David G. Kalergis, JD/MBA
Chairman of the Board | Chief Executive Officer
David G. Kalergis, JD/MBA
Chairman of the Board | Chief Executive Officer
David Kalergis is the co-founder of Diffusion Pharmaceuticals Inc., and has served as the company’s Chief Executive Officer since 2004. Under his leadership, Diffusion has grown into a publicly-traded 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 with a focus on improved treatments for solid cancerous tumors. TSC in newly diagnosed glioblastoma (GBM) was the subject of a successful end-of-Phase 2 meeting with the FDA in 2015, and the Company is now working on the implementation of Phase 3 programs.
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 first as head of Business Development and then as 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 its Audit Committee and as Chairman of its 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.
Vice Chairman of the Board
Mr. Blech, an experienced biotechnology entrepreneur and investor, brings to Diffusion over 35 years of expertise in the biotech industry. He has founded and served on the board of a number of companies that have produced major advances in a broad array of diseases, including the diagnosis of chlamydia, herpes, syphilis and HIV, and the treatment of cystic fibrosis, sexual dysfunction, multiple myeloma and many forms of cancer and hematological disease. Among the companies he has established are Celgene Corporation, the world’s leading company in cancer and hematology, ICOS Corporation that developed the drug Cialis and was purchased by Eli Lilly, Nova Pharmaceutical Corporation that developed a new treatment for brain cancer, Gliadel, and was purchased by Johnson & Johnson, Pathogenesis Corporation that developed the leading drug for cystic fibrosis and was purchased by Chiron, and Genetics Systems Corporation that developed the first rapid accurate diagnostic for chlamydia and the first accurate test to safe guard the world’s blood supply from the AIDS virus and was later purchased by Bristol-Myers Squibb.
Among the boards Mr. Blech currently serves on are Cerecor, Inc., a CNS company, ContraFect Corporation, an infectious disease company, Medgenics, Inc., a biotechnology company, and Edge Therapeutics, Inc., a company that treats life-threatening neurological conditions.
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.
Robert Adams, JD
Member, Chairman of the Compensation Committee
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, Chairman of the Nominating and Governance Committee
Mr. Giles has served as a director since the completion of the Merger in January 2016 and as a director of Diffusion LLC since 2008. Since July 2007, Mr. Giles has been the sole managing member of Panda Holdings, LLC, which engages in the investment and management of private capital. Prior to joining Panda Holdings, Mr. Giles served as the Chief Executive Officer of Virginia National Bank from July 1998 until June 2007 and thereafter continued to serve as the non-executive Chairman until December 2011. Prior to joining Virginia National Bank, Mr. Giles also served as the 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. He chairs the board of Expedition Trust Company and is a director of Door to Door Organics, Inc. Mr. Giles received a B.S. from the McIntire School of Commerce at the University of Virginia and a J.D. from the University of Virginia School of Law.
Member, Chairman of the Audit Comittee
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.
Robert Ruffolo, PHD
Member, Board of Directors
Dr. Ruffolo currently serves as President of Ruffolo Consulting, LLC, and sits on the Boards of Directors for numerous biotechnology companies, in addition to several non-profit charitable organizations. He previously served as President of Research and Development of Wyeth Pharmaceuticals and Corporate Senior Vice President of Wyeth (now Pfizer). Previously Dr. Ruffolo spent 17 years at SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline) as Senior Vice President and Director of Biological Sciences, Worldwide, and before that, he was Chairman of the Cardiovascular Research Committee at Lilly Research Laboratories.
During his distinguished career in the pharmaceuticals industry, Dr. Ruffolo played a significant role in the discovery and/or development of marketed products such as Carvedilol for the treatment of heart failure and acute myocardial infarction, Ropinirole for Parkinson’s disease, Dobutamine for congestive heart failure and Eprosartan for hypertension. He has authored nearly 500 full-length publications and over 200 abstracts, in addition to editing 15 books. Dr. Ruffolo was Editor-in-Chief of four international scientific journals, and has served on the editorial board of 29 international scientific journals. He has received numerous prestigious awards throughout his career, including the Discoverers Award for Carvedilol in heart failure. Dr. Ruffolo received a B.S. degree in pharmacy and his Ph.D. degree in pharmacology from The Ohio State University. Thereafter, he spent two years as a postdoctoral fellow at the National Institutes of Health.