Clint D. Hermes
Clint Hermes draws on his deep experience as general counsel at two teaching hospitals to advise clients on regulatory, accreditation, and corporate governance matters in academic medicine. In addition, Clint also offers clients practical advice and insights on all regulatory and contracting aspects of human and animal research.
Clint’s accomplishments on behalf of academic medical centers have been as varied as negotiating complex academic affiliation agreements; implementing enterprise risk management programs; securing dismissal of a qui tam action involving federal grant compliance; preparing clients for Joint Commission, AAHRPP, and ACGME reviews; lobbying HHS for changes to a PREP Act declaration; obtaining a favorable OIG Advisory Opinion; and establishing healthcare and humanitarian programs overseas.
Clint has extensive experience with the regulation of human and animal research, clinical trial registration and transparency, conflicts of interest, federal grants, biospecimens, data sharing, and expanded access to investigational products. His work on behalf of the research missions of academic medical centers and life sciences companies has taken him throughout Africa, Asia, the Middle East, and South America. He has served on numerous Institutional Review Boards (IRBs) in the United States and abroad, including as Vice Chair of a Harvard-affiliated IRB and of a biobank IRB abroad, and as science policy advisor to a foreign government.
Clint has authored numerous articles and book chapters (including one published by Oxford University Press) in the areas of international health projects and biomedical research and has been quoted in publications such as MIT’s Technology Review, Bloomberg Law, Modern Healthcare, and Canada’s Globe and Mail.
Memberships
American Health Law Association (AHLA)
Public Responsibility in Medicine & Research (PRIM&R)
1Day Sooner — Advisory Board
Relay Life Sciences — Advisory Board
East Tennessee Children’s Hospital — Institutional Review Board
Representative Experience
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Advise a public university system on compliance with the rules associated with grants and contracts from NIH, NSF, and the Department of Defense
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Lead Counsel to POINT Biopharma Inc. in its SPAC Business Combination with Research Alliance Corp. IRead More
Lead Counsel to POINT Biopharma Inc. in connection with its proposed SPAC business combination with Therapeutics Acquisition Corp. d/b/a Research Alliance Corp. I (Nasdaq: RACA), a special purpose acquisition company, sponsored by RA Capital Management. Upon closing, the combined company will be named POINT Biopharma Global Inc. and is expected to be listed on Nasdaq under the ticker symbol “PNT”.
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Represented Boston Children’s Hospital with intellectual property, business, and government contracting issues associated with VaccineFinder
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Assisted a prominent children’s hospital with a range of industry-sponsored and investigator-initiated research agreements
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Counseled a major research university with all regulatory and contracting aspects of a multi-national investigator-initiated clinical trial
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Counseled an academic medical center on international data protection regulations that apply to a global disease surveillance platform involving data from dozens of countries
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Advised research institutions and laboratory companies on Medicare billing for clinical trials, observational studies and other research
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Advised a national clinical trials network on identifying and managing conflicts of interest of senior leaders with multiple faculty, medical staff, and corporate relationships
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Advised a pharmaceutical company on federal grant funding and clinical trials for oncology and antiviral compounds
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Additional Experience
- Advised a research institution on research and health programs in Africa and Asia.
- Conducted research compliance and administrative efficiency review for large hospital system.
- Provided advice on federal grant compliance issues to a large private university.
- Reviewed and revised a clinical trial agreement template for a public life sciences company and assisted comply with domestic and foreign site contracting.
- Advised a Fortune 500 company on IRB, IDE, and EUA requirements in connection with a novel diagnostic.
- Advised a major research university on IND and IDE exemptions.
- Assisted a leading children’s hospital on global privacy law compliance for a line-level disease registry.
- Counseled a prominent university on research document retention requirements.
- Advised a health system on various COVID-19 clinical trials.
- Assisted research foundation with research affiliation agreement and clinical trial contracting.
- Assisted publicly traded life sciences company with compliance issues associated with research grants and off-label promotion.
- Reviewed IRB policies and procedures for children’s hospital.
- Assisted public university with federal grants compliance and international projects.
- Established a centrally-managed nationwide community hospital research site network.
- Advised a publicly traded medical device company on company-sponsored, investigator-initiated clinical trials, and negotiation of a CRO agreement.
- Assisted a university system with handling a research misconduct allegation and reviewing its research misconduct policies.
- Helped a large nonprofit hospital system clear a significant backlog of research agreements.
- On behalf of a research university, negotiated vendor agreements to enable a large digital health-powered clinical trial.
- Advised a life sciences company on clinical trials in South America and New Zealand.
Publications
Past Events
Media Mentions & Firm News
Additional News & Insights
Publication:
- “Chapter 4 – Regulation of Industry-Sponsored Clinical Trials,” The Fundamentals of Life Sciences Law: Drugs, Devices and Biotech, Co-Author (2014)
Speaking Engagements:
- “Considerations for International Health Care Infrastructure Projects,” American Health Lawyers Association (June 2016)
- “Developing a Responsible Healthcare Workforce,” Law and Medicine Conference – Qatar University (February 2016)
Accolades
GC Powerlist Middle East (2015, 2017)
Memphis Business Journal — Top 40 Under 40 (2008)
Nightingale’s Healthcare News — Best Healthcare Lawyers Under 40 (2004)
Massachusetts Super Lawyers — “Rising Star” (2003)