Strategy  ♦  Clinical  ♦  Regulatory  ♦  Reimbursement  ♦  Miscellaneous

 

Strategy

• Alignment strategy, trial design drug-test co-development effort in irritable-bowel syndrome

• Due-diligence of various investment opportunities (start-up and early stage) for VC firm

• Feasibility evaluation for creating new HEOR unit within diagnostic consulting firm

• Due-diligence of next-gen sequencing support and market access strategy for reagent supplier

• Identification of market access strategy for new diagnostic via integrated health systems

• Landscape development for Personalized Medicine, identification of investment opportunities

• Laboratory strategy, including LDT, CLIA versus 510(k), PMA kit development

 

Clinical

• Phase 2 and 3 clinical trial design for oncologic drug development effort

• Development and conduct of professional surveys and questionnaires

 

Regulatory

• Regulatory strategy for oncology drug development requiring companion diagnostic

• Support of pre-IDE submission and representation of diagnostic company at FDA

• Creation of regulatory strategy for new IVDMIA oncology gene expression assay

 

Reimbrusement

• Analysis of US reimbursement opportunities for Crohn’s Disease, NASH and NAFLD diagnostics

• Health economic evaluation and payer strategy of novel renal therapy

 

Miscellaneous

• Development of online education (multi-module course) for personalized health care

• Advisory committee and expert testimony at senior management and strategy retreats

• Board memberships and advisory functions at diagnostic and pharmaceutical companies

• Lectures and courses at national and international conferences and workshops