SPECIAL NOTICE
U -- Membrane Transporters in Drug Development
- Notice Date
- 4/8/2008
- Notice Type
- Special Notice
- NAICS
- 611430
— Professional and Management Development Training
- Contracting Office
- 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
- 1041472
- Point of Contact
- Jaclyn Stielper,, Phone: 301-827-7153, PatriciaPemberton,, Phone: 301-827-1022
- E-Mail Address
-
jaclyn.stielper@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Description
- The Food and Drug Administration intends to award a contract to Drug Information Association (DIA) of Horsham, PA. This is NOT a request for competitive quotes. The contract will be made on a sole-source basis in accordance with FAR Part 13. NAICS 611430. This contract will provide support to FDA/CDER in accordance with the following description of work: DESCRIPTION OF WORK 1. Background In March of 2004, the U.S. Food and Drug Administration (FDA) released a white paper entitled “Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.” 1 This report called for research to develop and validate new tools and methods for testing new medicines on the “critical path” from the laboratory to the patients. In FDA's view, the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences. The new science is not being used to guide the technology development process in the same way that it is accelerating the technology discovery process. For medical technology, performance is measured in terms of product safety and effectiveness. Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs. In many cases, developers have no choice but to use the tools and concepts of the last century to assess this century's candidates. As a result, the vast majority of investigational products that enter clinical trials fail. Often, product development programs must be abandoned after extensive investment of time and resources. This high failure rate drives up costs, and developers are forced to use the profits from a decreasing number of successful products to subsidize a growing number of expensive failures. Finally, the path to market even for successful candidates is long, costly, and inefficient, due in large part to the current reliance on cumbersome assessment methods. ------------------------------------------------------------------------------------------------------------------ 1 “Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,” www.fda.gov/oc/initiatives/criticalpath/whitepaper.html ------------------------------------------------------------------------------------------------------------------ This report1 also identified the need to build a new product development toolkit -- containing powerful new scientific and technical methods such as better evaluation tools, biomarkers for safety and effectiveness, and new clinical evaluation techniques. The agency sees these tools as urgently needed to improve predictability and efficiency along the critical path from laboratory concept to commercial product to ensure that basic discoveries turn into new and better medical treatments. 2. Context of Work/Public Health Benefit Recognizing the importance of having better evaluation tools, FDA cited development of these tools in its critical path document. We are gaining an increasing understanding of the critical role that membrane transporters can play in drug response, drug-drug interactions and toxicity. In particular, transporters in the intestine, liver and kidney work in concert with drug metabolizing enzymes to control systemic drug levels. Through influx and efflux mechanisms, transporters can determine tissue specific drug levels and thus are important determinants of organ specific drug toxicities such as nephrotoxicity, CNS toxicity and hepatotoxicity. In addition, inhibition of transporters by one drug could result in drug interactions with co-administered drugs. An example of transporter mediated drug toxicity is the drug cidofovir. This antiviral drug causes nephrotoxicity; however, when administered with probenecid an inhibitor of organic anion transport in the kidney, nephrotoxicity is prevented. FDA included co-administration of probenecid on its label for cidofovir as a means of preventing nephrotoxicity. A second example is bosentan, used in the treatment of pulmonary hypertension. This drug can cause hepatotoxicity by inhibiting the bile salt export pump, BSEP, an important transporter in the liver. Thus transporters play a critical role in drug safety. It is important for the FDA to think about how to evaluate drug-transporter interactions in vivo and in vitro. The International Transporter Consortium (Working Group) consists of pharmaceutical scientists in academia, industry and in the FDA who have expertise in drug transporters. The Consortium plans to sponsor a two-day workshop, which will include topics that will form the basis of the whitepaper, including: Proposed Workshop Topics •Overview: Current Knowledge of Transporters With a Focus on what are considered to be the key transporters: the efflux transporters, MDR1 and BCRP, and influx transporters in the families of OATs, OCTs, and OATPs. •Technical Challenges: Kinetic analysis; species differences; expression systems; in vivo models; •Role of Transporters in Drug Safety and Pharmacokinetics oDrug disposition oDrug-drug interactions; transporters in disease oPolymorphisms and genetics oIn vitro - In vivo relationships oBasic biology of transporters oCorrelation between inhibition of transporters and toxicity •Tools for Studying Transporters oImaging Methods oCell lines, membrane vesicles oQuantitative PCR for Transporter Expression Levels oMouse Models (humanized and knockout mice) oQSAR Models oPB-PK Modeling oDiscovery of Transporter Specific Inhibitors; RNAi, etc… •FDA Guidances oOverview and issues relevant to transporters 3. Scope of Work The Contractor shall work within and/or develop any necessary elements to produce the following deliverable Deliverable The contractor shall conduct a scientific workshop, in collaboration with the FDA and in the context of the Statement of Work. Such a workshop shall include input and participation from multiple stakeholders including Federal and State bodies, industry, academia and other potential partners in the field of nanotechnology. The details of logistics, agenda, attendees and workshop objectives shall be developed with the FDA Project Officer and designated FDA staff, and shall be outlined in separate documents between the contractor and FDA. the work is anticipated to be completed within twelve (12) months from the effective date of this award. 4. Deliverables and Timeline The activities and deliverables under this Scope of Work must be completed during a twelve (12) month period from the date of grant of this award. SECURITY AND PRIVACY: Performance of work may require the contractor personnel to have access to and use of data and information which may be considered proprietary to a government agency or Government contractor, or which may otherwise be o such nature that its dissemination or use, other than in performance of a subsequent work statement, would be adverse to the interest of FDA or others. FDA, thereof, owns all proprietary information and all copies. The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained except to authorized FDA personnel or upon written approval of Project Officer. Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contract; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation. FDA owns all proprietary information and all copies shall be returned to the FDA upon completion of the work for which it was obtained or developed. Due to the sensitive nature of the information involved, all contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise exempt from public disclosure (e.g., Privacy Act or Data Collected Under and Assurance of Confidentiality) may be disclosed to them. CONTRACTOR CONFORMANCE WITH APPLICABLE LAWS, REGULATIONS, POLICIES, AND STANDARDS: The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at http://www.cio.gov. HHS documents are found at http://www.cdc.gov/irmo. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. ANTICIPATED AWARD DATE: The anticipated award date is May 1, 2008; however, all dates in this announcement are subject to change. PROVISIONS and Clauses: The following FAR clauses apply to this notice. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, 52.217-8 Option to Extend Services. All information received by 2:00PM EST on April 15, 2008 will be considered by the Government. All responsible sources may submit a response, which if timely received, must be considered by the FDA. Responses to this notice must be sent via email to JACLYN.STIELPER@FDA.HHS.GOV no later than 2:00 PM on April 15, 2008. No phone calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=4b05a28e118eed88f0ab6428aae78007&tab=core&_cview=1)
- Place of Performance
- Address: 10903 New Hampshire Avenue, WO51, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01549248-W 20080410/080408221442-4b05a28e118eed88f0ab6428aae78007 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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