Bioasia 2016 report booklet by BioAsia2019

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EVENT REPORT

Foreword BioAsia 2016 Connecting the dots

Leveraging India to Succeed Globally With increasing pressure to reduce drug development costs and accelerate R&D programs, the global companies have started setting up R&D centres in Asia to take advantage of costeffective, yet highly skilled talent pool. India has emerged as a preferred destination for contract research and manufacturing activities, process reengineering and innovative R&D to act as a single destination with various enablers in place. The country is aided by a large, highly skilled community of scientists and researchers. Additionally, the governmentâ&#x20AC;&#x2122;s support in bringing a comprehensive IPR Policy, launch of â&#x20AC;&#x2DC;Make in Indiaâ&#x20AC;&#x2122; and financial support programs, regulatory reforms, etc. are expected to further boost the growth for Life Sciences industry. Under this backdrop, the thirteenth edition of BioAsia was organized with the theme of Leveraging India to Succeed Globally, with focus on connecting the dots to build stakeholder consensus and draw a distinct road-map to propel the sector growth. Witnessing participation from about 1300 delegates representing over 600 organizations and about 500 visitors from 50 countries, the event had a great reception from the life sciences community and the feedback received has been overwhelming. Besides, 1006 business partnering meetings were realized during the event. Through this post event report, we intend to bring to you the highlights of BioAsia 2016 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

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BioAsia2016 - Event Report Book

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BioAsia2016 - Event Report Book

At a Glance Introduction.............................................................05 International Advisory Board..................................06 Organizing Committee............................................07 Participant Profile.....................................................08 Ceremonies & Awards.............................................09 Keynote Lectures.....................................................17 CEO Conclave..........................................................23 Conferences.............................................................29 Satellite Events........................................................67 Media Coverage......................................................77 Feedback and Comments.......................................81

BioAsia2016 - Event Report Book

Introduction

February 8-10, 2016, Hyderabad, India.

With increasing pressure to reduce drug development costs and accelerate R&D programs, the global companies have started setting up R&D centres in Asia to take advantage of cost-effective, yet highly skilled talent pool. India has emerged as a preferred destination for contract research and manufacturing activities, process reengineering and innovative R&D to act as a single destination with various enablers in place. The country is aided by a large, highly skilled community of scientists and researchers. Additionally, the governmentâ&#x20AC;&#x2122;s support in bringing a comprehensive IPR Policy, launch of â&#x20AC;&#x2DC;Make in Indiaâ&#x20AC;&#x2122; and financial support programs, regulatory reforms, etc. are expected to further boost the growth for Life Sciences industry. Under this backdrop, the thirteenth edition of BioAsia was organized with the theme of Leveraging India to Succeed Globally, with focus on connecting the dots to build stakeholder consensus and draw a distinct road-map to propel the sector growth.

BioAsia2016 - Event Report Book

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, Bayer Consumer Healthcare, USA

Dr. Makarand S Jawadekar Former Director, Pfizer, USA

Dr. Nares Damrongchai Chief Executive Officer, Thailand Center of Excellence for Life Sciences (TCELS), Thailand

Dr. Nompumelelo H. Obokoh Chief Executive Officer, AfricaBio

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

Prof. Sirimali Fernando CEO, Coordinating Secretariat for Science, Technology and Innovation (COSTI) and Chairperson of the Board, National Science Foundation, Government of Sri Lanka

BioAsia2016 - Event Report Book

Organizing Committee

Chairman:

Dr. K V Raghavan

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

Members:

Mr. Arvind Kumar IAS

Secretary, Department of Industries and Commerce, Government of Telangana, Hyderabad

Mr. K. Manicka Raj IAS

Commissioner of Industries, Government of Telangana, Hyderabad

Dr. T Madhan Mohan

Advisor, Department of Biotechnology, Government of India

Mr. Venkat Narsimha Reddy

Vice Chairman & Managing Director, Telangana State Industrial & Infrastructure Corporation (TSIIC), Hyderabad

Dr. Vijay Kumar Kutala

Secretary General, FABA and Additional Professor of Biochemistry, Dept. of Clinical Pharmacology & Therapeutics, Nizamâ&#x20AC;&#x2122;s Institute of Medical Sciences [NIMS], Hyderabad

Dr. P V Appaji

Director General, Pharmaceutical Export Promotion Council, Government of India

Mr. CSN Murthy

Chief Executive Officer, Aurigene, Hyderabad

Dr. Ahmed Kamal

Project Director, National Institute of Pharmaceutical Education & Research and Acting Director, Indian Institute of Chemical Technology, Hyderabad

Dr. GVJA Harshvardhan

Director, Bharat Biotech International Ltd., Hyderabad

Mr. Utkarsh Palnitkar

Partner & National Head - Advisory & Life Sciences Practice, KPMG India, Mumbai

Mr. P. Gopal Krishnan

Director & Principal Consultant, Stabaka Consulting Pvt. Ltd., Hyderabad and Director, Foundation for Neglected Disease Research, Bangalore

Mr. Surya Rao

Managing Director, Technology Business Incubator, BITS Pilani, Hyderabad Campus

Mr. Saurabh Garg

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

Convener:

Mr. Shakthi M. Nagappan

Executive Secretary, FABA and Technology Development Professional, International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), Hyderabad â&#x20AC;&#x201C; Chief Executive Officer, BioAsia

BioAsia2016 - Event Report Book

Participant Profile

The number of delegates registered for the event was over 1300. In addition, over 500 visitors attended the 3 day global bio-business event. Norway participated as the Country Partner, while Spain and South Africa participated as Associate Country Partners. Over 50 countries took part in BioAsia 2016 with major delegations from Norway, Spain, South Africa, USA, Netherlands, Singapore, UK and Belgium. The International Tradeshow at BioAsia 2016 attracted about 80 companies and 37 start ups from across the globe.

BioAsia 2016 Participants during various sessions

BioAsia2016 - Event Report Book

Ceremonies & AWARDS

BioAsia2016 - Event Report Book

CEREMONIES

Inaugural Ceremony

With emphasis on Connecting the Dots this year, BioAsia 2016, under the theme ‘Leveraging India to Succeed Globally’, kick started its highly anticipated three-day conference on February 8, 2016, at the Hyderabad International Convention Centre in Hyderabad. The event was inaugurated by Shri Jupally Krishna Rao, Hon’ble Minister for Industries, Handlooms & Textiles and Sugar, Government of Telangana on February 8, 2016 at 06:00PM. The dignitaries present at the function include: •• Shri Jupally Krishna Rao, Hon’ble Minister for Industries, Handlooms & Textiles and Sugar, Government of Telangana •• Shri Susil Premjayantha, Hon’ble Minister of Science, Technology & Research, Sri Lanka •• Mr. Nils Ragnar Kamsvåg, His Excellency the Ambassador of Norway to India, New Delhi •• Dr. Magdalena Cruz Yábar, Her Excellency Chargée d’Affaires Embassy of Spain in India, New Delhi •• Prof. Ada Yonath, Nobel Laureate, Weizmann Institute of Science, Israel •• Shri Arvind Kumar IAS, Principal Secretary (Industries, Commerce and Energy), Government of Telangana •• Mr. Chris Stirling, Partner and Global Head of Life Sciences, KPMG

BioAsia2016 - Event Report Book

CEREMONIES

•• Mr. K. Manicka Raj IAS, Commissioner of Industries, Government of Telangana, Hyderabad •• Dr. P V Appaji, Director General, Pharmaceutical Export Promotion Council, Govt. of India •• Dr. Ahmed Kamal, Project Director, National Institute of Pharmaceutical Education & Research and Acting Director, Indian Institute of Chemical Technology, Hyderabad •• Mr. Venkat Narsimha Reddy, Vice Chairman & Managing Director, Telangana State Industrial & Infrastructure Corporation (TSIIC), Hyderabad •• Prof. P. Reddanna, Vice President, FABA and Dean, School of Life Sciences, University of Hyderabad, Hyderabad •• Dr. Ajit Shetty, Corporate Vice President Global Operations, Johnson & Johnson USA (retd.), Chairman Emeritus, Janssen Pharmaceutica, Belgium •• Mr. Mmboneni Muofhe, Deputy Director General, Dept. of S&T, South Africa •• Mr. M. Madan Mohan Reddy, Wholetime Director, Aurobindo Pharma Ltd., Hyderabad •• Dr. B. P. S. Reddy, Chairman and Managing Director, Hetero Drugs Ltd., Hyderabad •• Dr. Krishna M. Ella, CMD, Bharat Biotech International Ltd., Hyderabad •• Mr. Shakthi M. Nagappan, CEO, BioAsia & Executive Secretary-FABA, Hyderabad BioAsia2016 - Event Report Book

CEREMONIES

BioAsia 2016 Inaugural Ceremony in progress

Prof. Reddanna delivered the welcome address wherein he highlighted the theme of 13th BioAsia and briefed the audience on various conferences that were scheduled during the conference. He also highlighted that the country has experienced significant progress in the Life Sciences and Healthcare spaces, from drug discovery and innovation to digital health and healthcare. However, the industry has a few challenges to counter like escalating costs of drug discovery & intersection of computer science and bio-science. To address these challenges, the industry needs to focus on creation of an ecosystem for innovation, creation of clinical research centre, friendly government policies and incentives to drive the industry and collaboration to tackle challenges that are global in nature, such as environment and climate. Shri Arvind Kumar welcomed all the participants and said that it is that time of the year when the industry and stakeholders carry the event forward. He elaborated about the events and state policies that government is promoting, as a lot of development is taking place in Telangana in the field of Life Sciences. There is a plan to develop pharma-city near Hyderabad in Telangana, in its quest to make it as the capital city of pharmaceuticals in India. It would be spread across 5,000 acre and would be developed in two phases â&#x20AC;&#x201D; the first phase with 1,600 acre of land, which is already under implementation. Further, Telangana Government is in discussion with the Department of Pharmaceuticals to get a piece of land from the Indian Drugs & Pharmaceuticals Ltd (IDPL) to develop a medical devices park. In the coming years, it is expected that Telangana would also become a leader in vaccines in a major way. The best incentives and packages would be available for the life science sector. Mr. KamsvĂĽg highlighted that Norway and India have been collaborating in the field of healthcare since long. Norway, today, is focussing on innovation and technology with healthcare as a high priority. The Norwegian healthcare industry is dominated by small and medium companies. It believes, with the increasing use of technology, healthcare cost could be lowered. India has a young and vibrant talent ground and has the opportunity to solve health challenges with its affordable technology. 12

BioAsia2016 - Event Report Book

CEREMONIES

Dr. Yábar began her address by stating that latest biotechnology indicator in OECD countries indicates that Spain is ranked second in biotechnology with the presence of more than 2,400 companies. Spanish companies are focussing on biopharmaceutical, bioagri, etc. The research cooperation between Spain and India is growing as it has recently signed a MoU with India. Shri Premajayantha highlighted that the world is now integrated; the challenges of the recent financial and food crises have reminded people about this flat world and BioAsia would try to address these challenges. Sri Lanka and India could build and innovate jointly, and BioAsia can increase the collaboration between these two countries. In Sri Lanka, the life expectancy is increasing. As the poverty line has declined, people are looking forward to a good quality of life. Shri Rao, in his speech, announced many strategic partnerships and investments of over USD100 million (INR700 crore) with the industry. He also announced 13 land approvals for biotech and pharmaceutical companies. He also unveiled the 3-D walk of Pharma City and mentioned that approximately 4,000 acre of land has been already acquired for the Pharma City and that Genome Valley currently has 72 biotech units and an expansion of another 200 acre of land is being carried out. The Telangana Government has introduced TS-iPASS — a single-window clearance and self-certification programme for the industry. About 200 bulk drugs and 400 formulation units are present in the state. Telangana has 49 FDA-approved facilities and contributes to 30 per cent of India’s export. Hyderabad is the bulk drug capital of India and about 200 life sciences companies are present here. Hyderabad’s Pharma City is Asia’s biggest project and it would develop R&D, skill development centres, zero liquid discharge facility and quality certification labs. The government would strive to make Telangana a leader in innovation on the lines of Make in Telangana taking forward the motto of Make in India initiative. Further he mentioned that BioAsia has received delegates from 50 countries with major delegations from Spain and Norway. It has a thought-provoking theme, which would act as a catalyst for forming various partnerships. From poverty to prosperity, a new era has begun in India in the life sciences sector and is on a fast track road. The sector is growing fast and Hyderabad could leverage the opportunity as it has Genome Valley, which is India’s largest systematically developed biotech cluster. The state has also specific land banks for SMEs and it has achieved uninterrupted power supply. The state of Telangana has skilled manpower and good institutions in Hyderabad. The capital city has good infrastructure and best weather conditions, advantages that the life sciences companies would like to leverage for their growth and contribute to making India’s economic engine run faster.

BioAsia2016 - Event Report Book

CEREMONIES

Participants during the Inaugural Ceremony

Welcome Reception The first day concluded with a Welcome Networking Reception at Novotel Lawns attended delegates from 50 countries.

BioAsia2016 - Event Report Book

AWARDS

Genome Valley Excellence Award “Genome Valley Excellence Award” was introduced to recognize and honour eminent individuals and organizations for their exceptional contribution to Life Sciences Research & Industry. The Genome Valley Excellence Award 2016 was presented to Nobel Laureate Prof. Ada E. Yonath of Weizmann Institute of Science, Rehovot, Israel in light of her •• Exemplary research and the pioneering work on the structure and function of the ribosome •• Extensive contributions to the field of ribosomal crystallography and introducing cryo bio-crystallography •• Remarkable Contributions to the biomedical and therapeutic research by deciphering the structural basis for antibiotic selectivity while highlighting its effectiveness leading to structure-based drug design During her acceptance speech, Prof. Yonath highlighted that Israel provides 100 fellowships to Southeast Asian countries and out of this, it has given 88 fellowships to India, 11 to china and 1 to Taiwan. She also mentioned that her scientific work is inspired by an outstanding Indian scientist Mr. GN Ramachandran who also inspired her to draw protein collagen structure.

Hon’ble Minister of Industries, Government of Telangana presenting the award in presence of other dignitaries.

