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Kenneth Gorelick, M.D. has 30 years of experience in the development of drugs, biologics and medical devices in the human health care sector. He is currently a consultant to the biopharmaceutical industry. Dr. Gorelick has expertise with numerous approvals of BLAs, NDAs and MAAs. He has held the position of Vice President of Global Clinical Research and Development at Dupont Merck Research Laboratories, Inc. a research-driven pharmaceutical company. He was also Vice President of Drug Development and Chief Medical Officer at Genelabs, a biotechnology company focused on infectious and autoimmune disease. A brilliant teacher and outstanding communicator; Dr. Gorelick was Clinical Associate Professor of Medicine at Stanford University until 2000.  He has a B.S. from the State University of New York at Buffalo and a M.D. from Weill Medical College of Cornell University. Dr. Gorelick is Board Certified in Internal Medicine and Pulmonary Diseases and is a Fellow of the American College of Chest Physicians.

What People Are Saying

''Dr. Kenneth J Gorelick has worked for Asahi Kasei Pharma America Corporation as a medical consultant more than five years. He always contributed to our company from medical/scientific stand point; 1) global Ph3 study protocol design, 2) end of Ph2b FDA Meeting, and 3) medical/scientific presentation in an international conference. He is a chair of our Program Advisory Board. I firmly believe in his outstanding abilities for medical knowledge, especially in the infection disease such as a sepsis and in his tremendous industrial experience of global clinical development.’' 

Kazuhisa Tsuruta Ph.D., President, CEO & Chief Scientific Officer, Asahi Kasei Pharma America Corporation

I worked very closely with Dr. Gorelick for a nearly a decade on an innovative development program in infectious disease. His approach to development was thoughtful and innovative. He led very productive meetings with regulators and contributed significantly to our program.'' 

Vincent A Fischetti, PhD, Professor and Head of Laboratory of Bacterial Pathogenesis Rockefeller University

''I have worked with Ken on a very large global phase 2b program in inflammatory bowel disease for five years. From study design, protocol implementation and execution, studies conduct, FDA/EMA and other regulatory agencies interactions, studies analyses to the CSR and publications writing.  In my long career I have never met an individual with such a large and complete spectrum of experience and expertise. Unique medical knowledge and understanding of immunology. Very experienced drug developer with a huge expertise in regulations and FDA and global regulatory authorities interactions.  Ken has a unique skill-set in writing. Incredible talent in regulatory documents writing and in publications with a proven record of achievements.’'

Fabio Cataldi, MD, Global Clinical Development Team Lead Gastroenterology , Shire Pharmaceutical


Selected Bibliography


Stuve, O., F. Cataldi, V. Pradhan and K. J. Gorelick (2017). "Normal intrathecal leukocyte cell number and composition do not decrease the incidence of post–lumbar puncture headache." J Neuroimmunol 310: 69-71.

Vermeire, S., W. J. Sandborn, S. Danese, X. Hebuterne, B. A. Salzberg, M. Klopocka, D. Tarabar, T. Vanasek, M. Gregus, P. A. Hellstern, J. S. Kim, M. P. Sparrow, K. J. Gorelick, M. Hinz, A. Ahmad, V. Pradhan, M. Hassan-Zahraee, R. Clare, F. Cataldi and W. Reinisch (2017). "Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial." Lancet 390(10090): 135-144.

Vincent, J. L., M. K. Ramesh, D. Ernest, S. P. LaRosa, J. Pachl, N. Aikawa, E. Hoste, H. Levy, J. Hirman, M. Levi, M. Daga, D. J. Kutsogiannis, M. Crowther, G. R. Bernard, J. Devriendt, J. V. Puigserver, D. U. Blanzaco, C. T. Esmon, J. E. Parrillo, L. Guzzi, S. J. Henderson, C. Pothirat, P. Mehta, J. Fareed, D. Talwar, K. Tsuruta, K. J. Gorelick, Y. Osawa and I. Kaul (2013). "A randomized, double-blind, placebo-controlled, Phase 2b study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation." Crit Care Med 41(9): 2069-2079.


Daniel, A., C. Euler, M. Collin, P. Chahales, K. Gorelick and V. A. Fischetti (2010). "Synergism Between a Novel Chimeric Lysin and Oxacillin Protects Against Infection by Methicillin-Resistant Staphylococcus aureus." Antimicrob Agents Chemother.

Petri, M. A., R. G. Lahita, R. F. Van Vollenhoven, J. T. Merrill, M. Schiff, E. M. Ginzler, V. Strand, A. Kunz, K. J. Gorelick and K. E. Schwartz (2002). "Effects of prasterone on corticosteroid requirements of women with systemic lupus erythematosus: a double-blind, randomized, placebo-controlled trial." Arthritis Rheum 46(7): 1820-1829.

Kahn, J. O., K. J. Gorelick, G. Gatti, C. J. Arri, J. D. Lifson, J. G. Gambertoglio, A. Bostrom and R. Williams (1994). "Safety, activity, and pharmacokinetics of GLQ223 in patients with AIDS and AIDS-related complex." Antimicrob Agents Chemother 38(2): 260-267.

Greenberg, R. N., K. M. Wilson, A. Y. Kunz, N. I. Wedel and K. J. Gorelick (1992). "Observations using antiendotoxin antibody (E5) as adjuvant therapy in humans with suspected, serious, gram-negative sepsis." Crit Care Med 20(6): 730-735.