SOURCES SOUGHT
A -- Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center
- Notice Date
- 4/8/2008
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- SS-NIH-NICHD-BPCA-DCC
- Point of Contact
- LisaColeman,, Phone: 301-402-8552, RossKelley,, Phone: 301-435-6960
- E-Mail Address
-
lc304t@nih.gov, rk17a@nih.gov
- Description
- This announcement is not a Request for Proposals (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 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 541711 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) is planning to award a contract for a BPCA Data Coordinating Center (DCC) responsible for providing the requisite personnel, facilities and services to support aspects of data collection, analysis and reporting in support of regulatory reporting for the pediatric clinical trials, and select preclinical data conducted under the authority of the Best Pharmaceuticals for Children Act (BPCA). BPCA was initially authorized by Congress in 2002 and recently reauthorized in September 2007, to improve labeling information for drugs used to treat children. This is a follow-on procurement to the initial DCC that was awarded in 2003, to Premier Research Incorporated, of Philadelphia, PA. The purpose of this synopsis is to identify small business capable of transitioning from the existing contractor, in the case that they are not the successful offeror in a competitive competition, a series of on-going clinical activities, in addition to initiating and managing new studies under BPCA. BPCA Structure – NICHD is establishing the newest phase of BPCA, by establishing a consortium of contractors to provide overall support for BPCA activities. This structure will require a high level of interaction among the various contractors and with NICHD. This structure, henceforth termed the BPCA Consortium, will work together to construct, implement, and monitor the clinical and preclinical activities within the BPCA to improve the knowledge and labeling of drugs, biologics and devices used in children. NICHD anticipates that communications and collaborations amongst all Consortium contractors will occur through regular scheduled teleconference, on-line activities, and face to face meetings. This will be accomplished with the establishment of a “Consortium Steering Committee”, which will consist of the principal investigators (or senior staff representative) off all BPCA Contractors and the NICHD Project Officers of each contractor. In the coming year, NICHD anticipates awards of the following contracts in support of BPCA: • BPCA Clinical Trials Network (CTN) to serve as the master contractor for the conduct of preclinical and clinical trial studies under BPCA. • BPCA Data Coordinating Center (DCC) to manage and house all of the data generated from the Clinical Trials Network, including leadership, tracking and submission of all FDA regulatory documents generated under BPCA. • BPCA Repository to track and store all of the biological specimens generated from BPCA clinical trial activities. • BPCA Scientific Support (SS) to provide literature reviews, scientific analyses, market surveys and conduct workshops, symposia and conferences for the development of diverse pediatric therapeutic approaches to be utilized in the prioritization and selection of pediatric therapeutics for further study by BPCA. A major responsibility of the new BPCA-DCC will be to provide state of the art data capture and sharing in order to integrate the data from the clinical trials across dissimilar clinical specialties, and clinical sites. This also includes the integration of data from preclinical studies as well. The DCC’s responsibility will be to insure integrity of the data collected and the regulatory compliance with the FDA and NICHD policies on the conduct of clinical and preclinical studies. The activities conducted by the BPCA-DCC will support data collection, data tracking, and data analysis and data storage for the generation and submission of all necessary reports to the FDA. It is expected that the Contractor will understand and be able to perform and coordinate all of the regulatory responsibilities for NIH for the submission of Investigational New Drug (IND) applications and New Drug Applications (NDA), as applicable, under the reauthorized BPCA of 2007. The regulatory requirements of BPCA 2007 also include assisting NICHD in tracking Proposed Pediatric Study Requests submitted to the FDA by NICHD Project Officers. The contractual period for this award is seven years. The responsibilities of the BPCA-DCC will fall within the following categories: • Developing a Transition Plan and continuance of regulatory support for approximately 15 ongoing BPCA clinical trials and activities that are being managed by the current BPCA coordinating center, Premier Research, Inc. • Establish and manage a data collection, data analysis, and data storage system {in the form of datasets} that will support all pediatric clinical and preclinical activities under BPCA. The data from these activities will be placed into datasets, developed and maintained by the contractor that will be submitted to the FDA in the form of a Final study report and a public use dataset. • Provide leadership and support for all regulatory requirements associated with BPCA-related Investigational New Drug (IND) Applications and New Drug Applications (NDA or supplemental NDA), including coordination and management of all communications with FDA for clinical and preclinical trials and data. • Develop, coordinate, and maintain a BPCA Data Safety Monitoring Plan, to include the establishing and maintaining a Data Safety Monitoring Board. • Provide site monitoring and training necessary for protocol implementation in all clinical and preclinical sites. • Provide Statistical leadership for the analysis of clinical trials data for submission to the FDA—includes interim analyses and analyses for final study report. • Ability to acquire and maintain a pharmacy program for ongoing BPCA clinical trials. • Participate in the Steering Committee of the BPCA Consortium and provide logistics support for the Committee A broad range of regulatory, information technology, statistical, clinical trial coordination and monitoring, and administrative expertise will be necessary to carry out the requirements of this solicitation. The contractor shall be expected to demonstrate proven expertise in providing these requirements. