Medical Affairs and Ophthalmology Expert for Strategic Advisory Boards

Technical Consultant #2060


Expertise

  • Creation of backgrounders and slide sets for pharma and medical device companies.
  • Live training.
  • Medical writing: drug dossiers, medical letters, protocols, abstracts, posters, manuscripts, regulatory writing - CSRs.
  • Creation and administration of Investigator Initiated Study Proposals program.
  • Key opinion leader engagement.
  • Anatomy, physiology, and pharmacology of eye.
  • Methods training for the conduct of clinical trials.
  • Medical-legal review of educational background materials and promotional materials.

Expert Witness Experience

  • Visual function testing in a patient with an adverse outcome following LASIK (corneal surgery).

Experience

Undisclosed Company, Managing Director, 2012 - Present

  • Began a consulting practice to support medical education, medical affairs, and medical communications to small and mid-sized pharmaceutical and medical device companies.
  • Creation of backgrounders and slide sets for pharma and medical device companies.
  • Live training.
  • Medical writing: drug dossiers, medical letters, protocols, abstracts, posters, manuscripts, regulatory writing - CSRs.
  • Creation and administration of Investigator Initiated Study Proposals program.
  • Key opinion leader engagement.
  • Methods training for the conduct of clinical trials.
  • Medical-legal review of educational background materials and promotional materials.

ExecuPharm, Inc., King of Prussia, PA, Contract Writer - Medical Devices, 2012

  • Completed clinical evaluation reports: Investigational device exemptions, and investigator brochures.
  • Conducted training at investigator meetings and onsite including: ETDRS (Early Treatment Diabetic Retinopathy Study) set up and lighting calibrations as well as refraction training to optimize end points.

Merck & Co., Inc., North Wales, PA, Project Leader - Medical Director, 1998 - 2011

  • Creation of backgrounders and slide sets for pharma and medical device companies.
  • Live training.
  • Medical writing: drug dossiers, medical letters, protocols, medical monitoring (Phase I).
  • Administration of Investigator Initiated Study proposals program.
  • Key opinion leader engagement.
  • Methods training for the conduct of clinical trials.
  • Medical-legal review of educational background materials and promotional materials.

U.S. Medical Services, Senior Manager, 1998 - 2008

  • Developed medical education content for migraine, hypertension, and Type 2 diabetes. Initiated disease awareness program for treatment of obesity.
  • Served as Chairman of Merck IISP U.S. medical school grant review committee for ophthalmics and as lead medical reviewer for Ophthalmics Medical-Legal board (U.S. only).
  • Developed AMCP and global dossier for Cosopt™. Successfully testified at 10 state P&T committee hearings for formulary review and acceptance (100%).
  • Collaborated with strategic advisory board members: glaucoma, ocular surface disease, and retina.

Medical Education, Medical and Scientific Affairs , 2001 - 2005

  • Manager, trained sales reps in anatomy, physiology, and pharmacology of eye plus clinical efficacy and safety of products related to treatment of patients with glaucoma. Trained MSLs on issues related to glaucoma and retinal disease.
  • Collaborated with strategic advisory board members to reach consensus on key questions. Analyzed competitive intelligence. Reviewed in-licensing candidate recommendations as member of in-licensing review committee.
  • Acted as primary content developer, chief technical writer, and editor for cross-therapeutic disease modules related to Merck Internet medical resource.

Senior Medical Education Specialist, Medical and Scientific Affairs, 1998 - 2001

  • Developed disease and competitive medical education backgrounders. Answered unsolicited information requests from practicing ophthalmologists in U.S. Trained sales representatives and MSLs.

Independent Consultant, 1997 - 1998

  • Consulted with an array of biopharm clients on multiple aspects of clinical trials for Alzheimer's disease and spinal cord injury: protocol and case report form development.

Otsuka America Pharmaceuticals, Rockville, MD, Senior Manager, CNS drug products, 1993 - 1997

  • Oversaw $3.5 million clinical development budget and team of three. Liaised effectively with corporate Japanese business and research and development executives using appropriate Japanese etiquette.
  • Executed clinical development plan from Phase 1 through to early Phase 3, including contracts with CROs for data management, biostatistics, and medical writing; and analytical chemistry and central clinical labs.
  • Managed cross-functional clinical development team with lead staff from biostatistics, data management, medical writing, Regulatory Affairs, pharmacy, QA, marketing, PK, and safety. Developed NCE for neurodegenerative diseases.
  • Liaised with Phase III team for development of Abilify™ for treatment of schizophrenia.

Honors & Publications

Credentials

  • Senior staff fellow, National Institute of Mental Health
  • Five (5) Merck Special Achievement Awards
  • Generating large-scale, high-quality scientific content for new HSA/MSL training on an accelerated timeline. 4Q10
  • Significant contributions to our competitive counter-response to Combigan. 4Q07
  • Leadership in the support of the, "Update on Glaucoma: Roundtable Discussion Series." 3Q07
  • Coverage of global Medical Quality Assurance for Fact Finding and Recall Investigations; 4Q05.
  • Exceptional efforts in training the ophthalmic sales force at the semester meeting; 2Q04.
  • Eighteen (18) Merck Awards of Excellence

License

  • Optometrist - Virginia

Academic and Professional Affiliations

  • Association for Research in Vision and Ophthalmology
  • American Academy of Ophthalmology
  • Senior Fellow - Neuropsychiatry Branch, National Institute of Mental Health, Washington, DC
  • Trustee - Glaucoma Service Foundation, Wills Eye Hospital
  • Fellow - Visual Processing Branch, National Eye Institute, Bethesda, MD

Awards

  • Honors study abroad, University of Liverpool
  • Honors Graduate, Villanova University
  • Goldmann Stipend for graduate study, Drexel University
  • Research Scholar post, Cambridge University (U.K.)
  • National Eye Institute stipend for graduate study
  • Elected to Alumni Association Governing Board, George Washington University,
  • U.S. Senate nominee to be an assistant to President Bush's Science Advisor,(Office of Science and Technology Policy)
  • Elected to Sigma Xi, Scientific Honor Society
  • Elected to the American Academy of Ophthalmology
  • Elected to the ARVO Commercial Relationships Committee
  • Point person of the Intellectual Property symposium held annually at ARVO
  • Eighteen (18) Merck Awards of Excellence

Publications and Patents

  • Author and Co-Author of manuscripts, educational text, and abstracts.
  • One world patent.

Education

  • Ph.D. Human Physiology, George Washington University, Washington, DC
  • O.D. Optometry, Salus University, PA College of Optometry, Philadelphia, PA
  • M.S. Physiology and biophysics, Drexel University, Philadelphia, PA
  • B.A. Psychology and Biochemistry, Villanova University, Villanova, PA
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