Medical Experts Office (MEO)
Head of Division
Annastasiah Mudiwa Mhaka, PhD
Vice President of Strategic Alliances Development
Dr. Mhaka provides oversight for the Medical Experts Office. She leverages discovery science, technology and product development, medical know-how, business and financing insights to create transformative advances to positively impact global health. During her 15 years working on the coalface of business and science, she has identified and developed cross-industry collaboration amongst academia, biopharma, nanoelectronics, private equity, federal government, CROs, and NGOs. Throughout her tenure at Johns Hopkins Medicine, Booz & Company, and Acidophil, LLC., she has worked collaboratively with key thought leaders to co-found and finance new companies, develop early stage technologies, and to deploy population health strategies globally. Specifically, Dr. Mhaka led or supported 15+ deals in early-mid phase R&D that resulted in the discovery of new drugs, devices, and technologies that directly improved public health. Dr. Mhaka received a Bachelor of Science with highest honors in Chemistry from the University of Pittsburgh and a PhD in Cellular and Molecular Medicine from Johns Hopkins Medicine, where she discovered novel therapeutics for cancer.
Select Experts at a Glance
Adam Bell, PhD
Regulatory Affairs Advisor
Dr. Adam Bell brings more than 15 years of experience working in the biotech and pharma industries on the development of therapeutics and vaccines for a wide range of indications. Having held leadership roles in small and large biotech in discovery, lead optimization, pre-clinical/toxicology, manufacturing, clinical development, and regulatory affairs, he brings unparalleled insight into the design of product development programs from initial lead through proof of concept in Phase 2. Dr. Bell has led early-stage development of therapeutics and vaccines for indications including diabetes, heart failure, oncology, viral, bacterial, and parasitic diseases, Parkinson’s disease, spinal cord injury, and Crohn’s disease. He invented an approved product for diabetes. Prior to assuming overall responsibility for regulatory affairs at ClinicalRM, he managed a large vaccine portfolio for Walter Reed Army Institute of Research (WRAIR) and Naval Medical Research Center as a ClinicalRM employee. Onsite at WRAIR, he managed regulatory affairs and was an FDA contact for the malaria vaccine program, the human malaria challenge model, and the Pilot BioProduction Facility. Prior to joining ClinicalRM, Dr. Bell held various roles of increasing responsibility in biotech and large pharma, moving from discovery scientist to project leader, to Director of Medical and Scientific Affairs, where he supervised regulatory affairs, clinical development, toxicology, and biostatistics and provided project team leadership for domestic and international programs across multiple therapeutic areas. He has served as regulatory lead for pre-IND through EOP2 submissions and participated in meetings with FDA and other international regulatory bodies. Recent efforts at ClinicalRM include strategic consulting for Zika vaccines, Ebola vaccines, a novel anti-viral drug, and a potential new treatment for Parkinson’s disease.
Jere Boyer, PhD
Senior Scientific Advisor
Dr. Boyer is certified in Microbiology, Human Subjects’ Protection, and Clinical Research, providing scientific input and assessments for solicitations and responses as well as authoring over 50 White Papers and other articles in the areas of Microbiology, Infectious Diseases and human subjects’ protection. He also serves as a Professor of Microbiology and Immunology and Clinical Professor of Public Health and Community Medicine at the Northeast Ohio Medical University. Prior to joining ClinicalRM, he served as Director of Research at several local area hospitals in Ohio. Dr. Boyer also held several roles within the Philadelphia College of Osteopathic Medicine where he directed the mycology and parasitology clinical laboratory. Dr. Boyer is Chairman of the Ohio Academy of Science IRB and a board member of the local AHEC, providing educational activities and helping institutions involved in health education. He has earned numerous awards, notably a Lifetime Achievement Award in Human Subjects’ Protection from the National Association of IRB Managers.
Jerry Brown, MD
Medical Advisor and Principal Investigator
Dr. Brown is a skilled surgeon and the Medical Director at ELWA Hospital in Liberia. He serves as Principal Investigator for ClinicalRM with focus on West Africa Ebola studies. He and his team worked tirelessly to fight and contain the Ebola outbreak that ravaged Liberia in 2014, providing life-saving treatment, training staff, and educating patients and families. Dr. Brown was honored as TIME Magazine 2014 Person of the Year: Ebola Fighters and TIME Magazine100 Most Influential Persons in 2015.
