Provide medical and safety management of clinical trials as medical monitor for assigned programs; works closely with safety associates in evaluation, management, and assessment of adverse event reports.
Assist the Global Vice President in day-to-day management of medical and safety staff, as assigned.
Maintain a working knowledge of projects in his/her functional area for which i3 Research is responsible for medical and/or safety monitoring.
Support to Business Development through participation in core proposal team activities, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors, as requested.
Stay abreast of clinical and drug development information relevant to contracted programs by review of literature, attendance at medical/scientific meetings, and personal interchanges with consultants and investigators.
Provide a medical perspective to the design of clinical development programs and study protocols; provide expert input into the development, review, and editing of clinical documents.
Collaborate with sponsors and/or internal departments on the design and review of study-related documents and professional manuscripts.
Assist the Global Vice President as appropriate by serving as a mentor and role model for other medical and safety staff.
Assist the Global Vice President as required in identifying training needs and coordinate the implementation of training programs for medical and safety staff.
Independently, and in collaboration with Business-development staff, pursue novel business opportunities to enhance corporate revenue.
Interact with other functional units, such as project management, field monitoring, data management and statistics, et al. to ensure the highest level of client satisfaction through successful execution and completion of projects.
Maintain a high level of expertise with client projects and marketplace developments through reliable participation in internal meetings, including project tracking, and attendance at professional seminars and educational programs.
Provide protocol-related clinical and scientific training to project team staff members.
- Participate in medical/scientific education for i3 Research staff through scheduled lectures and seminars on subjects relevant to company projects and on areas of individual interest and expertise.
- Any other duties that may, from time to time, be assigned by the Executive Director, Medical Affairs.
2005-2007 Director, Global Pharmacovigilance and Head, Case Review Physicians Group - Global Pharmacovigilance
Schering-Plough Research Institute
Springfield, NJ, USA
- Managed a group of 13 safety physicians who reviewed single cases.
- Reviewed and revised SOPs and pharmacovigilance process guides.
- Served as leader of special project to transition review of clinical trial SAEs to GPV.
- Served as co-chair of team to develop case handling conventions.
- Coordinated medical review activities in implementation of new pharmacovigilance database (August 2006).
- Participated in other management activities within GPV.
2001-2005 Associate Director, Global Pharmacovigilance and Epidemiology
Sanofi-Aventis (formerly Aventis Pharmaceuticals)
Bridgewater, NJ, USA
- Primary responsibility for clinical safety and post-marketing surveillance of diabetes and other products.
- Reviewed single cases of adverse events, participated in preparation of PSURs, periodic reports, CTDs, risk management plans; reviewed issues and wrote reports (e.g., for labeling committee); reviewed draft publications.
- Participated as pharmacovigilance member of clinical teams (including multiple joint-development projects).
1998-2001 Associate Medical Director, Drug Safety Surveillance
Pfizer Inc. (formerly Parke-Davis Pharmaceutical Research)
Ann Arbor, MI, USA
- Primary responsibility for post-marketing safety of diabetes products.
- Reviewed single cases of adverse events, participated in preparation of PSURs and periodic reports, interacted with consultants, reviewed issues and wrote reports, supervised other physicians.
1997-1998 Medical Staff (part-time)
Missouri State Board of Registration for the Healing Arts
Jefferson City, MO, USA
- Reviewed medical records of registrants, participated in interviews of registrants, advised board on medical issues surrounding registrants.
1986-1998 Private Practice Physician (Endocrinology)
Midwest Diabetes Care Center
Kansas City/Independence, MO, USA
1985-1986 Private Practice Physician (Endocrinology)
Midwest Diabetes and Endocrinology Center
West Des Moines, IA, USA
1981-1985 Private Practice Physician (Endocrinology)
Downtown Yankton Medical Clinic
Yankton, SD, USA
1978-1985 Director of Medical Services (part-time)
South Dakota Human Services Center
Yankton, SD, USA
- Supervised physician assistants, laboratory services, substance abuse program, and nursing home unit.
- Provided internal medicine consultations.
- Served as member of senior staff.
1978-1985 Associate Professor of Internal Medicine and Psychiatry (part-time)
University of South Dakota School of Medicine
Vermillion, SD, USA
- Participated in third-year student internal medicine rotations, fourth-year student endocrinology, and other elective rotations.
- Supervised students on psychiatry rotations at SDHSC.
- Participated as full (not clinical) faculty in internal medicine and psychiatry departments.
