Biosimilars Day Two

08:00

Registration

Mr Sandeep Athalye
09:15

How to design the right clinical development programme for biosimilars

Dr Malcolm Mitchell
09:45

A clinical pharmacologist's view of biosimilars

10:45

Morning refreshments

Dr Rustom Mody
11:45

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

12:45

Lunch

Ms Caroline Boulliat
14:00

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

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
15:00

Afternoon refreshments

Mr Uwe Gudat
16:00

Post launch safety monitioring

Nitin Naik
16:30

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

17:00

Closing remarks from the chair

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