SOURCES SOUGHT
A -- Correlation of Mesalamine Pharmacokinetics with Local Availability
- Notice Date
- 7/14/2013
- 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
- SBSS-No-FDA-SOL-1120920
- Archive Date
- 8/6/2013
- Point of Contact
- Daniel Gregory Laidlaw Feldman, Phone: 301-827-0359
- E-Mail Address
-
daniel.g.feldman@fda.hhs.gov
(daniel.g.feldman@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- SMALL BUSINESS SOURCES SOUGHT NOTICE: CORRELATION OF MESALAMINE PHARMACOKINETICS WITH LOCAL AVAILABILITY NOTE: 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 and particularly 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 (541711, Research and Development in Biotechnology, Size Standard: 500 employees). 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, 541711, 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 (i.e. FBO, www.fbo.gov). 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). BACKGROUND Establishing bioequivalence (BE) for locally acting drug products is a challenge, such as for gastrointestinal (GI) locally acting drug products, for topical drug products, and for nasal and inhalation local action drug product. Mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA), is an anti-inflammatory drug used to treat ulcerative colitis. It targets the colonic epithelia cells and acts locally in the lower GI tract. Various strategies have been applied in oral dosage form development for mesalamine including developing extended release formulations (Pentasa, and Apriso), delayed release formulations (Asacol, Asacol HD, and Lialda), and pro-drugs (sulfasalazine, olsalazine sodium, and balsalazide disodium) in order to minimize systemic absorption and maximize the local availability of mesalamine. Under the Code of Federal Regulations Title 21 Part 320 (21 C.F.R. § 320), BE is defined as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." It is well established that plasma concentration is an appropriate surrogate of drug availability at the site of action for systemically available drug products. For locally acting drug products, the active moiety reaches the site of action before it enters the systemic circulation. Therefore, only plasma concentration might not be enough to establish bioequivalence for locally acting drug products. The FDA has recommended pharmacokinetic (PK) studies as part of bioequivalence recommendations for mesalamine pro-drug products and oral products. The hypothesis is that because mesalamine is rapidly absorbed from the intestine and, the plasma concentration profile reflects the local availability of mesalamine. In addition, dissolution tests in media with different pH values that reflect conditions in GI tract are recommended for mesalamine oral products, which will ensure similar releasing between the test and reference products in vivo. To test the above hypothesis and evaluate the recommendation, the correlation between plasma pharmacokinetics with local availability of mesalamine needs to be better understood. Currently there are several modified release oral products of mesalamine approved in the U.S., including Apriso 375mg capsule, Pentasa 250/500mg capsule, Asacol 400mg tablet, Asacol HD 800mg tablet, Delzicol 400 mg capsule, and Lialda 1.2g tablet. Two major delivery mechanisms are used to determine the local availability: pH-dependent release and pH-independent controlled release. The Contractor shall use three representative products, Apriso, Pentasa, and Lialda, for this procurement. The Contractor shall use a previously established Institutional Review Board (IRB) approved protocol, study design, and approved devices to obtain plasma concentration and intestinal concentration data of mesalamine and its metabolite, N-acetyl-mesalamine, from 36 subjects (12 for each modified release products indicted below). This procurement requires measurement of local drug concentration in different GI regions, pH values, and composition of GI fluid, which requires taking samples from different sites of the GI lumen. THIS WORK IS TECHNICALLY MORE DIFFICULT THAN REGULAR PHARMACOKINETIC STUDIES WHICH ONLY TAKE BLOOD SAMPLES FOR MEASUREMENT. The following publications the FDA used to draft this procurement: Forbes A, Cartwright A, Marchant S, McIntyre P, Newton M. Review article: Oral, modified-release mesalazine formulations--proprietary versus generic. Aliment Pharmacol Ther. 2003 May 15;17(10):1207-14. Lionberger RA. FDA critical path initiatives: opportunities for generic drug development. AAPS J. 2008;10(1):103-9. Rudolph MW, Klein S, Beckert TE, Petereit H, Dressman JB. A new 5-aminosalicylic acid multi-unit dosage form for the therapy of ulcerative colitis. Eur J Pharm Biopharm. 2001 May;51(3):183-90. Zhou SY, Fleisher D, Pao LH, Li C, Winward B, Zimmermann EM. Intestinal metabolism and transport of 5-aminosalicylate. Drug Metab Dispos. 