IND-Enabling Programs for Cell and Gene Therapies [Event Recap]

On Thursday, October 22nd, PCI Ventures and Covance co-hosted IND-enabling Programs for Gene & Cell Therapies.  Over 30 participants joined the webinar which focused on aspects of a gene and cell therapy preclinical program that are central to an IND submission –namely, in vivo pharmacology, toxicology and pharmacokinetics (PK) assessments using the appropriate models & test systems.  Guest speakers included Dr. Brian McIntosh and Dr. Jay Herman.  Dr. McIntosh is a Study Director, as Cell and Gene Therapy Lead, and is a contributing member of the Covance Cell and Gene Therapy Expert Working Group. He is passionate about developing safe and effective cell and/or gene therapies for patients. Dr. Herman is a regulatory toxicologist with 20 years of industry experience at both Covance and Wyeth pharmaceuticals and has worked on a large variety of molecules and therapeutic areas, including gene therapies. 

Throughout the presentation, attendees learned about; animal model selection in preclinical studies, routes of administration, including ocular and neural/brain tissue and safety study designs to guide determination of biologically relevant and clinically safe dose levels. The Covance team covered a lot of information during those 60 minutes.  Bhavana Mohanraj, portfolio manager at PCI Ventures, found the presentation helpful and said she looked forward to revisiting the webinar content again.

After their presentation, Dr. McIntosh and Dr. Herman welcomed questions from participants, taking the time to thoughtfully answer each inquiry. 

If you missed the live webinar or would like to revisit the presentation, you can watch here!