SPECIAL NOTICE
A -- "New Experimental Medicine Studies: Fast-fail trials (FAST)” - Copies of previously published SS notices
- Notice Date
- 12/16/2011
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-DA-RFI-12-001
- Archive Date
- 1/18/2012
- Point of Contact
- Marla Jacobson, Phone: 301-443-3775, Bruce E. Anderson, Phone: 301-443-2234
- E-Mail Address
-
jacobsonmj@mail.nih.gov, banderso@mail.nih.gov
(jacobsonmj@mail.nih.gov, banderso@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- HHS-NIH-DA-RDSS-12-242 Small Clinical Trials to Test Feasibility and Specific Target Engagement of Novel Pharmacological Treatment in Mood and Anxiety Disorders (FAST-MA), in Psychotic Spectrum Disorders (FAST-PS) HHS-NIH-DA-RDSS-12-240 Small Clinical Trials to Test Feasibility and Specific Target Engagement of Novel Pharmacological Treatment in Mood and Anxiety Disorders (FAST-MA) HHS-NIH-DA-RDSS-12-241 Small Clinical Trials to Test Feasibility and Specific Target Engagement of Novel Pharmacological Treatment in Autism Spectrum Disorders (FAST-AS) Request for Information (RFI): "New Experimental Medicine Studies: Fast-fail trials (FAST)" "This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and to gain information for project planning purposes." "New Experimental Medicine Studies: Fast-fail trials (FAST)" was previously referred to in Sources Sought Notices as Small Clinical Trials to Test Feasibility and Specific Target Engagement of Novel Pharmacological Treatment in Mood and Anxiety Disorders (FAST-MA), in Psychotic Spectrum Disorders (FAST-PS), and in Autism Spectrum Disorders (FAST-AS) Note: Small Business Sources Sought Notice numbers: HHS-NIH-DA-SBSS-12-240, HHS-NIH-DA-SBSS-12-241, HHS-NIH-DA-SBSS-12-242 were previously issued on www.fbo.gov on November 10, 2011. Note: Research and Development Sources Sought Notice numbers: HHS-NIH-DA-RDSS-12-240, HHS-NIH-DA-RDSS-12-241, HHS-NIH-DA-RDSS-12-242 were previously issued on www.fbo.gov on November 15, 2011. Background. The National Institute of Mental Health (NIMH) has recently published the above referenced Sources Sought notices for small research networks that can conduct early trials of new or repurposed compounds for treatment of mental disorders, intended to facilitate development of new therapeutics through a focus on molecular and clinical target engagement. (See: attachments of the three RDSS notices.) Three separate areas have been targeted: autism spectrum disorders, psychotic spectrum disorders, and mood/anxiety spectrum disorders. In keeping with the new NIMH RDoC program (http://www.nimh.nih.gov/research-funding/rdoc/index.shtml ), emphasis is placed upon the study of mechanisms associated with particular brain circuits or other neurobiological systems, as studied either within traditional DSM/ICD disorder categories or across a related spectrum of disorder categories. The major criteria for selecting research networks considered by NIMH include relevant experience and expertise of the investigators, availability of relevant patient populations in which to conduct trials, and the demonstrated capability of the research sites to conduct trials that involve the acquisition of a large and diverse number of molecular and clinical measures (e.g., PET, sMRI, fRMI, EEG/ERP, MEG, neurocognitive testing, emotion reactivity or regulation tasks). The general approach NIMH intends to take for these initiatives is to follow the concept of "experimental medicine." In this instance, the term is refers to the approach outlined recently by Littman & Williams (Nature Reviews Drug Discovery, 2005, 4:631-638): Experimental medicine is the use of innovative measurements, models and designs in studying human subjects for establishing proof of mechanism and concept of new drugs.... and for efficiently terminating the development of unsuccessful ones. Humans are the ultimate 'model' because of the uncertain validity and efficacy of novel targets and drug candidates that emerge from genomics, combinatorial chemistry and high-throughput screening and the use of poorly predictive preclinical models. The in-depth investigation of the effects of drugs and the nature of disease progression is becoming ever more feasible because of advances in clinical biomarkers. Thus, the intended emphasis is upon studies in humans rather than animal models, and upon a "fast-fail" paradigm to reduce development time and costs given the well-known high failure rates in early-stage drug development. NIMH anticipates that if these research networks are instantiated, any studies that are conducted will encompass the range from Phase I to Phase IIa, depending upon a variety of factors. These include (but are not necessarily limited to) such factors as whether a given compound is new or repurposed; the extent and strength of pre-clinical data; extent of data regarding