IDCRC Leader Profile: Jonathan Zenilman, MD
Since its inception, Jonathan Zenilman has served as the IDCRC Clinical Operations Unit (COU) director and member of the IDCRC Executive Management Team (EMT). The COU provides direct day-to-day operational support, management, and oversight for the IDCRC clinical research agenda – the planning, implementation, timelines for vaccines, biologics, therapeutics, diagnostics including prognostic and predictive markers, and devices, especially Phase I-IV clinical trials. This requires close coordination with all the units, the Vaccine & Treatment Evaluation Units (VTEUs) as the research implementation sites, NIAID staff, and NIAID-provided research support programs. The COU provides leadership on protocol development and implementation planning and is responsible for site selection, qualification, and management of protocol-specific sites.
“We have an incredible team in our COU. Our primary role has been in facilitating the implementation of approved protocols into actual operating clinical trials. This has included working with the sites to develop budgets, quality management plans, and project SOPs. We also have developed a process for matching appropriate sites to newly approved protocols,” says Zenilman.
Through his EMT work, Zenilman reviewed new concepts and provided go/no go advice on further investment and protocol development. “But the IDCRC does more than COVID-19 and more than vaccines! We are interested in other areas, especially sexually transmitted infections (STI), and we want to encourage concept development. Also, every member of the team is very invested in junior faculty development. This is an amazing track for developing the next generation of clinical trialists.”
Zenilman is a professor of medicine at Johns Hopkins University and has extensive experience in leading clinical epidemiology and clinical trials focused on sexually transmitted infections, Phase II-III trials of antimicrobials and diagnostics in outpatient and inpatient settings, and first-in-human Phase I trials conducted under controlled conditions which assessed toxicity and pharmacokinetics. He started his clinical research career as a CDC Epidemic Intelligence Service officer assigned to the Division of Sexually Transmitted Infections in 1985-87 and worked as a medical epidemiologist for two years afterwards. He setup a series of observational clinical trials and established the CDCs gonococcal resistance surveillance program. In 1989, he went to Johns Hopkins and has been involved in dozens of clinical trials and observational studies, initially in STIs, but then moved on to early drug development Phase I and Phase II studies.
His clinical trial work has been supported by NIAID, CDC, and commercial sponsors, and he has been a principal investigator (PI) and has managed sites in the Sexually Transmitted Infections Clinical Trials Group, HIV Prevention Trials Network, the Baltimore City Health Department STI program and the Johns Hopkins University Institute for Clinical and Translational Research. He has served on numerous NIH and CDC advisory committees and has participated in every revision of the STI Treatment Guidelines since 1989. He was previously site PI for the NIAID/DMID-funded Phase I clinical studies program that was one of the predecessors for the IDCRC and has extensive experience with DMID processes for quality assurance, site SOPs, FDA IND submissions, and protocol operationalization. Since 2012, he has been a member of the Johns Hopkins IRB, and has substantial experience in human subjects’ issues, ethics, and clinical research regulation, and served as a technical expert for the Presidential Commission on Bioethical Issues which investigated the U.S. Public Health Service Guatemala studies.
“The past year has been amazing because of the COVID activities. It is incredible to see the vaccine and therapeutics evolve from concept to completed clinical trials, and then read about it in the professional literature and lay press. I think everyone in our group gets enormous satisfaction from the sense that we each had a small part in making this happen,” says Zenilman.
Zenilman is stepping down from the IDCRC this summer. “I want to thank Dr. Zenilman for his service and contributions to the IDCRC. He played a critical role in the creation of the COU and contributed greatly during very challenging times,” says David Stephens, MD, IDCRC contact PI.
“We particularly appreciate his service in the inception and MOP development of the Site Selection Committee, the establishment of the sIRB process, contributions to developing COVID-19 studies, and for the many connections he brought to the table. We hope he shares in our pride for the network that he helped to create,” says Kathy Neuzil, MD, IDCRC PI.
“We have an incredible team in our COU. Our primary role has been in facilitating the implementation of approved protocols into actual operating clinical trials. This has included working with the sites to develop budgets, quality management plans, and project SOPs. We also have developed a process for matching appropriate sites to newly approved protocols,” says Zenilman.
Through his EMT work, Zenilman reviewed new concepts and provided go/no go advice on further investment and protocol development. “But the IDCRC does more than COVID-19 and more than vaccines! We are interested in other areas, especially sexually transmitted infections (STI), and we want to encourage concept development. Also, every member of the team is very invested in junior faculty development. This is an amazing track for developing the next generation of clinical trialists.”
Zenilman is a professor of medicine at Johns Hopkins University and has extensive experience in leading clinical epidemiology and clinical trials focused on sexually transmitted infections, Phase II-III trials of antimicrobials and diagnostics in outpatient and inpatient settings, and first-in-human Phase I trials conducted under controlled conditions which assessed toxicity and pharmacokinetics. He started his clinical research career as a CDC Epidemic Intelligence Service officer assigned to the Division of Sexually Transmitted Infections in 1985-87 and worked as a medical epidemiologist for two years afterwards. He setup a series of observational clinical trials and established the CDCs gonococcal resistance surveillance program. In 1989, he went to Johns Hopkins and has been involved in dozens of clinical trials and observational studies, initially in STIs, but then moved on to early drug development Phase I and Phase II studies.
His clinical trial work has been supported by NIAID, CDC, and commercial sponsors, and he has been a principal investigator (PI) and has managed sites in the Sexually Transmitted Infections Clinical Trials Group, HIV Prevention Trials Network, the Baltimore City Health Department STI program and the Johns Hopkins University Institute for Clinical and Translational Research. He has served on numerous NIH and CDC advisory committees and has participated in every revision of the STI Treatment Guidelines since 1989. He was previously site PI for the NIAID/DMID-funded Phase I clinical studies program that was one of the predecessors for the IDCRC and has extensive experience with DMID processes for quality assurance, site SOPs, FDA IND submissions, and protocol operationalization. Since 2012, he has been a member of the Johns Hopkins IRB, and has substantial experience in human subjects’ issues, ethics, and clinical research regulation, and served as a technical expert for the Presidential Commission on Bioethical Issues which investigated the U.S. Public Health Service Guatemala studies.
“The past year has been amazing because of the COVID activities. It is incredible to see the vaccine and therapeutics evolve from concept to completed clinical trials, and then read about it in the professional literature and lay press. I think everyone in our group gets enormous satisfaction from the sense that we each had a small part in making this happen,” says Zenilman.
Zenilman is stepping down from the IDCRC this summer. “I want to thank Dr. Zenilman for his service and contributions to the IDCRC. He played a critical role in the creation of the COU and contributed greatly during very challenging times,” says David Stephens, MD, IDCRC contact PI.
“We particularly appreciate his service in the inception and MOP development of the Site Selection Committee, the establishment of the sIRB process, contributions to developing COVID-19 studies, and for the many connections he brought to the table. We hope he shares in our pride for the network that he helped to create,” says Kathy Neuzil, MD, IDCRC PI.