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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 05, 2016 FBO #5369
DOCUMENT

A -- VA Clinical Science Research and Development Service (CSRD) Advancing PTSD research Industry Day. - Attachment

Notice Date

8/3/2016
 

Notice Type

Attachment
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

US Department of Veterans Affairs;Veterans Health Administration;Service Area Office (SAO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
 

ZIP Code

15212-5319
 

Solicitation Number

VA24016N0043
 

Response Due

8/17/2016
 

Archive Date

9/16/2016
 

Point of Contact

Bridget Kornish
 

Small Business Set-Aside

N/A
 

Description

In an effort to enable early and meaningful communications with Industry or other partners on the critical need to advance evidence-based pharmacologic treatment for posttraumatic stress disorder (PTSD) in Veterans, the Department of Veteran Affairs (VA) Clinical Science Research and Development Service (CSRD) has scheduled an Industry Day on September 22, 2016 for a technical discussion on advancing PTSD research, as noted below. VA will describe ways for research collaboration to develop and would expect to implement potential industry collaboration through a Cooperative Research and Development Agreement (CRADA) (see CRADA authority below). VA supports a program of scientific research from pre-clinical through implementation science, including small, medium and large clinical trials. VA is a long-standing leader in advancing knowledge of and treatments for PTSD in Veterans. While our research program has been particularly strong in establishing the evidence base and advancing psychosocial therapeutic treatments for PTSD, we recognize a critical need for more effective medications to be delivered, either as monotherapy or augmenting psychotherapy or other psychotropic medication. The current pharmaceutical approach for PTSD treatment does not fully and sufficiently achieve the desired benefit for the entire Veteran population with PTSD. We will provide clinical data to inform partners of the need and the potential for compounds that could provide relief for both VA patients and the general population. Unique resources for VA's clinical PTSD research program include a cadre of experienced clinical investigators, a highly participatory research population, and mechanisms in place to support every aspect of clinical research. VA is interested in partnering with industry to facilitate advancing evidence-based pharmaceutical treatments for PTSD in Veterans. Please also reference: Federal Register Notice PTSD DDI 2012 28917. NOTE: There is limited space available for both the planned Industry Day and the associated One-on-One sessions. As a result, VA is requesting that all interested parties (businesses and/or universities) submit a 1-page White Paper addressing how they could partner with the VA CSRD on one or more of the following specific areas of interest: 1) research in the early phase of drug development where the proposed compound has a target related to PTSD symptoms and which has pre-clinical evidence supportive of use in human subjects; 2) research on "repurposing" established pharmaceutical compounds to specifically target symptom subdomains in PTSD; and (3) other clinical research supportive of the stated effort to advance the evidence-base and implementation of medication for PTSD. These White Papers should be submitted to CSRD at vhablrd-csrd@va.gov and bridget.kornish@va.gov by August 17, 2016 NLT Noon EST. After a review of the White Papers, expected to be completed by August 22, 2016, VA will contact the potential partners who best address VA CSRD stated needs. At that time, those partners will be invited to attend the Industry Day on September 22, 2016 in Washington, DC. Industry Day: VA's Clinical Science R&D Service will hold an Industry Day on September 22, 2016 in Washington, DC. VA will brief invited partners for approximately 2 hours on the goals of the program, and provide information on partnering with VA in research studies. CSRD is particularly interested in providing information to facilitate PTSD medication research for PTSD in Veterans. The purpose of the Industry Day is to provide Industry with a detailed overview and knowledge regarding how to partner with the VA and for VA ORD to conduct market research. After the 2 hour brief, VA will have a Q&A session with industry partners. One-on-Ones: One-on-One meetings will be held on September 22, 2016 after the briefing session, Q&A and lunch break. Each invited partner will be allotted approximately 30 minutes and will be limited to 2 attendees at their one-on-one meeting. (Note: The allotted time is subject to change dependent on the number of participants. This notice will be amended if there are changes to the allotted time.) NOTE: The Government will not compensate industry participants for travel, lodging or any other expenses associated with this event. Primary Point of Contact: Inquiries should be directed to vhablrd-csrd@va.gov with a carbon copy sent to bridget.kornish@va.gov DISCLAIMER: This Industry Day is issued solely for information and planning purposes ONLY and does not constitute a Request for Proposals (RFP), a Request for Quotes (RFQ), an Invitation for Bids (IFB), or any other solicitation vehicle. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with attending this joint Pre-solicitation Conference and Industry Day. VA also reserves the right to reschedule and/or cancel this Industry Day. No solicitation document exists at this time. AUTHORITY: VHA Directive 1206, USE OF A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (May 13, 2015): a. A CRADA is an agreement established pursuant to the Federal Technology Transfer Act of 1986, Public Law (Pub. L.) 99-502 between Department of Veterans Affairs (VA) and one or more non-Federal, and Federal parties under which VA may accept, retain and use funds, personnel, services, facilities, intellectual property, equipment or other resources from the other party. In exchange, VA may provide personnel, services, facilities, intellectual property, equipment, or other resources, excluding funds, for research and development efforts that are consistent with VA's mission. If VA funding is required, VA must go through the acquisition and procurement channels. A CRADA defines the responsibilities and obligations of each party in conducting collaborative research and development, and provides the collaborating parties with certain rights to any patentable invention made by a Federal employee in the performance of the agreement. 062216tcg/DRAFT V1.0-LD/V1.1
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/21851e92efc94b0f8ba473183a92dec2)
 

Document(s)

Attachment
 

File Name: VA240-16-N-0043 VA240-16-N-0043.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2919845&FileName=VA240-16-N-0043-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2919845&FileName=VA240-16-N-0043-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04207593-W 20160805/160803235114-21851e92efc94b0f8ba473183a92dec2 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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