dosing; availability of measures (such as PET ligands) that can demonstrate engagement at the receptor/molecular level; and availability of measures to demonstrate engagement of clinical targets such as biomarkers, endophenotypes, or intermediate phenotypes. Further background material is available through recent papers about problems with the drug development process (e.g., Paul et al., "How to improve R&D productivity: the pharmaceutical industry's grand challenge," Nature Reviews Drug Discovery, 2010, 9:203-214; the Arch2POCM project, http://sagebase.org/partners/Arch2POCM.php ). The choice of the particular molecular, circuit-level or clinical mechanisms to be studied, the particular measures that will be employed to assess these mechanisms, and the choice of compounds to be studied is anticipated to be determined by the NIMH, with input from the Principal Investigator (PI) of the overall research network and the PIs of the network sites. NIMH anticipates that any compounds that are evaluated in these networks will already have an Investigational New Drug (IND) approval/clearance from the FDA in order to avoid unanticipated delays in testing. For purposes of this initiative, Phase I generally is used to refer to proof of mechanism or proof of principle - i.e., a demonstration that a targeted mechanism can be engaged in humans with some appropriate measures of physiological effect along with no adverse events/off target activity. For example, it might be demonstrated that a compound has occupied a given receptor, or that it produced one or more physiological or biochemical downstream effects as predicted from preclinical studies (e.g., EEG changes, decrease in a metabolite in CSF, etc.) and that any unexpected mechanism- related side effects have not been observed. Proof of clinical mechanism is here equated to proof of concept - a demonstration of clinical efficacy at doses shown to engage the specified target, ideally with some intermediate physiological or biochemical readout or biomarker (Phase IIa). NIMH is considering use of an Intellectual Property Option to Collaborator Clause similar to the following: NIMH may collaborate with an outside investigator who has proprietary rights to compounds and/or devices which may be assigned under this contract. This collaborator will be identified by the Contracting Officer's Technical Representative (COTR) at the time of assignment and in this case, the following option regarding Intellectual Property Rights will be applicable. Contractor agrees to promptly notify the NIMH and "Collaborator" in writing of any inventions, discoveries or innovations made by the Contractor's principal investigator or any other employees or agents of the Contractor, whether patentable or not, which are conceived and/or first actually reduced to practice in the performance of this study using Collaborator's Study Agent or Device (hereinafter "Contractor Inventions").Contractor agrees to grant to Collaborator: (1) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Contractor Inventions for research purposes only; and (2) a time-limited first option to negotiate an exclusive world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to all Contractor Inventions on terms to be negotiated in good faith by Collaborator and Contractor. Collaborator shall notify Contractor, in writing, of its interest in obtaining an exclusive license to any Contractor Invention within six (6) months of Collaborator's receipt of notice of such Contractor Invention(s). In the event that Collaborator fails to so notify Contractor or elects not to obtain an exclusive license, then Collaborator's option shall expire with respect to that Contractor Invention, and Contractor will be free to dispose of its interests in such Contractor Invention in accordance with its own policies. If Contractor and Collaborator fail to reach agreement within ninety (90) days, (or such additional period as Collaborator and Contractor may agree) on the terms for an exclusive license for a particular Contractor Invention, then for a period of six (6) months thereafter, Contractor shall not offer to license the Contractor Invention to any third party on materially better terms than those last offered to Collaborator without first offering such terms to Collaborator, in which case Collaborator shall have a period of thirty (30) days in which to accept or reject the offer. Contractor agrees that notwithstanding anything herein to the contrary, any inventions, discoveries or innovations, whether patentable or not, which are not Subject Inventions as defined in 35 U.S.C. 201(e),* arising out of any unauthorized use of the Collaborator's Study Agent and/or Device shall be the property of the Collaborator (hereinafter "Collaborator Inventions"). Contractor will promptly notify the Collaborator in writing of any such Collaborator Inventions and, at Collaborator's request and expense, Contractor will cause to be assigned to Collaborator all right, title and interest in an to any such Collaborator Inventions and provide Collaborator with reasonable assistance to obtain patents (including causing the execution of any invention assignment or other documents). Contractor may also be conducting other more basic research using Study Agent and/or Device under the authority of a separate Material Transfer Agreement (MTA), or other such agreement with the Collaborator. Inventions arising there under shall be subject to the terms of the MTA, and not to this clause.