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CONSULTING EXPERIENCE

I've worked with companies from the early development stage through market launch. The transition from scientific development to product/service development requires fundamental changes that respect the underlying innovations but address the needs of doctors, patients, payers, regulators, and investors. We can bridge the gap. 

PROJECT PROFILES

Size: 

Small and medium sized enterprises; companies from 4 employees to hundreds.

 

Segments:

  • Pharmaceuticals/therapeutics: cardiovascular, CNS, oncology, ophthalmology

  • Diagnostics: imaging devices, contrast agents,  in vitro genomic testing

 

Functions:

  • Clinical trial design, analysis, reporting

    • Literature review, clinical paradigm surveys

    • Assessment of regulatory and technical requirements

    • Technical development of imaging & testing procedures

    • Study design, implementation

    • Statistical plans & analysis

    • Publications & presentations

  • Market review and sizing

    • Review of disease area / epidemiology

    • Competitive assessment

    • Clinical utility & health economics

    • Forecasting, planning, & budgeting

  • Business development

    • Search for investment & partnership opportunities

    • Corporate funding through investment, partnership, or grants.

    • Deal assessment and execution

    • Post-merger integration / transitioning programs to acquiring firms

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Roles:

  • Independent contractor

  • Project work

  • Serve as Manager or Officer

EXPERIENCE

  • CXL Ophthalmics, COO: Developed market access plans for a drug/device combination; Drove Phase 2 and 3 development; Led partnering and financing initiatives.

  • Tyrogenex: Optimized phase 2 clinical program to increase efficiency and focus on phase 3 transition for an ophthalmic drug product. Contributed to phase 1 trial analysis and authored publications.

  • Xcovery: Furthered clinical development strategy and operations, and performed market analysis for a portfolio of targeted oncology drugs.

  • Veracyte: Consulted on the post-merger integration of a novel genomic test, clinical utility and health economic studies, coverage and reimbursement efforts, and market development.

  • Allegro Diagnostics, Director of Strategy and Business Development: Led funding and partnership efforts resulting in acquisition, planned and implemented medical information dossier development, clinical utility and health economic analyses, contributed to clinical and technical development and clinical validation studies, published in New England Journal of Medicine.

  • Lantheus Medical Imaging, Consultant to Medical Affairs: Assisted in post-merger integration of MRI contrast product, development of medical information system and marketing materials, recruited advisory board and conducted meetings, presented to physicians, sales staff, and FDA.

  • Epix Pharmaceuticals, Head of Imaging: directed the development of a targeting molecular imaging contrast agent in phase 3, FDA review process through approval, and the sale of the program to Lantheus. Performed technical and clinical development of imaging systems, resulting in high-impact publications. Contributed to clinical and business development for small-molecule drugs.

  • Lipimetix: Developed financial model, investment and partnership opportunities for a biologic cardiovascular rare disease drug program.

  • Embera Neurotherapeutics: Financial modeling, investment planning for a combination drug product for addiction treatment.

CURRICULUM VITAE

Professional Resume on LinkedIn

Academic Publications on Google Scholar

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