The New Roaring 20s and Advances in Gene Therapy Drug Development
Wednesday, November 18, 2020
Date: Wednesday, 18 November 2020
6:00 – 6:05 PM Welcome and Announcements (ONLINE)
6:05 – 7:05 PM Program Presentation (ONLINE)
7:05 – 7:30 PM Q & A (ONLINE)
*Times are approximate.
Executive Director, Regulatory Affairs
Neurocrine Biosciences, San Diego, CA.
After nearly 40 years of gene therapy research, we have finally entered an age of realization for patient treatments. Recent years have seen approved gene therapies in Europe and the US, and an explosion of clinical trials is underway. This presentation will provide an overview of gene therapy drug development for those interested in learning about development and licensure of gene therapy products. Intended for learners at all levels, the speaker will touch on case studies of approved therapies and challenges along the way to licensure.
Amanda Richter is a regulatory drug development expert with more than 20 years of experience in research and development of medical products, including 16 years of experience in Regulatory Affairs. She has expertise in small molecules and biologics, with a focus on rare disease development.
For the past 10 years, Amanda has worked in the field of gene therapy drug development. She joined Neurocrine in January 2020, where she serves as the regulatory lead for gene therapy programs under development in CNS diseases, including a Parkinson’s disease program which has received RMAT designation. Prior to Neurocrine, Amanda worked at Tocagen for 9 years, where she led the regulatory development of the company’s gene therapy programs, one of which received Orphan Drug designation from FDA and EMA, as well as Fast Track, Breakthrough Therapy, and PRIME designations for recurrent high grade glioma. She has previously held positions at Biogen Idec, Ambit Biosciences Corp, Santarus Inc, and Integra Lifesciences.
Amanda holds a Master of Science in Regulatory Affairs from the San Diego State University, and a Bachelor of Science in Microbiology from the University of California, Davis. She is Regulatory Affairs Certified (RAC, US and EU) since 2005, and is a member of SDRAN, RAPS, and TOPRA.
Not applicable - This is an online event
Online registration (ends 17Nov2020):
$10 SDRAN Member
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