Prof. Ada Yonath delivering her acceptance speech

BioAsia2016 - Event Report Book

AWARDS

BioAsia Innovation Award BioAsia Innovation Award was introduced to recognize Young Scientists / Students (below the age of 35 years) pursuing their research in any of the areas of biotechnology / life sciences, and who have created a product or process of applied value or for utility in the welfare of human society.

INR 1 Lakh Cash Prize, Memento and Citation awarded to Ms. Premnandhini Satgunam from L. V. Prasad Eye Institute, Prof. Brien Holden Eye Research Centre, Hyderabad for her project “Pediatric Perimeter - A Novel Device to Check Visual Field of Babies” and to Mr. Vijay Soni from Birla Institute of Technology and Sciences-Pilani, Hyderabad Campus/ National Institute of Immunology, New Delhi for his project “Depletion of M. Tuberculosis Glmu from Infected Murine Lungs effects the Clearance of the Pathogen”. In partnership with

BioAsia2016 - Event Report Book

Keynote Lectures

BioAsia2016 - Event Report Book

Keynote Lectures

Speaker: Prof. Ada E Yonath, Weizmann Institute of Science, Rehovot, Israel

Prof. Yonath delivered the keynote address on the structure and functions of ribosomes. She elaborated that DNA is a collection of genes and the information in DNA is stored in four structures. From DNA, the transcription is done to mRNA and subsequently, proteins are synthesised. The ribosomes are universal and functions in a similar way in all cells. A ribosome acts continuously for 5-40 peptide bonds in a second and hardly does any mistake. Ribosomes are universal factories that produce protein continuously by decoding information from DNA. As ribosomes play fundamental roles, many antibiotics target them. Over 40 per cent of the clinically useful antibiotics target protein biosynthesis, mostly to paralyse ribosomes. The antibiotics paralyse ribosomes by binding themselves to their functional sites. For example, erythromycin interferes with the protein tunnel. Resistance to antibiotics is one of the most severe problems in modern medicine. Combating to resistance is unlikely because bacteria wants to live; maybe, humans can only control its degree of resistance. The world needs to develop a better understanding between pathogens and useful bacteria, and accordingly design antibiotics specific to pathogens only.

BioAsia2016 - Event Report Book

Keynote Lectures

Speaker: Mr. Chris Stirling, Partner and Global Head of Life Sciences, KPMG

Mr. Stirling gave an overview of the global perspective — a warning and advice for the life sciences industry. According to him, the life sciences industry needs to radically change to continue to be successful. He characterises the industry like a polar bear in the Arctic. The ice is melting underneath and it needs a safer ground with changing conditions. He said that globally the healthcare systems are under significant pressure. The population is getting older, living longer and people are also getting fatter in addition to the rise in chronic diseases. By 2050, more people are expected to be in 60+ age group, than 15 or under, in the world. The government cannot continue to spend more and more as a percentage of GDP on healthcare. The government is desperate to lower the cost and the easiest thing to do is control the drug prices. In 2015, there was a significant reduction in drug prices. He also spoke about four global trends in the life science sector — M&A: There was an surge in M&A activities in 2015 as about USD300 billion worth of deals happened last year. Three major deals that are going on in the global life sciences space are: a) Pfizer-Allergan deal is worth USD160 billion. The merged company is expected to have a large revenue, equivalent to GDP of Denmark. b) Syngenta takeover by Chemchina — This deal is a USD40 billion takeover by a China-based company. c) Shire acquiring Baxalta — This is expected to create a rare diseases powerhouse. He further explained that the M&A deals are significant and are absolutely focussed, since companies are investing in their specific areas of strengths to move out of the areas where they cannot compete.

BioAsia2016 - Event Report Book

Keynote Lectures

Value: He emphasised that a radical new approach is now required in the healthcare system. Healthcare system does not need a salesman from life sciences companies, but it needs partners who can help in solving healthcare challenges. Patient Centric: He highlighted that all product-push models need to be replaced by service-oriented model with patients at its centre. Only 10 per cent of the total healthcare budget spend is on drugs, so the industry needs to focus on patients pathways. To be successful, it is really important that industry remains patient-oriented than productfocussed. India: He highlighted that the Indian industry has a depth in chemistry and biochemistry. The country has been manufacturing drugs for the entire world. The healthcare market in India would reach USD280 billion by 2020. The industry needs to focus on how it could resolve Indiaâ&#x20AC;&#x2122;s key pressing healthcare challenges. There would be a significant learning in this process and India could export this knowledge to other countries. India has a progressive technology sector and the industry needs to put health and technology together. For example, Intel devices help in providing rural healthcare services in India.

Audience during the lecture

BioAsia2016 - Event Report Book

Keynote Lectures

Speaker: Prof. Hilary Thomas, Partner and Clinical Lead – Life Sciences and Healthcare Advisory, KPMG and National Health Service, UK

Prof. Thomas highlighted three big drivers of change in the healthcare sector — a) Demographic: In 1981, there were 600 million people and now the number has doubled b) Globalisation: The pharmaceutical industry needs to move from product-push model to a service oriented model, and for this it requires a technology platform. It also needs to generate value across care pathways — through diseases awareness, prevention and diagnosis and then, treatment follow-up c) Consumer activation: All the stakeholders in the healthcare sector value chain — the payer, provider and patient — are more activated now, creating a change in the system. About 70 per cent patients consult online, where the size of self-management market is estimated at USD2.9 billion and mobile health app market at USD25 billion. All these things suggests that the industry needs to become more patient-centric. The new solutions to these changes are digital technology and the importance of care path. Life Sciences companies need to change their dialogues with customers. They need to develop a strategy that is both top-down and bottom-up, with patients at the centre of the value chain. It also needs to structure sales and marketing spends around patients.

BioAsia2016 - Event Report Book

Keynote Lectures

Speaker: Dr Rajendra Pratap Gupta, Chairman â&#x20AC;&#x201C; India & India Representative, Personal Connected Health Alliance, India

Dr. Gupta spoke about the internet of health and connected devices. About 306 million internet users were present in India in 2015, and this number would grow further in 2020. The country has changed from landline to mobile and from analogue to digital in its approach. In India, there is a significant burden of non-communicable diseases, and technology could play a vital role in addressing the concerns i.e., 80 per cent of diseases do not require the physical presence of a doctor to address patientâ&#x20AC;&#x2122;s queries/solutions. Software as a drug is reimbursed by the US FDA. By 2017, they would have geo mapped all restaurants and food items, having the calorific value and a software would inform about this to customers. Technology eliminates disrupters, as today, if doctors do not need technology, technology would not need them in future. Technology would have an equal role as doctors and the future of health would become digital health.

BioAsia2016 - Event Report Book

CEO Conclave

BioAsia2016 - Event Report Book

CEO Conclave

BioAsia - KPMG in India CEO Conclave

Time : 18:30 - 20:00 Hrs

Make in India Flavors of policy change

Venue : Hyderabad International Convention Centre

Date

: February 9, 2016

Panelists: •• Dr. Pankaj Bhai Patel, Chairman, Zydus Cadila •• Mr. Rogerio Ribeiro, SVP & Head, Emerging Markets, GSK •• Dr. Rajiv I. Modi, Chairman & Managing Director, Cadila Pharmaceuticals Ltd. •• Dr. Renu Swarup, Managing Director, BIRAC, GoI •• Mr. Prabal Chakraborty, Managing Director, Boston Scientific India •• Dr. Rajiv Sharma IAS, Chief Secretary, Government of Telangana •• Mr. Prasanta Biswal, CEO, International Biotech Park, Pune

Moderator: •• Mr. Utkarsh Palnitkar, Partner, Head of Advisory & Head – Life Sciences, KPMG in India

Context: With the slogan ‘Come, Make in India’, country is aggressively aiming to leverage vast pool of talents to achieve a valiant dream of creating India as the ‘manufacturing hub’ of the world. India is well-equipped to achieve this dream in the area of life sciences. With the presence of significant pool of talented and passionate human resource, who are capable of developing cost-effective manufacturing capabilities, along with a strong industry that has a global foot print, the nation is poised to become the pharmaceutical basket of the world. The sector is in the phase of witnessing significant growth in terms of revenue and is heading toward success. The sector already contributes significantly to the economic growth of the nation and could achieve much more for the Indian economy.

BioAsia2016 - Event Report Book

CEO Conclave

Further, India’s biotechnology sector is the third largest in the Asia Pacific region, and is edging to enter a new period of unprecedented growth. This has been fuelled with enabling ecosystem of growing investments, outsourcing undertakings, robust growth in exports and increasing government’s focus on the sector. Tangible steps have been taken toward setting up of national research laboratories, centres of academic excellence and several other institutes focussing on the sector have given a boost to the growth. All these factors reinforce each other to propel the sector movement up in the value chain. The time is ripe with opportunities to help the nation to become a major player in the life sciences sector around the world. CEO Conclave at BioAsia 2016 focussed on opportunities to drive industry’s growth agenda by focussing on key action areas.

Session Proceedings: Mr. Palnitkar highlighted that over the years the CEO Conclave at BioAsia has had many interesting conversations on trends and opportunities that has shaped the ever-evolving biopharma/biotech industry. In recent time, the Make in India initiative has caught the imagination of the nation and has brought focus to a segment of the economy that has been in shadows of the services sector for many decades. It is often being said that India has missed the manufacturing vehicle. But can the ‘Make in India’ initiative put India back on track? However, circumstances have changed and manufacturing itself is undergoing dramatic changes. The fourth industrial revolution which is the flavour of our time, and which the biotech sector wants to target take the growth of the sector to USD100 billion by 2025. The size of the Indian biotech industry is presently estimated at about USD5 billion, and to show us the road map to take this to USD100 billion, this session has a very eminent panel. Dr. Patel spoke about India’s advantage in the biotechnology industry. The country needs to really find out simple regulations that everybody can follow to manufacture products that are successful. There could be single regulatory agency for the biotechnology sector as it would help in faster growth. Today, the country has certain advantages. India is globally known as a large pool of scientific manpower, requires lower cost of capital investment in India to set up a manufacturing facility, etc. The disadvantage is the long period of approval for getting products launched. The country needs to find out ways by which it could be shortened without making a compromise on quality and safety. He stated that the biggest advantage of the country is the people of India, who want to work. The only thing is that the country needs is to create an enabling environment to cash in this sooner than later. He also spoke about the need for skill development in India. The industry has to play a role in bridging the skill gap and work with academia. The supply-demand situation is not correct as education programmes are not focussed on industry requirements. He also spoke about biosimilars and its ground realities in India. Currently, there is no common regulatory understanding of the biosimilars. The price of the biologics is not viable for the industry, so biosimilars are important. There is a significant opportunity in the developed markets, such as the EU and the US. The country’s pharmaceutical industry is 70 years old, however it’s biologic is only 10 years old, so it would take some time to reach the global levels. Dr. Sharma highlighted the steps taken by the Telangana Government for the industry. As India has been a regulated economy, there are a plethora of local laws that need to be adhered to. So, the Telangana Government came up with a policy known as TS-iPASS, which essentially aims at giving approvals to proposals in a time bound manner. The policy is meant to be hassle-free and free from bureaucratic challenges. So far, the policy has BioAsia2016 - Event Report Book

CEO Conclave

been very successful because it completely eliminates the interference with human beings and the government is giving approvals in a time bound manner, the maximum time being 21 days. After the launch of this policy six months ago, the government has approved 82 proposals and nothing is kept pending for more than 21 days. This is a major initiative that the Telangana Government has taken. The second important thing for the industry is the availability of physical infrastructure, land, water and electricity. The government is also coming up with the development of highly specialised clusters for niche industries, such as the pharma and biotech sector. The region of Telangana has seen power cut free summers last year, after two decades. On the issue of land, power and electricity, the government is having a compact policy. It is also planning a water grid where 10 per cent of water would be earmarked for the industry, which has started and the whole thing is expected to be completed within a period of three years. The Telangana Government is taking a lot of steps and has extended its full support for the industry. Mr. Ribeiro shared MNC’s criteria for investment in a country. The key criteria are predictability, transparency and framework that is consistent with international standards. A bureaucratic environment in a country negatively impacts the investment decision of a company. India emerges at the top from the strategic point of view, as it has the right skill sets, the quality of people, scientists and professionals. He also highlighted international competition for India in biotechnology. Brazil, Turkey and Russia are giving competition to India as they provide protection of long term IP. South Korea is committed to the biotechnology sector and it wants to aggressively tap the potential for biosimilars first and then nanotechnology. Mr. Modi highlighted his views on ‘Make in India’ initiative and innovation scenario in the country. Innovation is very important but on ground, today, the country has a wonderful ecosystem for ‘Make in India’. MNCs prefer to make in India because of its ecosystem of people and low cost of capital to build up. So the whole mood of the country is wonderful receptive and changing. The country has lot of youth here and to channelize this energy it need to focus on ‘Make in India’. In the last 7-8 months, the sensitivity of the government and receptiveness from the pharma companies have been good. That said, the industry needs to be further receptive toward new government regulations and policies. India is a leader in generics as one in ten tablets used by the Americans is either made by an Indian company or a global company having its manufacturing base in India. So, the power of ‘Make in India’ cannot be challenged in this sector. He said that the next decade is not only going to build and develop the bio-pharmaceutical sector, but is also going to put emphasis on imbibing innovations in its vast ecosystem. Dr. Swarup spoke about Biotechnology Industry Research Assistance Council (BIRAC) and its role for start-ups in India. The Department of Biotechnology (DBT) has supported research for 30 years and is now focussing on innovations. BIRAC has realised that innovation is now going to come from academia and start-ups, as a lot of research is happening in these segments. Earlier BIRAC was directing its funds and grant schemes toward academic research, but now for a couple of years it has started supporting startups and SMEs. Small Business Innovation Research Initiative (SBIR) was the first scheme that the DBT had first launched to support SMEs in this direction , following which it set up BIRAC — the only public sector in the Government of India that is focussing on just innovation ecosystem, nurturing the start-ups. In the last 18 months, the country started talking about ‘Make in India’ and ‘Start-up India’ initiatives, and BIRAC is very encouraged by this. It really wanted to take this forward. In the biotech sector, an innovation ecosystem is very important, even if the country has the best policies in place. Unless the whole 26

