Title: Biotech Drug Development Challenges and Case Studies (CMC)
Duration: 60 minutes - Available On Demand
Biotech product development for major markets such as US/EU as well as other regions of the world is continuing to increase. Analysis shows that developers who prepare global upfront strategies and utilize risk-based tools benefit from efficiency and save resources leading to faster market entry. This talk provides an overview of biotech drug development and focusses in the most common CMC pitfalls we have recently observed and how to avoid them.
- Updated overview of the multidisciplinary (CMC, non-clinical and clinical) requirements for the development of biotech products
- Outline of the recent regulations, highlights critical requirements
- Summary of the most common CMC pitfalls we have recently observed and how to avoid them
Director, Regulatory Affairs, PharmaLex
Zeb Younes has over 16 years of experience in biopharmaceutical / biosimilar development lifecycle from proof of concept through to, and beyond commercialization with both laboratory and desk based experience in process development, purification, formulation, method development, characterisation, validation, comparability, release and stability testing. Zeb has experience with ATMPs, vaccines, recombinant proteins including monoclonal antibodies and derivatives and over 10 different biosimilar products.