Ken has been a division officer/senior-level executive with over 33 years’ experience in four Fortune 100 pharmaceutical companies, including six years living and working in Japan. He has worked in virtually every therapeutic field and has made major contributions to 23 original and supplemental NDAs in the United States, marketing authorization applications in Europe and GAIYO summaries in Japan.
Dr. Wolski has demonstrated solid management skills in managing technically proficient preclinical and clinical scientists. Because of his extensive senior management experience, he has a strong background in bridging scientific and regulatory needs of INDs and NDAs with the commercial needs of a corporation. He has been engaged since inception in taking advantage of the ongoing efforts at harmonization of regulatory requirements across the United States, the European Commission, and Japan. Dr. Wolski has spent the past 10 years gaining extensive experience through early involvement in proof-of-concept and adaptive clinical trials that have led to marketed drugs.
Dr. Wolski grew up in Chicago, Illinois, where he graduated magna cum laude from Loyola University with a BS/NS degree and continued on to earn his MD degree at the Feinberg School of Medicine at Northwestern University. Following completion of his internship and residency in internal medicine and a research fellowship in immunology and rheumatology at Northwestern University and its affiliated hospitals, he became Assistant Professor of Medicine at Northwestern and subsequently moved on to the University of Wisconsin. Because of a strong interest in the process of drug development, he joined the pharmaceutical industry and has been active in it to the present day. Dr. Wolski is the Chief Medical Officer for the new company.