Grail Walsh Sipes

Grail Sipes is a partner and a member of Covington’s Food and Drug Practice and Life Sciences Industry Group.  Her practice covers all aspects of drug and biologic regulation, including clinical trials and drug development; FDA approval and marketing exclusivity considerations; drug marketing and promotion; and postmarketing surveillance.  She counsels many clients on issues related to personalized medicine, pharmacogenomics, and the collection of biomaterials for genetic and other research.  Ms. Sipes also has expertise in issues specific to the development of vaccines, including pandemic vaccines, and in the regulation of medical devices.  She regularly advises on a range of regulatory issues raised by corporate acquisitions and transactions in the pharmaceutical and biotechnology sectors.  Ms. Sipes is a magna cum laude graduate of Yale University and was the recipient of a Fulbright Teaching Fellowship. She earned her law degree from Harvard Law School.

Representative Matters

• Represented a major pharmaceutical manufacturer in congressional inquiries regarding direct-to-consumer advertising of drug products.
• Represented a coalition of major vaccine manufacturers in negotiating the 2005 passage of the Public Readiness and Emergency Preparedness Act (PREP Act), which provides liability protection for manufacturers of countermeasures such as pandemic influenza vaccine.
• Provided FDA regulatory counsel on Abbott Laboratories’ $3.7 billion acquisition of Kos Pharmaceuticals, viewed as a significant expansion by Abbott into the cardiovascular market.
• Provided FDA regulatory counsel on Northwest Biotherapeutics’ 13.1 million pound ($26 million) offering on London Stock Exchange’s AIM market.  Northwest Biotherapeutics develops immunotherapy products for cancer, often referred to as “cancer vaccines.”
• Represented the pioneer pharmaceutical industry in petitioning FDA on legal issues related to follow-on biologics, including the taking of proprietary data.
• Represented US drug sponsor in negotiating labeling changes and other regulatory actions arising from FDA Advisory Committee examination of major safety issues surrounding sponsor’s drug products.

Previous Experience

• Oliver, Wyman & Co., New York, NY, strategy consulting firm in financial services industry, Associate (January 1988 - November 1989)
• NYC Human Resources Administration, New York, NY, foster care and preventive services for children, Budget Manager (January 1990 - July 1991)

Publications and Speeches

• "Medical Devices: Classification and the Essentials of the Device Premarket Review Process," ACI’s FDA Boot Camp (9/23/2008)
• "Collecting and Testing Samples for Pharmacogenomic Research: Issues for Manufacturers of Drug and Biological Products," Update (with permission from FDLI) (September/October 2008), Author
• "Pharmacogenomics and Personalized Medicine," Presentation to BIO General Counsels’ Committee (11/2/2007)