Michael Masterman-Smith Email & Phone Number

Bethesda, Md, Us

• Member of executive core on $1.8B initiative to speed scale up of COVD-19 tests and technologies in all-of-government response to SARS-CoV-2 pandemic• Lead results-oriented cross functional team and SMEs advising portfolio companies commercializing COVID-19 and multiplex respiratory disease diagnostic technologies for POC and OTC use indications• Oversee technical development, clinical testing and regulatory submissions; conduct due diligence; make NIH funding recommendations; negotiate contracts; allocate resources; advise on derisking and product development milestones and deliverables; coordinate contract organizations

Bethesda, Md, Us

Team Lead for the U.S. National Institutes of Health Blueprint MedTech for Neuroscience Research. I advise and consult on accelerating the development and commercialization of cutting edge medical devices focused on ameliorating neurological diseases and conditions.The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program provides support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.

• Consult early stage pharmaceutical company on IP covering programmable targeted RNA delivery• Provide expertise on company strategy, oncology and neurological indications, preclinical and clinical development, regulatory strategy, business development

• Co-Founder and CEO of early stage company developing IP on wearable nanoelectronic circuitry for medical devices and industrial applications

The International Consortium for Research, Engineering, Acceleration of Technology Excellence (I-CREATE) is designed to support startups in developing innovative diagnostic technology and medical devices to enhance the nation's readiness for public health emergencies. This joint initiative was created between University Lab Partners (ULP) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. ULP is partnering with the Consortium for Improving Medicine with Innovation & Technology (CIMIT) at the Massachusetts General Hospital and Harvard Medical School and Science Exchange to establish the International Consortium for Research, Engineering, Acceleration of Technology Excellence (I-CREATE). This hub will focus on developing diagnostics and devices to detect, prevent, or respond to medical consequences that result from health security threats.

Company co-founder, board member of 2 early stage stealth companies.

Cynvenio Biosystems, Inc. is developer of advanced liquid biopsy circulating tumor cell capture technology.• Responsible for clinical development of liquid biopsy circulating tumor cell diagnostic technology with pharmaceutical applications in immunotherapy, therapeutic monitoring of circulating tumor cells, CAR-T cells, fetal monitoring• Led interdisciplinary matrix organization with 4 direct reports, 20 indirect reports • Managed diagnostic test development collaborations w/ immuno-oncology company Juno Therapeutics (acquired by Celgene 2018) and Baylor Miraca Genetics Labs (now Baylor Genetics)Worked in interdisciplinary matrix organization with 4 direct reports, 20 indirect reports • Created CLIA antibody evaluation program

Harmony Biosciences, Inc. is a biotechnology company focused on high sensitivity automated microfluidics-based single cell analysis for clinical diagnostics, drug development and life sciences research to enable precision medicine.• Founded start-up company commercializing automated single cell analysis technology• Wrote funding proposals and grants• Worked with academic collaborators on assay development protocols

Los Angeles, California, Us

Fellow in Dept of Bioengineering under Professor Dino DiCarlo on joint UCLA School of Medicine/School of Engineering cancer diagnostics technology development project• Clinically validated high throughput single cell deformability cytometry (DC) lab-on-chip technology• Determined diagnostic parameters for brain CSC in patient tumors

Los Angeles, Ca, Us

Worked on a multi-disciplinary collaborative California NanoSystems Institute/School of Medicine effort to develop tools and technologies to improve cancer diagnostics and treatment• Applied quantitative single cell analysis technology to profile heterogeneity in cancer stem cells • Developed automated single cell based drug screening technology• Tested methods to enhance precision, accuracy, sensitivity and selectivity (PASS) in drug screening

Los Angeles, Ca, Us

PhD in Molecular & Medical Pharmacology as part of advanced STEM training in the UCLA California NanoSystems InstituteThesis Title: A novel microscale approach for quantitative single-cell analysis of the PI3K-mTOR-Akt signaling pathways in human brain tumors and their tumor-initiating cells• Completed high impact NCI-funded precision oncology technology development project from inception through diagnostic testing and commercialization• Developed robust microfluidic-based single cell analysis technology• Surpassed program goals at 40% of the allotted budget• Proved brain cancer stem cells as key therapeutic targets

Los Angeles, Ca, Us

Set up and managed wet laboratory to produce a library of human brain cancer stem cell (CSC) lines for target identification and characterization, diagnostics, pharmacology R&D• Developed and optimized CSC propagation methods from patient biopsy material • Established library >150 human spheroid brain CSC lines for use in R&D (primarily glioblastoma)• Investigated CSC malignancy drivers, drug resistance and response indicators • Conducted drug discovery and managed contracts with Celgene, Geron Corp. and Stemline Therapeutics

Los Angeles, Ca, Us

Developed clinician interview for pediatric neuro-oncologists• Managed multi-institutional project including interview development, clinical validation, regulatory approval, ACCESS database development and maintenance• Coordinated clinical research activities across Geffen UCLA SOM, Dana Farber Cancer Institute of Harvard University SOM and St. Jude Children’s Research Hospital

Cytoscale Diagnostics, Inc. was a California NanoSystems Institute spin-off company commercializing a novel circulating tumor cell capture nanotechnology • Developed commercial SOPs• Served as link between academic and commercialization teams• Conducted IP analysis, freedom-to-operate, competitive analysis, market strategy

Cellfluidics, LLC was a California NanoSystems Institute spin-off company commercializing a novel microfluidics single cell diagnostics technology for precision oncology.• Played key role in securing federal Small Business Research Innovation funding• Served as the operational link between academic and commercialization teams• Developed IP, conducted freedom-to-operate, competitive analysis, market strategy

Irvine, Ca, Us

Murray Hill, Nj, Us

• Conducted in depth GUI analysis of B-to-B trouble tracking system• Identified system usage inefficiencies which resulted in cost-savings and additional sources of revenue

Bioengineering And Biomedical Engineering

Stem Training, Scientific Entrepreneurship, Rapid Prototyping, Systems Engineering, Microfluidics

Technology Commercialization And Innovation ‘Mini-Mba’

Phd, Molecular And Medical Pharmacology

Ma, Clinical Psychology

Bs, Industrial And Organizational Psychology