FDA Innovation Initiative
Wednesday, April 11, 9:00-10:30, Ballrooms C, University Hotel Minneapolis

Organizer: Ralph Hall, School of Law, University Of Minesota

"Innovation Issues: Entrepreneur in Residence"
Paul Sobotka, MD, Food and Drug Adminstration

"Payor/Provider View of Innovation"
Richard (Dick) Justman, UnitedHealth

Session Abstract:

Session Organizer Bio:

Ralph Hall, Distinguished Professor and Practitioner of Law, University of Minnesota Law School
Professor Ralph F. Hall has a J.D. from the University of Michigan Law School in 1977 and currently serves as Distinguished Professor and Practitioner at the University of Minnesota Law School where he specializing in FDA law and related areas. In addition, he serves as Counsel to the law firm of Baker & Daniels where he assists clients in FDA regulatory and compliance matters. He also serves as CEO of MR 3 Medical LLC, a start up medical device company working in the cardiovascular area. Prior to joining the University of Minnesota Law School, he was in senior legal positions with several major medical product companies. Professor Hall has written and spoken extensively on FDA matters.

Speaker Bios:

Paul Sobotka, MD, Food and Drug Adminstration
Paul Alan Sobotka, M.D., F.A.C.P., F.A.C.C. , currently serving as Entrepreneur in Residence, at the White House,- assigned to the Food and Drug Administration, matriculated from Stanford University with degree in Chemistry and obtained MD from the University of Illinois College of Medicine. He completed training in Internal Medicine at The University of Michigan, followed by specialty training in cardiovascular diseases at Northwestern University. Further education has been completed in health care economics and policy at the Harvard School of Public Health. Promoted to Associate Professor of Medicine and Physiology while at Loyola University in Maywood Il, he directed intensive care clinical services and participated in the heart failure and transplant programs; moving to Wayne State University School of Medicine where he served as Professor and Vice Chair of the Department of Medicine. Dr. Sobotka is currently on sabbatical from his post as a medical advisor to Medtronic. He has previously been Chief Medical Officer of Ardian, Inc, and CHF Solutions, founder of Advanced Heuristics, and executive director Merck, Inc.; he currently holds an appointment as Clinical Professor of Medicine/Cardiology at The Ohio State University and the University of Minnesota, while serving on staff at Hennepin County Medical Center. Dr. Sobotka has authored nearly 100 peer reviewed manuscripts and book chapters including manuscripts published in: The Journal Clinical Investigation, American Journal of Physiology, The New England Journal of Medicine, Lancet, Circulation, Circulation Heart Failure, Journal of Congestive Failure, Hypertension, Journal of Hypertension, Journal of the American Society of Nephrology, Journal of Congestive Failure, and the National Enquirer. His current research and clinical interests include neurosympathetic control of hypertension and volume homeostasis, heart failure and statistical methods.

Richard (Dick) Justman, UnitedHealth
Dick Justman is national medical director of UnitedHealthcare, a national health service delivery company. Dick is accountable for medical technology assessment, clinical support of pharmacy programs and clinical support of benefit administration. He has been with UnitedHealthcare since 1993. Dick received his bachelor’s degree from Cornell University and his MD degree from the State University of New York at Buffalo. He is board-certified in pediatrics, and received his postgraduate training at The University of Chicago Hospitals and Clinics and the Johns Hopkins Hospital. Dick practiced pediatrics in Minneapolis, Minnesota for fifteen years before joining UnitedHealthcare. He has served on the Institute of Medicine Forum on Drug Discovery, Development and Translation; the Institute of Medicine Committee to Identify Highly Effective Clinical Services; the American Medical Association CPT-5 Project; the American Medical Association Initiative to Transform Medical Education (ITME); and an expert panel developing an Evidence Report on diabetes education for children with type I diabetes, commissioned by the Agency for Healthcare Research and Quality (AHRQ). Dick currently serves on the AHRQ Stakeholders’ Panel for its Effective Health Care program.

Presentation Abstracts: