EDWARD L. KORWEK, Ph.D., J.D., is a lawyer/scientist in the Washington, DC, law firm of Hogan & Hartson L.L.P. and former co-director of the firm's life science group. He has a doctorate degree in biochemistry and law degree. He did post-doctoral work with the National Cancer Institute in molecular biology and has a special expertise in modern biotechnology-derived products, particularly foods and drugs. For over 25 years he has been involved in the subject of modern biotechnology regulation, a topic he has written and spoken extensively about. He is a regular speaker on diverse biotechnology issues, including labeling, organic food coexistence issues, cloning and liability considerations. He has participated in almost every major federal initiative, particularly rulemakings, involving biotechnology regulation and in many state-related activites.

Dr. Korwek is the author/editor of the 1997 United States Biotechnology Regulations Handbook and was a member of the US Department of Agriculture's Advisory Committee on Agricultural Biotechnology. He has been on several other governmental advisory committees pertaining to the subject of biotechnology, such as the NIH Recombinant DNA Advisory Committee; the US Congress, Office of Technology Assessment Advisory Committee on New Developments in Biotechnology; the Agriculture Biotechnology Research Advisory Committee; and the National Research Council, Commission on Life Sciences, Committee on Scientific Principles Underlying Environmental Release Decisions Involving Biotechnology.

His practice in the food and agriculture area involves providing advice on all aspects of FDA, USDA, EPA, and international regulation of foods and food ingredients, including on GRAS and prior-sanctioned substances, dietary supplements, and on ingredients and foods that are recombinant DNA-derived. Specific areas of his food practice include advising on food additive considerations, including what is a food additive, food additive petitions, and secondary direct food additives, and standards of identity. Dr. Korwek also provides regulatory advice on GRAS status and notifications, GRAS petitions, consultation procedures for new plant varieties, and food labeling, particularly labeling of biotech foods, and on other FDA and USDA issues, such as those pertaining to nutrition labeling, including nutrient content or health claims, functional foods, product fortification and recalls, and export issues. Other areas of his practice involve providing guidance on MCAN and Tera requirements for microbials under TSCA, as well as biopesticide requirements for PIPs. He also works on matters involving the Cartegena Biosafety Protocol, as well as on adventitious presence issues.

Dr. Korwek's practice in the drug area involves providing advice on all aspects of FDA regulation of human over-the-counter and prescription drugs, including antibiotics, insulin, and biological drugs. He has particular experience and background in biologics development and combination products. Specific areas of his drug practice include advising on Orphan Drug Act considerations, including what is the "same" drug for purposes of orphan drug exclusivity provisions; pharmacy compounding; strategies for obtaining approval, including clinical trial issues; manufacturing requirements; cellular and gene therapies, including cloning and tissue regulation, vaccines and generic drug regulation, as well as market exclusivity and drug life cycle strategies, and radiopharmaceutical regulation. He has worked on various issues related to many of the offices within the Center for Drug Evaluation and Research and nearly all divisions within the Center for Biologics Evaluation and Research. He also works on Drug Enforcement Agency (DEA) matters pertaining to controlled substances. Dr. Korwek provides regulatory advice on scientific misconduct matters, not-approvable letters, export requirements, sponsor and investigator warning letters, NDA, IND, and BLA submissions and FDA procedures, such as those pertaining to appeals, treatment INDs, parallel track mechanisms, and accelerated or expedited approval mechanisms. He also provides guidance on OTC monograph and switch issues and on drug advertising and labeling matters.. He has written and spoken extensively on biologics regulation.

Dr. Korwek is or was a member of the Editorial Advisory Board of the Biotechnology Law Report, the Food and Drug Law Journal, and the Journal of Biotechnology in Healthcare. He was also a two-time member of the Board of Directors of the Food and Drug Law Institute, as well as former Chairperson of the Institute's Publications Committee. He is a member of several legal and scientific associations, such as the American Bar Association, the American Association for the Advancement of Science, and the American Chemical Society.