McDermott Will & Emery, the nation's leading health law firm, announced Brian Malkin has joined as partner in the FDA practice of its Health Industry Advisory group based in Washington, DC. Brian's practice complements McDermott's broader life sciences and healthcare capabilities with decades of experience and perspective on critical regulatory and strategic business issues that life sciences, pharmaceutical and biologic companies seek in bringing new products to market and managing product life cycles.
The firm also announced that Michael Siekman and Jenny Chen have joined the Intellectual Property (IP) practice as partners based in the Boston office. The duo builds upon Boston’s active and diverse IP practice and will complement the Firm’s robust legal service offering to the life sciences and health industries.
"Aligning FDA regulatory and intellectual property strategy for drug development is more critical than ever and Brian's unique background will give our clients a strategic advantage," said Eric Zimmerman, head of McDermott's Health Industry Advisory practice group and a Washington, DC-based partner. "Incorporating Brian's practice into our existing FDA practice further strengthens our ability to assist innovators through all stages of approval."
"As the market and regulatory landscape evolves to focus on novel therapies, including orphan drugs and biosimilars, our team needs to deftly navigate the complex regulatory, policy and strategic business considerations for this space. Brian is a thought-leader on these issues and has helped several companies successfully bring life-saving products to market. We're thrilled to join forces," added Vernessa Pollard, head of McDermott's FDA practice and a Washington, DC-based partner.
Brian counsels pharmaceutical and biologic clients on FDA regulatory matters and intellectual property law, with an emphasis on patent strategy and litigation. His position at the intersection of FDA regulated products and patent law makes him an invaluable partner to drug developers, biotechnology clients, medical device companies and cannabis companies as they protect their innovations, bring their products to market and pursue transactional opportunities.
He is a key advisor regarding FDA regulated drugs development strategies and patent strategies, including: New Drug Applications (NDAs) and orphan/specialty drugs; 505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products; biologics and biosimilars; and cannabis-derived products. Additionally, he is an experienced litigator of Hatch-Waxman Act cases for both pharmaceutical and biotechnology clients and a strong partner in the boardroom, providing FDA and IP due diligence for deals and transactions in the life sciences space.
Brian holds a JD from The George Washington University Law School and a BA also from The George Washington University. While practicing law, Brian earned a BS in Biochemistry from the University of Maryland.
In commenting on the addition of Mr. Siekman and Ms.Chen, the Firm's Head of Strategy Michael Poulos noted, “We are laser-focused on smart expansion, and virtually every McDermott practice group and geography is focused on legal representation for the life sciences sector. Our new partners reflect our continuing strategic commitment to growing the pre-eminent life sciences practice in our industry.”
“The last few years have shown an increasing need for breakthrough innovations in the life sciences market. Patent protection is essential for bringing necessary technology to market, and Michael and Jenny truly understand what it takes to be a fearless client advocate during every stage of the IP lifecycle,” Bill Gaede, leader of the Firm’s Global Intellectual Property practice, said. “Michael’s and Jenny’s addition in Boston bolsters our IP capabilities in this leading region for life sciences innovators and research institutions as well as across our international platform.”
“This IP team is a natural part of our planned Boston expansion given the significance of the life sciences industry to our region,” Tony Bongiorno, litigation partner and Boston office managing partner, added. “We look forward to collaborating with Michael and Jenny on exciting opportunities across all of our practices in Boston.”
Michael focuses his practice on a broad range of intellectual property matters, including architecting patent prosecution strategies, life sciences partnering and transactions, licensing, post-grant proceedings and litigation. Leveraging more than 25 years of experience, Michael has built in-depth patent portfolios, advising clients in the biotechnology and pharmaceutical industries.
Jenny counsels both US and international clients in a variety of patent-related matters in the biotech and life sciences space, including prosecution, due diligence and post-grant proceedings. Her practice focuses on matters including cell and gene therapies, antibodies, diagnosis and pharmaceutical formulations. She is particularly experienced in strategic counseling on life cycle management of both biological and small molecule products.
Michael received his BS at Bates College and his JD at Boston University School of Law. Jenny received her BS from Fudan University, her PhD in pharmacology from Baylor College of Medicine and her JD from Northeastern University School of Law.