Report BioAsia 2013

NEXT IN BIOTECHNOLOGY

BIOASIA2013. A FACT FILE.

FOREWORD The emerging global shift from pharmaceutical drugs to biopharmaceuticals and its impact on human life and bio-business clearly underlines the dynamic and self evolving nature of Life Sciences. But the real challenge for us would be to comprehend the possibilities of this change and ride them into the future. It is this very challenge that BioAsia 2013, the 10th chapter of one of the most awaited, successful and broad-spectrum global platform on Biotechnology and Life Sciences chose to confront and explore quite successfully.

INDEX Introduction

07

Participant Profile

09

Ceremonies

11

Awards

15

Conferences & Panel Discussions

19

Breakfast Meetings

28

CEO Conclave

32

Workshops

36

BioAsia Connect

42

Biobazaar & Regulators’ Meet

46

International Trade Show

50

Special Collaborative Research Reports

54

Media Coverage

58

Feedback & Comments

62

BioAsia 2013 Conference - Recommendations

66

06

Sponsors While the success of BioAsia 2013 can certainly be attributed to its focused content, dynamic platform structure and its inherent ability to connect and optimize opportunities, it was ably supported and complimented by its sponsors; bodies of individuals esteem and repute each of whom are irrevocable contributors to this global event

Exploring Opportunities NEXT in Biologics & Biosimilars

With an eye on the emerging global shift from pharmaceutical drugs to biopharmaceuticals, the focus of BioAsia 2013, the 10th chapter of one of the widest global platforms on Life Sciences, was certainly a bio-future shaped by the new industry leaders: Biologics and Biosimilars. In order to enable this, it not only brought together countries, but also pharmaceutical giants, regulatory authorities, thoughtleaders, research scholars, trade experts and every other stakeholder of this industry face-to-face under the incisive theme of TECHNOLOGIES. BUSINESS. NEXT.

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The choice of focus is hardly surprising; studies clearly indicate that in the coming decade, Biologics will dominate the global biopharmaceutical drugs market -since 8 of the top 10 blockbusters of 2014-15 will be Biologics or biotechnological products. In close conjunction, Biosimilars are attracting attention fueled by the expiry of patents due on at least 48 Biologics over the next decade. In the current environment, India owns quite a few cutting-edge advantages: lower R&D costs, strategic plans for clinical trials, future commercial linkages with companies in the US and Europe, a solid foundation in scientific intellectual capital and technical framework ensuring world class quality standards. In fact, the Indian Biologics market already accounts for 62% of $ 3 billion revenue by the Biotechnology industry as a whole.

Clearly here lies the NEXT big opportunity especially when both the host-city - Hyderabad and Genome Valley are amongst today's finest faces of futuristic India.

PARTICIPANT PROFILE

Participant Profile The precise number of delegates for the event was 520. In addition, over 650 visitors attended the 3 day global biobusiness event. Spain participated as the Country Partner while Victoria (Australia) participated as the International State Partner and over 47 countries took part in BioAsia 2013 with major delegations from South Korea, Iran, Australia and Spain. The International Tradeshow at BioAsia 2013 attracted about 35 companies from across the globe. The event also saw the presence of over 60 global Life Sciences leaders and high profile speakers.

Geographic Distribution: India

57%

Asia

24%

Europe 13% Africa

1%

USA

5%

Demographic: Pharma/Biotech Company – 60% CRO/CMO – 15% Venture Capitalist/Investor – 12% Regulatory Agency – 8% Others – 5%

BioAsia 2013 participants attending various sessions

10

CEREMONIES

Inaugural Ceremony

12

Delivering the welcome address, Dr. KV Raghavan, Vice

Some of the other prominent people present at

President, FABA said that the conference will have a special

the event included -Ms.Carmen Vela Olmo,

Regulators’ Meet to discuss the issues in biopharma industry.

Hon'ble Minister of State for Research,

He stated that delegates from various countries like Spain, South

Development and Innovation, Ministry of

Korea, Europe, Africa and Indian states including Gujarat,

Economy and Competitiveness, Government of

Madhya Pradesh, etc. have come for the conference. He also

S p a i n , M r. I n g K y o K i m , P r e s i d e n t ,

said that the global forum has registered around 45 countries

Gangwon TechnoPark, South Korea, Dr. Maharaj

that day with more than 500 delegates including academicians,

Kishan Bhan, Former Secretary, Department of

regulators, and industry experts.

The event was inaugurated by Shri. Kiran Kumar Reddy, Hon’ble Chief Minister, Govt. of Andhra Pradesh. In his inaugural speech the minister said that he was happy that Hyderabad had taken a lead in the field of Biotechnology. He also mentioned that the Government of Andhra Pradesh was trying its best to be associated with such events which way to new thinking and led the field ahead. He also stated that India produced 60% of the world’s vaccines and out of this 30% was contributed by Andhra Pradesh. He concluded by saying that the conference would give direction to the world bringing in new initiatives which benefits the poor people, creating a brighter future.

