Development of Cell & Gene Therapies: Part 2
Sponsored by: Covance
- Gene Therapies
- Assay Design
Date: 18 June
Days to go: 23
Time: 4PM London/11AM New York
Key Safety Assessment Design and Regulatory Considerations
Cell & gene therapies have come of age with nearly a dozen or more products commercialized globally and approximately 1000 clinical trials underway as of the end of 2018. With an evolving regulatory environment and a unique and complex nature, cell and gene therapy candidates present significant development challenges, beginning in the preclinical development phases.
In this webinar, we will focus on nonclinical studies required or expected for IND/IMPD submissions and beyond. Part 2 of our series will describe how advanced therapies are defined and present preclinical study and regulatory/safety considerations and strategies for assessing advanced therapies.
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 safety assessment development program.
Brian McIntosh, PhD,
Study Director for Safety Assessment, Covance
Brian is a member of the Covance Advanced Therapies Drug and Device Development Group with overall responsibility for the scientific and technical conduct of the company’s nonclinical safety assessment studies. With more than 20 years of experience in laboratory research, Brian is an expert in regenerative biology and the development of cellular, gene and regenerative therapies. He is also the author or co-author of more than a dozen professional journal articles and conference presentations.
Key Learning Objectives
- Review the GLP assessment pathway to an IND/IMPD submission
- Understand preclinical program goals for advanced therapeutics
- Elaborate on issues to overcome for cell & gene therapy products
- Define fast track and breakthrough designation programs
- Research Scientists
- Program Directors
- Executives and Consultants in biopharmaceutical companies developing cell and gene therapies