Mark advises clients throughout higher education and the health care industry, including pharmaceutical companies, medical device manufacturers, biotechnology firms, IT companies, hospitals, and universities. He has extensive experience in legal issues related to research with humans and animals, stem cell and genetic research, research grants and contracts, research misconduct, international research and data privacy. In 2012, with Dr. Barbara Bierer, Mark started, and continues to serve as faculty co-chair of, the Multi-Regional Clinical Trials Center of Harvard University and Brigham and Women’s Hospital, a project designed to improve the planning, conduct and regulation of multi-national clinical trials, with a special emphasis on trials in the emerging economies.
Mark was a partner at Ropes & Gray from 2001-2008, before leaving to serve as Executive Vice President and Chief Administrative Officer at St. Jude Children's Research Hospital. Before returning to the firm, Mark also served as Senior Associate Provost for Research at Harvard University. At Harvard, he supervised the University’s sponsored research operations and was responsible for the full range of research policy and compliance issues, including human subjects research, research misconduct, export controls, conflicts of interest, and grants and contracts compliance. In 2012, during a period of intense regulatory scrutiny, Mark served as the managing director of Harvard's Primate Research Center.
Mark has particular experience in establishing legal structures and operational plans for international service and research projects, especially in emerging economies. For St. Jude, he established a vaccine study center in the Eastern Highlands of Zimbabwe, in collaboration with Africa University. While at Ropes & Gray, he started and served as the first executive director of Harvard’s extensive PEFPAR-funded AIDS treatment programs in Nigeria, Tanzania and Botswana, and later served as the chair of the oversight committee for that project. At Harvard, he worked with faculty from across the University to establish service, demonstration and research projects throughout the world, including China, Viet Nam, Colombia, Peru, and the Gulf States, among other countries.
Since 1986, Mark has taught at a number of law schools, including Columbia, NYU, Harvard, and Yale. The subjects he has covered include health care law and finance, public health law, the law of human subjects research, occupational health law, and managed care law. He currently holds a faculty position at Yale Law School, where he teaches health care law and finance and public health law, and at the Yale School of Medicine, where he teaches the history of the regulation of the medical profession, medical malpractice, and medical privacy.
Mark’s diverse legal background also includes senior policy and administrative positions at the New York State Department of Health and the New York City Department of Health, where, among other duties, he directed the Ryan White CARE Act program providing medical, substance abuse and mental health treatment to New Yorkers living with HIV/AIDS. In 1993, he served as legal advisor to the health reform efforts at the Clinton White House, and has been president of the New York State Bar Association Health Law Section (2007-2008).
- Quoted, “Will ‘One-in, Two-Out’ Order Hamper FDA’s Clinical Trial Regulations,” Bloomberg BNA’s Medical Research Law & Policy Report (March 15, 2017)
- Co-author, “Recent Changes in French Law Affecting Clinical Research and Trials,” Bloomberg BNA Medical Research Law & Policy Report (February 15, 2017)
- Co-author, “HHS Finalizes Comprehensive Revisions to the Common Rule,” Bloomberg BNA Life Sciences Law & Industry Report (January 26, 2017)
- Quoted, “White House Finalizes Scaled Back Research Regs,” Health Care Daily Report (January 18, 2017)
- Co-author, “21st Century Cures Act: Broad Revisions to the Federal Regulation of Medical Research,” Bloomberg BNA Medical Research Law & Policy Report (January 18, 2017)
- Quoted, “Obama Administration Still Wants to Release New Common Rule,” Life Sciences Law & Industry Report (November 18, 2016)
- Quoted, “Drug Industry May Face Less Scrutiny Under Trump,” Health Care Daily Report (November 10, 2016)
- Quoted, “Clinical Trials: New Clinical Trial Reporting Rule, Policy Toughen Enforcement,” Bloomberg BNA’s Medical Research Law & Policy Report (September 19, 2016)
