Cecil Nick | Vice President
PAREXEL

Cecil Nick, Vice President, PAREXEL

Cecil has been working in regulatory affairs and clinical development for over 30 years; for the last 25 years focused on biological medicines. Particular expertise in monoclonals and biosimilars, having worked on over ten such programs and participated extensively in Industry and International meetings on the subject.
He joined PAREXEL in February 2001 and has been involved with issues relating to clinical development, regulatory submissions, biosimilars, orphan drugs and training. In the last five years alone has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft development plans which are effective, highly efficient and achievable with extensive experience in the field of inflammatory disease.

Appearances:



Biosimilars Day 2 - Wednesday 1st November 2017 @ 09:00

Chair's opening remarks

Biosimilars Day 2 - Wednesday 1st November 2017 @ 09:55

Panel Discussion on regulation and IP followed by questions from the audience

  • European Regulators positions on interchangeability and public study results as an introduction to the debate on how best to share and communicate real world evidence and pharmacovigilance data.
  • What are the most appropriate means and platforms which could reduce the gap between regulatory science and medical practice and which could inspire others to follow?

Biosimilars Day 2 - Wednesday 1st November 2017 @ 11:50

Development considerations: Comparing major markets including US, EU, Japan and China

  • Different approaches to similarity of Quality attributes
  • Navigating different clinical data requirements – endpoints
  • Choice of reference product
  • Ethnicity and need for data from local patients
  • Interchangeability
  • Meeting with regulators
  • Conducting global studies

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