1999 Apr;27(4):479-85. PURPOSES/OBJECTIVES The purposes and objectives of this requirement are to determine if the plasma PK data is correlated with the local GI concentration and to improve the physiologically based models for colon absorption. PROJECT REQUIREMENTS To meet the purposes and objectives of this requirement, the Contractor shall perform all aspects of this study. The Contractor shall use three representative products, Apriso, Pentasa, and Lialda, a previously established Institutional Review Board (IRB) approved protocol, study design, and approved devices to obtain plasma concentration and intestinal concentration data of mesalamine and its metabolite, N-acetyl-mesalamine, from 36 subjects (12 for each modified release product). In particular, the Contractor shall: Ensure each subject receives a dose of mesalamine immediate release (IR) oral solution (Phase I) and one or more of the modified release products (Apriso, Pentasa, or Lialda) (Phase II). For Phase I of the study, the Contractor shall collect blood and urine samples and measure the concentration of mesalamine and its metabolite (N-acetyl-mesalamine) in plasma and urine. For Phase II of the study, the Contractor shall collect fluid samples in different GI regions, plasma, and urine as well as feces samples. The Contract shall measure the concentration of mesalamine and N-acetyl-mesalamine in each fluid and feces sample. The Contractor shall also measure in each fluid and feces sample GI physiological parameters, such as pH, and the GI fluid composition. Upon completion of collection of data delineated above, the Contractor shall perform pharmacokinetic data and statistical analyses for plasma concentration and GI local concentration. In addition, the Contractor shall perform physiologically based absorption modeling and simulation and validate these activities against the plasma concentration and GI local concentration data obtained from the above data collection and analysis. The Contractor shall be responsible for subject recruitment, supplies, equipment, and computational software for data and statistical analysis, modeling, and simulation. The Contractor must ensure all deliverables and tasks in this requirement meet the requirements of Sections 504 and 508 of the Rehabilitation Act of 1973, as amended, (Rehabilitation Act). The Rehabilitation Act, among other things, requires all electronic products prepared for the Federal Government be accessible to persons with disabilities, including those with vision, hearing, cognitive, and mobility impairments. The Rehabilitation Act insures Federal employees with disabilities will be able to use information technology to do their jobs and that members of the public with disabilities who are seeking information from Federal sources will be able to use information technology to access the information on equal footing with people who do not have disabilities. Information on Section 508 standards can be viewed at www.section508.gov. Work performed in this requirement shall be subject to compliance with the standards in effect as of the award date of the action. ANTICIPATED PERIOD OF PERFORMANCE The FDA anticipates a two year period of performance with an award date on or around September 10, 2013. OTHER IMPORTANT CONSIDERATIONS Established Study Protocol: The Contractor shall have an established study protocol specific to the above requirement to enable the FDA IRB to approve the study protocol for this matter within 60 days after the effective date of this procurement. Contractor Facility and Equipment: The Contractor shall have equipment and facilities for conducting all phases of the proposed research as specified above, including the appropriate instruments/devices to conduct an in vivo study that requires taking fluid samples from the small intestine and analytical instruments for measurements of mesalamine concentration in plasma and different regions in the GI tract, urine, and feces. 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 Dan Feldman at daniel.g.feldman@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, and shall include examples of successfully completing similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, Dun and Bradstreet (DUNS) number and size and business type (e.g. 8(a), HUBZone, etc.) based on the applicable NAICS code for the proposed acquisition (541711, Research and Development in Biotechnology, Size Standard: 500 employees). Potential offerors have until 7:30 am ET, Monday, July 22, 2013 to respond to the FDA.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/SBSS-No-FDA-SOL-1120920/listing.html)
- Place of Performance
- Address: Contractor's Facilities, United States
- Record
- SN03115844-W 20130716/130714233015-2bcd5b927c0ca151e57539363442922b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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