The importance of GLP compliance, as well as preparing an FDA-ready IND package will also be presented. This webinar will be valuable for anyone developing cell, tissue or gene therapy products, including those in the biopharmaceutical industry.
Cell, tissue and gene therapies represent an important and burgeoning class of FDA-regulated therapeutic products for treatment of disease ranging from AIDS to cancer. How does FDA view and regulate these products and what types of nonclinical studies are required to reach Phase 1 clinical trials and beyond? Getting FDA input at the earliest stages is crucial, and the pre PRE IND will be discussed as a venue for obtaining this early FDA feedback on your development program. Additionally, this talk will highlight the novel properties of these products, and what must be considered when designing nonclinical programs to support a US IND and ultimate licensure. Elements of study design will be discussed including study size, duration, choice of species and endpoints. The importance of GLP compliance, as well as preparing an FDA-ready IND package will also be presented.
Cell, tissue and gene therapies represent an important and burgeoning class of FDA-regulated therapeutic products for treatment of disease ranging from AIDS to cancer. How does FDA view and regulate these products and what types of nonclinical studies are required to reach Phase 1 clinical trials and beyond? Getting FDA input at the earliest stages is crucial, and the pre PRE IND will be discussed as a venue for obtaining this early FDA feedback on your development program. Additionally, this talk will highlight the novel properties of these products, and what must be considered when designing nonclinical programs to support a US IND and ultimate licensure. Elements of study design will be discussed including study size, duration, choice of species and endpoints. The importance of GLP compliance, as well as preparing an FDA-ready IND package will also be presented.
Areas Covered in the seminar:
- Unique properties of Cell and Gene Therapy Products.
- FDA Regulation of cell and Gene therapy products.
- The pre PRE IND process and working with the FDA.
- Efficacy and proof of concept studies - starting out on the right foot!
- Key considerations for nonclinical safety studies.
- Biodistribution Studies - Where does your product go?
- Tumorigenicity Data - An important piece of the puzzle.
- Presenting nonclinical Data to the FDA in your IND or BLA.
Who Will Benefit:
This webinar will be valuable for anyone developing cell, tissue or gene therapy products, including those in the biopharmaceutical industry or looking to commercialize novel therapies out of an academic or research environment as well as those with experience in small molecule drugs who have little experience dealing with OCTGT Products. Those who might benefit include:- Regulatory professional’s crossing over into cell and gene therapy products
- Researchers or academics wishing to commercialize cellular products
- Biotechnology Scientific staff
- CRO Study directors and technical staff
- Sr. Managers and CEOs of cell and gene therapy companies
Course Provider
David Pepperl,
