Speakers
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.
Frank W. Rockhold, PHD, MSC
Professor of Biostatistics, Duke Clinical Research Institute, Duke University Medical Center, United States
Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry and Government. His career includes senior positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer. He has held faculty appointments at six different universities, served as Chairman of CDISC, and is past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials and is widely published across a wide variety of research topics.
Jeffrey Francer, JD, MPA
Vice President, Head of International Regulatory Affairs and Global Regulatory P, Eli Lilly and Company, United States
Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff also leads Lilly’s global regulatory policy team. Jeff has led and advised biopharmaceutical companies and policy makers for over 25 years to craft regulatory systems that best meet the needs of patients and improve public health. Prior to joining Lilly in 2023, Jeff has served as Associate Chief Counsel of the FDA, Vice President and Senior Counsel at PhRMA, and Senior Vice President and General Counsel of the Association for Accessible Medicines.
Presentation - All Speakers
, United States
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