Cell and gene therapies (CGTs) present unique development challenges, from novel manufacturing processes and delivery methods to complex nonclinical programs and evolving regulatory expectations. For sponsors developing these therapies, engaging with the FDA early and often can help clarify development requirements, identify potential issues and inform a more efficient path to the clinic and commercialization.
The featured panelists will explore the FDA meeting options available to sponsors throughout development, including INTERACT, pre-IND, Type D and pre-BLA meetings. The featured speakers will discuss when each meeting may be appropriate, how to request a meeting and strategies for preparing focused briefing packages and effective questions. The webinar will also explore how sponsors can respond when a pre-IND meeting does not deliver the expected outcome and use FDA feedback to inform next steps.
Understanding how and when to engage with the FDA can help sponsors make better development decisions, reduce avoidable delays and advance cell and gene therapy programs with greater clarity and confidence.
Register for this webinar to learn how to prepare for productive FDA meetings and respond effectively to regulatory feedback throughout cell and gene therapy development.
Who Should Attend
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited to:
Drug Development
Clinical Operations
Medical Affairs
Regulatory Affairs
Project Management
What You Will Learn
Attendees will gain insight into:
When and how to engage the FDA through INTERACT, pre-IND, Type D and pre-BLA meetings
Strategies for developing effective meeting requests, briefing packages and questions
How to navigate FDA feedback and address challenges following an unsatisfactory pre-IND meeting
Register free on Xtalks:
https://xtalks.com/webinars/fda-meetings-engaging-regulators-throughout-cell-and-gene-therapy-development/