Biotechnology, Govt. of India, Dr. Freda LewisHall, Chief Medical Officer, Pfizer Inc., Dr. George John, Senior Advisor, Dept. of Biotechnology, Govt. of India, Dr. KV Raghavan, Vice President, FABA, Dr. PV Appaji, Executive Director, Pharmaceutical Export Promotion Council of India, Government of India, Mr. Manni Kantipudi, CEO, GVK Biosciences.

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Ms. Carmen Vela Olmo, Hon'ble Minister of State for Research, Development and Innovation, Ministry of Economy and Competitiveness, Government of Spain and Dr. George John, Senior Advisor, Dept. of Biotechnology, Govt. of India made an announcement of the Indo-Spanish Science & Technology Program. Ms. Vela said that India was a priority country for Spain and invited everyone for an Indo-Spanish breakfast to be held the day after morning.

The key note address was delivered by Dr. Freda Lewis-Hall who talked about the trends in global biopharma R&D. She said that a global age of biopharma was ahead of us which asked to sustain leadership in generics and expand into Biosimilars. She also talked about using Biosimilar advances to bring new solutions and also about changing the innovation model to highlight “focus” and “quality” which would lead to less attrition and increase in productivity. She suggested three areas where Genome Valley might build special advantage i.e. precision medicine, leveraging big data, and rescue & repurpose of medicines.

Dr. PV Appaji gave a vote of thanks and said that with the support of AP Govt. BioAsia would continue to do its best to promote biopharma investments and exports.

Welcome Reception The first day concluded with a Networking Reception at the Novotel lawns hosted by European Business and Technology Centre (EBTC) and co-hosted by Spain India Council Foundation and Centre for the Development of Industrial Technology (CDTI).

About 400 people from different countries participated in this networking dinner.

Valedictory Ceremony

14

The 10th edition of BioAsia, BioAsia 2013, Asia’s biggest technology and bio-business platform, which commenced on 28th January 2013 concluded on 30th January 2013. The Valedictory Ceremony was attended by eminent personalities including – • Ms. D Purandeswari, Honorable Union Minister of State for Commerce & Industry, Government of India • Dr. Khalid Chowdhary, President – FABA • Dr William Dar, Director General – ICRISAT • Mr. WookJae Lee, Director General, Global Business Bureau, Gangwon Provincial Government, South Korea • Mr. Pradeep Chandra IAS, Principal Secretary, Dept. of Industries & Commerce, Govt. of Andhra Pradesh • Mr. Sanjay Puri, President – AUSIB, Alliance for US-India Business • Dr. KV Raghavan, Vice President, FABA • Dr PV Appaji, Director General – PHARMEXCIL

AWARDS

The following awards were also presented at the inaugural ceremony:

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Genome Valley Excellence Award: “Genome Valley Excellence Award" was instituted by the Government of Andhra Pradesh to recognise and honour eminent individuals and organisations for their exceptional contribution to the Life Sciences Research & Industry.

Genome Valley Excellence Award 2013 was presented to Dr. MAHARAJ KISHAN BHAN, Former Secretary, Department of Biotechnology, Govt. of India in light of his – •

Extraordinary vision and leadership in changing the Indian Biotechnology landscape, as the Secretary to Government of India, Department of Biotechnology - the apex body for promoting and regulating biotechnology in the Country

•

Commitment to betterment of human health as a physician, clinical scientist and leading advocate in public health, immunisation and vaccines.

•

Relentless efforts and contributions to the society through various public and private initiatives

17 Pfizer Inc., USA Genome Valley Excellence Award 2013 was also presented to Pfizer Inc, USA in light of •

Its un-waivered commitment to patient health through various Global Health Initiatives, particularly in the emerging markets

•

Vision, leadership and focus on cutting-edge Research & Development and it's continued commitment to innovation in the biopharmaceutical space

•

Its support and backing to the initiatives clearly focused on preventing and treating orphan disease areas and also related therapeutic areas in Primary Care, Specialty Care and Oncology.

The following awards were also presented at the closing ceremony:

FABA Special Award: Dr. Vijay Datla, Chairman and

BioAsia Innovation Award 2013: (Rs.1 lakh cash prize,

Managing Director – Biological E Limited, was presented

memento and citation) was awarded to Paritosh Parashar

FABA Special Award.

of IIT Kanpur for a projection BMP Responsive Osteoblast Reporter Cell Line

BioAsia Young Minds Award 2013: (Rs.50,000 Cash prize, memento and citation) was awarded to Ms. Meghna D Kumar, St.Patricks Junior College, Hyderabad project on self retracting clothesline.

for the

CONFERENCES & PANEL DISCUSSIONS

Key statistics highlighted during the conference •

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Bio Pharma exports in India increased from Rs 17000 crores in 2004 to Rs 70,000 crores in 2012, of which Andhra Pradesh accounts for one third share Also, India is the largest exporter of generics in volume tonne

•

60% of small molecules market is contributed by India and similar success capability is there for Biosimilars

•

Spending on Biosimilars will increase but will constitute only 2% of total biologic spending

•

India Biotechnology sector is 3rd largest in Asia

•

India may become leader in Asia with opportunity in insulin market ($20 Bn) & interferons ($9 Bn).

