“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”

1. KEY SPEAKERS:-
Vimal Sanghavi, Vice President Clinical Trial Management,
Jim Thorn, EMEA Marketing and Applications Leader,
Martin Bluggel, CEO,
Pranjal Bordoloi, Senior General Manager – Late Phase Clinical Trials & Pharmacovigilance
Operations,
Pravin Ghadge, Head-Medical Writing & Pharmacovigilance,
Debolina Partap, AVP & Head Legal,
Siddarth S. Chachad, Head - Clinical Development,
Ashwani Pandita, Head Quality Management & Training,
Chirag Trivedi, Director & Head of Clinical Study Unit,
Manish Shah, General Manager, Global Clinical Operations,
Suresh Maroli, Head Clinical Pharmacology,
Sofi Joseph, Head – Regulatory Operations,
Yasmin Shenoy, Senior Director - Regulatory Affairs,
Milind Antani, Head - Pharma LifeSciences group,
Amey Mane, DGM-Medical Affairs,
V K Sharma, Associate Vice President,
Ambrish Srivastava, Asst Vice President,
Tej Krishen Bazaz, Director,
Lambda
SCIEX Separations (UK)
Protagen Protein Services (UK)
Lambda
Reliance Life Sciences
Wockhardt
Cipla
Glenmark
Sanofi
Wockhardt
Reliance Life Sciences
Pfizer
Sanofi
Nishith Desai Associates
Wockhardt
Unichem Laboratories
Alkem Labs
Thermo Fisher Scientific
Plus Many More...
Conference Hashtag - #VI_Pharma

2. ORGANIZED BY
ASSOCIATE PARTNER
SUPPORTED BY
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India
BRONZE PARTNER
SILVER PARTNER
SMS PARTNER
GOLD PARTNER

