Our Team

Quigley BioPharma offers decades of experience in vaccine and monoclonal antibody development from bench to bedside to assist our clients bring  products through to commercial success. Quigley's staff includes drug development professionals with scientific, medical, regulatory and operational expertise who have brought multiple products from early stages of development to regulatory approval. 

Thomas P. Monath
MD, FASTMH

Tom is an internationally known virologist and vaccinologist. He is especially well known for his work on yellow fever and other viral hemorrhagic fevers. He has over 30 years in senior positions in the biotechnology industry in Chief Scientific Officer, Chief Medical Officer, and directorship roles and led development efforts of five vaccines now licensed or in registration against Ebola (Ervebo®, Merck), dengue (DENGVAXIA®, Sanofi Pasteur), Japanese encephalitis (ImoJev ®, Sanofi Pasteur), West Nile (veterinary, PreveNile®, Intervet)), yellow fever (Arilvax®, Medeva) and smallpox (ACAM2000®, Sanofi Pasteur). He also led development of other late clinical stage products, including vaccines against Helicobacter pylori and Clostridium difficile, and monoclonal antibody against respiratory syncytial virus. Tom’s expertise and experience spans multiple subject matter areas, including CMC, bioanalytical testing, nonclinical and clinical development. 

Before joining industry, Tom served in uniform in the US Public Health Service and the US Army for 24 years. He was Director, Division of Vector-Borne Viral Diseases at the Centers for Disease Control and Prevention (CDC) and Chief of the Virology Division at USAMRIID. In these capacities he worked on the epidemiology and countermeasures for a variety of emerging and re-emerging infectious diseases, including on overseas assignments in Africa. Tom received his undergraduate degree and MD from Harvard and is board certified in internal medicine. He was Adjunct Professor at Colorado State University and at the Harvard School of Public Health. Tom was also a Partner in the venture capital firm, Kleiner, Perkins, Caufield & Byers, where he worked on investments in vaccine development and biomanufacturing.  

Tom has received many prestigious awards and has served on numerous government and international committees on infectious diseases, biosecurity, WHO expert committees and the National Vaccines Advisory Committee (USA) and is Past-President of the American Society of Tropical Medicine and Hygiene. In 2023, Tom was awarded the Albert B. Sabin gold medal, recognizing his long history of contributions to vaccine development. He has published over 435 scientific papers and 6 books on arboviruses, emerging infections, and vaccine development.

D. Gray Heppner
MD, FACP, FASTMH

Dr. Heppner is a vaccinologist and board-certified infectious disease physician with 34 years of research and development experience, including clinical trial design and execution in the US and overseas. His expertise includes preclinical, first-in-human, and field trials of new drug products in tropical medicine and biodefense.

He has held biotechnology leadership positions in government and in the private sector. Prior to forming Quigley BioPharma, Dr. Heppner was Chief Medical Officer (CMO) for Crozet BioPharma (2017-2023) advancing the rVSV-Nipah vaccine,  CMO (2015-2017) for BioProtection Systems, the infectious disease subsidiary of NewLink Genetics, for the subsequently licensed Ebola vaccine program, and Senior Scientist (2013-2015) at TASC/Engility  providing analysis and advice to the Defense Threat Reduction Agency for their biodefense vaccine portfolio. He was previously Vice President for Clinical Development (2011-12) at Crucell Inc., where he co-chaired the Research & Development Transition Team for Crucell’s integration into Johnson & Johnson. Colonel (ret) Heppner’s 23-year Army career culminated as Deputy Commander (2008-2011) of the Walter Reed Army Institute of Research (WRAIR), the Defense Department’s 2,000-person biomedical institute with operations in Africa, Asia, and Europe. As Chief of Immunology (1999-2008), and then as Director of the Division of Malaria Vaccine Development, he led the Army’s international malaria vaccine program. In partnership with Glaxo SmithKline, he spearheaded development of the RTS,S/AS malaria vaccine, which later gained Gates Foundation sponsorship, and provisional EMA/WHO approval. His program developed novel prime-boost vaccine strategies, trialed the first genetically attenuated live sporozoite vaccine, and manufactured and conducted the first safety, immunogenicity, and efficacy trials of pre-erythrocytic and blood stage vaccines MSP-1/AS, AMA-1/AS and LSA-1/AS. In 2003, he deployed during Operations Iraqi Freedom & Enduring Freedom as part of a Special Medical Augmentation Response Team to establish medical countermeasures to biowarfare threats at military treatment facilities. From 1993-1997, he led malaria vaccine, drug, and diagnostic research as Assistant Chief, then Chief, Department of Immunology and Medicine at the Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand.

Dr. Heppner received his BA and MD degrees from the University of Virginia, trained in internal medicine and infectious diseases at the Universities of Minnesota and Maryland, and maintains board certification in both specialties. He is an elected fellow of the American College of Physicians and the American Society of Tropical Medicine and Hygiene. His professional recognitions include the Undersecretary of Defense’s Award for Excellence for the Ebola response (2014), US Army Legion of Merit (2011), and Kiwanis International’s World Service Medal (2009). He is a consultant to public health and DoD research programs, a member of the Council on Foreign Relations, and recently served (2015-2021) on the U.S. Secretary of Health’s National Biodefense Science Board. He has published over 119 high impact scientific papers as reflected Google Scholar Hirsch (H)-index of 66, i10-index of 118.

Tracy Kemp, MPH

Tracy Kemp is a drug development professional with ~30 years of research and development experience, focused on clinical operations activities in the US and overseas. Tracy has held various senior leadership positions for companies focused on drug development efforts that support global public health efforts. In addition to oversight of clinical operations teams, Tracy has managed data management and medical writing functions, prioritizing team alignment with company and program goals. Priorities include development and oversight of program timelines, identification and management of partnerships with strategic vendors, budget and clinical site management. Tracy has a strong background and industry experience in various indications, including infectious and rare diseases, oncology and CNS.

Recent industry accomplishments oversight of clinical operations activities supporting the development of the rVSV-ZEBOV Ebola vaccine, in partnership with Merck & Co. Prior to her work on Ebola, Tracy was the clinical lead at Acambis Inc., where she was responsible for the oversight of clinical operations for various vaccine programs, including Japanese encephalitis, West Nile, Helicobacter pylori, Clostridium difficile and the ACAM2000® smallpox vaccine. 

Prior to her work in industry, Tracy was fortunate to serve as a Peace Corps Volunteer in Nigeria, supporting local health information collection initiatives for the Federal Ministry of Health and working on retrospective case studies of oral rehydration techniques for malaria. Tracy did her undergraduate work at Rollins College and has a Master’s Degree in Public Health from Boston University with a focus in Epidemiology.