•

Biosimilars will be a niche market as price erosion is not more than 25-30% as compared to generics where it reduced by 60%

•

Biosimilar market estimated to be$22 billion industry by 2020

•

8 out of top 10 drugs in 2014 to be Biologics

•

Between 2008 and 2015, 45 Biologics worth $60 billion to loose patent

•

35% of Europe's biopharma clinical trials are carried out by UK's centres of excellence

•

100 British companies operating in India including GSK

•

14% of the deals are in healthcare and Life Science advisory sector

•

Average return in industry (biologics - 9% to 9.5% IRR and Biosimilars 15% to 16% IRR)

•

Global pharma market is $880 billion out of which small molecule segment is $660 billion

Biologics and Biosimilars: Succeeding in the market of the future.

Tuesday, January 29, 2013 | 10:15am - 11:45am Panelists: •

Dr. Subir Basak, President (Global Discovery), Jubilant Life Sciences

•

Dr. S P Vasireddi, Chairman & Managing Director, Vimta Labs

•

Dr. Sahib M.K., Director, Genomics & Biotechnology, Wockhardt Research Center

•

Moderator - Mr. Sachin Joshi, GM Bioprocess, GE Healthcare Pvt. Ltd.

The focus of the session was on the current state of the Biosimilars industry in India and its capability in repeating the success of generics for Biosimilars as well. The panel also discussed the challenges relating to the industry in terms of costs, regulations, and innovation. Additionally, they emphasised on the need for partnerships in the business model.

Sponsored By:

Biomedical Research & Regulatory Environment: US FDA's recent Guidance and its impact

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Tuesday, January 29, 2013 | 12:15pm - 13:45pm Lead Speaker: •

Mr. Solomon Yimam, Asst. Country Director, (Clinical Research), US FDA India

Panelists: •

Dr. Alex Kudrin, Medical Assessor, Biological Licensing Division, MHRA, UK

•

Mr. Rajeev Nannapaneni, Director & VC, Natco Pharma Ltd.

•

Moderator – Mr. Vikas Dandekar, India Bureau Chief, Elsevier Business Intelligence

The session started with very insightful presentations on regulatory environment by Mr. Soloman Yimam on USFDA and Dr. Alex Kudrin on MHRA. Further, the panel discussed the need for coming up with innovative ideas in order to bring down the cost of Biosimilars. The panellists agreed that companies should go through learning curve in the home country and then move out to market their products in the developed nations. Dr. Alex Kudrin said that India will play a major role in the years to come as it has the capability to develop Biosimilars and succeed in the market.

Role of emerging markets in global Biologics arena: Would BRIC countries dominate 'Biosimilars'?

Tuesday, January 29, 2013 | 15:00pm - 16:30pm Lead Speaker: •

Dr. Salomon Azoulay, SVP Medical & Development, Emerging Markets, Pfizer

Panelists: •

Mr. KV Subramaniam, President & CEO, Reliance Life Sciences

•

Mr. Raman V Shetty, Clinical, Medical & Regulatory Director, Novo Nordisk, India

•

Dr. Venkat Jasti, Chairman & CEO, Suven Life Sciences

•

Moderator - Mr. K.V. Anantharaman, Prinicipal Analyst, Datamonitor Healthcare

The session started with the presentation by the lead speaker Dr. Salomon Azoulay. He talked about the growth drivers of the industry and the need for a multidimensional, cost effective and customisable business model. He agreed that India has the potential to become a global player in this market. The session then moved on to panel discussion where it was said that BRIC countries will succeed the market over next 10 years and today India is leading in the race among the emerging countries. The session also captured the Biosimilars opportunity in BRIC countries, the advantages of these countries and challenges faced by the industry in BRIC nations with respect to regulatory framework, technology etc.

Fostering IndustryAcademia Linkages in Life Sciences R&D

22

Wednesday, January 30, 2013 | 3:00 pm - 4:30 pm Chairman: •

Dr. J. Gowrishankar, Director, Centre for DNA Fingerprinting & Diagnostics(CDFD)

Panelists: •

Dr. Jordan L Cohen, Professor, College of Pharmacy, University of Iowa

•

Prof. Lam Kong Peng, Director, Bio-Processing Tech. Institute, A-Star, Singapore

•

Dr. Taslimarif Saiyed, Director and COO, Centre for Cellular and Molecular Platforms, NCBS-TIFR, Bangalore

•

Moderator - Mr. Vinod Kuberkar, Managing Director, VTK Life Sciences Advisory Services / Western Range Biopharmaceuticals Pvt. Ltd.

The panel discussed the major challenges facing the enabling of linkages and highlighted factors that needed to be addressed to deepen the linkages between academia and industry. It also talked about the need for establishing linkages by various institutes and companies with each other.

