Drug Re-purposing for Effective Alzheimer's Medicines (DREAM) Study

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background The repeated failures of disease-modifying treatments for AD have heightened the critical need for identifying effective treatments for this progressive neurodegenerative disease. The predominant approach to developing treatments for AD has relied upon drugs that target accumulation of the ?-amyloid protein in the brain. However, with a growing number of clinical trials that have failed to demonstrate the utility of this strategy, there is a critical need to identify novel molecular targets for effective AD treatments. Prior research under the direction of Dr. Madhav Thambisetty, NIA IRP, has identified several molecular pathways that are associated with the severity of AD pathology in the brain and the expression of clinical symptoms. Furthermore, this prior original research has also identified several commonly used medications that may correct these molecular abnormalities. These medications are currently in use for several non-AD indications. Therefore, the overall program objective in this proposal is to confirm these findings by performing data analyses in large prescription datasets to test whether prior exposure to these drugs protect against AD. Purpose and Objectives The purpose of the project is to perform data analysis to confirm whether these drugs protect against AD. Project Requirements The main objective of the requirement is (but not limited) to the following: Perform data analyses on large electronic health record (EHR) and/or medical insurance claims data containing drug prescription information, demographic characteristics and clinical outcomes to test whether exposure to specific drugs (approximately 20 drugs to be disclosed by NIA IRP and referred to as - NIA-AD drug list' hereafter) are associated with altered risk of incident AD and dementia. It is expected that approximately 10 drugs each will be tested in the base year and Option Year 1. Technical requirements The primary datasets to be used for the analyses are to include: i) Medicare fee-for-service Part D claims data and/or ii) Clinical Practice Research Datalink (CPRD). The contractor will provide evidence of exisiting access to the datasets including approvals required to use the data for the proposed analyses. The contractor shall provide evidence of prior work using the specific datasets indicated above in analyses similar to those described below. The contractor shall also provide evidence for resources and personnel available to complete analyses of 20 drugs in total over 2 years (as described below in "DELIVERY OR DELIVERABLES." The contractor must also have prior experience working on similar data analyses projects as a contractor with government entities (e.g., FDA, National Institutes, PCORI, etc.) The contractor shall provide a detailed analytical plan describing the proposed study design (eg: matched case-control, retrospective cohort study, etc) with clear explanation of the rationale. This plan should include details about the validity of AD/dementia diagnoses, definitions of drug exposures (eg: in matched users and non-users) and outcomes including a detailed description of potential confounding variables. Details should be provided on how confounding by indication will be addressed by methods such as propensity score matching. The analytical plan should address how immortal time bias will be addressed by using methods such as time-varying exposures. The analytical plan should include a detailed description of the statistical methods that will be used to assess differential risk of AD/dementia between the exposed/user and non-exposed/non-user groups. It should describe how competing risks will be addressed by methods such as - Fine and Gray' models. The use of robust variance estimators that account for clustering within matched sets must be addressed. The differential risk of incident AD/dementia between exposed exposed/user and non-exposed/non-user groups must be clearly summarized by appropriate metrics such as Kaplan-Meier plots. Anticipated period of performance Twelve month base period and one 12-month option period beginning on/about June 1, 2019 Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN 11:59 A.M. EASTERN DAYLIGHT TIME (EDT), FRIDAY, MAY 3, 2019, to Jon Gottschalk, Contracting Officer, at jon.gottschalk@nih.gov. 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. 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. 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).