Vascepa ADCOM Participants and Contact Information Public Speakers who gave testimony on behalf of Vascepa Ellen L Marmer, MD Pediatric Cardiology 520 Hartford Vernon Rockville, CT 06066 Phone: (860) 870-9366 Fax: (860) 870-9358 George Grunberger, MD, FACP, FACE 2013-2014 AACE Vice President Chairman, Grunberger Diabetes Institute, Michigan The Grunberger Diabetes Institute (GDI) 43494 Woodward Avenue, Suite 208 Bloomfield Hills, Michigan 48302 Phone: (248) 335-7740 Fax: (248) 338-7979 Dr. David Sabgir Cardiologist, Clinical Cardiovascular Specialists Mt. Carmel, St. Ann s, Ohio Phone: (614) 459-7676 or (614) 714-0407 Fax: (614) 459-7681 Email: David@walkwithadoc.org Karen Caruth, Executive Director Mended Little Hearts 8150 N. Central Expressway, M2248 Dallas, Texas 75206 National Office: Phone: (888) 432-7899 Fax: (214) 295-9552 Email: karen.caruth@mendedhearts.org Website: http://mendedlittlehearts.org/mlh-contact.shtml
Dr Gary Trager Endocrinologist, Director Center for Diabetes and Endocrinology 475 New York Ave Huntington, NY 11743 Phone: (631) 673-9422 Fax: (631) 673 9426 Website: http://mendedlittlehearts.org/mlh-contact.shtml Dr Elliot Brinton, President AM. Board of Clinical Lipidology Atherotech Diagnostics Lab 201 London Parkway Birmingham, AL 35211 Phone: (800) 719-9807 + Department of Atherometabolic Research Utah Foundation for Biomedical Research Salt Lake City, UT, USA 676 E Vine St Murray, UT 84107 Dr Gary A. Trager, MD Director - Center for Diabetes and Endocrinology 475 New York Avenue, Huntington, NY 11743, Phone: (631) 673-9422 Email: info@centerfordiabetesandendo.com Dr Eliot A. Brinton, MD, FAHA, FNLA President and Director - Utah Lipid Center The Utah Lipid Center 419 Wakara Way, Suite 207E Salt Lake City, UT 84108 Main Phone: (801) 585-7955 Assistant Phone: (801) 581-5533 or (801) 583-8852 After Hours: (801) 403-7530 Fax: (801) 606-7279 Email: eliot.brinton@utah.edu Glenn Hardesty DO Emergency Medicine, Arlington Emergency Medicine Associates 800 W Randol Mill Rd Arlington, TX 76012 Phone: (817) 548-6202 - from googleplus page, Phone: (817) 960 6200 - from Texas Health Arlington Memorial Directory
Representatives of the FDA at the Vascepa Adcom FDA Participants Websites: http://directory.psc.gov/hhsdir/eekey.asp?key=28920 www.fda.gov/regulatoryinformation/foi/default.htm Curtis Rosebraugh, MD, MPH Director ODE-II, OND, CDER, FDA Building WO22, Room 3214 Station -0002 Organization DHHS/FDA/CDER/OMPT/CDER/OND/ODEII Phone: (301) 796-2310 Fax: (301) 796-9717 Email: curtis.rosebraugh@fda.hhs.gov Jean Marc Guettier, MD Director Phone: (301) 796-4958 Email: jean-marc.guettier@fda.hhs.gov Eric Colman, MD Deputy Director Phone: (301) 796-1190 Fax: (301) 796-9712 Email: eric.colman@fda.hhs.gov James P. Smith, MD, MS Clinical Team Leader Phone: (301) 796-1317 Email: james.p.smith@fda.hhs.gov
