Maureen Bennett represents life sciences and health care clients conducting global clinical trials and research collaborations. For almost 20 years, Maureen has advised clients on the contractual, regulatory, and ethical issues associated with clinical research. She negotiates clinical trial agreements, reviews informed consents, provides advice regarding novel patient recruitment strategies, and assists with interactions with regulatory agencies, including the FDA. Maureen also advises clients on emerging regulatory issues affecting clinical research, including the utilization of social media in patient and physician recruitment, the development of virtual clinical trial and telemedicine networks, and personalized medicine strategies implementing the use of biomarkers and companion diagnostics.
Maureen also represents clients in the structuring of complex outsourcing arrangements between life sciences companies and contract research organizations (CROs). Maureen has recently assisted a pharmaceutical company in the negotiation of a master services agreement with a CRO for a Phase 3 clinical trial with more than 100 sites on four continents. 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 is the Life Sciences co-leader for the Firm's Health Care & Life Sciences Practice and is currently serving 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 Giant Step Conference 2015 and is a regular speaker at industry conferences. Maureen is a member of the Firm's LGBTQ affinity group.
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.
Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
New French Decree Clarifies the Scope of Biomedical Research, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
- May 2015Biosimilars 2014 in Review and What to Expect in 2015, The Biotech Connection in Boston
- October 5, 2017Belfast UK International Homecoming-Legal Symposium, "Marriage Equality and the Courts in the U.S."
- October 21, 2016ABA Life Sciences Legal Summit
- March 7, 2016Boston Bar Association - Are You Ready? The Frontiers of Clinical Research and the Evolving Common Rule
- December 2, 2015Boston Bar Association CLE - Medical Tourism: Legal Issues and Ethical Implications
- October 23, 2015Treating the Medical Tourist: Issues for Healthcare Providers and Their Counsel, ABA Section of International Law 2015 Fall Meeting
- October 21-22, 20158th Annual Boston-Northwest Ireland Golden Bridges Giant Steps Conference - Honorary Co-Chair and Shark Tank Judge
- October 2015The Legal and Ethical Implications of Medical Tourism, panel discussion
- March 4, 2015Negotiating 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)
"Women Worth Watching" award winner, Profiles in Diversity Journal (2015)
Who's Who Legal: Life Sciences (2019) — regulatory