William M. Hanes, JD, PhD

Biomedical & Translational Science Mastery: Dual JD/PhD expertise combining Molecular & Cellular Biology (Neuro-immunology focus) with global regulatory and IP frameworks. Over 15 years leading multi-center initiatives, extramural portfolios, and translational studies across CNS devices, bioelectronic medicine, cell therapies (CAR-T), and therapeutics.

Program

Planning, FOAs & Multi-Grant Governance: Substantial experience defining program priorities, drafting solicitations, and managing federal/state grant mechanisms and cooperative agreements. Chaired NIH-style peer-review panels (Significance, Investigators, Innovation, Approach, Environment), managing COI, summary statements, and budget justifications for 200+ applications and $4M+ in seed allocations.

Grantee

Advising, Post-Award Monitoring & Liaison: Delivered 1:1 scientific, operational, and legal counseling to PIs and early-stage startups on milestone roadmaps, technical bottlenecks, IP protection, and SBA compliance. Conducted progress evaluations and interfaced across NIH, NSF, SBA, FDA, state authorities, and university TTOs.

Senior Scientific Director & Executive Operational Advisor - WHJD - East Setauket, NY

(2025-05)

• Deliver scientific administration, regulatory strategy, and grant strategy services for high-growth biotech, medtech, and digital health ventures across cell-based therapies, medical devices, and therapeutics.
• Advised an academic team participating in a NIDA initiative evaluating a meditation platform designed to improve sleep parameters, stress recovery, and patient retention in residential Substance Use Disorder (SUD) treatment facilities.
• Author, review, and refine non-dilutive SBIR/STTR proposals, establishing cross-functional development roadmaps integrating R&D, preclinical protocols, FDA regulatory readiness, and budget justifications.
• Synthesize complex biological data with global patent eligibility frameworks (USPTO, EPO, WIPO) and FDA/EMA regulatory moats to de-risk technology portfolios.

Founder & Chief Executive Officer - SOMNIAL INC. - New York, NY

(2022-12 - 2025-05)

• Directed scientific, clinical, and regulatory execution for a novel medical device platform targeting nervous system and airway mechanics.
• Formulated preclinical data packages and managed regulatory interactions that successfully secured FDA Breakthrough Device Designation.
• Managed non-dilutive grant awards from European research and innovation funds, directing multi-national IRB clinical trial execution and milestone reporting.

Chief Operating Officer & In-House Counsel - iCELL GENE THERAPEUTICS LLC - Stony Brook, NY

(2017-05 - 2022-12)

• Built operational, scientific, and regulatory infrastructure supporting three concurrent clinical-stage CAR-T oncology programs.
• Directed cross-functional R&D, CMC, and legal teams for trial readiness; negotiated multi-million-dollar international licensing deals.

Senior Technology Commercialization Leader & Program Administrator - CENTER FOR BIOTECHNOLOGY – STONY BROOK UNIVERSITY - Long Island, NY

(2015-09 - 2022-12)

• Executive administrator for the NIH-REACH U01 Hub (Long Island Bioscience Hub), joining Stony Brook, Cold Spring Harbor, BNL, and Northwell Health. Drafted and issued Funding Opportunity Announcements (FOAs) and solicitations aligned with program priorities to address unfulfilled biomedical research gaps. Managed gated funding frameworks serving as direct conduits to SBIR/STTR Phase I/II awards.
• Operated at the Associate Professor level of scientific leadership over a 200+ project portfolio across devices, cell therapies, and pharmaceuticals. Chaired multidisciplinary review panels using NIH criteria; managed reviewer recruitment, score consolidation, COI waivers, summary statements, and $4M in seed funds—catalyzing $65M+ in follow-on capital.
• Formulated and executed the NYS-funded Applied Research & Development (ARAD) matching grant program ($30k/project) across diagnostics, research tools, and medtech. Monitored interim scientific progress reports, conducted facility reviews, and determined continuation funding recommendations based on milestone achievement.
• Provided 1:1 guidance to academic researchers on target validation, experimental rigor, and SBA compliance (51% PI rule). Taught commercialization workshops and sections of the Fundamentals of the Bioscience Industry Program course, and served as a judge for regional commercialization competitions.

Neuro-Immunology & Bioelectronic Medicine Research Scholar - FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH - Manhasset, NY

(2011-08 - 2015-08)

• Conducted foundational research in neural-immune regulation, bioelectronic medicine, neurocircuitry, and inflammatory pathways.
• Authored 25+ peer-reviewed publications and generated data packages securing major federal grants (NIH/DARPA).

Associate Patent Attorney & Scientific Specialist - LARSON & ANDERSON, LLC - Denver, CO

(2008-08 - 2009-08)

• Managed patent prosecution for medical devices, therapeutic platforms, and diagnostics, translating scientific mechanics into protected IP and guiding research to generate patentable subject matter.

Scientific & Legal Fellow - US EPA

(2006-01 - 2006-12)

Research Assistant / Student Researcher - MannKind Corp.

(2004-01 - 2005-12)

Research Assistant / Student Researcher - Rockefeller University

(2003-01 - 2004-12)

Research Assistant / Student Researcher - Uniformed Services University

(2002-01 - 2003-12)

Research Assistant / Student Researcher - Miami University

(1999-01 - 2002-12)

Ph.D. - Molecular & Cellular Biology (Immunology / Neuro-Immunology Focus) - Stony Brook University

J.D. - Intellectual Property Law - Benjamin N. Cardozo School of Law

B.A. - Microbiology - Miami University