Planning for Accelerated Approval: Timing is Everything

September 17th, 2026
11 a.m. EDT

Accounting for nearly one-quarter of novel drug approvals in 2025 compared to just 14% in 2024, accelerated approvals are rebounding as the industry adapts to recent FDA updates that reshaped the pathway ^[1,2]. While accelerated approval remains a valuable option for therapies addressing serious conditions and unmet medical needs, expectations have changed. Today’s sponsors must demonstrate not only compelling early clinical evidence, but also develop a well-defined strategy for confirmatory trials, regulatory compliance, and commercialization well before submitting for approval.

In this webinar, discover why timing is one of the most critical factors for accelerated approval. Our experts will discuss how early planning across clinical development, protocol design, confirmatory trial strategy, inspection readiness, and CMC can reduce risk and keep development programs on track. You will gain insights into aligning cross-functional teams, anticipating potential challenges, and building a development strategy designed to support long-term success.

Whether you are considering accelerated approval for a rare disease therapy or preparing an active development program, this webinar will provide strategies to help you plan with confidence and accelerate the path to patients.

Attendees will gain insights into:

• How recent FDA initiatives reshaped the accelerated approval pathway
• Integrating clinical, regulatory, operational, and CMC planning early to support accelerated approval readiness
• Practical strategies for designing confirmatory trials ahead of approval submission

Speakers:

Seth DePuy, Ph.D. – Sr. Director, Regulatory & Product Strategy 

Paulla Dennis – Executive Director, Program Strategy, Rare Disease, Pediatrics, Cell and Gene Therapy 

Sources:

• U.S. Food and Drug Administration. Advancing Health Through Innovation: New Drug Therapy Approvals 2025. Center for Drug Evaluation and Research; January 2026. Accessed July 2026. https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf 
• U.S. Food and Drug Administration. Advancing Health Through Innovation: New Drug Therapy Approvals 2024. Center for Drug Evaluation and Research; January 2025. Accessed July 2026. https://www.fda.gov/files/drugs/published/new-drug-therapy-2024-annual-report.pdf