BioAsia2016 - Event Report Book

CEO Conclave

innovation ecosystem is ready to make use of those policies, the sector is not going to take off to a growth trajectory. She emphasised that the country needs to focus on human resource, the infrastructure resource and most importantly the financial resources. BIRAC has focussed on these three parameters, and it now has the financial resources that invest right into an idea generation stage coming from an individual. Any individual/student can come up with an idea to apply for an incubation grant. BIRAC works right through an idea to the Proof of Concept (POC), early stage to late stage to product developments. BIRAC also tries to provide mentorship and guidance support to the individual/students. Bio-centres and cluster would play an important role in developing the biotechnology industry in India. The country currently has 500 start-ups in the biotech sector, which is expected to reach about 2,000-2,500 start-ups in the coming years, under the ‘Make in India’ and ‘Start-up India’ initiatives. Mr. Chakraborty spoke about the medical devices sector in India. He started his speech by providing a brief background on the medical devices situation in India. About 5-6 years ago, the stakeholders were really challenged to distinguish that medical devices are different from drugs. He applauded the government for the clear distinction now identified, and for recognising the medical devices as a sunrise sector. The government has allowed 100 per cent FDI apart from taking many positive steps for this sector. He highlighted that MNCs are not investing in India for high-tech medical devices. However, the industry is excited about new opportunities that are opening up. The ecosystem that is required for the medical devices sector is not existing perhaps the industry being too small. It is important to get the academicians, the industry, the government and other stakeholders to get together and start innovating first, and then start talking R&D. The other important thing is the draft Medical Devices Bill, which is awaiting approval in the Parliament. It would be important to have a separate regulatory system and perhaps a regulatory body for medical devices sector to grow. One more factor that the government needs to take steps on increasing the access for medical devices, so they could be used in different therapies. Mr. Biswal highlighted that the biotechnology development strategy was rolled out in 2005, and the sector reached a turnover of USD1 billion that year. The strategy was aimed at becoming a USD5 billion sector by 2010 and USD10 billion by 2015. But the sector in BioAsia2016 - Event Report Book

CEO Conclave

India has reached to become a USD5 billion industry in 2015 after coursing through many challenges. Moreover, out of 32 biotech parks and notified SEZs, only two are operational yet. Hence, the country needs to focus on infrastructure development for the biotechnology sector.

Participants during CEO Conclave

Recommendations: •• India needs to have a separate regulatory body for the biotechnology industry with simple regulations to allow the sector grow at a fast pace •• There is a need to establish more funding mechanism in the country to support start-ups in the biotech sector •• Internationally reputed framework could be adopted for the development of indigenous medical devices along with a separate regulatory authority •• India needs to focus on cluster development programme as it brings together small companies, academic institutes, start-ups along with large companies. The state policies need to drive the cluster development programme in India •• Industry needs to actively participate in bridging the skill gap by participating in curriculum design with academia, apart from imparting training to students.

CEO Conclave Panelists 28

BioAsia2016 - Event Report Book

Conferences

BioAsia2016 - Event Report Book

Conferences

Building a strategy for India and beyond 10.30 - 11.45 Hrs

Panelists:

• Dr. Krishna Ella, CMD, Bharat Biotech International Ltd. • Mr. Annaswamy Vaidheesh, VP South Asia & Managing Director, GSK India • Mr. Nitin Deshmukh, CEO, Kotak PE • Ms. Deepanwita Chattopadhyay, Chairman & CEO, IKP Knowledge Park • Ms. Anuradha Acharya, CEO, Mapmygenome

Moderator:

• Dr. Ajit Shetty, Chairman Emeritus, Janssen Pharma

Context:

To harness its bio-economy potential, India needs to have a coordinated effort among all stakeholders to increase investments and encourage innovations so as to reap benefits of the biotechnology revolution. Further, India could build a strategy to develop and retain quality talent, increase funding options and design policies in support of drug discovery efforts. Creating a conducive environment through a responsive regulatory framework is imperative to achieve the vision of making India a hub for bio-pharma. India could leapfrog challenges faced by the industry during the transition to bio-economy by adopting best practices from around the globe. Best practices from the US, SouthAfrica and other leading bio-economies could be leveraged by Indian stakeholders to adopt strategies so as to help achieve the dream to become bio-pharma basket for the world.

BioAsia2016 - Event Report Book

drug discovery & innovation Conference

Session Proceedings:

Ms. Chattopadhyay spoke about the policy changes that the government has recently introduced for start-ups, such as the Startup India Action Plan. Consequently, incubation and science parks have a more important role to play. The government is planning to set up 50 new incubators, five new bio-clusters, five new bio-tech centres and 150 new technology transfer offices. Biotechnology Industry Research Assistance Council (BIRAC) plans to devote a corpus of INR100–200 crores for its biotech equity fund to provide financial assistance to biotech and life sciences start-ups. About one-third of the Bharat Innovation Fund (USD 150 million) is dedicated to biotech sector. Further, India could introspect where it would like to reach in terms of finding the correct balance between science and commercialisation. India would have to assess its long and short-term goals in this field, and see the larger picture. Mr. Deshmukh mentioned about the funding scenario for the Life Sciences companies in their early stages. One of the biggest challenges in the early stages of these companies is funding. The government has taken few steps in setting up start-up funds. However, they have to go a long way in establishing and enabling the early stage innovation ecosystem. Biotechnology Industry Research Assistance Council (BIRAC) and angel investors are the existing biggest investors who are funding entrepreneurs during the early stage of an enterprise. BIRAC is credited for funding over 100 companies in this country and some of them are achieving remarkable results. Very few Venture Capital (VC) firms are focusing in this sector owing to the following key challenges: •• Regulations: The regulatory environment in the country is uncertain, be it for product approvals or for clinical trial timelines. The uncertainties also exist in getting the manufacturing licenses, etc. •• FDI and FIPP approvals: The delays that took place in the past have turned out to be significantly disadvantageous for the investors. •• Exits: Early investors have taken long time to exit the market, and therefore there exists reluctance from VCs to invest in this sector. Ms. Acharya is of the view that the country’s ecosystem is changing for start-ups in Life Sciences companies. There is a lot of positive intent that has come forth, whether it is from the government or from different areas, such as academic and others. However, the startups are still looking for solutions for the following challenges: •• Funding: Start-ups in Life Sciences space have a significant gestation period that most VCs and other investors look at before investing. •• Exits: Due to fewer options for local acquisitions and M&A, Life Sciences companies/startups have to constantly look outside India for further expansion. •• Tax exemptions: The new plan introduced by the government allows income tax holiday for the start-ups for the first three years of their operations. But, biotech companies, anyhow, do not make any profits during their initial years. So, it would be a good idea that an exception is given to biotech companies in this regard. Looking at the long term perspective, the country needs to look at healthcare at a holistic level wherein the focus should be on preventive care. This would mean not only looking at healthcare in terms of drugs, but giving equal importance to nutrition, food and vaccines.

BioAsia2016 - Event Report Book

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Mr. Vaideesh talked about the areas of country’s strengths that could be focused upon. According to him, India is a knowledge-driven country. Economically, we are not sound, but we could leverage the knowledge we possess. India is strong in generics, as we have a pool of chemists, biologists and technologists. To progress to the next stage, the country could focus on innovations. For innovations to happen, one needs to have an ecosystem that breeds innovations and people invest in those innovations. The Life Sciences industry could have a NASSCOM-like body, to directly report to the Prime Minister or someone who could drive the industry escalating its value. Dr. Ella mentioned about the vaccines scenario in the country. Due to change in travel, tourism and pandemic situations, such as Zika virus, it is increasingly costing the economy and impacting country’s tourism. So vaccines are not only impacting health of the masses, but also impact national economy significantly. He informed that we are truly following the ‘Make in India’ initiative and also, innovate in India; we developed the chikungunya vaccine and entered the clinical trials recently. The Life Sciences sector in India faces multiple challenges, such as lack of single-window clearance system for regulatory ecosystem, drug price control orders, less funding on education and R&D. Dr. Shetty highlighted the importance of innovation in the country. Innovation is simply the life blood of the life sciences industry. As we enter a new era of life sciences, affordable access will be the key. India has a large pool of talent and manufacturing base to provide affordable medicine to the world.

Recommendations:

•• The regulatory environment in the Life Sciences sector could be streamlined so that the drug approvals and manufacturing licenses are obtained in a timely manner. Moreover, the simplification of regulations for clinical trials could boost drug discovery efforts in the country. •• The Government could focus on Science Parks and Incubators to propel innovations in the country. •• The country could chalk down a strategy for both short as well as long term, aimed at Life Science sector. This could help in development of clear policies for the sector. •• Establishment of an industry body could drive the sector’s growth. This body could directly report to the highest government authorities. •• A focus on risk pooling mechanism to provide health coverage for all could reduce OOP expenditure in the country •• A focus on designing policies for preventive care to reduce the burden on curative care in the long run. •• A provision for funding for the Life Sciences companies in their early stages to help propel innovations in the country. •• Reducing the approval timelines for FDI could also attract VCs to this sector.

BioAsia2016 - Event Report Book

drug discovery & innovation Conference

From science to solutions — Innovative strategies in the drug discovery space 12:15 - 13:30 Hrs

Panelists:

•• Dr. Darren Ji, Global head of partnering, Roche •• Dr. Uday Saxena, CEO, Kareus Therapeutics, Switzerland •• Dr. GVM Sharma, Chief Scientist, CSIR-Indian Institute of Chemical Technology •• Dr. Ajith Kamath, Senior Director and Head, external R&D, Pfizer

Moderator:

•• Dr. Subir Basak, former president R&D, Jubilant Life Sciences

Context:

Robust innovations along with evolving delivery models have become inevitable to strengthen an industry’s core existence. Even though there is a growing obligation to strengthen R&D pipeline, the development of new medicines has continued to remain one of the most complex, expensive, sluggish and strictly regulated procedures. Although the efforts are being put together by the industrial players along with the academia and the government, large pharma companies are increasingly engaging in a range of risksharing partnerships with academics, federal agencies, start-ups, contract providers, and biotech and other pharma players to alleviate the risks of drug discovery and improve R&D efficiency. Successful adoption of innovative strategies, such as open innovation, crowd sourcing, high throughput screening, Big Data and Internet of Things, could accelerate drug discovery and bring drugs earlier to the markets.

Session Proceedings:

Dr. Darren Ji spoke about the various collaboration models followed by large pharma companies in drug discovery space. The various models adopted by Roche are — •• Strategic collaborations: It was first started by collaborating with Genentech, a US-based biotechnology company, which was later acquired while providing substantial autonomy over decision making. BioAsia2016 - Event Report Book

drug discovery & innovation Conference

•• Small collaboration: The company has about 200 active collaborations, asset in and asset out licensing agreements, upfront payments and royalties. •• Academic collaboration: It is working with various academic institutes by providing some seed fund along with imparting some technical guidance. Dr. Saxena talked about the challenges that companies encounter during drug discovery process. It takes 12 to 15 years and USD0.5 billion for drug discovery and requires a lot of patience. It is a huge problem for startups as well as for big companies. So the three problems cost, time and risk – Every single company large or small have to deal with these problems. Doctors and physicians are working closely with pharmaceutical companies in the global world but not working here in India. More physicians needs to work together with scientists to solve drug discovery challenges. He also emphasises on collaboration model as it leads to cost saving for pharma companies. During collaboration mindset of both industry and academia is very important as they should treat each other equally and a simple change in mindset for both industry and academia will lead to more collaboration. Dr. Sharma spoke about the collaboration model between the pharma industry and academia. Currently, the Indian Institute of Chemical Technology (IICT), Hyderabad is working with the industry in the areas of process chemistry and new lead generation. The Council of Scientific and Industrial Research (CSIR) has worked in labs until the completion of pre-clinical stage and later, would require support from the industry. IICT has established a molecule bank facility and also runs an Open Source Drug Discovery programme to support drug discovery efforts in the country. Dr. Kamath spoke about the importance of collaboration. According to him, drug discovery pipeline is drying up in large pharma companies and therefore, they are looking for partnerships. Drug discovery process is complex and the focus is changing now from small molecules to large molecules. Moreover, when patient treatment is getting sophisticated with all these constraints, partnerships could provide solutions. He also spoke about Pfizer’s various collaborations, such as — •• Providing Indian companies a few targets and allowing them to make various compounds for clinical trials •• Collaborating globally with asset-rich companies to in-licensea specific molecule •• Funding is provided to an academic lab in India to test new molecules •• Fee for service collaboration model is adopted with a research lab in India that is testing a cancer molecule on Indian genotype •• Started an incubator centreat IIT Delhi and would provide funding, mentoring support, access to infrastructure, etc. •• Set up a centre for therapeutics innovation in the US with 29 academia institutes as a business model, where scientists are now working with academia

Recommendations:

•• Collaboration among life science companies could reduce cost, time and risk associated with drug discovery •• Streamlining clinical trials regulations in India and simplifyingthis to help India regain its position as a clinical trial destination of choice •• Incentivisingindustry-academiccollaborations by building trust, andby co-locating industry and academia to help promote research •• Physicians could work with scientists in India to boost drug discovery efforts •• A dedicated fund for innovations could propel drug discovery efforts in the country. 34

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Industry consolidations and venture capitalism - What investors are thinking? / What is their take? 14:30 - 15:45 Hrs

Panelists:

•• Mr. Sanjiv Navangul, Managing Director, Janssen India •• Mr. Bobba Venkatadri, General Partner, Ventureast •• Mr. Vamesh Chovatia, Partner, Tata Capital •• Mr. Alpesh Dalal, M&A Head, Lupin •• Mr. Deepak Sapra, VP, Dr. Reddy’s Laboratories •• Dr. Jonathan Atkinson, Member of the Board & Partner, HGF Ltd., the UK

Moderator:

•• Mr. Sanjay Singh, Partner, Deal Advisory, KPMG in India

Context:

Due to the fragmented nature of the Indian pharmaceutical industry, the consolidation has become the need of the hour to sustain a healthy growth. To fill up the voids in their portfolio, the Indian companies are aggressively aiming at acquisitions, both in domestic as well as other emerging markets. Further, the Indian companies have already started acquiring companies in developed nations owing to target companies’ established product portfolio and FDA-approved manufacturing facilities, etc. Similarly, the global pharmaceutical industry is also making a transition toward a consolidation phase, as companies are seeking uncharted growth platforms following imminent expiration of patents. Needless to say, developing a drug is a time-consuming exercise in addition to being a capital-intensive proposition in comparison to acquiring a blockbuster drug for a pharmaceutical company or a research molecule from a small biotech firm.

