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Biosimilars Law Blog

Authors

Mike Druckman, Partner, Washington, D.C.

Attorney Mark Brennan Mike Druckman counsels pharmaceutical and biotechnology companies on FDA law and regulation. Prior to joining the firm, Mike worked for seven years in FDA’s Office of Chief Counsel (OCC), first as Associate Chief Counsel for Enforcement and then Associate Chief Counsel for Biologics. He served as co-team leader for the biologics team within OCC and advised FDA’s Center for Biologics Evaluation and Research (CBER) on legal and regulatory issues. In that capacity, he worked with CBER personnel to develop regulations and guidance in critical areas such as standards for approving and regulating influenza vaccines, blood products, and counterterrorism products. He also regularly advised CBER on safety, approval, and compliance issues, including Prescription Drug User Fee Act questions and risk minimization action plans. Mike also served on the OCC disclosure team, and advised the agency on protecting trade secrets and confidential commercial information and on responding to Congressional inquiries.

Jason Conaty, Associate, Washington, D.C

Jason ConatyJason Conaty practice concentrates on regulatory, enforcement, and transactional matters relevant to the pharmaceutical and biotechnology sectors. Jason counsels clients on matters before the FDA, including matters arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act. He focuses on intellectual property and clinical development issues; regulatory issues associated with company acquisitions; issues relating to the marketing and promotion of pharmaceuticals; as well as a range of life science- and technology-related litigation matters. Jason has a Ph.D. in biochemistry and molecular biology. Prior to joining the firm, Jason was a Fellow of the Leukemia and Lymphoma Society, Fellow in Genetics at Harvard Medical School.

David Fox, Partner, Washington, D.C.

David FoxDavid Fox has a leading practice in the regulation of new drugs and biological products, and also maintains a practice in the field of combination products. He has extensive experience in the approval process for new drugs and biological products, as well as the regulation of generic, 505(b)(2), and follow-on products. David works with pioneer pharmaceutical and biotechnology sponsors, and is frequently consulted on life cycle management issues. He assists clients in taking a critical approach to exclusivity issues, bioequivalence standards, dosage form innovations, and pharmaceutical labeling. He also advises companies on FDA review standards and is frequently engaged on internal appeals and formal dispute resolution matters involving new drug and biological product review standards. David served for more than six years with the FDA as Assistant Chief Counsel for Enforcement from 1994 to 1995, and as Associate Chief Counsel for Drugs from 1995 to 2000. While at the FDA, David served as counsel to a number of FDA programs, including counsel to the Office of Generic Drugs, counsel to the Office of the Ombudsman and Chief Mediator (now the Office of Combination Products), counsel on controlled substances and Drug Enforcement Administration matters, and counsel to the agency’s over-the-counter (OTC) drug program.

Media coverage:

Biosimilar Guidance Silent On Industry’s Biggest Questions,” Law360, 10 February 2012.

FDA’s Biosimilar Guidances Win Praise For High Hurdles, Flexibility,” The Pink Sheet,” 13 February 2012, Vol. 74, No. 7.

 

Jim Johnson, Associate, Washington, D.C.

Jim JohnsonJim Johnson advises clients on a variety of matters involving FDA’s regulation of pharmaceuticals and biological products. A substantial portion of Jim’s practice includes advising pharmaceutical and biotech clients on premarket approval issues and life-cycle management strategies. Jim has significant FDA experience, serving as an Associate Chief Counsel in the FDA’s Office of the Chief Counsel from 2005 to 2011, where he provided legal counsel on a range of regulatory issues to agency components, including the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. At FDA, Jim litigated cases on behalf of the agency in federal lawsuits challenging specific drug approvals, citizen petition responses, and actions under the Hatch-Waxman amendments, including bioequivalence, generic exclusivity, and patent-term extension determinations. He also has significant insight into the interactions between FDA and the U.S. Patent and Trademark Office (PTO), having advised the PTO on issues related to FDA-regulated products during his time at FDA.

Crystal Liu, Associate, Washington, D.C.

Crystal Liu advises clients on FDA regulation of pharmaceuticals and biological products. Crystal works with clients on life cycle management matters as well as advertising and promotion issues. She has also assisted clients with regulatory issues associated with drug company acquisitions.

Lynn Mehler, Partner, Washington, D.C.

Lynn MehlerLynn Mehler advises clients on pharmaceutical products. She served for 12 years with the FDA’s Office of the Chief Counsel, most recently as a Senior Counsel for Drugs. As one of the primary attorneys advising the agency on drug safety matters, Lynn has extensive experience in the agency’s use of Risk Evaluation and Minimization Strategies, required post-approval clinical studies and trials, and required safety label changes. In addition, Lynn was the primary attorney handling all FDA issues related to controlled substances and the Controlled Substances Act. She has also advised the agency on drug approvals and withdrawals, the Prescription Drug User Fee Act, Advisory Committees, clinical investigator disqualification, and federal preemption matters.

Anne Mutashi, Associate, Washington, D.C.

Anne Mutashi advises clients on FDA regulation of pharmaceuticals and biological products. Anne works with clients on life cycle management matters and on a broad range of regulatory issues. She has conducted regulatory due diligence associated with drug company acquisitions. In addition, she counsels clients in advertising and promotion issues.

George O’Brien, Associate, Washington, D.C.

George O’BrienGeorge O’Brien practice focuses on FDA regulation of pharmaceuticals and biological products. George works with clients on life cycle management issues and approval standards arising under the Hatch Waxman Act; the Biologics Price Competition and Innovation Act; and the Orphan Drug Act. He also assists clients on advertising and promotion issues for pharmaceutical and biotechnology products; clinical trials registration and results posting requirements arising under the FDA Amendment Act; and regulatory due diligence associated with drug company acquisitions.

Marie A. Vodicka, Regulatory Affairs Director, Washington, D.C

Marie A. Vodicka advises clients on pharmaceutical and biotechnology matters with a particular focus on biologics and biosimilars. She has extensive experience in U.S. and global pharmaceutical regulatory policy, including in emerging markets. Prior to joining Hogan Lovells, she worked at the Pharmaceutical Research and Manufacturers of America (PhRMA), the major U.S. pharmaceutical trade association, where she concentrated on regulatory policy and advocacy for the industry, especially the development of biosimilars pathways globally. While at PhRMA, she was instrumental in developing and advocating for the industry position for the Biologics Price Competition and Innovation and Act. Marie has a PhD in molecular and cell biology and, as a research scientist, was the recipient of numerous fellowship and grant awards and published in the scientific literature.