SOURCES SOUGHT
65 -- INDUSTRY DAY - CANNABINOIDS AND MEDICAL MARIJUANA
- Notice Date
- 2/26/2020 8:27:52 AM
- Notice Type
- Sources Sought
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E20Q0069
- Response Due
- 3/15/2020 8:59:59 PM
- Archive Date
- 06/22/2020
- Point of Contact
- Lynn.portman@va.govvhablrd-csrd@va.gov
- E-Mail Address
-
lynn.portman@va.gov
(lynn.portman@va.gov)
- Awardee
- null
- Description
- The Department of Veterans Affairs (VA) Clinical Science Research and Development Service (CSRD) is developing a research program to examine the potential for medical marijuana and cannabinoids to treat disorders and diseases prevalent in our Veteran population. Specifically, as an initial query, we are interested in better understanding the application of cannabinoids for treatment of neuropathic pain and for alleviating symptoms of posttraumatic stress disorder (PTSD). For the purposes of this announcement, the term cannabinoid includes any synthetic or plant-derived product that modulates activity of the endogenous cannabinoid system (cannabinoid receptors, endocannabinoid signaling or metabolism, etc.) that is reproducibly produced under good manufacturing practices (GMP). To establish a relationship with Industry partners and to select the most suitable compounds acting on endocannabinoid system with the strongest scientific evidence of their efficacy for treatment of the above-mentioned conditions, CSRD has scheduled an Industry Day for April 27th, 2020. VA will describe ways for developing research collaborations for industry partners and for implementing studies through a Cooperative Research and Development Agreement (CRADA) (see CRADA authority below). Unrelieved neuropathic pain experienced by Veterans after spinal cord or peripheral nerve injury contributes to depression, anxiety, disrupted sleep, and overall decreased quality of life. PTSD, also highly prevalent in Veterans, is a mental health problem often co-morbid with chronic pain. A large percentage of Veterans who seek relief from these conditions, resort to smoking marijuana or use unregulated dietary cannabis supplements, etc. It is therefore imperative to determine which cannabinoid compounds are truly effective, for which symptoms, in which populations, as well as the associated risks. VA is a long-standing leader in advancing treatments for conditions prevalent in Veterans and has a strong research program in establishing evidence-based treatments for pain and PTSD. Without the needed evidence base for medical marijuana, this will not be a treatment choice within VA. We hope to support a series of clinical trials, which in case of positive outcomes, will generate robust data to support the use of cannabinoid(s) for pain and/or PTSD (or one or more of its symptoms). Unique VA s resources for PTSD and pain 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 intends to partner with industry to facilitate the further understanding and development of evidence-based treatments such as medical marijuana and cannabinoids for neuropathic pain and PTSD in Veterans. WHITE PAPER: VA is requesting that all interested parties submit a one-page White Paper to provide information on 1) the formulation and route of administration of the cannabinoid preparation; 2) their ability to manufacture and/or supply test cannabinoid compounds produced under GMP; 3) For drugs not yet approved by the FDA, the IND number of the test compound or the supplier s intent and capacity to file IND application with the FDA; 4) scientific evidence supportive of the compound s efficacy for treatment of pain, PTSD or its symptoms. Preparations without such evidence will not be considered. These White Papers should be submitted to CSRD at vhablrd-csrd@va.gov & lynn.portman@va.gov by MARCH 15, 2020. After a review of the White Papers, expected to be completed by APRIL 1, 2020, VA will contact the potential partners who best address the stated needs. At that time, those partners will be invited to attend the Industry Day on April 27th, 2020 in Washington, DC. INDUSTRY DAY: VA s Clinical Science R&D Service will hold an Industry Day on Aril 27th, 2020 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. The purpose of the Industry Day is to provide Industry with a detailed overview and knowledge about partnering with the VA and for VA ORD to conduct market research. CSRD is particularly interested in obtaining information about cannabinoid drugs availability, likelihood of their approval by the FDA (if not yet approved), and the data supporting their use for pain and PTSD treatment in Veterans. After the 2-hour brief, VA will have a Q&A session with industry partners. One-on-One meetings: One-on-One meetings will be held 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 & lynn.portman@va.gov DISCLAIMER: This Industry Day is issued 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. Instructions to interested parties: -Submit a one (1) page white paper by 3/15/2020, 12pm EST to lynn.portman@va.gov & vhablrd-csrd@va.gov to include information on 1) the formulation and route of administration of the cannabinoid preparation; 2) supplier s ability to manufacture and/or supply test cannabinoid compounds produced under GMP; 3) for drugs not yet approved by the FDA, the IND number of the test compound or the supplier s intent and capacity to file IND application with the FDA; 4) scientific evidence supportive of the compound s efficacy for treatment of pain, PTSD or its symptoms.� Interested parties MUST provide evidence or will not be considered. -Confirm availability for VA Industry day to be held on 4/27/20 in Washington D.C. (Additional details and location will be provided to potential partners who have addressed the information requested in this notice).
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