David M. Shearer, MD
Through my proven leadership, operational and medical expertise in the pharmaceutical industry, I have championed over 100 pivotal phase 2 and 3 research projects resulting in high quality and timely regulatory agency submissions and multiple New Drug Applications (NDA’s) submitted into the FDA. I founded the Therapeutic Research Foundation, Inc. (TRF) a 501c3 non-profit and serve as President and CEO for the purpose of helping solve unmet healthcare needs in biotech, healthcare and underserved populations and was bestowed the Social Enterprise Reward/Award sponsored by reSet Social Enterprise Trust in 2013 for this initiative. I have previously worked with top Fortune 500 pharmaceutical companies such as GlaxoSmithKline, Pfizer, Bayer, Sanofi-Aventis, Mannkind and Forest Labs in multiple therapeutic areas as Central Nervous System, Cardiovascular and Metabolic. My physiologic approach to lifecycle management and pipeline development within the industry led to four-fold increases in company revenues and I was recognized as the Clinical Research Professional of the Year by Good Clinical Practice Journal (GCPj).
Additionally, I conducted research at the Cleveland Clinic Foundation within the neurosurgery unit in the areas of stroke, hydrocephalus and alzheimer’s disease, leading to multiple publications. Moreover, I successfully developed a Medical Science Liaison Program and White Paper for purposes of improving safety and efficacy in industry through developing key strategic relationships with key opinion leaders across the globe. My civic minded interest are further demonstrated by my volunteer service as a Board Member of the CT Health District (501c3) while conceptualizing and spearheading a community improvement project (Route 1 Corridor Plan) to redevelop and stimulate growth and opportunity for an underutilized section of town. The Plan was selected by the Connecticut Chapter of the American Planning Association as the recipient of the 2015 Regional Plan Award.
- My core competencies include:
• Entrepreneurial solutions to growth, including potential acquisitions, joint ventures and licensing.
• Manage and evaluate quality of clinical trial conduct, protocol design.
• Design, lead, execute and generate final reports for Phase 1-4 clinical trials, bioequivalence studies with clinical endpoints and pilot studies for new products.
• Spokesperson and representative for small businesses at congresses, professional and civic association meetings.