This Workshop addresses a step by stepwise approach to globalize your Biosimilars product covering the following: 08:50 - Opening

Remarks 09:00 - Regulatory landscape whats new 09:30 Bioequivalence studies 10:10 Bioanalytical 10:50 Morning Refreshment Break 11:20 Phase III design considerations 11:50 - Reference product 12:05 Operational Challenges 12:35- Safety data- pre and post market 12:50 Q & A 13:10 Lunch

Pre Conference Workshop: Wednesday 27th February 2013 Global Biosimilars Development from lab to clinic Half a day from: 09:00am 13:10pm
Your Workshop leader: Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International Rodeina Challand Executive Director Biosimilars Development; PRA International Has 25 years experience in Healthcare, Science Research and Pharmaceutical industry, across a wide range of roles including Clinical Development Strategies for Biosimilars in Hospira Inc and Head of Clinical Operations in the EU. After graduating from London University in Biochemistry, worked in Cancer Research for 6 years and then joint the Pharmaceutical Industry. For over 10 years she directed the conduct of phase l to phase lV clinical trials including large pivotal multinational, multicenter trials, most of which have led to Marketing Authorisation. She was the lead in the development of Hospiras first Biosimilar, Hospira GCSF, from lab to clinic. Rodeina was also a member of the European Generic Association Biopharmaceutical Group (EBG) who played a key role in the development of the EMA Biosimilar Guidelines since the start in 2004.

08:00 09:00 Registration

Program Day One Biosimilars and Follow-On Biologics 2013 Americas Thursday 28th February 2013

09:10-09:50 - Current Commercial Trends in Biosimilars: Seeing the Bigger Picture Assessing the Promise and Potential of Biosimilars Latest Progress in Biosimilar Development Provider Perspectives and Acceptance of Biosimilars Payer Perspectives and Formulary Acceptance Biosimilars ROI Considerations James Harris, CEO, Healthcare Economics LLC 09:50-10:30 - A US Regulatory Update on the Biosimilars Industry Outlook for Biosimilars An update on the Biologics Price Competition and Innovation Act (BPCIA) What does Abbott Laboratories stance on the BPCIA mean for the industry? What does the BPCIA mean for Healthcare reform? F. Owen Fields, Ph.D. Vice President, Regulatory Strategy WRD, Pfizer Bruce A. Leicher, Senior Vice President and General Council, Momenta Pharmaceutica, Inc. 10:30-11:10 US Biosmilars Law Opportunities and Challenges Open issues for FDA How implementation is proceeding Key signal of congressional intent Bruce A. Leicher, Senior Vice President and General Council, Momenta Pharmaceutica, Inc. F. Owen Fields, Ph.D. Vice President, Regulatory Strategy WRD, Pfizer 11:10 11:40 Morning Refreshments and Networking (Exhibitors Area)

09:00 09:10 Chairpersons Welcome and Opening Remarks Rodeina Challand, PRA International

14:20- 14:50 - ROUNDTABLES (1) A choice of roundtables to join to discuss topics pertaining to the biosimilars industry. Choose from the following topics: Legal/regulatory requirements PAT and biosimilars Market access Proving bioequivalence Biosimilars and BRIC Innovations and biobetters

14:50 15:30 - Biosimilars and Biomarkers: challenges and tribulations (Full Presentation to be announced shortly) Claudio Carini, MD, PhD, FRCPath, GlobalClinical Immunology & Biomarkers Lead, Pfizer

15:30 16:00 Networking Afternoon Refreshments (Exhibitors Area) 16:00 16:40 Addressing the challenges of Biosimilar Clinical Trials Dr. Nigel Rulewski, Vice President, Global Strategic, Drug Development, Quintiles

11:40 12:20 - Understanding the Global Regulatory Landscape for Biosimilars EU vs the US: what are the key differences? Understanding the differences in sourcing from US and EU markets What other countries do you need to be aware of? Nikhil Mehta, Ph.D. Vice President, World Regulatory Affairs Grp II, Merck & Co. Inc.

