SOURCES SOUGHT
A -- Small Clinical Trials to Test Feasibility and Specific Target Engagement of Novel Pharmacological Treatments in Psychotic Spectrum Disorders (FAST-PS)
- Notice Date
- 11/15/2011
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-DA-RDSS-12-242
- Archive Date
- 12/13/2011
- Point of Contact
- Marla J. Jacobson, Phone: 3014433775, Bruce E. Anderson, Phone: 3014432234
- E-Mail Address
-
jacobsonmj@mail.nih.gov, ba9i@nih.gov
(jacobsonmj@mail.nih.gov, ba9i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Small Clinical Trials to Test Feasibility and Specific Target Engagement of Novel Pharmacological Treatments in Psychotic Spectrum Disorders (FAST-PS) This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential Research and Development requirement. Note: A Small Business Sources Sought Notice number: HHS-NIH-DA-SBSS-12-242 was previously issued on November 10, 2011. Small businesses may respond to either notice, but do not need to respond to both. Interested businesses must demonstrate they currently have the necessary expertise, equipment and capacity in place to perform the project requirements stated below. The information from this market research will help the government plan their acquisition strategy. This is strictly market research. The Government will not entertain questions regarding this market research. Note: This is one of three Research and Development Sources Sought (RDSS) notices that were published for small clinical trials to test feasibility and specific target engagement of novel pharmacological treatments. Each RDSS notice is for treatments of a different group of disorders. If the interested business has capability with more than one group of disorders, it is not necessary to provide more than one capability statement/response. It is recommended however, that the capabilities with the other group(s) of disorders be referenced within the capability statement submitted. Background. Schizophrenia is a chronic, severe, and disabling mental disorder characterized by deficits in thought processes, perceptions, and emotional responsiveness. According to the 2005 National Comorbidity Survey-Replication study [Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication. Archives of General Psychiatry, 2005 Jun;62(6):617-27.], the prevalence estimate is that about 26% of the U.S. adult population is affected by mental disorders. About 1.1% of the populations ages 18 and older suffer from schizophrenia. These include schizophrenia and schizoaffective disorder. While there are many pharmacologic, psychotherapeutic, and combination treatment options available to clinicians, many patients with psychotic spectrum disorders respond poorly to the currently available therapies. Because of the substantial mortality and morbidity associated with inadequate treatment, serious mental illness is a major public health problem. The scope of this problem is vast both in terms of the numbers of affected individuals and the resultant societal and economic burden. Recent breakthroughs in basic science and in the understanding of complex illnesses offer promising new opportunities for researchers to pursue and offer new hope for those living with mental illnesses. Now is a critical time to take advantage of new breakthroughs and tools. But the paths for treatment discoveries are not clearly marked. Despite the tremendous advances in basic neuroscience and behavioral science that drive our understanding of the mechanisms underlying mental disorders, there is a dearth of new therapeutics in the discovery pipeline. [See From Discovery to Cure: Accelerating the development of new and personalized interventions for mental illnesses. Report of the National Advisory Mental Health Council's Workgroup (2010). http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/fromdiscoverytocure.PSf] The high cost of developing novel drugs, the high attrition rate of candidate therapeutics during development and clinical testing, and adverse effects contribute to the high rate of failure of new compounds in clinical trials. [Munos B. 2009. Lessons from 60 years of pharmaceutical innovation. Nature Reviews 8:959-968.] In 2009, the number of novel drugs approved by the U. S. Food and Drug Administration (FDA) for all disease areas continued to remain low, with only 19 new molecular entities approved. [Hughes B. 2010. 2009 FDA drug approvals. Nature Reviews 9:89-92] At this point, the success rates for Phase II projects are the lowest for any phase in the discovery pipeline. The success rates for Phase II projects have fallen from 28% (2006-2007) to 18% (2008-2009) [Arrrowsmith J. Phase II failures: 2008-2010. Nature Reviews Drug Discovery 10, 1 (2011)]. In contrast, the success rate for Phase III trials is much higher, around 50% [Arrrowsmith J. Phase III and submission failures: 2007-2010. Nature Reviews Drug Discovery 10, 87 (2011)] Phase II clinical trials that are well designed and well conducted can provide the data required to determine whether to proceed with a drug candidate into Phase III trials. Paul et al have described the need for a new paradigm for drug development based on "fast fail", i.e., focusing on proof of concept prior to proceeding to expensive Phase 3 trials. [Paul, SM, Mytelka, DS, Dunwiddie, CT, et al, How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nature Reviews Drug Discovery 9, 203-214 (2010)]. This paradigm calls for small, deep trials, focused on proof of concept "experimental medicine" trials, to demonstrate target engagement, safety, and early signs of efficacy. Experimental medicine moves into human studies quickly with