Mary Dunne Roberts, MD Clinical Reviewer Phone: (301) 796-4088 Email: mary.roberts@fda.hhs.gov Advisory Committee Panel David W. Cooke, M.D. Johns Hopkins University School of Medicine 200 North Wolfe Street, Room 3120 Baltimore, Maryland 21287 Phone: (410) 955-6463 Fax: (410) 955-9773 Email: dcooke@jhmi.edu Edward W. Gregg, Ph.D. Centers for Disease Control and Prevention 2877 Brandywine Rd Williams Building, Room 1505 Atlanta, Georgia 30341 Phone: (770) 488-1273 Fax: (770) 488-1148 Email: edward.gregg@cdc.hhs.gov Diana Hallare, MPH Consumer Representative 2520 Gist, Visalia, CA 93277 William R. Hiatt, M.D., FACP University of Colorado School of Medicine 13199 E. Montview Boulevard, Suite 200 Aurora, Colorado 80045 Phone: (303) 860-9900 Fax: (303) 860-1288 Email: will.hiatt@cpcmed.org
Mads F. Rasmussen, M.D., Ph.D. Novo Nordisk Inc. 100 College Road West Princeton New Jersey 08540 Phone: (609) 987-5800 Email: mdfr@novonordisk.com Ellen W. Seely, M.D. Brigham and Women s Hospital 221 Longwood Avenue Boston, Massachusetts 02115 Phone: (617) 732-5666 or (617) 732-5012 Fax: (617) 732-5764 Robert J. Smith, M.D. Providence Veterans Administration Medical Center 830 Chalkstone Avenue Providence, Rhode Island 02908 Phone: (401) 444 3420 Email: Robert_J_Smith@Brown.EDU + Hallett Center For Diabetes & Endocrinology 900 Warren Ave, Suite 302 East Providence, RI 02914 Phone: (401) 444-8850 Fax: (401) 444-7870 Brendan M. Everett, MD, MPH Brigham and Women's Hospital 900 Commonwealth Avenue East, 3rd Floor Boston, Massachusetts 02215 Phone: (617) 732-4969 Fax: (617) 264-9194 Email: beverett@partners.org Frank Harrell, Ph.D Vanderbilt University School of Medicine 2525 West End, Ste. 11000 Nashville, TN 37203 Email: f.harrell@vanderbilt.edu
Pamela Mcallister, PhD Fight Colorectal Cancer 1414 Prince St. Alexandria, VA 22314 Peter W. F. Wilson, M.D. Emory Clinical Cardiovascular Research Institute 1462 Clifton Road, Room 505 Atlanta, GA 30322 + The Emory Clinic 'A' 1365 Clifton Road, NE Atlanta, GA 30322 Phone: (404) 778-2746 Email: pwwilso@emory.edu Presenters for The Sponsors of Vascepa Mike Miller, MD, FACC, FAHA University of Maryland School of Medicine 655 W. Baltimore Street Baltimore MD 21201 Phone: (410) 328-6299 Fax: (410) 328-4382 Email: mmiller@medicine.umaryland.edu Harold Bays, MD, FTOS, FACE, FNLA Medical Director / President Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC Research Center) 3288 Illinois Avenue Louisville Ky. 40213 Phone: (502) 515.5672 Fax: (502) 214.3999 Website: www.lmarc.com Other HHS and FDA contacts Secretary Kathleen Sebelius Department of Health and Human Services 200 Independence Avenue S.W. Washington, D.C., 20201 Phone: (202) 690-7000 Email: Kathleen.Sebelius@hhs.gov
Margaret A. Hamburg DHHS/FDA/OC The U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Phone: (301) 796-5000 Email: Margaret.Hamburg@fda.hhs.gov Joshua Sharfstein Principal Deputy Commissioner FDA WO1 - Room 220 Janet Woodcock CDER Director FDA WO51 Room 6133 Curtis Rosebraugh (also listed above as ADcomm participant) CDER Office of Drug Evaluation FDA WO22 Room 3214 Mary Parks CDER Division of Metabolism and Endocrinology Products FDA WO22 Room 3362 John Jenkins CDER Director of New Drugs FDA WO22 Room 6304