16:40 17:30 - A Clinical Perspective Development of Biosimilars (Case Studies) Rodeina Challand, Executive Director, Biosimilars Development Scientific Affairs, PRA International .

17:30-17:40 - Chairpersons Closing Comment Rodeina Challand, PRA International 17:50 Networking Drinks Reception. Take your discussions further and build new relationships in a relax and informal settings.

12:20 13:00 - PANEL DISCUSSION: Obstacles and hurdles for entering the biosimilars market An interactive discussion on the barriers of entry for developing biosimilars; discussing topics such as Cost of development Legal requirements Technology demands James Harris, CEO, Healthcare, Economics LLC Nikhil Mehta, Ph.D. Vice President, World Regulatory Affairs Grp II, Merck & Co. Inc. Magdalena Leszcyniecka, CEO, STC Biologics

13:00 14:00 - Networking Lunch

17:50 Networking Drinks Reception. Take your discussions further and build new relationships in a relax and informal settings

Program Day Two Biosimilars and Follow On Biologics 2013 Americas Friday 1st March 2013
08:00 08:50 Registration 09:00 09:10 Chairmans Welcome and Opening Remarks

09:10 09:40 Addressing the development of Biosimlars and Preclinical challenges Determining appropriate types of pre - clinical studies Establishing criteria of Bioequivalence Addressing dissimilarities Distinction between equivalence vs. noninferiority Managing compressed time lines Senior representative awaiting for full presentation To be announced shortly 09:40 10:10 Comparability Exercise for Biosimilars Quality strategy in developing Biosimilars State- of the art analysis Case studies for Biosimilarity Martin Bluggel, Chief Business Officer, Protagen Protein Services GmbH

13:50 14:30 Panel Discussion : Understanding the Nuences and Implications of the FDA Guidelines on Biosimilars John M. Pakulski R.Ph. Head of US Biopharmaceutical Regulatory Affairs, Sandoz Inc. F. Owen Fields, Ph.D. Vice President, Regulatory Strategy WRD, Pfizer

14:30 15:00 - PAT and Quality Design for Biosimilars The current status of QbD for generics and what this means for Biosimilars Managing the high cost of manufacturing by implementing a QbD approach

15:00 15:30 Networking Afternoon Refreshments (Exhibitors Area) 10:10 10:40 Recommendations and requirements for the design of bioanalytical testing used in comparability studies for Biosimilar drug Development Jeff Thomas Project Manager / Principal Investigator Intertek Pharmaceutical Services

10:40 11:10 The Biosimilars (and Biobetters) Pipeline Implications for Product Developers Ronald A. Rader, President & Publisher of BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, Biotechnology Information Institute 11:10 11:40 - Morning Refreshments and Networking (Exhibitors Area) 11:40 12:10 Providing Bioequivalence for the regulators (Bioequivalence Services) Understanding what clinical data is needed for approval What other information can be used to prove Bioequivalence Bioequivalence of follow-on or biogeneric biological Dr. Zahra Shakrokh, Chief Development Officer, STC Biologics 12:10 12:50 Panel Discussion: Bioequivalance and current methods for proving it Dr. Zahra Shakrokh, Chief Development Officer, STC Biologics

15:30 16:10 Mass Spectrometry Analysis for Biosimilars Why mass spectrometry (MS) is growing in importance as comparator Using MS in comparing Biosimilars to originator: What are the benefits? Biosimilars-to-innovator comparisons Batch-to-batch comparisons Protein characterization Sian Estdale, PhD, Manager, Protein Chemistry, Biotechnology Division, Covance Laboratories

16:10 16:50 Immunogenicity and Biosimilars Protein Development Potential clinical consequences viz. immunogenicity Factors relating to immunogenicity Why testing for immunogenicity is important for biosimilars Sponsored spotlight presentation to be announced shortly 16:50 - 17:30 Protein aggregates and immunogenicity Protein aggregation and its implication for biosimliars development Inceasing safety awareness issues for protein aggregation Curtis W. Meuse, Scientist National Institute of Standard and Technology, NIST

12:50 13:50 Networking Lunch

17:30 17:40 Chairmans closing remarks