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 ONR, 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.
Thomas Byrne, JD
Secretary and Patent Strategist
Thomas Byrne has directed Diffusion’s intellectual property strategy since the Company was founded in 2001. He is an experienced pharmaceutical development executive with special expertise in related intellectual property law. His experience includes in-house counsel positions within both Genentech and Amgen. While at Amgen, he coinvented the erythropoiesis stimulating agent darbepoietin alpha (Aranesp®). From 1992-2000 he was a partner in the intellectual property law firm of Nixon and Vanderhye P.C. (Arlington, VA). Mr. Byrne is currently a consultant for start-up biotechnology companies on intellectual property, contract and business issues. He holds BS degrees from the University of Virginia in Chemical Engineering and Nuclear Engineering, an MS degree from Yale University in Biochemical Engineering, and a law degree from the University of Virginia.
Robert Adams, JD
Member, Board of Directors
Robert W. Adams, Esq., serves as a Director on the Company’s Board. Mr. Adams was, until his recent retirement, partner in the intellectual property law firm of Nixon & Vanderhye P.C. (Arlington, VA). He is a member of the Virginia State Bar and the International Trademark Association. His practice specialty over the past 25 years has been U.S. patent litigation and international patent licensing and negotiations. Mr. Adams received a BA from the University of Maryland in 1972 and a JD (with honors) from George Washington University in 1975
Mark T. Giles, JD
Member, Board of Directors
Mr. Mark T. Giles has been a Director of Diffusion Pharmaceuticals LLC since June 2008. He is the sole Managing Member of Panda Holdings, LLC, which engages in the investment and management of private capital. He has served as the Chief Executive Officer and Chairman of Virginia National Bank, President of two publicly traded bank holding companies and subsidiary banks in Texas, and practiced law with the banking group of a Houston law firm. Mr. Giles also served as the Chairman of VNBTrust. He is a founding director of Walk2Campus Properties, LLC, and chairs the boards of Relay Foods, Inc. and Expedition Trust Company. He serves on the boards of The Paramount Theater Foundation and The Paramount Theater Operating Company; and of the Thomas Jefferson Area United Way; and the Computers4Kids Program. He also serves on the Medical Affairs Board and Finance Committee of Martha Jefferson Hospital. In 1977, he received a BS degree from the McIntire School of Commerce at the University of Virginia. Mr. Giles received a J.D degree from the University of Virginia School of Law in 1980.
Member, Board of Directors
Alan Levin formerly served as Executive Vice President & Chief Financial Officer of Endo Health Solutions Inc. (Endo) from June 2009 until September 2013. Prior to joining Endo, Mr. Levin worked with Texas Pacific Group, a leading private equity firm, and one of their start-up investments. Before that, he was Senior Vice President & Chief Financial Officer of Pfizer Inc., where he worked for 20 years in a variety of executive positions of increasing responsibility. Mr. Levin received a bachelor’s degree from Princeton University and a master’s degree from New York University’s Stern School of Business. He is a certified public accountant and a member of the Advisory Board of Auven Therapeutics, a private equity fund, where he chairs the fund’s Audit & Risk Committee. He is also a member of the Board of Directors of Aceto Corp, a NASDAQ-traded company specialized in generics and pharmaceutical intermediate products and the Critical Path Institute, a nonprofit collaboration between the Food and Drug Administration and the pharmaceutical industry, focused on streamlining and accelerating the development and regulatory pathways for innovative medicines.