Timothy Endy, MD
Professor and Chair, Microbiology and Immunology and Vice-Chair for Research, SUNY Upstate Medical University. Tim has spent the last 20 years of his career performing clinical studies on dengue and emerging viruses as a principal or co-investigator while department head of large research programs. Through his research efforts he gained valuable experience navigating US and foreign regulatory environments for the conduct research in human medicine. His experience includes studies in the US and Thailand, a hepatitis E vaccine trial in Nepal, surveillance projects in the former Soviet Union countries (Georgia, Uzbekistan and Kazakhstan) and recent studies in Ecuador. He has participated as an investigator in phase I and II clinical trials involving vaccines and therapeutics and most recently in the dengue human infection model. A leader in antibiotic stewardship aimed at addressing multi-drug resistant nosocomial pathogens, Tim is board certified infections disease, and active clinician and previous Chief of Infectious Diseases. Tim received his BS in Biology at Penn State, his Masters in Public Health from Michigan U, and his MD from Uniformed Service University of the Health Sciences followed by residency and fellowship at Walter Reed. Tim is considered a world leader in the study of Dengue virus and has authored more than 20 clinical-research papers on the topic.
Kevin Gilligan, PhD
Senior Scientific Advisor
Dr. Gilligan is a virologist and emerging disease expert with over 30 years of experience in academia, government, and industry, in the development of vaccines, drugs, and diagnostics to address public health issues related to global emerging disease. Within ClinicalRM, he serves as a subject matter expert, providing scientific input on proposals, projects, and publications. Dr. Gilligan joined ClinicalRM from HHS/BARDA (U.S. Department of Health and Human Services/Biomedical Advanced Research and Development Authority), where he focused on developing drugs and diagnostics for pandemic influenza as Unit Chief and Senior Project Officer. As part of Commonwealth Biotechnologies, Dr. Gilligan directed research for virology and immunology, with an emphasis on production and testing of virus stocks and vaccine efficacy, including BSL-3 class pathogens, specifically manufacturing and titering 7 strains of Venezuelan Equine Encephalitis virus for the American Type Culture Collection organization. Dr. Gilligan managed a research group as Unit Chief at Bayer, assessing and ensuring the safety of biological products, and spent almost 3 years at USAMRIID where he and his team studied and developed an Ebola vaccine animal study. Dr. Gilligan earned his Undergraduate degree at Harvard University and his PhD in Virology from the University of North Carolina at Chapel Hill.
J. McLeod Griffiss, MD
Principal Investigator and Project Director
Dr. Griffiss is a board-certified internal medicine and infectious disease physician, who brings more than 40 years of clinical expertise to ClinicalRM. As a Global PI and Project Director, he has supervised the development of 14 clinical trial protocols and the successful completion of nine trials to date. Dr. Griffiss also leads the Sexually Transmitted Infection Clinical Trials Group, a network of clinical trial sites, and a Phase I Clinical Trial Unit for Therapeutics against Infectious Diseases, both funded by NIAID. He is a Professor of Medicine and Laboratory Medicine at the University of California, San Francisco, and a Staff Physician, Medical Service, at the San Francisco Veterans Affairs Medical Center. Dr. Griffiss has served in many roles in government, academia, and global health organizations. He is credited in over 100 peer-reviewed journal publications.
Leslie Lobel, MD
PhD, Senior Medical Advisor
Dr. Leslie Lobel is a member of the Department of Microbiology, Immunology and Genetics in the Faculty of Health Sciences at Ben Gurion University. In addition, he is a member of the Department of Emerging and Reemerging diseases and Special Pathogens at the Uganda Virus Research Institute (UVRI) in Entebbe, Uganda. Dr. Lobel’s work over the past 30 years includes studies on the profile of the immune response to various viral diseases including Ebola Virus and Marburg Virus, CCHF, Foot and Mouth Disease Virus, and Arboviruses, including the Flaviviruses and Zika. He develops viruses as antiviral agents and is very well known for his non-standard way of solving scientific enigmas and development of new methodologies. Dr. Lobel has established strategic collaborations with the Gorgas Institute in Panama, Evandro Chagas Institute in Belem, Brazil and Fiocruz Institute in Salvador, Bahia, Brazil for studies of the immune response to Zika virus in different cohorts and populations of patients for vaccine development.
Amos Ndhere, MD
Dr. Ndhere is a board-certified physician with over 10 years of experience in clinical and public health practice in Africa. He has been closely involved with clinical care and public health programs including HIV, malaria, and tuberculosis, among other diseases. In addition to his role within ClinicalRM, he serves as Principal Investigator and Chief Medical officer at ACE, a key strategic partner to ClinicalRM, and as an Adjunct Instructor in Family and Community Medicine at Northwestern University in Chicago, IL.
Bernhards Ogutu, MD
Bernhards Ogutu, MD, Principal Investigator at ACE Research, is a board-certified Kenyan Pediatrician and Medical Practitioner, Clinical Pharmacologist, and Chief Research Officer with the Kenya Medical Research Institute (KEMRI). Dr. Ogutu has over 20 years of clinical trial development and disease pathogenesis expertise. He is chair of board of management at ACE Research and a strategic partner of CRM with respect to clinical trials landscape and capabilities in Africa.
