lectures

Dr. D. Prabhakaran,Vice President, Public Health Foundation of India

Dr. Prabhakaran emphasised the need for multi-sectoral dialogue between biotechnology and public health players. He noted that science discovers, technology develops and public health delivers. So there should be a common ground and common dialogue between these three pillars. Collaboration has resulted in unprecedented transformation in life sciences, which leads to not only cost savings but even effective innovations in predicting, preventing and managing several diseases. He spoke about the Public Health Foundation of India, (PHFI) which is a public-private initiative that has evolved with collaboration with multiple constituencies, involving Indian and international academia, state and central government and other agencies. He added that India is experiencing rapid health transition resulting in an unfinished agenda of infectious diseases, nutritional deficiencies, unsafe pregnancies and challenges of escalating epidemic of non-communicable diseases. These challenges need a concerted public health response that can ensure efficient delivery of cost-effective intervention for health promotion, disease prevention and affordable diagnostics and therapeutic healthcare. He then drew attention to biotechnology innovations, which could be transformational as it has the potential to influence multiple diseases at multiple levels. These include gene mapping in control of epidemics and diseases eradication, including the role of microbiome and its interface with public health at one end of the spectrum to developing robust health management information system for surveillance and mapping at the other end. Several point-of-care rapid diagnostics for early detection of infection have the potential to reduce antibiotic resistance, which is emerging as major public health challenge in India. The Swasthya Slate is an example of integration of multiple care diagnostics tools on a single Android platform. It is a great example of frugal innovation can improve access to people in the health system. Biotechnology innovation can also make healthcare affordable and accessible to all. Specific examples include remote monitoring of cold chain of vaccines, because it’s a major issue in India. In the summers vaccines can become inactive. Bluetooth-enabled temperature-control mechanism can actually transmit the message to the control room and identify places where vaccines are not adequately controlled, which can then take immediate remedial actions. It also includes remote diagnosis through tele-health development and testing of national fixed-dose combination of several cardiovascular diseases. Polypill is a great example. He said that initially they thought making fixed-dose combination of cardiovascular drugs would be easy, but multiple interactions the drugs have makes this technology very difficult. However, some Indian companies have cracked the technology using microcapsules, which release the drug in different points of time and those have been tested and that’s where PHFI people come in the picture, to evaluate these technologies in people and can run clinical trials and scale it up to the population. Other key innovations that could change the landscape include big data, social media and cloud computing. Health promotion is a major aspect in non-communicable diseases and we have not yet harnessed the power of social media. Another could be embedded systems for tracking patients. The working group of international society for diseases

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prevalence is working on the surveillance issue. Surveillance is crucial in keeping a count on mortality, morbidity and secular trends, and helps in policy making and proper allocation of resources. However, surveillance is in its infancy in India and NCD surveillance has several issues that need to be addressed. PHFI is working on a cohort model of surveillance system to get data to identify mechanism and causation. For example, cholesterol is very important in increasing the propensity to heart attacks or conventional thinking in terms of diabetes, is unhealthy diet and low physical activity results in obesity, which increases insulin resistance and results in diabetes. He added that this is just conventional thinking; we would not know that obesity is just 8% in India but know that diabetes prevalence is around 10% in the population. However, in the US, prevalence of obesity is 60% but diabetes prevalence is only 10%. One can think that this can be due to beta cell dysfunction, interaction of hepatic infections, hepatic insulin resistance or organic pollutants deposited in the islets, which disable them. Biotechnology can help us by identifying these, and we can take corrective actions later on. Rapidly evolving geographic Information systems can help in mapping of diseases, and one can look at hotspots of chronic diseases and identify epidemics very early. For instance, the dengue epidemic can be contained very early by identifying the water spots and mosquitoes breeding grounds, and taking remedial actions. But despite the new ideas of innovation, we face challenges like we have limited knowledge on how to balance information needs of prescriber patients and payers against speedy access to better therapy. Biotechnology innovations are growing by the dozen, but to develop a viable business model they have to become more fugal and inexpensive. Lastly, the programme needs to adopt a trans-disciplinary approach. Most of the diseases and the epidemics that we face are beyond the purview of an interdisciplinary approach, and hence we require a trans-disciplinary approach. He said bringing public health on this platform of BioAsia is really visionary and congratulated the organisers. Given the strength of PFHI in capacity building, together with BioAsia, it can produce the next generation of leaders who would popularise the trans-disciplinary approach in disease prevention and management. He ended with a quote by a Swedish economist: “Health leaps out of science and draws nourishment from society around it.� Thus, to achieve the vision of a healthy India, the compass of research must extend from molecules to markets. The coalition of public health and biotechnology should mould the market for innovation, for better of health population. Ultimately health is human right.

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CEO Conclave

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CEO Conclave

Time : 18:30 - 20:00 Hrs

Navigating through key challenges to see the light of the day

Date

Co-Hosted By:

: February 3rd, 2015

Venue : ISB Hyderabad, Gachibowli

Panelists: •• Shri Sudhansh Pant IAS, Joint Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Govt. of India •• Mr. Mani Kantipudi, CEO, GVK Biosciences, India •• Mr. Maninder Hora, Senior Vice President, Pharmaceutical Development and Manufacturing Operations, Nektar Therapeutics, USA •• Mr. Arvind Vasudeva, CEO Formulations, Aurobindo Pharma, India •• Mr. Sanjiv Navangul, Managing Director, Janssen India •• Mr. Alok Sonig, Senior Vice President and India Business Head, Dr. Reddy’s Laboratories Ltd., India

Moderator: •• Mr. Vikas Dandekar, India Bureau Chief, PharmAsia News, Informa Business Information, India

Context: The pharmaceutical industry globally is faced with myriad challenges. Be it in the U.S. or in developing markets like India or China, cost of drugs and its impact on public health is raging and at most times, the center of high level political debate. Regulators are in a spot, often found wanting on questions like how much should a drug cost to the patient. In Europe, regulators have dismissed many bestselling brands on grounds that they were not found superior to the existing marketed products. Given the backdrop of spiraling cost of research into billions of dollars and the spending on drugs alone topping $1 trillion, the global industry is faced with a dilemma. How to make drugs available at a price that is acceptable by health systems and have enough left in hand to spend on research on newer compounds? On the other hand, countries like India, seen as the pharmacy of the world, with its low cost manufacturing capabilities facing serious issues on quality and compliance aspects, in the past few years. Is it really a GMP lapse or we have issues with the culture, allegations keep flying from international commentators. The problems on the two sides - innovators and generics - may be distinct. Of delivering high cost innovative drugs by multinational companies and for generic drug makers, the quest is to pass the stringent norms of the world regulators and ensure the poor nations get their quota of medicines. Can the two sides combine and make a formidable engine that helps reach medicines and the industry grow? We have in the recent past seen some such examples. The game changing licensing deals between Indian generics and Gilead for supplies of Sovaldi and also Harvoni generics is one that stands out as an ideal template. Are there more means to bring the two forces together? What challenges do we foresee in accomplishing this goal? CEO Conclave at BioAsia 2015 deliberated on the challenges and opportunities in addition to discussing the way forward for India to become the global leader in pharmaceuticals.

Session Proceedings: Shri Pant spoke about the strength of the pharma industry informing that it has made India proud over the last 20 to 30 years, and it is also the largest foreign exchange earner for the country. Nearly 50% of the income comes from exports. Today, the industry serves not only healthcare needs of the country but supplies medicines to more than 200 countries in the world.

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CEO Conclave

CEO Conclave Session in Progress

He highlighted that along with growth there are challenges. In the field of intermediates and bulk drug, in the large category of APIs we have become uncompetitive on price and imports have gone up. Imports from China are dominating the country. The government is looking at ways to incentivise bulk drug manufacturing in India through the Make in India campaign. The government is also working on package to revive the manufacturing of intermediates and API in the country. According to him, private sector is doing well. When we think of pharma, we think of the 20 top companies; however there are thousands of small and medium companies for whose benefit the government is thinking of forming a cluster, where infrastructure and monetary support for creating common research training manufacturing facilities will be created. The government is keen to take SME to the next stage so that they become quality conscious and they can export. Industry is also facing challenges on the medical devices side. Even though a lot of potential exists in country for domestic manufacturing, the industry is dependent on imports and only low-end syringes and gloves are domestically made. The government will soon bring out Recommendation:s to kickstart the industry. He also added that the Indian market is unique as we have branded generics. We had also seen generic stores such as the Jan Aushadhi stores. But these were not very successful. The government is looking to revive these stores. If generics are prescribed, the cost of medicine goes down. This will make affordable medicine reach a much larger part of the audience. Today, 80% expense is out of pocket expense. Mr. Sonig was of the opinion that access remains a challenge in country such as India, which is already operating on a low-cost generics model. According to him, access is multi-factorial issue, and pricing is one variable. The biggest variable is availability of infrastructure and availability of doctors. It’s the ability of the government to buy medicine and have its own medicine. Availability of doctors is the building block of access. He added that India is heterogeneous country and there is a resource mismatch between urban and rural. We see 72% of diseases in rural areas, while just 7% doctors and 20% of hospital beds are available in rural areas, indicating a huge supply-demand issue. The government needs to aim towards building primary healthcare centres in rural India. While at the same the big urban challenge is of vast migration from rural to urban city, thus posing challenge on infrastructure and public health. According to a leading consultant, India will have to build a Chicago every year to be able to deal with the challenge of migration and challenges of healthcare infrastructure and access. Jan Aushadi was a good initiative but the government needs to take significant steps in order to revive the same. If the government starts buying medicines, then 3 to4% of the GDP will be spent on healthcare. He was of the opinion that we need to be think disruption in a positive way. For bridging demand-supply gaps with regards to hospital, we should be testing the hub-and-spoke model. Various corporate hospitals are increasingly building hubs and linking it back to the city. He further emphasised that growth in the next five years will be driven by hospital acceleration. Mr. Navangul discussed that the problem we see in many countries is that we start focussing on wrong problem. According to him, the bigger life saviours are clean drinking water and vaccines, which makes lives better and longer. He emphasised the need to focus on these areas before focussing on price and other issues. China started giving huge subsidies and price advantage for APIs, we ran out of API business. In a scenario like this, neither the government nor the private sector can alone resolve the access problem, so everyone needs to work together.

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CEO Conclave

The problem is suspicion among partners, and hence causality of partnerships. It’s indeed commendable to note that eradication of polio was made possible in India. However, our problems are much larger. Today, the biggest economic burden is of the CVS and diabetes, and these issues are bigger than poverty and many other issues Mr. Vasudeva spoke about how we can forge better bonds with the government and improve supply of the generics industries. He emphasised that for delivering care, one needs a doctor for conducting the diagnosis, a pharmacy for dispensing and a regulator to give licence. He added that diagnosis can be done at any place but dispensing needs to be closer to the people. People have built health centres in villages manned by a nurse with a pharmacy, and the treatment is done by telemedicine, where doctor does diagnosis in city through mobile technology and prescribes medicines that are dispensed closer to the patient. If we are looking to improve access, we need better technology and infrastructure. Doctors can then in their spare time link with tele-centres. South Africa runs the model of postal pharmacy. Under this model a patient reaches out to the call centre and gives a background of disease as well as valid prescription that is scanned and sent to postal agency for delivery of medicine in flat 48 hours. Substantial cost can be saved and access can be enhanced by the use of technology. He also emphasised the need for the industry and the government to work together to enhance regulatory reforms and tendering. Another issue highlighted by him was the heavy reliance on import of APIs from our neighbouring country. India is the second-largest API manufacturer but is vulnerable on price grounds. This plug can be pulled any day and hence the government should look at backward integration to make this industry economical and secure. Mr. Kantipudi said that India is a source of generics drugs, medical devices and research services. He pointed out that it’s very easy for Western markets to think that these are of poor quality, as they are made in India. Hence, the need of the hour is to step up compliance to GCP and FDA manufacturing violations. He strongly believes that the regulatory framework needs to improve, and we do not need a foreign agency to come and say this to us but Indian regulators should be able to do this inspection at home. India also suffers from access to the latest innovator drugs. He stated that India’s perception of protecting IP is very high. If we work strongly on IP, the perception will be enhanced. Mr. Hora opined that quality is a loaded word. People think of quality as quality assurance. According to him quality is inbuilt and not tested. It is a culture and a mindset. When quality starts from top to the middle management and to people on the ground, then it is a success. If you are not aware of the timeline affecting quality of your product then people on the ground are most affected. He further explained that if a company is doing the business correctly, it is automatically following the quality requirements laid down by the regulators. He emphasised that quality is a culture we preach and practice, and is of paramount on everyone mind. He added that IP protection is an issue here in India. IP laws are different in India than in the rest of the world (ROW). We understand the requirements of Indian system vs our system. When we are doing invention work, frequent training of scientists and necessary regulatory protection should be fulfilled. On generic pricing, Mr. Sonig said that some generic companies are investing in proprietary research. Many are seen innovating on the drug delivery side. There are tremendous opportunities on PPPs for bringing down the cost; Jan Aushadi can be one such opportunity. There can be rewards for responsible pricing.

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(L to R) Mr. Maninder Hora, Mr. Mani Kantipudi, Mr. Vikas Dandekar, Shri Sudhansh Pant, Mr. Alok Sonig, Mr. Sanjiv Navangul, Mr. Arvind Vasudeva

Mr. Navangul said that micro-financing is complicated but can be done. He emphasised that we should all collaborate and do it together, we should look at issues with a stable mind and each ones issue gets resolved, we just end up pointing fingers at each other. Shri Pant said that public procurement is based on generics. Cut down budget on procurements, Rajasthan has 600 generics medicines with given free to the hospitals instead of branded generics, thus made saving in procurement. It is debated whether the government needs to supply free medicine in government and public health and hospital or not. He clarified the DPCO on pricing. Prior to 2013, it was a cost-based pricing model, but the industry felt it’s an intrusive model, and there were arbitrariness and it was not a transparent model. Then in 2013 it was shifted to market based pricing. All drugs of market share more than 1% were taken and averaged out to arrive at a median price. This was largely on demand of the industry. Even though we see a sea change in pricing policy, there are certain short comings and lacunae. He also pointed out government is making efforts to streamline the medical devices industry. Currently these devices are regulated as drugs and only 22 fall under the Drugs and Cosmetics Act (D&C Act) and are subject to price monitoring and only two under price control. Another 20 are under price monitoring at present. Regulation is quite weak for medical devices but the Drugs and Cosmetics Act is trying to amend and create a separate chapter for medical devices towards identifying list of essential devices. On marketing ethics, Mr. Vasudeva explained that some out of expenditure is incurred to create a brand X and create a distinction for my brand against the competitor brand perception. He clarified that it’s important to clarify what is warranted and required. Giving something to give for brand recall and brand perception and from A to Z expenses where one can discount. Mr. Navangul stated that anything that influences wrong judgment or treatment is objectionable. Ethics need not be enforced from outside. The Department of Pharmaceuticals has put on their website a code of conduct for marketing to healthcare professionals. If we don’t abide by this then it doesn’t become a level playing field and it gives a chance for something to go wrong. There should be no compromise on this. Mr. Sonig highlighted that marketing and sales team got to focus on medicine diagnosis and treatment. There is no compliance statute. There has to be no compromise- In terms of sales practice, a substantial number of companies are following the voluntarily code and soon it will take us all in right direction and he doesn’t see this as a concern. Shri Pant said a uniform code is floated for first six months, which is voluntary and onus is on various industry associations like OPPI. Lot of self-regulation is in place, but by end of May and June has a round of detailed consultation and decides on future course of action and makes a statute. The Medical Council of India today regulates the doctors. He said that government is trying to make provisions stringent for practitioners. He also suggested that top 20 to 25 companies should enter into a JV with FDA and industry for avoiding loopholes. He further commented on quality. He emphasised that quality should be inbuilt in the system; we need competent people to look at quality, design and transfer quality at site. He said that generally the system quality is very good, and most issues have come from the people practice. The challenge lies in getting skilled people. He clearly sees a gap and companies need to work on this. This gap can be bridged with good manpower training.

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CEO Conclave Reception

He also mentioned that Indian drug regulators are not funded enough. They do not have a platform for all stakeholders to come together and arrest the gaps in house. He also spoke about the drug device combinations, using the same drugs for other indications and how drug delivery can add value to the process. If there is merit seen in repurposing the same drug for other indication, then big companies would love to license and go into innovation. Mr. Sonig mentioned that India has advantage of in silicon technology with preclinical and genomics. Government should think of incentivising, repurposing or think of used patent and incremental innovation. He feels the law needs to change and only then discovery will happen. Law of the land currently doesn’t allow this. If we take any price cuts then it will have implication in many other countries. India is seen as price reference country, and a drop in prices will lead to drop in prices in 60 other countries and have implication globally.

