This webinar covers an introduction to cellular and gene therapies, which both use the body’s own cells and genetic information to fight diseases but do so in different ways. Cellular therapy uses actual cells as the therapy, whereas gene therapy alters the genetic material of a patient. Both types of therapies offer huge promise to treating and curing diseases that until recently had no treatment options.
While any drug development program can face pitfalls and uncertainties, developing cellular and gene therapies often present unique challenges above and beyond those encountered for small molecule drugs.
At the end of this webinar, attendees should have a better understanding of:
- Basic understanding of cellular and gene therapy
- Issues in integrating and non-integrating vectors
- Challenges in selecting First-in-Human (FIH) doses for cellular and gene therapy
Meet the Presenter
Devin Welty, Ph.D.
Senior Consultant, Nonclinical & Clinical Pharmacology
Dr. Welty has over 25 years of experience in preclinical and clinical pharmacology leading organizations and project teams from early discovery to approval and commercialization, most recently as the Global Head of DMPK at Shire. He has extensive experience in pharmacokinetics, pharmacodynamics, systems pharmacology, and model-informed approaches for candidate nomination and efficient clinical development strategy. He has supported the successful submission of more than 50 INDs/CTAs and more than 20 NDAs/MAAs/BLAs for small molecules, biologics, and gene therapy therapeutics.