Increasing Partnerships between Biologics Innovators and Biosimilars manufacturers

23

Tuesday, January 29, 2013 | 16:30 - 18:00 Hrs Lead Speaker: Dr. Shyam Bishen, Head, Emerging Markets Strategy & Commercial Development, Merck & Co. Panelists: •

Dr. Rajeev Soni, Associate Vice President -

•

R&D, Biocon Ltd. Mr. M.S. Mahadevan, President & CEO, BiOZEEN (Bangalore Biotech Labs Pvt.Ltd), India

•

Dr. Richard Lipscombe, Managing Director & CEO, Proteomics International, Australia

•

Moderator – Mr. Mahadevan Narayanamoni, Partner - Corporate Finance, Healthcare & Life Sciences Leader, Grant Thornton

Dr. Shyam Bishen began the session as the lead speaker and talked about the biosimilar companies in emerging markets exploring partnerships with biotech & pharma companies in US & EU to get help in developing and marketing in regulated markets. The panel discussion was concluded with the remark that partnerships with innovators and large pharma companies is clearly the way forward for Indian biotech companies when it comes to biosimilars. While several companies have built great marketing networks, product portfolios and manufacturing capabilities for generics, biosimilars will be a totally different ball game from the point of view of investments, quality, regulatory approvals and market access.

BREAKFAST MEETING

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Is Biologics and Biosimilars a not-to-miss opportunity? – An overall perspective Wednesday, January 30, 2013 | 10:15 - 11:45 Hrs Panelists: •

•

Dr. Philip J. Larsen, VP, Global Head – Diabetes Research & Translational Science, Sanofi-Aventis Dr. Ajit Shetty, VP Worldwide Operations, Johnson & Johnson & Chairman, Board of Directors, Janssen Pharmaceutica, Belgium

•

Dr. Charu Manaktala, Medical Director, Quintiles India

•

Mr. Anand Iyer, Head of Biotech Division, Strides Arcolabs Ltd.

•

Moderator - Mr. Aluri Srinivas Rao, Head – PE, Morgan Stanley PE

The session highlighted the opportunity in the biologics and biosimilars segment, notwithstanding the technical, regulatory and commercial challenges that the segment faces. The panel talked about the key considerations to be kept in mind at the time of manufacture of biosimilars. They also discussed the growing demand for insulin for diabetes in the market looking at the changing lifestyle of people.

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Next Big Trends in Healthcare: Regenerative Medicine & Stem Cells Wednesday, January 30, 2013 | 12:15 - 13:45 Hrs Lead Speaker: Mr. Deepak Sood, Business Director South Asia & Middle East, Lonza India, Panelists: •

Dr. Barbara E. Bierer, Professor of Medicine, Harvard Medical School

•

Mr. BN Manohar, CEO, Stempeutics Research Pvt. Ltd.

•

Dr. Geeta Jotwani, Scientist 'D', Division of Basic Medical Sciences, Indian Council of Medical Research

•

Moderator – Dr. Subhadra Dravida, MD, Tran-Scell Biologics Pvt. Ltd

The session highlighted the current state of regenerative medicine, recent developments / advancements, the impact of regulatory framework and government policy, improvement in clinical outcomes and the overall challenges in the new technologies getting adopted. Mr. Deepak Sood stated that Stem cell is the next big thing and will be invention of century if all goes well.

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Global Lifesciences Investments – Nurturing Entrepreneurship & Spin offs Wednesday, January 30, 2013 | 13:30-15:00 Hrs Panelists: • Mr. Anand Govindaluri, CEO, Govin Holdings, Singapore •

Dr. Makarand Jawadekar, Former Director, Pfizer

•

Dr. Prem Pavoor, Director, Fidelity Growth Partners India

•

Moderator - Mr. Vishal Gandhi, Founder & CEO, BioRx Venture Advisors Pvt. Ltd.

The panel discussed about India's ecosystem and the key factors for the success of biosimilar companies. They also talked about the deals taking place in India saying that currently 14% of all deals are in healthcare & lifescience advisory sector.

BREAKFAST MEETING

BREAKFAST MEETING

29

Indo – Spanish Power Breakfast Meeting Tuesday, January 29, 2013 | 9:00 am -11:15am

Indo-Spanish Breakfast Meeting at BioAsia 2013

Hosted by:

Indo – Victoria Power Breakfast Meeting Tuesday, January 29, 2013 | 08:00-09:30 Hrs

Indo-Victorian Power Breakfast Meeting at BioAsia 2013

Hosted by:

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CEO CONCLAVE

33

CEO Conclave – Changing Phase of Indian Life Science Industry Date: January 29, 2013 Mr. Richard Hyde, British Deputy High Commissioner, gave the keynote address stating that UK and India are natural partners for Life Sciences.

Moving on Mr. Utkarsh Palnitkar talked about the various developments in the industry in the year and the disappearing compartmentalisation of the classic sectors of Innovators, Generics and Service Providers and the creation of Biopharmaceuticals due to numerous numbers of collaborations.

To kick off the panel discussion, two questions were raised: “What skill-sets does the industry need now to win in the brave new world” & “ Are we gonna remain bystanders and be pushed by the world of change or are we gonna be agents of change?”

Dr. Cyrus Karkaria, of Lupin Pharma, expressed his views on why pharma companies are now drafting branches into Biotechnology and the driving force & competitive advantage for pharmas to diverge into this sector.

Mr. Alluri Srinivas, Morgan Stanley, shared his views on why it is alluring to invest in Life Sciences.

Mr. Manni Kantipudi, GVK Biosciences commented on the changing situations of the CRO post recession and quoted that the unique proposition for companies in India are the innovations and the innovativeness in thinking.

