NAME                                    William W. Quick, MD, FACP, FACE

 

DEPARTMENT                    Medical Safety Operations, Drug Safety

 

EDUCATION

 

1971-1972                             Fellowship, Endocrinology

                                                University of Missouri Medical Center

                                                Columbia, MO, USA

 

1968-1971                             Internship and Residency, Internal Medicine

                                                University of Missouri Medical Center

                                                Columbia, MO, USA

 

1968                                       Doctor of Medicine

                                                State University of NY

                                                New York, USA

 

1964                                       Bachelor of Arts

                                                College of Wooster

                                                Wooster, OH, USA

 

 

PROFESSIONAL EXPERIENCE

 

May 2010 to Present            Senior Medical Director & Head, Medical Safety Operations

                                                i3 Drug Safety

                                                Basking Ridge, NJ, USA

 

§         Provides safety management and medical oversight of pharmacovigilance activities.

§         Works closely with pharmacovigilance colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment. 

§         Ensures compliance with respect to evaluation, reporting and surveillance of clinical safety information.

§         Identifies, communicates and effectively manages potential safety issues.

§         Provides investigator support regarding safety concerns, medical emergencies, etc.

PROFESSIONAL EXPERIENCE, CONTINUED

 

§         Medical safety surveillance/signal detection for investigational products and marketed products

§         Discusses and resolves medical issues with clinical sites, Sponsors, and drug safety staff.

§         Medical review and interpretation for periodic and other safety reports (e.g., annual safety reports, PSURs, NDA clinical summary of safety).

§         Signal detection, benefit/risk assessment, and development of trend analyses.

§         Consults with internal and external customers in areas of drug safety, pharmacovigilance, and clinical research.

§         Supports business development through participation in core proposal team activities, feasibility assessments and review of proposals/contracts for medical services.

§         Line management of i3 Drug Safety physicians.

 

2008 to 2010                         Executive Medical Director for the Americas, Endocrinology & Metabolic Disease

                                                Medical & Scientific Affairs, i3 Research

Basking Ridge, NJ, USA

 

§         Provided 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.

§         Assisted the Global Vice President in day-to-day management of medical and safety staff, as assigned.

§         Maintained a working knowledge of projects in his/her functional area for which i3 Research is responsible for medical and/or safety monitoring.

§         Supported 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.


PROFESSIONAL EXPERIENCE, CONTINUED

 

§         Stayed 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.

§         Provided 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.

§         Collaborated with sponsors and/or internal departments on the design and review of study-related documents and professional manuscripts.

§         Assisted the Global Vice President as appropriate by serving as a mentor and role model for other medical and safety staff.

§         Assisted 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, pursued novel business opportunities to enhance corporate revenue.

§         Interacted 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.

§         Maintained 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.

§         Provided protocol-related clinical and scientific training to project team staff members.

§         Participated 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.

§         Performed any other duties that may, from time to time, be assigned by the Vice President, Medical & Scientific Affairs.

PROFESSIONAL EXPERIENCE, CONTINUED

 

2007 to 2008                         Senior Medical Director, Endocrinology & Metabolic Disease

                                                Medical & Scientific Affairs, i3 Research

Basking Ridge, NJ, USA

                                               

2005 to 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 to 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).

PROFESSIONAL EXPERIENCE, CONTINUED

 

1998 to 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 to 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.

PROFESSIONAL EXPERIENCE, CONTINUED

 

§         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

LICENSURE/CERTIFICATION, CONTINUED

 

1977                                       Certification

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

  • Founder and Medical Director, DiabetesMonitor.com website, 1995 – present

§         Writer of articles about diabetes for Diabetes Interview, 1998

§         Writer of articles about diabetes for Diabetes Digest, 1998

§         President, Diabetes123 (owner of www.childrenwithdiabetes.com), 2001 – 2002

PROFESSIONAL INTERESTS, CONTINUED

 

Diabetes Education and Diabetes Care

§         Member of Diabetes Care Guidelines Revision Task Force, American Association of Clinical Endocrinologists,   2005 – 2007

§         Writer of blogs about diabetes for MyDiabetesCentral.com, 2006 – present

 

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 – 2005

 

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); Stedman’s 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

PROFESSIONAL INTERESTS, CONTINUED

 

Recent Attendance at Professional Meetings

  • 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
  • International Diabetes Federation: World Diabetes Congress, Montreal, Canada October 18-22, 2009
  • American Diabetes Association: Annual Meeting and Scientific Sessions, Orlando, FL June 25-29, 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

 

 

SUMMARY OF THERAPEUTIC EXPERIENCE

 

Pharmacovigilance, endocrinology, internal medicine, clinical trials.

 

 

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, Zhang, S. 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.

 

Huang EA, Zdon GS, Moore RJ, Moran HJ, Quick WW. The impact of publishing medical specialty society guidelines on subsequent adoption of best practices: a case study with type 2 diabetes. Int J Clin Pract. Accepted for publication December 2009.

 

Dall TM, Zhang Y, Chen YJ,  Quick WW,  Yang WG, Fogli J. The Economic Burden Of Diabetes. Health Affairs. 2010, 29(2): 1-7.

 

 

AUTHENTICATION

 

The information contained in this document is accurate and complete to the best of my knowledge.

 

 

Employee/Contractor ID Number ___000541296________

 

 

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