Session Proceedings:

Dr. Atkinson spoke about the importance of Intellectual property (IP) during M&A deals. He sighted an example about a company in the UK where it reduced the price of acquisitions by about GBP700 million, because of the sub-optimal IP of the target company. He also spoke BioAsia2016 - Event Report Book

drug discovery & innovation Conference

about the importance of IP protection, as the culture in India generally focuses on branding in the internal market. However, for other markets, such as Japan, the protection of IP is a key focus area. Mr. Singh spoke about the M&A activities taking place in the global pharmaceutical industry. In 2015,M&A deals worth USD430 billion were executed, which is unprecedented. The largest deal announced was between Pfizer and Allergan, worth USD160 billion, which is yet to be executed. The smaller companies are either going public to grow or sold to larger companies. Mr. Venkatadri felt that the convergence of biology and technology would be bigger than the pharma industry and technology revolutions. The pharma industry was used to be driven by doctors, but is now moving toward becoming patient-focused. He also highlighted the role of venture capital (VC) firms for the start-ups. The US is considered to be ahead of the rest of the world in the start-up industry. It is mainly because VC firms not only provide money to start-ups, but also mentors them as well to solve business problems and strategic issues. Mr. Navangul shared the perspective of large pharma companies toward India. The companies view the Indian market with two sets of opportunities: •• Creating more access: Through M&As and partnerships, the companies could widen their reach and create more access. This does not necessarily mean buying companies or products, but the companies could look at accessing patients in a better way through partnerships. For example, for TB, diagnostics must be ensured at the right time and collaboration is needed to provide quick treatment. •• Innovation: A significant transformation is happening in the innovation front. Currently, knowledge, information and innovation are present in bits and pieces every where. All these cannot be done by a single company in-house and end-to-end, and therefore collaboration in this space would prove beneficial. Mr. Chovatia shared the perspective of private equity (PE) and VC firms toward the innovation and drug discovery. It is going to take some time for innovation-led funding as PEs manage third-party’s investments and therefore, the returns required are time-restricted in nature. The drug discovery companies does not generate good returns until 6‒7 years, as the molecules only advance to phase A by that time, while the fund’s life is about 8 years. If the life of a fund is increased to 15 years, then a lot of investment could be generated. PEs are still trying to pursue opportunities for playing in longer cycles even after having time and investment constraints. They are trying to achieve this balance by having milestones between the start and end-time of an investment. Mr. Sapra spoke about Dr. Reddy’s perspective on innovation partnership and alliances. The two important things that they consider for a partnership are compliance and convenience. To ensure innovation taking place at a greater pace, partnerships and sponsorships are necessary. Mr. Dalal highlighted the transformation in companies owing to innovation. The Lupin balances its investments in innovation as there is a requirement of regular returns and sustainable growth. The company is growing at a high growth rate, and it requires innovation and R&D support for growth, whereas scaling up is required for better margins. He felt that companies need to move up in the valuechain to transform and sustain growth.

BioAsia2016 - Event Report Book

drug discovery & innovation Conference

Recommendations:

•• M&A route to increasefocus toward patients and accessing them in a better way •• Increasing the life of a PE fund with up to 15 years to attract a lot of investments in the drug discovery space •• Support from VCs on mentorship to solve business problems and strategic issues for start-ups •• Boost innovationsthrough partnerships, as both partner companies could combine their strengths and work on common goals.

Biosimilars - Will biopharma landscape undergo a sea change? 16:15 - 17:30 Hrs

Panelists:

•• Dr. Suresh Jadhav, Executive Director, Serum Institute of India •• Dr. Ajay Bhardwaj, CEO, Anthem Biosciences •• Dr. Gopal Dasika, VP & Head – Biologics, Hospira •• Dr. Satakarni Makkapati, President, Biologics, AurobindoPharma •• Dr. Prabuddha Kundu, Co-founder & Executive Director, Premas Biotech

Moderator:

•• Mr. Ravind Mithe, Partner, BPS-S&O, KPMG in India

Context:

Marking a steady shift from manufacturing traditional vaccines, the Indian biopharmaceutical players are now stepping up their focus on biosimilars, as the global biosimilar market is forecast to reach USD35 billion by 2020 from an estimated USD1.3 billion in 2013. India is in a good position to leverage this opportunity as the cost of biosimilar development is relatively low as compared to in other competing countries. Moreover, India has released its biosimilar guidelines in 2012, and now the country is planning to release guidelines for fast-track approvals of biosimilars or biologics. Due to these developments, many local

BioAsia2016 - Event Report Book

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pharmaceutical companies are actively focussing on global and local biosimilar markets to leverage the significant potential. With regulatory approval pathways in Europe and the US becoming more transparent and streamlined, significant opportunity is opening up for the Indian companies in the space of biosimilars. Hence, the country could take proactive steps amid positive global and local regulatory developments.

Session Proceedings:

Dr. Jadhav spoke about the similarities in vaccines and biosmilars markets in order to highlight Indiaâ&#x20AC;&#x2122;s scope to replicate the success of vaccines in the biosimilar space. In the mid-1960s, there were no major companies manufacturing vaccines apart from 4-5 government-owned firms. Later, the private sector entered the market. Today, about 80 per cent of the products supplied to the UN agencies are manufactured by Indian companies. Biosimilarscould be leveraged the same way. He also highlighted that there are challenges for biosimilarsin terms of regulations and clinical trials in the country, but all stakeholders need to look at the significant export potential. The government could make a robust regulatory dossier so that exporters could comply with any regulators globally. Dr. Bhardwaj emphasised on simplifying regulatory approvals for biosmilars as India needs affordable drugs. Since new drugs are coming up mostly in the biological space and are very expensive, the country could benefit from simplified regulatory approvals mechanism, without sacrificing safety concerns. Approvals for known, well-acknowledged and specific biosimilars (like Diabetes) could be even fast-tracked. Dr. Dasika highlighted that biosimilars are complex and hard to make, and there is a lack of technology in demonstrating similarity between biologics and biosimilars. By demonstrating the quality of biosimilars, there is a chance of success for a company to pass through regulators based on rigorous science. The R&D activities in the last five years have increased in Indian companies, which impliesthat the Indian biopharma segment is evolving and could make its mark in the bisomilar space. The regulatory space for biosimilars in India is not as mature as it is in the generics space, but it is progressing in a rational manner and would require to prove its efficacy. Dr. Kundu spoke about the role of start-ups in research and innovation. Start-ups could first try to master simple steps and reproduce. For example, in the case of clone developments, they could focus on repetition and bring more innovation in the process. They could collaborate with large companies and research for being cost-effective through innovative measures. He also highlighted that the biosimilar segment in India is going to evolve and it would be similar for biologics. However, it is still a long way to go before biologics are launched because it would require a lot of investment.For immunogenic, an investment of few billion dollars is required, which is a significant sum in India. Dr. Makkapati explained two aspects of biosimilar market â&#x20AC;&#x201D; where to play and how to play. The five major markets for biosimilars currently include the EU, the US, Australia, Canada and Japan, but there is a high cost associated with them. On the other hand, Brazil, Russia, India, China and South Africa (BRICS) have a significant consumption potential, but due to the low disposable incomes returns are marginal.Other markets, such as Mexico, Indonesia, South Korea and Turkey, follow European Medicines Agency (EMA) guidelines and their

BioAsia2016 - Event Report Book

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regulatory environment has evolved to the levels of European and the US guidelines so companies could focus on quality to enter these markets. The best way to sail forward in the biosimilar market is to ensure that the regulatory advices are taken care of, because there is residual uncertainty in every biosimilar.

Recommendations:

•• Modifying regulations for approval of biosimilars to match the international quality and safety standards •• Simplified clinical trial regulations to develop biosimilars in India •• Focus on off-job or pre-job trainings along with on-job trainings to reduce the skill gaps for biosmilars •• Inculcate scientific culture in the education system to promote research and development activities.

Session Panelists

BioAsia2016 - Event Report Book

Conferences

Conference Sponsors

Supporting Organisation

TAB ESTD 2004 Reg.. No. 1303067

Context:

Rapid Diagnostics are a type of Point-of-Care (POC) diagnostics, referring to the ability to acquire clinical parameters where the patient is, thereby allowing faster results. Successful point-of-care testing has immense potential to reduce diagnostic and treatment delays, and impact patient outcomes. Rapid Diagnostics are particularly important in low-resource settings, where: • Harsh environmental conditions preclude the use of sensitive equipment • Technology, equipment, and training required for more complicated laboratory tests are lacking • Many patients cannot travel easily to the clinic to follow-up on results that take a long time While technological advances pertaining to POCT, in the last two decades, have been impressive, its relevance and success in developing countries needs to be reevaluated keeping in mind the dynamic and complex healthcare settings of these countries. The objective of the “Rapid Diagnostics Conference” of BioAsia 2016 was to highlight the current status and promising technologies in this area. The event brought together experts from diverse disciplines and backgrounds to highlight and deliberate on the points to be focused to make POCT more successful in the Indian context.

Introductory Remarks 11:00 - 11:05 Hrs Dr. Shanthi Naidu, Head, Laboratory Medicine, Care Hospitals (India) delivered the welcome address for the conference, highlighting the importance of Point-of-Care Testing (POCT) in health care today. She mentioned that India is still at a nascent stage in POC and there is an urgent need to get the protocol regimen of operations together for which the Laboratory / Hospital Information System should take the lead.

Lecture on Rapid Diagnosis of Tuberculosis: Where are we? 11:05 - 11:30 Hrs Prof. Sarman Singh, Head, Clinical Microbiology & Molecular Medicine, All India Institute of Medical Sciences (AIIMS), India, highlighted the prevalence of Tuberculosis (TB) as the number one killer disease among infectious diseases, in Asia and Africa, even today. He further informed about the various methods available for 40

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rapid diagnosis and detection of TB, including traditional ones like Smear Microscopy to more advanced Liquid Culture Systems, GeneXpert System etc., and few others currently in pipeline. He elaborated that there is an urgent need for development of bio-markers and also an ideal rapid test for detection of active TB cases.

Keynote Lecture on Point-of-Care Diagnostics: Current State-of-affairs, Limitations and Future 11:30 - 12:00 Hrs Dr. Deshratn Asthana, Associate Professor of Pathology & Director, Laboratory for Clinical and Biological Studies, Miller School of Medicine, Univ. of Miami, USA, spoke on how we can learn from the traditional laboratory settings and translate them into developing ‘Need-of-the-Hour’ elements in POC. He stressed upon that Point-of-Care has to focus on sensitivity, usability, efficiency, affordability and patient empowerment as key POC elements; and also the need for clinical need assessment, post-test counselling, waste management system etc. has to be thought of while designing a POC test. Another important observation made was regarding the importance of trained and skilled personnel, and not mere laboratory education, which is very imperative for the success of any POC setting.

Invited Lecture on Critical Care 12:00 - 12:30 Hrs Dr. Srinivas Samavedam, Director Critical Care, Century Hospital, India, presented a Clinician’s perspective of critical evaluation of POC testing. He stated that an early diagnosis in critical care is of utmost importance and POCT has the potential to greatly improve the turn around time and hence, shorten the patient’s stay in intensive care. It also minimizesthe burden on the central laboratory as well as ICUs; and provide better care to the needy patients by excluding the not-so-critical ones, resulting in optimal utilization of available resources. However, he highlighted the need for documentation and validation of these testing instruments against guidelines made using conventional laboratory techniques and legal validity of diagnostic decisions based on POCT alone.

BioAsia2016 - Event Report Book

Rapid Diagnostics Conference

Invited Lecture on Rapid Diagnostic Kits for Emerging Parasitic Diseases 12:30 - 13:00 Hrs Prof. M. Raman, Programme Head â&#x20AC;&#x201C; Vaccines, Translational Research Platform for Veterinary Biologicals (TRPVB), Tamil Nadu Veterinary and Animal Sciences University (TANUVAS), India, talked about the emerging parasitic diseases of zoonotic origin, affecting animals, directly, and humans, indirectly. He spoke about the common detection methods being used currently and how these are laborious and difficult to perform in a field/ farm set-up and hence a need for cost effective and quick diagnosis which saves time and labour. He opined that Rapid diagnostics is ideal for preliminary and emergency screening in tackling parasitic diseases and shared information about the latest rapid diagnostic tests developed by TRPVB.

Company Presentations 13:00 - 13:30 Hrs This was followed by presentations by Company Executives of Siemens Healthcare Diagnostics and Radiometer showcasing a range of rapid diagnostic products being offered by them.

Invited Lecture on QA and QC in POCT 14:30 - 15:00 Hrs Dr. A. S. Kanagasabapathy, Formerly Prof. Head of Clinical Biochemistry, CMC Vellore; Member of Clinical Chemistry Trainee Council Advisory Board of Clinical Chemistry of AACC (USA), discussed the importance of Quality Control and Quality Assurance in a POCT setup. He elaborated on the importance of effective quality management standards in place for POCT to provide value in general practice situations and harmonization of POCT instruments with the central laboratories. He also stressed on the need for adequate training and competency assessment for an effective Point-of-Care testing system.

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Invited Lecture on Affordable Diagnostics and Microfluidics 15:00 - 15:30 Hrs Dr. Amit Asthana, Principal Scientist and Ramalingaswami Fellow, Centre for Cellular and Molecular Biology, India, spoke about the various methods used for the fabrication of microfluidic devices. He made a special mention of Paper Microfluidic Devices and Micro & Nano Needles for vaccine delivery, which is an emerging area of interest in Rapid Daignostics.

Invited Lecture on Prognostic Markers and Possible Key Molecules in Diabetic Osteopathy 15:30 - 16:00 Hrs Prof. Andreas Nüssler, Professor of Trauma Research, Siegfried Weller Institute for Traumatology Research, University of Tuebingen, Tübingen (Germany), highlighted the correlation between Diabetes and demineralization of bones in the affected people, greatly increasing their risk of spontaneous bone fractures. He also talked about some genetic markers that can assist in ascertaining the extent of mineralization in these patients.

