Pharmaceutical and Biotechnology

Contacts:
Philip Katz, Washington, D.C.
Meredith Manning, Washington, D.C.
Elisabethann Wright
Carla Schoonderbeek
Robert F. Church

With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, including many with experience at the FDA and other key agencies and in industry, and others holding advanced degrees in relevant disciplines, we offer timely, effective counsel on matters that include product development, approval and post-approval compliance, and the development of next-generation products. High rankings in Chambers, PLC Which Lawyer?, and other global directories speak to the quality and impact of our services.

Whether your products are traditional drugs or biotechnology products, we work with you to successfully develop and commercialize products, addressing issues of regulatory approvals and compliance; coverage, reimbursement, and pricing; and careful use of intellectual property and regulatory exclusivities to manage product life cycles. Our multidisciplinary team leverages the skills and experience of colleagues in other disciplines — including healthcare compliance (such as coverage, reimbursement, pricing, and fraud and abuse prevention), public policy, intellectual property, corporate and securities law, and litigation — to provide integrated, strategic, and practical advice for successful product development and marketing and effective responses to regulators and competitors. We use our global network of 2,300 lawyers in more than 40 offices to support your multinational and cross-border strategies, opening your innovations to a global presence that maximizes their potential.

Awards and Rankings

• Ranked number one in PLC's Life Sciences Industry Super Leagues and in PLC's Life Sciences Regulatory Super Leagues, (2012)
• Ranked number one in the District of Columbia in healthcare: pharmaceutical/medical products, Chambers USA (2011)
• Ranked number one in Brussels in EU regulatory for pharmaceuticals and biotechnology, Legal 500 (2011)
• Individual lawyers recognized by Chambers, PLC Which Lawyer?, The Best Lawyers in America, and SuperLawyers
• Consistently top ranked (first tier) in Germany for pharmaceutical and medical devices law, JUVE Handbook

• Bob Brady, Rob Church, Mike Druckman, David Fox, Joe Levitt, and Meredith Manning were all Associate Chief Counsels for Enforcement at the FDA.
• Bob Brady was also Associate Chief Counsel for Biologics, Associate Chief Counsel for Foods, and Executive Assistant to the FDA Commissioner.
• David Fox was also Associate Chief Counsel for the Center for Drug Evaluation and Research, with responsibility for generic drug issues and controlled substances, among other areas.
• Meredith Manning also served as an Assistant U.S. Attorney in the U.S. Attorney's Office for the District of Columbia, responsible for FDA-related cases.
• Robert Church was also Associate Chief Counsel for Drugs and later spent eight years at Amgen; his positions included head of Global R&D Compliance and Associate General Counsel leading the Development, Regulatory, and Compliance law group.
• Lynn Mehler was Senior Counsel for Drugs at FDA and one of the primary lawyers advising the agency on drug safety matters and on FDA issues related to controlled substances and the Controlled Substances Act.
• Joe Levitt's time at the FDA included years as Director of the Center for Food Safety and Applied Nutrition, Deputy Director for Regulations and Policy in the Center for Devices and Radiological Health, and service as Executive Assistant to the FDA Commissioner, in addition to other senior positions in the Commissioner's office.
• Marie Vodicka was the Associate Vice President, Scientific and Regulatory Affairs for Pharmaceutical Research and Manufacturers of America (PhRMA).

• Phil Katz serves on the board of directors of the Food and Drug Law Institute.
• Many of our associates serve as members of client companies' Promotional Review Committees, gaining invaluable hands-on experience and enhanced appreciation of the day-to-day work done by our in-house colleagues.