Brian J. Malkin Joins McGuireWoods' Washington Office to Lead the Firm's FDA Regulatory Team
WASHINGTON, March 11, 2014 /PRNewswire-USNewswire/ -- Brian J. Malkin, a premier food and drug law and intellectual property lawyer, is joining McGuireWoods LLP's Washington office as senior counsel to lead the firm's Food and Drug Administration regulatory team.
Malkin brings a 20-year law practice to McGuireWoods, including the past nine years in the New York and Washington offices of Frommer Lawrence & Haug LLP, where he concentrated on the confluence of food and drug law and patent law.
His practice included new product development for all types of products regulated by the FDA, including pharmaceuticals, biological products, medical devices, dietary supplements, foods, tobacco products, and cosmetics. As part of the life cycle management of these products, Malkin focused on maximizing patent portfolios with new product exclusivities such as orphan drug exclusivity, and product development options such as 505(b)(2) new drug applications. In addition, he was involved in all phases of Hatch-Waxman generic drug product development and patent litigation and has been involved in developing similar opportunities in biotechnology, known as follow-on biologics or biosimilars in the United States. His practice also included due diligence evaluations, patent prosecution, licensing, and commercial transactions, which added value beyond traditional attorneys with only FDA or patent experience.
Immediately after law school, Malkin worked as a regulatory counsel at the FDA in both the Office of the Commissioner and the Center for Drug Evaluation and Research, where he focused on new product evaluations, compliance issues related to clinical investigations and human subject protection, and intellectual property. Malkin ran the Patent Term Restoration Program and handled other exclusivity issues under the Hatch-Waxman Act, including a variety of key regulatory and public hearings, rulemaking, and agency guidance documents.
After his service with the FDA, Malkin worked at Hyman, Phelps & McNamara, P.C., where he decided to return to school to obtain a degree in biochemistry to combine his extensive knowledge in food and drug law with patent law. Based on his experience and his private practice, Malkin saw this as an unmet need in the Hatch-Waxman space, where he has frequently practiced.
"McGuireWoods is delighted to have the wealth of knowledge and experience that Brian Malkin brings to our firm," said Joseph K. Reid III, who chairs the firm's Regulatory and Compliance Department. "This is great news for clients who look to McGuireWoods for solutions in the increasingly complicated and fast-growing field of life sciences law."
"In addition to FDA and intellectual property work that I have done in the past, I am looking forward to working with McGuireWoods' industry-based life sciences and healthcare practice groups that cover every type of corporate transaction," Malkin said. "In addition, I plan to work closely with McGuireWoods Consulting to help forge effective health policy recommendations and directives with FDA in mind."
Malkin did undergraduate study at Johns Hopkins University and George Washington University in the 1980s, earning his bachelor's degree in economics and political science from GWU in 1988. He graduated in 1991 from the GWU Law School and later earned his biochemistry degree in 2004 from the University of Maryland.
During the past few years, he created and has principally written a popular blog focusing on FDA legal issues. He will oversee a similar blog already in production at McGuireWoods that promises to take advantage of the firm's strong life sciences industry group.
McGuireWoods LLP is a full-service law firm with more than 900 lawyers in 19 offices worldwide. McGuireWoods Consulting LLC provides full services in government relations, strategic communications & grassroots, and infrastructure and economic development services. The Washington office is at 2001 K Street N.W. For more information, visit www.mcguirewoods.com and www.mcguirewoodsconsulting.com.
SOURCE McGuireWoods Consulting
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