Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors?  This webinar will explore both Right-to-Try legislation and existing Expanded Access Programs, including:

  • Understanding sponsor responsibilities under these programs and when products may be eligible for these program
  • Evaluating options such as treatment protocols, treatment INDs, and emergency use
  • Discussing development risks associated with participation in these programs

The presenters will also provide several examples from both their personal experience as well as noteworthy examples that have made the news.

Featured Speakers

David Shoemaker, Ph.D.

Senior Vice President, R&D
Rho

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas, including hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and anti-bioterrorism agents. 

Kevin Barber, Ph.D.

Vice President, Regulatory Strategy & Submissions
Rho

Dr. Kevin Barber has more than 20 years of experience in regulatory affairs and drug development, working for both sponsor companies and CROs, across all stages of development from pre-clinical through product launch and post-approval life cycle management.  He has lead the preparation and execution of integrated regulatory strategy and clinical development plans for products in therapeutic areas including dermatology, nephrology, urology, women’s health, neurology, cardiovascular diseases, virology, oncology, immunology, infectious diseases, blood products, and gene therapy.

Karl Whitney, Ph.D.

Assistant Vice President, Operations
Rho

Dr. Whitney has 15+ years of experience in the pharmaceutical industry, specializing in clinical and regulatory aspects of pharmaceutical development. During this time, he has led multiple integrated drug-development programs spanning the development spectrum by planning, managing, and overseeing concurrent manufacturing, nonclinical, clinical, and regulatory activities.

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