SOURCES SOUGHT
B -- Evaluation of Clinical and Safety Outcomes Associated with Conversion from Brand-Name to Generic Tacrolimus products in high risk Transplant Recipients
- Notice Date
- 4/24/2013
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1116098
- Archive Date
- 5/23/2013
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Drug Evaluation and Research (CDER) Office of Generic Drugs (OGD) to identify sources that can conduct a three year study on Evaluation of Clinical and Safety Outcomes Associated with Conversion from Brand-Name to Generic Tacrolimus products in high risk Transplant Recipients. This is a Sources Sought Notice to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide the services described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, 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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The applicable North American Industry Classification System (NAICS) code is 541712, Research and Development in the Physical, Engineering and Life Sciences with a size standard of 500 employees. Though the target audience for this sources sought are small businesses, all capable parties may respond. Background Tacrolimus is the primary immunosuppressive drug used to prevent rejection of transplanted organs. It was first approved as capsule and injectable dosage forms with trade name Prograf by the U.S. FDA in 1994 and currently there are a total of six approved generic tacrolimus capsules, and more Abbreviated New Drug Applications (ANDAs) referencing Prograf capsules are pending for FDA review. The transplant community has concerns about the interchangeability of generic tacrolimus capsules in patients. It is stressed that bioequivalence (BE) of generic immunosuppressants should be demonstrated in transplant patients and subject to tighter BE standards. In addition, concerns prevail that tacrolimus blood levels must be monitored following every generic substitution, thereby offsetting some savings from generic substitution. The Agency believes that single-dose, two-way crossover BE studies in healthy subjects are generally more sensitive at detecting formulation difference than BE studies in patients that are usually carried out to the steady state. Approved generic drugs are considered interchangeable with the brand product and other approved generics under all approved indications and conditions of use, and no additional testing/monitoring of patients should be necessary when a generic substitution occurs. To address transplant community's concern, in 2012 the Agency funded a research study to compare the pharmacokinetics (PK) of two most disparate generic tacrolimus capsules (selected based on bioequivalence and pharmaceutical quality data) to Prograf in stable liver and kidney adult transplant patients. However, interchangeability of multiple generic tacrolimus capsules (e.g., >3) in high immunologic risk patients such as pediatric, African American patients and others are still questioned by the transplant community. There would be tremendous challenges to conduct conventional bioequivalence studies with multiple product switches. For example, long study duration and inconvenience to perform venous whole blood sampling, especially in high risk patients, may result in high patient dropout rate. Tacrolimus trough concentration is the most common measure of tacrolimus treatment monitoring as the area under the concentration-time curve (AUC) was shown to correlate well with the trough level. A well controlled, prospective, abbreviated pharmacokinetic study that makes a direct comparison between brand and generic tacrolimus trough concentration in high risk transplant patients after multiple product switches may help address the interchangeability issue raised by transplant community. Statement of work (SOW) or Objectives The objectives of this proposal are to monitor the tacrolimus trough concentration in high immunologic risk patient populations after switching of all marketed tacrolimus capsule products and to evaluate the necessity of therapeutic monitoring following each substitution. The outcome of this study can help respond to public concerns regarding the quality of generic tacrolimus and improve review practices of generic tacrolimus if necessary. Furthermore, it will help explore innovative study designs to compare brand and generic products in patients. At a minimum, the following studies shall be conducted in this project: 1. Retrospective analysis of clinical databases and electronic records from a large integrated healthcare systems about tacrolimus trough concentrations, as well as clinical and safety outcomes, in patient population upon tacrolimus products switch. 2. Prospective crossover study design to monitor tacrolimus trough concentrations in high immunologic risk transplant patients after switching of all marketed tacrolimus products (as indicated above). The trough concentrations shall be analyzed throughout the study period and may be conducted with the dried blood spot method. The studied tacrolimus capsule products shall be characterized in terms of potency, impurity, in-vitro dissolution, and other quality attributes. Any side effects or adverse reactions, as well as liver and kidney function (as measured by serum creatinine levels) shall be monitored in patients during the study period. Statistical analyses shall be conducted to determine whether there are any significant differences in patient trough concentrations within each product evaluation period and among different product evaluation periods. Deliverables Reports (i.e., quarterly progress reports, annual reports and final report), containing the description of experiments and data analysis, shall be provided to the FDA in both paper and electronic format. In addition, all of the raw data from the experiments shall be provided to the FDA in both paper and electronic format, along with these reports. Interested parties submitting capability statements shall be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to provide the required services. Respondents shall limit their capability statements to no more than ten (10) pages in length, and must include: 1. Provide two company names, mailing address, e-mail address, telephone number, and point of contact name, number and email address who can verify the demonstrated capabilities identified in the responses. 2. Business name, DUNS number, business address, business website, business size for NAICS 541712 and status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. 3. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN that are applicable to this potential requirement. 4. If the company has a Government approved accounting system, please identify the agency that approved the system. 5. 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.. Interested parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before May 8, 2013 by 12:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, Office of Acquisition & Grants Services, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1116098. Disclaimer and Important Notes. 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. Confidentiality. 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)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1116098/listing.html)
- Place of Performance
- Address: Contractor Facility, United States
- Record
- SN03044903-W 20130426/130424235055-a2958a9c9f20665124ed07d3ef2a75a6 (fbodaily.com)
- Source
-
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