Scientist Genentech-Roche South San Francisco, California
Upon completion, the participants will be able to describe PKPD aspects, challenges and considerations in successful development related to preclinical and translational approaches for cell and gene therapies
Upon completion, the participants will be able to implement a viable preclinical and translational PKPD development strategy for cell and gene therapies.
Upon completion, the participants will be able to propose First-in-Human dose for these new modalities and be able to meet regulatory requirements and standards in their submissions.
10:30 AM – 11:00 AM ET
Regulatory Considerations and Expectations for Translational PKPD Aspects of Cell and Gene Therapies Sandhya Sanduja, Ph.D. – U.S. Food and Drug Administration
11:00 AM – 11:30 AM ET
Selecting FIH Starting Dose for Adoptive T Cell Therapies and PK/PD Considerations Hardik Mody, Ph.D. – Janssen Research and Development, LLC
11:30 AM – 12:00 PM ET
Modeling and Simulation of Viral Gene Therapies: Applicability and Feasibility Nagendra Chemuturi, GDMPK – Takeda
12:00 PM – 12:30 PM ET
Considerations in Design and Development of Gene Therapy Products: A Translational PKPD Perspective Annie Clark, PharmD, Ph.D. – BioMarin Pharmaceutical Inc.