Ellen C. Cooper, M.D., M.P.H.
Summit’s President is Dr. Ellen Cooper, MD, MPH, who brings extensive clinical development and regulatory expertise from FDA and industry in addition to her clinical training in infectious diseases. Dr. Cooper served as the first Director of the Antiviral Drugs Division and later as Deputy Director of the Office of Biologics Review at FDA, in addition to other key appointments and duties within the agency. She served as Director of the Department of Clinical Research and Information at the American Foundation for AIDS Research (AmFAR), the largest privately funded AIDS research organization in the country. Dr. Cooper also served at the senior management level in the pharmaceutical and biotech industries, including Syntex Research and ViroPharma, Inc.

Patricia D. Williams, Ph.D.
Summit's COO is Dr. Patricia D. Williams, an executive with over 25 years experience in drug discovery and development in the pharmaceutical, biotechnology and contract service industries. Dr. Williams is a pharmacologist skilled in all aspects of preclinical development. Dr. Williams has held various management positions in the pharmaceutical (Bristol-Myers, Eli Lilly, American Cyanamid), biotech (Glycomed, Ligand, Biochem Pharma) and the contract services (SRA Life Sciences, Therimmune, GeneLogic) industries. Dr. Williams has created and established highly effective drug development teams which have successfully advanced over 50 small molecules and biologics into clinical development.

David Houck, Ph.D.
Dr. David Houck, Summit's Vice President of Pharmaceutical Development, is an accomplished chemist and drug developer with over 25 years of Chemistry, Manufacturing, and Controls (CMC) experience in the pharmaceutical and biotechnology industries. At Summit, Dr. Houck assists companies with formulation development, manufacture, and release testing of their therapeutic candidates for preclinical and clinical studies. Dr. Houck has contributed to the advancement of numerous drug leads and marketed pharmaceuticals at Merck, Sterling Winthrop, OSI Pharmaceuticals, and Scynexis, has authored/co-authored over 25 articles, and holds ten patents.

Arulasanam Thilagar
As Vice President of Preclinical Development,
Dr. Arulasanam Thilagar offers over 25 years of preclinical drug development experience with a strong background in investigative and regulatory toxicology. At Summit, Dr. Thilagar is responsible for developing customized client-specific preclinical strategies for implementation and subsequent submission to the FDA and other regulatory agencies. Dr. Thilagar served as the CEO of three preclinical contract research organizations, including SITEK Corporation, the ADMET Group, and SB ChemTox. Dr. Thilagar has authored/co-authored dozens of articles in peer-reviewed journals, and has been an invited speaker at national and international meetings. He also acts as an advisor to numerous companies and serves as a scientific reviewer for technical publications.

Gary W. Wolfe, Ph.D.
As Vice President of Preclinical Services, Dr. Wolfe provides strategic input into the design and implementation of preclinical studies intended for drug registration. Dr. Wolfe is a board-certified toxicologist with over 25 years experience in contract research, focusing on the design, implementation and interpretation of preclinical pharm/tox studies for the pharmaceutical/biotechnology and government industries. Dr. Wolfe has held management roles at several large preclinical CROs.

Florence Kaltovich, M.S., M.H.S., RAC
Ms. Florence Kaltovich, Summit's Vice President of Regulatory Affairs & Quality, brings 18 years of combined regulatory affairs and quality assurance experience. At Summit, Ms. Kaltovich develops regulatory and quality compliance strategies, prepares regulatory submissions, and interacts with regulatory agencies. Ms. Kaltovich advises and trains clients on current Good Manufacturing Practices (cGMPs) and she routinely performs quality audits of manufacturing facilities worldwide. As a former FDA Scientific Review Officer, Ms. Kaltovich reviewed numerous regulatory marketing applications for a wide variety of products. As a former FDA investigator, Ms. Kaltovich conducted numerous inspections of manufacturing facilities and is knowledgeable of quality issues. Ms. Kaltovich previously held complementary roles at Science Applications International Corporation (SAIC) and PAREXEL International Corporation.