Group Lead, Midlands and Wales Advanced Therapy Treatment Program & head of Business and Project Development, Advanced Therapies
University of Birmingham
Conference Day 2
Wednesday, September 13th, 2017
9:10 AM Panel Discussion: Writing The Rulebook – Industry Harmonisation, Vendor Collaboration And Process Optimisation
- Recap of the current industry paradigm: Where are we now and where do we want to be in the next five years?
- Discuss the need for cross-boarder and crosscompany collaboration to drive therapy commercialisation
- Examine the reality of achieving CMO – sponsor harmonisation: How realistic is this given the industry fragmentation?
- Identify the critical success factors in building industry capability and collaboration and how this can be translated into process optimisation for efficient therapeutic development
- Discuss the Cost of Goods (COGs) pressure on SME manufacturing processes, and where outsourcing fits into the cost-efficiency equation
- Examine the risks to outsourcing ATMP-based manufacturing processes, particularly pertaining to extractables and leachables, process compatibility and regulatory compliance
- Analyse the management of external partners and CMOs across the product development lifecycle to ensure alignment from early stage development through to commercialisation