In the wake of numerous months of planning, preparation and research, the first Post-Traumatic Stress Disorder State of the Science Summit will be held to investigate current prospects for drug treatment of PTSD. Co-hosted by the U.S. Army Medical Materiel Development Activity's Neurotrauma and Psychological Health Project Management Office, and the Joint Program Committee/Military Operational Medicine Research Program, this Department of Defense-sponsored meeting is scheduled for June 13-14, 2017, at the National Conservation Training Center in Shepherdstown, West Virginia. Approximately 140 thought-leaders and leading researchers in the field of PTSD will gather to discuss next steps in drug development to combat this problematic condition.
Entitled "Pathophysiology of Post-Traumatic Stress Disorder: Rethinking Drug Targets," the invitation-only summit will bring together experts from government, industry and academia, and will include various plenary topics, poster presentations and working group sessions designed to advance the field of PTSD drug treatment. Dr. Kimberly del Carmen, Planning Committee co-chair and NPH PMO product manager, understands the logistics of coordinating a conference of this scale, as she has been helping to guide the effort soon after its inception in November 2014 -- and she is very excited that it is finally coming to fruition this year.
"This has been quite a learning process for our team," said del Carmen. "We've certainly gained a tremendous amount of knowledge on how to organize and schedule a conference, with all of the parts that come into play -- but we're very glad it's almost here.
"But because of all our efforts, we are hoping that great things will come of this summit," she continued. "The information we gather and explore can potentially inform the entire pipeline of drug development for PTSD."
Emphasizing that this will be a working meeting, del Carmen outlined the two-day agenda, which will include over 25 presentations from subject matter experts, prior to the start of working group sessions that begin mid-morning on the second day. Thoughtfully crafted by the Leadership Committee, the plenary lineup will feature overarching topics such as "Drug Development," "Revisiting PTSD Treatment Trials," and "Rethinking Drug Targets for PTSD," before leading into sessions that focus on critical pathophysiological domains in the field.
To create a more engaging and productive learning environment during the domain topics, each will end with a first-reaction segment from the Expert Panel members, followed by a question and answer session involving the audience.
"The 13 members that comprise the Expert Panel come from the DOD, academia, industry and other government agencies, and they are all leaders in their fields," said del Carmen. "This panel will also lead the working groups, with one member moderating each respective team, and they will provide the groups' results at the end of the meeting."
As co-chairs of the Leadership Committee, del Carmen and Dr. Ronald Hoover, MOMRP PTSD portfolio manager, have spent the past two and a half years preparing for this single event, and prospects remain high that their dedication and efforts will be rewarded with a successful outcome that may enlighten PTSD treatment research and development going forward.
Although it is clear where this project stands now, del Carmen detailed how it all began.
"We started planning for this meeting in the fall of 2014, after a Drug Treatment for PTSD In-Process Review," she explained. "The [U.S. Army Medical Research and Materiel Command's] Principal Assistant for Acquisition, Dr. Kenneth Bertram, and the Principal Assistant for Research and Technology [at that time], Dr. Frazier Glenn, charged the NPH PMO and MOMRP with putting together this meeting, to determine the next steps in drug development for PTSD treatment.
"A decision was made to discontinue development of a study to test trazadone for the treatment of patients with PTSD, and we needed to begin looking at potential next steps," she continued. "But in order to develop drugs of any kind, USAMMDA must partner with industry and/or academia to share resources."
At this time, only two drugs are approved by the U.S. Food and Drug Administration for the treatment of PTSD, and del Carmen said that both are only modestly effective, especially among the military population. She stressed that this critical summit must help to determine the pathway for developing new drugs that are potentially more effective.
Said del Carmen, "While the long-term goal is to help treat our Warfighters affected by PTSD, the short-term outcome of this meeting is to come up with a prioritized list of drugs for future development, as well as a prioritized list of pathophysiological domains for future research."
As a working meeting comprised of subject matter experts, the invited attendees are strictly tasked with finding solutions to report by the end of the session. This is not a conference merely for listening to new findings -- each person in attendance is expected to offer information and provide insight on how to move forward in the field of PTSD treatment. The primary goal of assembling the working groups is to explore and discuss viable options for drug development, and to make informed recommendations.
"Following the meeting, the final results will be given to the Drug Treatment for PTSD Integrated Product Team," said del Carmen. "The IPT will then make recommendations that will be briefed to our Milestone Decision Authority, which is at the Defense Health Agency. The recommendation that comes from this will determine the stage of our next Milestone brief, which will depend on how far along the proposed PTSD drug is in its development, and what the evidence looks like."
Once the findings are reviewed, del Carmen said that the possible drug candidate(s) will be selected, and the next step may involve releasing a Request for Proposals to solicit applicants suitable for development of the new product. The DHA must approve the RFP in order to move forward, and the process will eventually lead to clinical trial testing of the drug within the military population.
While the NHP PMO monitors the spectrum of PTSD treatment drugs currently in development, del Carmen admits that because of the number of research entities throughout the world, it can be difficult to remain up-to-date at every turn.
"Last fall [2016], we released a Request for Information to find out what drugs are being developed for PTSD treatment," she said, "and we received a handful of responses regarding drugs which we were not aware of previously.
"That's what makes this State of the Science Summit so exciting -- it's possible that at the meeting, we'll find out about new approaches that have the potential to be revolutionary in the treatment of PTSD."
The effort put forth by all involved in organizing this important summit certainly parallels USAMMDA's mission to protect, treat and sustain the health of Service Members throughout the world, and to care for our veterans when they return home scarred from battle -- with wounds both seen and unseen.
"I am very pleased that this meeting is finally being realized this June," said del Carmen. "It's extremely important that we gain new insight to develop effective drugs to treat our Warfighters who are dealing with the effects of PTSD. They deserve all we can do to help them."
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