Panel Discussion on Practical Clinical Skill 16:30 - 17:35 Hrs Chairperson: • Dr. Shanthi Naidu, Head,Laboratory Medicine, Care Hospitals, India Panelists: • Dr. D. Suhasini, Senior Consultant and HOD, Department of Biochemistry & Therapeutic Drug Monitoring, Apollo Health City, Jubilee Hills, Hyderabad • Dr. Shyam Tapadia, Managing Director, Tapadia Diagnostic Centre A panel discussion on current status, acceptance and success of POCT in differenthealthcare settings like laboratory, hospital / clinic, home, rural and community set-up was chaired by Dr. Shanthi Naidu. She spoke about the increased usage of POCT in present times and also highlighted the challenges being faced. Although a variety of POCT devices are readily available and in use now-a-days, Dr. Naidu strongly recommended the need for education and awareness among patients and their care-givers for optimal storage and handling of these devices and timely testing and calibration in the central laboratory so as to ensure quantitative accuracy in the results

BioAsia2016 - Event Report Book

Rapid Diagnostics Conference

displayed. Dr. Tapadia supported Dr. Naiduâ&#x20AC;&#x2122;s view by recommending extensive training for usage and handling of POCT devices like Glucometers. The panel further elaborated on the sensitivity and monitoring issues related to other devices like Oral Anticoagulant Therapy Monitoring using PT/INR, since these are highly sensitive devices and it is slightly difficult to monitor them in a home set-up. Dr. Suhasini discussed about the auto-calibration feature available in most of the presentday devices but, nevertheless, stressed on the need for a frequent calibration with the central laboratory set-up. Dr. Tapadia further added that every cassette, cartridge or strip used in these POC devices should have an in-built control of a known value for any quantitative test, as sometimes the environmental conditions at the time of usage and intermittent handling & storage is improper, resulting in faulty values. Dr. Naidu also mentioned that the automation of equipment has brought down the level of technology in the laboratory and the quality of personnel handling them, as they lack the basic training and field experience required to perform efficiently. Dr. Tapadia and Dr. Asthana, based on their experiences of working in the under-developed healthcare settings, opined that POC investment is more relevant in areas which lack infrastructure and facilities to perform elaborate diagnostic tests. They added that the POCT in a rural set-up, within its limitations, would serve a greater purpose of screening for the basic tests.Taking a cue from the Australian POCT operational model, Dr. Suhasini stressed on the need for a creative PPP to make POCT more affordable and viable, specially for Indiaâ&#x20AC;&#x2122;s rural set-up. The success of the Australian model is majorly attributed to the training and involvement of local tribesmen and similar approach was suggested for India as well. Dr. Tapadia recommended that POC should be primarily used for screening purposes rather than as testing devices, in the Indian set-up. There is a need to develop a panel of tests for Indian population, keeping in mind their testing needs. He emphasized on microbiology as one potential area for POCT as the conventional methods are very time consuming and laborious. The discussion concluded that Point-of-Care is here to stay and we need to change our mind set and play our roles well, so that it can complement the present healthcare setup.

BioAsia2016 - Event Report Book

Rapid Diagnostics Conference

Recommendations:

• Training, skilled operations and competency, as in other fields of laboratory medicine, is of utmost importance in POCT also. • POCT has to be necessarily under the laboratory regimen of control, including quality control and the knowledge of technicality. External QC of the testing equipment is a challenge in India and needs to be studied, for inclusion in future. • Patient demographics is a key element in POCT development. Benefit and medical outcome has to be assessed either by manufacturer or person responsible for marketing the test device and the user information should be made available in layman’s language. • Validation of these instruments, specially in case of critically ill patients, must be done in comparison to guidelines made using conventional laboratory technology. • Since the turn-around time of POCT is significantly lower than central laboratory testing, judicious use of POCT can greatly reduce the emergency stay in a hospital set-up. • Some of the areas recommended for POCT intervention are bedside testing in coagulopathy and thrombocytopenia, preventing unnecessary transfusions, and microbiology for rural healthcare settings.

Participants during the Rapid Diagnostics Conference

BioAsia2016 - Event Report Book

Conferences

Conference Co-Organizer

Opening Remarks: 10:30 - 10:45 Hrs Ms. Jilmil Joshi, ACRO India Ms. Joshi welcomed the participants to the Clinical Research Conference on behalf of FABA and ACRO India.

Welcome Address: 10:45 - 11:15 Hrs Mr. Nageswara Rao, Head - Global Business Development (Clinical), Syngene International Ltd. Mr. Rao gave the welcome address and introduced ACRO’s recent developments and activities to the audience. He also mentioned about ACRO’s efforts in putting together a database of healthy volunteers with support of DCGI to avoid cross participation in the clinical trial studies which would be rolled out in April 2016.

Session Talk: Biosimilars - Make in India for Global Market 11:15 - 11:45 Hrs Dr. Pranjal Bordoloi, Assoc. VP – Medical Affairs & Pharmacovigilance, Veeda Clinical Research Dr. Bordoloi spoke about the Make in India campaign and how Biosimilars is placed in the initiative. He explained the definition of the biosimilar drug stating that it is a biotherapeutic similar to an already licensed biological product in terms of quality, efficacy & safety. The development of a biosimilar drug is slow and expensive and on average it is around USD 2 million to 100 million and for small generics it is USD 1 to 5 million. He spoke about the history of Biosimilars and mentioned that it started in India back in 2000 and first guideline for approvals and marketing in India were brought in 2012. He stated that no. of biologics approved by USFDA was 46

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around 226 till 2012-2013 and there has been a sharp increase in the same with 15 being monoclonal antibodies, showing an increased adoption of large molecules. Also, 7 of the top selling drugs in 2014 were biologicals and many of the patents for these blockbusters would be expiring in 2020 creating a huge market space for biosimilars. The share of biologics in pharma sales was 46 billion in 2002 and became 169 billion in 2012 and will become 17% of the market share by 2017 with revenue of 221 billion. He further stated that India is doing very well in generics with about USD 11 billion drug exports to the globe which is about 20% of the global market and India ranks 4th in drugs by volume. The biosimilar industry is growing at 30% currently in India. As on date, we have 22 market authorizations in EU, 8 active substances from 17 manufacturing companies and around 7 biosimilar under registrations. He also mentioned that Indian companies like Dr. Reddyâ&#x20AC;&#x2122;s, Intas Biopharma, Biocon, are producing biosimilars which are being registered in International Markets. Talking about the contribution to the Make in India campaign, he stated that starting with cloning and process development, India is strong with more than 15 years of experience and with huge talent pool of developing around 40 biosimilars, 24 of which are already in the market. However, currently most of clones are procured from outside. In preclinical area, we have good CROs across India working on biosimilar development; however primary studies are not allowed in India currently. Clinical studies in India are mostly conducted for domestic registrations and some healthy volunteer studies for US/EU registrations. Very few phase 3 biosimilar studies are happening in India. Also manufacturing and pharmacovigilance areas have a huge potential in India. India is thus, capable of replicating the huge success of the generics market in the biosimilars as well.

Session Talk: Regulatory pathway for Biosimilars in India compared to Global guidelines 12:15 - 13:30 Hrs Dr. Rajashree Devarakonda, Vice President, India & Asia Pacific, Voisin Consulting Life Sciences Dr. Devarakonda explained about Biologics & Biosimilars, how similar a biosimilar should be taking into account the drug efficacy and patient safety issues, importance of biosimilar guidelines, complexities of products and processes and challenges in development. She mentioned that unlike generics, biosimilars are not identical and manufactured differently and have different properties with regards to quality, purity, stability and immunogenicity making guidelines important. She also highlighted the opportunities in the biosimilar market as a lot of companies are looking at a semi regulated markets like India to reduce their R&D costs. She also explained about the steps involved in the biosimilar development and quality requirements. She briefed about the guidelines of US FDA, EMA and DCGI. She urged the industries, researchers to involve the regulators early on in the process so as to avoid issues and reinvestment in the later stages, have a good study design and programme development to ensure that hospitals & other end users are ready to buy in the product. BioAsia2016 - Event Report Book

Clinical research Conference

Session Talk: Pharmacovigilance in Biosimilars 14:30 -14:50 Hrs Dr. Shoba Rajagopal Krishnakumar, Head - PV & Medical Affairs, Norwich Clinical Services Dr. Rajagopal stated that despite the fact that biosimilar and reference drug can exhibit similar efficacy, biosimilar may exhibit different safety profile in terms of nature, seriousness or the incidence of adverse reactions making pharmacovigilance for biologics including biosimilars, pose additional challenges as compared to small molecules. She also stated that the regulatory requirements for pharmacovigilance of biosimilars is same as that of the reference product but with more stringent monitoring. She also spoke about the EMA guidelines, its requirements & risk minimization and management practices and safety monitoring. She concluded saying that pharmacovigilance is a very important tool to gain additional knowledge and collect safety data for biological and biosimilars due to limitations of randomized controlled clinical trials; the keywords are traceability, proactive risk management, immunogenicity and collaboration between companies.

Session Talk: Clinical trial requirements for Biosimilars 14:50 - 15:20 Hrs Dr. Charu Gautam, Associate Vice President, Global Clinical Operations, Cliantha Research Dr. Gautam explained that for a generic molecule, there is a need of the proof of quality with bioequivalence study with no substantial clinical data requirements, but for biosimilars we need to have a full dossier with pre-clinical requirements, robust comparability data, bioequivalence as well as a clinical trial study. She also spoke about the guidelines laid down by the USFDA and also by EMA. According to Indian guidelines, which are unique as they involve inputs from academia, regulators and industry, clinical trial requirements are a PKPD study, a safety efficacy study and an immunogenicity study. Very often, there has been an attempt to club these studies but this is an option particularly in cases where product is safe on healthy subjects/volunteers. She also spoke about the key challenges in the biosimilar clinical development that need to be avoided to reduce the risk of missing out on similarities with the reference product and support the marketing authorization. The challenges range from the extent of clinical data requirement, extent of clinical

BioAsia2016 - Event Report Book

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programme, reaching out to investigator site, getting healthy volunteers, challenges in logistics to challenges in handling PK sampling at site, etc.

Session Talk: Analytical challenges in Biosimilar projects; the technology and the know-how 15:20 - 15:45 Hrs Dr. Ranjan Chakrabarti, Vice President and Head â&#x20AC;&#x201C; Global Biologics Lab Operations, United States PharmacopeiaIndia Dr. Chakrabarti spoke about the public standards as they are critical for patient protection and consumer confidence. He said that itâ&#x20AC;&#x2122;s important that multiple manufacturer samples need to be tested before they come up with the standard and standardization need to focus on key potency and safety characteristics. He also said that compendial standards are not directly pertinent to ensure clinically meaningful difference between a proposed drug and an innovator product but it helps FDA to access similarity with respect to certain key quality attributes of the product. He also spoke about the analytical procedures and standards available for monoclonal antibodies which are available at USP. He concluded saying that public standards form an integral part of the multi-tiered safety net that assures access to high quality medicine and it supports and complement the regulatory assessment.

Participants during Clinical Research Conference

BioAsia2016 - Event Report Book

Conferences

Technology transforming Life Sciences 10:30 - 11:45 Hrs Panelists:

•• Mr. Michel Pettigrew, President and COO, Ferring Pharma, Switzerland •• Prof. Lee Cronin, FRSE, FRSC Regius Chair of Chemistry, School of Chemistry, University of Glasgow •• Mr. Subramanyam Guttina, Senior Lead Consultant, Watson Cognitive Computing for Healthcare and Life Sciences, IBM India •• Dr. Sai Praveen Haranath, American Board certified in internal medicine, Apollo Hospitals

Context:

When all major companies across different industries, globally, are vying to leverage technology and innovation to edge over their competitors, the life sciences sector is not far behind either. There is hype about how ‘Big Data’ could help in fast and efficient discovery of drugs, which otherwise could incur a development cost of about USD2.6 billion and require 10,000 drug candidates, according to an industry report, for testing a single drug successfully. The large sizes of clinical trials and higher failure rates for drugs in proving their superiority have led companies ponder the use of big data analytics to expedite the drug discovery process. Technology advancements such as 3D printing technology could contribute to manufacturing drugs, medical equipment and prostheses. Further, 3D printing could play a vital role in regenerative medicine to create synthetic skin, blood vessels, etc. The next big thing in the life sciences sector is not going to be a new drug or a new operation, etc. The next big thing is expected to be information technology that could change the way life sciences is delivered. Tech giants have realised this potential, and are re-organising their strategies and structure to make healthcare and life sciences an epitome of their future growth.

Session Proceedings:

Mr. Pettigrew was of the view that earlier patients used to rely on doctors for their clinical health information. However, now patients are taking control and evaluating data for their diseases. They are monitoring their own health and investigating treatment options. Technology is impacting the healthcare sector as about 85 per cent of patients are using mobile technology and 67 per cent physicians are using mobile technology to gain knowledge, connect with peers and exchange scientific documents. 50

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He highlighted that IT companies such as Google and Apple are collecting healthcare data. This implies that they would have an important role in healthcare in the near future. He also highlighted that technology is impacting life sciences companies through areas, such as data intelligence, crowd sourcing for trials, digitalised clinical studies, life cycle management, patients and healthcare professionals (HCP) engagement, improved risk management and health economic analysis. Another important area has been identified as wearable tech, which would impact lives significantly. As a result of new technologies discussed above, patients are becoming proactive in identifying their healthcare concerns in detail. Digital revolution, hence, is expected to revolutionise the pharma industry and the healthcare sector.

Prof. Cronin spoke about â&#x20AC;&#x2DC;Chemputerâ&#x20AC;&#x2122; that would also robotic chemical synthesis and print out any drug. The idea is to make a device that can print drugs just the way 3D printer technology creates an object. The device could be connected with a drug discovery search engine to have downloadable drugs. A universal ink could be used to print drugs and then patients could have their own medicines. Patients simply have to download a software and then go ahead to print the specific drug that they need.