1974-1981 Private Practice Physician (Internal Medicine)
Yankton Medical Clinic (formerly Yankton Clinic, PA)
Yankton, SD, USA
1972-1974 Deputy Chief of Medicine, Department of Internal Medicine
US Public Health Service, Alaska Native Medical Center
Anchorage, AK, USA
LICENSURE/CERTIFICATION
1986 to Present: Medical License
State of Missouri
(Previous medical licenses in Iowa, Kansas, Nebraska, and South Dakota, all now inactive or not renewed)
1994: Fellow
American College of Endocrinology
1986, 1992, 1997:
Certified Diabetes Educator
National Certification Board for Diabetes Educators
1977:
Fellow
American College of Physicians
1977:
Subspecialty Board on Endocrinology, Diabetes and Metabolism
American Board of Internal Medicine
1974:
Certification
American Board of Internal Medicine
PROFESSIONAL INTERESTS
Diabetes Education and Diabetes Care
- American Association of Diabetes Educators
Board of Directors, 1979 1987
Treasurer
Vice President
President-Elect
President, 1985 1986
- American Diabetes Association
President, SD Affiliate, 1974 1975
Missouri Affiliate, 1986 1998
Kansas City Chapter of MO Affiliate: Board of Directors, 1987 1994
Served on several state committees of MO Affiliate, 1987 1997
Representative to Central Council of ADA, 1985 1991
Eastern Jackson County Chapter of MO Affiliate: Board of Directors, 1995 1997
- Medical Director, Midwest Diabetes Care Center, Inc., 1986 1998
- Missouri Department of Health, Bureau of High Risk Intervention, Diabetes Advisory Committee, 1990 1998
Co-chair, 1991 1994
Chair, 1994 1998
- Author, The Other Tests Your Doctor Orders. Diabetes in the News, August, 1988
- Reviewer for articles about diabetes for The Medical Letter® On Drugs and Therapeutics, 1993 1998
- Writer of articles about diabetes for Diabetes Interview, 1998
- Writer of articles about diabetes for Diabetes Digest, 1998
- Diabetes123 (www.diabetes123.com) (owner of www.childrenwithdiabetes.com and www.diabetesmonitor.com) President, 2001 2002
- Member of Diabetes Care Guidelines Revision Task Force, American Association of Clinical Endocrinologists, 2005 2007
Medical Education
- Associate Professor of Internal Medicine and Psychiatry, University of SD, 1978 1985
- Lecturer and Preceptor, Goppert Family Practice Residency, Kansas City, 1987 1994
- Lecturer and Preceptor, University of Health Sciences, Kansas City, 1988 1992
- Lecturer on Endocrinology, Critical Care RN Review Courses, at Baptist Medical Center, and at Saint Joseph Health Center, 1988 1993
- Lecturer, Bess Truman Family Practice Residency, Kansas City, 1996
- Numerous lectures on diabetes and endocrinology topics for American Diabetes Association and Juvenile Diabetes Foundation Chapters, local diabetes support groups, and professional education meetings
Drug Safety
- Member, Drug Information Association, 1999 present
- Member, International Society for Pharmacoepidemiology, 1999 present
PROFESSIONAL INTERESTS, CONTINUED
Medical Applications of Computers
- Member, Medical Informatics Committee, Columbia-Independence Regional Health Center, 1993 1998
- Beta tester, health-related and other software: DesignWorks (1993); MedCoach (1995); Stedmans Medical Dictionary (1996)
- Author of website, Diabetes Monitor (at http://www.diabetesmonitor.com), 1995 1998
- Educational Sharing Session: Diabetes on the Internet; American Association of Diabetes Educators Annual Meeting, August, 1995
- Medical Director, children with DIABETES (at http://www.childrenwithdiabetes.com), 1995 2003
- Member of Advisory Board, Quackwatch (at http://www.quackwatch.com) ("Your Guide to Health Fraud, Quackery, and Intelligent Decisionmaking"), 1997 present
- Medical Director, Diabetes Monitor (at http://www.diabetesmonitor.com), 2004 present
- Member of Information Technologies Committee, American Association of Clinical Endocrinologists, 2004 2007
Recent Attendance at Professional Meetings
- American Diabetes Association: Annual Meeting and Scientific Sessions, San Diego, CA June 19-22, 1999
- International Society for Pharmacoepidemiology, Annual Conference on Pharmacoepidemiology, Boston, MA August 26-29, 1999
- Drug Information Association: "Drug Safety Surveillance and Epidemiology Training Course", Ypsilanti, MI October 11-13, 1999
- University of Michigan / Lilly Research Laboratories: "Enhancing Clinical Trial Quality and Compliance", Ann Arbor MI March 27, 2000
