FDA Meetings:
Engaging Regulators Throughout Cell and Gene Therapy Development

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 toward the clinic and commercialization. Two questions anchor every FDA interaction along that path: what the therapy is ultimately meant to become and how the evidence to support that goal will be generated. Each FDA meeting is an opportunity to refine both.

In this webinar, multi-disciplinary experts will explore the FDA meeting options available to sponsors throughout development, including INTERACT, Pre-IND, Type D, and Pre-BLA meetings, and their distinct purpose: an INTERACT meeting pressure-tests the product concept before costly IND-enabling work begins, the Pre-IND meeting turns that concept into an executable clinical program, a Type D meeting resolves a discrete issue before it becomes a program-level problem, and the Pre-BLA meeting assesses whether the development package is ready to become a marketing application. The discussion will cover when each meeting may be appropriate, how to request a meeting, and strategies for preparing focused briefing packages and effective questions. And when the conversation doesn’t go as planned? The experts will share how sponsors can respond to an unsatisfactory Pre-IND meeting and use the experience to inform next steps.

Understanding how and when to engage with the FDA can help sponsors make better development decisions, reduce avoidable delays, and move their CGT programs forward 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.