The US FDA’s Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy Designation, Accelerated Approval Program, Priority Review, and Fast Track Designation can reduce your product’s development and approval timelines if pursued at the optimal time and implemented appropriately.  Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about the timing and planning for each of these opportunities and determine what is best for your product’s development program.  This webinar will explain the differences between these programs, describe strategies to determine which program may be right for your product, and discuss FDA expectations and requirements for each program.

Featured Speakers

Genna Kingon, Ph.D., RAC

Associate Director, Regulatory Strategy

Dr. Genna Kingon, Associate Director, Regulatory Strategy, has participated in and contributed to the regulatory strategy and submission management from pre-IND to post-approval. Her experience includes leading teams for a 505(b)(1) program for a BTD product, including management of the study-level biostatistics and programming activities and CSR development for the Phase 3 program through NDA submission-readiness. Also, she serves as the program director leading multi-disciplinary teams in the strategy, management, and development of multiple INDs/IDEs and associated marketing application activities for a portfolio of related products. With over a decade of experience in scientific writing and editing clinical and nonclinical documentation, which includes several publications in peer-reviewed scientific journals, Dr. Kingon also serves as lead regulatory author on multiple programs for submissions to FDA and to various international regulatory authorities. She has contributed to the strategy and development of CMC efforts and has authored the CMC section for two IND submissions. Dr. Kingon has led the preparation, review, and coordination of a variety of regulatory and clinical documents, including integrated summaries of safety and efficacy, package inserts with annotation, FDA meeting request letters and briefing packages, protocols, investigational plans/brochures, CSRs, IND/NDA/BLA gap analyses, and annual reports.

David Shoemaker, Ph.D.

Senior Vice President, R&D

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas, including hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and anti-bioterrorism agents.  He has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs.  He has managed or contributed to more than two dozen NDAs, BLAs, and MAAs.  Dr. Shoemaker has moderated dozens of regulatory authority meetings for all stages of development.  His primary areas of expertise include clinical study design and regulatory strategy for development of novel drug and biological products.


Register now for this webinar