biomarkers, including imaging, to demonstrate biological effects. These types of small proof of concept trials could help de-risking a new compound or demonstrating a "fast fail" for a new target. Purpose and Objectives. This initiative seeks to expeditiously test new compounds for psychotic spectrum disorders, including schizophrenia and schizoaffective disorder. The outcome of this initiative is also expected to lead to enhanced understanding of specific target engagement by such compounds and development of innovative treatment approaches for psychotic spectrum disorders. The specific aims of this initiative are: • To expeditiously perform randomized clinical trials to demonstrate target engagement, safety, and early signs of efficacy of such promising interventions in a well-characterized cohort of patients diagnosed with psychotic spectrum disorders. • At a minimum, each clinical trial shall be an adequately controlled study in patients with psychotic spectrum disorders. • Depending on pilot data available for interventions selected for testing, each trial may be a single-site or multisite study with a number of subjects adequate to address the primary hypotheses with a minimum power of 0.80. Sufficient patients should be enrolled in each study to establish proof of concept and/or inform a judgment whether the particular intervention warrants more extensive evaluation in larger clinical trials. • To establish a small group of clinical trials sites that will focus on identifying and testing promising pharmacological interventions for the treatment of psychotic spectrum disorders. • To further study and evaluate interventions that showed efficacy in a previous proof of concept (POC) clinical trial under the FAST-PS in larger clinical trials. Project requirements. NIMH anticipates that collaboration between multiple scientific investigators and organizations will be required. The specific experience, ability, and capabilities necessary to perform this work include (but are not limited to) the five (5) items below: 1) Experience in performing clinical trials of pharmacological interventions in psychotic spectrum disorders specifically, including appropriate control groups; 2) Ability to recruit significant numbers of subjects with psychotic spectrum disorders from multiple representative sites, and the ability to retain and follow up subjects in an ongoing clinical trial; 3) The capability to include appropriate measures to gauge target engagement and serve as biomarkers (e.g., imaging, EEG, ERP, pre-pulse inhibition, PET, clinical); 4) The capability to provide scientific oversight, facilitate collaboration among the investigators, integrate complex protocol management, data acquisition, bio-statistical data analysis and reporting of results from clinical trials involving subjects with psychotic spectrum disorders; 5) Experience collaborating with multiple experts and stakeholders (investigators, clinicians, advocates, and consumers) in psychotic spectrum disorders research. Anticipated period of performance. September 2012 - September 2019 Capability statement/information sought. Capability statements should clearly state/describe your ability, experience, and resources to design and carry out the services described above, and should include: 1. Responses to each of the above 5 listed capabilities 2. Staff expertise that would be working on this project, including their availability, experience, and formal and other training 3. Prior completed projects of similar nature 4. Your business size (number of employees and gross annual revenue), your eligibility under 8(a) or other set-aside programs, as applicable (note: the applicable NAICS code for this requirement is 541711, 500 employees; and Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp 5. Your management structure, history of your organization (e.g., number of years in business and DUNS #) 6. Company name, address, Company point of contact phone and email address 7. Teaming Arrangements: All teaming arrangements should also include the above-cited information and certifications for each entity on the proposed team. 8. The maximum number of pages for submission is 15 pages Disclaimer and Important Notes. This notice does not obligate the Government to award a contract 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. Responses will be held in a confidential manner. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. If the Government decides to issue a solicitation, a Request for Proposal (RFP) will be available solely via the FEDBIZOPPS web page at http://www.fedbizopps.gov/. It will be the offeror's responsibility to monitor the FEDBIZOPPS web page for the release of any solicitation and amendments, and to download the RFP and all attachments. Responses to this notice should be received no later than the posted due date, and can be sent either by mail, fax, or e-mail (jacobsonmj@mail.nih.gov) to the point of contact listed. If using the U.S. Postal Service or commercial overnight services, please send an original plus two (2) copies of your response. Note: for commercial overnight services, use the Rockville, MD. 20852 address. Capability statements will not be returned and will not be accepted after the due date. This Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. No reimbursement will be made for any costs associated with providing information in response to this Notice. Respondents will not be notified of the results of this evaluation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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- Record
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