Recommendations: •• Government needs to incentivise bulk drug manufacturing in India and create clear regulations for medical devices. •• Innovation is the next big opportunity. The government, industry and doctors and all other stakeholders need to put their head together and create framework for fostering innovation and payment structure. •• Risks are higher in innovation but Indian Industry needs to take baby steps in delivery and in repurposing. •• Quality should be built as a culture and mindset •• Local inspectors should be equipped to do quality inspection than just the FDA •• Both industry and the government needs to work together in order to enhance regulatory reforms and tendering mechanism for improving access to healthcare. •• Government and industry should jointly address the challenge of quality and quantum of skilled manpower required. •• Government should review Jan Aushadi programme on priority basis, which will make the affordable medicine reach a much larger part of the audience.

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Technology Conferences of BioAsia is a Science-Business bridge, that aims bring together a transdisciplinary environment for driving innovation in the life sciences industry. The tech conferences have been carefully structured in order to leverage technology trends for business relationships and help you put technology in the development relay across the world through co-development opportunities. While presenting an opportunity to explore partnerships and channels for extending businesses between industry and academia, BioAsia’s tech conferences will cover contemporary developments in research and will assist in building capabilities to break the technology development resistors for smooth flow of technology and collaborations.

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Conference Co-Organizers

Doing more with less: Accelerating India’s biopharma industry? 10:30 am to 11:45 am, 3 February 2015

Panelists: •• Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech International Limited, India •• Dr. Harish Iyer, CEO, Shantha Biotechnics Limited, India •• Mr. CSN Murthy, CEO, Aurigene Discovery Technologies, India •• Dr. Neelima Khairatkar Joshi, Senior VP and Head, NCE Discovery Research, Glenmark Pharmaceuticals, India •• Dr. Seema Kantak, VP, Research and Preclinical development, Nektar Therapeutics,India •• Dr. Stefan Hart, Director, New Ventures Singapore/SEA/India, Johnson and Johnson Innovation, Singapore

Moderator: •• Dr. Ajit Shetty, Corporate Vice President, Global Operations, Johnson and Johnson, USA (retired) and Chairman Emeritus, Janssen Pharmaceutical, Belgium

Context: Indian pharma and life sciences companies have strong generics capabilities, but to foster innovation, they need an enabling environment and a change in cultural mindset. In the coming decade, we will see Indian generic companies innovating to move up the value chain. Innovation comes with huge risks and pay offs and will be a game changer for the industry. Given the heterogeneity of the Indian population and growing disease burden, Indian companies need to look at solving society problems at large, especially in the area of rare and neglected diseases. India needs to establish a global network of innovation; we need scientist and clinicians networks. Engineering and management people need to be connected too. The need of the hour is to create an ecosystem to cross-fertilise ideas as well as encourage scientists in universities to patent by bringing the concept of incubators and involving the industry. We need to drive innovation and create success in order to provide for all the necessary channels. Stakeholders will find ways of partnering once we are successful. The focus needs to be on finding ways to succeed rather than on creating an environment that is more feasible.

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Session Proceedings: Dr. Ella spoke about the inherent strength and challenges of innovation in drug discovery. He expressed that India is a highly efficient country and has made significant progress in the field of drug discovery. Vaccines companies and pharmacies are making a tremendous impact globally. Need for India is to look at the society’s problems to arrive at innovation. A lot has changed with the government funding programmes like Biotechnology Industry Research Assistance Council (BIRAC). India though is facing many regulatory hurdles for conducting trials in India and are hence moving to neighbouring countries such as Vietnam and Russia. Further, India doesn’t have a culture of sharing resources and relatively weak collaboration between the industry and academia. The latter is still seen to be focused more publishing rather than solving real problems. He was of the opinion that partnerships are very important. If partnerships happen in early stages, they can strategize better. He suggested that industry makers need to be allowed to participate in policy making process. Dr. Iyer spoke about the need to understand the target and see how we can speed up the older technology and leapfrog to newer techniques. He emphasised the need for scientists’ and clinicians’ networks as well as the importance of having the engineering and management people connected. The need of the hour is to create an ecosystem to cross-fertilise ideas as well as encourage scientists in universities to getting their work patented by bringing the concept of incubators and involving the industry. Dr. Kantak highlighted opportunities that young entrepreneurs are exposed to at the student level. The question we need to ask is whether we are providing enough internship at the university and industry levels. She urged that we think globally but create locally and work towards the development of a global collaboration spirit. Mr. Murthy spoke about the numerous changes he has seen in the last 10 years and laid emphasis on creating successful partnerships. The biggest focus should be on finding ways to succeed, rather than focus on creating an environment that is more feasible .The driver for partnership is success. Success will breed itself and ecosystems will adapt for fostering innovation. He added that companies here face the classical problem of what to work on and how to differentiate. Around 30% to 40% work is on natural resources, and plant products offer great diversity. Dr. Joshi agrees that Indian pharma companies have the necessary capabilities but face financial issues. Not many opportunities are available for small and medium-sized companies as the process is cost-intensive. The IP environment is also an evolving process and an area for synergy to be created between the industry and academia with no facilitators is required. Companies that want to take their product to the last stage need sufficient resources. While India is at par in terms of costs, but needs to create a culture of questioning and critical thinking in order to drive innovation. Dr. Hart highlighted about J&J endeavours to advance biopharma innovation by creating a network that can combine resources, ideas and technologies in new ways. They have created a global network of innovation centres to advance transformational healthcare solutions into products in order to improve the life of patients all over the world. To be in proximity of the innovators and foster strong collaboration among the different stakeholders, they have established four innovation centres, the latest being the Asian network. They are committed to form a strong team that can contribute to the expertise and funding. They also want to be a part of the strategic partnership, mentorship, advice, collaborative research through VC support and start an incubator to bring capabilities together. He added that India has been strong in generics and requires a different culture for innovation as well as the mindset that is compatible with huge risks and payoffs. The government and academics will play a significant role in creating a sustainable ecosystem for innovation.

Recommendations: •• India needs to stop looking outside as innovation has to be country-specific to be able to solve society’s problems at large, especially in the area of rare and neglected diseases. The focus needs to shift to prevention from cure. •• India has been strong in generics but lacks collaboration. It needs to alter its mindset for innovation and create a culture of questioning and critical thinking. The government and institutes need to work in tandem to create a sustainable ecosystem for innovation. •• We must understand how we can speed up the older technology and leapfrog to newer techniques. The government needs to look at creating a central technology bank which will work as a repository with single point access and review. •• Areas for synergy need to be created between the industry and academia, and enough internship has to be provided at the university as well as the industry level. Initial research should be done in universities and then translated.

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Collaborating to bring effective treatment to market 12.15pm to 1:30pm, 3 February 2015

Panelists: •• Dr. Ludo Lauwers, Senior Vice President, Janssen Pharmaceutical, Belgium •• Dr. Prasad Sunkara, President and CEO, Innova Therapeutics Inc, USA •• Mr. Solomon Yimam, Assistant Country Director, USA FDA India Office •• Mr. Paul Willis, Director, Drug Discovery, Medicines for Malaria Venture, Switzerland •• Mr. Marcel Moester, Coordinating/Specialist Senior Inspector, Dutch Healthcare Inspectorate, Ministry of Health, Welfare and Sports, Netherlands •• Dr. Phil Kearney, Director, Licensing and External Research, MSD, Australia •• Dr. Shridhar Narayanan, Director, Research Foundation for Neglected Disease Research, and Former Director, AstraZeneca Research Labs

Moderator: •• Mr. Vikas Dandekar, India Bureau Chief, PharmAsia News, Informa Business Information, India

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Context: Boundaries are shrinking and companies, governments and academia across the world have to find new models for working together in order to bring effective therapies to the market, which is easier said than done. In the coming decade, we will witness pharma and biotech companies collaborating to bring innovative treatments to the market. Pharma MNCs are looking for opportunities to co-develop drugs and buy or in-license molecules from Indian companies. Drug discovery is going to be a collaborative process going forward and for this collaboration to succeed, the parties involved need to create a win-win situation. They need to build trust and understand that confidentiality is crucial. If Indian companies wish to see their compounds advance, they need to find a suitable partner and license to them. Innovation companies in India need to look at high-value licensing deals as well as return on value and take much bigger risks, as out-licensing is the only model that will sustain. We have seen that while big pharma funding is not an issue, the regulatory pathway for clinical trials is a major deterrent and companies don’t know how to progress form the various phases of clinical trials. In order to advance the molecule and see it at a global level, licensing is the only way to go.

Session Proceedings: Dr. Kearney spoke on importance of GMP. He is of the opinion that the falsification of drugs and lack of GMP are big threats to the system. Unique identifiers and 2D barcodes as safety features to counter this problem and emphasised the need to strengthen the supply chain, manage risks as well as the importance of inspection and enforcement. Mr. Moester spoke on behalf of European regulatory inspectors. All that they are doing as part of the regulation is aimed towards good of the patients. Highlighted salient features of the European regulatory system, threats to the system, measures that they have taken and how they are working with other stakeholders and regulators in other countries. He said that in some respect Europe and India are similar, as both have close to 30 states within a union. He added that recently they have introduced registration of active substance or the API. He highlighted that good manufacturing practices (GMP) play an important role in ascertaining the quality of the drug. He talked about the spectrum of patient care and importance of disease management, diagnosis and pharmacovigilance, which needs to be dealt with in order to effectively treat the patients. The EU regulatory system has a model for compliances to GLP, GMP, post market surveillance and good pharma practices. He added that currently regulatory systems lack mechanisms to measure compliance to good diagnosis and prescription practices. Industry today is facing numerous threats like falsification of drugs, lack of GMP and data manipulation. Several measures have been taken in this regards such as enhancing the safety features by making use of unique identifiers technology like 2D barcode. This is already in place in India. Further, it is important to strengthen the supply chain. At the moment, internet sales are not much regulated. Non-compliance with GMP invites strong penalties like the suspension of market authorisation and supply. He added that they are collaborating with other regulatory bodies like WHO and USFDA for carrying out inspection. He highlighted growing prevalence of pharmaceutical crime and a convention called Medicrime, which is formed for prevention of such crimes. By registering with the Medicrime convention, all members follow a common definition of crime. Falsification of drug can be one such case. Whatever happens in one of countries with respect to falsification of drugs and APIs, has immense effect on rest of the world and hence we need to work together to build confidence in each other’s regulatory system and work towards common standards. PICS is an organisation of inspectors and around 47 countries are members of this inspection body. They use GMP and procedures to do inspection and facilitate training of inspection. Mr. Willis was of the view that partnerships are crucial going forward. They are themselves entering into new partnerships and collaborations with suitable partners across the world (strategic partnerships with AZ on malarial drugs, for example). Generally, they float a tender and get requests from partners. While screening partners (right from the initial stage to the clinical trial as well as post marketing), an external advisory committee provides the necessary checks and looks for people who have the capability and expertise to deliver. Drug discovery is changing and is predominantly going to be a collaborative process. Hence, we need to work in tandem in order to defeat the neglected diseases. Dr. Narayanan is of the view that partnerships on infectious diseases have reduced. Collaboration in terms of the science involved is important but so is collaboration amongst the government, pharma and philanthropy for funding. Dr. Sunakara has been trying to put together a small fund and take the entrepreneurial rout. He believes that opportunities to arbitrage the talent pool and fund ideas need to be provided to build companies based on IP and proprietary

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technologies to pave the way for bigger companies. . US universities have technology transfer offices to encourage patenting, the government needs to obtain funding from outside. Dr. Lauwers said that Collaboration is necessary for risk sharing as its takes 14 years and 3 billion euros to develop a compound. For creating successful partnerships, it is important to build trust. They are currently involved in 40 competitive projects with the industry, and are facing various hurdles in projects with universities including talent search and time taken to agree on the outcome of a project. Universities in the US are focussing on generating revenues. They are collaborating with the industry on corporate knowledge and entering boot camps. Students and doctors need to be brought together and paid for the work, even though timeliness and goals are different. The government needs to get actively involved as it can play a major role in the field of neglected and rare diseases. He believes there is a need to foster relationships and create an ecosystem for creating jobs and generating revenues Mr. Yimam emphasised that they are working with the DCGI and state regulators to conduct more workshops. Government will be launching more programmes to equip inspectors. PIP collaboration could be looked as an option, where several organisations get together to form a consortium such as the IMI in Europe. India is great in the generic space but can excel at innovation too. We can create an ecosystem for drug discovery in charitable mode and forge partnerships in the IP space. Need to look at a creating model with other countries for sharing of knowledge. Collaborations like Indo-US Scientific Technical Subcommittee, the US-India Fund, and the Indo US Vaccine Plan are examples of these models. The primary aim should be to support collaboration, which will ultimately reduce the burden of infectious diseases around the world.

Recommendations: •• Organisations need to get together and form consortiums such as the IMI in Europe. •• Collaboration amongst the government, pharma and philanthropy for funding is as important as scientific collaboration. The government needs to incentivise funding to academicians who are interested in a taking the leap to collaborate with the industry, and who are focused on solving a specific problem. A mechanism where the collective is greater than the sum of the individual parts will go a long way in incentivising the scientists. •• Government programmes such as BIRAC provide short term grants. There is a need to set up a common platform for the VC and industries to expedite the process of funding.

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Conference Co-Organizers

Investing in the NEW 2.30pm to 4pm, 3 February 2015

Panelists: •• Professor Mark Caulfield, Director, William Harvey Research Institute and Genomics, England •• Dr. Subir Basak, Global President (R&D), Jubilant Lifesciences, India •• Dr. Ramanuj Dasgupta, Group Leader, Cancer Therapeutics and Stratified Oncology, Genome Institute of Singapore •• Dr. Ramareddy V Guntaka, Health Sciences Center, University of Tennessee, USA •• Mr. Sreevatsa Natrajan, CEO, Sapien BioScience Pvt Ltd, India •• Ms. Shobha Vijayaraghavan, VP, Business Development, Connexios Life Sciences, India •• Mr. Jon Mowles, Sector Specialist, Life Sciences, UK Trade and Investment

Moderator: •• Mr. Madhur Rathaur, Director, Operations, PRTM, PwC India

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Context: Genetics, genomics and proteomics approaches are identifying specific patient populations and treatment regimens for targeted treatment opportunities. The future of the drug discovery lies in investing in the newer sciences of genomics, proteomics and regenerative medicines, which will redefine the treatment for diseases. At present, these sciences play a relatively small role in the lab. However, with cheaper genomic technologies and better biomarker screening technologies, pharma will be able to decipher the messages encoded in our genes and put diseases under the spotlight as never before, while finding better outcomes. A lot of work is being done in the area of genetic medicine around the world. Several Indian companies have novel compounds in their pipeline and are looking for suitable partners. New in-vitro and in-vivo assay and disease models are being generated to reach targeted therapeutics and speed up the drug discovery process by bringing in the biology much earlier. We need to create access to talent and technology. Currently, less than 10,000 jobs are created in this sector, which itself is a huge challenge. Another big challenge is bringing together the talent to create a sustainable business and service the industry for creating a portfolio of candidates. The focus needs to be on targeted therapeutics. The industry is witnessing an amazing group of new scientists in Bengaluru, who are establishing models for drug delivery and stem cell biology. They are expected to pay a critical role in taking this science to the next level. India needs to be aware of all the options such as the availability of bio banks to further the discovery process. Bio banks provide flat frozen cells, and extract RNA and live cells, which can help model diseases and understand the resistance as well as design suitable combinations of treatment options. While considerable work has been done in the area of sequencing, we need to now focus on real-time modelling of the disease with a hope that when we sequence, we may be able to find early drivers rather than late consequencers. When you have a spectrum of patient samples across various stages of cancer, you begin to understand which are more aggressive as well as which one is the driver and which one the passenger.

Session Proceedings: Ms. Vijayaraghavan spoke about the need to focus inwards than outwards and look at India as a big market. Indian companies should stop looking outside for drugs that bring more money. Indian population has enough ethnic difference and companies should target efforts to our population. We also need to strengthen the ecosystem in which we operate today. We should look at Western models, where the industry has successfully collaborated with the academia. In the US, the academia is seen as a service provider. Academia can work with the industry on platforms that bring in revenue, which in turn helps start-ups. Closer home, even we can look at outsourcing some of the services to the academic organisations. Prof. Caulfield stated that India is strong in chemistry and hence well placed to take things to the next level. India needs to combine computational biology with chemistry as well as forge partnerships. Dr. Basak spoke on various issues perplexing the discovery part in India. Firstly he highlighted the need to create access to talent as well as technology. Currently, less than 10,000 jobs are created in this sector, which itself is a huge challenge. Another big challenge is bringing together talent and creating a sustainable business and service the industry for creating a portfolio of candidates. While India is known for being a manufacturing hub, we are now seeing innovative drugs coming out of the country. He also foresees significant barriers to play in biosimilars across the value chain. First generation biosimilars ran out of patents 10 years but no regulatory mechanism or protection has been offered. Some countries did well with government support like Korea and India. We need better understanding of the regulatory mechanism. There is a gap between biobetters as only a few are available today. Companies are now looking at monoclonal antibodies, which are the most advanced second-generation biosimilars. Technology is also changing rapidly, and even the lifecycle of products is very different for different markets. Partnerships may be required to create a sustainable model for the future. Secondly, he agreed that computational biology needs to be combined with a strong base in chemistry. We have exhibited strong capabilities for vaccines as well as large molecules, and an evolving tool for technology and infrastructure development is fast emerging. Thirdly, discovery is essential but a very small part is done today. Most of the funding is spent on development. For discovery, we require reforms and collaboration. He stated that forging partnerships between the industry and academia for India-centric problems is crucial as the genotype is different for Indian patients. He mentioned the need to collaborate in an effective and sustainable fashion.

