Maureen Bennett chairs the firm’s global Life Sciences Practice Group.

She represents pharmaceutical, medical device and biotechnology companies in connection with a wide range of commercial and regulatory issues, with a particular emphasis on global clinical trials. Her practice includes the negotiation of clinical trial agreements and contract research organization (CRO) agreements and related regulatory and ethical issues in connection with multisite, multijurisdictional clinical trials. She also advises clients regarding strategic research collaboration agreements between life sciences companies and academic medical centers.

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

Ms. Bennett resides in Boston, Massachusetts and is a member of the American Health Lawyers Association and the Boston Bar Association.

Ms. Bennett has lectured extensively on the conduct of global clinical trials, and is recognized for her experience with the special legal and ethical issues associated with clinical trials conducted in emerging regions. Her public presentations include:

• Clinical Trials in Emerging Regions of Latin America (CHI Latin America Drug Development Conference, March 2010, Philadelphia PA)
• Clinical Trials in Emerging Regions (American Conference Institute, February 2010, New York, NY)
• Global Clinical Trials/The Edge of Medical Tourism (Medical Tourism International Congress, November 2009, Cartagena, Colombia)
• Conducting Clinical Trials in the US and Abroad: Navigating the Rising Tide of Regulation and Risk (American Health Lawyers’ Association Life Sciences Institute, October 2009, Washington DC)
• Clinical Outsourcing Alliances in Central and Eastern Europe (NextLevel Pharma Conference, October 2009, Boston, MA).
• 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 Bio- Industry Association, 2004, Phoenix, AZ; Massachusetts Biotechnology Council, 2005, Cambridge, MA).

Representative Experience

• Advising a major pharmaceutical company in the management of clinical trial agreement negotiations in nine countries in Central and South America.
• 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.
• Serving as onsite counsel to a US-based pharmaceutical company in managing multijurisdictional clinical trials on an accelerated basis in the United Kingdom, United States, Portugal, France, Taiwan, Brazil, Italy, Australia and Canada.
• Advising a pharmaceutical company in connection with anticorruption issues in Russia and China.
• Advising pharmaceutical companies in CRO contract negotiations for global clinical trials.
• Assisting an academic medical center in a research collaboration agreement with a CRO.
• Advising pharmaceutical company on the establishment of data monitoring committee governance documents.
• Advising pharmaceutical companies on drug export requirements in Africa.
• Advising pharmaceutical companies on informed consent and data privacy issues.
• Advising a CRO regarding clinical trial agreement requirements in Japan.
• Advising pharmaceutical companies in regard to conflict of interest guidelines involving compensation to health care professionals.
• 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 in connection with 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.