3. CONFERENCE INTRODUCTION:-
The biosimilar industry had a tough 2013 driven by the Indian economy having to experience one of its most turbulent times. Indian bio-pharma sector decelerated
to 5.2 per cent in 2013 from an average growth of 12 percent in the previous year. Adverse policy moves like the foreign direct investment (FDI), drug pricing,
clinical trials and compulsory licensing made the matters worse. An overactive US FDA hauled up several leading Indian pharma companies for non-compliance. All
these negative developments together turned 2013 into an 'Annus Horribilis’ for the Indian bio-pharma sector. The global biosimilars market is expected to be worth
$19.4 billion by 2014, growing at a Annual Growth Rate (CAGR) of 89.1% from 2009 to 2014.The American products Follow-on protein market (including North
America and Latin America) is expected to account for nearly 35.3% of the total income in 2014. By 2015, the sales of biosimilars is expected to hit USD 3.7bn, a
near exponential increase from USD 378 million back in 2011.
There are currently more than 80 biosimilars under development worldwide and this market could potentially become the only fastest-growing biologics sector by
2020. So, where did all this momentum come from? Why does biosimilars suddenly display an accelerated growth potential? And how have market dynamics
received and encouraged this growth? If Indian biopharmaceutical players are to compete effectively on the global scale and capture 10% of the global biosimilars
market by 2020, India’s private sector will have to invest a considerable amount of capital in building the necessary manufacturing capacity and skills base. At the
same time, the Government of India will also have to provide the necessary enabling environment. India’s biopharma sector consists primarily of monoclonal
antibodies, vaccines, recombinant proteins and diagnostics, and the guidelines for biosimilars are already in place.
Almost 50 biosimilars have already reached the Indian market, and they are sold at discounts of as much as 85%, putting them within reach of the masses. Demand
seems likely to grow considerably, as India becomes more affluent. US investment bank Goldman Sachs estimates that the number of Indians with annual incomes
of between $6,000 and $30,000 may increase by 250-300 million during the next decade alone. The global biosimilars market has even more potential for the most
efficient Indian biosimilars manufacturers, as the market will be characterised by price competition, even when there are only a less number of rival products. It is
said, the manufacturers of branded products are likely to use second-generation products with more convenient administration schedules as a means of defending
their territory. Few of these manufacturers may also try to crowd out the competition by producing their own biosimilars. So the competition is likely to be intense.
One of the most critical problem faced in India is the inaccessibility to healthcare. To address this issue, the government needs to not only relook at its public health
policy but also bring in various regulatory reforms including a smarter approval of pathway that cuts the cost of drug development to allow affordable innovations.
Regulatory reforms also need to address issues related to intellectual property and also clinical trials. Use of technology for procurement and distribution will also
enable better access to the drugs
This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.
Hence, this 5th Biosimilars Congregation 2014 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. This Biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliver
safe, biosimilar products to the marketplace. 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 5th Biosimilars Congregation 2014. I wish and pray that all our efforts will be
beneficial to our industries folks at large.
WHY SHOULD YOU ATTEND:-
broader scope bringing the whole communications value chain together?
dedicated networking drinks time,meet the leading international vendors
Expand your knowledge
Get more from the event, with a Enjoy and make the best out
of our showcasing the products of tomorrow in the co-located
exhibition. 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 margin
KEY THEMES DISCUSSED AT THIS SUMMIT:-
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Commercialization and development strategies to gain a competitive advantage
Calculating possible revenue streams from biosimilar production
How should the pharma and generics industries approach the quickly emerging and developing biosimilar market?
What is the future of next generation Biosimilars?
The commercial challenges and opportunities to develop Biosimilars
The growing importance of biobetters over biosimilars
Gain in-depth knowledge on role of technology transfer - How does this affect market access?
How do policy makers shaping the contours of this new generic frontier, what implications they have for present biologic drug development & patent protection?
Next generation monoclonal antibody development and clinical challenges faced with biosimilar drug development
Technical case study for analytical and clinical comparability strategies
The Legal/IP for Biosimlars
How to maximise strategic partnerships to enter into the biosimlar market
New frontiers in cell line development and opportunities in biosimilars
How to reach the target audience more effectively and quickly.
Evaluating the key criteria that has to be considered to gain speedy entry into Biosimilar market
How global pharmaceutical market is turning to be more specialized & precise?
Identifying the experience on follow on biologics, generics and biosimilars has been so far
Gain up to date insight about the regulatory landscape and how it is effecting the industry
Boost your industry knowledge and relationships by networking and learning from key industry and academic leaders
WHO SHOULD ATTEND:-
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:
Biopharmaceuticals/ Biotherapeutics, Follow on Biologics/Follow on Proteins, 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
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India

