McDermott Names Co-Leaders of Expanded FDA Practice
WASHINGTON, DC (April 6, 2016) — McDermott Will & Emery announced today the expansion of its Food and Drug Administration (FDA) practice. Partners Vernessa Pollard and Veleka Peeples-Dyer have been named co-leaders of the practice, based here.
Ms. Pollard and Ms. Peeples-Dyer joined the Firm in March 2016 and June 2015, respectively. Together, the two partners will execute a comprehensive strategy to expand the Firm’s FDA regulatory capabilities and services for pharmaceutical, medical device and technology companies.
“Life Sciences companies that develop, manufacture, market and distribute FDA-regulated products for the U.S. market are among the most highly regulated entities across the globe,” said Stephen W. Bernstein, partner and head of McDermott’s Health Industry Advisory Practice Group. “These companies rely on experienced, trusted advisors who understand the industry and can provide strategic regulatory and business advice on all aspects of the product life-cycle from development, through commercialization and post-market management and compliance. We are delighted to offer exactly this capability through our expanded FDA practice, with Vernessa and Veleka at the helm.”
Under their capable leadership, Ms. Pollard and Ms. Peeples-Dyer will strengthen McDermott’s offerings on the full range of FDA regulatory and compliance issues. McDermott’s clients include pharmaceutical, biotechnology, medical device, health IT and digital health, consumer product companies, retailers and investors. McDermott’s FDA practice co-leaders will ensure full coverage for clients in areas of clinical trials and good clinical practices (GCP), regulatory strategy and market-entry pathways, regulatory reporting and pharmacovigilance, labeling, advertising and promotion, current good manufacturing practice (cGMP) and Quality System Regulation (QSR), development and commercialization agreements, licensing, compliance and enforcement. Ms. Pollard and Ms. Peeples-Dyer also lead McDermott’s FDA regulatory due diligence for M&A and other transactions. Their combined substantive experience and diverse perspectives uniquely positions them to lead McDermott’s FDA practice.
“Vernessa and Veleka provide deep industry and subject-matter experience, innovative thinking and practical guidance to help our clients address challenges at every stage of a product’s lifecycle,” said McDermott co-chair Peter J. Sacripanti. “We’re very excited to work with them as they take our FDA practice in a variety of new directions.”
Ms. Pollard brings significant agency and industry perspective to McDermott’s FDA practice. She joined McDermott’s Washington, DC office from another AmLaw 100 firm, where she advised clients on regulatory, compliance, and legislative matters involving medical devices, pharmaceuticals, digital health products and solutions, health information technology, and other products. She formerly served as Associate Chief Counsel for Enforcement in the Office of Chief Counsel at the FDA. During her tenure at the FDA, Ms. Pollard represented the agency in a variety of major litigation matters, and advised agency clients on compliance and regulatory issues.
Ms. Peeples-Dyer brings extensive industry perspective as a former executive-level counsel and strategic advisor to leading biopharmaceutical companies. Prior to joining the Firm, Ms. Peeples-Dyer was Executive Director, Legal and Head of Corporate Compliance at a publicly-traded global biotechnology company. She advised the company on a range of critical issues, including the development and execution of product launches, post-marketing efforts and compliance infrastructure. Her experience includes conducting internal investigations, developing, implementing and conducting legal and compliance training programs and advising on federal and state transparency, lobbyist and disclosure issues, including the Federal Physician Payments (“Sunshine”) Act.
“Life Sciences companies are among the most sophisticated consumers of outside legal talent in the market place,” added Jeffrey E. Stone, co-chair of McDermott Will & Emery. “They expect outside counsel to demonstrate a broad understanding of the issues and inter-relationships among multiple business segments as well as deep subject-matter expertise on a full range of regulatory issues. Together, Vernessa and Veleka will leverage their combined experience to help our clients navigate this increasingly complex regulatory landscape.”
Ms. Pollard and Ms. Peeples-Dyer will also augment McDermott’s Health Industry Advisory Practice Group, which is at the forefront of legal issues arising from the convergence of health care, cybersecurity and technology. McDermott is one of the few law firms that maintain the experience and depth to support an entire practice group focused on health information systems. Additionally, Ms. Pollard and Ms. Peeples-Dyer will work closely with the team at McDermott+Consulting, a separate affiliate of the Firm that serves health clients with one-stop reimbursement strategy, lobbying services, data analytics and modeling, and policy advice.
McDermott Will & Emery is a premier international law firm with a diversified business practice. Numbering more than 1,000 lawyers, we have offices in Boston, Brussels, Chicago, Dallas, Düsseldorf, Frankfurt, Houston, London, Los Angeles, Miami, Milan, Munich, New York, Orange County, Paris, Rome, Seoul, Silicon Valley and Washington, D.C. Further extending our reach into Asia, we have a strategic alliance with MWE China Law Offices in Shanghai.