Biosimilars Day Two

08:00

Registration

Mr Bernd Liedert
09:00

Opening remarks from the chair

Mr Bernd Liedert, Program Director Biosimilars, Boehringer Ingelheim Pharma Co Gmbh
Mr Sandeep Athalye
09:15

How to design the right clinical development programme for biosimilars

Mr Sandeep Athalye, Vice President and Head CDMA, Biosimilars, Boehringer Ingelheim
Dr Malcolm Mitchell
09:45

A clinical pharmacologist's view of biosimilars

Dr Malcolm Mitchell, Medical Fellow, Eli Lilly and Co
Panel discussion
10:15

PANNEL DISCUSSION:Understanding the challenges and opportunities that face biosimilar clinical development

Moderator: Mr Sandeep Athalye, Vice President and Head CDMA, Biosimilars, Boehringer Ingelheim
Moderator: Dr Malcolm Mitchell, Medical Fellow, Eli Lilly and Co
Nitin Naik, Vice President-Global Life Sciences, Frost and Sullivan
10:45

Morning refreshments

Ms Andrea Laslop
11:15

European regulatory update for biosimilars

Ms Andrea Laslop, Head of Scientific Office, Medicinal Products for Human Use - European Medicines Agency
Dr Rustom Mody
11:45

Application of High Throughput Strategies from Clone to Commercial to Speed up Development of Biosimilars

Dr Rustom Mody, Senior Vice President and Head R&D, Lupin Biotech Ltd
Panel discussion
12:15

PANNEL DISCUSSION:An update on global regulatory frameworks for biosimilar approval

Ms Andrea Laslop, Head of Scientific Office, Medicinal Products for Human Use - European Medicines Agency
Mr Uwe Gudat, Head of Safety, Biosimilars, Merck Serono
Mr Steiner Madsen, Medical Director, Norwegian Medicines Agency
12:45

Lunch

Ms Caroline Boulliat
14:00

Analysing current market trends to understand how to drive biosimilar commercial success

Ms Caroline Boulliat, Immunology Franchise Head of Biosimilars for Europe, Middle East and Africa, Hospira
Mr Bernd Liedert
14:30

Credible Extrapolation Strategies for Biosimilars with special Emphasis on TNF Antagonists

  • Analogies between comparability and similarity exercises
  • Similarity across different modes of action: Preclinical support
  • Most sensitive study populations for extrapolation of clinical performance
  • Beyond the regulator´s blessing: Physicians´, patients´, payers´view
Mr Bernd Liedert, Program Director Biosimilars, Boehringer Ingelheim Pharma Co Gmbh
15:00

Afternoon refreshments

Mr Uwe Gudat
16:00

Post launch safety monitioring

Mr Uwe Gudat, Head of Safety, Biosimilars, Merck Serono
Nitin Naik
16:30

Promise of Biosimilars- Go to Market Strategies for $27B Chase

Nitin Naik, Vice President-Global Life Sciences, Frost and Sullivan
17:00

Closing remarks from the chair

last published: 09/Feb/16 16:05 GMT
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