Translational Clinical Pharmacology in Cell and Gene Therapy

Cell and gene therapies are transforming modern medicine by offering potentially curative treatments for patients with serious and rare diseases. In this webinar, Devin Welty, Vice President of Clinical Pharmacology at Allucent, discusses the rapid growth of this field and the challenges associated with translating preclinical data into safe and effective first-in-human doses.

With hundreds of ongoing clinical trials and increasing regulatory scrutiny, determining the correct starting dose for cell and gene therapy products has become a critical challenge in drug development. Unlike traditional therapies, these treatments often involve complex biological mechanisms, immunogenicity risks, and long-lasting therapeutic effects.

Advanced approaches such as clinical pharmacology, model-informed drug development, and translational drug development strategies help researchers better predict dose response relationships and improve first-in-human trial design. These approaches are particularly important for emerging therapies such as AAV gene therapies and CAR-T cell therapies, where traditional pharmacokinetic methods may not apply.

Learn more about the accelerating growth caused by transformative, curative and durable effects for unmet medical needs. The challenges that come along when growth happens so rapidly. As well as translational clinical pharmacology in AAV and CAR-T therapies.

What you will learn

• The rapid growth of cell and gene therapy development and its regulatory challenges
• Key considerations for determining first-in-human starting doses
• Translational clinical pharmacology strategies for AAV gene therapies
• Modeling approaches used to understand CAR-T cell therapy kinetics and response
• How model-informed approaches can improve safety margins and clinical trial success