SOURCES SOUGHT
B -- Joint Workshop-Cytokines as Therapeutic Agents
- Notice Date
- 8/8/2008
- Notice Type
- Sources Sought
- NAICS
- 813319
— Other Social Advocacy Organizations
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- FDA1047454
- Archive Date
- 8/29/2008
- Point of Contact
- Nicholas E Sartain,, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- THIS IS FOR MARKET RESEARCH PURPOSES ONLY, NOT A REQUEST FOR PROPOSAL OR SOLICITATION. The Food and Drug Administration, Jefferson Laboratories, in Jefferson, Arkansas, is seeking business sources, including service-disabled veteran-owned small businesses, HUBZone small businesses, and 8(a) certified companies. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The government is seeking capability statements from sources that are capable of providing a Joint Workshop on: “Cytokines as Therapeutic Agents: Finding a Path Forward” I. Background: The mission of the FDA Center for Drug Evaluation and Research (CDER) is to assure that safe and effective drugs are available to the American people. CDER promotes, protects and enhances the health of the public through drug development, evaluation and continued safety monitoring throughout the drug life cycle. To accomplish its mission CDER must contend with many important challenges. Failure rates in clinical development have remained largely unchanged over the past two decades. FDA’s Critical Path Initiative (CPI) seeks to identify and address scientific and technical obstacles to optimize the development of safe and therapeutically important medical products. Under the Critical Path Initiative (CPI), FDA is trying to identify innovative ways to enhance drug development and reduce the time it takes to bring therapeutically important and safer medical products to the market by leveraging prior knowledge. To date, recombinant and purified cytokines have fallen short of their promise as therapies. Despite outstanding therapeutic promise and sound scientific rationale, most cytokine therapies have failed to establish clinical utility. The FDA seeks to establish a forum for joint discussions with the biopharmaceutical industry to facilitate product development for unmet medical needs in the context of the agency’s Critical Path Initiative. The purpose of this workshop is to provide a forum to discuss the successes and failures of recombinant cytokines as therapeutic agents for treating human diseases, including cancer and autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. This conference will provide a forum to review the scientific and clinical basis of both successful and unsuccessful attempts to develop cytokines as therapeutic agents. It will also provide a forum to develop strategies to increase the probability of clinical success of recombinant cytokines as therapeutic agent’s in future clinical trials. The meeting is designed as a forum to critically assess the factors that are limiting the clinical development of cytokines as therapeutic agents. The FDA anticipates participation by scientists and clinicians from other federal agencies (e.g., NIH, NIST), the biopharmaceutical industry, academic institutions, consortia that may contribute to future clinical trials (e.g., Biomarker/Genomic Consortia) and others to actively participate in this unique conference. The overall goal of the workshop is to identify areas for improvement and to coordinate, develop and disseminate novel approaches to current scientific hurdles that are impairing the development of cytokine products. II. Objective: FDA wishes to collaborate on the development of a scientific workshop to address the role of cytokines as therapeutic agents. III. Scope of Work: The Contractor shall work within and/or develop any necessary elements to produce the following two (2) deliverables within a twelve month (12) period. Should it be necessary to extend the period over which this work is to be completed, a no-cost extension may be requested in writing. Such a request must be reviewed and approved by the FDA Project Officer with concurrence from the FDA Contracting Officer. All data and outcomes associated with this scope of work shall be provided through the Program Officer, to the FDA on both electronic format and in hard copy. A final report shall be prepared by the Contractor, summarizing the deliverables of this award. This report must be submitted to the FDA Project Officer electronically and in hard copy. Any public disclosure of the aforementioned report and outcomes must be reviewed by the FDA Program Officer and designated staff, and cleared for dissemination. Deliverable #1 The contractor shall conduct a forum, in collaboration with the FDA and in the context of Sections 1 and 2 of this 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. 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. Deliverable #2 The Contractor shall, with input from meeting participants, other stakeholders and FDA staff, lead the development and publication of a workshop. Such a workshop may contain, but may not be limited to discussion of the following elements: •improved methods for identifying disease targets, •alternative methods for enhancing and targeting cytokine delivery, and •physicochemical modification of cytokines to prolong their bioavailability The associated North American Industry Classification System (NAICS) Code is- 813319- Other Social Advocacy Organizations; Small Business Size Standard is $6.5 million. Potential contractors must indicate business size, proof of any set-aside certification and company’s DUNS number and provide a contact name, the mailing address, phone number and email address of point of contact. Please provide the following information to determine if the company can meet the requirement. At a minimum provide the following: Capability statements must include experience with scientific conferences and the offeror’s ability to bring together leading scientists from academia and industry, as well as junior investigators, engineers, physicians, executives, policy makers, educators, media and government officials in an impartial environment creating an open forum for discussion of current research, its applications and implications. Interested Contractors must respond with capability statements which are due in person, by postal mail, fax or email to the point of contact listed below on or before August 14, 2008 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OSS/OFFAS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference solicitation number FDA1047454. For information regarding this market survey, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=33f4d782f9065bac179030849f844e5b&tab=core&_cview=1)
- Place of Performance
- Address: 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01635809-W 20080810/080808224319-33f4d782f9065bac179030849f844e5b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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