- American Association of Clinical Endocrinologists: Annual Meeting, Atlanta, GA May 3-7, 2000
- American Diabetes Association: Annual Meeting and Scientific Sessions, San Antonio, TX June 9-12, 2000
- Drug Information Association: "Improving Pharmacovigilance Working Practices: The CIOMS V Initiative", Washington, DC December 11-12, 2000
- American Diabetes Association: Annual Meeting and Scientific Sessions, Philadelphia, PA June 23-26, 2001
- American Diabetes Association: Annual Meeting and Scientific Sessions, San Francisco, CA June 14-18, 2002
- Regulatory Affairs Professionals Society: "Essentials of US Regulator Affairs/Overview of Devices," webcast, June 10, 2003
- Endocrine Society Annual Meeting, Philadelphia, PA June 19-22, 2003
- Regulatory Affairs Professionals Society: "Essentials of US Regulator Affairs/Advertising, Labeling and Post-marketing Requirements", webcast, July 8, 2003
- Drug Information Association: "3rd Annual Workshop for Contemporary Pharmacovigilance and Risk Management Strategies", Washington, DC January 12-15, 2004
- Regulatory Affairs Professionals Society: "Risk Management Definitions, Concepts and Best Practices", Clark, NJ March 25, 2004
- Drug Information Association: "Data Mining in Pharmacovigilance," webinar, May 18, 2004
- American Diabetes Association: Annual Meeting and Scientific Sessions, Orlando, FL June 4-8, 2004
- Regulatory Affairs Professionals Society: "Preparing for NDA meetings with the FDA", Princeton, NJ November 18, 2004
- American Diabetes Association: Annual Meeting and Scientific Sessions, San Diego, CA June 10-14, 2005
- American Diabetes Association: Annual Meeting and Scientific Sessions, Washington, DC June 9-13, 2006
- Endocrine Society Annual Meeting, Toronto, Canada June 1-5, 2007
- American Diabetes Association: Annual Meeting and Scientific Sessions, Chicago, IL June 22-26, 2007
- American Diabetes Association: Annual Advanced Postgraduate Course, New York, NY February 6-8, 2009
- American Diabetes Association: Annual Meeting and Scientific Sessions, New Orleans, LA June 5-9, 2009
PROFESSIONAL MEMBERSHIPS
1991 to Present: American Association of Clinical Endocrinologists; Charter Member
1979 to Present: American Association of Diabetes Educators
1994 to Present: American College of Endocrinology
1972 to Present: American College of Physicians
1972 to Present: American Diabetes Association
1999 to Present: Drug Information Association
2004 to Present: Endocrine Society
1999 to Present: International Society for Pharmacoepidemiology
SUMMARY OF THERAPEUTIC EXPERIENCE
Endocrinology, internal medicine
ABSTRACTS
Quick WW, et al. Reporting Rate of Jaundice/Hyperbilirubinemia in Troglitazone Treated Patients Has Decreased. American Association of Clinical Endocrinologists, May 2000, Atlanta, GA
Quick WW, et al. Reporting Rate of Liver Transplant and Death with Troglitazone Has Decreased. American Diabetes Association, June 2000, San Antonio, TX
Huang EA, Zdon GS, Moore RJ, Moran HJ, Reidel V, Quick WW. Trends in early metformin monotherapy for newly diagnosed type 2 diabetes in the United States, 2001-2007. American Diabetes Association, June 2009, New Orleans, LA
PUBLICATIONS
Quick WW. Diagnosis of diabetes: use of the oral glucose tolerance test. Mo Med. 1972 Apr;69(4):275-7
Quick WW. Filing and retrieving medical literature. JAMA. 1979 Aug 24-31;242(8):710-1.
Quick WW. Pathophysiology of Diabetes. In Diabetes Education: A Core Curriculum for Health Professionals, American Association of Diabetes Educators, 1988; Second Edition, 1993
Zhang Y, Dall TM, Mann SE, Chen Y, Martin J, Moore V, Baldwin A, Reidel VA, Quick WW. The Economic Cost of Undiagnosed Diabetes. Population Health Management. 2009, 12(2): 95-101.
Dall TM, Mann SE, Zhang Y, Quick WW, Seifert RF, Martin, J, Huang EA. Distinguishing the Economic Costs Associated with Type 1 and Type 2 Diabetes. Population Health Management. 2009, 12(2): 103-110.
Zhang Y, Dall TM, Chen Y, Baldwin A, Yang W, Mann SE, Moore V, Le Nestour E, Quick WW. Medical Cost Associated with Pre-Diabetes. Population Health Management. 2009, 12(3): 157-163.
Chen Y, Quick WW, Yang W, Zhang Y, Baldwin A, Moran J, Moore V, Sahai N, Dall TM. Cost of Gestational Diabetes Mellitus in the U.S. in 2007. Population Health Management. 2009, 12(3): 165-174.
22 June 2009