Maureen Bennett co-chairs the firm’s global Life Sciences Industry Group. She represents pharmaceutical, medical device and biotechnology companies in connection with a wide range of commercial and regulatory issues associated with global clinical trials. Her work includes the negotiation of clinical trial agreements, clinical research organization (CRO) agreements and related consulting agreements for multijurisdictional trials.

Maureen also assists life sciences companies with cross-boundary acquisition and investment transactions as well as product supply, manufacturing and development agreements.

Maureen is serving as co-chair of the 2011 American Health Lawyers Association (AHLA) Biomedical Innovations conference in Washington DC.

She also is the co-author of a 2009 white paper published by the AHLA, entitled “Conducting Clinical Trials in the United States and Abroad: Navigating the Rising Tide of Regulation and Risk.”

Maureen has lectured extensively on the conduct of global clinical trials and pharmaceutical and medical device regulation including the following:

• “US and EU: Rethinking Medical Device Regulation – Potential Impact on Manufacturers” (Hong Kong Medical & Healthcare Device Industries Association seminar, October 2010, Hong Kong).
• “A World Apart: Understanding Differences in US and EU Medical Device Regulation” (FDAnews webinar, August 2010).
• “Clinical Trials in Emerging Regions of Latin America” (CHI Conference on Drug Development in Latin America, March 2010).
• “Global Clinical Trials” (Silicon Valley Association of General Counsel, December 2009, Santa Clara, CA).
• “Global Clinical Trials/The Edge of Medical Tourism” (Medical Tourism Medical Congress, November 2009, Cartagena, Colombia).
• “Clinical Outsourcing Alliances in Central and Eastern Europe” (NextLevel Pharma Conference, October 2009, Boston, MA).
• “Conducting Clinical Trials in the US and Abroad: Navigating the Rising Tide of Regulation and Risk” (AHLA Life Sciences Law Institute Conference, October 2009, Washington DC).
• “Good Clinical Practice Challenges in Emerging Regions” (American Conference Institute, Clinical Trials Conference, February 2009, New York City, NY).
• “International Destinations for Clinical Trials” (Annual World Medical Tourism & Global Health Congress: Legal Workshop, September 2008, San Francisco, CA).
• “Streamlining CTA Agreements” (American Conference Institute, Clinical Trials Conference, September 2007, Boston, MA).
• “Global Clinical Trials” (BayBio Exposition, April 2006, Silicon Valley, CA).
• “Clinical Trial Disclosures in the New Corporate Regulatory Climate” (Arizona Bioindustry Association, 2004, Phoenix, AZ; Massachusetts Biotechnology Council, 2005, Cambridge, MA).

Maureen resides in Boston, Massachusetts.

Experiencia Reciente

• Advising several US- and Japan-based pharmaceutical companies in the management of multijurisdictional pre- and post-marketing clinical trials including sponsored research trials and investigator-initiated trials in the United States, Canada, Mexico, European Union, Central and South America, and Asia.
• Managing the negotiation of more than 150 clinical study agreements for a US‑based pharmaceutical company in multiple countries in Central and South America.
• Serving as onsite counsel to a US-based pharmaceutical company in managing multijurisdictional clinical trials on an accelerated basis in the UK, the United States, Portugal, France, Taiwan, Brazil, Italy, Australia and Canada.
• Advising pharmaceutical companies in CRO contract negotiations for global trials.
• Advising private investors in connection with investment in a US-based CRO.
• Advising pharmaceutical companies regarding drug export requirements in Africa.
• Assisting a multinational pharmaceutical company with the development of informed consent and HIPAA templates for use in global trials.
• Advising a CRO regarding clinical trial agreement requirements in Asia.
• Advising a US-based pharmaceutical company on evolving regulatory, trade association, physician group and other standards regarding conflict of interest.
• Advising pharmaceutical companies in contract manufacturing and bulk drug substance supply and distribution agreements.
• Advising a medical device company in connection with US regulatory requirements related to product line divestiture.
• Advising pharmaceutical companies regarding clinical registry and study results reporting obligations, as well as Securities and Exchange Commission clinical trial disclosure issues.
• Advising a Japan-based medical device company in connection with adverse event reporting requirements and related liability issues in several countries in Europe.