Kristopher M. Paolino, MD
Medical Advisor Associate Professor of Medicine SUNY Upstate Medical University and retired Major, United States Army, Medical Corps. Dr. Paolino graduated Suma Cum Laude from the University of New England with a BS in Biochemistry, then received his MD from the University of Buffalo and completed his internship and residency as a fellow at the Walter Reed Army Medical Center. Kris is board certified in Infectious Diseases and Internal Medicine. While at the Walter Reed Army Institute of Research (WRAIR), Kris was Chief of the Clinical Trial Center. He managed the day-to-day operations and staff in this center as well as participating as an investigator and working with internal and external collaborators on the execution of the trials. Kris ran the WRAIR CTC from 2012 through 2016 and during that time was instrumental in raising the trial volume from less than 10 trials per year to more than 15 per year. Kris is a seasoned trialist with a specialty in infectious diseases. He has chaired safety committees, was a member of and chaired the WRAIR IRB, and has been an investigator on more than 30 trials.
Mark Polhemus, MD
Director, Center for Global Health and Translational Science, SUNY Upstate Medical University. Mark is a practicing infectious disease doc with more than 15 years of experience as a clinical research investigator. A retired Army colonel, Mark has consistently held positions of leadership over the last 10 years of his career. Beginning in the early 2000s, Mark was Director of US Army Medical Research Unit in Kenya and the Walter Reed Division of Malaria Vaccines in Maryland. Conducting small and large malaria vaccine trials while at Walter Reed, Mark then moved to the Pentagon where he was Director of Medical Systems in the Office of the Assistant Secretary of the Army for Acquisitions, Logistics and Technology. Following his retirement from the Army, Mark joined the faculty at the SUNY Upstate Medical University and since starting there in 2011 has held positions of increasing levels of responsibility culminating with his present position as Director of Global Health and Translational Science. Mark has authored more than 20 peer-reviewed publications in clinical research and is an active clinical investigator, presently principal investigator on Phase 1 and Phase 2 Dengue vaccine trials. Mark is also principal investigator on a long-term dengue surveillance project and a waterborne disease surveillance project in Ecuador.
Robert Salata, MD
Dr. Robert Salata is an infectious disease specialist currently serves as a Professor of Medicine, Epidemiology and International Health at Case Western Reserve University where he also is Chair of the Department of Medicine at University Hospitals Cleveland Medical Center. Dr. Salata joined UH in 1985 and served as Chief of the Division of Infectious Diseases & HIV Medicine for nearly 20 years as well as Executive Vice-Chair of the Department of Medicine for seven years. Dr. Salata’s research activities focus on the epidemiology of infectious diseases, clinical trials of new therapeutic agents for emerging infections, and clinical HIV/AIDS research. He is internationally recognized as a researcher in clinical trials and has received continuous funding for these activities from the National Institutes of Health. With 28 years of collaboration with colleagues at Mulago Hospital and Markerere University in Uganda, Dr. Salata is a renowned expert in global health and has facilitated activities in Africa beyond infectious diseases to cardiovascular medicine, oncology, neurology and genetics.
MD, Medical Advisor
Dr. Trzcinski is a board-certified pediatrician with over 6 years of clinical practice in pediatric hospitalist medicine, who provides internal Medical Monitoring on ClinicalRM global studies. Prior to joining ClinicalRM, Dr. Trzcinski’s clinical research concentrated in pediatric orthopedic medicine, pediatric neurology, and tropical medicine. She held positions at Columbia-New York Presbyterian and New York University Langone Medical Center and spent a considerable amount of time in Guyana and Haiti as visiting medical faculty.
Jonathan Zenilman, MD
Dr. John Zenilman has been in practice more than 20 years and currently serves as Chief, Division of Infection Diseases, at Johns Hopkins Bayview Medical Center and a Professor of Medicine with expertise in Herpes infections, Infectious Diseases, Osteomyelitis, Sexually Transmitted Diseases. He is engaged in developing biomarkers for sexual behavior that can be used in survey research; performing studies of risk behaviors in highly vulnerable populations; developing molecular diagnostic techniques for detection of resistant determinants for N gonorrhoeae in non-culture based systems; using datasets from the Baltimore City Health Department to understand STD trends and behaviors; developing a research program in noscomial infections; and clinical research in the natural history and microbiology of chronic wounds in the outpatient setting. His research interests are in surgical infections; epidemiology of surgical and burn wound infections; antimicrobial resistance; skin and soft tissue infections; HIV prevention; hospital epidemiology; sexually transmitted diseases (STDs); AIDS; and infectious diseases.
MD, Senior Medical Advisor
Dr. Hoover is a board-certified infectious disease physician with over 30 years of experience in preclinical and clinical research, including previous head of the U.S. Army Brucellosis Preclinical Vaccine Program. Dr. Hoover leads ClinicalRM’s CRO services infectious disease efforts and is a retired US Army Medical Corps officer, familiar with medical countermeasure product development, and serves as scientific and medical lead for ClinicalRM’s Ebola research efforts.