| |
|
 |
About Wendy Stephenson: Curriculum Vitae
WENDY P. STEPHENSON, MD, MPH, MBA |
| |
| Contact Information |
| Address: |
1816 Carmel Place
Maple Glen, PA 19002 |
| Phone: |
1-215-628-2755 |
| E-mail: |
info@wendypstephenson.com |
| |
| Employment |
|
| 2004-Present |
Principal
Wendy Stephenson & Associates LLC, Maple Glen, PA
Providing a broad range of support and advice to pharmaceutical and biopharmaceutical companies in the area of drug safety. Clients include Abbott Laboratories, Adolor Corporation, Alkermes, Inc., Allergan, Inc., Amgen Inc., Biogen Idec, Inc., Auxilium Pharmaceuticals, Inc., Bionovo, Inc., Centacor Research & Development, Inc., Cephalon, Inc., Computer Sciences Corporation, Cubist Pharmaceuticals, Inc, Elan Pharmaceuticals, Inc., Elixir Pharmaceuticals, Inc., Endo Pharmaceuticals, GE Healthcare, Genentech, Inc., Genzyme Corporation, Inflexxion, Inc., J & J PR&D, LLC, Merck & Co, Inc., Millennium Pharmaceuticals, Inc., Novartis, Inc., Ortho-McNeil Janssen Scientific Affairs, LLC, Luitpold Pharmaceuticals, Metabasis Therapeutics, Inc., PAREXEL International, LLC, Pfizer, Inc., PhRMA, Premier Research Group plc, Relsys International, Inc., Regeneron Pharmacueticals, Inc., Sanofi Aventis, Shire Pharmaceutical Development Inc., Teijin Pharma Limited, Vicuron Pharmaceuticals Inc. ViroPharma, Inc., and Wyeth Pharmaceuticals. |
| |
1998-2004
1997-1998 |
Senior Vice President & Chief Safety Officer
Vice President & Chief Safety Officer
Wyeth Pharmaceuticals, Collegeville, PA
Recruited by Wyeth, subsequent to withdrawal of diet drugs Redux and Pondimin from the market. Responsible for complete overhaul of Wyeth’s safety organization, systems and processes. Responsible for oversight of Safety, Labeling, Epidemiology and Health Outcomes Research on a global basis and including all stages of development and marketing, for a wide range of products, including prescription drugs, vaccines, other biologics, devices, over-the-counter drugs and consumer products. Managed a number of important
safety issues, some resulting in drug withdrawals (Duract, Rotashield), some resulting in significant new warnings (Premarin, Prempro) and some resulting in pharmacovigilance and/or risk management plans, including the design and implementation of prospective epidemiology studies and registries. Represented Wyeth on CIOMS Working Groups focused on clinical safety. |
| |
1995-1997
1991-1994
1990-1991 |
Executive Director
Senior Director
Director
Worldwide Product Safety & Epidemiology
Merck & Company, Inc, West Point, PA
Responsible for integratiing domestic and international departments into global safety fuction. Developed medical evaluation and epidemiology functions to expand the safety remit beyond routine compliance with reporting regulations. Provided leadership and vision for a growing department at a time when regulatory concept of global harmonization was just beginning to evolve. Oversaw the development of three generations of home-grown safety sytems, the last of which is still in
use. Responsible for global safety oversight for a broad range of new products, principally drugs and vaccines, includiing the first statins Mevacor and Zocor, ACE inhibitors Vasotec and Prinivil, the first angiotensin II receptor inhibitor Losartan, the first bisphosponate Fosamax, the first alpha reductase inhibitor Proscar, the first protease inhibitor Crixivan and a new live virus vaccine Varivax. Represented Merck on CIOMS Working Groups focused on clinical safety. |
| |
1989-1990
1987-1989 |
Director
Associate Director
Epidemiology Research
Merck & Company, Inc., West Point, PA
Provided epidemiology expertise to clinical project teams (including those for Mevacor, Zocor, Fosamax, Proscar) for designing clinical programs and evaluating safety issues. Provided expert advise and consultancy to the safety department for the epidemiological evaluation of safety issues and interpretation of safety signals. Provided epidemiological support for the development of cost-effectiveness models (e.g., cost effectiveness of cholesterol-lowering) and health outcomes
studies (e.g., outcome of prostatectomy) in support of marketed products. Provided leadership for the planning and design of a new safety system. |
| |
1984-1986
1983-1984 |
