Executive Track

Executive Track: Trial, Study, and Program Success: Establishing Risk Tolerance and Evaluation Criteria for Cell & Gene Therapy Products

Executive Education Speaker(s)

• 

  Victoria Demby, PhD (she/her/hers)

  Senior Vice President, Global Regulatory Affairs
  Adlai Nortye USA Inc.
  New Hope, Pennsylvania

  Handouts
• 

  Claudia Lin, Ph.D (she/her/hers)

  Executive Vice President
  Pharmatech Associates
  Berkeley, California
• 

  Jason Bock, Ph.D.

  Co-Founder + CEO
  CTMC
  Houston, Texas
• 

  Daniel Norris, Ph.D.

  Executive Director, Pharmacokinetics and Clinical Pharmacology
  Ionis Pharmaceuticals
  Carlsbad, California

In this informative and insightful conference session, we will delve into the critical aspects of establishing risk tolerance and appropriate evaluation criteria for the screening, selection, and development of modern, high-cost Cell & Gene Therapy Products.

Join us as we explore the intricate process of navigating the complexities of trials, studies, and programs in the field of Cell & Gene Therapy. Our expert speakers will provide valuable insights into identifying and managing risk, setting evaluation criteria, and optimizing success factors in this rapidly evolving landscape.

Key Topics:
- Navigating the interface between therapeutic promise and clinical risk – where does this lead the overall business case?
- Understanding risk tolerance in the development of Cell & Gene Therapy Products
- Implementing effective evaluation criteria for screening and selection processes
- Strategies for mitigating risks and maximizing success in trials, studies, and programs
- Best practices for assessing the viability and potential of modern therapies
-How to handle the complex CMC programs so that manufacturing and quality can support your anticipated product success