Principal
CurrentDecisive Biomedicine partners with innovators in molecular information to help executive teams optimize corporate strategies integrating proprietary biotechnologies with new product development planning to expedite the adoption of novel decision-making tools that improve clinical outcomes. Experience in academic bench science, hands-on patient care, and corporate management enables consultative guidance based on informed translational medicine, thereby providing a cross-functional resource at the hub of research and development, clinical, commercial, regulatory, reimbursement and corporate finance activities. The expertise provided enables partners to target the desired niches of information convergence, such as:• interfacing genomic and proteomic outputs with HIPAA-protected clinical datasets;• defining target product profiles (TPPs) that not only impact health economics but alsoachieve return-on-investment goals;• tailoring clinical study designs to satisfy evidence expectations for reimbursement andpractice guidelines assessments;• managing biospecimen inflows and test result outflows via LIMS and telemedicineapplications;• streamlining multi-parameter algorithm and analytical performance metrics for self-guided practitioner and laboratorian learning; and• designing development programs to achieve corporate imperatives based on strategiesfor laboratory developed tests (LDTs) in CLIA-accredited laboratories or FDA 510(k) clearance of in vitro diagnostic kits.Recent engagements: cf DNA and RNA genomic/epigenomic biomarkers for cancer early detection; infectious disease NGS diagnostics; oncology biomarkers from genetically engineered mouse models (GEMMS); predictive biomarkers for inflammatory diseases; Covid-19 molecular diagnostic product development; point-of-care (POC)dried blood spot collection device; gut microbiome biomarkers for inflammatory disease; POC home blood monitoring; lung disease biomarkers; and pancreatic cancer molecular diagnostics.
