Attendees - Food and Drug Administration

Attendees Caryl Auslander Public Policy Specialist AABB 8 10 1 Glenbrook Road Bethesda,MD 20878 Phone: 301-215-6514 Fax: 30 l-907-6895 Regina Ballinger, RN (press) Associate Editor, AdComm Bulletin Liquent 7 Fannies Meadow Ct. Westminster, MD 21158 Phone: 410-857-6390 Elise Berliner, PhD Technology AssessmentProgram Center for Outcomes and Evidence Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Phone: 301-427-1612 Fax: 301-427-1639 Email: eberline@,ahra.m Ron Billingsley Director of Government Relations Respironics, Inc 10 10 Murry Ridge Lane Murrysville, PA 15668 Phone: 724-387-4475 Fax: 724-387-5018

Jim Bowman MD MSM FACS Medical Officer Chronic Care Policy Group CMS/CMM/CCPG 65-07-02 7500 Security Blvd Baltimore, MD 2 1244 Phone: 410-786-0009 Fax: 4 1o-786-0594 [email protected] Jody Lannen Brady Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, Virginia 22203 Phone: 703-525-4890 x242 Sara Estes Burns Government Relations Associate Society for Women’s Health Research 1025 Connecticut Avenue NW Suite 701 Washington, DC 20036 Barbara J. Calvert Director, Reimbursement Strategies Guidant Corporation 1310 G St. NW Suite 770 Washington DC 20005 Phone: 202-508-0812 Fax: 202-508-0818

Erica Bisguer Director Boston Healthcare Associates, Inc. 75 Federal Street, 9th Floor Boston, MA 02110 Phone: 6 17-482-4004 Fax: 6 17-482-4005 Gretchen Bowker Endocyte, Inc. Director of Regulatory Affairs 1205 Kent Avenue West Lafayette, IN 47906 Phone: 765-463-7175 Fax: 765-463-927 1 [email protected] [email protected]

[email protected] www.euidant.com Jill Canino Health Policy Advisor Health Policy Source, Inc. 801 Pennsylvania Avenue, N.W., Suite 625 Washington, DC 20004 Work: 202-347-8936 Fax: 202-3 18-4533 Cell: 202-302-4896 [email protected]

Attendees Tanisha V. Carino, Ph.D. Manager The Health Strategies Consultancy LLC 1350 Connecticut Ave, NW Suite 900 Washington, DC 20036 Phone: 202-207-3677 Fax: 202-467-4455

Richie Crider Editor Guide to Medical Device Regulation Thompson Publishing 1725 K Street N W 7”’Floor Washington, D.C. 2b006 Phone: 202-739-9706 Fax: 202-739-9501 rcrider~thompsoncom

Andrea Chamblee, Esq., RAC Adjunct Professor Johns Hopkins University RA Manager Cambrex Bioscience Walkersville, Inc 8830 Biggs Ford Road Walkersville, MD 21793-0127 Fax: 301-845-6452 Voice: 301-898-7025 ext 2288 [email protected]

Chris Dinegar Vice President, Education Association for the Advancement of Medical Instrumentation Arlington VA 22201 Phone: 703-525-4890 Fax: 703-276-0793 [email protected]

Yuan-yuan Chiu, Ph.D. Senior Director, Strategic Operations Washington D.C. Office Genentech, Inc 1399 New York Ave, NW Suite 300 Washington DC 20005 Phone: 202-296-7272 Shana M. Christrup, MPH Deputy Director of Legislation Centers for Disease Control and Prevention, Washington Office 200 IndependenceAvenue, SW Washington, DC 20201 Phone: 202-690-8598 Direct: 202-205-2154 Email: [email protected] Thomas A. Connaughton Vice President, Legislative Affairs Cook Group Inc. Suite 700 North 1001 Pennsylvania Ave. N.W. Washington, DC 20004 Phone: 202-661-3320 [email protected]

Jay Dunigan Director of Professional Relations & Reimbursement Abbott Diabetes Care Abbott Laboratories 6 Misty LN Londonderry NH 03053 Phone: 603-437-7226 Fax: 603-2 18-6195 Richard M. Eaton Industry Manager, Ultrasound Imaging Section and Nuclear Section NEMA 1300 N. 17th Street, Suite 1847 Rosslyn, VA 22209 Phone: 703-841-3248 Fax: 703-841-334s E-mail: [email protected] Lily 0. Engstrom Senior Policy Advisor to the Asst. Sec. for Public Health Emerg. Preparedness Office of Public Health Emergency Preparedness HHH, Room 6386 Phone: 202-205-4727 (at OPHEP) Phone: 301 -594-3084 ext. 155 (at FDA)

