FDA Rare Disease Guidances and 2026 Drug Development Data Featured in Webinars
Life sciences attorneys will host a March 3 webinar on FDA draft guidances for cell and gene therapies. A March 31 webinar will examine 2026 drug development data from a survey of 150 industry leaders.
The Food and Drug Administration (FDA) has released three draft guidance documents addressing expedited programs for regenerative medicine therapies, innovative designs for clinical trials of cell and gene therapy products (CGTs) in small populations, and postapproval methods for capturing safety and efficacy data for CGTs. Life sciences regulatory and 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' to provide an overview of recent FDA efforts to promote greater transparency and efficiency in the development of CGTs and personalized, bespoke therapies for rare diseases.
The webinar presenters will examine the three draft guidance documents and discuss the proposed 'plausible mechanism' pathway and how it aligns with the principles reflected in the draft guidances.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.
Separately, a free webinar titled 'Drug Development Insights: What New Industry Data Reveals for 2026' will be held on Tuesday, March 31, 2026 at 11am EDT (5pm CEST/EU-Central). The webinar will explore key signals from the 2026 Pulse research by the PPD clinical research business of Thermo Fisher Scientific, which surveyed 150 leaders at biotech and pharmaceutical organizations worldwide for the fourth annual Pulse industry report. The findings reveal a clear throughline: uncertainty is shaping decisions across R&D, from strategy and investment to execution.
The Trump Administration is transforming the life sciences industry, not through legislation, but through regulation, as the FDA's regulation of life sciences products and enforcement of the Food, Drug and Cosmetic Act is altering the foundation of the industry. In 2010, the Obama Administration largely disrupted the healthcare industry with the Affordable Care Act.