Ledwith has over 30 years of experience in nonclinical and clinical development across diverse modalities and therapeutic areas, in both large pharma and a mid-size biotech.  He has led nonclinical safety organizations, participated on the leadership team for DPMK/Pharmacometrics, been a member of internal governance committees, and driven major organizational changes including R&D integrations of newly acquired companies.  He has also led global product development teams for programs at every stage of clinical development and post-licensure.  Dr. Ledwith has an extensive publication record and history of successful interaction with regulatory bodies, and his work has been cited in regulatory guidelines for vaccines and gene therapy.  He received his BS in Chemistry from the College of William and Mary, PhD in Biochemistry & Biophysics from the Medical College of Virginia, and MBA from the Wharton School, University of Pennsylvania.