Engel & Novitt, L.L.P.

EngelNovitt, PLLC ("EngelNovitt") is managed by John Engel, who, together with Anita Novitt (now retired), originally founded the firm of Engel & Novitt, LLP in 2003. Mr. Engel brings over 25 years of experience working with the innovative biopharmaceuticals, clinical trial, and life sciences industries and, in doing so, 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 the Manager-Member of EngelNovitt. 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 EngelNovitt, 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.