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Dr. Dasgupta shared that they are working on designing specific targeted cancer-signalling pathways. They use targeted screening, functional and genomic approaches for identifying the drivers of metasis and drug resistances. They have developed various models from genograms of patients suffering from colon and lung cancers. In these, the PDX model is trying to generate 3D micro spheroids and developing new modelling for high throughput screening to identify key drivers for metasis and drug resistances. He said that the focus needs to be on targeted therapeutics, which quite evidently is in chemotherapy at present. There exists tremendous potential in collaborating with researchers. India today is witnessing amazing group of new scientists in Bengaluru, who are establishing models for drug delivery and stem cell biology. According to him they are the critical mass of people who can take science to the next level. He added that the government should incentivise funding academics who are interested in taking the leap to collaborate with the industry and are focused on solving problems, where the collective is greater than the sum of the individual parts. And a mechanism that can fund these opportunities will go a long way to incentivize the scientists. Dr. Natrajan talked about the concept of bio banking. Bio-banking is a relatively new concept in India and building awareness is a challenge not just in India but even around the globe. Bio banks provide flat frozen cells, and extract RNA and live cells, which can help model diseases as well as understand resistance and design suitable combinations of treatment options. It has also proved beneficial in the immune profiling of cancer. Today researches are conducted on up to 40-50% known cell lines and are not from the organ we can think of. Connecting research with the human context enables you to fail fast and make sure that only the horses with legs reach the goal posts. Bio banks are platforms for layering several technologies furthering the diagnosis and treatment practices. He further said the acceptance and awareness of bio banks is a challenge. Mr. Mowles mentioned that UKTI has started the following two government initiatives: 1. The Self Therapy Catapult has been set up to fast-track projects in the area of genetic medicines. He said that in the field of genetics across the world, they have set up one facility, with 100 staff is operational and open to even international organisations. He added that the government has recently given permission to build a GMP facility. 2. They are also building a bioprocess centre, taking advantage of the experiences in UK and India, and would be ready by end of the year. They are looking at setting up a technical advisory board for regenerative medicine and the development and production of biologics drugs. India has the requisite strength, and all it needs to break silos and collaborate with UK. Many stakeholders like the academia, industry and NHS are working in siloes today. India should aim at programs like UK MHRA. Dr. Guntaka spoke about the shift towards prevention and need for greater collaboration within the stakeholders. Lot of new infections are surfacing in India and nobody is addressing the local issues. Companies need to look at country’s internal problems and come up with practical solutions. Initial research should be done in academia and then be translated further. However, academia can do research only if funds are available. If the academics, government and industry work together and collaborate on funding, a lot can be done. He added that a lot of work is being done in sequencing. We should focus on real time modelling of disease with a hope that when we do sequencing we may be able to find early drivers than late consequencers. We are a long way from gene therapy, and understanding at the expression level what is the phenotype relationship. The concept of recurrence diagnostics was discussed. When you have a spectrum of patient samples across various stages of cancer then you start to understand which are more aggressive and which is the driver and passenger. Mr. Natarajan opined that we can leverage IT by linking it to healthcare life sciences. He added that if data can be combined with life sciences, it will pave the way for innovation. Big data will enable genomics and this will be possible because of the sheer number we have.

Recommendations: •• We need to focus on India-centric problems and view India as one big market. •• We need to create access to talent as well as technology. •• We need to strengthen the ecosystem in which we operate today and learn from western models, where the industry has successfully collaborated with the academia.

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•• Creating areas for synergy between the industry and academia, with enough internship opportunities at the university and industry levels. Initial research should be done in universities and then translated. •• The government should incentivise funding academics who are interested in taking the leap to collaborate with the industry and are focused on solving problems. •• We need to create awareness about bio banks and their advantages. •• Many stakeholders in the industry are working in siloes and we need to break them down. •• We need to now focus on real-time modelling of the disease with a hope that when we sequence, we may be able to find early drivers. •• We need to set up a technical advisory board with respect to regenerative medicine as well as the development and production of biologics drugs. We must understand how you can speed up and leapfrog older technology to give new technology. The government should look at creating a central technology bank, repository of technology, one place access and review. •• We need to find ways of combining data with the life sciences field, as it will pave the way for innovation.

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Conference Co-Organizers

Funding drug discovery 4pm to 5.30 pm, 3 February 2015

Panelists: •• Dr. J B Gupta, Chief Scientific Officer, GVK Bio Sciences, India •• Dr. Wenyong Wang, MD, Investment Banking, Evolution Life Sciences Partners, USA; Acting Chief Business Officer, Viventia BIO, Canada •• Dr. PKS Sharma, Head Technical, BIRAC •• Prof. P Yogeeswari, Professor, Department of Pharmacy; Associate Dean, Sponsored Research and Consultancy Division, BITS Pilani, Hyderabad

Moderator: •• Mr. Vishal Gandhi, Managing Partner and CEO, BIORx Venture Advisors, India

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Context: Funding is still a big challenge for the drug discovery process. Reports suggest that the Indian government has been spending around 254.54 million USD each year on high-risk biotech research in the country, to support R&D and innovation. However, private funding in innovative R&D is extremely low. What are the key challenges and new funds available? Can the government play a big role here? Will the new government redefine the way we do research in India? New funding opportunities are being given by the VC and BIRAC programmes. A majority of primary research must be done at the academic level and scaled up to the industry level with the right support. Academic and industry should embrace each other and trust each other –It will be difficult to bring a big shift from paper publishing to patenting. The government also needs to provide the necessary infrastructure by creating clusters on the lines of Biopolis in Singapore and China. We should also create a central technology bank, which can act as a repository of technology, one place to access and review all technologies.

Session Proceedings: Prof. Yogeeswari spoke about the technology business incubator which is started a year back at BITS Pilani. Before the incubator program they faced problem transferring technology from university to industry as no proper policy was in place. They have worked on various industries sponsored projects for big pharma, where institute worked more as service provider and library creators. However, there were gaps in collaborating with the industry. The industry was only interested in NCE with proof of concept and patents. Even confidentiality was an issue for the industry. Today, a lot has changed in terms of policy and efforts for creating entrepreneurs; this in turn has resulted in a change in attitude for faculty and students who are aspiring to bring the clinical candidates from the lab. To propel this initiative further, the university announced that anyone who has a technology can start a company, and the institute will transfer to the industry free of cost to see if this could be commercially viable project. It is still difficult to bring in a big transition from paper publishing to patenting, as paper publishing is still the limelight in universities. At the moment it is difficult to break the mindset of university do things outside their comfort zone to bring start-ups. But, going forward it is a possibility that every university may come out with commercial technology. Enormous funding opportunity is available with government scheme for basic research in India. However, not much of patenting is happening at the academia. Research performance rating can be looked as one way of incentivising academia for patenting. The way ahead for strengthening industry-academia partnerships would be to attract industry inputs for funding, showcase confidentiality, change attitude and deliver on committed timelines. She added that the biggest gap is that university over promises and under delivers and this should be a big learning for the university. For bringing more innovation, both industry and academia should embrace each other in collaboration mode and create trust. Academia need to step up and reach to industry as they have many solutions. Mr. Gandhi highlighted that at the moment not many people interfacing between technology providers and the business takers. They have identified this spot and they are working on Bio Student program with BIRAC and DBT where they pick up students from university and empower them with business ideas, and help them understand the value of IP they are working with. They help them generate interest among the industry, go and showcase their invention to industry and get absorbed by industry, which they had started as a CSR initiative. Dr. Wang commented on foreign funding programmes in countries like the US, UK and Canada. He identified two prevalent chains of thoughts from an investor’s perspective. One is play safe, as majority of medicine is already there for small molecules, we need to make them safer and efficacious, it’s no less than innovation. Second, is playing smart. If you already have a molecule, next eye for global market. Truly innovative big pharma company will be interested if you play safe and smart. Corporate ventures funding biopharma innovations at early stage, is referred as Smart money. Everyone today is following a herd mentality by blinding following on few therapy areas like immune therapy. However, the need of the hour is to identify the big leap, if you are in the big leap you will have small setbacks. For example South Korea, is coming up with innovations in three key areas: automation, robotics and higher education with exchange programmes with best universities. Life sciences has been identified as the next big area for innovations. Already they are working on bio banking, setting up world class labs and advancing manufacturing. He added that from the India perspective, we need to look at what we are good at and work on that. World acknowledges that India is good at IT. Healthcare IT ventures have doubled in last one year and digital health has evolved in India. He added that one must follow passion and marry with entrepreneurship to get the desired returns. Chemistry has become routine but biology is the future. How we play smart in terms of biologics funding to see good returns will be the key differentiator. Dr. Gupta spoke about how Glenmark has a sustainable model for carrying out research through out-licensing deals. For all their deals that have happened so far one central component is out-license at a suitable stage. Participate in high-value

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licensing deal and look for return on value and take much bigger risks. Out licensing at the earliest is the mantra for success and find a suitable partner outside India. Funding is a big problem in India and especially to entrepreneurs. BIRAC has been providing funding but is not seeing good projects and other hand we have good science but no funding. It is important to understand why the marriage between good project and funding is not happening. It takes long to get the funding and infrastructure is not in place. Government should look at building technology clusters on the likes of Biopolis in Singapore and China. Infrastructure is a gap, we are not investing in the technology, and Government has promised a lot for the private player on technology front but not delivered. Another big challenge is that we don’t have a rich library of compounds, in particular for infectious diseases. He added that going forward academia and industry collaboration has to grow. We also should create a central technology bank, which can act as a repository of technology, one place to access and review all technologies. Dr. Sharma commented on BIRAC’s method of catalysing the biopharma vision for India, and how India could be the hub of biopharma innovation. He elaborated that country needs a central approach for addressing issues concerning biopharma industry. BIRAC has started a nation biopharmaceutical accelerator programme. In this programme, they start by doing situation analysis to see where the talent, funding and infrastructure are placed currently, to avoid duplication of resources. Need is to bring infrastructure, human resource and technology together. This programme will be like a consortium, on the lines of C-Camp in Bengaluru. This programme will be rolled in the next one to two years’ time and they are working on it. The BIRAC centre of excellence programme is also coming up, which will be a central approach. In this programme they would identify two to three niche disease areas to focus on like vaccines or monoclonal antibodies. BIRAC helps with filing patents, where IP is owned by the company. In all, 17 products, 11 technologies and 25 patents have been generated from BIRAC in just three years, and it is definitely contributing to the success of the bio-economy. BIRAC today has rich library of compounds. However, there is a need to have libraries of compound for infectious diseases. 70% BIRAC funding goes to PPP projects. They are giving seed funds and where they see opportunity they are inviting VC and trying best to support funding. At the moment grant of 50 lakh INR may not be enough for start-ups. Need to arrange a common platform for VC and industry to expedite the process of funding. Academia is good at basic research and industry is good at scaling up, and they have to come together to grow further. He added that the accelerator programme supported by BIRAC not only provides funding but provides complete mentorship to take the journey forward. Even the entrepreneurs should ask and search for funding and do their homework. At time they may not get VC right away. Crowd funding works well in the West, but we are still 10 years behind.

Recommendations: •• Government programmes such as BIRAC provide short-term grants. A common platform that expedites the funding process for VC and industry needs to be set up. •• Areas for synergy need to be created between the industry and academia and enough internship has to be provided at the university as well as the industry level. Look for creating areas of synergy between industry and academia - giving enough internship at the university and industry level. Initial research should be done in universities and then translated. •• The academia and industry need to embrace each other and build trust on both sides. The former has to step up and reach out to the industry. •• The government needs to learn from successful models, such as the Biopolis in Singapore, from across the world –The Singapore government has put efforts to bring academics together with industry, changed the grant structures and brought clinician on board. •• The government needs to look at creating a central technology bank which will work as a repository with single point access and review. •• Out-licensing at the earliest is the new mantra for success.

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Newer model of supply chain: Is the current supply chain capable? 10.30am to 11.45am, 3 February 2015

Panelists: •• Prof. Saral Mukherjee, Associate Professor, Production and Quantitative Methods, IIM (Ahmedabad) •• Dr. Ravi Prakash Mathur, Senior Director, Supply Chain Management, Dr. Reddy’s Laboratories, India •• Mr. Anindya Chaudhary, Senior Director, Head - Consumer Health Care, Sanofi Aventis, India •• Mr. Shankar Mehdaiya, Director, Micropark Logistics, India •• Mr. Javin Bhinde, Executive Director, Syncore Consultancy, India

Moderator: •• Ms. Meghana Reddyreddy, Principal, PwC India

Context: The Indian pharma sector is diverse and fragmented, with multiple touch points in the supply chain process, which includes numerous stockists and distributors. Hence, retailers need an interaction of multidimensional functions such as manufacturing, planning, marketing and sales to ensure that the supply chain objectives are met. The session touched on the choke points in the Indian pharma sector and how they can be overcome given the constraints in the system. If supply chain is at the core of the business for an organisation, then the organisation must always strive to improvise the supply chain process in order to stay ahead of its competitors.

Session Proceedings: Mr. Chaudhary emphasised the unique nature of Indian supply chain, wherein any distributor can supply to any retailer. Market pull should determine the production plan. He focussed on the crucial role that sales can play in the success of the supply chain and pointed out the huge interface of the sales function in getting the supply chain right. He said that when the sales team understands what item is moving from the shelf and where it is moving from, the team can work backwards and correct or double its efforts to achieve the objective.

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Ms. Reddya moderated the session by asking insightful questions as to how a mind shift is made possible at the distributor level to help them give visibility to someone at the top like a pharma manufacturer. Mr. Chaudhary responded that the solution is to give the best ROI to the distributor and arrive at a win-win solution. Mr. Bhinde said that the solution is to put supply chain at the centre of the organisation and not view it as just a cost centre. The best approach is to create a cross-functional team comprising of members from the sales, manufacturing and planning teams to give relevant inputs to the SCM process. Prof. Mukherjee stated that there should be a change in the mindset at the organisation level. There is even the question of ethics that needs to be looked at, considering there are unethical practices in the form of bribes given by distributors for their sale quota or targets to be fulfilled. Dr. Mathur suggested that the SCM policies must be reviewed on a continuous basis. There must be real-time updates for replenishment of stocks. He said we must get in lean concepts and adopt multi-laning; for instance, looking separately at dedicated capacity, made-to-order and so on. Ms. Reddyreddy said that companies need to sell the notion of an adaptive, responsive, segmented supply chain to their business partners and make deliberate choices on how to configure the supply chain. Mr. Mehdaiya gave his views on SCM benchmark practices followed by other industries. For example, a study of Nike’s practices shows that the company can track any product sold from any shelf anywhere in the world. Likewise, Nokia is integrated with its 250 vendors for the over 1,000 components that go into the manufacture of a Nokia phone. By drawing a parallel with other industries, he showed that we need to build such capabilities in pharma too. Dr. Mathur pointed out that we need to build visibility to a granular level and need to have a mechanism to trace back to the batch number on a strip and disseminate the relevant electronic information. Mr. Chaudhary wrapped it up saying that organisations need not wait for the perfect solution considering the IT and data challenges, disparate systems of billing, multiple layers of regulatory requirements. There is a need to integrate all capabilities to make SCM effective, which is a step-by-step process. He mentioned partners like AWACS that have helped to build bridges between disparate systems. Mr. Bhinde stated that we need to synchronise actions of stakeholders to achieve the common goal i.e. what the patient wants. Another suggestion was customer segmentation and adopting supply chain practices accordingly. For example, oncology might have its complications, drugs for acute or chronic diseases and each type requires a different planning system. How we use that data into planning determines how well the supply chain works. Ms. Reddyreddy wrapped up the session by concluding that SCM is a holistic top-down capability-building project that a company needs to undertake. The only difference between a big company and a small company is the complexity of the supply chain. Every stakeholder needs to understand the implications of the supply chain on the business strategy so that the company is on a competitive project.

