Legal Perspectives on Recent FDA Guidance

Michael Druckman leverages his prior experience at the FDA – and what he has learned since then while extricating companies from regulatory problems – to anticipate and prevent life science clients from getting into trouble in the first place. Mike understands the business challenges that companies face in a highly regulated environment. Mike chairs the firm's Cell, Tissue, and Gene Therapies Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular products to help people with serious health problems. Mike also advises companies with a full range of regulatory challenges involved in investigating new drugs, biologics, and combination products, obtaining FDA approval for those products, and in promoting, se ling, and distributing them.

His experience also includes the Drug Supply Chain Security Act, pharmacy compounding, expanded access/compassionate use clinical trials, orphan drug exclusivity, and precision medicine and companion diagnostics. While in the FDA Office of the Chief Counsel, Mike also advised on medical countermeasures. He served on the FDA's Pandemic Influenza Planning and Preparedness Team, and helped draft guidance on pandemic and seasonal flu vaccines and a regulation on Strategic National Stockpile product labeling. In his years at the firm, Mike has advised on Emergency Use Authorizations, select agents and toxins and Dual Use Research of Concern (DURC), and various issues involving vaccines and other products.

Eman Al-Hassan is a Senior Associate in Global Regulatory at Hogan Lovells. Eman delivers clear and concise advice to pharmaceutical and biotechnology clients of all shapes and sizes to help them achieve their business goals. Prior to joining the firm, Eman practiced as a patent attorney with a boutique intellectual property (IP) firm where she gained valuable technical and business strategy experience managing the IP assets of large corporations. Eman also served as a federal law clerk at the U.S. District Court for the Central District of California, working on a wide variety of cases.

Eman holds a certification in Bioscience Industry Law and Practice from the Keck Graduate Institute, where she counseled biotechnology corporations as a part of her course practicum. Eman earned her degree in chemistry from the University of Toledo where she served as an active member of the American Chemical Society. Leveraging her experience working in the IP space as well as a technical background in chemistry, Eman is qualified to provide guidance to companies on issues at various stages of drug development.

Ashley Grey is an Associate in Global Regulatory at Hogan Lovells. Ashley provides strategic FDA regulatory and compliance advice to help pharmaceutical and biotechnology clients navigate FDA's ever-evolving regulatory framework. Leveraging her prior experience in public health and post-market surveillance research for drugs and devices, Ashley counsels clients on a variety of questions related to FDA's complex regulatory landscape. Ashley's practice includes: product development, product lifecycle management, pharmacovigilance, human cell and tissue products, Good Clinical Practice, advertising and promotion, bioresearch monitoring, human subject protection, Freedom of Information Act, compounding, device 510K clearance, imports and exports, and due diligence. 

In law school, Ashley served as a Senior Solicitations and Submissions Editor for the Howard Law Journal, where she published a note on the international pharmaceutical patent regime under the TRIPS Agreement. She also assisted low-income medical device inventors in submitting patent applications as a participant in the Intellectual Property Patent Clinic and served as an extern for the World Bank's Mediation Services unit. Before law school Ashley obtained a master's degree in public health from the Columbia University Mailman School of Public Health.

Jennifer DeMatteo, MCM, CIC, is the Director of Regulations and Standards for the Eye Bank Association of America (EBAA). She oversees the EBAA Accreditation program, Medical Standards process and serves as their regulatory liaison. She received her bachelor’s degree in microbiology from the University of Pittsburgh and a Master of Science degree in clinical microbiology from Hahnemann University (now Drexel University). She was responsible for directing the Infection Prevention and Control (IPC) and Employee Health programs and personnel in major tertiary hospital and ambulatory care settings.  Jennifer has been a Healthcare Epidemiologist for over 20 years and is certified in Infection Control & Epidemiology (CBIC).