Our Network of Consultants

Senior executive and consultant in Life Sciences focused on applying precision diagnostics to liquid biopsies to ascertain the molecular profile of single or multiple cells captured and enriched from blood and cerebral spinal fluid.

Experience:
- Ph.D. in molecular genetics, 20 plus years biotechnology experience in R&D, technology and product development, project and operations management, leading to the design, development, manufacture and commercial launch of RUO products, CE marked, and FDA PMA and 510(k) cleared molecular diagnostic assays.
- Broad knowledge focused on state-of-the-art technologies for application in human and molecular genetics, molecular/immuno-diagnostics, and cell biology, directed toward advancing personalized medicine in rare gene disorder and complex diseases through precision diagnostics.
- Application of strategic and tactical operations to reduce timelines and meet multi-million dollar milestones for the successful launch of multiple products from concept to commercialization.
- Managed R&D, product development, and a P&L for a $230M cell culture business.
- Developed 1 and 5 year strategic road maps for new and mature products.
- High level of interpersonal skills managing multiple disciplines for innovative cross-functional projects, which include R&D, computational biology, phase-gate product development, business and market development, clinical studies, tech transfer to manufacturing for RUO and IVD products under design control, FDA QSR and ISO 13485:2016 compliance in cGMP environments.
- “Roll up sleeves” management style to motivate, lead and mentor individuals, in small and large teams, in multi-national matrix corporations, building organizations from the ground up, and meeting project timelines and financial milestones.
- Presentations to executive management, company boards, scientific meetings, investors and multiple publications in top scientific journals
- 10 issued patents and receipt of $4.4M in NIH grants.
- Broad network of key opinion leaders in human and infectious diseases leading to collaborations and partnerships.

Capabilities:
- Transition research companies and their technologies into product development power houses, converting research projects or Research Use Only (RUO) products for use as Laboratory Developed Tests (LDTs) or In-Vitro Diagnostic (IVD) medical devices.
- Develop end-to-end processes, from feasibility to validation via the IVD (510k or PMA) or LDT route for molecular and cellular diagnostic tests.
- Serve at the intersection of assessing technology in M&As.
- Generate focused strategy plans from Marketing (VOC) to Product Development of VOC generated diagnostic assays, to the transfer of developed assays, to Manufacturing/Operations for the manufacture of medical devices under ISO13485.