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Attendees Carol A. Kelly Executive Vice President AdvaMed, Advanced Medical Technology Association Health Care Systems and Federal Legislative Policy 1200 G Street NW, Suite 400 Washington, DC 20005-38 14 Direct: 202-434-7203 Fax: 202-783-8750 [email protected] Kathleen Kenney, Senior VP MSA Medical Group RockPointe Business Air-park 400 MSA Drive Tarentum, PA 15084 [email protected] Ed Kensik (PRESS) Associate Editor Medical Product Outsourcing Magazine 70 Hilltop Road Ramsey, New Jersey 07446 Phone: 201-825-2552 ext. 333 Fax: 201-825-0553 Kevin M. Kirby (703) 84 l-8403 THE MORAN COMPANY 1655 N. Fort Myer Drive Suite 1250 Arlington, VA 22209 [email protected] Frank A. Kyle, Fr., D.D.S., MS. Manager, Legislative & Regulatory Policy American Dental Association 1111 14* St. N.W.; Suite 1100 Washington, DC 20005 Phone: 202-789-5 175 Fax: 202-789-2258 [email protected]

Scott M. Lassman Assistant General Counsel Pharmaceutical Research and Manufacturers of America 1100 Fifteenth Street, NW Washington, D.C. 20005 Phone: 202-835-3470 E-mail: [email protected] Kelly L. Lavin Regulatory Analyst American Osteopathic Association 1090 Vermont Avenue NW, Suite 5 10 Washington, DC 20005 Phone: 202-414-0140 ext. 238 Phone: 800-962-9008 Fax: 202-544-3525 Mark B. Leahey, Esq. Executive Director Medical Device Manufacturers Association 1900 K Street, NW, Ste. 100 Washington, DC. 20006 Phone: 202-496-7 124 Fax: 202-496-7756 [email protected] Teresa Lee Associate Vice President, Payment & Policy AdvaMed, Advanced Medical Technology Association 1200 G Street, NW Suite 400 Washington, DC 20005-38 14 Phone: 202-434-72 19 Fax: 202-783-8750 [email protected] Daniel N. Lerman, Ph.D. Office of Science Pohcy & Planning Office of the Director, NIH 1 Center Drive, Bldg. 1, Rm. 2 18 Bethesda, MD 20892 Phone: 301-496-9286 Fax: 301-402-0280 [email protected]

Attendees Caroline Loew, Ph.D. Vice President, Scientific and Regulatory Affairs Pharmaceutical Researchand Manufacturers of America 1100 Fifteenth Street, N.W. Washington, D.C. 20005 Phone: 202-835-3558 Fax: 202-835-3597 Vadim Lubarsky Technical Advisor Coverage and Analysis Group, Office of Clinical Standardsand Quality Center for Medicare and Medicaid Services 7500 Security Blvd. Baltimore, Md. 2 1244 Phone: 41 o-786-0840 Email: [email protected] Michael Mabry Assistant Executive Director of Policy Society of Interventional Radiology 10201 Lee Highway Suite 500 Fairfax, VA 22030 Phone: 703-691-1805 Charles Mathews Associate Boston Healthcare Associates, Inc. 75 Federal Street, 9th Floor Boston, MA 02110 Phone: 6 17-482-4004 Fax: 6 17-482-4005 Brian Mayhew Global Regulatory Policy-Bethesda Merck & Co., Inc. Two Bethesda Metro Center Bethesda,MD 208 14 Phone: 301-941-1419 Connie Robinson@?Merck.com

Deven McGraw Associate Patton Boggs LLP 2550 M Street, NW Washington, DC 20037-1350 Phone: 202-457-6132 Fax: 202-457-63 15 dmcgraw@nattonbog;rrs.com Brian Mech, Ph. D., M. B. A. Director of Business Development Second Sight 12744 San Fernando Rd., Bldg. 3 Sylmar, CA 91942 Phone: 818-833-5026 Fax: 818-833-5067 [email protected] Nancy Brandish Myers, Esq.S. Special Assistant/Senior Strategic Advisor to the Acting Deputy Commissioner for Operations Office of the Commissioner Food and Drug Administration Phone: 301-827-3314 Email: [email protected] Emily Niederman ITEM Coalition 1875 Eye Street, N.W., 12th Floor Washington, D.C. 20006 Phone: 202-349-4243 emilv.niedermanO,pnsv.com Josh Ofman VP, Reimbursement & Payment Policy Amgen 1300 I Street, NW Suite 470 East Phone: 202-354-97 19 Fax: 202-289-6368 Mary O’Donovan Senior Scientist Genetech 1DNA Way Mail stop 242 South San Francisco 94080 Phone: 650-225-8071 Fax: 650-225-4171 Odonovan.mar@&ene.com