Mr. Guttina enlightened the listeners about IBM Watson cognitive computing. IBM Watson is a cognitive technology platform that uses natural language processing and machine learning to reveal insights from a large amount of unstructured data. It is helping doctors in the oncology segment. The industry has a dearth of biomarkers, hence the software would be beneficial in giving suggestions based on the scientific data published. However, the final decision would lie with oncologists. The software has also the ability to suggest for clinical trial requirements. In India, only 55 oncology doctors graduate each year, however over one million cancer patients are added every year. Cognitive computing could help doctors in treating such a significant number of patients, as doctors sitting in the main centre could treat patients remotely.

BioAsia2016 - Event Report Book

digital health & healthcare IT Conference

Dr. Haranath said that technology is transforming life sciences and it also has the ability to modify the future of critical care. Minimal invasive therapies and nanotechnology are the themes of the future. Rapid innovation would derive critical care to a new level, where the future critical care team would consist of doctors and technology. Approximately 70,000 ICU beds are present in India and 80 per cent of these are in the private sector; technology would play an important role in increasing the access to healthcare. In rapid diagnostics, the technology adoption is slow but it is expected to change. Technology could also help in increasing accessibility. For example, Apollo has e-access and tele-ICU that doctors use to take care of patients remotely. Innovation is taking place in the Indian healthcare sector and rural India would benefit first, however, other parts of the world would also see the impact.

Recommendations:

•• Life Sciences companies need to adopt a digital approach to connect with patients. This could help in reaching out to more people with new drug therapies, as patients are constantly searching for better outcomes. •• Technology has the ability to help doctors in making evidence-based diagnosis and could take more informed treatment decisions. •• Critical care could be delivered at remote locations with the help of tele-ICU and telemedicines. •• Technology could be adopted to help increase access to medicines and deliver personalised treatment options to many patients.

Participants interacting with the panelists

BioAsia2016 - Event Report Book

digital health & healthcare IT Conference

Reimagining healthcare — The millennial perspective 12:00 - 13:15 Hrs

Panelists:

•• Mr. Jeyaseelan Jeyaraj, Director Oracle Health Sciences, Asia Pacific Oracle Corporation •• Mr. Odd Arild Lehne, Senior Vice President — International Operations, Oslo Medtech and Managing Director — PubGene AS, Norway •• Dr. Satish Prasad Rath, Chief Innovation Manager, Xerox Innovation Group •• Mr. Rahul Mullick, Head — ICT & Supply Chain, Bill and Melinda Gates Foundation, India •• Mr. Bhuvaneashwar Subramanian, Market Intelligence Manager & SME, Healthcare & Life Sciences, Marketing Strategy, Hewlett Packard

Moderator:

•• Mr. Aditya Rath, Partner, KPMG in India

Session Proceedings:

Mr. Subramanian said that the fundamental change in the healthcare sector is the point of care delivery shifting toward homes from hospitals. The delivery of care needs to focus more on patients’ engagements to achieve better outcomes. Hewlett Packard (HP) has taken an initiative to establish cloud-based ‘e-health center’ to provide affordable primary health services. One of the key challenges in India is to provide good quality care at a sustainable cost. HP has converted shipping care containers to primary care centres. Data is transferred to cloud to enable doctors in cities to provide teleconsultation services. Mr. Mullick spoke about the role of technology in improving healthcare delivery. Technology could play a big role in reducing the number of deaths due to child birth. Death due to child birth is primarily attributed to three main factors — low BP, low hemoglobin count and low blood sugar. Technology could help track these factors and suggest corrective measures accurately.

BioAsia2016 - Event Report Book

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The delivery infrastructure is lacking in the country and regardless of digitalisation, it is important to have a strong delivery infrastructure. The country also need to focus on preventive healthcare. The government has developed an app ‘Kilkari’ for mother and infant care. The low weight birth of baby could be monitored and tracked by technology to save a lot of lives. Dr. Rath was of the view that the country is moving from analogue to digital era, and this would give much more scientific data to analyse, helping in taking more precise decisions. One single solution would not work as a remedy for all challenges. There is a need to go for personalised medicines. The society is moving toward chronic diseases and continuous recording of data could help proper management of these diseases. If applied in the right area and at the right time, then technology and smartphones, together, could change the way healthcare is delivered. He highlighted that tele-medicine has evolved in the country, but the industry still do not have medical grade sensors to diagnose diseases. About 80 per cent health burden is for curing and monitoring chronic diseases. The country needs to focus on preventive care to reduce chronic diseases burden. Mr. Lehne was of the view that by 2040, the countries need to increase healthcare resources by 40 per cent, and something needs to be changed to lower this requirement. The chronic diseases burden is increasing e.g., chronic obstructive pulmonary disease (COPD) patients tend to believe they are more sick. So a computer tablet answering simple questions could help reduce the burden. There is a significant gap between the kind of service that the government is providing and the kind of service expectation patients have. Technology could be the solution to bridge this gap. Mr. Jeyaraj highlighted that in the past, medicines offered were based on doctors’ wisdom, but now the approach is changing toward evidence-based solutions. In 2016, the entire DNA sequence could now be done in USD1,000. The country needs to maintain health record of every patient, and digital health could change the healthcare landscape significantly. The government has been spending a lot of money for different programmes — 22 national and state level programmes to be precise, however, they are not inter-connected. Here, too, technology could play an important role to improve efficiency for delivering the results of the programmes.

Recommendations:

•• There is a need to record and analyse data from chronic disease patients in order to reduce the hospitalisation rate and burden of healthcare expenses. •• The healthcare delivery infrastructure needs to come first before digitalization, as the country’s healthcare infrastructure is below global standards. •• It is vital to develop medical grade sensors to accurately record healthcare data from wearable devices. This could help in taking more concrete steps toward preventive healthcare.

BioAsia2016 - Event Report Book

digital health & healthcare IT Conference

New wave of digitisation: Doorstep to boardroom 14:15 - 15:30 Hrs

Panelists:

•• Mr. Gopal Devanahalli, COO, Manipal Health Enterprise •• Mr. Kumar KV, Vice President – IT, Narayana Health •• Mr. Prashant Gupta, Head, Cloud, Microsoft India •• Dr. Ruchi Dass, MD, Health Cursor Consulting •• Mr. Abhishek Pramod Kumar, IAS, Technical Advisor to Hon’ble Minister of IT, Government of Telangana •• Mr. Gaurav Maini, Managing Director, Vital Health Software

Moderator:

•• Dr. Anthony Vipin Das, Team Principal & Chief Architect of eyeSmart EMR, LV Prasad Eye Institute

Session Proceedings:

Mr. Devanahalli spoke about the steps taken by the Manipal hospital group to adopt technology and increase patient experience — •• Adopting technology beneficial to both patients and doctors; recently launched a mobile app to allow patients to check their clinical records •• Adoption of technology in clinical research; joined hands with IBM for WATSON for the technology that oncology doctors could use. Further, teamed up with Masimo to monitor patients on continuous basis •• Adopting internet for a combination of internet, and bricks and mortar model. •• The hospital has rolled out EMR data last year and is trying for the past one year for the doctors to use this data. Mr. Kumar emphasised that digital is definitely a reality and hospitals are experiencing a wave of IT adoption and integration. The next wave would be to connect hospitals with patients. A unified messaging app has been launched in Narayana Health for this purpose. BioAsia2016 - Event Report Book

digital health & healthcare IT Conference

He also added that there is a lot of structured and unstructured data, and the healthcare sector needs to take some steps for data consolidation. The time has come to create a community cloud and healthcare providers could lead from the front. Dr. Dass said that data has become a reason to make more predictable solutions in healthcare. As patients have also started adopting mobile health, more data would be generated. The country could analyse this data to focus on preventive care. She also added that there is no concept of accountable healthcare in India. Moreover, there is no incentive for doctors to adopt EMR. The hospitals are also adopting it on a voluntary basis and it is not yet mandatory. Mr. Maini highlighted that the younger doctors are increasingly using more technology to connect with their patients. The technology could help in quickly addressing patients queries e.g., ‘Mera doctor’ — a technology platform to meet doctors — that would be used to do virtual counselling and solve patients’ queries. Vital Health has done a pilot with Karnataka Government in which they have provided cheap tablets to record data and hence, are doing away with stacks of register to maintain data. After this, the government can do an analysis to address patients’ needs more efficiently. Mr. Gupta highlighted that mobile and cloud are changing the healthcare paradigm. Microsoft has three data centres in India, and when there is a large data to be handled, one has to think differently. About 290 million people are suffering from blindness in the world and 54 million of them are in India; technology can be used to specifically identify and solve this challenge. Mr. Pramod Kumar highlighted that the country needs to have digitisation in healthcare as digital data can help reduce the treatment costs. The country also needs to make a provision that electronic health records are transferred to other stakeholders. Data could also be used in forecasting diseases, as all medical institutes carry out geographical analysis and the government could use the data to take corrective and preventive steps. The country needs to make a consortium of health records. If that kind of an initiative is taken by different hospitals, patient’ treatments could be addressed in a better manner.

Recommendations:

•• Adoption of technology to help in connecting patients with doctors; mobile apps could be highly effective for healthcare communication, as it would allow patients to stay in touch with doctors •• India needs to record healthcare data in a streamlined way for due analyses, and to develop more predictable solutions •• EMR adoption could give a unified and comprehensive data to doctors as well as patients. This would help track data over time to improve patients’ health safety.

BioAsia2016 - Event Report Book

Conferences

Conference Co-Organizer BioAsia 2016

MEDICAL DEVICES Conference

February 10, 2016 | HICC, Hyderabad, India

Recalibrating strategy — what companies are doing differently? 10:30 - 11:45 Hrs

Panelists:

•• Ms. Shikha Maheshwari, Associate Director, Abbott, India •• Mr. Prabal Chakraborty, VP and MD, Boston Scientific, India •• Mr. Umesh Uday Shankar, Business-Head sales, Healthware •• Dr. Jaishree Kasliwal, CEO, Quality Council of India

Moderator:

•• Mr. KV Ramanand, Partner, KPMG in India

Context:

According to an industry report, the global medical device market, whichis valued at USD228 billion and is expected to grow at a CAGR of 4.1 per cent annually to reach up to USD477 billion by 2020, has been caught in a perfect storm driven by the consumer shifting to a value-based model, whereby the products with optimum efficacy with competitive costs seize higher sales. Physicians are no longer the decision makers, and the shifting of power into the hands of payers and hospital administrators is forcing large medtech players to bring down cost of devices, which were previously priced at a premium level. In India, a lack of clear regulation to monitor all the stages of lifecycle of a medical device hampers the growth of the industry. Moreover, the absence of an autonomous government body to look after the medical device sector also adds up to the challenges faced by the sector. Moreover, a task force in India has recommended a separate price control order for

BioAsia2016 - Event Report Book

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medical devices. The medical device companies, in future, would need to come up with holistic strategies across all levels of healthcare delivery to attain sustainability.

Session Proceedings:

Mr. Shankar spoke that international companies in India are focused on manufacturing lowcost models.The country is used as a market for local consumption and not for high-quality R&D since the ecosystem is not conducive. Indian companies donot have enough profit margins. If, say, a US company earns a profit of USD100, then in India it would be USD 50-60. Therefore, profitability is an issue in India. Dr. Kasliwal touched upon the challenges of quality standards in India for medical devices. As such there are no Indian standards for medical devices. The country only has ISO 9000 and ISO 13485, which are generic in nature and do not adequate for the Indian medical device market. Moreover, the country does not have independent and fully equipped labs to test the quality of medical devices. The government is taking a few steps to streamline the quality standards and establish medical device testing laboratories. Mr. Chakraborty applauded the government for distinguishing medical devices from drugs. The National Medical Device draft bill is awaiting approval in the RajyaSabha. But, there is a requirement of a separate body for medical devices. There is a shortage of regulatory staff and the central government is trying to recruit over 3,000 staff in its regulatory bodies. The government could also focus on the training requirement for new recruitments. He also emphasised on creating awareness for medical devices in the country. The awareness would create a big market size in India, which would then be seen as a lucrative proposition for the companies to come to India and start their manufacturing arms. The global companies are now moving their R&D centres from the US and Europe to Bengaluru. Hence, the country could incentivise R&D efforts in medical device space. Ms. Maheshwari analysed that India needs to invest more to acquire the expertise required for manufacturing medical devices. The country could conduct large-scale clinical trials and bring in adopt newer technology usage to enable this. She said technology and IT would help reaching the patients, create awareness and create an environment which is faster and better.Further, this would release the burden of patient monitoring. With the advent of 3D modelling, lowering the cost of manufacturing medical devices has become a possibility.

Recommendations:

•• Implementing the National Medical Policy bill to streamline regulations could boost medical device sector •• The government could establish a separate regulatory approval process for medical devices at par with the pharmaceutical sector •• Establishing a fully equipped medical device testing lab by all stakeholders concerned to ensure quality •• Creating awareness for medical devices in the country by all stakeholders to increase the current market size •• India could invest more in R&D activities to help create and manufacture high-end medical devices.

BioAsia2016 - Event Report Book

medical devices Conference

Developing countries and need for affordable medical devices 12:00 - 13:15 Hrs

Panelists:

•• Mr. Mohit Malhotra, Managing Director, Stryker •• Dr. Anurag Asthana, Site Director, Medtronic Engineering & Innovation Center

Moderator:

•• Mr. Surajit Banerjee, Director, Strategy, KPMG in India

Context:

Affordable healthcare is anessential global need, as about 700 million people are expected to be living below the poverty line as of 2015 according to an industry report. Affordability is a key factor in developing countries to determine whether healthcare solutions are reaching out to the masses. India with a billion-plus people hasa divergent genetic make-up, wherethe basic healthcare remains out of reach for a majority of its population. Nowadays, medical device companies are realising commercial potential in ‘frugal innovation’. Companies are designing products that are affordable and more adopted to the emerging country environment. Affordable medical devices could improve health outcomes and the quality of life. Affordability is becoming an important factor for a country similar to India. A Rangarajancommittee report released in 2014 had indicated that 29.6 per cent (363 million) people of India was poor in 2011-12. Further, addressing the disparities in accessing medical devices is a challenging task, as it requires enhancing regulatory, and developing innovative technologies, management and procurement assessment systems. India has the potential to become a leading manufacturer for affordable medical devices. The driving factors behind India’s innovation in medical device industry are the availability of talent pool, growing domestic and export demand, and disruptive impact by reduction in costs.

