Dr. Lenehan is a uniquely qualified physician-scientist and senior executive with broad experience in clinical and academic oncology, molecular biology, anti-cancer targeted pharmaceutical drug development, cardiovascular biotechnology, and laboratory research, who is engaged in and can effectively view translational medicine from clinical, scientific, and business perspectives. He is especially well-experienced in assisting the pharmaceutical and biotechnology industries in the successful transition from pre-clinical to clinical phases of investigational oncology drug development.
Dr. Lenehan is a critical thinker and skilled communicator who is particularly adept at conveying cutting-edge advances in cancer genomics, emerging anti-cancer therapies, and cardiovascular risk assessment to his colleagues, outside investigators, and consultancy clients. He is a proven leader and effective manager who is well versed in Phase I, II, and III clinical trial design/conduction and international regulatory strategies, including those for FDA’s IND, NDA, Pre-Sub, 510(k), and De Novo submissions and EU’s medical device directives, including CE Marking. He is most intrigued with the potential for significant patient benefit and healthcare savings by fostering precision medicine through a combination of disease prevention, molecular prognostics, and targeted therapeutics.