Maureen Bennett represents life sciences and health care clients conducting global clinical trials and research collaborations. For more than 20 years, Maureen has advised life sciences companies, CROs (contract research organizations), academic medical centers, health care systems, patient focused organizations, and digital health companies on the contractual, regulatory, and ethical issues associated with clinical research.
Maureen regularly advises clients on emerging issues in clinical research, such as strategies to meet clinical trial diversity and health equity objectives, the design and implementation of compliant decentralized clinical trials and telemedicine networks, the structuring of patient recruitment programs, and the development of complex outsourcing arrangements between sponsors, CROs, and site management organizations. She has assisted several clients regarding the conduct of global trials for therapeutics and vaccines to address COVID-19.
Maureen also negotiates clinical trial agreements, reviews informed consents, and assists with interactions with and inspections by regulatory agencies, including the U.S. Food & Drug Administration (FDA).
She also represents clients in the assessment and mitigation of regulatory risks and the negotiation of liability allocation arrangements in M&A, licensing, and other commercial transactions.
Maureen formerly served as co-chair of the Boston Bar Association's Health Care Section. She was honorary co-chair for the 8th Annual Boston-Northwest Ireland Golden Bridges Conference 2022 and is a regular speaker at health industry conferences.
Maureen is a member of the national Board of Directors for Lambda Legal and is co-chair of the Jones Day LGBTQ+ affinity group. She is a member of the Boston College Women's Softball Advisory Board.
The following represents experience acquired prior to joining Jones Day.
Advised a Japanese life sciences company with its proposed acquisition of a U.S. contract manufacturing organization.
Advised a U.S. health care system with its expansion of a unique, personalized medicine-based clinical research study to sites in the Middle East and Europe and advised on related U.S. IDE regulatory issues.
Advised a U.S.-based biotech company with a multicountry analysis of statutory and ethical committee requirements to provide access to study a drug after completion of a clinical trial and assisted the company with development of clinical trial agreements, informed consent, and related regulatory issues in several South American jurisdictions.
Advised a U.S.-based genetics company with laboratory testing agreements, data protection, and other regulatory issues in connection with genetics testing arrangements in the U.K. and Russia.
Advised a U.S.-based biotech company with the development of informed consent and data privacy authorizations for use in the U.S., Australia, and multiple European jurisdictions.
Assisted a Japanese life sciences company with several confidential buy- and sell-side transactions.
Assisted a U.K.-based specialty pharmaceutical company in connection with the development of policies regarding the payment of health care professionals and anticorruption issues in Hong Kong, Taiwan, and Singapore and with the development of compliant centers of excellence product training programs in Hong Kong and Japan.
Assisted a specialty patient recruitment firm with analysis of subject recruitment and advertising regulations in multiple ex-U.S. jurisdictions.
Assisted a top three pharmaceutical company, on an outsourced basis, with the negotiation of more than 150 clinical trial agreements in nine South and Central American jurisdictions.
Assisted a clinical data management provider in establishing a commercial agreement with a top three global pharmaceutical company, including providing legal analysis of pharmacovigilance transactions in a number of jurisdictions, including Japan, China, India, multiple EU jurisdictions, and the U.S.
Drafted and negotiated pharmaceutical product distribution agreements on behalf of California-based company for Australia and New Zealand markets.
Drafted and negotiated collaboration agreement between a top three pharmaceutical company and National Comprehensive Cancer Network regarding grant arrangements and a series of investigator-initiated trials in the oncology space.
White House Guidance on Implementing NSPM-33: Standardization of Disclosure and Security Measures for Federal Research Funding
- October 5, 2017
Belfast UK International Homecoming-Legal Symposium, "Marriage Equality and the Courts in the U.S."
- November 9, 2016
Jones Day Global Life Sciences Conference – 2016 Issues & Trends
- October 21, 2016
ABA Life Sciences Legal Summit
- May 4, 2016
Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry
- March 7, 2016
Boston Bar Association - Are You Ready? The Frontiers of Clinical Research and the Evolving Common Rule
- December 2, 2015
Boston Bar Association CLE - Medical Tourism: Legal Issues and Ethical Implications
- October 23, 2015
Treating the Medical Tourist: Issues for Healthcare Providers and Their Counsel, ABA Section of International Law 2015 Fall Meeting
- October 21-22, 2015
8th Annual Boston-Northwest Ireland Golden Bridges Giant Steps Conference - Honorary Co-Chair and Shark Tank Judge
- October 2015
The Legal and Ethical Implications of Medical Tourism, panel discussion
- March 4, 2015
Negotiating an Effective Clinical Trial Agreement and Limiting Litigation Exposure, ABA Life Sciences Legal Summit, Speaker
- Boston College (J.D. cum laude 1985; B.A. magna cum laude 1982)
- Massachusetts and California
The Legal 500 US — recognized in health care: life sciences (2018)
Who's Who Legal: Life Sciences (2019-2020) — regulatory
"Women Worth Watching" award winner, Profiles in Diversity Journal (2015)