Pharmaceutical Regulatory Strategy Assessment for Novel Therapeutics

Technical Consultant #2085


Expertise

  • Strategic regulatory aspects of the development of novel therapeutics encompassing initial registration - approval and life-cycle management of multiple pharmaceuticals (in multiple therapeutic areas).
  • Planning and execution of interactions with regulatory authorities (esp. US FDA).
  • Regulatory due diligence review and appraisal of therapeutic development programs, regulatory aspects in the development of a pharmaceutical for the legal defense.
  • Regulatory due diligence input on potential acquisition, licensing and partnership opportunities.

Expert Witness Experience

  • VIOXX (Merck & Co.) tort litigation: multiple depositions and grand jury testimony.

Experience

Undisclosed Company, Owner and Principal, 2013 - Present

  • Provide assessment, advice and assistance to therapeutics developers on the strategic regulatory aspects of the development of their projects, including their interactions with governmental regulatory authorities, for a wide range of clients (small start-ups, moderate sized established companies and large multinational corporations).
  • Conduct interactions, on behalf of the client, with the U.S. FDA including informal discussions and organize formal Agency meetings (e.g. VXDS, Early Development, Pre-IND, End of Phase II, Public Advisory Committee).
  • Provide regulatory due diligence review and appraisal of proposed therapeutics development projects for pharmaceutical developers and venture capital firms.

Merck Research Labs, Merck & Co., North Wales, PA, 1992 - 2013

Positions Served

Director, Regulatory Affairs, Domestic, 1992 - 1997
Senior Director, Regulatory Affairs, Domestic, 1997 - 2005
Executive Director, Regulatory Affairs, Domestic, 2005 - 2006
Executive Director, Global Regulatory Strategy, Policy and Safety, 2006 - 2013

  • Provided guidance to project teams and management on regulatory aspects of development for Metabolic and Endocrinologic (most recent focus), Rheumatologic, Cardiovascular, Neurologic, Urologic, Dermatologic, Antimicrobial, Antifungal, Gastrointestinal and Oncologic drug development candidates.
  • Directed interactions with U.S. governmental regulatory authorities, FDA related to drug development candidates.
  • Led the submission and regulatory authority interactions during authority review for 9 New Drug Applications (NDAs) and World-wide Marketing Applications (WMAs), more than 50 major supplemental NDAs and WMAs, and more than 30 U.S. INDs.
  • Organized and led Merck's participation in more than 50 U.S. FDA conferences and meetings (e.g. VXDS, Early Development, End of Phase II, Pre-NDA, FDA Advisory Committee NDA Review, etc.).
  • Core member (Regulatory) for multi-functional therapeutic franchise oversight committees: Diabetes and Obesity, Arthritis, Analgesia, Urology, and Dermatology.
  • Conducted regulatory due diligence reviews and assessments of potential acquisition, partnership and licensing opportunities.
  • Merck regulatory lead for integration of joint ventures, partnerships, mergers and acquisitions. Regulatory member of MRL, Merck task forces and cross functional committees, as assigned.
  • Merck and Pfizer Joint Development Committee (Ertugliflozin): Merck regulatory representative.
  • Merck and Schering-Plough (MSP) Joint Venture Cholesterol Task Force: Merck regulatory lead representative, Merck Global Regulatory Team leader.
  • Bristol Myers Squibb/Merck Partnership (Diabetes) Combined Functional Development Team: Merck regulatory representative.
  • Merck and ONO Joint Development Committee (Sitagliptin in Japan): Merck regulatory representative.
  • Merck Project Team for VIOXX: Co-Chairman.
  • MRL Risk Management Implementation Team: Regulatory representative.
  • MRL Pharmacogenomics Task Force: Regulatory representative.
  • Medical-Legal Review Board (for promotional activities) for VIOXX: MRL physician member.
  • Medical-Legal Executive Committee: MRL representative.
  • Regulatory Affairs-Domestic new liaison recruitment: Lead.
  • MRL Research Document Review Committee: Founding core member.
  • RNA Development Task Force: MRL Regulatory representative.
  • PhRMA Working Group on Cardiovascular Risk Assessment in Diabetes Drugs: Core member.
  • Merck Regulatory Lead in preparing and participating in legal defense of VIOXX (rofecoxib) in multiple legal actions: provided multiple depositions in civil tort suits and testimony to a federal grand jury; was not called to testify in any legal trials (i.e. as an expert witness).

National Institutes of Health, (NIDDK), Bethesda, MD, 1981 - 1992

Scientific Officer, Diabetes Control and Complications Trial, 1987 - 1992

  • Medical and scientific oversight and administration of large multicenter, randomized, controlled clinical trial.

Chief, Diabetes Programs Branch, Division of Diabetes, 1984 - 1992

  • As Chief of Diabetes, Endocrinology, and Metabolic Diseases programs: Development and administration of an extramural portfolio of grants, contracts and cooperative agreements greater than $100 million a year related to Diabetes.
  • Supervised six Program Directors and support staff.

Medical Staff (Diabetes Branch), Clinical Center, NIH, 1984 - 1992

  • Provide outpatient clinical care to Endocrine Clinic patients.
  • Supervision and training of clinical endocrine fellows in outpatient clinic.

