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overview
The field of Cell and Gene Therapies (CAGTs) holds tremendous promise for providing transformative benefits for unmet clinical needs. However, biological complexity poses many challenges throughout the lifecycle of CAGT product development. Keeping up-to-date with key trends and the latest Health Authority (HA) updates, as well as understanding the phase-specific HA requirements, provides a roadmap for planning a CAGT development program. This knowledge can help you bring these complex treatments to market faster and more efficiently.
This webinar will discuss:
- Overview of Key Trends in the Cell and Gene Therapy Space
- FDA Regulatory Updates
- Restructuring of the Cell & Gene Therapy Office at FDA (formerly OTAT/CBER, now known as OTP)
- PDUFA VII initiatives
- Recent high-profile public comments by CBER/FDA Upper Level Management on Accelerated Approval relevant for CAGT sponsors
- Maximizing Interactions with OTP: Focus on INTERACT Early Engagement Meeting
- Expedited Development Programs: Focus on RMAT (Regenerative Medicine Advanced Therapy) for CAGT
- Operationalizing Delivery to Patients for Investigational Trialing
- Importance of Manufacturing Quality Products for Patients – Investigational and Commercial
- Lessons Learned for CGT clinical development
- Important take home messages from recent FDA approvals of CAGT products
Click here to register for this free webinar
Speakers
Chris Learn
PhD, PMP, Vice President, Cell and Gene Therapy Center of Excellence, Parexel International
Steve Winitsky
MD, Vice President, Technical, Regulatory & Access, Parexel International
Speaker Bios
Chris Learn
PhD, PMP, Vice President, Cell and Gene Therapy Center of Excellence, Parexel International
Chris has 20 years of clinical trial execution and team management experience, a subject matter experts overseeing the clinical development programs of >20 cell and gene therapy programs in rare disease, CNS, pediatrics, and oncology for emerging biotech portfolios and large-cap pharma. His current interests and commitments lie in the phasing of dose, route, and administration of cell and gene therapies in the clinic and how to use innovations in immunotherapy to drive these unique therapies further in improving patient outcomes.
Steve Winitsky
MD, Vice President, Technical, Regulatory & Access, Parexel International
Steve spent more than 11 years at the FDA as a former Medical Officer, Team Leader, and Acting Branch Chief in the Center for Biologics Evaluation and Research’s (CBER’s) Office of Tissues and Advanced Therapies, which has recently been renamed the Office of Therapeutic Products (OTP). He has extensive experience with the review and supervision of cell and gene therapy (CGT) applications, including sponsor requests for Breakthrough Therapy and Regenerative Medicine Advanced Therapy designation. He also supervised numerous Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) and pre-IND meetings for CGTs.
Who Should Attend
Who should attend this webinar?
Organisation type: Pharmaceutical, Biotechnology, Biopharmaceutical
Job functions:
– Clinical Operations
– Clinical Research
– Commercial
– Executive
– General Management
– Health Economics & Outcomes Research
– Market Access
– Market Research
– Medical Affairs
– Medical Communications
– Medical Operations
– Operations
– Outsourcing
– Portfolio Management
– Procurement
– Product Development
– Project Management
– Regulatory
Event Code of Conduct
This code explains our expectations and rules, which includes general good practice behaviour – because actions can impact others and everyone has a role to play in getting it right.
Anyone not following these rules or behaving in an unacceptable way will be asked – and expected – to stop doing so immediately and may be removed from the event. Read our Event Code of Conduct here.