SOURCES SOUGHT
A -- Best Pharmaceuticals for Children Act (BPCA) Clinical Trials Network (CTN)
- Notice Date
- 10/30/2008
- 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, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- SBSS-NICHD-BPCA-2009-09
- Point of Contact
- Alice M. Pagán,, Phone: 301-435-6959, Elizabeth J. Osinski,, Phone: 301-435-6947
- E-Mail Address
-
alice.pagan@nih.gov, eo43m@nih.gov
- Small Business Set-Aside
- N/A
- Description
- This announcement is not a Request for Proposal (RFP) and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this synopsis is to identify small business organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement this acquisition may be solicited as a 100% small business set-aside. All small business organizations (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. This requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees. BACKGROUND The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is seeking a Small Business capable of designing, conducting and overseeing the clinical, scientific, and technical aspects of pediatric drug development, including pre-clinical studies, formulations development, and conduct of pediatric clinical trials via a network of clinical sites in order to conduct research in various pediatric therapeutics areas. These trials will be conducted under the authority of the Best Pharmaceuticals for Children Act (BPCA), which was reauthorized in September 2007, to improve labeling information for drugs used to treat children. NICHD anticipates that the clinical studies conducted under BPCA will focus on the pharmacokinetics, pharmacodynamics (PK/PD), safety and efficacy of therapeutics (drugs and devices) used in children. The purpose of this contract is to create a BPCA Clinical Trials Network (CTN) with experts knowledgeable about pediatric drug development, who through their knowledge and experience can design and conduct pre-clinical and Phase 1-3 pediatric clinical trials. Studies performed in the CTN will encompass a large range of conditions that affect children and may include, but not be limited to, studies of drugs and devices used in the following therapeutic areas: gastrointestinal diseases, including gastroesophageal reflux disease; cardiovascular diseases, including hypertension and hypotension; infectious diseases, including methicillin resistant Staphylococcus aureus (MRSA) infection; respiratory diseases, including asthma; metabolic disorders, such diabetes and obesity; oncology; neonatal research; rare diseases; and drugs or devices used in the treatment or prophylaxis of chemical or biological agent exposures. These studies will be conducted with pediatric patients, who encompass a large range of severity and age, including: out-patient ambulatory care through intensive care, and pre-term infants through adolescents. The results of these clinical trials will be used to improve the Food and Drug Administration’s (FDA) pediatric labeling of drugs. We anticipate there will be 6-12 therapeutic areas studied under this contract (anticipating 2-4 therapeutic interventions per therapeutic area). NICHD currently has a BPCA data coordinating center (DCC) under separate contract that provides data-management, data monitoring, auditing, electronic data submission to FDA and regulatory document support to/for ongoing and proposed clinical trials, and therefore will not be a requirement of this contract. Potential sources must demonstrate and document the following in their capability statements: 1) ability to manage a clinical “Network” that will be complex and capable of performing multiple pediatric trials; 2) ability to coordinate diverse clinical trial activities with other contractors, including the DCC and the NICHD repository; 3) experience in pediatric drug development; 4) capability to design, perform and analyze results of pre-clinical studies and pediatric clinical trials(both domestically and internationally); and 5) ability to identify and subcontract with investigators/clinical sites who will be responsible for recruiting neonates, infants, children, and adolescents in the various pediatric therapeutic areas described above. Organizations that submit capability statements in response to this notice will be evaluated on their ability to provide evidence of the following areas of expertise and experience: TECHNICAL REQUIREMENTS * Requisite personnel and dedicated staff with experience in managing, designing, conducting, maintaining, and coordinating clinical trial activities in the areas of PK/PD, safety and efficacy studies for pediatric patients. * Evidence of knowledge and experience in managing special complexities associated with the design and conduct of pediatric clinical trials including patient recruitment and retention, and ethical issues including those related to parental permission and patient assent. In some instances, the pediatric trials may be conducted with exemption from informed consent, which offerors should address in their statements. * Experience conducting clinical trials in accordance with Good Clinical Practice standards (GCP) and in conformance to FDA Guidance on performing drug trials in pediatric populations, which includes the maintenance of a communications system in compliance with FDA requirements for the submission of Adverse Event Reports. * An understanding of the resources and expertise needed for pre-clinical and pediatric clinical trial simulation for PK/PD, safety and efficacy trials. * Ability to manage a pediatric clinical trial that will include multiple Principal Investigators. * An understanding of adherence to Federal regulations pertaining to human research, and requirements for security and confidentiality of research records. * Ability to solicit, negotiate, award, administer, and monitor multiple, ongoing subcontracts in accordance with FAR Part 44. * Evidence of personnel and services capable of performing statistical analyses of pediatric clinical trials. * Experience providing technical support for research activities that may include: planning and conducting meetings with protocol committees; creating protocol development plans and operating protocol development teams ; drafting and editing protocols; and developing site-specific, protocol-specific budgets for each protocol. * Ability to acquire or develop pediatric friendly formulations of drugs with FDA approval as needed at specific clinical sites. Offerors shall assure that pediatric friendly formulations are manufactured in accordance with Good Medical Practices (GMP). * Ability to conduct bioavailability and bioequivalence studies, as needed. * Ability to generate a plan for acquiring, distributing, dispensing, handling, and administrating study drugs. *Ability to generate, maintain and present data necessary to meet all regulatory and reporting requirements of the FDA for labeling of pediatric indications; including maintenance of necessary datasets for submission to FDA and Investigational New Drug (IND) applications. Small Businesses that meet the applicable size standard and believe that they possess the capabilities described above are required to submit one electronic version via email to alice.pagan@nih.gov in addition to four (4) hard copies of their capability statements to the attention of Alice Pagán at the address provided below by 4:00 PM EST on November 14, 2008. See http://www.sba.gov/size/ for information on what is a small business and part 121.106 of the SBA's Small Business Size Regulations on how the SBA calculates the number of employees. Overnight deliveries should be mailed to the National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Boulevard, MSC 7510, Bethesda, Maryland 20852. Capability statements must identify the business status of the organization and should be limited to no more than fifteen (15) pages, excluding an Appendix for resumes. Resumes may be included in an Appendix which does not count in the fifteen (15) total page limit. The Appendix, which may only include resumes, is limited to fifteen (15) pages. NO COLLECT CALLS OR FACSIMILES WILL BE ACCEPTED. SEE NUMBERED NOTE 25.
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