WEBINAR: Preclinical Considerations in Cell and Gene Therapy Product Development
Presented by Absorption System’s Chief Business Officer, Vatsala Naageshwaran
About this webinar:
In vitro and in vivo preclinical evaluation of cell and gene therapy (CGT) products contributes significantly to characterization of the product benefit versus risk profile. The field is currently expanding rapidly, with many candidate therapies advancing into clinical testing and many more progressing through preclinical pipelines. As the number of early-stage candidate products continues to increase, so does the need to define effective preclinical development strategies that support clinical translation. Given the diverse and often multi-functional nature of these therapies, it is not possible to define a one-size-fits-all preclinical program for cell and gene therapy. Instead, preclinical studies need to be customized to support the feasibility of the proposed administration route and appropriate application procedure, address the candidate product’s specific therapeutic properties, and fully characterize any potential safety concerns.
- Discover the diversity of cell and gene therapy products
- Describe the preclinical testing approaches to guide product development
- List the regulatory requirements to support an Investigational New Drug (IND) submission for a first-in-human (FIH) clinical trial and a Biologics License Application (BLA).