Medical Staff Fellow, Diabetes Branch, Arthritis, Diabetes, Digestive and Kidney Diseases, 1981 - 1984

  • Clinical and Research Training in Endocrinology

Yale-New Haven Hospital, New Haven, CT, Resident, Internal Medicine, 1978 - 1981

  • Under Chief of Service, Clinical Training in Internal Medicine.

Accomplishments

  • Worldwide Marketing Applications (incl. US NDAs) for JANUVIA, JANUMET, JANUMET XR, JUVISYNC
  • More than 30 major product labeling supplemental NDAs and WMAs for ZOCOR, MEVACOR, PROSCAR, VIOXX, EMEND, ARCOXIA, JANUVIA, JANUMET, JANUMET XR
  • Over 50 U.S. FDA conferences and meetings (Topics: VXDS, Early Development, End-of-Phase II, Pre-NDA, FDA Advisory Committee NDA Review)
  • More than 30 original U.S. INDs.
  • U.S. NDA: ZETIA, VYTORIN, VIOXX, PROPECIA and Muraglitizar.

Honors & Publications

Credentials

  • Diplomat, American Board of Internal Medicine, Endocrinology and Metabolism. NIDDK/NIH Medical Staff Fellow: Clinical and Research training in Endocrinology
  • Diplomat, American Board of Internal Medicine, Internal Medicine. Yale-New Haven Hospital Resident in Internal Medicine: Clinical Training in Internal Medicine
  • Fellow, American College of Physicians

License

  • Medicine (PA)

Certifications

  • Program for Advanced Training, Harvard School, Biomedical Research Management Public Health
  • Regulatory Training Course II, Drug Information: Marketing Applications & Post Approval Phase
  • Executive Presentation Program, Communications
  • Executive Leadership Program, Leadership
  • Communications Course, Communications

Academia

  • Member, Subcommittee on Diabetes, Secretary's Task Force on Black and Minority Health, DHHS
  • Diabetologist, Sorbinil-Retinopathy Study, Clinical Center, NEI/NIH
  • Member Advisory Board of the National Diabetes Information Clearinghouse, NIDDK
  • Reviewer, Annals of Internal Medicine, Diabetes Care, Diabetes, Journal of Hormone and Metabolic Research,
  • Member, Research Resources Cross Group, JDFI/WHO World Conference on Diabetes Research
  • Member, Working Group on Hypertension in Diabetes, National High Blood Pressure Education Program NHLBI, NIH
  • Director of Clinical Studies, World Health Organization/DDEM, Collaborating Center for Diabetes Research, Training and Education, NIDDK
  • Executive Secretary, Diabetes Mellitus Interagency Coordinating Committee
  • Member, Committee on Scientific Programs, Endocrine Society
  • Member (NIH Liaison), Veterans Administration Diabetes, Advisory Group, DVA
  • Member (NIDDK Representative), Fetal Tissue Steering Committee, NIH
  • Member, Consolidated Work Group for Resource Recommendations, JDFI/WHO Second World Conference on Diabetes Research
  • Vice Chairman, Diabetes Mellitus Interagency Coordinating Committee
  • Vice Chairman, Health Issues Working Group on Diabetes in Minorities, Office of Minority Health, DHHS
  • Participant, Somatostatin Analogs and Diabetic Retinopathy Meeting, National Eye Institute
  • Member, American Diabetes Association Ad Hoc Expert Committee on the Prevention of Type I Diabetes Mellitus.
  • Member, American Diabetes Association Ad Hoc Expert Committee on the Prevention of Type I Diabetes Mellitus
  • Associate Editor, Diabetes Care
  • Member, Aging and Chronic Diseases Scientific Panel, NIH Strategic Plan
  • Member, Working Group on Obesity, NIDDK

Consulting (Academic Industry)

  • Cause of Death Survey, National Center for Health Statistics
  • National Diabetes Advisory Board
  • NHANES III Survey, National Center for Health Statistics
  • International Nomenclature of Diseases, Council for International Organization of Medical Sciences, WHO/UNESCO
  • Office of Health Technology Assessment, Agency for Health Care Policy and Research, USPHS.
  • Division of Metabolism and Endocrine Food and Drug Administration

Academic and Professional Affiliations

  • American College of Physicians, Fellow
  • American Medical Association
  • Pennsylvania Medical Society
  • American Diabetes Association
  • Endocrine Society
  • Drug Information Association
  • Academy of Physicians in Clinical Research
  • Association of Clinical Research Professionals (member, Global Conference Planning Committee [4 year term)
  • Alpha Omega Alpha Medical Society

Awards

  • Multiple Awards of Excellence, Special Divisional Awards and Quarterly Stock Option Awards, Merck & Co.
  • National Institutes of Health Award of Merit
  • National Institutes of Health Director's Award
  • Outstanding Service Award, American Diabetes Association
  • Alpha Omega Alpha Medical Society

Publications and Patents

  • Published scientific papers:16
  • Published scientific abstracts (scientific meeting presentations and posters): 6
  • Presentations: 15

Education

  • M.D. Washington University, St. Louis, MO
  • Ph.D. Biological Chemistry, Washington University, St. Louis, MO
  • B.A. Biochemistry, University of Pennsylvania, Philadelphia, PA
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