Attendees Ronald Podraza, J.D. Chief Executive Officer Reimbursement Principles, Inc. 801 West Mineral Avenue, Suite 20 I, Littleton, CO 80120 Phone: 303-703-1572 Mandy M. Raab PhD, MSIS Project Manager & Scientist MSA Medical Group RockPointe Business Airpark 400 MSA Drive Tarentum, PA 15084 Phone: 724-265-6576 [email protected] Karen Riley (PRESS) US Editor Clinica: World Medical Device & Diagnostic News Phone: 301-927-1485 [[email protected] Kathy Rutherford Director, Regulatory Affairs Adobe Medical International Phone: 201-760-6464 ext 207 Michele M. Schoonmaker, Ph.D. Specialist in Genetics Health Care and Medicine Section Division of Social Policy Congressional Research Service 101 IndependenceAve, SE Washington, DC 20540 Phone: 202-707-7839 [email protected] Jeffrey Shuren, M.D., J.D. Assistant Commissioner of Policy Office of Policy and Planning Office of the Commissioner Food and Drug Administration Phone: 301-827-3360 Fax: 301-594-6777 Email: [email protected]

Jayson Slotnik Director, Medicare Reimbursement and Economic Policy Biotechnology Industry Organization 1225 Eye St NW, Ste 400 Washington DC, 20005 Phone: 202-3 12-9273 [email protected] Brad Stolshek Associate Director Medical Affairs Amgen 1300 I Street, NW Suite 470 East Phone: 202-354-9719 202-289-6368 Daniel C. Sullivan M.D. Associate Director, NCI Cancer Imaging Program Associate Director, Division of Cancer Treatment and Diagnosis, NCI; Chair, NIH Bioengineering Consortium (BECON). Phone: 301-496-9531 Email: cip.cancer.gov Saira Sultan Director, Federal Affairs Sanofi-Synthelabo, Inc. 655 Fifteenth Street, NW Suite 450 Washington, DC 20005 Phone: 202-639-8620 Cell: 202-360-9985 Email: [email protected] David N. Sundwall, M.D., Senior Medical and Scientific Officer American Clinical Laboratory Association 1250 H Street, NW, Suite 880 Washington, D.C. 20005 Phone: 202-637-9466 Fax: 202-637-2050

Attendees Ashley Thompson Senior Associate Director, Policy Development American Hospital Association 325 7th Street, NW, Suite 700 Washington, DC 20004-2802 Phone: 202-626-2340 Fax: 202-626-43 19 athompson(ii2aha.org

Sarah E. Wells Director, Health Policy & Payment Boston Scientific Government Affairs 133 1 Pennsylvania Avenue, NW Suite 550 South Washington, DC 20004 Phone: 202-637-8021 Fax: 202-637-8028 [email protected]

Angel S. Torres-Cabassa,Ph.D. Senior Scientific Advisor Office of Combination Products Food and Drug Administration combination@?fda.nov

Theresa Wiegmann Director of Public Policy, Special Counsel AABB 8 10 1 Glenbrook Road Bethesda, MD 20878 Phone: 301-215-6554 Fax: 301-907-6895

Steve Walker Abigail Alliance Andrew Watkins, J.D., Ph.D. Director. Technology Transfer Office Office of the Chief of Science Centers for Disease Control and Prevention Phone: 770-488-8600 Fax: 770-488-86 15 fax Email: [email protected] Keith Webber, Ph.D. Acting Director Office of Biotechnology Products OPS/CDER./FDA HFD-121 Phone: 301-443-5125 Fax: 301-443-5235 Jill Wechsler (PRESS) Washington Editor Pharmaceutical Executive mag 77 15 Rocton Ave. Chevy Chase, MD 208 15 Phone: 301-656-4634.

Robin Wiley Manager of Regulatory and Legislative Affairs, Cook Group Inc Suite 700 North 1001 Pennsylvania Ave. N.W. Washington, DC 20004 Phone: 202-66 l-3320 [email protected] Neil E. Wummer Regulatory Affairs Director AstraZeneca LP 1800 Concord Pike P.O. Box I5437 Wilmington, DE 19850-5437 Phone: 302-885-4564 Fax: 302-886-2822 Stephen Vastagh Industry Manager, NEMA Medical Products Department 1300 N. 17thSt. Suite 1847 Arlington, VA 22209 Phone: 703-841-3281 Fax: 703-841-3381 Ste [email protected] www.nema.org/medical www.medicalimaging.org

Attendees