Dr. Krishna Ella, Bharat Biotech, shared his views on the growth of healthcare budgets in India.

The panellists discussed the various aspects of the foreign ownerships of Indian companies, the government's interventions and attractiveness of the Indian market, the latest trends and the challenges in the industry.

Sponsored by:

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WORKSHOPS Shaping Future Innovations

37

Master Class on Emerging Trends in Intellectual Property Rights in Biotechnology: Monday, 28th January, 2013, 9:00 am - 4:00 pm

The Master Class on Emerging Trends in Intellectual Property Rights in Biotechnology has been designed to sensitise and expose the IP management professionals to the emerging trends in IP in the field of Biotechnology. The Master Class has been designed to give insights to appropriate models of IP delivery and its effective management in this field.

The Master Class, apart from interactive sessions with experts in the fields of IP and Biotech, also had a strategic game session which gave a hands-on experience of IP management to middle and senior level IP managers. It also interfaced strategies at National and International levels in leveraging IP with innovation.

The simulation game for owners of IP provided information on key ingredients for successful monetisation of IP and helped the participants to modulate their behavior in IP negotiation, bargaining, sharing and licensing events. It promoted development of key leadership competencies and strategic thinking. This session was led by IP Dome-IP strategy advisors.

Coordinated by:

Master Class on Entrepreneurship in Life Sciences 38

Monday, 28th January, 2013, 9:00 am - 4:00 pm

With entrepreneurship gaining increasing interest in the areas of BioPharma and Life Sciences, BioAsia led a pioneering initiative to organize an entrepreneurship workshop as part of BioAsia 2013.

BioAsia partnered with Atharva Lifesciences Consulting Pvt. Ltd., a Life Sciences consulting firm to deliver this initiative.

The company has conducted a number of entrepreneur workshops all over the country – and has exposed nearly 5000 science enthusiasts to the process of entrepreneurship. They also publish “Funding Your Science Idea” – a publication tracking funding opportunities globally for Indian entrepreneurs.

The workshop exposed science professionals to many facets of science entrepreneurship, innovation, and leadership.

The workshop featured corporate leaders, venture capitalists and entrepreneurs in various stages of a startup and established firm lifecycle.

This workshop had many exciting and powerful sessions. These included: Overview and Opportunities of the Life Sciences sector, Creating a Business Plan for a Venture in Life Sciences, Funding Opportunities in Life sciences, Intellectual Property Management: The secrets of IP management and a Discussion: Secrets from the DOers! Real world experiences of Entrepreneurs who DO! Experienced industry experts from all over the country participated to contribute to the proceedings. These included: Mr. Karnvir Mundrey, Director, Atharva Lifesciences Consulting; Mr. Ganesh Ramakrishnan , Associate Vice President, Private Equity Tata Capital Ltd., Mr. Ravi Bhola, Partner, K&S Partners; Dr. Shirshendu Mukherjee, Strategic Advisor Welcome Trust , Mr. Janarthanan, Finance Head, Lifespring (Nadathur Group), Dr. Radha Rangarajan , CEO , Vitas Pharma and Dr. Ajit Nair, Director, Vins BioProducts.

The workshop received an enthusiastic response, with attendees from many organisations including Harvard University, Dow Corning, Thermo Scientific, and a number of individuals looking to begin an entrepreneurship innings in this exciting field!

Coordinated by:

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Master Class on Private Equity in Life Sciences Monday, 28th January, 2013, 9:00 am–4:00 pm

BioAsia in association with the BIORx Venture Advisors organized a focused workshop on Venture Capital and Private Equity. The workshop was supported by BIRAC, a Govt. of India enterprise keeping in view only the well structured agenda that was put on and also its commitment to promote sustainability of Biotechnology ventures in India.

Inaugurated by Dr. MK Bhan, Former Secretary to Government of India, Department of Biotechnology, the workshop was attended by about 30 select participants ranging from CEO/CFO and CSOs of major private companies of India. The workshop was aimed at providing an insights on VC/PE industry in India with reference to Life Sciences sector , various valuation methodologies, technical and legal due diligence. The feedback received for this limited ticket workshop has been very encouraging.

Coordinated by:

40

Tech Transfer Summit Innovation through technology Wednesday, 30th January, 2013, 9:30 am - 11:30 am

Next generation off shoring will be driven by innovation and technology capabilities. Industry, Academia and R&D institutes need to rethink on their positioning strategies and build competencies in line with transition of off shoring criteria. In addition, Bio-pharma sector, especially, requires technology delivery mechanisms in order to sustain business for the future. Technology transfer round table at BioAsia 2013 explored the scope of constituting Indian ‘BioPharma Innovation Network’ as the primary theme by bringing together the elements of Bio-Pharma innovation together.

Purpose: Round table is a carefully selected focus group from industry, academia and government that shall work on major factors that influence ‘igniting innovation’ in Life Sciences industry. The roundtable shall draft the recommendations for policy makers and publish it for the consideration of Innovation Council.

Participants: A judicious mix of key influencers from Bio-Pharma & Life Sciences; • Industry • Academia • Research Institutions • IP Consultants • Capital Advisors • Policy makers

Coordinated by:

BIOASIA CONNECT – Identity. Interact. Connect

43

BioAsia Connect BioAsia 2013 featured a dedicated B2B-portal, the BioAsia Connect, which assisted delegates in their business development and licensing activities with hand–picked companies from the Global Life Sciences market.

