Use of Large Real-World Datasets to Improve Practice Guidelines and Clinical Study Designs in Metabolic Diseases

Dara Schuster, MD., Senior Medical Director, Global Clinical Development, Labcorp Drug Development

Dr. Dara Schuster is a healthcare executive with extensive clinical, pharmaceutical industry and leadership experience.

As the CEO of T1D Exchange, Inc., a nonprofit type 1 diabetes research organization, Dr. Schuster built and aligned the mission, vision and 5-year strategic plan, managed all operational aspects of the organization, delivered three unique, functioning data platforms and developed external partnerships for type 1 diabetes research and philanthropy.

Prior to this, Dr. Schuster worked at Eli Lilly & Company from 2012-2018, with her last role being Senior Medical Director, Lilly Diabetes USA and Puerto Rico. In this role, she provided leadership in the areas of medical planning for late phase clinical trials and oversight of the research plans across the Lilly Diabetes Portfolio for USA. Dr. Schuster was responsible for oversight of the medical affairs launch teams for the new Lilly Diabetes assets as well support of strategy execution for existing molecules. She also worked in the area of real-world evidence use for patient care innovation.

Dr. Schuster is a graduate of The University of Kentucky School of Medicine. She completed residency in a combined Internal Medicine and Pediatrics Program and fellowship in Adult and Pediatric Endocrinology at The Ohio State University. She was on faculty there from 1996-2012. During her tenure she worked as a clinical endocrinologist, teacher, researcher and hospital administrator. Dr. Schuster currently holds the academic title of Adjunct Professor.

Barry J. Goldstein, MD, PhD, Vice President and Therapeutic Area Head, Cardiovascular, Metabolic, Endocrine and Renal, Labcorp Drug Development

Dr. Barry J. Goldstein is a board certified Endocrinologist who is an internationally recognized authority on diabetes mellitus. Dr. Goldstein has over 30 years of broad experience in clinical and basic R&D in academia and industry. He was Vice President and Therapeutic Area Head for Diabetes and Endocrinology at Merck from 2008-2013 and his clinical development experience spans from small molecules, combination therapies, novel insulin analogs, biosimilars, incretin peptides and novel biologics. Dr. Goldstein joined Labcorp Drug Development in 2013 to assume the position he currently holds.

Dr. Goldstein received his combined MD/PhD degrees from the University of Rochester School of Medicine and Dentistry and completed postdoctoral research and clinical fellowships at the Joslin Diabetes Center of Harvard Medical School. In 1992, he joined Jefferson Medical College in Philadelphia, where he spent 16 years as Professor and Division Chief for Endocrinology and Diabetes. Dr. Goldstein expanded basic and clinical research programs at Jefferson, elevated the reputation of the clinical practice to a tertiary referral center and established a robust Phase II-IV clinical trials unit. Dr. Goldstein has served as PI or Co-PI on over 100 clinical trials. He is an elected member of the ASCI and AAP, a past Associate Editor of the two major journals is his specialty, DIABETES and the JCEM, and has served on many grant review and scientific advisory panels. His numerous contributions to the literature include more than 225 research papers, editorials, monographs, book chapters and co-editorships.

John W. Kennedy, MD, President, AMGA Foundation, Chief Medical Officer, AMGA

Dr. John Kennedy previously served as division director of endocrinology at Geisinger Health System in Danville, PA, where he led the clinical, education, research and quality program development and expansion for the health system.

Prior to his role at Geisinger, Dr. Kennedy served as managing partner at Diabetes & Endocrinology Associates, P.A., in Hamilton, NJ. There, he transitioned the hospital-owned group into a four-physician specialty private practice.

Dr. Kennedy is board certified in endocrinology, diabetes and metabolism. He received his Doctor of Medicine degree from Jefferson Medical College, now the Sidney Kimmel Medical College, in Philadelphia, PA. He performed his internal medicine residency at Thomas Jefferson University Hospital in Philadelphia, PA, and his fellowship in diabetes, endocrinology and metabolism at the Joslin Diabetes Center and Beth Israel Deaconess Medical Center in Boston, MA. Dr. Kennedy graduated Phi Beta Kappa from Dartmouth College in Hanover, NH, where he received his Bachelor of Arts degree in chemistry.