Gene Therapy Webinar: “Nonclinical Development in Gene Therapy, building on 12 years of the Lovelace Biomedical Center of Excellence in Gene Therapy”
Did you miss our webinar on nonclinical gene therapy development?
You can still watch the live presentation by Dr. Jake McDonald, and Dr. Janet Benson here: https://www.webcaster4.com/Webcast/Page/2117/31458
Download the pdf presentation slides here: Lovleace Biomedical Gene Therapy Webinar 06FEB2020
The design of preclinical safety and biodistribution studies to support an Investigative New Drug application for a gene therapy product to the FDA are different in several important ways than those for small molecule therapies. Lovelace Biomedical has been performing Gene Therapy studies towards IND submissions for nearly 12 years. Dr. Janet Benson has been involved with the Lovelace Gene Therapy Center for the entire duration. Dr. Benson has over 40 years of experience in Toxicology and drug development, and will present on some examples of her experience in the nonclinical development of Gene Therapies.
This webinar provides a brief introduction to gene therapy, with focus on AAV based therapies applied to a range of target organs. We will review what, in our experience, major differences exist between development of gene therapy and small molecule drugs that impact protocol design, timing and cost of studies. We will also address respiratory tract delivery of gene therapy products and the associated considerations. Helpful references will be provided.
People who should view this webinar:
- Toxicologists and Pharmacologists at Pharmaceutical/Biotechnology companies who desire a primer on design considerations for gene therapy studies
- Regulatory scientists who want to understand more about design approaches and limitations for nonclinical development
- Academic investigators or innovators who desire to know more about the drug development process for innovations that they may have from their laboratory