Assistant Professor of Medicine, Biostatistics and Epidemiology
Instructor of Medicine, Biostatistics and Epidemiology
Department of Medicine, Division of General Medicine/Primary Care
University of Massachusetts Medical Center, Worcester, MA
Combination of research, clinical and teaching responsibilities. Co-PI on a number of NIH grants studying the epidemiology of coronary heart disease (CHD) as well as the impact of preventative interventions for CHD. Taught primary care medicine to medical students and interns in General Medicine. Developed a primary care health information system (PCHIS) for the UMass Primary Care Clinic. Taught biostatistics and epidemiology to medical students and Primary Care fellows. Maintained
clinical practice in primary care medicine. |
| |
| Participation on CIOMS Working Groups focused on Clinical Safety |
| 1990- Present |
Member of the Council of International Organizations of Medical Sciences (CIOMS) Working Groups II - VI on clinical drug safety. The CIOMS Working Groups, under the auspices of the World Health Organization, have provided a forum for experts from industry, government and academia to address issues of mutual interest and concern. Published proposals often influence national legislation and industry practice. Co-Chair of CIOMS VI. CIOMS Working Groups and their
resulting publications include:
| CIOMS II: |
International Reporting of Periodic Drug-Safety Update Summaries (1992) |
| CIOMS III: |
Guidelines for Preparing Core Clinical-Safety Information on Drugs (1995) |
| CIOMS IV: |
Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals (1998) |
| CIOMS III/V: |
Guidelines for Preparing Core Clinical-Safety Information on Drugs
Second Edition including Development Core Safety Information pre-approval. (1999) |
| CIOMS V: |
Current Challenges in Pharmacovigilance: Pragmatic Approaches (2001) |
| CIOMS VI: |
Managing Safety Information from Clinical Trials (2005) |
| CIOMS VII: |
The Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials (2007) |
|
| |
| Education |
|
| 1969-71 |
|
Case Western Reserve University (Mathematics) |
| 1972-73 |
B.A. |
Temple University (Mathematics) |
| 1973-75 |
M.S. |
Temple University (Biostatistics) |
| 1975-79 |
M.D. |
Temple University |
| 1982-85 |
M.P.H. |
University of Massachusetts (Epidemiology) |
| 2005-07 |
M.B.A. |
Wharton School, University of Pennsylvania (Finance) |
|
| |
| Postgraduate Training and Fellowship Appointments |
| 1980-1981 |
Resident in Family Practice
Case Western Reserve University
Fairview General Hospital, Cleveland, OH |
| 1981-1983 |
Resident in Preventive Medicine
University of Massachusetts Medical Center, Worcester, MA |
| |
| Faculty Appointments |
| 1993- |
Adjunct Scholar, Clinical Epidemiology Unit
Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania Medical Center, Philadelphia, PA |
| |
| 1988-1990 |
Visiting Scientist, Department of Health Sciences Research
Mayo Clinic, Rochester, MN |
| |
| 1984-1986 |
Assistant Professor of Medicine/Biostatistics/Epidemiology
Department of Medicine, Division of General Medicine/Primary Care
University of Massachusetts Medical Center, Worcester, MA |
| |
| 1983-1984 |
Instructor of Medicine/Biostatistics/Epidemiology
Department of Medicine, Division of General Medicine/Primary Care
University of Massachusetts Medical Center, Worcester, MA |
| |
|
| Hospital Appointments |
| 1983-1986 |
Staff Physician
University of Massachusetts Medical Center, Worcester, MA |
| |
| Certification and Licensure |
| 1979 |
Diplomate, National Board of Medical Examiners |
| 1984 |
Board Certified, Preventive Medicine and Public Health |
| Ongoing |
Licensed to practice medicine in Pennsylvania |
| |
| Memberships in Professional and Scientific Societies |
American Medical Association
Pennsylvania Medical Society
International Society for Pharmacoepidemiology
Drug Information Association
Healthcare Businesswomen’s Association |
| |
| Bibliography |
| Stephenson WP, Doern G, Gantz N, Lipworth L, Chapin K: Pharyngeal carriage rates of Haemophilus influenzae and prevalence of ampicillin resistant Haemophilus influenzae among day care children in Central Massachusetts. Amer J Epidemiol 122:868-875, 1985.
Hitzhusen JC, Taplan ME, Stephenson WP, Ansell JE: Vitamin B12 levels and age. Am J Pathol 85:32-36, 1986.
