Dave is a greatly experienced professional with over 30 years’ experience in the Pharmaceutical world in the fields of Toxicology and Drug Development working for pharmaceutical companies along with major Contract Research Organizations. Most recently, Dave served as Vice President for Early Development for a small pharma company developing novel small molecules for the treatment of inflammatory diseases such as atherosclerosis, arthritis, asthma and, latterly, diabetes. In this role, he was responsible for transitioning all new compounds from Discovery into Development and from there to the Clinic, Reporting to him were Toxicology, Drug Metabolism, Pharmacokinetics, Drug Manufacturing, Analytical Chemistry, Formulation and Clinical Supplies. Comfortable in relationships with both clients and regulatory agencies worldwide, Dave advises on all preclinical issues and partakes in the preparation and submission of regulatory documents such as INDs and NDAs.
Officers
G. Alexander Fleming, MD
Founder and Executive Chairman
Thomas Seoh, J.D.
President and Chief Executive Officer
Brian Oscherwitz, MBA, PMP
Chief Operating Officer
Clinical Development
Ramachandra (Ram) G. Naik, M.D.
Regulatory Strategy and Operations
Biostatistics
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Pre-Clinical
CMC, Formulation/Process Development & Sourcing
Medical Device
QA/QC
Medical Writing/Electronic Submissions
Kristi Hultberg, B.S.
Botanicals
Government Relations and Public Affairs
Defense & National Security Practice
Commercialization and Business & Corporate Strategy