Development of Cell & Gene Therapies: Part 1
Sponsored by: Covance
- Gene Therapies
- Assay Design
Date: 21 May
Days to go: 2
Time: 4PM London/11AM New York
Key Preclinical Bioanalysis Design and Testing
Cell & gene therapies have come of age, with nearly a dozen or more products commercialized globally and approximately one-thousand clinical trials underway as of the end of 2018. With an evolving regulatory environment and due to their unique and complex nature, cell and gene therapy candidates present significant development challenges beginning in the preclinical phases of development.
In this webinar, we will focus on the key bioanalytical testing considerations for nonclinical studies required or expected for IND/IMPD submissions and beyond. This will focus on critical elements of in-life biodistribution studies including the assay design and validation requirements for QPCR and RT-QPCR assays.
For research scientists and consultants developing cell and gene therapy products, this webinar will provide valuable scientific and regulatory insights as part of an effective and efficient development program. Register today for this live webinar!
Principle Scientist, Cell and Gene Therapy – Biopharmaceutical CMC solutions
Paul Byrne has over twenty years’ experience in the CRO business and has worked at various levels including Study Director and Head and Molecular Biology. Paul currently focuses on the analytical support required for Cell and Gene Therapy molecules within the pre-clinical, CMC and clinical testing areas.
Key Learning Objectives
- Review the GLP assessment pathway to an IND/IMPD submission
- Outline tools to assess the distribution, persistence and shedding of cell and gene therapy products in target and non-target tissues
- Understand validation requirements for QPCR-based assays in biodistribution studies
- Apply tools and approaches to reduce the risk of contamination during biodistribution studies
- Research Scientists
- Program Directors
- Executives and Consultants in biopharmaceutical companies developing cell and gene therapies