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General Workshop Overview:
Workshop will cover the following topics:
This highly specific workshop will enlighten the workshop attendees about the relationship between Oligonucleotide Drug Development Companies (Drug Sponsor) and Manufacturing Organisations for both, Drug Substance and Drug Product (CMO / CRO). Building and maintaining the relationship will be covered as well as the question: In-house manufacturing or outsourcing to a CMO.
Who should attend?
Anyone interested in the manufacturing of oligonucleotide therapeutics at a CMO / CRO including R&D Researchers, Manufacturing Personnel, Quality Assurance, Project Management, Business Development and Scientific Management.
GMP Oligonucleotide Manufacturing - Do It Yourself or Use a CMO?
Wave Life Sciences decided to build their own drug substance manufacturing capabilities early on. Only a few sponsors in the oligo world do this at such an early clinical stage. I will be discussing the pros and cons of having your own GMP facilities and how this became a reality at Wave.
Hagen Cramer, Senior Director of Manufacturing, Wave Life Sciences, USA
How to Foster a Successful Client – CMO/CRO Relationship?
Focusing on key assets, small pharma and biotech companies typically outsource activities related to manufacturing and quality control of drug substance, drug product and the clinical trial material itself. Nevertheless, as sponsor of the clinical trial the outsourcing party is still responsible for the quality of the clinical trial material and needs to assert that the CMO/CRO fulfills regulatory and legal requirements. A quality-based approach to CMO/CRO selection and client oversight will be presented.
Stefan Vonhoff, Vice-President CMC, Noxxon Pharma AG, Germany
Considerations for Establishing a Sustainable Supply Chain for API Supply for a Commercial Oligonucleotide
Oligonucleotide CMO’s are largely untested in terms of their ability to provide continuous sustainable supply of commercial API over a product life cycle. The talk will cover considerations for a consistent and reliable API supply chain including starting materials, facilities and analytical methods that are well understood, with risks identified and mitigated, and ruggedness, as well as robustness, built in.
Mike Webb PhD, Consultant, MikeWebbPharma Ltd, United Kingdom