Ansell JE, VanderSalm TJ, Stephenson WP, Szymanski I, Fournier L: In vivo survival of red blood cells processed by a bubble or membrane oxygenator during cardiopulmonary bypass surgery. Texas Heart Institute J 13:247-251, 1986.
VanderSalm TJ, Stephenson WP, Ansell JE, Okike ON, Marsicano TH, Rooney K: Epsilon - aminocaproic acid: its role in reducing postcardiac surgical bleeding. A double blind randomized study. J Thoracic and Cardiovascular Surgery 95:538-40, 1988.
Ellison RC, Stephenson WP, Capper AL, Goldberg RJ, Hosmer DW, Humphrey KF, Ockene JK, Gamble WJ, Witschi JC, Stare FJ: Effects on blood pressure of a decrease in sodium use in institutional food preparation. The Exeter-Andover Project. J Clin Epidemiol 42:201-208, 1989.
Guess HA, Stephenson WP, Sacks ST, Gardner JS: Beyond pharmacoepidemiology: The larger role of epidemiology in drug development. J Clin Epidemiol 41: 995-996, 1989.
Bradford RH, Shear CL, Chremos AN, Dujovne C, Franklin FA, Hesney M, Higgins J, Langendorfer A, Pool JL, Schnaper H, Stephenson WP: Expanded Clinical Evaluation of Lovastatin (EXCEL) Study: Design and Patient Characteristics of a Double-Blind, Placebo-Controlled Study in Patients with Moderate Hypercholesterolemia. Am J Card 66:44B-55B, 1990.
Stephenson WP, Chute CG, Guess HA, Schwartz S, Lieber M: Incidence and Outcome of Surgery for Benign Prostatic Hyperplasia Among Residents of Rochester, Minnesota: 1980-87, A Population-Based Study. Urol 38(1 Suppl):32-42, 1991.
Laties AM, Shear CL, Lippa EA, Gould AL, Taylor HR, Hurley DP, Stephenson WP, Keates EU, Tupy-Visich MA, Chremos AN: Expanded Clinical Evaluation of Lovastatin (EXCEL) Study Results II. Assessment of the Human Lens after 48 Weeks of Treatment with Lovastatin. Am J Card 67:447-453, 1991.
Chute CG, Stephenson WP, Guess HA, Lieber M: Benign Prostatic Hyperplasia: A Population-Based Study. Eur Urol 20(suppl 2):11-17, 1991.
International Reporting of Periodic Drug-Safety Update Summaries. Final report of CIOMS Working Group II (1992). Council for International Organizations of Medical Sciences, Geneva.
Guidelines for Preparing Core Clinical-Safety Information on Drugs. Report of CIOMS Working Group III (1995). Council for International Organizations of Medical Sciences, Geneva
DeGroen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson WP, Freedholm D, Pryor-Tillotson S, Seleznick MJ, Pinkas H, Wang KK: Esophagitis Associated with the Use of Alendronate. NEJM 335(14): 1016-21, 1996.
Manson JM, Freyssinges C, Ducrocq MB, Stephenson WP: Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproduc Toxicol 10(6): 439-446, 1996.
Rosenberg L, Stephenson WP, Rao RS, Palmer JR, Strom BL, Shapiro S. The diagnosis of renal cell cancer in relation to hypertension (United States). Cancer Causes & Control 9(6):611-4, 1998
Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals. Report of CIOMS Working Group IV (1998). Council for International Organizations of Medical Sciences, Geneva.
Guidelines for Preparing Core Clinical-Safety Information on Drugs. Second Edition Report of CIOMS Working Groups III and V (1999). Council for International Organizations of Medical Sciences, Geneva.
Sharrar R, LaRussa P, Galea S, Steinberg S, Sweet A., Keatley RM, Wells M, Stephenson WP, Gershon A: The Postmarketing Safety Profile of Varicella Vaccine. Vaccine (19): 916-923, 2001.
Current Challenges in Pharmacovigilance: Pragmatic Approaches. Report of CIOMS Working Group V (2001). Council for International Organizations of Medical Sciences, Geneva.
Managing Safety Information from Clinical Trials. Report of CIOMS Working Group VI (2005). Council for International Organizations of Medical Sciences, Geneva.
Stephenson WP, Hauben M: Data Mining for Signals in Spontaneous Reporting Databases: Proceed with Caution. Pharmacoepidemio Drug Safe 16: 359-365, 2007.
The Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials, Report of CIOMS Working Group VII (2007). Council for International Organizations of Medical Sciences, Geneva.
^ back to top
|
|
|
