FIH TO CLINICAL ACCELERATION CONCURRENT Quality, process development, process optimization
Friday, June 2, 2023 09:15 AM - 10:15 AM
Room 252AB
FROM FIH TO CLINICAL ACCELERATION
Concurrent
Chair
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd, UK
Speakers
Kowid Ho, PhD, Head of International Technical Regulatory Policy, F. Hoffmann-La Roche, Switzerland
Christiane Niederlaender, PhD, Vice President Technical CMC, Parexel International, UK
Florence Salmon, PhD, Vice President, Preclinical Development and Regulatory Affairs, Ridgeline Discovery, Switzerland
Discuss the challenges of process development when accelerating clinical development, and how this puts quality (CMC) on the critical path. Regulators encourage the use of QbD principles; however, this approach requires more up-front work, and deeper characterisation. We ask the question whether this is compatible with accelerating clinical development. From a business perspective there is a need to de-risk the product before investing the time and money in a commercial process. This often means there is a lot of process development work and characterisation to undertake after FIH, with inevitable need to establish comparability. When the next study might be sufficient for an initial (e.g., conditional) approval, a process suitable for the initial commercial phase is needed. The next talks cover process development and the development of the analytical tools needed.
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd, UK
Speakers
Kowid Ho, PhD, Head of International Technical Regulatory Policy, F. Hoffmann-La Roche, Switzerland
Christiane Niederlaender, PhD, Vice President Technical CMC, Parexel International, UK
Florence Salmon, PhD, Vice President, Preclinical Development and Regulatory Affairs, Ridgeline Discovery, Switzerland
Discuss the challenges of process development when accelerating clinical development, and how this puts quality (CMC) on the critical path. Regulators encourage the use of QbD principles; however, this approach requires more up-front work, and deeper characterisation. We ask the question whether this is compatible with accelerating clinical development. From a business perspective there is a need to de-risk the product before investing the time and money in a commercial process. This often means there is a lot of process development work and characterisation to undertake after FIH, with inevitable need to establish comparability. When the next study might be sufficient for an initial (e.g., conditional) approval, a process suitable for the initial commercial phase is needed. The next talks cover process development and the development of the analytical tools needed.
