Life Sciences Regulatory and Compliance Attorneys to Host Webinar Focused on FDA Regulatory Developments for Rare Disease Therapies

Life sciences regulatory & compliance attorneys will host a webinar on March 3 titled “FDA Rare Disease Focus: New Cell and Gene Therapy Draft Guidances; Plausible Mechanism Pathway for Bespoke Therapies.”

The webinar will provide an overview of recent Food and Drug Administration’s efforts to promote greater transparency and efficiency in the development of cellular and gene therapy products (CGTs) and personalized, bespoke therapies for rare diseases.

The presenters will examine three recently released FDA draft guidance documents highlighting expedited programs for regenerative medicine therapies, innovative designs for clinical trials of CGTs in small populations, and postapproval methods for capturing safety and efficacy data for CGTs.

The speakers will discuss the proposed “plausible mechanism” pathway and consider how it aligns with the principles reflected in the draft guidances. They will also address continuing uncertainties created by the FDA guidances and potential impacts for developers of CGTs and other rare disease therapies.

The webinar is hosted by life sciences regulatory and compliance partner Joshua Oyster and life sciences regulatory and compliance counsel Beth Weinman.