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.
Dr. Clet Niyikiza
Senior Consultant for Regulatory Affairs
Dr. Clet Niyikiza serves as Diffusion Pharmaceuticals LLC’s Senior Consultant for Regulatory Affairs. He is also the Founder, President and CEO of L.E.A.F. Pharmaceuticals, LLC after serving as the Executive Vice President of Development at Merrimack Pharmaceuticals, Inc. from 2009 until 2014. Dr. Niyikiza also served from 2005 to 2009 as a Vice President and Medicine Development Leader at GlaxoSmithKline where he oversaw global anti-cancer assets medicine development strategy. Prior to that, Dr. Niyikiza joined the pharmaceutical industry in January 1991 with Syntex Corporation (since acquired by Roche Holding AG), in Palo Alto, California, working on the discovery and development of the pain medication, ALEVE®. He then held multiple high level positions at Eli Lilly from 1993 to 2005. At Lilly, Dr. Niyikiza was credited for groundbreaking research in the field of antifolates. He developed, over those years, a strong international network of investigators and regulatory authority policy makers that resulted in effective development and efficient registration of 10 New Drug Application indications on many of Lilly medicines, including EVISTA® and the two popular anticancer drugs GEMZAR® and ALIMTA®. Dr. Niyikiza’s landmark scientific achievements that led to the successful development of ALIMTA® were the subject of a front page Wall Street Journal article on April 21, 2004.
Since 2005, Dr. Niyikiza has been a member of President George H. W. Bush’s C-Change national forum dedicated to the advancement of cancer research, treatment and prevention. He is a member of the American Association for Cancer Research and the American Society of Clinical Oncology. A native of Rwanda and father of three children, Dr. Niyikiza holds a doctorate in Mathematics from Indiana University-Bloomington, Indiana, U.S.A.
In addition to his passion for cancer research, Dr. Niyikiza’s other interests are designing and building homes for his family, and empowering and developing young scientists through research and collaborative initiatives.
Thomas Byrne, JD
Senior 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.
Senior Consultant for Manufacturing
Doug is a pharmaceutical engineer with more than 35 years of experience including shepherding 15 new compounds through clinical manufacturing and commercial start-up. He has in-depth experience with the technical and the compliance requirements of aseptic operations from design of facilities through validation of sterile manufacturing processes. He has managed projects between pharmaceutical companies on both sides of outsourced/contract manufacturing. For the past ten years, with Commissioning Agents, Inc., Doug has provided a dozen clients with hands-on guidance for process improvements, troubleshooting, and new product start-up. Doug holds degrees in Chemical Engineering from Virginia Tech and the University of Virginia.
Brian Bollwage, JD
Senior Consultant for Regulatory Affairs
Brian D. Bollwage, JD is a career regulatory professional that provides strategic regulatory solutions for products at all stages of development in the product life cycle. Mr. Bollwage has more than 30 years experience in the health products industry permitting him to design regulatory strategies which expedite progress to market. Presently he serves as the Vice President of Strategic Regulatory Affairs at Theorem Clinical Research a mid-sized contract research organization. He has previously served as Regulatory Counsel at i3Research and during tenures with Johnson & Johnson, Pharmacia, Hoechst-Roussel, and Bristol-Myers Squibb he has managed the preparation, submission, research activities and associated FDA liaison activities of over 150 INDs and 25 successful NDAs or BLAs. He received the J.D. from Rutgers Law School, an M.B.A. from Fairleigh Dickinson University, an M.Sc. in Biology from Rutgers University and a B.A. in Biology from University of Bridgeport. In addition, he holds an appointment as Assistant Professor of Food and Drug Law at Temple University and speaks and publishes actively on numerous Food and Drug Law topics.
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.