Recommendations: •• The top management needs to change its mindset and understand how SCM can unlock value for sales and in turn increase profitability. •• SCM needs to be at the centre of the organisation and not a support function. We need to partner with the supplier’s supplier and customer’s customer to unlock value for SCM •• There is a need to have a seamless prioritisation logic to replenish stock daily by means of continuous review to avoid the problem of stock-outs. •• We need a robust IT infrastructure by way of ERP to enable segmenting of supply chain in order to integrate wholesalers, stockists, service providers, customers on an end to end basis •• A paradigm shift is needed in the mindset of top management to view SCM as one of the biggest business enablers and not as a cost centre in the organisation. •• Companies should maintain an ‘e-pedigree’, an electronic document that provides data on the history of a particular batch of a drug, and maintain the data on a cloud server with a database of wholesalers, retailers, service providers to integrate the chain of stakeholders end to end. This would enable complete visibility of data for stakeholders. •• We need to synchronise actions of all the elements in the supply chain so that everyone works towards the common goal, which is what the patient wants.

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Traceability of drugs and anti-counterfeiting 12pm to 1.30pm, 3 February 2015

Panelists •• Mr. Ameesh Masurekar, Director AIOCD Pharmasofttech AWACS Pvt Ltd, India •• Mr. B Raveendran, CEO, Supply Chain and Talent Acquisition, LBW Consulting, India •• Mr.PV Raju, Biological E Ltd, India •• Mr. AJ Reddy, VP Sourcing and Procurement, Mylan Laboratories Limited, India •• Mr. Rajesh Advani, VP, Tech Mahindra, India

Moderator •• Mr. Vivek Padgaonkar, Director, Projects and Policy, OPPI, India

Context: Only 21% of large pharma companies had a dedicated anti-counterfeiting project team. As per a newspaper article in the Times of India, a study revealed that one in five medicines sold in India are fake. About 75% of drugs in the world are sourced from India but less than 1% drugs produced are tested. Technology should play a significant role in tracing counterfeit drugs. Counterfeit drugs are not just a problem for the manufacturer but also for the distributors, retailers and customers. Ultimately, counterfeit drugs are a threat to the patient and hence pharmacovigilance is the need of the hour.

Session Proceedings: Mr. Reddy emphasised the significance of volunteering product recalls in the interest of patient safety. He stressed on awareness, ownership and accountability beyond regulatory enforcement in context of patient safety. Mr. Raju recalled that RFID technology to combat counterfeiting was used widely by Pfizer and Astra Zeneca. Mechanisms such as 2D or 1D barcoding can also help. Currently, companies use RFID technology to track medicines that are temperature-sensitive and are transported in cold storage so that fluctuations in temperature can be monitored. Mr. Masurekar shared a study of how barcode scanners are revolutionizing the liquor industry in Delhi. Every bottle of liquor was tracked with an RFID or a 2D/3D barcode which is a low cost solution for Indian market considering that the amount spent of a barcode scanner was negligible. Barcode scanning was best suited to keep track of inventory and reconcile production and sales. This is also an anti-counterfeiting mechanism by design. If the barcode is repeated, it can be detected. Every liquor manufacturer has information of store-wise inventory and sales. Tata Consultancy Services enabled this mechanism and helped

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the government track and reconcile excise duties on liquor. At a cost of about 10 paise per sticker, the benefits are tremendous as billing time and inventory management is also achieved. The similar mechanism of barcode scanning should be adopted in the pharma industry so that it is a holistic solution for tracking products along the supply chain and works as an anti-counterfeiting mechanism—all of this at a very affordable cost. Mr. Padgoankar stated that the industry stakeholders need to take initiatives themselves to combat counterfeit drugs rather than waiting for the government to step up efforts in this area, in the interest of both brand protection as well as patient safety. He stated that availability, affordability and accessibility were the three critical points for growth of this sector. On counterfeiting legislations, Mr. Rajesh said that we need to look at how different countries have adopted various legislations against counterfeit drugs and that would be an inspiration for countries like India. Mr. Reddy said government should be made an enabler than expect them to perform a policing role in terms of regulation. Mr. Masurekar said that customers should be empowered; we can have a live inventory search where a customer by way of an app can track the required drug at a nearby store. This futuristic solution is planned to be implemented in Jan Aushadi to be launched in Delhi in July 2015. It is a simple and low cost solution. It will encourage the government to participate and regulate. Mr. Raveendran said that the government needs to have a stringent punishment for selling counterfeit drugs such as in the case of psychotropic drugs. Under the NDPS Act, the punishment for selling psychotropic drugs is 10 years. It is imperative for the company to maintain details of manufacture, consumption, return and destruction. Similar laws must be put into action to contain the issue of counterfeit drugs. Accountability of the drug is on the company to maintain the record of whom the drug was sold to, maintain the lorry receipt of the issue of drugs, track quantities sold to various distributors, etc. Mr. Raju suggested that NPPA along with inputs from OPPI can allow manufacturers to charge extra for the cost of barcoding and include the cost on the NLEM in the coming year to encourage manufacturers. Mr. Padgaonkar emphasised that accountability for counterfeit drugs rests on the organisation and said that OPPI would take Raju’s suggestion forward with NPPA. Mr. Reddy stated that there is also information available online on counterfeit drugs for the benefit of the public. Mr. Raveendran stated that even the customer might be accountable as most consumers know the fact that they are purchasing a counterfeit drug. The person who has the drug in his possession is held questionable to explain the source he procured if from. In most cases, there wouldn’t be a bill so it becomes difficult to track back. Mr. Reddy stated that once traceability and investigation takes place, even the API manufacturer will be accountable along with the drug manufacturer, even the raw material provider may be questioned, as long as it is a legal trade based on an invoice. Traceability becomes a challenge in India because of the 600,000 distributors, over 100,000 stockists and sub-stockists. The US and EU have drug safety reporting. There must be dedicated numbers where customers can call or send SMS and report counterfeit drugs. India is in an infancy stage in terms of pharmacovigilance. Companies need to have more control over distributors and appointment of sub-stockists. Companies need to perform due diligence during the appointment of distributors. Companies should educate their brand protection department about counterfeit drugs. Mr. Reddy opined that social media is more effective than regulatory action to know about counterfeit drugs being sold. Mr. Padgaonkar wrapped up the session and concluded that the panel’s views on various aspects of the supply chain will help companies understand and enable SCM to be a competitive advantage to the organisation.

Recommendations: •• The company needs to be held accountable and even the society must take responsibility to police counterfeit drugs rather than expecting the government to intervene by way of policy decisions •• RFID, scanning and barcoding technology is the most effective and low-cost solution in the Indian scenario to track drugs and is anti-counterfeiting by design. It helps manufacturers trace the drug and pharmacists to monitor their inventory. •• Companies need to have more control over distributors and the appointment of sub-stockists and conduct strict due diligence during the appointment of distributors. •• Companies should educate their brand protection department on the issue of counterfeit drugs. •• Customers should become more knowledgeable and insist on a bill on purchase so that traceability is maintained in case the drug later on turns out to be counterfeit. The problem of counterfeit drugs through illegal manufacture and trade routes still persists. 46

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Conference Co-Organizer

Challenges and future of supply chain management 2.30pm to 4pm, 3 February 2015

Panelists: •• Mr. Ravinder Bolangdy, CEO, Hyderabad Menzies Air Cargo, India •• Mr. Raam Babu, Managing Director, Pulse Pharmaceuticals Pvt Ltd, India •• Mr. Kevin Broadbeck, Nektar Therapeutics, USA •• Mr. Mohan Joshi, Mentor, Management Advisor and President, Rotary Club of Bombay West, India •• Mr. K Venkatesh, Head Commercial, UCB, India •• Mr. Sudheendra Kulkarni, VP, Janssen Pharmaceuticals, India

Moderator: •• Mr. Vivek Padgaonkar, Director, Projects and Policy, OPPI, India

Context: In the pharma industry, supply chain management (SCM) is a complete, end-to-end value chain. In the API market, we are in a borderless place. From the perspective of global trade, companies are procuring from other countries such as China due to the cost factor. Companies in India do not have the liberty to price their drugs due to regulatory restrictions and therefore in the light of diminishing margins, it is imperative for companies to focus on operational efficiency. For instance, companies such as Apple are renowned for their supply chain and for having the best inventory turns in industry. An efficient supply chain has a direct impact on a company’s profitability and we can draw a correlation between SCM and profitability of a business. A leaner process helps management of space, in other words, warehouse management, logistics process and enhances the ability of a business to invest and grow. There are cost pressures from every side. The efficiency of SCM can be a strategic input in optimising cost. Suppliers should be encouraged if there are strong entry barriers in the country in the form of documentation, visits, and trials. This is because exit barriers are also tough and all stakeholders in the industry can get consistently good quality material if the entry barriers are high in a market. From a logistics point of view, one needs to select service providers as per the customer’s criteria with the manufacturer.

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Cost is not the only yardstick for selection that the customers use. Their needs are most important and hence service expectations of the end user must be met for the business to thrive.

Session Proceedings: Mr. Joshi opened the discussion emphasising that visibility of information is critical for the supply chain process in pharma to function effectively. Various stakeholders can reach a consensus and have a better decision-making process only if data is accurate and available to all. He opined that we need to interpret Make in India as ‘produce in India’ for the rest of the world. We need forward looking plans to produce efficiently and ship to the point of consumption and also meeting cost parameters at the same time. We need to think on the lines of what our contribution would be to the world. We need preparedness to fight global competition. Mr. Kulkarni added that India is known globally for its API capability. Can we leverage our Indian brand for API to the best extent possible? There are companies from Taiwan, Korea, Brazil and Argentina that are our competitors in API. Indian companies can stay ahead of the competition only when customers get the best product at the right time, expected quality and affordable cost. Mr. Broadbeck stated that the key challenge he could foresee is on understanding the regulatory environment in India. As barriers reduce globally, the need to comply with regulatory requirements of different territories increases. Understanding and complying with regulations in manufacturing practices, quality, storage and distribution is the key. The FDA has provided guidelines to treat a contract manufacturing organisation (CMO) as part of the sponsoring organisation from the point of view of compliance. The training imparted to the CMO and the quality of output has to be up to the same standards expected by the regulator of the sponsor itself. Indian companies need to understand the huge responsibility involved in this area and scale up to global standards. The panel felt that if look at the current imbalance in our trade situation, emphasis on Make in India campaign is a welcome move to be able to balance that out. Supply chains will evolve with the growth in Make in India. There will be several challenges such as growth in logistics to support the SCM needs. Supply chains will evolve and logistics will also need to upgrade and keep pace. Mr. Joshi added that companies need not reinvent the wheel. Companies need to create the capability to make goods in India and, at the same time, follow good manufacturing practices, adhere to global standards such as environmental standards in manufacture and disposal, and child labour. We need to have a no-exceptions-allowed policy in terms of compliance. Mr. Kulkarni stated that Make in India needs to be a collaborative effort; all stakeholders must exchange ideas, thoughts and have an end-to-end collaboration to build a competitive advantage for India. Mr. Padgaonkar added to the panel discussion views and highlighted the government perspective on industry issues. He said the Modi government has introduced three task forces for the industry, the medical vertical, medical equipment/ devices and ‘e-samiksha’. There is ongoing industry-academia interaction and industry-NGO interaction to identify challenges, opportunities and gaps. Mr. Broadbeck also stated that Indian manufacturers have reached global consumers but they still have to reach a high level of trust among the end users. A patient needs to know and trust when and where the medicine was manufactured, whether it was stored appropriately and whether it meets the standards expected in terms of quality and use. Mr. Bolangdy broached the topic of the effect of ecommerce on SCM in pharma. He stated that from a business model point of view, B2B might not work in pharma due to credibility of vendors involved. B2C will happen in a very gradual way. Accessibility in India is an issue that needs to be addressed due to long distances between pharmacies in rural areas. Telemedicine has reached the end user but medicine has to cross the barrier of accessibility in all parts of the country. The e-commerce model may work in the near future for OTC drugs as long as the pharmacist keeps a tab on the quantity sold based on an online prescription. Such models will change the dynamics of supply chain and even the logistics model will have to change to support e-commerce. Mr. Venkatesh had the same view and said that e-commerce facilitates better efficiency. We need to use technological advances and devices in a way that opportunities can be tapped. E-commerce will make impact on solving the accessibility problems. Mr. Bolangdy added to the point saying that the payment mechanism would have to change to enable this for pharma. RBI currently does not allow a B2B gateway for payment for the sale and purchase of medicines. 48

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The panel felt that the key bottlenecks where the government can intervene by way of policy decisions were as follows: •• Aspects of replacement of material (medicine) exported and also the restrictions on distribution and export of free samples •• Customs clearance process for pharma •• Adopting policies such as those in other countries where a research licence is issued so that pharma producers can manufacture in small quantities say milligrams only for research so that they don’t get stuck in procedures that impede research •• Government support in fostering partnerships and stepping in where intervention is required The session concluded with the observation that since pharma is heavily regulated in India (considering there are six different regulatory bodies for pharma) due to the nature of the industry, it is the industry players who need to grow their business and profitability by optimising SCM models. Technology has a part to play in growth. However, it remains to be seen whether regulatory changes can be made and whether e-commerce can kick off in a big way and unlock value for pharma as it has for other industries.

Recommendations: •• SCM needs to be the focal point for operational efficiency. Due to price restrictions on pharma, it is SCM efficiency that can be a profit driver for pharma. •• There is a need to harness information coming from the market and gauge the flow of products within the supply chain, and technology can be used as an enabler to achieve this. •• The industry needs to strengthen vendor relationships and develop an ability to forge long-term relations. Vendors are to be viewed as partners in growth. •• For the Make in India campaign to succeed in pharma manufacturing, multiple challenges need to be overcome. These mainly include having fewer touch points, enabling easy availability of information and supporting this with growth in logistics. •• Indian companies have broken barriers of trade over the years and are known world over mainly for API capabilities. It is important for Indian companies to develop a global mindset to bank on the best opportunities.

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Conference Co-Organizer

Conference Sponsor

Context: Enthusiasm and hope are increasing around rapid and point-of-care (POC) diagnostics for diseases of global health importance. In this context, it is essential that the researchers, end users and all the stakeholders have a deeper insight into the challenges for development, use and scale-up of these assays beyond nucleic acid amplification platforms. There is a need to stimulate development of next generation diagnostic tools, such as Lab-on-a-chip technology with a potential to be used for the detection of biohazards in the field without a need for dedicated laboratories. There is a growing need of rapid diagnostics systems in a developing country such as India, and given its advantages, rapid diagnostics is showing considerable growth and will continue to, going forward. Some major advantages of rapid diagnostics include the following: •• Cost advantage: Low capital cost •• Faster turnaround time •• Proper decision support to in providing appropriate healthcare service and education to the doctor and clinicians. It can help doctors with: •• Providing better healthcare delivery and reducing healthcare disparity •• Emphasising on preventive and predictive personalised medical care vis-à-vis curative care •• Despite the known advantages of rapid diagnostics, major problems associated with the field include: •• Untrained manpower: Lack of trained staff to conduct RDTs •• Lower accuracy and precision: RDTs identify the evidence of exposure to pathogens but are not subtype specific. •• Nonstandard metrics to evaluate RDTs: TAT, identified as an advantage of RDTs, has not been defined in a standard manner and there are multiple definitions which are considered as per convenience (for instance, whether it is from sample collection to result generation or sample received to result generated). The objectives of the track on “Rapid diagnostics – Today and beyond” of the BIOASIA 2015 were to focus on the potential of next generation diagnostic assays, especially in the healthcare and biodefense sectors. The event brought together experts from diverse disciplines and regulators to highlight and debate on the unmet needs/emerging needs in healthcare, and defense.

Welcome Address 10.30 am to 10.35 am, 3 February 2015 Dr. V Lakshmi, Professor and Head, Department of Microbiology, Nizam’s Institute of Medical Sciences, Hyderabad, delivered the welcome address for the conference, elaborating on the requirement of innovative, rapid, easy to use, sensitive and specific diagnostic technologies besides specifying the challenges at different levels of the healthcare system. She also elaborated on the various presentations to be discussed during the conference

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Company Presentations 10.35 am to 11.15 am, 3 February 2015 Thus was followed by presentations by Company executives of DiaSys Diagnostics, MolBio Diagnostics, BioMed Diagnostics and Siemens Healthcare Diagnostics on the rapid diagnostic assays’ product range being offered by them.

Guest talk by Dr. K Sekhar, Chief Controller, R&D, Missile Systems and Low Intensity Conflicts (MS&LIC), DRDO 11.15 am to 11.45 am, 3 February 2015 Dr. Sekhar spoke on the issue of countering bio-terrorism as well as requirement of rapid diagnostics abilities for the same. He elaborated on the various kinds of biological warfare agents besides explaining the requirement of counter measures—a four point biodefense mechanism starting with detection and identification followed by protection, decontamination and medical management.

