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. The featured speakers 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. Attendees will gain insights into aligning cross-functional teams, anticipating potential challenges and building a development strategy designed to support long-term success.
Whether teams are considering accelerated approval for a rare disease therapy or preparing an active development program, this webinar will provide strategies to help plan with confidence and accelerate the path to patients.
Register for this webinar to learn how early planning can improve accelerated approval readiness and reduce clinical, regulatory and operational risk.
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
Speakers
Seth DePuy, PhD, Sr. Director, Regulatory & Product Strategy, Premier Research
Seth DePuy is a Scientist and Mentor with over 10 years of research experience in both academia and industry and over five years of experience in drug development and regulatory affairs for a broad range of therapeutic areas and unique drug products and/or dosage forms. Seth is accomplished in performing thorough background research and assessing scientific and regulatory information to develop/support regulatory strategy and produce quality on-time deliverables to all stakeholders. His key experience includes (but is not limited to) regulatory strategy and support of US FDA meetings, IND applications and maintenance, expedited programs and designation applications and NDA submissions. Seth possesses significant expertise in 505(b)(2) drug development and the unique strategies required for this development pathway.
Message Presenter
Paulla Dennis, Executive Director, Program Strategy, Rare Disease, Pediatrics, Cell and Gene Therapy, Premier Research
Paulla Dennis has been dedicated to rare disease and pediatric clinical research for more than 25 years, specializing in gene therapy for the last 10+ years. She is highly experienced in operational delivery after spending 17 years at a pediatric hospital running the Clinical Research Services group, where she delivered pivotal studies in several rare pediatric disorders inclusive of gene therapies. Paulla has an additional eight years’ experience in the CRO setting in startup project management as well as in program strategy, delivering rare pediatric disease and advanced therapies studies.
As Executive Director, Program Strategy, Paulla advises, consults, plans and directs the design and strategy for prospective and ongoing rare, pediatric and gene and cell therapy studies. In her current role, she provides strategies and solutions for operational excellence in this complex clinical research setting with a focus on patient and family pathway planning and comprehensive site assessment and educational support.
Paulla has extensive experience in Phase I-IV studies in a global setting, including autosomal, neurological, metabolic and endocrine diseases. Her key experience areas include rare/ultra-rare disease, pediatrics, gene therapies and neurological (neuropsychological, neurodegenerative and neuromuscular) indications.
Message PresenterWho 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 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
Xtalks Partner
Premier Research
Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.
Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.
Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. To learn more visit premier-research.com.
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