SOLICITATION NOTICE
A -- Advanced Development of Pharmacotherapies for the Prevention and Treatment of Deployment-Related Post Traumatic Stress Disorder (DR- PTSD).
- Notice Date
- 5/7/2010
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-10-R-0030
- Response Due
- 7/9/2010
- Archive Date
- 9/7/2010
- Point of Contact
- Shannyn Scassero, 301-619-2640
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shannyn.scassero@det.amedd.army.mil)
- Small Business Set-Aside
- Service-Disabled Veteran-Owned Small Business
- Description
- The Assistant Secretary of Defense for Health Affairs, Defense Health Program Medical Research and Development Office is soliciting proposals for the Defense Medical Research and Development Program (DMRDP) Advanced Development Award to be funded in fiscal year 2010 (FY10). The goal of the DMRDP is to advance the state of medical science in those areas of most pressing need and relevance to todays battlefield experience, and to the capability needs of the Joint Force Health Protection (JFHP) Concept of Operations (CONOPS), as delineated in the tasks described in this Request for Proposals (RFP). The objectives of the DMRDP are to discover and explore innovative approaches to protect, support, and advance the health and welfare of military personnel, families, and communities; to accelerate the transition of medical technologies into deployed products; and to accelerate the translation of advances in knowledge into new standards of care for injury prevention, treatment of casualties, rehabilitation, and training systems that can be applied in theater or in the clinical facilities of the Military Health System (MHS). The DMRDP funds research and development spanning basic research through advanced clinical development. For this RFP, the Department of Defense (DoD) requests proposals to develop advanced therapeutics for the prevention and treatment of Deployment-Related Post Traumatic Stress Disorder (DR-PTSD). Selected efforts will encompass the initiation of the Technology Development (TD) Phase of the DoD Acquisition System and will specifically address development of a therapeutic(s) for DR-PTSD indications from a Technology Readiness Level (TRL) of at least 5 through completion of all requirements in TRL 8, as defined by the Technology Readiness Assessment (TRA) Deskbook in Appendix H, which can be downloaded at: http://www.dod.mil/ddre/doc/May2005_TRA_2005_DoD.pdf The objective is to determine whether a pharmacological intervention strategy to treat Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) service members and veterans with DR-PTSD can demonstrate safety and effectiveness, while ensuring an acceptable risk-benefit ratio. For the purpose of this RFP, DR-PTSD refers to any service member with a diagnosis of PTSD incurred while on active duty status and is in any of the stages of the OEF/OIF deployment cycle (i.e., Train-up/Preparation, Mobilization, Deployment, Employment, Redeployment, Post-Deployment, and Reconstitution). DR- PTSD also refers to OEF/OIF veterans diagnosed with PTSD who are not presently on active duty (e.g., retired, discharged, reserve status, etc.), but deployed at least once to OEF/OIF. Research Focus Areas of Interest: Area of Interest 1: Pharmacological treatment of OEF/OIF service members/veterans with DR-PTSD in duration of one year or less. Area of Interest 2: Pharmacological intervention for DR-PTSD prophylaxis among: a.OEF/OIF service members/veterans who experienced a traumatic event consistent with the Diagnostic Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criterion A1 (but not necessarily criterion A2) for PTSD who are experiencing distressing symptoms, but do not yet meet full criteria for PTSD. b. OEF/OIF service members/veterans immediately after experiencing an A1 event consistent with DSM-IV criterion A1 (but not necessarily criterion A2) for PTSD. Area of Interest 3: Development of novel pharmacological treatment for OEF/OIF service members/veterans with DR-PTSD of duration that is more than one year. Area of Interest 4: Efficacy determination of off-label and/or FDA-licensed drugs frequently used to treat PTSD among OEF/OIF service members/veterans, but having limited, or no, empiric evidence of efficacy (e.g., benzodiazepines, mood stabilizers, etc.). Area of Interest 5: Comparative effectiveness drug studies among OEF/OIF service members/veterans using drugs with established and/or putative efficacy in treating DR-PTSD. (e.g., alpha-1 adrenergic agonist, selective serotonin reuptake inhibitors, atypical antipsychotics, etc.). NOTE: There is increased interest in expanding the armamentarium of evidence-based medications available to manage selected prominent symptoms of DR-PTSD, such as sleep disturbance or impulsive aggression, as well as to treat PTSD symptoms more broadly. This RFP invites studies designed to establish efficacy data of medication effects on specific target symptoms or clusters of symptoms, as long as there is a convincing rationale for this approach. The Government herein reserves the right to issue one contract or multiple contracts based on a best value determination. Any resulting award will be issued as a performance based acquisition with a base period of performance of 2 years with 3 one-year options. A cost-type contract is anticipated. The Contractor will be responsible for providing all resources necessary to perform.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-10-R-0030/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02143795-W 20100509/100507234808-b00293f65d95e9cdf7f00d4dd17e11a0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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