Guest talk by Dr. Shantikumar Nair, Director, Amrita Centre for Nanosciences and Molecular Medicine, Dean Research, Amrita Vishwa Vidyapeetham University 12.15 pm to 12.45 pm, 3 February 2015 Dr. Nair presented nanotechnology applications in the biomedical science for diagnostics as well as the treatment of diseases. He spoke on the usage of imaging as an important technology for diagnostics and pointed out positive practical results, for both diagnostics and therapy, from various technologies such as photonic rapid diagnostics, contrast products, RF sensitive products etc, while emphasizing on the fact that diagnostics need to be combined with therapy.

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Current Technologies & Latest Trends in POCT 12.45 pm to 13.45 pm, 3 February 2015

Panelists: •• Dr. Quadri, Scientist ‘D’, Pathology Division & Center for Advanced Research in Preclinical Toxicology, National Institute of Nutrition (ICMR), Dept. of Health Research, Ministry of Health & Family Welfare •• Dr. Shalini Gupta, Assistant Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi •• Dr. BV Ravi Kumar, Founder, Chairman and Managing Director, Xcyton, India

Moderator: •• Dr. V. Sritharan, Consultant & Head, Dept. of Molecular Diagnostics & Biomarkers, Global Hospitals, India

A panel discussion on current technologies and latest trends in POCT was moderated by Dr. V Sritharan Consultant & Head, Department of Molecular Diagnostics & Biomarkers, Global Hospitals, India. He spoke on the presence of various POC devices at the different levels of healthcare and highlighted the need for diagnostics to give feedback to the clinicians in order to help them with therapy decisions. He also spoke on the gap of POC in serving the population and its need in the society at large rather than limiting it to hospitals or clinics. Dr. Quadri, spoke on the available POCTs in the market and associated issues such as the unavailability of subtype specific POCTs as well as POCTs that can differentiate the vaccinated animals from others. He also spoke on technologies that have the potential to become future POC technologies. These included antibody binding to protein with nucleic acid amplification, carbon nanotube etc.

Dr. Gupta, presented gave a presentation on the role of nanomaterials in rapid diagnostics and POCT devices. She spoke on the designing challenges associated with a good POC system. She also elaborated on the increasing role of colloids in the biomedical science using results from associated researches as examples.

Dr. Kumar, presented on a rapid, comprehensive, cost effective, accurate and decision oriented diagnostic technology. He explained the syndrome evaluation system (SES), an in-house technology which can be used for simultaneous evaluation of all probable pathogens that cause syndrome. He emphasized the need for diagnosis while specifying the lack thereof as a bigger problem compared to the more common practice, which is the indiscriminate use of antibiotics.

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Adoption of POC tests in Hospitals & Laboratories 3 pm to 4pm, 3 February 2015

Panelists: •• Dr. Ramesh S. Paranjape, Director, National AIDS Research Institute, India •• Dr. Shanthi Naidu, Consultant Biochemist, Care Hospitals, India •• Dr. Sunil T Pandya, Head, Dept. of Anaesthesia, Pain and Critical Care, Fernandez Hospital, India

Moderators: •• Dr. Nayana Joshi, Dept. of Gastroenterology Nizam’s Institute of Medical Sciences, Hyderabad •• Dr. Rachel Jacob, Dept. of Biochemistry, Nizam’s Institute of Medical Sciences, Hyderabad A panel discussion on adoption of POCTs in hospitals and laboratories was moderated by Dr. Joshi, Dr. Jacob, and involved perspective on POCT from the end users’ point of view. •• Dr. Naidu, spoke on the various challenges and issues associated with POCTs in India. She highlighted their advantages versus lab tests such as costs and the need to define non-standard terms such as turnaround time. She laid special emphasis on the need for training programmes and certification courses for the paramedics and medical professionals working on POCTs before they grow in India. •• Dr. Pandya, presented the benefits of rapid diagnostics based on real life clinical scenarios. While majorly in favour of RDTs, he did agree with the previous speaker that an RDT ecosystem requires stringent regulations or guidelines, an adequate number of properly trained manpower for conducting the tests and POCTs to be under the purview of central laboratory.

Key Industry Trends and Market Opportunities 4pm to 5pm, 3 February 2015

Panelists: •• Dr. Lalit Kant, Senior Scientific Adviser, Bill & Melinda Gates Foundation, India •• Mr. Sriram Natarajan, Director, Tulip Group, India •• Mr. Nalini Kant Gupta, Founder/Managing Director, Advanced Microdevices Pvt. Ltd., India •• Dr. Lysander Menezes, Team Leader – Maternal Child Health and Nutrition, PATH, India

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Moderator: •• Dr. Manmohan Parida, Joint Director & Head, Department of Virology & Bioprocess Scale-up Facility, Defence Research & Development Establishment (DRDE), DRDO, India A panel discussion on key industry trends and market opportunities involved representatives from the industry and investors presenting their views on the current state of the diagnostics industry and its future. They were asked to elaborate on the way in which different agencies look at the industry as the insights may be useful and serve as guidelines for the academia, entrepreneurs, start-ups and manufacturing companies in identifying market opportunities. Dr. Kant, presented the work done by the foundation, specifically in the diagnostics department. He specified the diseases targeted by the foundation recently along with the investment break-up across those diseases. He elaborated on the objectives of the foundation and specified the current priority areas in terms of diseases that the foundation is looking forward to fund in the future along with the testing requirement in those prioritized areas, which are HIV and TB. Mr. Gupta, spoke on entrepreneurship and opportunities in the diagnostics industry and used lateral flow immunoassay as an example to elaborate on the same. He spoke on the specific potential opportunity in developing clinically useful antibodies. He emphasised the importance of growth in innovations and interactions between various industry stakeholders. Dr. Menezes, India, presented on designing an innovative ecosystem for the rapid diagnostic space. He spoke on the planned investments of the foundation. He elaborated on the various reasons why good ideas in academic institutions do not translate into commercial market opportunities and specified different ways to manage these industry problems and make them fit for the market.

Regulatory Oversight 5pm to 5.45pm, 3 February 2015

Speakers: •• Dr. Shivraj Dasari, MD, SLS Cell Cure Technolgies Pvt. Ltd. National & International perspectives of regulations for POCTs & other Rapid Diagonstics Assays •• Dr. Shesheer Kumar, CEO, RAS Lifesciences - Industrial perspectives of the regulations Dr. Dasari discussed on the National and International perspectives of the regulations for the POCTs and other Rapid diagnostic assays within India and other countries. Dr. Kumar provided information on international regulatory affairs, especially those related to IVD kits focusing more on the ASEAN nations. He provided key pillars of the ASEAN regulatory system and spoke elaborately on the licensing and marketing scenario in the ASEAN countries. He explained various parameters in the Common Submission Dossier Template (CSDT) while drawing a comparison with the Indian regulatory market. He also provided benefits and challenges associated with regulatory regime in ASEAN markets and the learnings India can draw from the same in order to improve the ease of doing business.

Recommendations: •• Specificity: The major requirement from a rapid diagnostics tests is specificity. It is a key metric to evaluate RDTs as it prevents collateral damage. •• Theragnostics: Diagnostics need to be combined with therapy so that future diagnostic techniques can aim at providing immediate diagnostics followed by immediate therapy. •• Training of manpower: The dearth of properly trained staff is a major challenge in developing POCT. There need to be certification courses and training for the staff that provides RDT services. •• Centralized data centre: A centralized data centre with documentation of all the test results needs to be set up. All POCTs data must come under the purview of a centralized lab.

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Do you think India is ready for the rapid technological changes shaping healthcare globally? 11.15am to 12.15pm, 4 February 2015

Context: The session was about discussing the people, process and technology issues and the changes impacting the healthcare industry. There are several challenges, especially in healthcare delivery, such as shortage of doctors, nurses, paramedics and hospital beds. In addition, healthcare services are not accessible and affordable to most users. The use of digital technologies such as the internet of things (IoT), mobility, cloud and big data can help in increasing the availability of quality and affordable healthcare to the bottom of the pyramid. Although these services are not universally available, they are moving in the right direction.

Guest Talks: Ms. Sangita Reddy, Joint MD, Apollo Hospitals, India, started by describing the usage of healthcare services from a patient-doctor relationship to an ecosystem and the decision of using healthcare services from an individual to internet, social media, offers, etc. The healthcare and IT environment is changing with the adoption of mobility, connectivity and wearables. The first tele-consultation in India started in 2000 and has seen significant adoption by patients who, on an average, travel 65 km to avail these services. Standards around storing and securely sharing health records will ensure interoperability of data across the healthcare ecosystem. In addition, using predefined national IDs such as the Unique identification number (UID) will help in providing better healthcare services using digital technologies to drive non-linear growth and help in overcoming the shortage of doctors, nurses, paramedics and hospital beds. Mr. BVR Mohan Reddy, Founder and Executive Chairman, Cyient and Vice-Chairman, NASSCOM, India, discussed the availability and adoption of digital technologies helping the bottom of the pyramid access better healthcare services. There are likely to be 20 billion connected devices currently which will communicate among themselves to generate data that can be analysed to generate more insights about the user. This is being driven by lower-cost devices, ubiquitous connectivity and big data analytics. He discussed remote monitoring of devices to ensure device availability and preventive maintenance, which will ensure higher availability and reduce the cost for users. Passive and active devices are used to collect vital health parameters that can be analysed using big data to personalise health care for the users.

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Mr. TSY Aravindakshan, National Manager (Industry Solutions), Health, Microsoft Corporation (India) Pvt. Ltd., mentioned about democratisation of healthcare with people, process and technology being the key pillars. Healthcare industry is going through a massive transformation with a focus on patient experience. As part of customer engagement the areas of focus are auto automation for things that are due and move from episodic care to continuity of care. A simple example like getting SMS reminders for health check up with the doctor will prove beneficial. The cloud infrastructure offers a potent alternative to store and process data for a population as large as India’s. Solutions such as tele-health, telemedicine and online consulting can provide geographical freedom to patients. Further, with higher penetration of IoT, the healthcare industry can transform from reactive care to proactive care, such that the home becomes a centre for primary and secondary care and patients come to hospitals only for tertiary care. The industry is investing significantly in digital technologies and moving to an opex-based model from a capex-based system for deploying cloud and mobility solutions across geographies. This is leading to the launch of new services while optimising costs for the healthcare provider.

Recommendations: •• Digital technologies such as mobile and IoT with data connectivity are being increasingly adopted by users. The healthcare industry can leverage these to provide affordable and quality care to the masses. •• Users have increasing access to information and make decisions on using the services of healthcare providers based on social media, user reviews, etc. Healthcare services need to focus on quality of service and good patient experience to attract patients. •• IoT can help in better monitoring of devices to ensure higher availability and usage of these devices. This will ensure optimal usage of device and reduction in cost. •• Standards for electronic records and interoperability are defined by the government. The healthcare ecosystem should adopt them quickly to provide healthcare services to users across service providers and geographies. •• Users are willing to avail quality healthcare solutions. The ecosystem should focus on building these solutions using technology to better serve the customers. •• At patients’ end, Original equipment manufacturer (OEMs) and software vendors have opportunities with both sensors and applications to capture vital health parameters and transfer them to the right processing point. •• The medical fraternity may consider getting trained in using the right technology to deliver highly available, accessible and affordable healthcare services. •• Adoption of technology will be a constant challenge in this sector. The ecosystem will have to work in tandem to educate and deliver benefits of technology-assisted healthcare services. •• Consider IT infrastructure being moved from on-premises to the cloud as it reduces cost and makes the infrastructure highly available. As large volumes of data gets generated and stored, various analytics solutions can be used to make healthcare services more predictive and preventive.

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Medical fraternity and the usage of technology 12.15pm to 1.30pm, 4 February 2015

Panelists: •• Mr. Srinivas Prasad, CEO, Philips Innovation Campus, India •• Dr. Sai Praveen Haranath, Consultant, Intensivist and Pulmonologist, Apollo Hospitals, India •• Dr. Rajkumar Songa, Senior Consultant, Wockhardt, India •• Dr. Jitesh Bhatt, General Manager, M-Healthcare (Innovations), Vodafone India Limited

Moderator: •• Dr. Anthony Vipin Das, Chief Advisor and Strategy, Healthcare Innovation, Ministry of Health and Family Welfare, Government of Telangana, India

Context: The session was about discussing and exploring how technology has influenced and impacted the medical fraternity. There are several challenges that the medical and healthcare industry is going through, such as availability, accessibility, affordability and adoption. Various aspects of technology such as mobility, analytics, sensors, EMR, telemedicine, automation were discussed in the context of healthcare. A variety of new ideas were discussed, which are powered and enabled by technology. There are existing opportunities that open up where the medical industry and the technology industry intersect.

Session Proceedings: Mr. Prasad in his opening remarks mentioned about the challenges of accessibility and affordability faced by the industry. There is a need to find technology solutions that can address them. For instance, how technology can enable home beds for primary healthcare and reduce the burden on the number of beds in hospitals. Digital technologies, including social, mobile, analytics, cloud and sensors, offer exciting opportunities for the sector. Dr. Haranath mentioned how behavioural psychology was a big challenge for adoption and needs to be conquered. If patients do not adopt, the solution gets stuck at the last mile. He also mentioned about his experience in remote monitoring using teleICU. It can help patients have to connect with doctors easily. Even after being discharged, patients can be monitored remotely. Technology can capture vital parameters and send them to doctors, who can then visit once a week than daily.

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Dr. Bhatt mentioned how Vodafone is investing heavily in propagating digital consumerism. M-enabling the healthcare sector is one of the key initiatives. In the healthcare sector, there is a need to create a sustainable business model for all the players. Vodafone’s WAP-based chat service with doctors has been successful. The service has 10 million users and that too with no advertisements. The key is in making technology more consumer-friendly. Overall, Vodafone is looking at m-enabling large healthcare providers by investing in the ecosystem so that the digital healthcare grows. On EMR, Dr. Haranath said that the key challenge is how doctors can type data in addition to interoperability issues. Indian doctors do not document much, and it is widely known that there are medical errors happening at large scale even though we do not know about them. Hence, EMR needs to be seen as a prevention mechanism. In the US, the systems are built to prevent one error in a million. In India, we are satisfied to avoid one in a 1,000. So the solution is that if it’s simpler, it is better. But the more complex it is, it is more useful. For example, a doctor can look up the historical data of a person in the ICU and provide better treatment and not redo things that have been already done. There can be two types of solutions: scanning the handwritten documents or having a scribe to manually maintain the patient history. Dr. Songa’s believes that people have greater comprehension of technology now than ever before. Penetration of mobile telephone has been amazing. Alongside, IVR technologies have matured. This can help in capturing data through phones through the IVR interface into the national database. In such a scenario, patients can call the IVR and the data can get transcribed and stored in a central database. This can be of immense value and different types of physicians can get data for analytics. If we can make this happen, we are on to something big. On technology entrepreneurship, Dr. Haranath mentioned that big companies are providing technology in charitable mode. In Apollo, since the stakeholders are located within a single campus, it becomes easy to communicate and collaborate. Similarly, getting the right team and giving them the right resources and enough time can help turn ideas into reality. End of the day, all these initiatives need to be economically feasible. Another example is how hackathons have helped drive innovation in this sector. Dr. Das shared the hackathon experience with MIT where various players from the industry were brought together for a week and were asked to build solutions on ophthalmology. The results were inspiring. Dr. Das mentioned that of the 40,000 apps in stores, only 17,000 are being used. Dr. Songa mentioned that choices are huge and mobile apps need to empower the user. As a vision, he mentioned how a platform can be built where the business owner can pick and choose from modules- just like Dell PCs. This kind of platform will give flexibility and less vulnerability in building and using apps. Dr. Haranath mentioned that medical apps need to be validated medically. Major public health issues need to be analysed and apps can be built for those areas. The industry needs to be realistic about what technology can do and what it cannot. Power and internet issues need to be factored in. For app to be successful, it needs to help deliver value to patients and doctors. Dr. Bhatt’s opinion is that innovation that helps strengthen the relationship between patient and doctors will have higher chances of success. Short messaging service (SMS), unstructured supplementary service data (USSD) and wireless application protocol (WAP)-based direct healthcare to consumers is working well for Vodafone. On innovation in devices, Mr. Prasad mentioned how they are good at technology but needs the medical fraternity for clinical adoption. This has helped them in creating successful products and solutions. Devices need to have high quality, reliability, supportable and connected. Dr. Das mentioned about exploring DIY open hardware. An example he shared was Fourscope, which creates foldable microscopes at a cost of less than 50 cents. In conclusion, Dr. Songa highlighted the risk that technology may become master rather than slave. Additionally, wearables can make healthcare affordable and personalised. Mr. Prasad concluded that data is king, connectivity is life and usability is success. Dr. Haranath’s remarks were about making the five ‘I’s work for the sector: inexpensive, integrated, inspire, inclusive and imaginative. Dr. Bhatt urged the audience to keep things simple and billable.

