Medical Affairs and Ophthalmology Expert for Strategic Advisory Boards

Technical Consultant #2060

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).

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.

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

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