On September 14, 2026, FDA convened a Part 15 hearing to discuss "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs." The meeting was a compilation of 2 minute segments for 80 public commentators representing a diverse community of academia, patients, advocates, service providers, and industry.
Yes, automation can process volume. What it can't do is exercise clinical judgment on a case that doesn't fit the pattern, defend a causality assessment to a health authority inspector, or carry a program's institutional history from one reviewer to the next. Those are not workflow steps. They're physician functions.
Alexis Pinçon, MD
Director, Global Medical Services & Medical Writing
The first oncology JCA reports show that this new EU assessment process is anything but routine. Here's what sponsors can learn from early submissions, and how to prepare for what's ahead.
Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.
With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.