Army Medicine: Women Fighting Ebola
According to an April 15 World Health Organization situation report, there have been more than 25,791 reported or suspected cases of Ebola virus disease, with more than 10,600 deaths. While countless men and women across the U.S. Army Medical Research and Materiel Command and the U.S. military have made critical contributions to the fight against the Ebola virus disease outbreak in West Africa, we are focusing on the daily feats achieved by four remarkable women.
Lt. Col. Jennifer M. Kishimori
When Soldiers are deployed, they face countless dangers, including natural threats such as infectious diseases. Lt. Col. Jennifer M. Kishimori, director of the Force Health Protection Division with the U.S. Army Medical Materiel Development Activity, helps Warfighters combat in-theatre threats. Kishimori and her team manage the DOD's Force Health Protection Investigational New Drug program. This effort provides urgent diagnostic, therapeutic or preventative treatment capabilities using investigational countermeasures employed when no U.S. Food and Drug Administration-approved drugs exist.
It can take years to get a product licensed by the FDA, time a Soldier on the ground doesn't have. Kishimori's team makes products demonstrated to be safe in advanced development, available for use under FDA-regulated protocols or via Emergency Use Authorization mechanisms. She also has a direct line to reach chief executives at manufacturing companies and key decision makers at the Centers for Disease Control.
For example, in response to the Ebola outbreak, Dr. James Karaszkiewicz, a senior product manager in Kishimori's division, and Ms. Patricia Beverly, a regulatory scientist in the Division of Regulated Activities and Compliance, worked with the U.S. Army Medical Research Institute of Infectious Diseases and the joint project manager - Medical Countermeasure Systems to provide diagnostic tests for an Ebola Zaire Real-Time PCR Assay Test Kit, securing FDA emergency use authorization on Aug. 5. This was the first Ebola assay granted an EUA in response to the outbreak, and became a "gold standard" test in the United States.
"Being part of the team, it's very humbling and feels very historic fighting this level-4 pathogen at this scale," said Kishimori. "You feel like you're making a difference, and we're strengthening these relationships so we'll be more prepared in the future."
Dr. Laura Brosch
As the WHO convened research and development experts in search of medical solutions for the Ebola outbreak, it also consulted experts in research bioethics.
Dr. Laura Brosch, director of the USAMRMC's Office of Research Protections, helped DOD personnel and their research partners ensure that investigations involving human or animals subjects were conducted in accordance with federal, DOD, Army, USAMRMC and international regulatory requirements.
"The USAMRMC involvement in OCONUS clinical trials in developing countries has been based on a host Nation partnership, where our work enhances host national capacities and considers ethical issues of great importance to our partners," said Brosch.
As the U.S. begins supporting EVD treatment trials in West Africa, ethical issues abound. Beginning with the research design, Brosch explained that, unlike many clinical trials, when dealing with Ebola the decision to conduct randomized trials has been controversial. Brosch added that even offering diagnosed patients the opportunity to participate in a clinical trial must be done with great care.
Brosch explained that when designing clinical trials, the overseer needs to not only obtain informed consent from trial participants, but also ensure care is available in the event there is a research-related injury. This includes ensuring the investigational product is available to the afflicted population should it be effective.
Reflecting on the U.S. response to the epidemic, Brosch said she was amazed by the "unprecedented cooperation" among U.S. government agencies, pharmaceutical companies, the WHO and West African ministries. She added that she has been equally impressed with round-the-clock dedication of key Ebola scientists and support staff from the USAMRMC. She also praised the command's work facilitating Ebola countermeasures development.
Lt. Col. Wendy Sammons-Jackson
When the WHO reported an outbreak of EVD in Guinea, the phone calls from the DOD and program partners to USAMRMC headquarters began trickling in. As DOD's premier medical research command with decades of experience in infectious disease, the command was a go-to organization to seek and find answers regarding the disease. Once the Nation mounted a whole-of-government response to the epidemic, the sheer number and complexity of inquiries became a deluge.
As the military deputy, Principal Assistant for Research and Technology Lt. Col. Wendy Sammons-Jackson is a self-described "air-traffic controller" with a microbiologist acumen.
"I worked in the past as an investigator at the U.S. Army Medical Research Institute of Infectious Diseases and the Military Infections Disease Research Program office," said Sammons-Jackson. "Leadership knew my background and asked me to play a lead role with the USAMRMC response."
Initially, Sammons-Jackson oversaw all Ebola-related requests that came to the command. She began educating the Army on the disease, keeping key decision makers appraised of what the command was doing as well as its needs moving forward; this included educating stakeholders on the products the USAMRMC had in its arsenal, in the development pipeline, and those tools that were years away from being developed.
Preparing products for take-off, Sammons-Jackson "directed air traffic." If approached by a vendor with a promising countermeasure that wasn't yet ready, she worked to identify available resources and contacts they could approach to make it ready.
As Operation United Assistance got underway, the USAMRMC's response became more formalized. The command stood up an Ebola Response Management Team led by Col. Stephen Thomas, the deputy commander for operations at the Walter Reed Army Institute of Research. Sammons-Jackson quickly found her niche as lead for all Ebola-related lab operations.
Now that the dust has settled, Sammons-Jackson said she is helping the command determine its ongoing role in East Africa. As she looks to the future, she also takes a brief moment to look backward.
"The infectious disease field is near and dear to my heart. You could spend forever in the lab and don't get to see any of the benefits. This is different," she said. "Hopefully our team has helped in some way."
Lt. Col. Julie Ake
It's mid-January and Lt. Col. Julie Ake has been collaborating with academic and industry colleagues in partnership with the WHO to develop and execute upcoming Ebola vaccine studies in West Africa. She is an infectious diseases physician and the associate director for Vaccine Research at the U.S. Military HIV Research Program, centered at the Walter Reed Army Institute of Research where she works to advance the development of HIV vaccine candidates in preclinical and early clinical studies. Ake is establishing a trial site in Abuja, Nigeria to test the cAd3 Ebola vaccine candidate.
The MHRP supports the Walter Reed Program-Nigeria, which will begin testing the cAd3 Ebola vaccine in a Phase II study taking place at 10 sites in four West African countries this spring. She credits her host-Nation colleagues for their critical contributions to the research.
"At all our sites we have excellent local investigators. They are true partners who do so much more than follow direction from headquarters in the U.S.," said Ake.
During her tenure at the MHRP, Ake served as an investigator in multiple clinical and laboratory focused protocols, including investigational drug and international studies. She is the protocol chair for RV 329: African Cohort Study; RV 262, an international Phase I DNA/MVA HIV vaccine trial; and for RV 398, an upcoming Phase 1 trial of a novel monoclonal antibody therapy in East Africa and Thailand. According to Ake, these studies are possible because of the MHRP's sustained investment in a research infrastructure to conduct clinical studies in endemic areas. She added that a critical component of this work has been continued community engagement.
Of her experience responding to the crisis, Ake said she finds it rewarding to work in global health.
"Not a lot of people who join military medicine think they will have an opportunity to contribute to global health. It was not until I was a part of the infectious diseases community in the military that I could appreciate the historical significance of the contribution of military medicine to global health and its long reach around the world developing important new products and even delivering critically important health care services."
The outbreak of EVD in West Africa is the largest, longest and most severe in the nearly four-decade history of this disease, according to the WHO. Each of these women has reiterated that their contributions are a part of a greater effort across the USAMRMC, DOD and the global community to eradicate EVD. We thank them, and the countless others, who have selflessly toiled to defeat this deadly, faceless enemy.