Roster of the FDA/CDRH Gastroenterology and Urology Devices Panel December 3, 2010

Transcription

1 CHAIRPERSON Roster of the FDA/CDRH Gastroenterology and Urology Devices Panel December 3, 2010 Karen L. Woods, M.D. Clinical Associate Professor of Medicine Baylor College of Medicine, Houston, TX VOTING MEMBERS Jason T. Connor, Ph.D. Biostatistician Berry Consulting, LLC, Orlando, FL Christian P. Pavlovich, M.D. Associate Professor, Brady Urological Institute Johns Hopkins Medical Institutions, Baltimore, MD TEMPORARY VOTING MEMBERS Joseph J. Cullen, M.D. 1 Professor, Department of Surgery, Division of Gastrointestinal, Minimally Invasive & Bariatric Surgery University of Iowa, Iowa City, IA Jon C. Gould, M.D. Associate Professor, Department of Surgery University of Wisconsin School of Medicine and Public Health, Madison, WI Thomas H. Inge, M.D., Ph.D. Director, Center for Bariatric Research and Innovation Cincinnati Children s Hospital Medical Center, Cincinnati, OH John G. Kral, M.D., Ph.D. Professor of Surgery and Medicine, Department of Surgery SUNY Downstate Medical Center, Brooklyn, NY Walter J. Pories, M.D. Professor of Surgery East Carolina University, Greenville, NC Drew B. Schembre, M.D. Chief, Division of Gastroenterology Virginia Mason Medical Center, Seattle, WA Steven D. Schwaitzberg, M.D. Chief of Surgery Page 1 of 6

2 Cambridge Health Alliance, Boston, MA Jeffrey L. Zitsman, M.D. Director, Center for Adolescent Bariatric Surgery New York-Presbyterian Morgan Stanley Children's Hospital/Columbia University Medical Center, New York, NY INDUSTRY REPRESENTATIVE Terry N. Layton, Ph.D. Technical Officer, Biomedical Engineer Laytech, Inc., Long Grove, IL CONSUMER REPRESENTATIVE E. Francine Stokes McElveen, J.D. Senior Advisor to the President for Legal Affairs Coppin State University, Baltimore, MD PATIENT REPRESENTATIVE Melanie G. Coffin 2 DESIGNATED FEDERAL OFFICER Margaret McCabe-Janicki, B.S. Center for Devices & Radiological Health Food and Drug Administration, Silver Spring, MD 1 Dr. Cullen is a consultant to the FDA/CDER Gastrointestinal Drugs Advisory Committee. 2 Ms. Coffin is a consultant to the FDA/CDER Oncologic Drugs Advisory Committee. Page 2 of 6

3 PANEL BIOGRAPHIES Karen L. Woods, M.D. Dr. Woods is a gastroenterologist at The Methodist Hospital in Houston, TX. Dr. Woods has served as the Elected Secretary of the Medical Staff at The Methodist Hospital since 2009, and she has served on numerous medical staff committees. She also holds an appointment as Clinical Associate Professor of Medicine at Baylor College of Medicine, Department of Medicine, Gastroenterology Section. Dr. Woods earned her B.A. (Biology) and M.D. degrees at the University of Missouri - Kansas City, Kansas City, Missouri. Jason T. Connor, Ph.D. Dr. Connor is uniquely trained as a biomedical engineer and a Bayesian biostatistician. He works at a statistical consultant designing Bayesian adaptive clinical trials for Berry Consultants. He received his PhD in Statistics & Public Policy from Carnegie Mellon University. He has coauthored over 50 papers in clinical journals. He recently finished a six-year term as an Associate Editor of The American Journal of Gastroenterology. Jason holds an Assistant Professor of Medical Education appointment at the University of Central Florida and was visiting professor at the Johns Hopkins University Bloomberg School of Public Health summer of He is a fellow of the American College of Gastroenterology. Christian P. Pavlovich, M.D. Dr. Pavlovich is an Associate Professor of Urology at Johns Hopkins, Directs Urologic Oncology at Johns Hopkins Bayview Medical Center, and is Fellowship Director for the Johns Hopkins Urologic Oncology Fellowship. Dr. Pavlovich trained in Urology at Cornell/New York Hospital, then did a 2-year fellowship at the National Cancer Institute in Bethesda prior to joining the Johns Hopkins faculty in 2001 where he is a busy minimally-invasive cancer surgeon who treats primarily prostate, kidney, and bladder malignancies. In addition, he has maintained NIH and Department of Defense funding for research work identifying urinary markers for prostatic disease. He currently has over 70 publications relating to the diagnosis, treatment, and prognosis of patients with urologic disease. Joseph J. Cullen, M.D. Dr. Cullen is a Professor of Surgery at the University of Iowa and Chief of Surgical Services at the Iowa City VA Medical Center. He finished his surgery residency at the University of Iowa in 1991 and did a NIH research fellowship in digestive diseases at the Mayo Clinic from He is currently funded from the VA Merit review program and the NIH. He has published more than 100 papers in peer review journals and over 20 book chapters. Jon C. Gould, M.D. Dr. Gould is an Associate Professor of Surgery at the University of Wisconsin School of Medicine and Public Health. He completed a fellowship in Minimally Invasive Surgery at the Ohio State University in 2002 before coming to Wisconsin. At the University of Wisconsin, he currently serves as the Chief of Minimally Invasive and Bariatric Surgery, the Co-Medical Page 3 of 6

