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The Engel & Novitt management and leadership team is headed up by its founding partners, John Engel and Anita Novitt, along with the exceptional scientific expertise of the firm's Chief Scientist, Dr. Gillian Woollett. The unique Engel & Novitt multi-disciplinary Team brings over seven decades of experience working with the innovative biopharmaceuticals and clinical trial industries in a variety of capacities. Each member of our Team has established a reputation for devising and implementing creative, yet practical, solutions to the challenges confronted by the law firm's clients.
John M. Engel, Esq. is a founding partner of Engel & Novitt, LLP and its Managing Limited Liability Partner. Mr. Engel specializes in food and drug, public health, and administrative law, and health information technology and science policy and legislation. He provides strategic counseling on a wide range of legal/regulatory, intellectual property, and marketing initiatives affecting pharmaceutical, biotechnology, and medical device companies, as well as organizations representing health care professionals and their patients.
Mr. Engel's work includes collaborative research and license agreements, human subject protections and related bioethical considerations in the clinical development process including IRB review and informed consent, drug development, FDA approval and regulatory oversight of drugs, devices, and biologicals, agency adherence to the administrative law dictates of the Administrative Procedure Act ("APA"), agency litigation involving the APA and the Freedom of Information Act ("FOIA"), challenges to pharmaceutical patent and non-patent exclusivity rights, promotion of FDA-regulated products, standardization and privacy of electronic medical records, and policies affecting the health care professional and patient communities.
In his practice, Mr. Engel also addresses a wide range of post-approval compliance and marketing issues involving both FDA and other agencies, including the Federal Trade Commission and the Consumer Products Safety Commission. Prior to founding Engel & Novitt, Mr. Engel spent over 15 years with another Washington food and drug firm holding a diverse range of positions of increasing responsibility. Among the government and academic appointments Mr. Engel held before joining his prior law firm was his legislative staff service in the U.S. Senate.
Mr. Engel was awarded his J.D. magna cum laude from Georgetown University Law Center and his B.A. magna cum laude from The Catholic University of America. Mr. Engel is a member of the Virginia State Bar and District of Columbia Bar. He is admitted to practice before the United States Supreme Court, the United States Courts of Appeal for the D.C. Circuit, the United States Courts of Appeal for the Fourth Circuit, and the United States District Court for the District of Columbia.
Anita D. Novitt, Esq. is a founding Limited Liability Partner with Engel & Novitt. Ms. Novitt brings nearly two decades of pharmaceutical experience to the firm, most recently serving as Director of Product Information and Labeling at Novartis Pharmaceuticals Corporation. Her background is primarily in drug development, including positions in Clinical Research, Project Management, and Drug Regulatory Affairs in a number of U.S.-based and global pharmaceutical corporations. The projects in which she has been extensively involved span a number of therapeutic areas, including Immunology, Anti-Infectives, Cardiology, Oncology, and OTC products. Using this broad corporate experience and scientific background, she provides effective, innovative input to life cycle management and product development strategies.
Ms. Novitt holds a B.S. in Biology from St. Peter's College, an M.S. in Zoology from Rutgers University, and a J.D. from Seton Hall University. She is admitted to practice in the state of New Jersey and the District of Columbia.
Gillian R. Woollett, M.A., D.Phil. is Chief Scientist at Engel & Novitt. Dr. Woollett leads a unique multi-disciplinary Team and applies her scientific, policy, and communications expertise developed across the breadth of the biotechnology and pharmaceutical industry in both domestic and international settings to devise innovative, strategic approaches to assist the law firm's pharmaceutical and biotech clients in achieving their strategic business objectives.
Recognized as the world's leading expert on follow-on protein products/follow-on biologics ("biosimilars" in the European Union), Dr. Woollett addresses an array of scientific and science policy issues in connection with legislative, regulatory, public affairs, and communications initiatives involving Dr. Woollett's expertise and broad experience working with government, industry, the research community, and the media. Over the past eight years, Dr. Woollett has held leadership positions in the two trade organizations representing the innovative biotechnology and pharmaceutical industries, where she managed policy on research, development, and manufacturing, regulatory affairs, and all related issues in biologics and biotechnology.
Dr. Woollett joined Engel & Novitt from the Biotechnology Industry Organization (BIO), where she served as Vice President, Science and Regulatory Affairs. At BIO, Dr. Woollett established and led the Organization's new Department to support BIO companies' interactions with regulatory agencies in all aspects of their discovery, development, and manufacture of biotechnology-based medicines. Dr. Woollett also represented the biotech industry with the media, and she was the scientific and regulatory voice behind BIO's public policy, advocacy, and business development activities and on international, as well as domestic, regulatory and science issues. Providing scientific substantiation at various levels of technical detail in a diverse array of fora, Dr. Woollett was the industry's point of scientific interface with other academic and professional organizations, and published BIO's web page for public information on all aspects of biotechnology at http://science.bio.org.
Previously, Dr. Woollett served as Assistant and then Associate Vice President Biologics and Biotechnology for PhRMA, with responsibilities for all activities concerning biologics and biotechnology. At PhRMA, Dr. Woollett managed the Association's Board and Committee initiatives on a diverse range of biologics and biotechnology issues. She served as PhRMA's liaison with regulatory health authorities, testified for the Association before Congressional and State legislators as well as international organizations, and served as PhRMA's media representative especially on biotechnology and genomics. In addition to other initiatives, Dr. Woollett was publisher of the PhRMA World Wide Web page, Genomics - a Global Resource.
Dr. Woollett holds appointments on the Centers for Disease Control and Prevention National Center for Infectious Diseases Board of Scientific Counselors, and the Department of Commerce Materials Technical Advisory Committee, and she serves as a reviewer for the American Association for the Advancement of Science NIH Policy Fellows Program. Dr. Woollett was awarded her B.A. with Honors (Biochemistry) and her M.A. from Cambridge University, and her D.Phil. (Immunology) from the University of Oxford in the United Kingdom, and she was a Post-Doctoral Research Fellow in the Department of Molecular Biology at Edinburgh University.
Erin C. Stewart, M.S. serves as Regulatory Scientist at Engel & Novitt. Ms. Stewart joined the firm from BIO, where she served as Science and Regulatory Affairs Manager. Among her previous positions, Ms. Stewart played an integral part of the team sequencing the human and mouse genomes at Celera Genomics, and she held laboratory positions of increasing responsibility at Bioqual Inc., Life Technologies, and the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI). Ms. Stewart was awarded her M.S. in Biotechnology by Johns Hopkins University.
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