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: A. Provide a description and documented evidence of the experience and expertise of the staff. Provide names of projects and references, noting those in support of submission of data to FDA for new drugs, distinguishing previous experience from current projects. Response must include sufficient detail to demonstrate: 1. Experience in organizing, managing and monitoring approximately 15 on-going pediatric clinical trials at any given time, with the potential for initiating over the course of the contract up to approximately 30 drug studies, where each study may have up to 50 study sites both domestic and international. 2. Demonstrated capability and experience in performing all regulatory requirements for pediatric drug development domestically and internationally including; preclinical, Phases 1, and 2 clinical trials. This includes the capability and experience in preparation and submission of IND and NDA applications and amendments required by the U.S. FDA and other international regulatory agencies, such as the European Medicines Agency (EMEA). 3. Demonstrated capability to work in a consortium of contractors 4. Capability and experience in developing public use datasets that will inform the abeling of drugs used in children. 5. Demonstrated capability and experience in simultaneously managing multiple clinical trails domestically and internationally, and management of a large volume of data for submission to regulatory agencies. 6. Capability and experience in providing statistical leadership in the development of clinical and preclinical protocols for submission to the FDA. This includes the capability in providing statistical expertise and the development of statistical analysis plans for all regulatory submissions of BPCA clinical trials. 7. Capability and experience in training and certification for data coordinators of study sites. 8. Demonstrated capability and experience in developing and implementing standard operating procedures that detail and delineate relationships and responsibilities between the Coordinating Center and the BPCA Network, including the BPCA Clinical Trials Network (CTN), the BPCA Repository and the NICHD Program Office. 9. Capability and experience in establishing and maintaining a communication system in compliance with U.S. Food and Drug Administration (FDA) requirements for the submission of Serous Adverse and Adverse Event Reports. 10. Capability in monitoring accuracy of adverse event reporting. 11. Capability in establishing and supporting all of the activities of a Data Safety Monitoring Board. 12. Capability and experience in integrating the operations and clinical trial data of all clinical sites in performing studies for pediatric indications. 13. Capability in monitoring the accuracy, completeness and quality of data gathering, data entry, and data analysis. 14. Capability in quality control procedures, including adherence to good clinical and laboratory practices, site audits, in-house data base audits and database validation. 15. Capability and experience to assure that each clinical site has a current approved Federal Wide Assurance Number on file with the Office for Human Research Protection (OHRP). 16. Capability to acquire and maintain a pharmacy program for ongoing BPCA clinical trials. This includes the ability to ship, label, and monitor drug supply for ongoing clinical studies conducted under BPCA. 17. Provide logistical support to the BPCA Consortium Steering committee for teleconferences and meetings. B. Provide a description and documented evidence of the experience and expertise of the organizations Information Technology and Security capabilities. Response must include sufficient detail to demonstrate: 1. Experience in establishing, administering, and supporting a state of the art, efficient, reliable, secure, and responsive systems for the collection, management, quality assurance and reporting of study data, 2. Experience in establishing and supporting public use datasets that can operate under tiered access. 3. Experience in establishing a system for electronic communication linkages among the BPCA Consortium Structure, the NICHD Project Officer, and the BPCA Steering Committee. 4. Capability to develop computer programs, meeting NIH FISMA security requirements, that will support the data management, analyses, and storage for the clinical trials conducted under BPCA. This includes demonstrated capability in preparation of data and data analysis for the development of datasets that will be submitted to the FDA, published on the FDA docket, and public use datasets that can be used for peer reviewed publications, for example. Interested organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies in addition to four (4) hard copies of their capability statement, addressing the areas above. Please limit responses to fifteen (15) pages or less. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by no later than 4:00PM local time on April 24, 2008. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8 (a), or other corporate or non-corporate entity). NO COLLECT CALLS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL IN ADDITION TO THE 4 HARD COPIES. See NUMBER NOTE 25. Responses should be no more than 15 pages. These pages exclude resumes. INQUIRIES Lisa K. Coleman Contracting Officer National Institute of Child Health and Human Development NIDDK OA, National Institutes of Health 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6963 Fax: 301-402-3676 E-mail: lc304t@nih.gov OR Ross Kelley Contracting Officer National Institute of Child Health and Human Development NIDDK OA, National Institutes of Health 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6960 Fax: 301-402-3676 E-mail: rk17a@nih.gov
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