Recommendations: •• The industry at large will have to consider the right format to standardise the data across heterogeneous systems and components. •• Healthcare hackathons and similar events will bring the ecosystem on a single platform where collaboratively problems can be identified and solution prototypes can be quickly built for demonstration and evaluation for funding and taking them to next level. This will foster an environment of innovation like never before.

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Analytics driven insight for improving healthcare effectiveness 2.30 to 4pm, 4 February 2015

Panelists: •• Dr. R Sukumar, President and Founder, Optimal Strategix Group, USA •• Mr. Gopal Devanahalli, Senior Vice President, Manipal Health Enterprises Ltd, India •• Dr. Anthony Vipin Das, Chief Advisor and Strategy, Healthcare Innovation, Ministry of Health and Family Welfare, Government of Telangana, India •• Dr. Prem Kishore V, Global Head Healthcare and Medical Device Practice, Tech Mahindra, India •• Dr. Ruchi Dass, CEO, HealthCursor Consulting Group, India

Moderator: •• Mr. Sudipta Ghosh, Partner and Analytics Leader, PwC India

Context: The session was about discussing the various applications and new areas of using big data and analytics in the healthcare sector. The panelists presented various case studies and ideas on how the benefits of personalisation, predictability and prevention can be derived by the industry using analytics. There are challenges related to standardisation in data formats across the various points of system: generation, transmission, storage and processing. However, the industry has a big opportunity to leverage big data and analytics capability to make products and services more relevant and effective.

Session Proceedings: Mr. Ghosh opened the session by setting the context of analytics in general. There are four types of analytics that can bring immense value to the sector: descriptive (describing the historical data), diagnostic (investigating an issue), predictive (predict the future) and prescriptive (enabling decision making and solutions). There are several challenges, including regulatory, cost, volume of data, challenges of technology generating data and interoperability across various service points. Mr. Devanahalli shared that Manipal Hospitals are using analytics to help them in the customer experience, operations and clinical categories. On customer experience, he shared their approach of getting the ABCD right (A = appointments, B = billing, C = clinical records, D = discharge). An iPad-based feedback system has been deployed to collect feedback, which

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can be analysed quickly. About 60% of the in-patients and 30% of the out-patients give feedback and the net promoter score is calculated from this feedback. This helps them identify the major issues and start initiatives in those areas. The other area of leveraging analytics is in customer outreach. For example, analytics can help in designing a campaign, but then the data has to be captured before, during and after the campaign to get a complete picture. Analytics will also help in creating strategies to engage patients. He mentioned Manipal’s initiatives on listening and analysing user-generated data from blog sites, social sites and so on to know what people are saying about the hospital and its services. He highlighted the issue of information siloes. For example, customer ID may get re-generated across the hospitals of the same chain in different areas. However, analytics has helped them in operation to optimise lab resources and so on. Clinical analytics has been tough due to lack of proper EMR systems. There is an initiative to make data capturing simpler for doctors using iPads. Once this system is launched, clinical analytics will be an interesting opportunity. Dr. Kishore narrated how analytics can be of use in patients’ experience from distress to discharge. It is important to understand the difference between analytics and reporting, and that analytics need to be actionable. He shared the case study of effective ambulance utilisation using analytics. Analytics revealed that the number of accidents is higher on weekends near pubs. This kind of data helped them reposition ambulances such that they can reach the accident spot quickly. Analytics can help reduce cost, improve operational and clinical efficiencies and minimise re-admissions. He also shared a case study on how predictive analytics can help prevent epidemics. There was an initiative of physical out-reach programme where vans were sent to villages. Accredited social health activists (ASHA) workers were given a mobile application. If they found people with fever in a village, then they can captured this data from the mobile app and send it to the district medical officer in real time. Within 24 hours the reports were available, the patients were quarantined, medications were started and the situation was brought under control in a short amount of time. This example shows how analytics can serve to prevent diseases and help the community move from illness to wellness. Dr. Sukumar emphasised that for analytics to be effective, one needs to start by stating clear end objectives as there is lot of data and it is easy to get lost in it. He illustrated this process with an example of a new drug discovery. The key objective is how this drug can be differentiated in the market place. How will this drug benefit the payer, drug maker, the patient, care giver and others in the value chain? It becomes important to understand the mind of the prescriber and drug user, so that the drug development can become targeted from the beginning rather than facing surprises at the launch. To summarise, the starting point is to define the objectives clearly. Next, drive the right type of hypothesis and analytics in order to accomplish the right type of results that needs to be delivered. Some of this can be done using technology on a continuous basis. But some of this will require human intervention of data scientists to make the right sense of the preventive models and interventional analytics. Dr. Dass presented her experience of how the right type and amount of data is still not easily available in emerging economies. She said that the insights shared by the Nike and iPod solution, like “people walked more in Europe as compared to the US” are not easily actionable. She shared her experience of working in Melghat, which is considered as the malnutrition capital of India. One of the WHO initiatives was to provide food and nutrients to children and lactating mothers to address this issue. In one year, they found that the infant mortality came down to less than 50%. The key factor was that the officials were registering births but discontinued registering of deaths. Hence, the reports were false. It is important to look at technology at the fore front and the service layer as the second. Technology can help capture data and the service layer, say on the cloud, can help store and analyse them effectively. She also presented a case study of how actionable analytics can help create and drive interesting business models. The case in point was Mediphone, a 24x7 phone service offered by Airtel in partnership with Fortis Hospitals. Each call costs around 35 INR, which includes consultation and prescription. Prescriptions are sent via email and SMS. She concluded about how the opportunities in big data and analytics are exciting, but there is still a lot that needs to be done to have the right quality and quantity of data to derive actionable insights from. Dr. Das started by saying that the journey of analytics is a long one. He mentioned the project of networking 128 centres in four states of India which was started five years ago. There are lot of insights to learn from. What are the learnings? Technology as an enabler is important to capture data. It should enable delivering rich user experience through real-time analytics. He mentioned their initiatives with Microsoft of geo-mapping the patients. This helps them identify the next geography to focus on and integrate. He shared his vision about having evidence-based medicine on the fly. To this extent, he invited the fraternity to open the data for professionals and the public, which can help in learning, collaboration and more. He gave an example of how Arvind Eye Care Centre in Madurai has put up surgical data in the public domain. He also restated that networking of 100 centres has helped them in understanding the disease burden, planning, strategy and investments forecast. They will share this data in the public domain for the larger good of society.

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Mr. Ghosh invited the panel to comment on how analytics has helped in staffing. Mr. Devanahalli shared his experiences from Manipal hospital about managing nursing staff force. Nurses spend 60% of their time in data entry. They are trying to measure their productivity, and based on this data they will look at training and other employee development needs.

Recommendations: •• Mechanisms—hardware and software—need to be defined at the patients’ end for the data to be captured at regular intervals. With smartphones and data connectivity, patients should be enabled to capture data for primary and secondary care at the home itself. The cloud can be considered for storing such volumes of data. •• EMR formats need to be standardised. The industry and government will have to work out policy and regulations for the same. This will enable interoperability of data across heterogeneous systems. •• The process of analytics needs to start with setting up clear objectives on what are the final results and outputs. The analytics models need to be then thought of, built and deployed. •• Consider non-confidential data to be shared in public domain. This will help the fraternity to learn, advice, collaborate and contribute for larger good of moving the society from illness to wellness. •• The industry needs to receive, process and respond to predictions and similar insights to provide preventive healthcare. •• The social media has emerged as a platform where health-related data is shared, discussed and promoted by users. Social media analytics will be a key to getting insights about different areas of health care based on the amount of conversations going on in this space. •• Other business and operational analytics can be deployed to effectively increase revenues and manage costs in a multi channels commerce environment.

Guest talk by health futurist Mr. Martin Kelly, CEO, HealthXL, Ireland 4pm to 5pm, 4 February 2015

Context: In this session, Mr. Kelly addressed the audience about the inception and value propositions of HealthXL’s offerings. He mentioned how innovation requires a different attitude, involving passion and bit of ‘craziness’. HealthXL offers an integrated platform of various ecosystem players, which entrepreneurs can leverage to create solutions collaboratively. Entrepreneurs need to be closer to the customers to understand their needs better and have a continuous communication channel so that the chances of success of their business and ideas are enhanced. He invited aspiring entrepreneurs to partner and contribute to this initiative.

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Session Proceedings: Mr. Kelly initiated the session by mentioning how 70% of the population does not have access to healthcare services in India. Typically, the cost of healthcare services continues to be high and tough to afford. It will require the industry to do things differently to change the cost structures. However, with problems come opportunities. Referring to the US health data, he mentioned that investment in digital health has been doubling year-on-year for last three to four years. Innovation in this sector has been growing significantly. Hundreds of start-ups have been funded by venture capital in this area. Mobile and internet have transformed industries such as retail, travel and entertainment, but healthcare is a bit different. There are challenges of patient information and who is going to pay for the innovation. It sometimes requires an outsider view for Innovation. People such as Steve Jobs, Mark Zuckerberg and Jeff Bezos can be considered as outsiders when seen from the lenses of the healthcare sector. These people can be thought as ‘crazy’ and ‘passionate’. And these are the qualities required for individuals to drive innovation and change. Media often portrays entrepreneurs as rockstars and celebrities. But the reality is that they work very hard and have made a lot of sacrifices to reach where they are today. He then shared the case of Ashifi Gogo, CEO of Sproxil, which specialises in anti-counterfeiting of pharmaceuticals. This company started in Nigeria, which is a tough market to begin with. In three years, they have been recognised as one of the most innovative healthcare companies. Now, the company is expanding in India and Pakistan. This is a good testimony of how through personal drive and ambition, amazing things can happen. HealthXL was started as they wanted to make business easy for entrepreneurs in the healthcare sector by providing an ecosystem. HealthXL is an independent platform to enable global players to work collaboratively around common problems. He introduced his team and ecosystem partners. They identify common areas of interest and then sponsor entrepreneurs to work on solutions. Quarterly events are held around the world where advisors, investors, entrepreneurs, physicians and others are brought on a single platform to create opportunities. One example of partnership announced was that between IBM Watson and Geppetto Avatars. They are building an interesting solution for patients with Parkinson’s to help them with diagnosis and self-management. This is a great opportunity to bring value to each other. In similar fashion, he invited the audience to partner with HealthXL and take the digital health sector to the next level with innovation and entrepreneurship.

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Addressing NCDs and role of government and corporates in prevention and management of NCDs 9.30am to 5pm, 4 February 2015

Context: The prevalence of non-communicable diseases (NCDs), also known as chronic diseases, has grown at an alarming rate in the past few years. More recently, NCDs have accounted for close to two-thirds of the mortalities in India resulting out of diseases while communicable or acute illnesses have accounted for the rest. A study by the National Institute of Health and Family Welfare highlights the magnitude of the problem by reporting that there is going to be a loss of about 17.9 million potentially productive years in India because of mortalities resulting out of NCDs. This is more than the US, Russia, China and South Africa combined together, thus reinforcing the need to address NCDs. There is a growing need to address NCDs in India, more so because of the peculiar nature of NCDs which include longer duration and slow progression rate. However, there are multiple challenges in addressing NCDs in India: •• High disease burden •• High premature mortality and case fatality •• Insufficient and uneven health system distribution causing access related challenges •• High cost of treatment along with high out-of-pocket expenditures •• Emphasis on curative care rather than preventive care •• Information asymmetry A number of solutions in pilot phases are being conducted in order to resolve the challenges to provide effective healthcare services to address NCDs. However, scaling up these solutions in a cost-efficient manner cannot be done without the financial and execution support of the government as well as corporate entities.

Guest Lectures: Dr. D Prabhakaran, Vice President, Public Health Foundation of India (PHFI) delivered a session on ‘Addressing the burden of NCDs in India’. The session highlighted the need to address NCDs in India followed by major challenges encountered. He spoke of the various approaches to conduct studies at different levels viz. population and individual levels in order to identify correlating elements. He also emphasised the importance of technology in addressing the issue of NCDs at various levels of healthcare.

Dr. Damodar Bachani, Deputy Commissioner (NCDs), Ministry of Health and Family Welfare, Government of India, spoke on the government’s efforts to prevent and control NCDs. He acknowledged the delay in addressing NCDs because of the emphasis on communicable diseases. He spoke on the change in the approach of the government to support only evidence based studies now. The session also explained the current NCD control programme of the government being conducted with the involvement of multiple ministries besides elaborating on its convergence with other active health programmes of the government.

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Dr. G V S Murthy, Director, Indian Institute of Public Health (IIPH), Hyderabad, presented a case study on blindness caused by diabetes and hypertension. He spoke on the various factors that correlated with the increased prevalence of diabetes. He also presented the findings from a case related programme conducted in 11 cities in India highlighting the importance of integrating intervention programmes at different levels that can be used for the prevention of blindness due to diabetes.

Dr. Sailesh Mohan, Senior Research Scientist, PHFI, presented a case study on the innovations in the management of diabetes. He presented feasibility and effectiveness analysis of using innovative management of NCDs with the help of findings from an internal project. He spoke of using a multi-component and multilevel comprehensive integrated package of interventions aimed at improving the outcome of managing diabetes and hypertension.

Role of Corporate in management and prevention of NCDs 2.40am to 3.40pm, 4 February 2015

Panelists: Ms. Jami L. Taylor, Senior Director, Global Access Policy, Janssen Global Services, J&J, USA Mr. Mark Allan, Executive Director, Max Institute of Healthcare Management, Indian School of Business Mr. Prabhat Kumar Sinha, Manager Patient Relation and Communication (Oncology) Novartis Healthcare Pvt. Ltd. Mr. Manish Bajaj, Senior Director, Global Generics, Reddy’s Laboratories Ltd.

Moderator: Dr. Nikhil Tandon, Professor & Head - Dept. Of Endocrinology & Metabolism, AIIMS, New Delhi

Context: Dr. Tandon began the discussion by stating the importance of all stakeholders in the healthcare sector, especially in the case of NCDs. He spoke of the silo-based working model of the pharma industry and the need for linkages between

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corporates and academia. He also gave a brief perspective on non-healthcare parameters that affected NCDs such as impact of the food and beverage industry, the promotion of healthy versus unhealthy foods, requirement of diagnostics and domestic NCEs, etc. Mr. Bajaj, spoke on the innovation technology required to address NCDs in the Indian market and the efforts being put in by Dr Reddy’s towards this. He spoke of the guiding principle being followed for NCDs which included looking at the whole cycle of the disease, from diagnosis and prescription at the doctor level to adherence at the patient level. Mr. Sinha, spoke of the evolving CSR scenario in the Indian market. He spoke of the importance of tangible and outcome oriented CSR activities being taken up by corporates and the related reporting requirements of the government. He also spoke on the belief of Novartis towards the shared value concept of CSR Ms. Taylor, mentioned the need for additional capabilities and strategy change by companies to address NCDs in developing markets and capture the opportunities with it. She spoke of the integrated solutions approach to NCDs which goes beyond a single-intervention approach through the usage of adjacent products and technologies to bring in a more cost-efficient package of solutions. She also laid emphasis on the interception of disease to be combined with the treatment and delivery of therapy. Mr. Allan, spoke of the beginning of a mindset change in the corporate world towards providing solutions as compared to the traditional transactional approach of product selling. He emphasised on the requirement of effective primary care for NCDs and a commitment from product companies to look at primary healthcare as a part of their ecosystem.

Recommendations: Opting for task-sharing to improve primary healthcare capacity and access to manage burgeoning patient load Increasing usage of technology at different levels of healthcare to reduce disparities: Usage of technologies such as mobile health in surveillance, geographical information systems (GIS) to identify chronic hotspots and correlated elements, electronic health records (EHRs) for maintaining data and decision support system for delivery to be promoted Promoting pharmacological innovations such as polypills to help address NCDs by improving adherence to treatments Promoting quality improvement programmes (QIPs): QIPs directed at improving the delivery of care and in-hospital quality of care for patients to improve the outcome. E.g. providing a checklist to the doctor, a medical handover, is extremely useful and may help with evidence based treatment for NCDs. Include and harness the traditional approaches such as yoga for improved and cost-efficient delivery of healthcare services

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Conference Co-Organizer

Guest Lectures: 3.40am to 4.30pm, 4 February 2015

Capacity Building of Healthcare Practitioners in NCDs- A Model Program from India Dr. Sandeep Bhalla, Programme Director Training, Centre for Chronic Conditions and Injuries (CCCI), PHFI, New Delhi, presented a model programme being conducted on capacity building of health practitioners in India. He spoke of the various education and certifications courses started for diabetes, CVDs and thyroid disorders and the result emerging out of these courses in terms of evidence based medicine capacity building.

Bringing Clinical Research into the Next Decade: Innovations & Global Strategies Dr. Nikhil Tandon, Professor & Head - Dept. Of Endocrinology & Metabolism, AIIMS, New Delhi, also delivered a session on innovation and global strategies related to bringing clinical research in the next decade. He spoke of considering clinical research as a continuous entity and not segregating it into basic clinical and public health because of the associated interactions between it. He also elaborated on disruptive innovations that may result in a paradigm shift in the execution of healthcare services besides presenting current technologies that are in evaluation or in the initial stage of usage.