Session Proceedings:

Dr. Asthana spoke about patient needs in the emerging and developed markets for medical devices. The needs are same for both the markets, barring the only difference is the access to healthcare services. The awareness is low in developing market for medical devices. The government and industry would have to work together to increase awareness. If access and awareness are improved, affordability would follow based on economies of BioAsia2016 - Event Report Book

medical devices Conference

scale. Affordability could also be achieved if the industry comes up with products which are reusable, instead of being disposable to lower the costs. Cost per procedure could be decreased if such technologiesare adopted, e.g.,lowering the cost of products in surgeries by tailoring it to specific needs without compromising on the standard of care. Further, in the last 4-5 years, there has been a lot of data gathering with the advent of Internet of Things (IoT) and Big Data. IoT is quite applicable to the medical devices segment both for implanted and un-implanted devices. Technology could be used to know the effectiveness of devices, whether it is fulfilling its obligations or not. If data is gathered to analyse this, there is a possibility of significant improvement in the outcome. It would be helpful in getting better products based on custom needs. Similarly, it would also help the insurance companies in gauging the risks. Therefore, medical devices could help capture and correlate data for a better outcome. He also said that India has good capabilities in terms of R&D and abundancein talent favours the proposition. The positive factorscould provide unique solutions and scale up these solutions to sell elsewhere. One of the major differences is that healthcare costs do not pinch the pockets of developed markets, but in India these costs damage the budget of families. Mr. Malhotra spoke about the accessibility of medical devices in developing market. Rural population is approximately 700 million in India. There is a need to develop access, create an ecosystem, which in turn would help in affordability of healthcare. The government couldhelp form policies, encompassing end-to-end processes. Access to healthcare would increase both in terms of quantity and quality, if policies are formed on these lines. The country needs to focus on ‘Make in India’ for this segment, but it is a long journey, and a long process. With regard to the regulatory framework, Drugs and Cosmetics Act came into enforcement in 1945. This Act was amended a bit later to include medical devices as well. However, we need a separate regulatory body for medical devices as it does not come under drugs or cosmetics. Our industry could play a role in working with the government to come up with a solution for the future. He also emphasised that the needs of a large company and start-ups could be matched to produce better results. Large firms could provide market and access options, while the start-ups focus on innovating for the local needs. The country also needs to focus on strengthening IP, as itcould provide freedom to MNCs to generate and increase margins, not monopolise.

Recommendations: •• The country could establish a separate regulatory body for medical devices. The regulatory body needs to interact with industry on a regular basis to come up with better solutions. •• The government and industry needs to work together to increase patient awareness for medical device segment, as this could help curing many diseases. •• The government needs to facilitate medical device sector in terms of incentives, tax-sops, export benefits, etc. These steps could facilitate ‘Make in India’ initiative to develop lowcost medical devices in the country. •• Adequate training provisions could be implemented in educational curriculum so as to evolve trained medical engineers that are fit for medical device industry. •• Strengthening of IP environment is required in the country so as to protect technology in the medical device sector. 60

BioAsia2016 - Event Report Book

medical devices Conference

A patient centric approach - Convergence of Medtech, Diagnostic companies, healthcare providers 14:15 - 15:30 Hrs

Speakers:

•• Dr. Om Manchanda, CEO, Dr Lals Pathlabs •• Mr. Bejon Kumar Misra, International Consumer Policy Expert, Partnership for Safe Medicines •• Mr. Rajesh Dhalal, Venture Partner and Advisor, Johnson & Johnson •• Mr. Ashish Gawade, Co-founder, Jeevtronics

Moderator:

•• Dr. Seemant Jauhari, CEO, Research and Innovations, Apollo Hospitals

Context:

To improve the healthcare systems globally, the innovative thoughts could be aligned to improve access, quality and cost, and more specifically, their adoption. The healthcare system in most developing nations, including India, revolves around physician‒dependent decisions. The increasing pressure from payers, regulators, more informed and cautious consumers for affordable improved quality healthcare is shifting the paradigm from ‘clinicalcentric’ to ‘patient-centric’ care. Physicians are encouraging patients to remain engaged throughout their care and live a healthy lifestyle with the aid of technology. In the era of personalised medicines, consumers are increasingly using web, connected devices and innovative health information technologies. These help themin self-monitoring, facilitating interactions and exchanging information with doctors, and supporting treatment adherence where convergence is appearing as a holistic andan affordable healthcare solution at a lesser cost. Sooner than later, ‘patient-centric healthcare’ approach is expected to shape the driver of healthcare industry, where quality and affordability of care remain fundamental. Following this approach, every part of the healthcare delivery system would benefit, which is driven by market forces and societal desires to access improved healthcare services, with reduced costs. Coherence between the three pillars of medtech, diagnostic companies and BioAsia2016 - Event Report Book

medical devices Conference

healthcare providers seems to be the answer to bring about enhanced healthcare services to patients across geographies.

Session Proceedings:

Dr. Manchanda spoke about patient centricity for pathology labs. Owing to patient centricity, pathology labs have become more accessible now. Earlier, a lab was, say about 30-40km away from patients. Now, with the advent of technology, the collection has even reached patients’ homes. Similarly, the result reports could be collected digitally, by downloading from the internet. The outcome of all this activity has allowed a customer to book a test online and get the sample collected by labs’ representatives from their homes. He also spoke about upcoming trends in diagnostics in the next 5-10 years. Earlier, customers used to visit a physician whenever they observed any irregular symptoms. This has changed in recent times, when customers visit to check if they are fine or not. In future, even this would change, where a customer would know if he/she is fine but would want to check whether he/she is likely or prone to get affected by any problem or disease. For chronic diseases — where one needs to manage the optimum levels of hormones on a regular basis through drugs and medicines — owing to patient centricity, the digital revolution would enable the devices to suggest and guide patients on dosage and frequency of drugs to be taken. Mr. Dhalal emphasised on the need to develop local affordable products to meet the demand. Presently, there is a need for local products, which could satisfy the local needs of the market. For example, in case of blood group monitoring, the requirement in India is for simple products with basic functionality of switch on and switch off. The cost of the instrument is also a major concern for the Indian population, and developing such products is a challenge for companies. He also said that there would be a lot of convergence between patient and technology in next 10 years. The patient would be able to carry out the diagnostics himself and treatments would be based on data provided/shared through internet or to online doctors.The situation would be a utopia, where patient would know everything because of data analytics. Mr. Gawade told that the future holds promise for new devices to come-up, making life more convenient. Students from smaller towns would become physicians. ICUs are expected to be created in smaller towns and medical facilities would be available at the district level — including advancement in ambulance equipment and feature installations. Many provisions would be available quickly for disaster relief and emergency situations. For devices, services and maintenance are important. With IoT, manufacturers and dealers could remote-monitor the product and carry out some minor fixes, especially helpful for those operating in the hinterland. Mr. Misra spoke about the growing customer focus on quality. The customer now asks to show evidence of quality provided. It must be determined that the safety of the patient and the quality standards are not compromised.Everyone demands to follow international standards, but healthcare practitioners need to check whether global standards are relevant and applicable in India. Companies are becoming more focussed toward patient centricity, capturing feedback from users to improve quality. He also empahsised that a neutral and more credible organisations would emerge in future, on which patients would depend for taking informed decisions. There is a need of strong regulatory framework, as the law enforcement mechanism is in a challenged state currently. Voluntary and self-regulatory reforms are needed which could be achieved with doctors and

BioAsia2016 - Event Report Book

medical devices Conference

top scientists coming together, and deliberating. The industry could be encouraged to give the best and regulate on its own, such that the quality and standards are not compromised. Dr. Jauhari said that the country needsenablers to translate ideas into products. With the advancement of technology there would also be advancement in terms of logistics to supply diagnostics and collect samples.

Recommendations:

•• The adoption of technology could help connect with patients holistically and also empower them to manage on their own in some cases. •• Medical device companies needs to adopt a customised approach for Indian population to provide customer centric products. •• The convergence of diagnostic device, medtech and healthcare providers could provide more predictability for diseases and help in preventive care. •• Voluntary and self-regulatory reforms are needed so that patients could establish a strong relationship of trust with diagnostic, medtech and healthcare providers. •• All stakeholders need to create and support a patient-centered culture in which patients’ preferences, values and needs are recognised.

Participants during the panel discussion

BioAsia2016 - Event Report Book

Conferences

Conference Co-Organizer

Context:

As per a WHO report, Cardiovascular Diseases (CVDs), the leading cause of premature death, including heart attacks, strokes and other circulatory diseases, would be the largest cause of death and disability in India by 2020 and accounting for 35.9% deaths by 2030. With this in mind, the Health and Access conference was organized as an educational initiative towards achieving the Sustainable Development Goals to reduce burden of CVDs and discuss effective innovative solutions for prevention, diagnostics and cure. The event brought together stakeholders to ensure a strong focus on health, NCDs, and the other areas critical to the global prevention and control of CVDs and stroke. It is only through these efforts that human development will be realized and sustainable.

Session Proceedings: Invited Lecture: Burden and causes of Cardiovascular Diseases (CVDs) in India 10:45 - 11:45 Hrs Prof. D. Prabhakaran, Vice President- Research and Policy, PHFI and Executive Director, Centre for Chronic Disease Control (CCDC) Prof. Prabhakaran in his presentation gave an introductory talk about PHFI and its work in the arena of public health education, research and training. He enlightened the audience about the burden and causes of cardiovascular diseases (CVDs) in India and as well as the various research activities of Centre for Chronic Conditions and Injuries (CCCI) in NCDs. He discussed about technology supported, task-shifting based, chronic disease management across the spectrum of health care and elucidated about various CCCI studies such as the SIMCARD study on Hypertension, mPower Heart Project on Hypertension and Diabetes, CARRS-Trial on Diabetes, YogaCare Trial; mWellcare project: an innovative m-health software application ( for Integration of Chronic Care) and UDAY project.

BioAsia2016 - Event Report Book

health & access Conference

Invited Lecture: Translational Research to Improve Outcomes - Exemplar of Community Based Diabetes and Hypertension Prevention and Control in India 12:00 - 12:45 Hrs Dr. Sailesh Mohan, Senior Research Scientist and Associate Professor, PHFI Dr. Mohan in his presentation described the rationale for addressing the increasing burden of chronic conditions in India and shared select exemplars of translational research leveraging community based approaches. He said that translational research transforms currently available knowledge into useful measures for everyday clinical and public health practice. He mentioned about the various current national responses vis-Ă -vis policies and programs in India to advance NCD control and emphasised the need for exploring alternatives to improve NCD prevention and control. As an exemplar exploring such alternative strategies, he discussed about the UDAY project which aims to implement and evaluate multicomponent, multi-level, interventions to prevent, detect, reduce the risk of diabetes and hypertension and to improve management.

Invited Lecture: Human Resource Development for Chronic Conditions Management and Research 12:45 - 13:15 Hrs Dr. Sandeep Bhalla, Program Director Training â&#x20AC;&#x201C; Centre for Chronic Conditions and Injuries (CCCI), PHFI Dr. Bhalla discussed about the Human Resource Development for Chronic Conditions Management and Research. He explained that the training division of CCCI, at PHFI is extensively working on capacity building of Primary Care Physicians (PCPs) in management of NCDs through various certificate courses which got global recognitions and have already trained over 13000 doctors. Currently 5000 doctors are enrolled in various courses. He described the training model and the roles and responsibilities of various stakeholders of the certificate courses. He said that the training model of PHFI was widely accepted by the medical practitioners as well as by the state governments for the training of their medical officers. The courses are also recognized by many international bodies like International Diabetes Federation (IDF) and South Asian Federation of Endocrine Society (SAFES).

BioAsia2016 - Event Report Book

health & access Conference

Invited Lecture: Diagnostics in CVD 14:15 - 15:30 Hrs Dr. Rakesh Sahay, Professor of Endocrinology, Osmania Medical College & Consultant Endocrinologist & Diabetologist, Mediciti Hospital, Hyderabad, Secretary, Endocrine Society of India, Secretary, Chairman, AP Chapter of RSSDI Dr. Sahay discussed about the role of point of care devices in screening and diagnosis. He mentioned about the EDSS in management of CVDs and task shifting and centralized screening tests (SMBG, Ambulatory Blood Pressure Monitoring and other similar tests). In his presentation he focused on the newer technologies in the management of CVD risk factors.

Recommendations:

•• The development and evaluation of innovative, community based sustainable approaches for prevention and control is required. •• Task sharing leveraging innovations can potentially contribute to improvements in prevention and control. •• Ongoing well characterised cohorts can provide platforms to embed new research and address priority questions for advancing prevention and control. •• Training of Primary Care Physicians can help meet the challenges of effectively managing NCDs •• Involvement of state government for training of Medical Officers in NCD Management. •• EDSS in management of CVDs is required

Participants during the Health & Access Conference

BioAsia2016 - Event Report Book

Satellite Events

BioAsia2016 - Event Report Book

Satellite Events

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 life sciences market at the event. During 2 days of networking, 1006 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.

B2B Meetings during BioAsia 2016

BioAsia2016 - Event Report Book

Satellite Events

Pharmexcil’s International Buyer - Seller Meet Pharmexcil, with the support of Ministry of Commerce and Industry, Govt. of India,successfully hosted technical seminars & one to one meetings with regulators and procurement agencies from 11 countries – 21 delegates. BioBazar - One to One Meetings with Regulators and Procurement Agencies (Buyer-Seller Meet):Pharmexcil had invited 21 overseas delegates including regulatory officials and procurement agencies from various countries (Cambodia, Egypt, Ghana, Iran, Mozambique, Myanmar, Namibia, Nigeria, Philippines, UAE and Uganda). The meet was scheduled in three different tracks, namely, •• One to one meeting, with regulators of various countries, on biological products •• One to one meeting, with procurement agencies, on biological products and pharmaceuticals by various government organizations. •• One to one meeting with biopharmaceuticals and medical device suppliers. Technical Seminars:The technical seminars were also scheduled in three different tracks, namely, •• Regulatory requirement for approval of biological products of various countries. •• Procurement mechanism of biological products and pharmaceuticals by various government organizations. •• Recent updates on bio-pharmaceuticals and medical devices of various countries. All together in the above meetings, 50 Indian registered delegates from 40 companies participated to establish their business relationship with global counterparts. The event helped a lot of registered Indian companies to forge new business partnerships. During the meet, it was established that pharma companies are required to obtain product registrations in the importing countries and due to formal protocol,the export of products might also get delayed.

