Five Ways COVID-19 Changed the Future of Protocol Design for Vaccine Development

April 19, 2022
11:40 to 12:25 EDT / 12:35 to 1:20 EDT

Many vaccine-preventable diseases continue to affect the world’s population and require our immediate attention. The urgency surrounding COVID-19 vaccine development prompted creative thinking and re-evaluation of entrenched approaches to clinical trials. At the same time, it presented challenges for continued development in a highly vaccinated and seropositive population. As we begin to identify our next priority vaccine research areas, can we apply some of the COVID-19 protocol design characteristics to future vaccine development?

Join this roundtable, hosted by FHI Clinical, to discuss and compare experiences with COVID-19 and how those might be relevant when designing trials for other indications.

About the Facilitators

Vice President, Global Strategy
FHI Clinical

With more than twenty years of experience in clinical research monitoring and management, Ghiorghis Belai serves as FHI Clinical’s Vice President, Global Strategy. In this role, Belai is responsible for managing FHI Clinical’s relationships with sponsors and sites, and he works on project feasibility to ensure optimal implementation of trials.

Belai previously served as Director of Clinical Operations for FHI 360, where he managed the clinical research unit based in Nairobi, Kenya, while supervising and mentoring the FHI 360 Africa Regional Clinical Research Unit. In this role, Belai was responsible for reviewing study protocols, coordinating study implementation of multi-center and multi-country trials in Africa, and ensuring that studies adhered to protocol requirements and applicable regulations and guidelines.

With a background in clinical research, Belai has also worked as a clinical research associate for PharmaNet Development Group, Inc., and PPD, where he participated in multiple multi-center clinical research studies, assisted with project data clinical review and management, and presented at investigator meetings for assigned studies. In addition, Belai monitored sites according to applicable standard operating procedures and Food and Drug Administration guidelines and reviewed case report forms for adherence to protocol requirements.

Senior Medical Advisor
FHI Clinical

Dr. Jon “Ben” Woods is a pediatric infectious disease physician and retired United States Air Force Colonel. Before supporting FHI, he was President of HJF Medical Research International (HJFMRI), a subsidiary non-profit of the Henry Jackson Foundation for the Advancement of Military Medicine. Prior to HJFMRI, he was Senior Antimicrobial Resistance (AMR) and Tuberculosis Technical Advisor to the Global Health Bureau at USAID. He has broad US domestic and international infectious disease clinical, programmatic and research experience spanning over two decades. His experience ranges from directing the US Army’s medical research field station in Kisumu, Kenya, overseeing pediatric malaria vaccine trials and infectious disease surveillance, serving as the Defense Intelligence Agency’s lead Medical WMD Advisor and Subject Matter Expert (SME) for design of their deployable microbial forensics laboratory, to supporting investigational new drug (IND) applications for emerging and biological warfare threat agents and running the biosafety level-4 (BSL-4) treatment facility,while at the US Army Medical Research Institute for Infectious Disease (USAMRIID) at Fort Detrick, Maryland. 

Dr. Woods received his Doctor of Medicine degree from the Uniformed Services University of the Health Sciences (USUHS), completed residency training in pediatrics at Wright Patterson Air Force Base Hospital/Wright State University and his fellowship in pediatric infectious diseases at the USUHS, where his research focused on animal models of enterohemorrhagic Escherichia coli disease.

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