Role of Information Technology to Help Clinicians and Patients for better management of NCDs & DSS in the New Healthcare Landscape Dr. Pramod David Jacob, Chief Medical Officer, Lifetrenz Technologies, Bangalore, presented a session highlighting the role of IT in maintaining healthcare data--healthcare information technology (HIT). He elaborated on the methods and problems associated with the creation and maintenance of electronic health record (EHR) data. He also spoke on the usage of a clinical data repository (CDR) or clinical data warehouse (CDW) to store EHRs for the efficient usage of technology in addressing NCDs.

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Conference Co-Organizer

Clinical Research: Indian regulatory landscape 11.15am to 12.15pm, 4 February 2015

Panelists: •• Mr. Solomon Yimam, Assistant Country Director, US FDA India Office •• Dr. Khalid Khan, Managing Director, Fermish Clinical Technologies Pvt. Ltd., India •• Ms. Maggie Massam, Head of Business Development, Clinical Practices Resource Datalink (CPRD), MHRA, UK •• Ms. Divya Chadha Manek, NIHR Clinical Research Network, UK

Chairperson & Moderator: •• Mr. Apurva Shah, Founder & Group Managing Director, Veeda Clinical Research Pvt. Ltd.

Context: India despite having about 17% of the world population, conducts less than 2% of the world’s clinical trials. The country with its huge population, diversity, skilled English investigators and low cost is an attractive option for clinical trials. India is a significant source of global medicine producing about 25% of world pharmaceutical production by volume and about 10% by value. The country is also the second largest supplier of drugs to the US. Authorities such as the Central drug standard control organization (CDSO), Directorate general of health services (DGHS), Drug controller general of India (DCGI) are responsible for enforcing compliance with Food, Drugs and Cosmetics Act in India. These authorities review and approve new drug applications, applications for trial and control over the quality of imported drugs. The industry has several forward-looking initiatives to encourage growth. The government has recently sanctioned 9,500 crore INR to the DCGI to be used over the next five years and has opened up about 5,000 posts for investigators and 200 for doctors for the review of the trial process. There is also a proposal to take the process of applying for clinical trials online. Addressing clinical research challenges has already started and it is up to the industry to align itself to the right ethical practices.

Session Proceedings: Mr. Yimam started off by giving an overview of the clinical research process. He listed out the FDA requirements that the Food, Drugs and Cosmetics Act requires all new investigations, drugs and biologics to undergo clinical trials on human subjects in order to demonstrate the efficacy of these products prior to approval for sale in the US. Through review of

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clinical trial protocol, the FDA ensures the rights, safety and wellbeing of subjects who participate in these trials and verifies that the clinical trial data is both accurate and reliable. The marketing applications to the FDA are new drug applications (drugs) (NDA), biologics licensing application (biologics) (BLA), pre-market approval (devices) (PMA) and new animal drug application. Mr. Yimam also listed the penalties for non-compliance of the rules set by the FDA such as the issue of a warning letter and putting the trial on hold in circumstances where safety standards are not met. Inspections are conducted to check data integrity, whether studies are conducted in accordance with rules, misrepresented or unrealistic data, suspicion of fraud or misconduct, previous history of investigations. There is much activity in the clinical trial industry. The rate of growth has however declined post 2010. Companies conducting clinical trials must first register themselves with the DGCI and enter their details in a database. India follows an investigational new drug (IND) application process that allows for drugs developed in the country to be tested on Indian patients in phase 1 trials (the first level of testing in humans). Indian regulations do not permit phase 1 testing of drugs that were developed abroad. However, once these drugs have completed phase 1 studies abroad, development at phase 2 and 3 levels may be continued in India. There are also regulations for the accreditation of the ethics committee, investigators and clinical trial sites. Maharashtra has the highest number of registered ethics committees in India followed by Gujarat and Andhra Pradesh. Next, Mr. Khan gave an overview of the evolution of the Indian clinical drug trial industry, the challenges faced by the company and the ways and means of addressing them by the regulatory authority. In 2015, e-submission to the DCGI office was enabled for the vaccine division. It is expected that by December 2015, all application submission processes will go digital. There is also a proposal to have a paid pre-submission meeting at the DCGI to identify missing documents in the dossier and go for a speedy review process when the application is submitted. Another proposal is the accreditation of the principal investigator (PI) and sites in association with NABH which issued guidelines for the accreditation of clinical trial sites in hospital. The government recently sanctioned 9500 crore INR to the DCGI to be used over the next five years and opened up about 5000 posts for investigators and 200 for doctors for the review of the trial process. Ms. Massam gave a brief background on the set-up of the Medicines and Healthcare Products Regulatory (MHRA) and the National Institute for Biological Standards and Control (NIBSC), UK. The role of the Clinical Practice Research Datalink (CPRD) is to collect anonymous primary care data from the National Health Service (NHS) for companies to help them conduct feasibility studies, identify patients for the trial by setting specific inclusion and exclusion criteria and complete the trials quickly, in a cost-effective manner and in compliance with safety norms. Every major event for the patient such as vaccination, blood tests, etc with the general practitioner is recorded as primary data which enables regulators and companies to conduct drug safety studies on the drugs released in the market. The customers of the CPRD include the FDA, the MHRA, other regulatory bodies, pharma and biotech companies which conduct such studies. Ms. Manek spoke on the role of the National Institute for Health Research (NIHR) and the UK clinical research environment. The UK government supports companies in a huge way to come to the UK confidently to conduct clinical trials in a viable manner. One of the other initiatives is a UK-wide clinical research infrastructure to enable up to phase 4 of clinical trials to be conducted and also ensure that the NHS is equipped to deliver commercial contract studies. The NIHR is an infrastructure which is funded by the Ministry of Health to the tune of half a billion pounds every year in order to ensure that the NHS is equipped and has facilities and a dedicated team to run trials. There is a three-tiered system for clinical research. To set up an ethics committee, it generally takes 60 days. To enable costing and contract negotiations, the NHS has pre-approved tools and templates in order to reduce timelines. In 2010, 324 commercial contract studies were performed in the UK and in the current financial year, more than 600 studies are being conducted. The volume of patients recruited into clinical trials is increasing and the CPRD provides handholding through the entire procedure. Indian companies can benefit from the support, access to patients, expertise and resources of the NHS. Mr. Shah concluded the session with statistics stating that India despite having about 17% of the world population and high disease burden, hosts less than 2% of the world’s clinical trials. Countries such as the UK have been doing their best

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to encourage timely and cost-effective trials so that drugs can be manufactured at a low cost by eliminating wastage at every level. In recent times, the Supreme Court has removed obstacles in conducting trials and for the first time, there are two joint drug controllers in the DGCI. He suggested that if electronic filing is also introduced, it would greatly enhance the transparency and efficiency of the trial process. The clinical research industry is a huge socio-economic boon for the country and can thrive with the right investment, manpower and government support.

Recommendations: •• Good lab practices (GLP) must be followed for clinical trials else there are strict penalties for non-compliance. •• Reliability of the clinical trial process, data integrity and compliance of safety standards must be maintained for conducting trials in an ethical manner. •• FDA regulations with respect to clinical trial protocol to be explained in detail with factors that trigger investigations by the FDA.

Indian Biosimilar Guidelines and the Global Alignment 12.15pm to 1.30pm, 4 February 2015

Dr. Anand Eswaraiah

Mr. Prasath Palanisamy

Speakers: •• Dr. Anand Eswaraiah, Head - Clinical Development & Regulatory Affairs, Clinigene International Limited, India •• Mr. Prasath Palanisamy, Head of Bio-Pharma, Vimta Labs, India

Context: Biosimilars are crucial as they address a lot of life threatening medical conditions in the field of healthcare. India has been a pioneer in the case of biosimilars same as that of in generics. Succeeding China, India has the highest number of FDA approved biosimilars, about 50, in the past many years. We have the important set of guidelines with respect to biosimilars and product specific guideless which was issued on September 15, 2012.

Session Proceedings: Mr. Palanisamy gave brief account of the quality considerations required to characterize a biosimilar molecule. He mentioned that any biological product has to be characterized with respect to purity, potency and safety and it should be done in a clinical setting without major clinical differences. He spoke about the stepwise characterization called as “head to head comparative study” which is required to compare the biosimilar product against a reference product for establishing BioAsia2015 - Event Report

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the biosimilarity. Initially it should start with a physico-chemical characterization followed by biological characterization and then the molecule should be checked for its safety, efficacy and potency at both the preclinical and clinical setting. Based on these evaluations the specifications for quality, safety and efficacy is established and is compared against the established specification of a reference product. He also discussed the stages involved in the manufacturing of a biosimilar product and the steps required to confirm the biosimilarity. The manufacturing processes have to be optimized so that the producing product has highly similar quality attributes between biosimilars and reference product and as per the EMA guidelines, the biosimilar molecule has to be given at the same dosage as that of reference product. He also spoke about how the specification of a biosimilar product is impacted due to variability in terms of an analytical method, manufacturing batches, etc. This analytical method should be sensitive enough to determine the variations arising because of the quality attributes which are used before and after the manufacturing process and also should be able to demonstrate whether there is a variability in terms of specifications when compared against the innovative product. Dr. Eswaraiah furthered the discussion by explaining the pre-clinical and clinical aspects of demonstrating the biosimilarity. He stated that the Indian guidelines basically refer to the biosimilars which are either manufactured in India or being imported to the country. These products also need to be well characterized through various analytical methods to prove the biosimilarity. He stated that the selection of the reference product is an important aspect of developing a biosimilar product as one need s to compare the product with the developing biosimilar product. The pre-clinical data that needs to be submitted to the DCGI office should include the typical pharmacodynamics studies which has in-vitro and in-vivo studies. As biosimilars are unique when compared to small molecules there is need to rely more on in-vitro methods that include cell based bio-assays and in-vivo methods when there is no enough data to generate the pharmacodynamics aspects of the biosimilar products. Other toxicology studies like mutagenicity, reproductive toxicity and carcinogenicity are done for a new drug which is a requirement as per the Indian regulations. He stated that the ‘Repeat dose’ is one the controversial aspect of Indian guidelines and one of the mandatory data which the applicant need to submit which includes repeat dose 28 days study with 14 days recovery period doses either in one relevant species or two species that includes a rodent and a non-rodent. This is unique especially for India as the other countries consider the animal models inappropriate when it comes to protein bio therapeutics development. He mentioned that animal studies do not generate relevant data and the closest a study could generate relevant data is on the primates. He also briefly mentioned about the immunogenicity testing also typically done in animal models. He gave an overview of the clinical trial data that need to be submitted as per the guidelines that state that one needs to submit a comparative pharmacodynamics data which can be generated as a stand-alone study and this can be a single pharmacodynamics study or it can be a multi dose pharmacokinetic dose study or a comparative pharmacodynamics study. Generally as per the European guidelines, the pharmacodynamics and pharmacokinetic studies are clubbed together as a one single study called as PKPD study. The other important data that needs to be submitted is phase-3 clinical safety and efficacy study in appropriate indication and in case if a product is approved for multiple indications, a data needs to be generated from the most prescribed indication. All the other indications from this data of multiple indications can get approval. Although the Indian guidelines are not very clear in this aspect. Indian regulators unlike small molecule new drugs studies also ask for post marketing studies, which are non comparative pharmacovigilant or post marketing surveillance studies especially to gather immunogenicity data because the number of subjects which are recruited in phase-3 studies or early stages could be small from the Indian perspective. He then compared the Indian regulations to the global regulations, stating that Indian regulation is based on the WHO biosimilar guidelines and the European biosimilar guidelines still does not have the FDA guidelines yet. The typical difference is that as per the Indian regulations, the reference product may or may not be marketed in the Indian market, this is an advantage for India as other regulatory agencies insist that the reference product must be locally marketed. Other major difference is that the Indian regulators ask for an extensive preclinical data unlike other regulators. Other major difference is the PKPD and phase-3 studies which are mandatory in India but not globally. He stated that India should be a destination for biosimilar product development since the local regulatory framework is almost aligned with the global regulatory framework and it is easy to extrapolate data here. The other one is the market exclusivity which exists outside India. India accepts only patent exclusivity and not market exclusivity which enables lot of MNC’s to establish a market in India. Also because of the high growth in healthcare sector in India owing to large unmet health needs, availability of a large patient pool, increased access and government interest in healthcare and the feasible cost of development, R&D and manufacturing, India poses as the biggest destination for biosimilars.

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Conference Co-Organizer

Bioequivalence studies in India 2.30pm to 3.30pm, 4 February 2015

Panelists: •• Dr. Charu Gautam, Director, Global Director, Veeda Clinical Research Pvt. Ltd., India •• Dr. Mukesh Agarwal, Vice President, Clinical Research Division, Vimta Labs Ltd., India

Chairperson & Moderator: •• Mr. Apurva Shah, Founder and Group Managing Director, Veeda Clinical Research Pvt. Ltd., India

Context: The CRO industry in India conducting bioequivalence studies is over a decade old. India has a lot of advantages for conducting these studies such as strong presence of pharma industry, CROs having world class infrastructure, availability of well trained skill, readily available patient database and regulatory guidelines by DCGI and a quick approval process of about 2-3 months. All these factors make Bioequivalence studies a major source of bread and butter for CROs in country.

Session Proceedings: Dr. Charu briefed the audience about the science of bioavailability and bioequivalence and about the newer studies available in the market currently as per the regulatory requirements. She stated that the goal of bioequivalence studies is to bring a generic product in the market and India currently leads in conducting bioequivalence studies. The use generic drugs is important to bring down the cost of therapy. She also informed about the formulation requirements before conducting these studies – having same active ingredient, identical in strength, dosage form and the route of administration and should have the same labeling and after having proved it to be pharmaceutically equivalent by certificate of analysis or in vitro studies, you need to prove it to be bioequivalent either by the Pharmacokinetic or a Pharmacodynamic method or through a clinical end point study. She also mentioned that the batch requirements should match along with the manufacturing with the reference product. Hence a pharma equivalent and a bioequivalent product is therapeutically equivalent and hence therapeutically interchangeable. Bioequivalence studies have also made the approvals process much

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simpler as they are a combined phase 1 & phase 2 studies and eliminated the requirement of preclinical or animal studies. She also stated that with the growing volume of these studies, challenges have also evolved which majorly include control of the volunteer population, informed consent procedures, lengthy AV consent procedures, recruitment of healthy human population – postmenopausal women, elderly subjects, etc., standardization of compensation for the subjects, standardization of cleaning and safety procedures, awareness of these studies in general population and media. Moreover, certain studies require actual patient volunteers to test oncology products, immunosuppressant, etc. also face similar challenges of following a strict timeline and standardization of procedures. She also mentioned Bioequivalence approaches of topical drugs – PK, PD, Clinical & In Vitro, need to be applied based on the action of the drug, it’s absorption into the blood stream & regulatory requirements. She then talked about the role of placebos in these studies and how they pose a challenge when presented to the ethics committee or to DCGI for approval. The best solutions for a placebo arm to have a proper justification is to build in a rescue clause in the protocol, close monitoring & multiple visits, and a proper instruction to the subjects to report any deterioration effect. Other challenges include – sample size selection, high withdrawal or dropout rates, patient recruitment, use of alternate therapies by patients, retention sample, etc. In order to overcome these challenges, during the protocol design, we should consider the patient logistics including shipping of samples, sample size, blood volume & other restrictions, placebo arm should be thoroughly evaluated, statistician should enroll smaller numbers in placebo, site to have proper infrastructure, dedicated staff to collect samples, training of the site team, sample retention & IP replenishment to be considered, good documentation practices at site, etc. Dr. Mukesh stated that safety is the most important element of the trial and is a part of GCP requirement. The safety of the volunteer is of paramount importance. As a part of pre study, there is a review of protocols, ICF’S, study of the document by the ethics committee which will be reviewed and assessed. He informed about the volunteer development team which recruits the volunteers and works as per the IC approved protocols. He addressed the significance of having a Common Voluntary Database among all the Indian CRO’S and the implementation of finger print system. In this system, identified volunteer undergoes the verification process where medical document and the details of the volunteer will be entered. The volunteer can be tracked based on the enrolment date and his last sampling date and the same can be exported into excel or PDF document as per the requirement. It also has all the security features so that the data is protected and gives access privileges to the investigator. It has an electronic signature with an integrated audit reel. It also provides the data level encryption and is managed by 5 different vendors for the ease of data transfer. It also has the desired ISO certifications. At registration desk the volunteer is identified by using the VMS using the finger print. It also helps to track the adverse events encountered by the volunteer. After volunteer registration, the standard BMI takes place followed by age verification. The volunteer has to provide a self-declaration that states he is fit to be taken for the study and the he is subjected to physical examination and ECG which is mandatory. It is very important that the volunteer is made aware of his rights by which he understands why he is participating in the trial, the side-effects and also that he can withdraw from the study without stating any reasons there of. The entire process is AV recorded as per the new guidelines and it is archived which should be retrievable. And the investigator has to be qualified as per GCP and should be able to manage the volunteer in case of an adverse event. To manage the volunteer safety during the conduct of study, the paramedic staff and a volunteer will be manning the CPU’S all the time which contain an ICU with a proper backup facility including a ventilator and a tie-up with an ambulance to take the volunteer to the nearest hospital and an external specialist will be hired if the case demands. After the study, there will be a post study to ensure that the volunteer is fit and has come to normal health conditions. For participant compensations of the study, there is an elaborate set of guidelines which is open for the public domain on the website. There are various formulae given by DCGI on how to compensate the volunteer if he/she gets hurt because of the trial. For the import of biological samples, ICMR has given an elaborate set of guidelines.

