Eric Levenson
Biological Reviewer FDA/CBER - [Virtual]
Eric is a biological reviewer in the Office of Gene Therapy/ Office of Therapeutic Products (OTP)/ CBER. He reviews a wide range of direct acting gene therapy products including DNA, RNA, or peptide therapeutics delivered by nanoparticles carriers, oncolytic viruses, and cancer active immunotherapies. An interdisciplinary scientist, he has degrees in chemistry and biochemistry (M.S., Ph.D. University of Delaware) and published with extensive training in virology, immunology, and chemical biology. Prior to joining OTP, he was a reviewer of allergenic products and conducted basic research on host IFN response to viral infection in OVRR/CBER.
Seminars
More Information to Come Soon!
The regulatory landscape for mRNA is changing and becoming increasingly complex with new products in clinical development from cancer immunotherapies to cell therapies. Drug developers require further clarity and collaboration with the regulatory authorities to reach their milestones. This panel will feature regulatory and policy experts who will share their understanding of getting new mRNA products into market.
- How are the current global policies and government decisions impacting the mRNA industry?
- How as a community can we work with the regulators to reduce impact on development timelines whilst improving trust with the global community?
- What will it take to see the next therapy successfully achieve market authorization and which indications or innovations will lead to this effort?
