Maureen Bennett | Abogados

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.

Experiencia

Riverside acquires CRIO, Inc.Jones Day advised The Riverside Company in the acquisition of CRIO, Inc., a leading provider of eSource and other eClinical software for clinical trial sites, CROs and the pharmaceutical/biotech market.

Reneo Pharmaceuticals announces reverse merger with OnKureJones Day is representing Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM) in an all-stock reverse merger between Reneo and OnKure, Inc., a privately-held, clinical-stage biopharmaceutical company valued at $170 million that is focused on the development of novel precision medicines in oncology.

Saint Luke's Health System of Kansas City merges with BJC HealthCareJones Day advised Saint Luke's Health System of Kansas City in its merger with BJC HealthCare.

Sumitomo acquires assets and rights related to lefamulin from NabrivaJones Day advised Sumitomo Pharma Co., Ltd. in the acquisition of assets from Nabriva Therapeutics plc and various wholly-owned subsidiaries. This acquisition includes assets from the U.S., Ireland, and Austria in support of the development, manufacture, marketing and commercialization of lefamulin in the People’s Republic of China, Hong Kong, Macau and Taiwan.

Astellas acquires Iveric bioJones Day advised Astellas Pharma Inc. in the $5.9 billion cash acquisition of Iveric bio, Inc., a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.

KKR acquires IVI-RMA GlobalJones Day acted as U.S. counsel in the €3 billion acquisition of IVI-RMA, a group specialized in assisted reproduction techniques.

Parker Hannifin sells Human Motion and Control Business Unit to Ekso Bionics Holdings, Inc.Jones Day represented Parker Hannifin Corporation in the sale of its Human Motion and Control Business Unit to Ekso Bionics Holdings, Inc. for an aggregate purchase price of $10 million.

EDAP completes follow-on public offering of American Depositary SharesJones Day represented EDAP TMS, a global leader in robotic energy-based therapies, in connection with its follow-on public offering of 3,066,667 American Depositary Shares (ADSs) on the Nasdaq Global Market.

Riverside portfolio company acquires Jupiter Life Science Consulting (Jupiter)Jones Day advised The Riverside Company in connection with the acquisition and financing by portfolio company Red Nucleus of Jupiter Life Science Consulting (Jupiter), a leading provider of commercial and market access strategies for global pharma, biotech, and medical device companies with its primary focus in rare disease, hematology/oncology, metabolic, and neurology therapeutic areas.

Cardinal Health acquires the Bendcare CPO-GPO entity and makes a minority investment in the Bendcare MSOJones Day advised Cardinal Health, Inc. in the acquisition of the Bendcare group purchasing organization (CPO-GPO) entity and a minority investment in the Bendcare management services organization (MSO).

Riverside portfolio company acquires Medical Marketing Solutions GroupJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company Medical Marketing Solutions Group (MMSG), a leading medical education company that provides strategic services, scientific and medical communications, and operational and event management services to global biopharmaceutical companies.

City of Hope acquires Cancer Treatment Centers of AmericaJones Day advised City of Hope, a world-renowned, National Cancer Institute (NCI)-designated comprehensive cancer research and treatment organization, in connection with its acquisition of Cancer Treatment Centers of America, a network of oncology hospitals and outpatient care centers across the United States.

Sotera Health acquires Regulatory Compliance AssociatesJones Day advised Sotera Health in the acquisition of Wisconsin-based Regulatory Compliance Associates, Inc.

Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).

Bridge to Life announces first close of $56 million growth financingJones Day advised Bridge to Life, Ltd. in its $56 million capital raise consisting of a secured credit facility and a Series A preferred equity investment.

EDAP completes follow-on offering of American Depositary SharesJones Day represented EDAP TMS, a global leader in robotic energy-based therapies, in connection with its follow-on offering of 4,150,000 American Depositary Shares (ADSs) on the Nasdaq Global Market.

MedShape acquired by DJOJones Day advised MedShape, Inc., a privately held orthopedic medical device company founded in 2005, in connection with its acquisition by DJO, a subsidiary of Colfax Corporation.

Riverside portfolio company acquires PPM Advisory Group and OrtleyBioJones Day represented The Riverside Company in connection with the acquisition by portfolio company Red Nucleus of PPM Advisory Group and OrtleyBio, leading providers of scientific operations and communications services to global biopharmaceutical companies and brands, with a primary focus on oncology and hematology therapeutic areas.

Sumitovant Biopharma acquires remaining stake in Urovant SciencesJones Day advised Sumitovant Biopharma in its acquisition of all of the outstanding shares of Urovant Sciences Ltd. not already owned by Sumitovant at a price of $16.25 per share in cash.

AbbVie acquires Mitokinin, Inc.Jones Day advised AbbVie Inc. in its exclusive right to acquire Mitokinin, Inc., a biotechnology company developing PINK1-targeted therapeutics for the treatment of neurodegenerative diseases, following completion of IND enabling studies on Mitokinin's lead PINK1 compound.

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.

December 2024 Commentary

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

MaureenBennett

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Experiencia

FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-Enabled Medical Devices

FDA Remote Regulatory Assessments Are Not So Remote Anymore

FDA Launches the Center for Clinical Trial Innovation

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

FDA on Board With Continuing Remote Inspections

FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

Senate Judiciary Committee Revisits Drug Pricing Reform Bills

MaureenBennett

Partner

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Experiencia

FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-Enabled Medical Devices

FDA Remote Regulatory Assessments Are Not So Remote Anymore

FDA Launches the Center for Clinical Trial Innovation

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

FDA on Board With Continuing Remote Inspections

FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

Senate Judiciary Committee Revisits Drug Pricing Reform Bills

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