Key Speakers Include - Company Profiles and Conferences

Conference Hashtag - #VI_Pharma
Key Speakers Include:-
Arun Bhatt, President,
Clininvent Research
R. H. Jani, Senior Vice President, Clinical R&D,
Purnima Sharma, Managing Director,
Dilip Pawar, Director and Head Clinical Development,
Kaustubh Berde, Vice President & Head - International Formulations, Panacea Biotec
Yatin Gokarn, Narotam Sekhsaria Distinguished Professor of Chemical Engineering,
Institute of Chemical Technology. (Former Associate Director, Genentech (San
Francisco) )
Anurita Majumdar, Director - Medical & Regulatory - India & South Africa, Eli Lilly
Kedar Suvarnapathaki, Head - Regulatory Affair,
Yasmin Shenoy, Director-Regulatory Affairs,
Milind Antani, Head-Pharma LifeSciences group,
Cadila
Biotech Consortium India Limited BCIL
Annaswamy Vaidheesh, Vice President- Government affairs Asia Pacific, Johnson &
Johnson
Bobby George, Asssitant Vice President and Head, Regulatory Affairs, Reliance Life
Sciences
Dr Reddys
Chirag Trivedi, Associate Director - Project Management & Strategic Initiatives, Sanofi-
Aventis
Plus Many More...
Boehringer Ingelheim
Sanofi-Aventis
Nishith Desai Associates

SUPPORTED BY
3rd Biosimilars Congregation 2013
9th April 2013, Hyatt Regency, Mumbai, India
PLD SPONSOR
ORGANIZED BY

CONFERENCE INTRODUCTION:-
India is one of the biggest sources of biosimilars and is also an emerging market for biosimilars with its high population and investment in technology. It can emerge
as one of the leaders in global biologic development by the end of this decade
According to Global Industry Analysts Inc.. The global biopharmaceutical market was valued at $138 billion in 2012 and is expected to grow to over $320 billion by
2020. A research predicts that annual revenues for biopharmaceuticals have been rising year on year since 2001. In 2011, biopharmaceuticals accounted for 15.6%
of the total pharmaceutical market. The next decade could see a paradigm shift in biomanufacturing technologies, including improvements in equipment efficiency
and the introduction of novel therapies. In particular, disposable bioprocessing equipment and microbial technologies are expected to dominate the manufacturing
environment and become the “hallmark” of biopharmaceutical manufacturing. Biologicals have potential to reach up to 50% share in global pharmaceutical market in
the next few years.
Indian firms seem keen on repeating their successes achieved in developing and commercializing biosimilars. Also, the Indian biotechnology industry is also gaining
momentum, the biosimilars sector is predicted to treble in value in the next five years, from $481 million in 2011 to $1.4 billion in 2016. More than 20 biosimilar
companies are currently operating in India, with around 55 products already on the market. India is one of the leading contributors in the world biosimilar market
and is the third-largest in the Asia-Pacific region, after Australia and China.
The recent establishment of regulatory guidelines for biosimilars in India is expected to add further momentum to the growth of the global biosimilars market.
Increasing pressure from governments and insurers for greater biologic competition, there exists an incredible opportunity for biosimilar producers to capitalise on
what is set to become the fastest growing sector of the pharmaceutical industry. Due to the limited clinical database at the time of approval of a biosimilar, vigorous
pharmacovigilance is required. & Biosimilars are set to become an important part of the future medicines market.
The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.
Hence, this 3rd Biosimilars Congregation 2013 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical
development, to the legal and economic aspects. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. This
event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting Biosimilars development.
It gives me great pleasure in welcoming all of you to the Virtue Insight's 3rd Biosimilars Congregation 2013. I wish and pray that all our efforts will be
beneficial to our industries folks at large.
KEY THEMES DISCUSSED AT THIS SUMMIT:-
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How should the pharma and generics industries approach the rapidly emerging and developing biosimilar market & what are the future trends for the Biosimilar
market?
Finding the current and future issues in Biosimilars & how to build Public Confidence and Interest?
How to maximise the strategic partnerships to enter into the biosimlar markets
Analysing the next generation monoclonal antibody development & the clinical challenges with biosimilar drug development
Identifying the successful development plans for the biosimilars market in India
What are the considerations and capabilities required for biosimilar product development
How to overcome challenges in development and commercialization of Biosimilars & How to determine the right investments & potential returns?
Evaluating the key criteria that need to be considered to gain speedy entry into Biosimilar market
New frontiers in cell line development and opportunities for biosimilars
Innovative ideas - How to reach the target audience more effectively and quickly.
Why is the patient safety a concern in the Biosimilar & how to design and conduct global biosimilar clinical trials?
What are the necessary requirements for approval and launch of a biosimilar trial?
How to determine the pricing strategies of biosimilar companies.
What are the regulations and guidance for development and manufacture of biosimilars in India
Legal/IP for Biosimlars
How to protect formulations in biosimilar products between the licensing parties.
Identifying the best strategy adopted by global biosimilar companies.
What originators and follow-n companies need to know?
Power packed Q&A session moderated by chairperson where everybody is a speaker
Be part of a major networking opportunity
WHO SHOULD ATTEND:-
WHY SHOULD YOU ATTEND:-
3rd Biosimilars Congregation 2013
9th April 2013, Hyatt Regency, Mumbai, India
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:
Biopharmaceuticals/ Biotherapeutics, Follow on Biologics/Follow on Proteins/Biosimilars, Biologics/Biotechnology/ Biogenerics, Legal Affairs, Intellectual Property
Health Economics, Pricing and Reimbursement, Clinical Immunology, Principal Scientist, Chief Scientific Officer, Process Control and Analytical Technologies, Analytical
Characterisation, Regulatory Compliance, Pharmacovigilance, Drug Safety & Risk Management, Quality Affairs/ Quality Control, New Product Development, Process
Science, Portfolio Management, Research & Development, Business Development, Business Operations, Scientific Affairs, Commercial Affairs, Marke
3rd Biosimilars Congregation 2013 – “Uniting industry leaders to analyse advanced commercial developments & to identify successful management
strategies of Biosimilars”
Get more from the event, with a broader scope bringing the whole communications value chain together? Enjoy and make the best out of our dedicated networking
drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business
models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your
tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and
litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for
increased profit margins.

