David G. Kalergis, JD/MBA
Company Co-Founder|Chief Executive Officer
David Kalergis, along with Professor John Gainer, is co-founder of Diffusion Pharmaceuticals LLC, and, since 2004, has served as the company’s Chief Executive Officer. Under his leadership, Diffusion has grown into a clinical-stage drug development company commercializing a novel proprietary pharmaceutical technology. Clinical trials of Diffusion’s lead compound, trans sodium crocetinate (TSC), began in 2007 to explore its use in indications including peripheral artery disease and radiation sensitization in the treatment of cancerous tumors.
Before attending graduate school, David worked as an intelligence analyst for the U.S. Government. In 1982, after receiving MBA and JD degrees from the University of Virginia, he was associated with the New York City law firm of Dewey, Ballantine, Bushby, Palmer & Wood, practicing in the areas of corporate finance, public offerings and mergers and acquisitions.
In 1991, David became the first private investor in Pharmaceutical Research Associates, Inc. (PRA), a contract research organization providing clinical trials services to international pharmaceutical and biotechnology companies. PRA went public in 2004 and is now among the world’s largest CROs. David served on PRA’s Board of Directors, and, from 1991 to 1994, as head of Business Development before being named General Counsel. In these capacities he was involved in the planning and implementation of all phases of pharmaceutical clinical trials across a wide range of indications.
After leaving PRA, David became associated with the University of Virginia in an initiative to more closely link high-technology industry with research. He met Professor John Gainer and the two launched Diffusion Pharmaceuticals shortly thereafter. David has remained involved with the University’s efforts to encourage the spin-out of new high technology companies.
David is a founding director of publicly traded Virginia National Bank, and served on its board until May 2012. While on the Virginia National Bank board, he served on the Audit Committee and as Chairman of the Assets and Liabilities Committee. Other past board service includes the Virginia Biotechnology Association.
David graduated from the University of Virginia College of Arts and Sciences with a B.A. in Psychology. In 1982 he graduated from the Combined Program of the Colgate Darden Graduate School of Business Administration and the University of Virginia School of Law, receiving both J.D. and M.B.A. degrees. David is also a graduate of the Harvard Business School’s Leadership and Strategy in the Pharmaceutical and Biotechnology Industry program.
John L. Gainer, PHD
Chief Scientific Officer | Company Co-founder
Dr. John L. Gainer was Professor of Chemical Engineering at the University of Virginia, serving as a member of the faculty from 1966-2005. As co-founder and Chief Scientific Advisor of the Company, and the inventor of the trans bipolar carotenoid family of molecules, he plays a critical role in charting the path of their further development and commercialization. He has authored more than 100 scientific journal articles, including more than 30 published in medical journals. He has spent four decades investigating the transport properties of small molecules in solvents and biological systems. His recent research, funded by the Office of Naval Research, has focused on the use of trans bipolar carotenoid molecules to treat hemorrhagic shock, which is the major cause of death in combat, and to treat Acute Respiratory Distress Syndrome (ARDS.)
Professor Gainer has spent two sabbaticals investigating drug actions and related research in the laboratories of major pharmaceutical companies. He has been a member of the International Society for Oxygen Transport in Tissues since its inception in 1973. He has received several teaching awards, including the University of Virginia Alumni Association’s Distinguished Professor Award and the Outstanding Teacher Award from the Southeastern Section of the American Society for Engineering Education. Dr. Gainer received his PhD in Chemical Engineering from the University of Delaware in 1964.
David R. Jones, M.D.
Chief Medical Officer
David R. Jones, M.D. While serving as Diffusion’s Chief Medical Officer, Dr. Jones is also Professor of Surgery and Chief of Thoracic Surgery at Memorial Sloan-Kettering Cancer Center in New York, NY. He received his medical degree from West Virginia University, his surgical training from West Virginia University and the University of North Carolina at Chapel Hill. He then did a postdoctoral research fellowship in molecular oncology at UNC-Chapel Hill. Dr. Jones has published more than 170 scientific articles, authored or co-authored over 30 book chapters, and served as Principal Investigator or Co-Investigator of 17 clinical trials. He is or has been funded in cancer research through the NIH, DOD, and multiple other funding sources on over 18 grants throughout his career. He has given over 250 presentations on his clinical and research interests nationally and internationally.
Ben Shealy, CFA/MBA
Chief Financial Officer
Ben Shealy has over twenty years of experience in financial management and private and public corporate financings. As CFO of the Company, Mr. Shealy has responsibility for implementing the Company’s overall financial strategy and directing the performance of day-to-day operational finance matters. Prior to joining Diffusion Pharmaceuticals, he was Vice President of Finance at Corporate Software where he directed M&A activities which involved overseeing the firm’s $100+ million investment in several start-up high technology companies, and the sale of Corporate Software to Level 3 Communications. Mr. Shealy also was responsible for Corporate Software’s financial planning and analysis functions and the corporate budgeting activity ($1.2 billion of world-wide sales). Mr. Shealy’s Wall Street background encompassed both the sell-side (Donaldson, Lufkin & Jenrette and Prudential Securities) and the buy-side (John Hancock). Mr. Shealy received a BS in Accounting from San Jose State University, an MBA in Finance from Columbia University in New York City, and is a CFA Charter holder.
Senior Project Manager
Kelly Hoy has over twenty years of diverse experience in the drug development industry. She joined the Diffusion team in February 2004 to coordinate the writing, assembling, and filing of the Company’s Investigational New Drug (IND) Applications following all federal guidelines and receiving Food and Drug Administration (FDA) approval. She serves as the main point of contact for the FDA to facilitate activities that satisfy their needs to move the Company’s clinical program forward. In addition to managing the two INDs she has successfully submitted and received approval for two Orphan Drug Designations. Kelly has continued to increase her role and responsibilities and in addition to her regulatory role she has assumed the role of Senior Project Manager for Diffusion manufacturing and clinical trials. She serves an integral role in overseeing the manufacturing process as the first point of contact with contracted manufacturing vendors ensuring all operational aspects meet the projected scope of work, budget and timeline. She ensures the conduct of clinical studies are carried out by the project team, including assigned contactors, in accordance with the company’s Standard Operating Procedures, Good Clinical Practices, and ICH guidelines to fulfill all federal and local regulations. Managing multiple site projects includes maintaining tracking tools; analyzing, evaluating, and reporting on study progress to ensure conduct is according to company’s timelines and needs.