AAV Gene Therapy – A Road Map to IND Submission
April 23rd, 2020
11:00am PST; 2:00pm EST
The webinar will focus upon the common issues which might delay the IND submission or pre-IND interaction with FDA. We will discuss how to design your in-vitro or in-vivo studies timely and effectively to overcome these issues, with a view toward current regulatory guidelines and the expectations of regulatory agencies.
In this webinar you’ll learn:
- Common roadblocks & mitigation strategies
- Designing studies effectively and efficiently
- Compiling the IND package & interactions with FDA
Who should attend?
- Scientists, Postdoctoral fellows, PIs (Cell & Molecular Biologist)
- Project/Account Managers
- Regulatory personnel
- CGT start-up aspirants
Vibhor Gupta, Ph.D.
Director of Business Operations
Cell and Gene Therapy
About the presenter:
Vibhor Gupta, Ph.D. is the Associate Director at Absorption Systems, supporting Cell & Gene Therapy services since August 2018. Dr. Gupta has completed his Ph.D. in Biochemistry and Oncology from Jawaharlal Nehru University, New Delhi-India in 2010 and moved to the United States in early 2011 to pursue his postdoctoral fellowship at University of Pennsylvania-Philadelphia. While working at Greenberg laboratory, Dr. Gupta focused his research on Autoimmune diseases and inflammatory responses. In 2016, Dr. Gupta joined the Gene Therapy Program as a Senior Research Investigator and Regulatory Writer at UPenn. Working closely with Prof. James M. Wilson, Dr. Gupta contributed to several Cell & Gene Therapy projects and assisted in drafting several INDs to the FDA. During his research career, Dr. Gupta has experienced numerous molecular biology techniques, developed biochemical assays, published more than ten manuscripts/review articles and presented his work worldwide in diverse fields of life sciences including Metabolism, Oncology, Autoimmune diseases, and Cell & Gene therapy.