Recommendations: •• To have an online national database which is being proposed by ACRO to be used by every single CPU in the country. •• Have retina scan instead of a biometric because of the abuse of biometric scan which involves participation of various IT companies to host the applications and make it available to all CROs

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Conference Co-Organizer

Challenges and solutions for conducting clinical research in India 3.30pm to 4.30pm, 4 February 2015

Panelists: •• Dr. Jeroze Dalal, General Manager, Clinical Operations, GlaxoSmithKline Pharmaceuticals •• Dr. Shariq Anwar, Head Operations, Max Neeman Medical International Limited

Chairperson & Moderator: •• Dr Kiran Marthak, Director, Lambda Therapeutic Research Limited

Context: The session focussed on the challenges faced by players in conducting clinical trials in India and solutions for them. One of the main challenges faced is the timeline to get approvals for the completion of trials which cannot be committed in advance due to the regulatory procedures involved in India. The other challenge is the availability of investigators trained in ICH GCP guidelines that need to be addressed.

Session Proceedings: Dr. Dalal opened the discussions stating that the pillars of clinical trials were integrity and the quality of clinical data, ethical aspects and safety and well-being of the subjects. There are two opposing forces to the growth of the industry. The first are the regulatory forces such as Indian GCP, amended schedule Y, ethical guidelines for biomedical research on human participants, etc. The other is the rising negative media coverage on clinical trials such as the following: •• Commercialisation of clinical research •• Exploitation of subjects •• Deaths in clinical trials •• Regulatory laxity

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•• Compensation for subjects •• Informed consent observations by an independent auditor •• Fraud •• Unethical trials •• Subjects being used as guinea pigs She stated that India is the only country with AV recording for volunteer consent which is a welcome move. There are media reports where compensation is not paid to the participants of clinical trials. Dr. Anwar continued the discussion with critical points to consider for clinical trials in India. He emphasised that the safety of volunteers is paramount–pre, during and post the trial. Companies must ensure that no vulnerable groups are enrolled in the study. He pointed out a few areas of focus which can be summed up as under the following: •• Focus on training of investigators with respect to ICH GCP guidelines •• Protocol compliance to be ensured with no waivers •• Monitoring visits to be made and deviations to be reported to the ethics committee •• Put site on hold in case of an issue •• Audits at site level to understand the procedure from the investigator and get 100% participation from investigator •• AV consent mandatory in India The moderator concluded stating that investigators need to be made aware of the audit implications and be trained regularly in the light of the strict compliance procedures. Infrastructure support must be given so that companies can complete trials.

Recommendations: Compliance with ethical standards is critical thus requiring the training of investigators with respect to ICH GCP guidelines. Monitoring visits and regular audits need to be conducted in order to point out deviations to the ethics committee. Concerns with regard to the investigators or the practices followed at the site need to be addressed promptly as patient safety is paramount.

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BioAsia Connect BioAsia Connect is a dedicated B2B portal for online business partnering, event scheduling at BioAsia, assisting the delegates in their development and licensing activities with handpicked companies from the global lifesciences market at the event. During 2 days of networking 900 business meetings have been scheduled and realized onsite, enabling the participants to discuss new business prospects and commercial agreements in addition to the networking receptions and CEO Conclave.

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International Buyer - Seller Meet

Organised by:

Minister Commerce and Industry Govt. of India

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International Tradeshow With a special focus on Medical Devices, Diagnostics, Scientific & Analytical Equipments, the International Tradeshow at BioAsia 2015 attracted about 85 companies from across the globe. The exhibitors’ participation included Country Booths from Thailand, UK; State Booths from Kerala, Karnataka and Uttar Pradesh; Government Bodies such as TSIIC, Dept. of Biotechnology, DBT-BIRAC, Telangana Tourism; Academic Organizations like PHFI, NIPER, CKMNT, BCIL; MNCs and Domestic Companies like Dr. Reddy’s Laboratories, Aurigene Discovery, Lambda Therapeutics, Siemens Healthcare, Jubilant Lifesciences, GE Healthcare, Cadila Pharmaceuticals, Dotmatics Ltd., ILPE Asia Pvt. Ltd., Alere, Aptar Pharma, Incessant Technologies, Minitab, Panexcell Clinical Lab Pvt. Ltd., Noki Technologies, Molbio Diagnostics, BioMed Diagnostics, KAN-THT; Startups like BumpDocs, Doctrz, eKincare, Body N Spice and Industrial Parks like Ticel Biopark, ICICI Knowledge Park; Trade Bodies like Hungarian Investment Promotion Agency, etc. Around 450 visitors participated in the tradeshow during the event.

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Bio Park Visit BioAsia 2015 featured an exclusive guided visit to the Genome Valley - India’s first systematically created lifescience cluster and the largest concentration of multi-tenanted labspace infrastructure in an organized cluster. About 75 delegates visited the Genome Valley which entailed tours to the Genome Valley industries, innovation corridors and premier institutions within the cluster.

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Bio Job Fair BioAsia 2015 hosted a unique initiative in association with BioHiring - Bio Job Fair 2015 that was conducted as a part of the BioAsia 2015. It was a first of its kind platform from BioAsia to create a single window of opportunity which brought together more than 500 companies and thousands of aspiring jobseekers. The Job fair was scheduled for 3rd February 2015 during BioAsia 2015 and was attended by 250 jobseekers. It allowed participants to meet industry leaders and career advisors from leading life sciences, Healthcare and Pharmaceutical companies through interactive sessions. This also helped them to gain first hand insights about domestic and international job scenario in this field, next five year outlook and tips for career success. Additionally, candidates also had access to all the stalls of exhibiting companies, where they further explored possible career opportunities. Hiring Partner

Technology Showcase BIRAC Regional Innovation Centre (BRIC) at IKP Knowledge Park, Hyderabad organized a technology showcase to promote life sciences technologies that are being developed by start-ups or academic institutes. The objective was to provide a platform to innovators seeking potential R&D collaborations, licensing partnerships and market/expert feedback. In line with the theme of BioAsia 2015, selected technologies were showcased from Digital Health, Drug Discovery and Rapid Diagnostics. Sample technologies being showcased were as follows 1. FLIP - Ear-worn Health Tracker 2. BACMAM Protein Expression Platform for StructureBased Drug discovery. 3. Drug Loaded Magnetic Nanoparticles for Treatment of Brain Tumors 4. Remote Cardiac Monitoring and Cardiac Telemetry 5. A ‘point-of-sample-collection’, Cervical Cancer Screening system. 6. Companion Diagnostics for Diabetes Management

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BioAsia Launch Pad BioAsia 2015 saw the release of the State Lifesciences Industry Policy of the Government of Telangana in the presence of the Hon’ble Minister Shri Jupally Krishna Rao, Minister of Industries & Commerce, Government of Telangana. The major highlights of the policy are: Granting permissions and certifications to industries on time, approvals within 15 days for mega industries and to other MSME within 30 days, allotment of 11,000 acres of land in Hyderabad dedicated to pharma sector, which is going to be developed with top-notch infrastructure and state of the art facilities.

Release of Pharmaceutical Export Promotion Council of India’s (Pharmexcil) 4th edition of the “Indian Biopharmaceuticals Industry” report book, covering details and information on various government policies, important guidelines and incentives available to exporters of pharmaceuticals, biological, biopharma and bioservice sectors.

Launch of the “Integrated Allergy Standards of India”, India’s first initiative by 220 allergy specialists and the only scientific body to monitor and label hypo-allergic products in India.

The International Society for Disease Surveillance (ISDS), an independent nonprofit professional organization based in Brighton, MA, U.S.A. launched the first-of-its-kind ‘trans-disciplinary NCD work-group for clinical, academic and public health professionals’ at the inauguration of the Healthcare and NCD Conference co-organized by Public Health Foundation of India (PHFI) at BioAsia 2015.

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BioAsia Healthcare Devthon

BioAsia Healthcare Devthon, a co-creation exercise brought healthcare experts, engineers, technologists and designers together onto one platform to discover, design and rapidly prototype technologies and solutions in the life sciences and healthcare fields. The goal was to facilitate the development of products and services that address unmet needs and are positioned to be rapidly adopted by healthcare stakeholders.

Areas of Focus •• Digital Health and Healthcare IT •• Medical Electronics and Devices •• Rapid Diagnostics

BioAsia Healthcare Devthon comprised of 3 phases: (i) Domain Immersion on January 10th at Apollo Health City and Kamineni Hospitals, where engineers interacted with doctors to understand the challenges first hand (ii) Design thinking and Ideation on January 17th, where Dheeraj Batra of D-Labs ISB and Design thinker Honey Bajaj introduced the concept of human centric design and design thinking. Team Srujana from LV Prasad Eye Institute’s Center of Innovation showcased devices developed employing a similar user centric approach. (iii) The Prototyping Phase happened on 24th and 25th January at Apollo Medical College, where inter-disciplinary teams prototyped solutions to the challenges they had identified. The 21 ideas were whittled down to 11. Apollo healthcare professionals from cardiology, pulmonology, oncology, psychiatry, hospital IT and radiology visited the venue and interacted with the teams and gave their feedback and guidance when necessary. The teams also visited relevant departments in Apollo Hospitals for further validation.

An eminent jury picked the top ideas: 1. Dr. Anthony Vipin Das, LVPEI 2. Kiran Gedela, Founder and MD, Oasis Labs 3. Prof. M.B. Srinivas, Dean, BITS Pilani Hyderabad Campus 4. Ramesh Loganathan, MD, Progress Software 5. Dr. Sumeet Roy, CEO, Kamineni Life Sciences

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Satellite Events

The following teams were selected by the jury to showcase their technologies at BioAsia 2015: G-Mode: Improving 2D ultrasound images and video to enable 3D features that extend the usefulness of ultrasound diagnostics Dexter: Ward and ICU management app and software that enhances doctors’ productivity Dr. Connect: Collaboration and crowd-sourcing app for clinicians Muscle: Wearable technology to monitor stresses on the knee and other stress bearing parts Self-feeding utensil: Feeding aid for amputees and patients suffering from debilitating conditions Electronic Peak Flow Meter: Digital peak flow meter to measure and wirelessly transmit peak flow volume to smartphones TAPPP: Uber-like application for home healthcare professionals

At BioAsia, the jury picked these three teams: 1. Team Self-feeding utensil (Sharathchandra Chilkuri, BHV Manikantaswamy, G Vijayabhaskar) Prize: INR 1 lakh 2. Team G-mode (Jyothin Madari, Dipika Bablani, Sandeep Konam, Aditya Gupta) Prize: INR 60,000 3. Team Electronic Peak Flow Meter (Guruswamy Revana, Pratima Kumari, Rasool Shaik) Prize: INR 40,000

Principal Partners

Healthcare Innovation Cell Ministry of Health & Family Welfare Government of Telangana

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Supporting Organizations


Media Coverage

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Media Coverage

BioAsia 2015 Media Campaign Overall Coverage Categories

Pan India Visibility - 13 Cities

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Media Coverage

BioAsia 2015 Media Campaign Coverage Spread – Before the event and during the event

English vs Vernacular Print Media Coverage

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Media Coverage

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FEEDBACK & COMMENTS

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Feedback & Comments

“I found BioAsia 2015 to be a very interesting experience. We are all satisfied being here because we got a very good response. We have lots of visitors and some business deals, so we are very happy. I think here in Hyderabad the industry is very active and I am very impressed about how Hyderabad is building the same.” Dr. Nares Damrongchai, CEO, Thailand Center for Excellence in Life Sciences (TCELS), Thailand

“This is the 12th edition of BioAsia and there has been a good participation from both academia and companies worldwide. As time progresses, we hope to see more and more international biotech and pharma companies coming in though.” Mr. CSN Murthy, CEO, Aurigene Discovery, India

“It was a pleasure to be a part of this conference. Healthcare is getting less invasive and more pervasive with the use of wearables/ multiple devices. There is a trend towards ubiquitous access to the healthcare systems.” Ms. Sangita Reddy, Joint Managing Director, Apollo Hospitals Group, India

“BioAsia 2015 brought together a wide range of stakeholders and the programs were timely, relevant and substantive. I would like to congratulate you and your team for putting together a successful event. I look forward to our continued collaboration.” Mr. Solomon Yimam, Assistant Country Director, U.S. FDA India Office

“The business from clinical trials is going to be good at BioAsia 2015. There are a lot of Indian companies in clinical trial space, ready to use new ways. The timing is good for both Indian companies and for us. We are very optimistic that we will have a good business.” Ms. Maggie Massam, Head of Business Development, Clinical Practice Research Datalink (CPRD), UK

“Events like BioAsia will help us in accelerating the innovative solutions for India for “Make in India” movement gather momentum” Mr. Srinivas Prasad, CEO, Philips Innovation Campus, India

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Feedback & Comments

“The experience at BioAsia 2015 has been good and the technology showcase for all the start-ups, industry bodies, has been organized well. We had come here to showcase technologies of the start-ups and also academic institutes. We were looking for a platform where industries meet and we landed in BioAsia.” Mr. Neeraj Kathuria, Chief Manager, IKP – BIRAC Regional Innovation Centre, India

“I was particularly impressed to see a lot of startups being supported at BioAsia 2015. It is good for us to showcase our products here with a lot of B2B customers, tech innovators and healthcare space.” Mr. Kiran Kalakuntala, CEO and Founder, eKincare, India

“Increasing burden of Non communicable Disease in India requires multi stakeholder engagement and a dedicated track on public health and access with a focus on NCD in BioAsia 2015 has been a praiseworthy initiative. Health system approach to tackle NCDs is the need of the hour and this could be a great platform to learning and sharing of innovations and best practices”. Mr. Prabhat Kumar Sinha, ManagerPatient Relations and Communications (Oncology), Novartis Healthcare Private Limited, India

“Well attended conference with a large variety of audience” Ms. Divya Chadha Manek, Industry Business Development Manager, National Institute of Health Research, UK

“The Healthcare Innovation Cell (HIC), Government of Telangana was invited to participate in the BioAsia 2015 Digital Health & Healthcare-IT Conference at HICC, Hyderabad. The work was well received and the discussions were quite informative and it was encouraging to see the work being done around the country in Healthcare IT” Dr. Anthony Vipin Das, Strategic Advisor, Healthcare Innovation, Ministry of Health & Family Welfare, Govt. of Telangana, India

“I appreciate the efforts of the organizers of BioAsia 2015, an event filled with enthusiastic participants from divergent sectors like Industries, Academia, Government, Funding sources, International venture capitalists, start-up teams and so on. It has been a refreshing event for me with lots of networking possibilities and being a panelist was a great experience in sharing my experience and perspectives from the academic world with the Industry giants from Asian countries. BioAsia has been driving the right ecosystem for innovators in drug discovery research.” Prof. P. Yogeeswari, M.Pharm, Professor, Department of Pharmacy & Associate Dean, Sponsored Research and Consultancy Division, Birla Institute of Technology & Science-Pilani, Hyderabad

“What was quite notable was the level of awareness about analytics in order to driver greater insights using big data technologies in order to have less invasive and more pervasive healthcare.” Mr. Sudipta Ghosh, Partner, PwC India

“BioAsia is one of the premier events that happen in India. Being on the international advisory board, I try to raise the awareness about what is going on in the countries like India and what India is doing to explore some more opportunities in biotechnology.” - Dr. Makarand S Jawadekar, Former Director, Pfizer, USA

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www.2015.bioasia.in

Organizers

Conference Co-Organizers

Supported By

Knowledge Partner

Event Partner

Country Partner

Associate Country Partner

BioAsia Secretariat #301, Gayathri Nest, Shri Shyam Nagar, Telecom Nagar Gachibowli, Hyderabad – 500032, Telangana, India. Tel.: +91+91 40-3000 4005 / 4006, Fax: +91 40-3000 4007 Email: info@bioasia.in

BioAsia 2015 Report  

BioAsia 2015 Report

BioAsia 2015 Report  

BioAsia 2015 Report

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