Glad you could join and gain insights from Thomas Page Ph.D! Look forward to seeing you at the next one!
CMC Regulatory Affairs at Astellas Pharma US Cell Therapy??CMC-RA??Biologics??Pharma ??Innovative science into VALUE for patients
?? Stepping Out of My Comfort Zone – First ISPE Boston Chapter Event?? Today, I’m celebrating a personal milestone – engaging with an amazing group of professionals at ISPE Boston Area Chapter ??. I attended the event "Delivering Speed to Market: The Challenges Behind Program Execution", which focused on bringing innovative therapies to patients. As a CMC regulatory professional working on Cell and Gene Therapy (CGTs), I found the discussion on the process changes and comparability strategies for the success of product development and commercialization. Darius Pillsbury’s insights on risk-based decision-making resonated with me. The points on the necessity of an appropriate regulatory strategy to accelerate timelines through expedited regulatory pathways, such as RMAT (FDA), Breakthrough Therapy (FDA), and PRIME (EMA) designations, were spot on. During the Q&A session, it was emphasized that cross-functional risk assessment is essential. Better understanding the impact of changes through risk assessment in Matrix teams is key to addressing challenges during implementation. This led to the next presentation by Thomas Page Ph.D, who discussed the importance of Risk based approach/Gap assessment. He shared how it helps create better control strategies and continuous monitoring, which ultimately builds knowledge about the process and product. Additionally, he introduced the emerging role of vendor management in accelerating project timelines. A huge thank you to everyone I met today for your warmth, advice, and inspiring conversations. Beth Fulton, Sade Mokuolu PhD, Audrey Berner Looking forward to many more events like this! It was truly an educational and interactive experience. #ISPE #CellAndGeneTherapy #Networking #Growth #ProfessionalDevelopment #RegulatoryStrategy #RiskAssessment #ContinuousImprovement