08:30 – Coffee and registration - An opportunity to meet and to
network with your conference colleagues.
09:30 – Chairperson opening remarks
MARKET OVERVIEW & ANALISYS
09:40 – Morning Keynote Address 1 – Key drivers for the
development of biosimilars
• Identifying the future of Biosimilars in Specific Emerging Markets
• What are the key opportunities in the emerging markets?
• Analysing the key action plan necessary to fast-track the
development of current biosimilars market
• Overview of Biosimilar Trends in other countries – what are the
lessons to be learned?
10:10 – Morning Keynote Address 2 – Analysing the next
generation monoclonal antibody development & the clinical
challenges with biosimilar drug development
• What are the special requirements for demonstrating bio similarity
of monoclonal antibodies?
• The advancement of monoclonal antibody technology and the
enhancement of oncologic disease therapy by next generation
antibody drugs
• Promising early clinical studies and growing interest
• The clinical challenges in the biosimilar drug development:
manufacturing, preclinical testing, and clinical trial implementation
• Future opportunities
Yatin Gokarn, Narotam Sekhsaria Distinguished Professor of
Chemical Engineering, Institute of Chemical Technology.
(Former Associate Director, Genentech (San Francisco) )
CHALLENGES & OPPORTUNITIES
10:40 – Keynote Panel Discussion: Market Opportunities and
Commercial Challenges
• Update on biosimilars in India - Current trends for biosimilar
approvals, and new and future Guidelines – Get yourself updated
• How to commercialise biosimilar?
• Finding the opportunities in emerging markets
• Scientific advice and how to achieve the best Dossier
• Identifying the latest technological advances in Biosimilar
• Pricing and reimbursement of biosimilars – Identifying successful
pricing strategies
Moderator:
Panellists:
Annaswamy Vaidheesh, Vice President - Government affairs
Asia Pacific, Johnson & Johnson
(http://www.linkedin.com/pub/annaswamy-vaidheesh/5a/b4b/458)
Yatin Gokarn, Narotam Sekhsaria Distinguished Professor of
Chemical Engineering, Institute of Chemical Technology.
(Former Associate Director, Genentech (San Francisco) )
Kaustubh Berde, Vice President & Head - International
Formulations, Panacea Biotec (http://www.linkedin.com/pub/kaustubhberde/6/62a/10a)
11:20 – Morning Coffee/Tea & Discussion
3rd Biosimilars Congregation 2013
9th April 2013, Hyatt Regency, Mumbai, India
CLINICAL STUDIES FOR BIOSIMILARS
11:40 – Clinical Studies of Biosimilars: Trials and Tribulations
• Biosimilars are not generics but complex molecules
• Non-clinical tools for predicting clinical safety and efficacy provide
limited information for planing clinical trial.
• Some of the characteristics of biosimilars - formulation,
immunogenicity - require special attention
• Conduct of biosimilar trials requires a thorough regulatory and
ethics review and competence in the sponsor / site team
Arun Bhatt, President, Clininvent Research
(http://www.linkedin.com/pub/arun-bhatt/5/431/958)
12:10 – Afternoon Keynote Address – Determining the type &
volume of clinical data that is essential for establishing
biosimilarity
• Striking a balance between requiring larger and more
sophisticated trials and facilitating market entry for biogenerics
• Understanding the patient perspective in the biosimilar
conversation
o Biologic and biosimilar safety & efficacy
o Pharmacovigilance: collecting, monitoring, researching,
assessing and evaluating adverse events
o Cost to the patient
o Therapeutic substitution issues
o Barriers to care
• DCGI – requirement and their opinion
• Extrapolating data obtained in clinical trials for a reference product
to support biosimilar applications
12:40 - Networking luncheon - Take your discussions
further & build new relationships in a relaxed
& informal setting...
RESEARCH-BASED INDUSTRY BIOSIMILAR
14:00 – What does the future of India pharma hold? &
Research-based industry biosimilar strategies
• Overview of EMA and FDA biosimilar guidelines–lessons to be
learned?
• Combining multivariate results to identify successful outcomes
• The new innovator hub? A move towards R&D
• What are the different approaches, that the companies taking?
• Outlining the challenges that exist at every phase of research
• Successful designs for R&D collaborations and tech transfer
necessary for the biosimilars Market