Organised by:

BioAsia2016 - Event Report Book

Satellite Events

Start-up Showcase Government of India has envisaged a Digital India and has been working towards the use of technological interventions to improve healthcare. With about 500 start-ups as on date in the healthcare space and the announcement of Start-Up India initiative, India is all set to capitalize on the next big global opportunity in healthcare. With a spotlight on “Digital Health and mHealth”, the Startup Showcase brought together leaders from life sciences, healthcare, medtech, IT, incubator and startup community from over 50 Countries under the same platform to systematically facilitate cross pollination of ideas.

Opening Keynote by Mr. Jay Krishnan, CEO, T-Hub

Session moderated by Mr. Ramesh Loganathan, President HYSEA & VP (Products) & Centre Head, Progress Software India

37 start-ups featured in BioAsia 2016, representing countries like India, Singapore and Sri Lanka, adding an international flavour to the start-up showcase. The following 5 start ups were selected by the jury for the start-up pitching session and were awarded citation titled -

BioAsia’s Top 5 Promising Health Start-ups to lookout for in 2016

BookMeds

Centre for Technology Assisted Reconstructive Surgery (CTARS) 70

BioAsia2016 - Event Report Book

OurHealthMate

Axio Biosolutions

Call Ambulance

Satellite Events

Participants during the Startup Session

Start-up Showcase Participants

Startup Showcase Partner:

Startup Showcase Powered by:

Supporting Organisations:

BioAsia2016 - Event Report Book

Satellite Events

International Tradeshow With a special focus on Medical Devices, Diagnostics, Scientific & Analytical Equipments, the International Tradeshow at BioAsia 2016 attracted about 80 companies and 37 start-ups from across the globe. The exhibitorsâ&#x20AC;&#x2122; participation included Country Booth from Norway, Government Bodies such as TSIIC, Government of Telangana, Dept. of Biotechnology, Govt. of India; Academic Organizations like PHFI, NIPER-Hyderabad, CKMNT, BCIL, ICMR-NCCS, DSIR-CCMB-CRTDH; MNCs and Domestic Companies like Aurobindo Pharma Ltd., Lambda Therapeutics Pvt. Ltd., Siemens Healthcare, Jubilant Lifesciences, GVK Biosciences Private Limited, MINITABQSUTRA, Natco Pharmaceuticals, Bio-Rad Labs., Cleanrooms Containments, Premas Biotech Ltd., Radiometer, Shantha Biotech Pvt. Ltd., Shree Biocare India, Vins Bioproducts Ltd.; Startups like Ameya Life, Axio Biosolutions, BookMeds, Call Ambulance, CTARS, ConnViva Technologies Pvt. Ltd., Cyclops Medtech, Medical U I, OurHealthMate, PSPR 3D Tech and Industrial Parks like ICICI Knowledge Park etc. Around 500 visitors participated in the tradeshow during the event.

BioAsia2016 - Event Report Book

Satellite Events

BioAsia2016 - Event Report Book

Satellite Events

Bio-Park Visit BioAsia 2016 featured an exclusive guided visit to the Genome Valley - Indiaâ&#x20AC;&#x2122;s first systematically created life science cluster and the largest concentration of multi-tenanted lab space infrastructure in an organized cluster. About 200 delegates visited various clusters like Genome Valley, (which entailed tours to the Genome Valley industries, innovation corridors and premier institutions within the cluster), Apollo Health City, amongst others.

BioAsia2016 - Event Report Book

Satellite Events

International Interactions BioAsia AMCHAM MedTech Breakfast

A breakfast roundtable meeting of the AMCHAM Medical Devices Committee members was organized on 10th February during BioAsia 2016 in Hyderabad. The meeting was Chaired by Shri. Arvind Kumar IAS, Principal Secretary (FAC), Government of Telangana and Mr. Prabal Chakraborty, Chairman, AMCHAM Medical Devices committee led the discussions from AMCHAM side. The meeting was well attended by AMCHAM Medical Devices Committee Members and included representatives from Boston Scientific India, Stryker India, Abbott Healthcare, KPMG UK, BD India, KPMG India and St. Jude Medical. From the AMCHAM secretariat, Mr. Gaurav Mendiratta and Ms. Sandya Rodrigues attended the meeting.

MedTech Breakfast Sponsored by Boston Scientific Sponsored by:

BioAsia AMCHAM Pharma Committee Meeting A breakfast roundtable meeting with the AMCHAM Pharmaceuticals Committee members was organized on 9th February during BioAsia 2016 in Hyderabad. The meeting was Chaired by Shri. Arvind Kumar IAS, Principal Secretary (FAC), Government of Telangana. Members present during the meeting included Mr. Sanjiv Navangul, Chairman, AMCHAM Pharma Committee and MD, Janssen India, Mr. Nick Mitchell, Co-Chair, AMCHAM Pharma Committee and MD, Phenomenex India, and representatives from MSD India, KPMG UK, KPMG India and a few members from Hyderabad Chapter. From the AMCHAM secretariat, Mr. Gaurav Mendiratta, attended the meeting.

AMCHAM Pharma Committee Meeting

BioAsia2016 - Event Report Book

Satellite Events

International Interactions Indo-Spanish Power Breakfast

Hosted by:

Indo-Norwegian Reception

Hosted by:

BioAsia Launch Pad BioAsia 2016 witnessed the unveiling of the 3D video of Hyderabad Pharma City during the Inaugural Ceremony on 8th February, in the presence of the Hon’ble Minister Shri Jupally Krishna Rao, Minister for Industries, Handlooms & Textiles and Sugar, Government of Telangana. It was announced that some of the major pharmaceutical companies have already shown interest to invest in around 5000 acres of land within the Pharma City for setting up their commercial operations.

Another announcement regarding investments to the tune of INR 1000 Crore was made during the event, including a Switzerland company ‘Ferring Pharmaceutical’, which plans to invest USD 25 million in Hyderabad for Pharmaceutical Development.

Hon’ble Minister for Industries, Shri Jupally Krishna Rao with Mr. Michel Pettigrew, President and COO, Ferring Pharma, Switzerland 76

BioAsia2016 - Event Report Book

Media coverage

BioAsia2016 - Event Report Book

Media coverage

BioAsia 2016 Media Coverage BioAsia 2016 Media Coverage Overall Coverage Categories BioAsia 2016 Media Coverage

Overall Coverage Categories

Pan India Visibility – 14 Cities

BioAsia2016 - Event Report Book

Media coverage

Coverage Spread – Before the event and during the event

English Vs Vernacular Print Media Coverage

English Vs Vernacular English Vs Vernacular Media Coverage PrintPrintMedia Coverage

BioAsia2016 - Event Report Book

Media coverage

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

“This international global bio business forum has made tremendous progress in terms of international partnerships, participation from all sectors of industry, collaboration with firms of high repute & facilitation of several meaningful business interactions.” Shri Jupally Krishna Rao, Hon’ble Minister for Industries, Handlooms, Textiles & Sugar, Government of Telangana

“BioAsia 2016 was an experience wherein I learnt a lot. I wish India the best in Science, Technology, Innovation, Drug Design and Biotechnology.” Nobel Laureate Prof. Ada E. Yonath, Weizmann Institute of Science, Israel

“I was very impressed with the level of organization, implementation and hospitality. Scale of Genome Valley is unbelievable and was impressed to see the development of such a critical mass in Telangana state. The theme Connecting the Dots is relevant & crucial to take the global bio-agenda forward as it suggests connection of various sectors of biotechnology, connecting countries and forging partnerships. India is leading the way in know-how and South Africa can take lessons back home. Platform like BioAsia 2016 is an excellent opportunity for youngsters to explore possibilities and learn from the experts.” Dr. Bongani Maseko, CEO, AfrciaBIO

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

“BioAsia has grown from strength to strength & there were some very exciting topics being brought from innovation, diagnostics, pharmaceuticals, medical devices, Health IT and Big Data. It has been a very enriching BioAsia.” Dr. Ajit Shetty, Chairman, International Advisory Board – BioAsia & Chairman Emeritus, Janssen Pharmaceutica, Belgium “BioAsia was an excellent platform to promote Norwegian businesses and companies. Our experience has been very effective and fruitful.” Mr. Helge Tryti, Commercial Counsellor, Royal Norwegian Embassy, Head - Innovation Norway, India

“This event has been very inspiring. I met a number of interesting people who are innovating in healthcare, not only addressing western world problems but also unique Indian healthcare issues. I was surprised to see how energetic everyone is and my experience has been really positive. The theme Connecting the Dots is perfect, as it suggests innovation and collaboration in a collective way.” Prof. Lee Cronin, Regius Chair of Chemistry, University of Glasgow, UK

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

“BioAsia allowed us to meet and interact with relevant international stakeholders and high level executives from our customer base. The venue allowed for an open discussion and the participants did not feel inhibited while interacting with other attendees. We also had a very nice time seeing the high tech industry during the Genome Valley tour.” Mr. Daniel Yoshikawa, Global Product Manager, Bio-Rad Laboratories, USA

“It is absolutely fantastic to see such a vibrant biotechnology and pharmaceuticals industry in India. There is good international presence here and have met delegates from a number of different countries. Now India is a place on the map – a destination to look out for. Its my first visit to this conference but certainly one that I would want to repeat.” Dr. Jonathan Atkinson, Board Member and Partner, HGF Ltd., UK

“BioAsia has been a focal point for many stakeholders to come together and build a better healthcare ecosystem in the country. This year, participation from stakeholders, government and start-ups was huge. This is going to be the most important calendar event for healthcare stakeholders, as we go by.” Mr. Sanjiv Navangul, Managing Director, Janssen India

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

“Congratulations for the excellent coordination done at the BioAsia event. For us, it definitely helped us again to give visibility to Spain as Associate Partner Country at the forum in to our business in India, give a new impetus and R&D relations between Spain and India in the field of biotech and life sciences and showcase to the Spanish delegation the business and R&D capacities of Indian researchers and companies in generics, vaccines, biosimilars and agribiosciences and help in making contacts with stakeholders from Asian, European and Western countries. Please extend on behalf of the Embassy of Spain our heartfelt thanks and congratulations to the Government of Telangana and FABA, without their support the participation of Spain at the event would not have been possible. We at the Embassy are looking forward to our continued collaboration with the State of Telangana and FABA.” Mr. Adrián Gutiérrez, Chief Representative of CDTI India & Southeast Asia & Science and Technology Counsellor, Embassy of Spain in New Delhi, India

“It has been a forum to meet and connect with a wide variety of people from different healthcare industry segments like Pharma, IT, VC, Big Pharma Generics, Biotechnology, Clinical Trials etc. There were a host of discussions which were beneficial for industry on how to collaborate and grow together in healthcare space. India is at the forefront of the healthcare space and to have people from a large segment of the world being represented at BioAsia is a great thing.” Mr. Deepak Sapra, VP, Dr. Reddy’s Laboratories Ltd.

“Event has been absolutely outstanding, with participants from 50 countries. Some of the sessions on Venture Capital, Private Equity & mHealth were excellent. It is a mustattend event & a perfect platform for showcasing where the industry is headed.” Ms. Anju Ghangurde, South Asia Editor, Scrip Intelligence, Informa

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

“It has been a remarkably successful meeting. There have been some excellent presentations. There were around 1006 one-on-one partnerships meetings scheduled, which is a remarkable number.” Dr. Robert Naismith, Chairman, Jujama Inc., USA

“India is supplying vaccines to 150 countries & contributing to immunization of 80% of current infant population.” Dr. Suresh Jadhav, Executive Director, Serum Institute of India Ltd.

“My experience has been excellent. There was tremendous response to the Health and Access conference emphasizing on ‘Biotechnology and IT discover and Public Health delivers’. Prof. D. Prabhakaran, VP, PHFI & ED, Centre for Chronic Disease Control

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

“The quality of discussions, panelists and participants was much higher than previous editions. Complex issues in public healthcare were very well discussed. Pockets of expertise like Drug Discovery, Venture Capital, Private Equity, Molecule Development and Clinical Science were featured very beautifully in BioAsia 2016.” Mr. Bobba Venkatadri, General Partner, Ventureast

“It has been an amazing experience. BioAsia has been a fantastic platform for many like-minded individuals and organizations to come together to discuss, deliberate and collaborate.” Dr. Anthony Vipin Das, Team Principal & Chief Architect, eyeSmart EMR, LV Prasad Eye Institute

“This is one conference that I look forward to every year. This is a very high impact conference with the right topic, right agenda and right mix of impact makers and stakeholders from industry & policy making. The discussions have been really insightful and they will add a lot of value to the ongoing debate in healthcare and life sciences.” Dr. Rajendra Pratap Gupta, Chairman India & India Representative, Personal Connected Health Alliance

BioAsia2016 - Event Report Book

FEEDBACK & COMMENTS

“The conference was quite interesting with a great number of startups, demonstrating some great solutions. Further, I was amazed by the breadth of topics, BioAsia has managed to cover in a short span of 3 days. I wish your group all success for future events and look forward to participating as well.” Mr. Bhuvaneashwar Subramanian, Specialist, Market Intelligence, Life Sciences SME, HPE India

“Congratulations on organizing such an excellent event. Thanks for inviting me to be a part of the event. I enjoyed being there and interacting with the participants.” Dr. Rakesh Sahay, Professor of Endocrinology, Osmania Medical College & Chairman, AP Chapter of RSSDI “BioAsia 2016 was a great event that has over the years promoted the Country and the Region as a destination for biotech sector as well as helping the growth of the sector through both business and policy oriented interactions.” Mr. Prasanta K. Biswal, Chief Executive Officer, International Biotech Park Ltd., Pune

BioAsia2016 - Event Report Book

Organizers:

Supported By:

BioAsia Secretariat: #301, Gayathri Nest, Telecom Nagar, Gachibowli Hyderabad - 500032, Telangana, India. T: +91 (40) 2300 0205 / 206 E: info@bioasia.in, www.bioasia.in

Knowledge Partner: