The political issues circling the FDA this year could potentially ripple into biopharma on a scale that’s never been seen before. All eyes are on the FDA’s response to recent court rulings around the abortion pill mifepristone — and the potential effects on other approvals that might be questioned. What does the future look like, exactly? Join Endpoints’ Senior Editor Zachary Brennan in an expert panel to unpack what may come next. We’ll also touch on how the FDA is looking for new ways to spur more rare disease drug development with a fireside chat.
As we adjust to the post-COVID environment, hear from industry leaders about the biotech global investment and drug pipeline environment. In addition, we'll look at why biotech companies are increasingly exploring clinical opportunities in APAC, to achieve FDA accepted data and what actionable strategies can be implemented to leverage APAC's streamlined regulatory processes and accelerated clinical development. Our Regulatory affairs leaders from North America and Australia will share insight into processes supporting a robust clinical program, and how Phase 1 FDA accepted data from Australia, specifically, can launch global drug development programs.
Experts answer questions on embracing FDA’s guidance on the use of real world data (RWD) to understand how your organization can navigate data quality, curation, and management challenges for better research.