The FDA Expands the Types of Confirmatory Evidence Sources to Support Drug Effectiveness Studies
Download our white paper on the FDA Expansion of Types of Confirmatory Evidence Sources for Drug Effectiveness Studies. Learn how the inclusion of real-world data (RWD) and evidence from natural history studies can improve your integrated evidence strategy to help expedite regulatory approval and bring your product to market more efficiently to the patients who need it most.
Hear from UBC’s Chief Scientific Officer, Annette Stemhagen, DRPH, FISPE, Senior Director, Epidemiology, Irene Cosmatos, and Executive Director, Evidence Development Study Solutions, Judy Lytle, PhD, MBEE, PMP on how recent FDA draft guidance from September 2023 paves the way for opportunity to capitalize on advancements in RWD & RWE to support the evaluation of drug effectiveness.
Get your copy for insight and perspective on: 
- 2023 FDA Draft Guidance for the industry
- Confirmatory evidence from natural history
- Confirmatory evidence from RWD sources
- Related case study examples
Partner with UBC experts to plan a valuable evidence generation strategy that results in the real-world evidence needed to help prove drug effectiveness and ensure regulatory compliance.
Complete the form to learn more and access our white paper: FDA Expansion of Types of Confirmatory Evidence Sources for Drug Effectiveness Studies
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Bekki Bracken Brown
President & Chief Executive Officer
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.