14:30 – Afternoon Keynote Panel Discussion: Biosimilars
development and impact on clinical practice
• How should biosimilars be developed?
• What are the regulatory challenges and expectations currently in
India and what can we expect?
• What does an ideal legal/regulatory framework looks like for a
successful biosimilar model?
• What impacts will we see in patients and what does this mean for
drug developers?
• What can companies do to ensure the Quality and safety of
biosimilars?
Moderator:
Bobby George, Asssitant Vice President and Head, Regulatory
Affairs, Reliance Life Sciences
Panellists:
15:10 - Future of Biosimilars/Biobetters in India
• Considering the growing importance of biobetters over biosimilars
• Considering and comparing facts like – ROI, gaining competitive
edge, faster approval timeline and Innovator responses to the
threat of competition
• Successful methods for biobetter developments
• Partnering trends of biosimilars & biobetters in emerging markets
• What different development approaches are companies taking?
• What will be the involvement of companies in
India vs. those in developed countries?
15:40 - Afternoon Tea/Coffee
BUSINESS MODEL
R. H. Jani, Senior Vice President, Clinical R&D, Cadila
Dilip Pawar, Director and Head Clinical Development, Dr
Reddys
Chirag Trivedi, Associate Director - Project Management &
Strategic Initiatives, Sanofi-Aventis
BUSINESS MODELS
BIOMANUFACTURING, BIO-PROCESSING & PRODUCTION
16:00 - Tactical alliance between innovators, generics
manufacturers and biotechs in emerging markets
• Identifying the legal considerations for the market access?
• How will the partnerships and collaborations aid in branding and
market positioning of the products?
• Will this trend have a significant impact on R&D and driving
innovation from the big Pharma companies
3rd Biosimilars Congregation 2013
9th April 2013, Hyatt Regency, Mumbai, India
REGULATION OVERVIEW & UPDATE
16:30 – Panel Discussion - Update on Indian biosimilar
regulations & overcoming regulatory challenges in Asian
Biosimilar market –Today & Tomorrow
• What are the regulations and guidance for development and
manufacture of biosimilars
• Update on biosimilar, India regulation – way forward
• Current practices in India and examining various methods to
improve biosimilar
• Important insights on rapidly evolving biosimilar regulations in the
market
• Strategic challenges in the evolution of Indian regulations in next
decade
• Keep abreast with the changing international regulations of
biosimilar
• How to protect formulations in biosimilar products between the
licensing parties.
• Legal for biosimilars - turning antitrust laws to your advantage in
the generics and biosimilars
• Legal/IP for biosimlars
Moderator:
Panellists:
BUSINESS MODEL
Milind Antani, Head-Pharma LifeSciences group, Nishith Desai
Associates
Kedar Suvarnapathaki, Head - Regulatory Affair, Boehringer
Ingelheim
Yasmin Shenoy, Director-Regulatory Affairs, Sanofi-Aventis
Bobby George, Asssitant Vice President and Head, Regulatory
Affairs, Reliance Life Sciences
Anurita Majumdar, Director - Medical & Regulatory - India &
South Africa, Eli Lilly (http://in.linkedin.com/pub/dr-anurita-majumdarmd/20/a57/a86)
17:10 - Chairperson's closing remarks and end of conference
17:15 - 18:00 Networking Drinks - Take your discussions
further & build new relationships in a relaxed
& informal setting...
End of the 3rd Biosimilars Congregation 2013

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