4 Director for the UW Health Bariatric Surgery Program, and the Medical Director for the UW Health Clinical Simulation Program. Thomas H. Inge, M.D. Dr. Inge is Associate Professor of Surgery and Pediatrics at Cincinnati Children s Hospital/University of Cincinnati. He has worked as a pediatric surgeon at Cincinnati Children s since completing his training in July He has directed the institution s Surgical Weight Loss Program for Teens since 2004 and has performed over 135 minimally invasive weight loss procedures for adolescents during that time. Dr. Inge's clinical and research focus is adolescent bariatric surgery. His clinical research has been continuously funded by NIH since He is currently the Principal Investigator and Study Chairman of Teen-LABS, an NIDDK U01 funded multicenter outcome study of teens undergoing weight loss surgery. He is co-investigator on 2 other R01 funded projects examining the role of surgery for management of adolescent obesity. John G. Kral, M.D., Ph.D. Dr. Kral is Professor of Surgery and Medicine at SUNY Downstate in Brooklyn since 1988 when he became Director of Surgery at Kings County Hospital after having established a Division of Surgical Metabolism in 1981 at St Luke s Hospital and the NIH Obesity Research Center, Columbia University, operating on severely obese patients and studying body composition, appetitive behavior and adipose tissue metabolism. Dr. Kral, a graduate of the University of Göteborg, Sweden, received his MA and taught Behavioral Neuroscience while attending medical school, followed by surgical residency, performance of pre-clinical and human research on adrenergic receptor agonists and defense of his PhD thesis: Surgical reduction of adipose tissue in Subsequently he performed the first vagectomies for obesity in humans. A cofounder of the American Society for Bariatric Surgery in 1983, Dr. Kral initiated and coorganized the NIH Consensus Conference: Gastrointestinal Surgery for Severe Obesity in 1991 and was President of the NY State Society of Surgeons Dr. Kral has performed investigator-initiated drug research and been co-investigator of medical devices. After discontinuing clinical practice he continues studies of early-life stress and intra-uterine precursors of chronic overnutrition, subdural drug delivery in behaving primates and editorial activities, leadership of the Diabesity Discussion Group of The NY Academy of Sciences, teaching and mentoring. Walter J. Pories, M.D. Dr. Pories is the Director of the Bariatric Surgery Research Program at the Brody School of Medicine, East Carolina University. He is a graduate of Wesleyan University in Connecticut, the University of Rochester and is certified in general and cardio-thoracic surgery. He and his colleague, William Strain, PhD, were the first to identify zinc as an essential element and to incorporate trace elements into animal feeds and nutrient preparations for humans. He was also the first to find that full remission of type 2 diabetes could be achieved with the gastric bypass operation, to describe wound suction, and to invent radio-opaque surgical drains. Page 4 of 6

5 Steven D. Schwaitzberg, M.D. Dr. Schwaitzberg is Chief of Surgery at the Cambridge Health Alliance and Associate Professor of Surgery at Harvard Medical School. He is a former IRB chair and has written extensively in the field of device and procedure innovation. He is the incoming president of the Society of American Gastrointestinal and Endoscopic Surgeons. Dr Schwaitzberg is a graduate of the Johns Hopkins University and Baylor College of Medicine. Jeffrey L. Zitsman, M.D. Dr. Zitsman is Associate Clinical Professor of Surgery at the College of Physicians and Surgeons, Columbia University, and Director of the Center for Adolescent Bariatric Surgery at the Morgan Stanley Children s Hospital of NY Presbyterian/Columbia University Medical Center. He is a graduate of Johns Hopkins University and received his medical degree from Tufts University. Dr. Zitsman is a member of the Committee on Childhood Obesity of the American Pediatric Surgical Association and a member of the Program Committee and the Pediatric Committee of the American Society for Metabolic and Bariatric Surgery. Terry N. Layton, Ph.D. Dr. Layton is a Biomedical Engineer who started his career as a design engineer for urological medical devices in He now is a technical executive with Laytech, Inc actively involved in product design, regulatory approval, and clinical evaluation for new health care markets and business ventures. In addition to his involvement in the medical device industry, he also is a Visiting Professor at the University of Illinois, Chicago Department of Bioengineering teaching classes on medical device industry 'skill sets' and consults in technology assessment for both private and government organizations. E. Francine Stokes McElveen, J.D. Ms. Stokes McElveen serves as the Senior Advisor to the President for Legal Affairs at Coppin State University, a constituent institution of the University System of Maryland. She provides legal advice and counsel to executive officers, directors and other senior academic and administrative leaders regarding a broad range of laws, regulations, risk and policies that impact the institution. Prior to coming to Coppin State University, Ms. Stokes McElveen served as an assistant to the President of Morgan State University for government and state relations. She is also a former assistant State s Attorney for Baltimore City. Melanie G. Coffin Ms. Coffin is a Patient Representative who has personal experience with obesity and weight control issues. In addition to her own weight loss journey, Ms. Coffin has spent 15 years working with as many as 500 people a week that were dealing with issues of weight, health, behavior, exercise, and nutrition. Page 5 of 6

6 Margaret McCabe-Janicki, B.S. Ms. McCabe-Janicki holds a Bachelor of Science in Chemistry with a concentration in German. She has worked for FDA since 2003, first as a chemist at FDA s Center for Biologics Evaluation and Research in the Office of Vaccines Research and Review (OVRR), and then as CBER s Institutional Animal Care and Use Committee Coordinator. Margaret now serves as CDRH s Designated Federal Officer for the Gastroenterology and Urology, General and Plastic Surgery, and Hematology and Pathology Devices Panels, and for the Devices Good Manufacturing Practice (GMP) Advisory Committee. Page 6 of 6