- The document outlines the agenda and speaker details for the 5th Biosimilars Congregation 2014 conference taking place on September 10th, 2014 in Mumbai, India. - The conference will bring together leaders in the pharmaceutical, biotechnology, and regulatory fields to discuss challenges in biosimilar development and the evolving regulatory landscape. - Key topics to be covered include assessing biosimilar similarity, strategic choices for biobetters and biosimilars, safety evaluation, regulatory updates, and emerging market opportunities for biosimilars in countries like India.

1. KEY SPEAKERS:-
Rohit Arora, Associate Director - Medical Affairs & Strategy Implementation,
Anita Krishnan, Senior Research Scientist,
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,
Ashima Bhatia, Vice President Global Clinical Research & Development,
Suresh Maroli, Head Clinical Pharmacology,
Sofi Joseph, Head – Regulatory Operations,
Yasmin Shenoy, Director - Regulatory Affairs,
Milind Antani, Head - Pharma LifeSciences group,
Tej Krishen Bazaz, Director,
Sanofi
Lupin
Reliance Life Sciences
Wockhardt
Cipla
Glenmark
Sanofi
Wockhardt
Reliance Life Sciences
Pfizer
Sanofi Aventis
Nishith Desai Associates
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

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:-
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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. 11:40 – Substitution And Interchangeability Of Biosimilars And
Biologics
• Regulatory aspects of interchangeability in biologics, including
biosimilars
• Issues with regard to substitution in the case of multiple
biosimilars
• Clinical aspects of substitution in biosimilars
• How will you demonstrate the higher standards of
interchangeabiity?
08:30 – Coffee and registration
09:30 – Morning Chair’s opening remarks
09:40 – Similarity in Biosimilars
10:10 – Strategic Choices For
Biobetters And Biosimilars
10:40 – Morning Coffee/Tea & Networking
• The need for similarity in analytical, biological and preclinical
aspects
• The challenges faced in achieving similarity
• Steps in assessing similarity
• Case study of a failed technology transfer for a biosimilar product
• Today’s biosimilar market and expectations for the future
• Commercial attractiveness for Antibody Drug Conjugate
• Antibody Drugs Conjugates – developing the therapeutic windows
• Leveraging the biosimilar development expertise into biobetters
Morning Keynote Address 1:
Morning Keynote Address 2:
Afternoon Chair’s person
14:00 – The Science and Business of Reference Standards
14:30 – Safety Evaluation in Biosimilars
15:00 – Afternoon Coffee/Tea & Networking
15:20 – Evaluating the potential revenue streams achievable
from biosimilar production
15:50 – Updates on current regulatory landscape
• Investing on Biosimilar: what to expect for a return on investment
(ROI)
• Profit margins in production of biosimilar
• Presentation of a biosimilar sales forecast from a manufacturing
view
• Evaluation of biosimilar in unit floor prices in a hyper-competitive
market
Anita Krishnan, Senior Research Scientist,
Pravin Ghadge, Head - Medical Writing & Pharmacovigilance,
Rohit Arora, Associate Director - Medical Affairs & Strategy
Implementation,
Lupin
Reliance Life Sciences
Sanofi
(http://www.linkedin.com/pub/anita-krishnan/11/bb9/28)
(http://www.linkedin.com/pub/dr-pravin-ghadge-
md/15/835/1a4)
(http://www.linkedin.com/in/drrohitarora)
MARKET ANALYSIS
CHALLENGES & OPPORTUNITIES
12:10 - 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,
Ashima Bhatia, Vice President Global Clinical Research &
Development,
Ashwani Pandita, Head Quality Management & Training,
Sanofi
Thermo Fisher Scientific
Wockhardt
Glenmark
(http://www.linkedin.com/pub/dr-chirag-trivedi/21/b0/344)
(http://www.linkedin.com/pub/dr-tej-krishen-bazaz/17/776/612)
(http://www.linkedin.com/pub/dr-ashima-
bhatia-md/15/945/728)
(http://www.linkedin.com/pub/ashwani-pandita-rqap-
REGULATORY
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
Siddarth S. Chachad, Head - Clinical Development,
Anita Krishnan, Senior Research Scientist,
Suresh Maroli, Head Clinical Pharmacology,
Cipla
Lupin
Reliance Life
Sciences
(http://www.linkedin.com/pub/anita-krishnan/11/bb9/28)
12:50 - 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
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
Debolina Partap, AVP & Head Legal,
Milind Antani, Head-Pharma LifeSciences group,
Yasmin Shenoy, Director-Regulatory Affairs,
Sofi Joseph, Head–Regulatory Operations,
Wockhardt
Nishith Desai
Associates
Sanofi Aventis
Pfizer
(http://www.linkedin.com/pub/debolina-partap/1b/388/424)
(http://www.linkedin.com/pub/milind-antani/2/69a/5b5)
(http://www.linkedin.com/pub/sofi-joseph/12/307/632)
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India