- Quoted, “Informed Consent: Court Dismisses Guatemala VD Study Suit, But Allows Refiling,” Bloomberg BNA’s Medical Research Law & Policy Report (September 13, 2016)
- Quoted, “FDA Cleans Up IRB Regulatory Language for Noncompliance,” Bloomberg BNA Medical Research Law & Policy Report (April 4, 2016)
- Co-author, “Impact of the European Union’s Approved General Data Protection Regulation On Scientific Research and Secondary Uses of Personal Data,” Bloomberg BNA Medical Research Law & Policy Report (Feb. 17, 2016)
- Co-author, “Corruption Risks in International Clinical Trials: Navigating Between Anti-Bribery Laws and Local Circumstances,” Bloomberg BNA Medical Research Law & Policy Report (Jan. 6, 2015)
- Co-author, “The CLIA/HIPAA Conundrum of Returning Test Results to Research Participants,” Bloomberg BNA Medical Research Law & Policy Report (July 15, 2015)
- Co-author, “India’s Proposed Amendments to the Drug and Cosmetics Act: Compensation for Injuries to Clinical Trial participants and the Criminalization of Clinical Research,” Bloomberg BNA Life Sciences Law & Industry Report (January 23, 2015)
- Quoted, “Indian Regulators Propose Draft Legislation with New Penalties for Clinical Trials,” FDANews’ Drug Industry Daily (January 6, 2015)
- Co-author, “National Institutes of Health Issues a Notice of Proposed Rulemaking on Clinical Trials Registration and a Draft Policy on Registration and Reporting of Results for NIH-Funded Clinical Trials,” Bloomberg BNA’s Medical Law & Policy Research Report (December 2014)
- Co-author, “Reviewing HIV-Related Research in Emerging Economies: The Role of Government Reviewing Agencies,” Developing World Bioethics (December 2014)
- Co-Author, “Impact of Proposed Federal Research Regulation Amendments (the Common Rule NPRM) on Life Sciences Companies,” Bloomberg BNA Life Sciences Law & Industry Report (November 13, 2015)
- Quoted,” India Creates Expert Panel to Review Drug Application Forms, Procedures,” International Pharmaceutical Regulatory Monitor (November 12, 2014)
- Quoted, “Edits to ethics code rankle,” Nature (November 11, 2014)
- New EU Clinical Trials Regulation and its Interaction With Proposed EU Privacy Regulation and Proposed EMA Policy on Clinical Trials Data Transparency,” Bloomberg BNA Medical Research Law & Policy Report (August 20, 2014)
- Quoted, “Alternatives to GCP Standards Said Needed To Ensure Trial Quality in Emerging Markets,” Bloomberg BNA (September 5, 2013)
- Co-author, "EMA Draft Policy on Publication and Access to Clinical Trials Data Provides Broad Researcher Access to Participant-Level Data," Bloomberg BNA Medical Research Law & Policy Report (July 17, 2013)
- Co-author, “HIPAA Final Rule Clarifies Major Research Issues,” Bloomberg BNA’s Medical Research Law & Policy Report (February 6, 2013)
- Co-author, “European Union Negotiations Reach Agreement on New Clinical Trials Regulation,” Bloomberg BNA's Medical Research Law & Policy Report (February 5, 2014)
- Mark Barnes and Sarah Blumenthal, "Implications of the Federal Physician Payments Sunshine Act for Clinical Research," Bloomberg BNA Medical Research Law & Policy Report (November 21, 2012)
- Quoted, “Anti-Health Reform Measures DOA After High Court Ruling,” Health Care Law360 (November 7, 2012)
- Co-author, “Proposed Revisions to the Federal Common Rule: Implications for the Role of the IRB in Institutional Oversight Programs,” Bloomberg Health Law Rep. (February 6, 2012)
- Co-author, “Protecting Research Participants While Reducing Regulatory Burdens,” 306 JAMA 2260 (November 23-30, 2011)
- Co-author, “The Obligation to Provide Antiretroviral Treatment in HIV Prevention Trials,” 21 AIDS 1229-1231 (2007)
- Co-author, “Informed Consent: FDA Draft Guidance on Emergency Research,”BNA Med. Research Law & Pol’y Rep. 634 (September 20, 2006)
- Co-author, “Washington University v. Catalona: Ownership and Use of Human Biologic Materials Collected for Research,” BNA Med. Research Law & Pol’y Rep. (May 3, 2006)
- “HIPAA and Commercial Clinical Research,” Good Clinical Practice: A Question and Answer Reference Guide (May 2006)
- Co-author, “Clinical Trials in 2006: Trial Registration, International Research, Research Billing, Adverse Events, and Secondary Uses of Data and Tissue,” BNA Med. Research Law & Pol’y Rep. 26 (January 1, 2006)