USAMMDA's Force Health Protection Division Conducts Training in Germany
Members of the U.S. Army Medical Materiel Development Activity's Force Health Protection Division traveled to Germany earlier this year for a week-long temporary duty assignment, which included a one-day training session the group provided to staff at the U.S. Army's Landstuhl Regional Medical Center. The annual instruction provides refresher training for LRMC staff members who work with the FHP Division's investigational new drug products and treatment protocols, as well as updated information on the U.S. Food and Drug Administration's Good Clinical Practices guidelines.
Army Lt. Col. Sandi Parriott, FHP director, led the training team, which included FHP staff members Dr. Chia-Wei Tsai, Sr. Scientist, and Marianne Erlichman, product management support, and Cyndi Donovan, protocol monitor from the U.S. Army Medical Research and Development Command's Office of Regulated Activities.
"USAMMDA's FHP Division is the Department of Defense's lead agent for rapid operationalization of investigational or emergency use products when no FDA-approved or feasible solution is available," said Parriott. "As a highly specialized DOD capability, opportunities such as these are imperative to educate command teams and staff on FHP's products and treatment protocols not available to the Warfighter elsewhere."
As a long-time member of the FHP team, Erlichman has been involved in more than ten training exercises in Germany, which makes her extremely familiar with the both the process and the military units stationed in and around Landstuhl. She feels the trip accomplished the team's intended goals.
"More than 25 staff members from groups including Infectious Disease, Pharmacy, Nursing, Traumatic Brain Injury, the laboratories, and the Human Research Protection Office attended the training," she said. "These attendees received an overview of the FHP Division, treatment protocol reviews with associated diseases, a review of additional FHP IND products, and refresher training for GCP principles, investigator and protocol team responsibilities, good documentation practices, adverse and serious adverse event reporting and recording, and product accountability."
Donovan provided GCP refresher training for staff members requiring GCP certification, and training certificates were given to all who completed the session.
In addition to the training they provided at LRMC, the group conducted a review of treatment protocol regulatory binders with LRMC regulatory staff members. Following this, they traveled to the U.S. Army Medical Materiel Center–Europe in Pirmasens, Germany, to discuss various matters regarding the shipment of products, and to conduct an inventory of FHP products stored at USAMMC-E.
Throughout the week, the team traveled between Landstuhl and other U.S. military sites, which included the U.S. Army Europe Command, the Regional Health Command–Europe and the U.S. Army Africa Command, where they participated in meetings with the Surgeon's cell leadership of each organization. These face-to-face meetings afforded the FHP team the opportunity to assess firsthand information regarding the need for medical countermeasures.
Army Col. Gina Adam, USAMMDA commander, who was in Landstuhl in support of USAMMDA's Warfighter Health, Performance and Evacuation Project Management Office, was present at two of the leadership meetings. "The work the FHP Division does is important for not just Army, but DOD Service Members around the globe," said Adam. "Doing the work to conduct training, carry out inventory checks at product locations, and inform other commands of FHP's capabilities is critical to ensuring the sites are ready when called upon to activate their treatments."
As the team prepared to leave for Germany, the coronavirus epidemic was just beginning. Erlichman said the situation prompted much discussion overseas with others in the various commands, with regard to FHP's then upcoming treatment protocol utilizing IND Remdesivir as a possible therapy for COVID-19.
"We were able to let people know what FHP was planning in response to the coronavirus if the spread worsened, because we didn't know then just how bad it would be," said Erlichman. "So, when the pandemic hit, many knew that FHP had a treatment protocol with IND Remdesivir for COVID-19. Since then, FHP has established sites at LRMC, Tripler Army Medical Center, William Beaumont Army Medical Center and 20 other locations worldwide for this treatment protocol."
Erlichman said the team was very pleased with the outcome of the trip, and that it was very successful overall.
"Based on our evaluation sheets from the training session, the trip was very successful and we accomplished a great deal during the week we were in Germany," she said. "Nothing replaces face-to-face visits, and everyone we met seemed very happy and appreciated how far we had traveled to come meet with them. We were very pleased to find that all of our IND products at LRMC's pharmacy and USAMMC-E were accounted for with no discrepancies, and all of the products are being stored appropriately."
"Also, at LRMC, Lt. Col. Parriott and Dr. Tsai were able to meet personally with a number of protocol staff with whom they had only communicated by email or phone, including the principal investigator, sub-investigators, and the medical monitor," Erlichman added. "I think it is very important to make the effort and meet people face-to-face in the places that they work."
Erlichman said the team plans to return to Germany next year, if all goes well. The FHP team has recommended the continuation of annual visits to engage personnel at FHP IND pre-positioned product locations and their associated stakeholders. The group feels it is imperative for product managers and regulatory team members to meet regularly with protocol staff such as principal investigators, and pharmacy and logistics personnel, as all can benefit from this direct engagement. Erlichman believes these meetings enable a greater understanding of the challenges and requirements necessary for executing the IND products and treatment protocols during the often "short-fuse," emergency scenarios.
"It is much easier, and more effective, to interact with people after you have made that face-to-face human connection – and I think many people are feeling this right now, in light of the situation we're dealing with, having to work from home every day."
USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. USAMRDC is leading research to prevent, detect and treat COVID-19. USAMMDA is applying existing field-leading research capabilities, a global research network and established partnerships to support the Whole-of-Government response to COVID-19.