*35 U.S.C. 201(e): The term "subject invention" means any invention of the Contractor conceived or first actually reduced to practice in the performance of work under a funding agreement: Provided, that in the case of a variety of plant, the date of determination (as defined in section 41(d) (FOOTNOTE 1) of the Plant Variety Protection Act (7U.S.C. 2401(d)) must also occur during the period of contract performance. Protection of Proprietary Data. Data generated using an investigational agent and/or Device proprietary to a Collaborator will be kept confidential and shared only with the NIMH and the Collaborator. The Contractor retains the right to publish research results subject to the terms of this contract. Information Sought. Comments about any aspects of this initiative are encouraged. These include the composition of these research networks, their capabilities, and the types of trials that are conducted. Examples of the kinds of comments that might be submitted under this RFI include, but are not limited to: • What capabilities with respect to clinical targets are particularly valuable for the sites within research networks (e.g., PET, sMRI, fRMI, EEG/ERP, MEG, neurocognitive testing, emotion reactivity or regulation tasks)? • Are there particular RDoC constructs (see http://www.nimh.nih.gov/research-funding/rdoc/index.shtml ) that appear particularly promising for new compound development with respect to one or another of the three study areas of autism spectrum disorders, psychotic spectrum disorders, and mood/anxiety spectrum disorders? • What targets (molecular and/or clinical) appear particularly promising for evaluation with respect to one or more of the three study areas of autism spectrum disorders, psychotic spectrum disorders, and mood/anxiety spectrum disorders? (Please specify the area) • Is it worth giving consideration to a broader or narrower range of trials than the Phase I to Phase IIa space that has been specified? For example, would it be useful to include research conducted before the IND phase in network evaluation (e.g., studies done under the aegis of the Exploratory IND); in what circumstances might this be useful? • Comments on the potential use of the Intellectual Property Option to Collaborator clause. Submission Requirements. Responses to this RFI are optional and will be accepted through 12:00p.m local time, January 3, 2012. Responses to the RFI may be received by mail or electronically to Marla Jacobson, jacobsonmj@mail.nih.gov. Responses by mail shall be submitted to: Marla Jacobson NIDA Neuroscience COAC R&D Contracts Management Branch (CMB) Supporting: National Institute of Mental Health (NIMH) Attention: RFI on NExMedS 6001 Executive Blvd, Rm 8154 (MSC 9661) Bethesda, MD 20892 [For commercial overnight services use: Rockville, MD 20852] Responses by Facsimile will not be accepted. You will not receive individualized feedback on any suggestions. Please do not include any personally identifiable or confidential information that you do not wish to make public. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government's use of such information. Disclaimer and Important Notes. 52.215-3 REQUEST FOR INFORMATION OR SOLICITATION FOR PLANNING PURPOSES (OCT 1997) (a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation. (b) Although "proposal" and "offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. (c) This solicitation is issued for the purpose of: obtaining knowledge and to gain information for project planning purposes. This Request for Information (RFI) is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. This notice does not obligate the Government to award a contract or grant or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. Responses to this RFI are voluntary and may be anonymous. Any identifiers (e.g., names, institutions, e-mail addresses, etc) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with scientific working groups convened by the NIH, as appropriate. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). As previously indicated, the NIH may use the information gathered to develop grant, contract, or other funding initiatives.
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