After decades of slow and steady progress, cell and gene therapies are experiencing important breakthroughs, demonstrating potential to slow disease progression, improve outcomes, and in some cases, potentially cure an array of illnesses. However, navigating complex clinical and regulatory hurdles for these new and cutting-edge therapies is presenting new challenges for developers, particularly for those using accelerated approval pathways. Join experts from Cardinal Health Regulatory Sciences as we explore critical factors to help reduce your risk of failure and increase speed to market. Topics covered, include:

  • Cross-discipline (clinical, non-clinical, quality) communication
  • Developing realistic timelines
  • Importance of strategic alignment
  • Demonstrating product understanding

Featured Speakers

Debra Aub Webster, PhD

Director of Advanced Therapy Medicinal Product Development
Cardinal Health Regulatory Sciences

Debra Aub Webster, PhD, is Director, Advanced Therapy Medicinal Product Development with Cardinal Health Regulatory Sciences. Previously, Dr Webster was a nonclinical pharmacology/toxicology reviewer within FDA’s Division of Anti-viral Drugs in the Center for Drug Evaluation and Research. She provides consulting and program leadership for clients developing regenerative medicines and advanced therapies.

John Jameson, PhD

Senior Scientist of Regulatory Affairs and Product Development
Cardinal Health Regulatory Sciences

John Jameson, PhD, is a Senior Scientist, Regulatory Affairs and Product Development with Cardinal Health Regulatory Sciences. Previously, Dr. Jameson was a reviewer in the Pharmacology/Toxicology branch within the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER) at FDA.

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