4. Biosimilar Clinical Trials –
Challenges and Strategies
11:40 – Topic TBC
12:10 - Expanding the Role of Capillary Electrophoresis for the
Development, Characterization & Quality Control of Biologics
08:30 – Coffee and registration
09:30 – Chairpersons’s opening remarks
09:40 –
10:10 – Reaching and
demonstrating Biosimilarity by state of the art analytics
10:40 – Morning Coffee/Tea & Networking
• Regulatory demand for demonstrating biosimilarity
• Monitoring reference molecule
• Matching critical quality attributes during development
• Comparability exercise
V K Sharma, Associate Vice President,
Pranjal Bordoloi, Senior General Manager – Late Phase Clinical
Trials & Pharmacovigilance Operations,
Martin Bluggel, CEO,
Speaker TBC,
Jim Thorn, EMEA Marketing and Applications Leader,
Unichem Laboratories
Lambda
Protagen Protein Services (UK)
Medidata (UK)
SCIEX
Separations (UK)
(https://www.linkedin.com/pub/v-k-sharma/23/ba/197)
(https://www.linkedin.com/pub/martin-bl%C3%BCggel/2/891/89a)
(https://www.linkedin.com/pub/jim-thorn/9/361/428)
Morning Keynote Address 1:
Morning Keynote Address 2:
14:30 – Safety Evaluation in Biosimilars
15:00 – Clinical trials of Biosimilars: Challenges and
opportunities
15:30 – Afternoon Coffee/Tea & Networking
15:50 – Challenges in Patient Recruitment and Retention
• Regulatory aspects of a Biosimilar clinical trial
• Protocol development-Innovation in endpoints
• Challenges in the clinical operations
• Patient-centric approaches to increase patient recruitment
• Enhancing the site capabilities to improve the patient experience
• Social media and physicians involvement to improve patient
recruitment and retention
• Addressing the ‘weak link’ in medical research
Pravin Ghadge, Head - Medical Writing & Pharmacovigilance,
Amey Mane, DGM-Medical Affairs,
Reliance Life Sciences
Wockhardt
(http://www.linkedin.com/pub/dr-pravin-ghadge-
md/15/835/1a4)
(https://www.linkedin.com/pub/dr-amey-mane/6/156/7b1)
MARKET ANALYSIS
CHALLENGES & OPPORTUNITIES
13:50 - Panel Discussion: Strategies to Improve Sponsor, Site,
and CRO
Moderator:
Panellists:
• Overview of recent trends in clinical research
• Cultural considerations for a successful partnering
• Effective biosimilars clinical study designs for india
• Identifying the role of each stakeholder
Chirag Trivedi, Director & Head of Clinical Study Unit,
Tej Krishen Bazaz, Director,
Manish Shah, General Manager, Global Clinical Operations,
Ashwani Pandita, Head Quality Management & Training,
Sanofi
Thermo Fisher Scientific
Wockhardt
Glenmark
Lambda
(http://www.linkedin.com/pub/dr-chirag-trivedi/21/b0/344)
(http://www.linkedin.com/pub/dr-tej-krishen-bazaz/17/776/612)
(https://www.linkedin.com/pub/manish-shah/18/678/1a2)
(http://www.linkedin.com/pub/ashwani-pandita-rqap-
gcp/14/997/590)
(https://www.linkedin.com/pub/vimal-sanghavi/11/bb9/577)
Vimal Sanghavi, Vice President Clinical Trial Management,
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India
11:00 – Panel Discussion: Challenges And Opportunities For
Biosimilars In Emerging Markets
Moderator:
Panellists:
• Market size of biosimilars in the emerging market
• Selling of biosimilars in the emerging markets having government
protectionism
• Competition concentration of biosimilars in the emerging market
• Emerging markets that are highly attractive for biosimilars in india
Ambrish Srivastava, Asst Vice President,
Siddarth S. Chachad, Head - Clinical Development,
Suresh Maroli, Head Clinical Pharmacology,
Alkem Labs
Cipla
Reliance Life
Sciences
12:40 - Networking - Take your discussions
further & build new relationships in a relaxed
& informal setting...
luncheon

5. 17:00 – Chairperson’s closing remarks and end of conference
V K Sharma, Associate Vice President, Unichem Laboratories
(https://www.linkedin.com/pub/v-k-sharma/23/ba/197)
17:10 - 18:00 Networking Drinks - Take your discussions
further & build new relationships in a relaxed
& informal setting...
16:20 – Panel Discussion: Regulatory Updates and
Development
Moderator:
Panellists:
• Clinical approvals for biosimilars
• Regulatory differences between the DCGI, FDA, EMA and local
agencies in india and other emerging markets such as china & SEA
• How to demonstrate the process consistency and its requirements
• Updates on Biosimilars guidelines in indian market
• Regulatory demand for demonstrating biosimilarity
Milind Antani, Head-Pharma LifeSciences group,
Debolina Partap, AVP & Head Legal,
Yasmin Shenoy, Senior Director - Regulatory Affairs,
Sofi Joseph, Head–Regulatory Operations,
Nishith Desai
Associates
Wockhardt
Sanofi
Pfizer
(http://www.linkedin.com/pub/milind-antani/2/69a/5b5)
(http://www.linkedin.com/pub/debolina-partap/1b/388/424)
(http://www.linkedin.com/pub/sofi-joseph/12/307/632)
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India
REGULATORY

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