- Drug development strategy, preclinical and clinical plan development, regulatory and re-imbursement strategy.- Commercial strategy, forecasting, technology assessment, valuation, licensing, due diligence- Business plan development, pitch deck preparation, IP strategy, presenting to investor and companies

Assessment of early stage companies with novel pharmaceutical, biotechnology and life science technologies for commercialization potential.Develop plans to increase company value and decrease risk by evaluating business, clinical, regulatory, preclinical and intellectual property strategies.

Conceptualized and incorporated strategies to demonstrate unique compound features to address unmet clinical needs, product differentiation, PK, safety or patentability for preclinical and clinical studies; led IP portfolio and business development efforts.• Designed preclinical studies to evaluate potential in dyslipidemia, fatty liver, inflammation and asthma in multiple species; wrote and submitted NIH SBIR and R21 research grants• Responsible for overseeing and writing patent application sections resulting in filing of 23 applications and granting of 1 patent vital to protect lead program.• Incorporated PCSK9, lipid particle analysis and gene profiling across preclinical and clinical studies to demonstrate additional differentiation characteristics of novel proprietary omega-3 compounds.• Opened discussions with leading diagnostics firm to investigate anti-diabetic potential of MAT9001 in prediabetic state in prospective pilot study study being planned in Mexico .

drug development planning, commercial strategy, new product planning, forecasting, technology assessment, KOL recruitment, business and program strategy for start-ups

Led commercial strategy efforts for early stage development programs and business development opportunities within CVM Therapy Unit. Represented Therapy Unit as Commercial Lead for US, EU, Japan and Emerging Market business units, Worldwide Business Development group, Regulatory Affairs, Clinical Development teams, Portfolio Management group, Manufacturing and Market Access groups. Managed internal and external personnel in primary/secondary market research and competitive intelligence efforts to understand real-world market value of assets on a global basis. • Led development of the commercial vision for Type 2 diabetes program that guided formulation of appropriate clinical plan. • Consulted with drug discovery unit leadership on therapy area strategy to ensure efforts would deliver most commercially attractive portfolio.• Conceived of a franchise opportunity in wound healing that expedited business development activities. • Developed and presented valuations of assets to Senior Management to inform go/no-go decision making.

Led efforts in providing transparent valuation of disease area assets and investment options for internal R&D programs, licensing candidates and M&A opportunities for cardiovascular, metabolic and ophthalmic therapeutic areas. Identified information gaps in data necessary for global forecast development. Designed and led projects to obtain critical information.• Facilitated consensus-building on asset forecasts resulting in aligned commercial view among executives.• Spearheaded efforts between project teams, regional commercial organizations and project management that ensured corporation was prepared for annual late-stage portfolio funding review process.• By mentoring offshore group responsible for providing market data and project briefing documents, improved quality of work product.• Received 2 Silver Level Awards for outstanding contributions to pazopanib ophthalmology development project and to the Forecasting Enhancement Project.

Identified market uses and developed life cycle strategies for new products to increase revenue. Responsible for protecting value of company’s products and inventions by managing intellectual property (IP) strategy. Member of due diligence team for assessing in-licensing/acquisition opportunities. Directed qualitative/quantitative market research projects with external vendors. • Led efforts to identify new uses for Lovaza resulting in identification of 3 additional therapeutic opportunities.• Organized portfolio management group which enhanced executive decision making capabilities surrounding program prioritization and resource allocation. • Implemented system to manage IP that simplified internal inventing process and reduced costs by 30%.• Acquired and developed patents that prolonged lifespan of products on market.

Formulated strategies and identified issues for lead attorneys and partners regarding freedom to operate, patent infringement and competitive barriers for clients’ IP portfolios in litigation, prosecution or under licensing consideration. Performed due diligence analysis on novel technologies. Advised attorneys during deposition process. • Devised argument for ANDA litigation case that was chosen by Senior partners for use in Circuit Court appeal.

Led consulting teams on major assignments for top multinational pharmaceutical, biotech, diagnostic and medical device companies, start-ups and individual inventors to resolve issues concerning unmet need gaps, technology assessment, clinical impact and real market potential for emerging therapeutics. Provided assessments of business threats and opportunities, enhancement of product portfolios, and competitive environment analysis.• Influenced business plan development, resource and asset allocation as part of due diligence projects conducted for company Boards and executives.• Formulated comprehensive strategic analyses in the fields of CNS, respiratory, cardiovascular, diabetes and diabetic complications, pain, arthritis, urology, oncology and molecular diagnostics which were part of a $20 million publication portfolio.

Company pharmacologist for start-up venture. Managed scientists and research associates in evaluating proof of concept, pharmacology, pharmacokinetics, safety and toxicology of potential therapeutic agents, with annual budget of $2 million. Reported project updates to Board of Directors. As part of business development team, presented therapeutic potentials of R & D programs to potential partners. Designed aspects of Phase I, II and III clinical trials. Responsible for preparing documents to support regulatory filings.• Quickly adapted technique for detecting microalbuminuria not available from CRO contractors that provided vital data in securing $40 million co-partnership deal.• Developed novel class of Type II anti-diabetic agents resulting in the filing of two patent applications.

Developed highly-sensitive diagnostic immunoradiometric assay which was used in a NIH-EPA Superfund study evaluating impact of environmental hazards on human reproduction. Isolated unique hCG-like peptide hormone from female human pituitary glands in close collaboration with researchers at Cambridge University to determine its structure.

Evaluated pharmacological properties of novel thymic peptide hormones discovered by Allan Goldstein on interferon production. Analyzed interferon levels in serum and lymphocytes of patients at high-risk for AIDS. Developed diagnostic assay for herpes simplex II virus used in detecting CNS viral infection.