6. FLOOR PLAN:- Book your stalls now before they run out !!!
1
2 5
3
4
CONFERENCEHALL1
CONFERENCEHALL2
CONFERENCEHALL3
1
Coffee / Tea / Networking Area
POOL
SIDE AREA
NETWORKING
LUNCHEON
4
5 6
2
3
REGISTRATION
DESK
6
5th Biosimilars Congregation 2014
FLOOR PLAN - Book your stalls now before they run out !!!

7. Queries:
Payment terms:
Substitutions/name changes or cancellations:
Indemnity:
Fee:
How we will contact you:
Should you have any questions on bookings,
Please feel free to contact us.
Email:
Web:
India Office: Tel: +91 044 64536444
Virtue Insight requires the full amount to be paid before the
conference. Virtue Insight may refuse entry to delegates who have
not paid their invoice in full.
There is a 50% liability on all bookings once made, whether by post,
fax, or email. There is a no refund policy for cancellations received
on or after one month before the start of the event. Should you decide
to cancel after this date, the full invoice must be paid. Conference
notes will then be sent to you. Unfortunately, we are unable to transfer
places between conferences and executive briefings. However, if you
cannot attend the conference, you may make a substitution/name
change at any time, as long as we are informed in writing by email,
fax or post. Name changes and substitutions must be from the same
company or organization and are not transferable between countries.
Virtue Insight reserves the right to make alterations to the
conference/executive briefing content, timing, speakers or venue
without notice. The event may be postponed or cancelled due to
unforeseen events beyond the control of Virtue Insight. If such a
situation arises, we will refund your registration fee and we will try
to reschedule the event.
The conference fee includes lunch, refreshments and conference papers
provided on the day. This fee does not include travel or hotel
accommodation.
Virtue Insight's preferred method of communication is by email and
phone. Please ensure that you complete the registration form in full
so that we can contact you.
Kohinoor Continental Hotel
Andheri Kurla Road
Andheri ( E )
Mumbai 400059 - India
Tel: 91 22 66919000 / 91 22 28209999
General information Venue:
info@virtueinsight.com
http://www.virtueinsight.com
www.virtueinsight.com
News Updates:
Please tick if you do not wish to receive email updates in
the future
Registration Form
10th September 2014, Kohinoor Continental Hotel, Mumbai, India
Early Bird Discount Rate Till 28th July 2014
Standard Rate (From 29th July 2014)
Group Bookings
Spot Registration:-
Methods of Payments:
By Bank Transfer:
1 Day conference per delegate - Fee: INR 5,000 + Tax
1 or 2 Day conference per delegate - Fee: INR 06,000 + Tax
For 3 and above delegates - per delegate - Fee: INR 05,000 + Tax
1 Day conference per delegate - Fee: INR 07,000 + Tax
Forename ............................Surname ................................
Job Title ..............................Company ................................
Official Contact Number .......................................................
Address .............................................................................
.............................................................................
Country ...............................Postcode..................................
Phone ..................................Fax ........................................
Email .................................................................................
I confirm that I have read & agree to the
terms and conditions of booking..... (Please Tick)
Signature ...........................................................................
Complete and return the above registration form via
post or email, together with your cheque payable to Virtue Insight.
Virtue Insight
830092431
IDIB000V080
Indian Bank.
118 - 119, Indira Nagar, Valasaravakkam,
Chennai 600 087,Tiruvallur district,Tamil Nadu, India
By Cheque -
Account Name -
Account Number -
Sort code -
Bank Address -
Registration Form Details:
RESERVATION PRICING: