Clint D. Hermes
Clint Hermes draws on his deep experience as general counsel at two academic medical centers to advise clients on regulatory, contracting and corporate governance matters. He also offers clients practical advice and insights on all regulatory and contracting aspects of human subjects research. Clint has extensive experience with – and has been widely published on – biomedical research regulatory matters involving:
- The Common Rule.
- INDs and IDEs.
- Clinical trial registration.
- Conflicts of interest.
- Research misconduct.
- Federal grant funding.
- Animal research.
- The use and sharing of research data and biospecimens.
- Human research protection program design and implementation.
- Expanded access to investigational products.
Through his counsel, Clint enables clients to engage in productive partnerships by structuring contracts among the various parties needed to carry out a clinical trial or other research collaboration both domestically and in foreign jurisdictions. His work across continents has included the following:
- Advising a research institution in establishing a clinical trial in Eastern Zimbabwe, including site evaluation, training of local research staff, and establishment and education of a community advisory board in Mutare.
- Working in Ethiopia, Rwanda and Vietnam on behalf of NIH- and USAID-funded projects.
- Structuring a tissue collection research project in Thailand.
- Providing extensive advice regarding healthcare delivery, research, and medical education in the Arabian Gulf.
- Contracting with international affiliates of a U.S. hospital throughout Latin America and the Middle East.
Memberships
American Health Law Association (AHLA)
Public Responsibility in Medicine & Research (PRIM&R)
1Day Sooner — Advisory Board
Representative Experience
-
Read 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”.
-
Read More
Represented Boston Children’s Hospital with intellectual property, business, and government contracting issues associated with VaccineFinder
-
Read More
Assisted a prominent children’s hospital with a range of industry-sponsored and investigator-initiated research agreements
-
Read More
Counseled a major research university with all regulatory and contracting aspects of a multi-national investigator-initiated clinical trial
-
Read More
Counseled an academic medical center on international data protection regulations that apply to a global disease surveillance platform involving data from dozens of countries
-
Read More
Advised research institutions and laboratory companies on Medicare billing for clinical trials, observational studies and other research
-
Read More
Advised a national clinical trials network on identifying and managing conflicts of interest of senior leaders with multiple faculty, medical staff, and corporate relationships
-
Read More
Advised a pharmaceutical company on federal grant funding and clinical trials for oncology and antiviral compounds
-
Read More
-
Read More
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.
- Advised a Fortune 500 company on IRB, IDE, and EUA requirements in connection with a novel diagnostic.
- Advised a major research university on IND exemptions.
- Assisted a leading children’s hospital on the restructuring of an international disease registry.
- Counseled a prominent university on research document retention requirements.
- Advised a health system on various COVID-19 clinical trials.
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)