SOURCES SOUGHT
B -- Clinical Study: Induced Pluripotent Stem Cell Cardiomyocyte Generation
- Notice Date
- 7/22/2014
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDASS1133767
- Archive Date
- 8/14/2014
- Point of Contact
- Howard S. Yablon, Phone: 240-402-7630
- E-Mail Address
-
howard.yablon@fda.hhs.gov
(howard.yablon@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Sources Sought: Small Business This is a 100% 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 (541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) ( Size Standard: 500 employees). Your responses to the information requested will assist the Government in determining the appropriate acquisition method. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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. 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). Title of Study: Induced Pluripotent Stem Cell Cardiomyocyte Generation for FDA Clinical Study BACKGROUND Individual patients respond differently to medical therapies. Personalized medicine uses a diagnostic test to predict how patients will respond to therapies. FDA is currently conducting a clinical study to evaluate the ability of novel electrocardiographic (ECG) methods to identify how five drugs interact with the heart's ion channels. The title of the study is "Five Period Crossover Study of the Ability of Late Sodium or Calcium Current Block (Mexiletine, Lidocaine or Diltiazem) to Balance the Electrocardiographic Effects of hERG Potassium Current Block (Dofetilide or Moxifloxacin)." However, these ECG methods can be used only after subjects receive the drugs. Methods have been developed to take blood or skin cells from individual subjects, reprogram the cells to induced pluripotent stem cells (iPSCs) and subsequently differentiate the cells to cardiomyocytes. The subject-specific iPSC-cardiomyocytes can then be studied in laboratory assays to determine how each subject's cells respond to drugs. Previously, this has been performed for patients with congenital long QT syndrome and it was shown that the subject-specific iPSC-cardiomyocytes exhibited the same characteristics (prolonged action potential duration or QT) as the patients clinical ECGs. The objective of this contract is to reprogram peripheral blood mononuclear cells (PBMCs) to induced pluripotent stem cells (iPSCs) and then differentiate the iPSCs to cardiomyocytes for 201 human subjects. The contractor would then work interactively with FDA while laboratory electrophysiology assays are performed to study the response of the iPSC-cardiomyocytes to the same drugs that were studied clinically. REQUIREMENTS: The contractor will generate iPSC-cardiomyocytes from 201 subjects in the FDA clinical study. Subsequently, the subject-specific iPSC-cardiomyocytes will be studied in laboratory electrophysiology assays by FDA to determine if the each subject's iPSC-cardiomyocyte's drug-concentration dependent response predicts the clinical ECG drug-concentration dependent response. The period of performance will be over a 36 month period. Specific Tasks: Task 1: Study Protocol The Contractor shall develop a study protocol including description of cell reprogramming into a pluripotent state, along with cardiomyocyte differentiation. Task 2: Generation of Induced Pluripotent Stem Cells (iPSCs) The Contractor shall reprogram peripheral blood mononuclear cells (PBMCs) into induced pluripotent stem cells (iPSCs) for all 201 subjects. For each subject, sufficient iPSCs should be generated to differentiate the required number of iPSC-cardiomyocytes identified in Task 3. In addition, 5 vials (>1 million viable cells per vial) of iPSCs per subject should be shipped to FDA and 10 vials (>1 million viable cells per vial) of iPSCs per subject shall be stored until further instruction by FDA for potential submission to a biobank. Unused PBMCs shall be stored and returned to FDA upon request. The contractor shall have the ability to store all cells up until the end of the Contract (36 months). Upon complete generation of iPSCs, the contractor shall submit a report to FDA including quality control testing results. Task 3: Differentiation of iPSCs into Cardiomyocytes The Contractor shall perform terminal differentiation of iPSCs from Task 2 into cardiomyocytes (iPSC-cardiomyocytes). Differentiated iPSC-cardiomyocytes shall exhibit biochemical and electrophysiological characteristics of normal human ventricular cells, form electrically connected monolayers, and demonstrate spontaneous beating. The cells shall remain pure and alive in culture for at least three (3) weeks after plating to allow consistent drug testing. The contractor shall ship to FDA enough cells for plating ten 96-well plates of iPSC-cardiomyocytes in a beating syncytium for each of the 201 subjects. The iPSC-cardiomyocytes shall be shipped by the end of the first year of the contract. The Contractor shall provide FDA with all necessary plating and culturing media to maintain each batch of cells in culture for up to 1 month. The Contractor shall provide FDA with certificates of analysis on each batch of iPSC-cardiomyocytes, including purity, sterility, plating efficiency, and viability of the cells, as well as results of functionality assessment analysis, including spontaneous beating rate and field potential duration according to the Contractor's quality control standards. Task 4: Communicate with FDA during electrophysiology assay study period (years 2 and 3) FDA will study patientsubject-specific drug effects using iPSC- cardiomyocytes obtained from the Contractor. There may be need for FDA to communicate with the Contractor during this period and for the Contractor to work interactively with FDA during this phase including FDA's preparation of scientific manuscripts. Place of Performance: All work under this study shall be performed at the Contractor's facility. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement electronically to Howard Yablon at howard.yablon@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement shall be no more than five pages, excluding a cover page and table of contents. The FDA will be determining capability based on the ability to perform the above services as delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, DUNS number, size and business type (e.g. 8(a), HUBZone, etc.) based on the applicable NAICS code for the proposed acquisition. Potential offerors have until 5:00 PM ET, Wednesday, July 30, 2014 to respond to the FDA.
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- Record
- SN03433579-W 20140724/140722235344-a5718e9866216e02e1a1cd468fd5014d (fbodaily.com)
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