In Q3 2022, PDA hosted a very engaging and informative vaccine session (see below for the session program and members of the planning committee) during the PDA Europe Biomanufacturing Conference in Amsterdam. As vaccine development and production have impacted the lives of countless people worldwide over the past three years, the Biopharmaceutical Advisory Board (BioAB) considers it prudent to provide a summary of the event, key talking points and themes discussed for the benefit of the greater PDA organization and the industry.
One of the topics that took center stage was PDA Technical Report No. 89, which triggered discussions regarding:
- Considerations for control strategies
- Considerations for lifecycle management
These three themes were all on display, with both industry and health authorities bringing opportunities for further development and conversation. Accelerated regulatory pathways, expedited CMC reviews and interaction between regulatory bodies were highlighted by the U.S. FDA/CBER, with industry representatives calling out regulatory harmonization, specifically pertaining to WHO guidelines and ICHQ12.
Robin Levis, PhD, from FDA/CBER, provides her perspective on vaccine life cycle management, and is emphasizing the role of FDA/CBER in facilitating expedited vaccine development through the following:
- Regulatory pathways (e.g., accelerated approval, fast track, rolling review submission, breakthrough therapy and priority review)
- Expedited review of CMC information, preclinical and clinical protocols, and clinical trials data and early expedited reviews of manufacturing and testing facilities
- International collaboration between regulatory agencies in review to achieve regulatory convergence/harmonization
Levis’s presentation also discussed lessons learned from the recent Emergency Use Authorization (EUA) of COVID-19 vaccines and the potential to apply this learning to vaccine lifecycle management. While some approaches could be considered, the FDA must still ensure that vaccines approved or authorized under the EUA are supported by adequate scientific and clinical data. It was acknowledged that regulatory harmonization can be a key enabler but remains a work in progress.
As we are all aware, the COVID-19 pandemic has triggered a reevaluation of vaccine development and production, with heavy emphasis on the incorporation of new modalities, expedited timelines, defined quality requirements and lifecycles and post-approval change management. It is clear there is a desire to preserve and expand upon the gains made during the pandemic, not only regarding levels of collaboration across the industry and health authority partners but also in terms of scientific rigor and the ability to manage challenges within established systems. The BioAB at PDA would like to be a conduit and support the efforts of the Vaccines Interest Group and document the best practices from the past several years to enhance ongoing efforts as well as provide a means of knowledge management for generations to come.
We invite those interested in vaccine development and production, lifecycle management and building upon the successes of the worldwide efforts in fighting COVID-19 to join the interest group to maintain the momentum and bring new therapies to clinics sooner for our patients and our society.
Session Chairs and Moderator: Michael De Felippis, PhD (Eli Lilly & C0.) and Andrew Chang, PhD (Novo Nordisk A/S)
- Welcome from the session Co-Chairs
- Overview of PDA Vaccine Technical Report
- Jane Halpern, PhD (Executive Director, Regulatory Affairs at the International AIDS Vaccine Initiative).
- Lessons Learned from COVID-19 Pandemic on Vaccine Lifecycle Management
- Jennifer Eck, PhD (AstraZeneca)
- Vaccine Lifecycle Management: Regulatory Perspective
- Robin Levis, PhD (OVRR/CBER/FDA)
- Applying ICH Q12 Principles for Vaccine Lifecycle Management
- Thierry Gastineau, PharmD, Global Head Quality Innovation, Culture & Engagement, SANOFI vaccine
- Panel Discussion (moderators: Michael De Felippis and Andrew Chang)
About the Author
Max De Long is a Director and Senior Principal at Genentech’s cell and gene therapy organization. He values his volunteer experiences, both with industry forums such as PDA, where he is the Vice Chair of the Biopharmaceutical Advisory Board, and with early educational mentorship programs in his local community. Max is an active member of the early career professional community at PDA, and he is always looking for developing talent within the industry.