Representative experience

Coordinating defense of a manufacturer of implantable class III medical devices against alleged liability in clinical trials after a voluntary worldwide product withdrawal.

Representing a global pharmaceutical company on several claims arising out of clinical trials in China.

Representing a leading research university in connection with a voluntary disclosure of irregularities in reimbursement of research patient care costs under NIH grants.

Conducted regulatory due diligence on an acquisition target that helps drug companies and contract research organizations recruit subjects for clinical trials.

Assisted a large academic medical center in planning and overseeing a privileged audit of its global clinical trial network to evaluate compliance with FDA’s Good Clinical Practice regulations.

Lawyers in 11 countries conducted research and offered practical advice to assist Amarin’s efforts to address worldwide patient privacy and vital status concerns for its cardiovascular outcomes trial.

Advised LabCorp on its US$1.2bn acquisition of Chiltern, a research organization focused on clinical services, and its US$371m purchase of Sequenom, a pioneer in noninvasive prenatal testing.

Assisting biotech and pharma companies in evaluating and addressing significant data integrity and GCP compliance concerns raised in their clinical trials.

Assisting a leading European biotech company on the roll-out of a Phase III clinical trial throughout 21 countries.

Working with numerous pharma and biotechnology clients to prepare and negotiate domestic and international clinical trial agreements and other sponsored research agreements.

Advising numerous pharmaceutical and biotechnology clients on protecting their IP rights and managing their exposure to liability.

Assisting numerous companies in understanding the ClinicalTrial.gov disclosure requirements under the 2016 final federal regulations.

Advising a U.S. company on new statutory requirements for holding clinical trials in Russia, including arrangements with the investigator and mandatory insurance of patients.

Assisting in a complex dispute relevant to interlocutory remedies sought by the claimant to obtain late enrollment in a pending clinical trial.

Advising a university on terminating an investigational new drug application over the objection of an employee / principal investigator.

Regularly counseling companies on their financial arrangements with investigators and related disclosure obligations to FDA pursuant to the FDA financial disclosure regulations.