The partnering community comprised of participants from 47 countries including delegations from Spain, Australia, South Korea, Iran, Nepal, Singapore etc.

BioAsia 2013 successfully conducted B2B (one to one business meetings) during the event with in a dedicated partnering area. It offered individual meeting spaces for the private one-to-one meetings and during the 3 days of networking more than 450 business meetings were realised in addition to the networking receptions, power breakfast meetings and CEO Conclave, enabling participants to discuss new business prospects and commercial agreements.

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BIOBAZAAR One platform. Multiple benefits. &

REGULATORS’ MEET Impacting Bio-business

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BioBazaar & Regulators’ Meet The sole objective of this unique international buyer-seller meet is to promote the interests of the Indian Biopharma and Medical Device sectors. This time BioBazaar was the “one stop” for various Biopharmaceutical products.

As per IMS statistics global Biopharmaceutical market in 2011 was valued around USD 157 billion and has grown around 11% CAGR during the last 5 years. It is expected that by 2016, Biopharmaceuticals will touch USD 200-210 billion. The global trade during 2011 in this sector stood at USD 950 million as per UNCOMTRADE. Eyeing this dramatically expanding market and promoting/branding the Indian Biopharma sector, Pharmexcil with support of Ministry of Commerce and Industry, Govt. of India, successfully organised the International Business Meet during BioAsia 2013. The event covered various Biopharma products such as vaccines, monoclonal antibodies, bio-generics, blood products and medical devices.

About 23 international delegates from 14 countries participated in this business meet. The delegates were from Algeria, Argentina, Belarus, Egypt, Jamaica, Jordan, Kyrgyzstan, Lithuania, Malaysia, Myanmar, Nigeria, Singapore, Tanzania and UK. More than 66 Indian delegates participated to establish their business relationship with their counterparts.

This mega event was scheduled in different business sessions and a technical session during January 28 – 30, 2013.

More number of Indian delegates later reported that they developed good business leads through this event. In Pharma sectors, as the companies are required to obtain product registrations in the importing countries, it would take some time for actual conversion of business leads. It is hoped the future statistics will reflect this conversion.

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Organized by:

INTERNATIONAL TRADE SHOW Showcasing Opportunities

51

International Tradeshow With a special focus on Medical Devices & Analytical Equipment along with the Supply Chain/Logistics, the trade show at BioAsia 2013 attracted about 35 companies from across the globe and 15 BioAsia Innovation and Young Minds short listed candidates.

The exhibitors’ participation included booths from Spain, Iranian Biotech, government bodies such as Karnataka Biotechnology & Information Technology Services (KBITS), Madhya Pradesh Biotech Council, Indian Institute of Chemical Technology (IICT), ICRISAT, DBT-BIRAC, MNCs; domestic companies like GVK Biosciences, Bharat Biotech, Lonza, IKS International, Netherlands, Gene Reach Biotechnology Corporation, Taiwan, MakroCare Clinical Research, Proteomics International, Australia, ViruSureGmBH, Germany, research & educational institutions. Around 1200 delegates/visitors participated in the tradeshow during the event. Pavilion showcasing Genome Valley was the highlight of the tradeshow.

Delegates at BioAsia 2013 International Tradeshow

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BIOASIA RELEASES OF SPECIAL COLLABORATIVE RESEARCH REPORTS

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BioAsia Releases of Special Collaborative Research Reports Ms. D Purandeswari, Minister of State for Commerce and Industry, released the special report by BioAsia – Grant Thornton on the key trends and alliances in the Biologics and Biosimilars markets. The Minister also released BioAsia – ISB’s report on Intellectual Property Regime and Lifesciences •

BioAsia - Grant Thornton Report covers the recent developments in the Biosimilars opportunities particularly partnerships and regulatory dynamics in key global markets

Considered a major hope for the effective treatment of several diseases that have no cure till date, development of biotech medicines has been embraced as a core research and development area across some of the largest and populous economies in the world.

With rising healthcare costs, the impending patent cliff and a relatively slow pace of development of generics, development of Biologics is regarded as one of the most promising frontiers in pharmacotherapy, with Biologics expected to have a global market to the tune of US$ 3.7 billion by 2015.

Benchmarking against the performance and regulation in the leading nations of the world indicates that the value generation opportunity of Biosimilars is dependent on several factors, including speed of development, clarity in regulation, ease of access and particularly the roles of all stakeholders. Potential aside, there remain regulatory challenges, success of clinical trials as well as safety and efficacy tests which are characterised by a huge investment outlay.

In this paper, we attempt to bring out recent developments in the segment (particularly partnerships / collaborations / alliances), the opportunities that players could potentially exploit and the regulatory dynamics in key global markets.

BioAsia-Grant Thornton Report Release on Insights into the Biosimilars market An overall perspective

56

•

BioAsia-ISB report captures the impact of the changes in Indian Patent Law on strategies and competitiveness of local players

To many industry experts within and outside the Indian pharmaceutical industry, the recent changes to the Indian patent law is a watershed event this is likely to have long-term implications on the competitiveness of the industry. Yet even after seven years from the event little is known about how the changes influenced the industry. Many domestic firms believe that the new patent law is likely to halt their aspirations to become a dominant generic player while many multinational firms believe that the new law will open up their firms to new market opportunities well beyond those in the developed world. In this report we paint a broad brush on how the most recent changes to the Indian patent law influenced firm strategies and the competitiveness of local players in the industry. Given the current sets of firm capabilities that Indian and foreign firms are armed with, we believe the new patent law is likely to result in both these categories of firms reconfiguring their strategies. Also, how firms adapt to the new reality will determine their performance in this new era. We present our broad findings and our conjecture on the long term implications of the new patent law on the Indian pharmaceutical industry.

BioAsia-ISB Report release on TRIPs and Innovation Trends in the Indian Biopharmaceuticals Industry

MEDIA COVERAGE

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MEDIA COVERAGE The power and reach of the media was amply demonstrated in BioAsia 2013 which successfully showcased the purpose, business mandate and its goal of bringing together key industry stakeholders. The intent, of course, was to charter a dynamic road map ahead for the future of Life Sciences.



Total media coverage generated: 443 news clips

 Coverage in print media: 213 news clips  Electronic coverage: 16 news clips  Online coverage: 214 online write-ups  Coverage in business pages: 76 clips  Coverage in English dailies is 46% more than the

coverage in regional dailies Pre Event

Event

 Highest coverage was in English dailies and

Category Analysis

regional dailies

English Dailies Regional Dailies Online Electronic Media Magazines

 Media coverage has increased by over

Coverage Analysis

125% in 2013

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FEEDBACK & COMMENTS

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Dr. Alex Kudrin, Medical Assessor, Biologicals Licensing, MHRA, London “It was a great pleasure attending the BioAsia. I am glad that my presentation was received with interest and raised grounds for further scientific discussion.

BioAsia was an extremely successful event which opened avenues for the constructive dialogue between different stakeholders and companies in finding ways of strengthening the collaboration around development of biological medicines and ensuring that India will become a truly global player in development of innovative medicines in next decade.

The event was a great achievement and contribution into the Biotechnology sector of Indian economy and the organisers should be truly proud for the level of your commitment, enthusiasm and execution throughout such a lively and comprehensive conference!”

Dr. Solomon Yimam, Assistant Country Director (Clinical Research), U.S. FDA India Office “BioAsia 2013 was a very informative and excellent conference; I am so glad that I was able to participate and contribute to the event.”

Dr. Shyam Bishen, VP & Head, Emerging Markets Strategy & Commercial Development Merck & Co “It was a pleasure to participate in BioAsia 2013 and I’m glad to hear that overall the event was well attended and a great success! I too felt that there was a lot of energy at the conference where participants really benefited from listening to experts such as world’s top regulators. It was also a great place to network” Dr. Charu Manaktala, Medical Director, Quintiles India “My congratulations to the organisers for putting together a great event.”

The speaker line-up was good and had an optimally balanced representation from different quarters such as Indian and multinational pharma/biotech companies/ CROs/ academia/ regulatory agencies. There was a significant representation from regulatory authorities around the world including the ones that are considered the thought leaders.

Apart from this, the other notable feature was that most panel discussions were chaired by a person who was technically neutral. This allowed very balanced and open discussions.”

Mr. Stephen Tierney, Managing Director, IKS International, Netherlands “The organisers did a great job: quick responses, even on the day itself. Good infrastructure available for the exhibitors.

For IKS it was a very productive fair, and we got out of it what we wanted. So thank you for all the good efforts.”

Mr. Anand Govindaluri, Founder & Chief Executive Officer, GO-VIN HOLDINGS Pvt.Ltd, Singapore "I was impressed to see the confluence of global thought leaders from biotech community attend at BioAsia 2013. In particular, I found the panel discussions and networking sessions to be extremely helpful. I congratulate the organisers of BioAsia 2013 for putting up a great event."

Mr. K.V. Anantharaman, Principal Analyst – Healthcare, Research & Analysis, Datamonitor Healthcare, “The event was organised very well and it offered a great opportunity for the industry folks to learn, discuss and network. I was very happy to be part of it. I was delighted to meet and hear the thought leaders discuss issues pertaining to the Biosimilars industry.”

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Dr. Barbara Bierre, Senior Vice President of Research, Brigham and Women’s Hospital “Thank you. I thought it was a most informative and excellent conference. Thank you for including me!”

Mr. Aluri Rao, Managing Director, Morgan Stanley “You guys are very fantastic. The feedback is very good. I thoroughly enjoyed it.”

Mr. Vikas Bhargava, Director, India Operations, IKS International “From our perspective we perhaps got what we want-brand visibility and product exposure. The infrastructure provided was truly benchmarked. I hope that the future initiatives would be better showcased and I wish you all success. I would also like to convey my personal appreciation to the organisers for the excellent co-ordination and support.”

