SOURCES SOUGHT
A -- Systems Biology Approach for Predicting Complex Drug Interactions
- Notice Date
- 7/29/2010
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in 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
- FDA1077950
- Archive Date
- 8/18/2010
- Point of Contact
- Emily Hunt,
- E-Mail Address
-
emily.hunt@fda.hhs.gov
(emily.hunt@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. Statement of Work: 1.1 Background Concomitant medications can alter drug disposition abruptly and are of particular concern in terms of both safety and efficacy. Therefore, the FDA has provided a guidance document2 to the pharmaceutical industry on the study design, data analysis, and labeling language of drug drug interaction (DDI) studies. One challenge with DDI evaluation is the numerous factors affecting interactions (e.g., complex drug characteristics, genetic polymorphism, polypharmacy, ontogenic development of metabolizing enzymes, and disease conditions, etc.) making it impossible to address all these questions by conducting in vivo studies. Commercial software for predicting DDIs using a systems biology approach is available. 2 "Guidance to Industry: In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling," www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidancesf 1.2 Objective 1.2.1 The Office of Clinical Pharmacology has seen an increased number of sponsors utilizing modeling approach to optimize DDI study design or determine the need of DDI studies in recent years. It is critical to establish an internal knowledge base in this area. 1.2.2 This work shall focus on building a physiologically based pharmacokinetic model for a specific drug with complex properties. A direct gain from this project is the ability to predict drug interactions involving this drug as the perpetrator. More importantly, the substantial gain in our knowledge and experience with modeling a drug with complex characteristics in its disposition as well as multiple mechanisms of inhibition potential can be applied to other drugs to enhance our ability in drug interaction evaluations and regulatory decision making in the FDA. 1.3 Scope of Work 1.3.1 To describe the work involved, it is important to know that the drug (X) has a chiral center and the project requires the following drug related materials: (a) Subject drug X as a racemate (b) Each of the R and S isoforms of the drug (i.e., R X and S X); one of the isoforms is not commercially available and its acquisition (or synthesis) is the contractor's/vendor's responsibility. (c) A total of three major metabolites (M1, M2 and M3) with M1 and M2 being stereoisomers of each other. These metabolites are not commercially available and are contractor's/vendor's responsibility to acquire them as part of this contract. 1.3.2 Independently and not as an agent of the Government the contractor/vendor shall furnish the necessary personnel, and services, except as provided in the schedule, and otherwise do all things necessary for the performance of the work as described below: 1.3.2.1 Conduct CYP inhibition studies using pooled human liver microsomes and recombinant CYP isoenzymes. Two (2) individual CYP isoenzymes will be required, using six (6) drug or drug related materials: (a) drug X as a racemate (b) R X (c) S X (d) M1 (e) M2 (f) M3. The contractor/vendor is responsible for all materials needed for the studies. The inhibition studies shall include investigations on mechanism based/time dependent inhibitions. 1.3.2.2 Develop models to predict drug interactions with the subject drug as the perpetrator. The models shall incorporate the enzyme kinetics and CYP inhibition parameters for Drug X. A total of three (3) models shall be developed with one (1) for each: (a) Drug X as a racemate (b) R X (c) S X. 1.3.2.3 Provide all drug related materials as described in 1.3.1. Small businesses are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform the task described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 10 pages, and must include: 1. Demonstrated experience of performance and/or ability to supply all required services and materials. 2. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 3. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 4. If qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 5. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 6. Identification of any GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 7. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding ten (10) pages in length. Phone calls will not be accepted or returned. Interested firms or individuals may submit the requested information to: emily.hunt@fda.hhs.gov or US Food and Drug Administration Emily Hunt 5630 Fishers Lane / HFA-500 OAGS/DAO Rm 2080 Rockville, MD 20857
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1077950/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02221736-W 20100731/100729234907-011f85d524ce569ddbde1420245ac8f2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |