SOURCES SOUGHT
B -- Pharmacogenetic Testing on Drug Efficacy
- Notice Date
- 5/16/2008
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- FDA-SOL-08-00668
- Point of Contact
- David - Kordel,, Fax: 301-827-7151
- E-Mail Address
-
david.kordel@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- FDA-SOL-08-00668 This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) that can provide the following analytical report: Background: The notion that drugs do not have the same effects in every patient is well spread among healthcare professionals. For decades physicians have used characteristics such us age, weight and sex to select the right treatment for their patients. This approach, though very useful in the clinical practice, seems to have reached its limit. There are still a large number of patients that do not respond to standard treatments or suffer from adverse effects. In recent years, advances in genomic research offered new possibilities toward the individualization of drug therapies. One good example is the application of genomics to the use of warfarin. The important variability in the response to warfarin is explained in part by genetic variants in the warfarin target, an enzyme called VKORC1, as well as the enzyme that clears warfarin from the body (CYP2C9). Patients with certain VKORC1 genetic variants are warfarin sensitive and require low warfarin doses. Likewise, patients with certain CYP2C9 genetic variants eliminate warfarin slowly and are more likely to have serious bleeding events when administered standard doses of warfarin. Pharmacogenetic testing, along with other characteristics of the patient, can provide an estimate of the therapeutic warfarin dose, improving the effectiveness and safety of anticoagulant therapy. Diagnostic tests to identify these and many other genetic variants relevant to the prescription of drugs are commercially available. However, the integration of genetic information to guide drug prescription is still limited. One of the reasons for such limitation is the scarcity of data supporting the clinical utility and the practical application of pharmacogenetic testing. The collection of that kind of data for each pharmacogenetic test and each drug by performing traditional clinical studies can be very costly and as such unlikely to occur. Therefore, it is important to identify other resources that can assist us in obtaining the necessary information to facilitate the use of genomics in the clinical practice. Pharmacy benefit providers collect and organize clinical and prescription data from their users. Many of these providers have also encouraged physicians to use certain pharmacogenetic tests as a guide to their prescription decisions and have developed the infrastructure to allow the prescription of the tests and the delivery of the results in a timely manner within their system, assuring the test results can be used effectively. The significant amount of data these providers collect and their experience in implementing pharmacogenetic testing make them a valuable resource to evaluate the utility of using genomics to aid drug prescribing. A.Key Objectives 1) Identify drugs whose effectiveness and/or safety profiles can be improved by utilizing genetic information to guide prescription: Many drugs pose challenges in selecting the right dose or the patients that may benefit from them. However, pharmacogenetic tests are not available for all of these drugs. FDA aims at identifying the drug-test pairs that could be effectively applied to guide prescription. 2) Identify available pharmacogenetic tests that can be effectively performed and utilized using a prescription-driven program: Some technical characteristics of the test can limit the application of pharmacogenetic testing to the patient care (e.g. by requiring sophisticated methods to obtain the sample or taking several days to deliver results). 3) Quantify the prescription of these drugs among users of the selected pharmacy benefits provider: For most drugs, the utility of pharmacogenetic testing in the clinical practice is related to the number of patients that are prescribed the drug and, therefore, would benefit from the new approach. 4) Identify prescription patterns among users of the selected pharmacy benefits provider: In addition to the number of patients that could potentially benefit from genetic-guided drug prescriptions, the characteristics of the patients that receive the drug (e.g. age, weight, race, etc.), the disease being treated, other drugs these patients receive, etc. are important factors affecting the utility of pharmacogenetic testing. 5) Evaluate the utility of pharmacogenetic testing in the clinical setting: Pharmacogenetic testing has the potential to increase the number of correct prescriptions for the selected drugs (the right drug at the right dose). 6) Evaluate the effect of pharmacogenetic testing on the effectiveness and safety of the selected drugs in the clinical setting: By guiding prescribers in selecting the right drug at the right dose, pharmacogenetic testing can improve clinical outcome by increasing the rate of treatment response and decreasing the rate of treatment failure and the number and severity of adverse events. 7) Evaluate the ability of a prescription-driven feedback program to facilitate the utilization of pharmacogenetic tests in the clinical practice: It is necessary to identify effective ways to inform prescribers and patients about the test and its results, to make and implement the decisions based on the test results. C.Scope of Work This project shall be a collaborative effort of the FDA with a Pharmacy Benefit Provider (PBP). PBP shall have access to a large patient database, which will allow us to measure the impact of pharmacogenetic testing. Upon selecting the drug-test pairs to be included in the study, FDA shall investigate the collaborator’s database to identify two cohorts of patients: those receiving the standard therapy and those receiving the pharmacogenetic-aided treatment. Effectiveness and/or safety of the selected drugs will be compared between the two cohorts. The metrics for evaluating impact on effectiveness/safety will be specific to each drug/pharmacogenetic test included in the study. Examples of these metrics are: • Dose adjustment • Treatment discontinuation or treatment substitution • Number/ length of hospitalization • Emergency room visits • Adverse events: bleeding events, sedation, vomiting, headache, insomnia, tremor, weight loss Phase 1: A pilot study with warfarin shall be conducted to measure the impact of genetic testing for CYP2C9 and VKORC1. This will provide a solid case study and will serve to establish the process (standard operating procedures or SOP). Duration: 6 months. Phase 2: Project expansion – following the SOP developed in phase 1, a list of other drug-test pairs, e.g. CYP2D6 and atomoxetine or selected opioids (codeine, oxycodone, hydrocodone, tramadol) shall be explored. Duration: 18 months. This project will be completed in two years. All results will be published in peer-reviewed literature. D.Key Tasks 1) Access to database containing rich and quality data from users on: • Drugs prescription, dose, dose adjustments and discontinuation of treatment • Moderate and severe adverse events to treatment, number of doctor’s office visits and number of hospitalizations with the corresponding length of stay and cause in the period of drug prescription • Time data to allow analysis of temporal relationship of all the above mentioned parameters 2) Access, experience and infrastructure to facilitate pharmacogenetic testing and appropriately organize and store the test results 3) Access to database containing rich and quality data from at least 1000 patients on: • Warfarin prescription, dose, dose adjustments and number of INR tests for at least 6 months • CYP2C9 and VKORC1 test results or capability to facilitate testing and appropriately organize and store test results • Bleeding events, number of doctor’s office visits and number of hospitalizations with the corresponding length of stay and cause in the period of warfarin prescription • Time data to allow analysis of temporal relationship of all the above mentioned parameters 4) Delivery of: • Weekly oral reports and monthly meetings on the progress of the project • Quarterly written progress reports (electronic version) • Draft of final report for FDA review due 60 days before the completion of the project. • Electronic versions of all presentations, reports, methodologies, and models in formats compatible with IBM PC Systems, preferably Microsoft Office The weekly and monthly meetings will be used to monitor the progress of the project and to make adjustments to the plan as needed. The quarterly written reports will be evaluated, edited and kept for our records. • The final report shall be a joint effort between the contractor and the FDA. 5) Optional: A minimum of one of the PBP staff member who is knowledgeable about the use of the software and the organization of the data within the database to work directly in the project. This staff member shall dedicate significant amount of his/her time to the project and shall be readily available to address our questions, comments and needs on the project. 6) Optional: Publishing the results in peer-reviewed literature E.Deliverables Please note that the deliverables listed below are sequential and may overlap as the study progresses. These are also one-time deliverables. 1) List of drugs whose effectiveness and/or safety profiles can be improved by utilizing genetic information to guide prescription. Timeline: 3 months. 2) List of available pharmacogenetic tests that can be effectively performed and utilized using a prescription-driven program. Timeline: 3 months. 3) Written report on selected drugs utilization among users of the selected pharmacy benefits provider. Timeline: 6 months. 4) Written report on prescription patterns among users of the selected pharmacy benefits provider. Timeline: 6 months. 5) Written report on the effect of pharmacogenetic testing on the effectiveness and safety of warfarin in the clinical setting. Timeline: 8 months. 6) Written report on the effect of pharmacogenetic testing on the effectiveness and safety of the selected drugs in the clinical setting. Timeline: 24 months. 7) Written report on the utility of a prescription-driven feedback program to facilitate the utilization of pharmacogenetic tests in the clinical practice. Timeline: 24 months. F.Capability Statement 1) Detailed quote of the PBP will have a maximum length of 15 pages and will be delivered as original with two copies. 2) PBP shall invoice on a monthly basis (or as appropriate) detailing accomplishments. The performance period will be two years from the time of award. 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 provide the required specific instrument. Responses to this notice shall be limited to 15 pages, and must include: 1. 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. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541690 (size standard, $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by 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). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. 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). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. 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. THIS NOTICE IS FOR PLANNING PURPOSES ONLY, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request 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 request. The Government will 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 announcement. Responses must be sent to this notice no later than 10:00 a.m. EST on May 26, 2008 submitted by email to the attention of David Kordel, Contract Specialist for consideration. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
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