Hon’ble Choi, Moonsoon, Governor of Gangwon Province, Republic of Korea “I’d like to take this opportunity to express my appreciation for the warm hospitality shown to Gangwon delegation visiting Hyderabad to discuss about the economic cooperation between Gangwon and Andhra Pradesh and to attend BioAsia 2013. The visit allowed an opportunity to reaffirm that both regions shared a vision for economic development by promoting high-tech industry and concrete will for mutual cooperation. Moreover, a platform for future collaboration in bio-Industry was established by signing MoU between APIIC and Gangwon Techno Park. Our entrepreneurs are also prospecting productive outcome from networking activities held in BioAsia 2013.”

Ms. Carmen Vela Olmo, Hon’ble Minister of State, Secretariat of State for R&D&I – MINECO, Spain “My sincere congratulations for the excellent organization of the event. For the Secretariat of State for R&D and Innovation (Spanish Ministry of Economy and Competitiveness) participating in this well-established forum focusing on Biotechnology, with excellent track record in terms of participation, from India and abroad, of research institutes and companies across the Life Science value chain has been considered a priority in order to give continuity to our joint bilateral efforts with our Indian counterparts, namely DST (Department of Science and Technology) and DBT (Department of Biotechnology) aimed at promoting and further enhancing basic and applied R&D co-operation between Spanish and Indian collaborators in the field of Biotechnology and Life Sciences, health and medical research.

In my opinion, the participation of Spain at this specific biotech forum for dialogue and exchange of knowledge, will undoubtedly enhance and give a new impetus to our institutional, S&T and business co-operation with India in Biotech and Life Sciences sector, and particularly, with the state of Andhra Pradesh.”

BIO ASIA CONFERENCE 2013 RECOMMENDATIONS

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Recommendations 1. Strengthening partnership ties between large pharma companies and innovators 2. Need for collaboration between Industry and Regulators 3. Build an impetus mechanism for research and innovation for timely translation of discoveries to products 4. Need for biotech incubators cluster development and investment in competency development 5. Formation of an innovative PPP model that can be a potential solution in an increasingly challenging environment 6. Focus on regenerative medicines

1. Strengthening partnership ties between large pharma companies and innovators The current trends indicate that the kind of resources that are necessary for developing Biosimilars create high entry barriers, not only for small and mid-sized companies, but also the larger, and well-established generics players, and biopharmaceutical companies.

Recommendation Partnering within companies is becoming an important element in the networks of innovation. It enhances sustainability of an investment/capability of a company. Forming strategic alliances not only reduces manufacturing cost but also supplements the capabilities of the collaborating companies to focus on their core competencies that is one deals with product development and process while the other bring along marketing and technical knowhow 2. Need for collaboration between Industry and Regulators Currently, companies face challenges regarding the approval of Biosimilars in India. Other countries also face a problem of unclear guidelines for Biosimilars which is a big obstacle in the growth of the industry.

While regulators are thinking about new policies and coming out with new guidance notes, the industry is facing several challenges such as product differentiation, meeting requirements for inter-changeability, increasing cost of cGMP requirements on facility/manufacturing as compared to traditional drugs etc.

Recommendation Continuous dialogue between industry, supply networks and regulatory agencies is necessary for the development and manufacturing of new products. What the industry needs is a single window mechanism to regulate the research, manufacture, importation and use of products of modern Biotechnology.

3. Build an impetus mechanism for research and innovation for timely translation of discoveries to products While there has been a decline in drug approvals due to late stage failures and lack of innovation in the research pipeline, big pharma companies have started realising that in order to remain profitable it is important to collaborate with academia to enhance quality of R&D Recommendation The industry and academia linkage provides access to talent pool, laboratory infrastructure and research grants / funding and the need to commercialise ideas For industry, the benefits lie in quality R&D and a decrease in R&D budget and for the academia, it provides access to resources and funding.

4. Need for Biotech incubators and cluster development and invest in competency development Bioincubators provide infrastructure support, scientific facilities, funding support and other management services that help initiate and develop scientific inventions and contribute towards the formation of entrepreneurial companies through an array of business support resources.

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5. Formation of an innovative PPP model that can be a potential solution in an increasingly challenging environment The demand for Biosimilars is increasing gradually and the trend shows that there is likely to be a capacity gap in the future. Thus, small and medium-sized biopharmaceutical companies are likely to be severely challenged unless they find the means to scale-up and meet the market demand.

Recommendation The way forward is to enter into public-private engagement which helps emerging markets to position themselves for entry into the developed markets.

Also, PPP models can be an important instrument for translational research in medicine where significant investment is required 6. Focus on regenerative medicines Since the past few years, the field of regenerative medicine is gaining momentum and as the understanding of stem cells becomes clearer, more and more companies will target this segment of Biologics. It is an attractive opportunity as it includes translational research based on the latest and most advanced technology. Currently there are 275 therapeutic companies having focus on regenerative medicine and there are 240 cell based therapies in clinical market.

Recommendation As regenerative medicines have gone from research phase to clinical trial, private partnerships with academic and government will critical to ensure success of the same.

204, ‘B’ Block, Imperial Apartments, Greenlands Circle, Ameerpet, Hyderabad-500 016, Andhra Pradesh, India Tel: +91 40 6644 6477 / 6577, Email: info@bioasia.in www.bioasia.in