Maureen Bennett leads 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 associated with global clinical trials. Her work includes the negotiation of clinical trial agreements, contract research organization (CRO) agreements and related consulting agreements for multijurisdictional trials. 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 has lectured extensively on the conduct of global clinical trials including:

• 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 (American Health Lawyers Association (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 Bio- Industry Association, 2004, Phoenix, AZ; Massachusetts Biotechnology Council, 2005, Cambridge, MA).

Representative Experience

• 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 pharmaceutical companies in CRO contract negotiations for global trials.
• Advising pharmaceutical companies in drug export requirements in Africa.
• Advising pharmaceutical companies on informed consent and privacy issues.
• Advising a CRO regarding clinical trial agreement requirements in Asia.
• Advising pharmaceutical companies in regard to conflict of interest guidelines.
• 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.