Mark O. Thornton, MD, MPH, PhD brings over 20 years of experience in the biologics development arena, including six years at FDA CBER, 14 years in the biotechnology and pharmaceutical industries, and more than two years at Biologics Consulting. As an industry physician, Dr. Thornton’s most recent positions were Chief Medical Officer and Chief Development Officer at biotechnology companies developing cutting edge products, primarily in the oncology setting. In these roles, he developed a wide breadth of experience leading Phase 1-3 clinical trials in numerous oncology settings and in many classes of drugs and biologics, including small molecules, monoclonal antibodies, gene and cell therapy and cancer vaccines. Outside the cancer arena, Dr. Thornton has also led or helped lead the development teams responsible for the FDA approval of two Biologics License Applications, one each for an immunologic agent and a preventive vaccine.
As a Medical Officer in the FDA CBER Division of Clinical Trial Design and Analysis, Dr. Thornton’s focus was on biologics therapeutics, mostly in oncology, infectious disease and inflammatory disease settings. While serving at the FDA, Dr. Thornton led or helped lead the FDA review teams responsible for the successful licensure of two Biologics License Applications, one each in an oncology and infectious disease indication.
Dr. Thornton has also provided guidance to investment and venture capital firms, as well other stakeholders interested in due diligence of clinical, safety and/or regulatory programs of biotechnology and pharmaceutical companies. Dr. Thornton also has developed expertise in FDA regulatory policy, and has published five Op-Eds in the Wall Street Journal since 2007 on issues covering the span of drug development policy. Dr. Thornton is a member of the American Society of Clinical Oncology and the Johns Hopkins Medical and Surgical Society.
Drug Development and Licensing Strategy: Optimizing and streamlining clinical development programs through use of tools such as adaptive clinical trial designs; Shortening the critical path to market by optimizing regulatory development strategies through the use of tools such as surrogate endpoints.
Clinical Trials: Assist in protocol design; Medical / Safety monitoring of ongoing clinical studies; Assist in clinical and safety data analysis Assist in writing of Clinical Study Reports.
Regulatory Affairs: Assist in preparation for FDA meetings: pre-IND, end-of-phase 2, pre-NDA/BLA, etc.; Assist in writing of regulatory submissions: briefing documents, clinical sections of INDs, BLA/NDAs, Orphan Product, Breakthrough Therapy Designation, etc.
Due Diligence and Drug Policy: Determining the status of the clinical and regulatory programs of pharmaceutical and biotechnology companies of interest, e.g.  likelihood of clinical trial success,  probable time to data,  critique and evaluate regulatory communications; Advise on the possible impact of the ongoing regulatory policy changes (PDUFA, etc.) on product development plans.