Sr. Director / Head of Genetic Medicines, Global Regulatory Affairs Roche-Genentech
Description: A presentation on “The FDA Under New Administration” will bring the audience a comprehensive and timely understanding of the regulatory environment in the U.S. healthcare and life sciences sectors under new leadership. Specifically, the audience can expect to gain: Key Takeaways for the Audience: 1. Understanding Policy Shifts in 2025 and Beyond 2. Impact on Biotech decision-making and approval process 3. How AI can help facilitate and expedite Drug Development & Innovation 4. Implications for Rare Diseases & Personalized Medicine 5. Risks and Opportunities for Cell and Gene Therapy 6. Actionable Insights
Learning Objectives:
1. Understanding Policy Shifts
Insight into how the new administration’s priorities are influencing FDA policies and enforcement strategies.
Changes in focus areas such as drug approvals and public health emergencies.
2. Leadership Impact
Overview of new FDA leadership and advisors and how their philosophies may impact regulatory oversight.
Discussion on transparency, scientific rigor, and expedited review processes.
3. Drug Development & Innovation
Updates on initiatives like the phase-out of animal testing and alternative New Approach Methodologies.
Impacts on timelines, costs, and innovation in biotech and pharma.
