Serious or life-threatening diseases remain a large unmet medical need in the United States, as many do not currently have effective therapies. As innovative therapies are increasingly researched and developed, including regenerative medicine therapies, it is important to expedite such treatments to ensure patients are treated as quickly as possible. Thus, the FDA expedited review programs, such as the Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Regenerative Medicine Advanced Therapy (RMAT) Designation, are vital for increasing the likelihood for advancing an investigational product to market. This presentation will focus on what these expedited review programs are, the incentives for obtaining such designations, and the required information/data to better position your investigational product for success.
Learn key regulatory definitions related to the FDA expedited review programs, including FTD, BTD, and RMAT Designation.
Understand the requirements and benefits of a successful FTD, BTD, and RMAT Designation application, and when to submit such documents to the FDA.
Recognize the importance of expedited review programs, such as FTD, BTD, and RMAT Designation, and their impact on reducing drug development time.
Regulatory Affairs Professionals,
Regulatory Affairs Operations Specialists,
Quality Assurance (QA) Professionals,
Compliance Officers,
Clinical Research and Development Teams,
Pharmaceutical Manufacturers,
Quality Control (QC) Professionals,
Clinical Operations Professionals,
Legal and Compliance Professionals
Dr. Isaiah Manoogian | Senior Regulatory Affairs Scientist
Dr. Isaiah Manoogian graduated from the University of Connecticut School of Pharmacy in May 2021. After earning his doctorate, he moved to DC to begin his career in the pharmaceutical industry as a Post-doctoral Regulatory Affairs Fellow. Following the completion of the 1-year Fellowship, Isaiah is now a Senior Regulatory Affairs Scientist with Pace® Life Sciences. In his current role, Isaiah has solely authored and supported numerous successful applications to FDA and EMA, including orphan drug designations (ODD), rare pediatric disease designations, and fast track designations. He has also helped develop several meeting requests and briefing packages in various disease states to assist clients meet with FDA to increase the likelihood of their program’s success. In addition, he has assisted with the preparation and submission of multiple Investigational New Drug applications to the FDA, as well as worked on various feasibility assessments for clients to determine the best paths to regulatory success.