David G. Kalergis, JD/MBA
Chief Executive Officer | Company Co-Founder.
David G. Kalergis, JD/MBA
Chief Executive Officer | Company Co-Founder.
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.
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
Dr. Jones has served as Diffusion’s Chief Medical Officer since September 2012. In addition to serving as Diffusion’s Chief Medical Officer, Dr. Jones is also the Fiona and Stanley Druckenmiller Endowed Professor for Lung Cancer Research and Chief of Thoracic Surgery at Memorial Sloan-Kettering Cancer Center in New York, NY, a position he has held since 2013. From 2007 to 2013, Dr. Jones was Professor of Surgery and Division Chief for Thoracic & Cardiovascular Surgery at the University of Virginia. In addition to his clinical practice, Dr. Jones has published more than 220 scientific articles, authored or co-authored over 35 book chapters, and served as Principal Investigator or Co-Investigator of over 30 clinical trials. Dr. Jones received his undergraduate degree in Chemistry and M.D. from West Virginia University. He then completed his thoracic surgery residency and a postdoctoral research fellowship in molecular oncology at the University of North Carolina – Chapel Hill.
Thomas E. Byrne, JD
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.
Chief Business Officer
Mr. Hornung is the Chief Business Officer of Diffusion Pharmaceuticals Inc. Mr. Hornung has over twenty years of experience in the biopharmaceutical industry. As CBO of the Company, Mr. Hornung has responsibility for implementing the Company’s overall business development strategy and will manage investor, bank, and analyst relationships. Prior to joining Diffusion Pharmaceuticals Inc., Mr. Hornung held the position of Chief Financial Officer at Contravir Pharmaceuticals, Inc. Prior to Contravir, Mr. Hornung held positions of increasing responsibility with PTC Therapeutics Inc., most recently serving as Vice President of Finance. During his tenure at PTC Therapeutics (December 2002 through March 2014), Mr. Hornung oversaw the IPO process in which PTC became a publicly traded company. Mr. Hornung also held positions of increasing responsibility with Elan Pharmaceuticals (formerly The Liposome Company) from 1998 through 2002. At Liposome and Elan, he was responsible for strategic planning and operations of the company’s UK-based European headquarters. Earlier in his career, Mr. Hornung worked for a clinical research organization where he was responsible for project management and all financial aspects of the company. Mr. Hornung holds a Bachelor of Science in Accounting from the William Paterson State University of New Jersey. He lives in Virginia with his wife Kristin.
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.
Director of Project Management
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.
Harry Cook RPh/MBA
Vice President, Clinical Operations
Harry Cook has over 36 years of experience in the pharmaceutical industry performing a variety of functions including: clinical strategy development, project leadership, clinical process ownership, related financial/resource management, CRO contracting/management and pharmaceutical sales. Mr. Cook’s experience includes major exposure to the NDA process and hands-on oversight of the clinical function including trial design, budgeting, investigator selection, site initiation, monitoring, data analysis, report writing, and pharmacovigilance. He has interacted effectively with thought leaders and company personnel at all levels. Mr. cook has either led or been instrumental in more than 14 major drug submissions in the United States and abroad in a variety of therapeutic areas.
Anna Grace, MA, RN, CCRP
Anna Grace has over 15 years of experience in clinical drug and device trials, in both NIH and Industry-sponsored research. Her experience spans that of research team manager, trial manager, research consultant, study monitor, and study coordinator. In her largest project to date, Anna managed the first-ever phase 3 pre-hospital-initiated trial of treatment for acute stroke, and oversaw a team of 15 nurse coordinators carrying out trial activities utilizing all hospitals and EMS providers in Los Angeles County.
Here at Diffusion, Anna manages and coordinates the day-to-day conduct of clinical trials. She liaisons with clinical research sites, EMS providers, CRAs, and vendors, and is an integral part of the team responsible for review and approval of clinical protocols, informed consent forms and case report forms. She is responsible for creating training materials and providing study-specific training to sites and EMS providers, as well as overseeing the IRB and contract submission and approval processes for multiple trial sites. Anna collaborates with vendors and trial sites to manage investigational drug supply, including shipment, distribution to research pharmacies, and accountability throughout all phases of the trial process. She ensures that clinical studies are carried out by the company, contractors, and site-based teams in adherence to the company’s SOPs and federal and local GCP and ICH guidelines, and manages operations to ensure that trial conduct is meeting the company’s timelines and needs.