NEXT IN BIOTECHNOLOGY

B I O A S I A 2 0 1 3 . A F A C T F I L E .

FOREWORDThe 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

SponsorsWhile 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

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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, thought-

leaders, research scholars, trade experts and every other

stakeholder of this industry face-to-face under the incisive

theme of TECHNOLOGIES. BUSINESS. NEXT.

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.

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PARTICIPANTPROFILE

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.

Participant Profile

Geographic Distribution:

India 57%

Asia 24%

Europe 13%

Africa 1%

USA 5%

Pharma/Biotech Company – 60%

CRO/CMO – 15%

Venture Capitalist/Investor – 12%

Regulatory Agency – 8%

Others – 5%

Demographic:

BioAsia 2013 participants attending various sessions

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CEREMONIES

Inaugural Ceremony

Delivering the welcome address, Dr. KV Raghavan, Vice

President, FABA said that the conference will have a special

Regulators’ Meet to discuss the issues in biopharma industry.

He stated that delegates from various countries like Spain, South

Korea, Europe, Africa and Indian states including Gujarat,

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

said that the global forum has registered around 45 countries

that day with more than 500 delegates including academicians,

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.

Some of the other prominent people present at

the event included -Ms.Carmen Vela Olmo,

Hon'ble Minister of State for Research,

Development and Innovation, Ministry of

Economy and Competitiveness, Government of

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

Gangwon TechnoPark, South Korea, Dr. Maharaj

Kishan Bhan, Former Secretary, Department of

Biotechnology, Govt. of India, Dr. Freda Lewis-

Hall, 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 ReceptionThe 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.

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Valedictory Ceremony

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

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AWARDS

Genome ValleyExcellence Award:

The following awards were also presented at the inaugural ceremony:

“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

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FABA Special Award: Dr. Vijay Datla, Chairman and

Managing Director – Biological E Limited, was presented

FABA Special Award.

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

memento and citation) was awarded to Paritosh Parashar

of IIT Kanpur for a projection BMP Responsive Osteoblast

Reporter Cell Line

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:

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 for the

project on self retracting clothesline.

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CONFERENCES & PANEL DISCUSSIONS

Key statistics highlighted during the conference• 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.

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:

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

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

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.

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

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.

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Fostering Industry-Academia Linkages in Life Sciences R&D

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.

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

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BREAKFAST MEETINGS

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.

Increasing Partnerships between Biologics Innovators and Biosimilars manufacturersTuesday, January 29, 2013 | 16:30 - 18:00 Hrs

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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.

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

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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.

Next Big Trends in Healthcare: Regenerative Medicine & Stem Cells Wednesday, January 30, 2013 | 12:15 - 13:45 Hrs

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BREAKFAST MEETINGS

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.

Global Lifesciences Investments – Nurturing Entrepreneurship & Spin offsWednesday, January 30, 2013 | 13:30-15:00 Hrs

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BREAKFAST MEETINGS

Indo – SpanishPower Breakfast MeetingTuesday, January 29, 2013 | 9:00 am -11:15am

Hosted by:

Indo-SpanishBreakfast Meeting

at BioAsia 2013

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Tuesday, January 29, 2013 | 08:00-09:30 Hrs

Indo – VictoriaPower Breakfast Meeting

Hosted by:

Indo-VictorianPower Breakfast Meeting

at BioAsia 2013

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CEOCONCLAVE

Sponsored by:

CEO Conclave –Changing Phase of Indian LifeScience Industry

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.

Date: January 29, 2013

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WORKSHOPSShaping Future Innovations

Master Class on Emerging Trendsin Intellectual Property Rightsin 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:

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Master Class onEntrepreneurship in Life SciencesMonday, 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 onPrivate Equity in Life SciencesMonday, 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:

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Tech Transfer Summit -Innovation through technologyWednesday, 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 ‘Bio-

Pharma 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:

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BIOASIA CONNECT – Identity. Interact. 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.

BioAsia Connect

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BIOBAZAAROne platform. Multiple benefits.

REGULATORS’MEETImpacting Bio-business

&

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.

BioBazaar & Regulators’ Meet47

Organized by:

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INTERNATIONALTRADE SHOWShowcasing Opportunities

Delegates at BioAsia 2013 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.

International Tradeshow

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BIOASIA RELEASESOF SPECIALCOLLABORATIVERESEARCH 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 ReportRelease on Insights into theBiosimilars marketAn overall perspective

BioAsia Releases of Special Collaborative Research Reports

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BioAsia-ISB Report release onTRIPs and Innovation

Trends in the IndianBiopharmaceuticals Industry

• 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.

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MEDIACOVERAGE

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.

Pre Event Event

Category Analysis

Coverage Analysis

English Dailies

Regional Dailies

OnlineElectronic Media

Magazines

MEDIACOVERAGE

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

Highest coverage was in English dailies and

regional dailies

Media coverage has increased by over

125% in 2013

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FEEDBACK& COMMENTS

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.”

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BIO ASIACONFERENCE 2013RECOMMENDATIONS

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.

Recommendations 67

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.

RecommendationAs regenerative medicines have gone from research phase to clinical trial, private partnerships with academic and

government will critical to ensure success of the same.

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