A -- Best Pharmaceuticals for Children Act Pediatric Clinical Trials Network

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 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 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 a multi-site network of clinical sites 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 recently 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, safety and efficacy of therapeutics used in children. The purpose of this contract is to create a BPCA Clinical Trials Network with experts knowledgeable about pediatric therapeutics that can inform the prioritization process for BPCA {through literature reviews, health services data, and information from unpublished data}, conduct pre-clinical activities, design pediatric clinical trials, and perform Phases I-III clinical trials. These studies will encompass a large range of conditions that affect children and may include, but not be limited to studies of drugs used in the following therapeutic areas: Cardiovascular Diseases, including the treatment of Hypertension and Hypotension; Infectious Diseases, including the treatment of MRSA; Respiratory Diseases, including the treatment of Asthma; Metabolic Disorders, such as the treatment of Diabetes and Obesity; Bioterrorism therapeutics research; Oncology; Neonatal research; and Rare Diseases. 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 drugs studies conducted under this contract. NICHD currently has a BPCA data coordinating center 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, which will not be a requirement of this contract. Potential sources must demonstrate and document the following in their capability statements: 1) experience in pediatric drug development; 2) capability to perform pre-clinical studies; 3) ability to design the clinical trials; 4) 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; and 4) ability to serve as a repository for biological samples and clinical data. The offeror shall oversee and coordinate all aspects of a pediatric clinical trial network, which will require recruitment of pediatric patients (both domestically and internationally) in the various therapeutic areas stated above, who may be critically ill, patients in an ambulatory care setting, or a very small population of patients that require specific expertise. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise by providing evidence of the following: Technical requirements - Requisite personnel and dedicated staff with experience in designing, conducting, maintaining, and coordinating clinical trial activities in the areas of pharmacokinetics (PK), pharmacodynamics (PD), safety and efficacy studies for pediatric patients. - Evidence of knowledge of the issues/complications associated with the design and conduct of pediatric clinical trials, including, recruitment, ethical issues, and issues relating to parental consent and patient assent. In some instances the pediatric trials may be conducted with exemption from informed consent ?which should be addressed in offerors? statements. - Experience in PK/PD modeling expertise in order to develop and write PK studies for the clinical sites, as well as, staff capable of conducting subset analyses of PK data. - Evidence of personnel and services to develop and review new and ongoing research activities, which will include the provision of pre-clinical studies and statistical analysis development and expertise. o Pre-clinical, clinical and statistical analysis services will include scientific, technical, and administrative support for the development, implementation, and analysis of the specified research. - Evidence of maintaining experienced staff capable of creating pediatric friendly formulations of drugs being studied that will be provided to the clinical sites in appropriate forms. In addition, the offeror should have the ability to conduct bioavailability studies, as needed; and assure that pediatric friendly formulations are manufactured in accordance with Good Medical Practices (GMP). - Ability to identify, and when necessary, contract with experts experienced in specific pediatric therapeutic areas including experts who may help develop and prepare Proposed Pediatric Study Requests. - Experience in planning and conducting meetings with protocol committees, investigators, data monitoring committees, and technical support for research activities. - Experience with creating and operating protocol development teams and protocol development plans; drafting and editing protocols; maintaining necessary documentation for application submissions in compliance with FDA requirements. - Ability to develop site-specific, protocol-specific budget for each protocol. - An understanding of the resources and expertise needed for pediatric clinical trial simulation including PK/PD, safety and efficacy. - The ability to solicit, negotiate, award, administer, and monitor multiple, ongoing subcontracts in accordance with FAR Part 44 - The ability to generate, maintain and present data necessary to meet all regulatory and reporting requirements of the FDA in regard to labeling for pediatric indications; including maintaining necessary datasets for submission to FDA and including Investigational New Drug (IND) applications. - Experience in monitoring protocols including implementation, ;Internal Review Board (IRB) review and approval prior to protocol initiation, patient assent/consent and confidentiality requirements, Federal bioresearch regulations and requirements for security and confidentiality of research records. - Experience in conducting clinical trials in accordance with Good Clinical Practice standards (GCP) and in conformance to FDA Guidance on performing drug trials in pediatric populations, including maintenance of a communications system in compliance with FDA requirements for the submission of Adverse Experience Reports. - Ability to generate a plan for acquisition, distribution, dispensing, handling, administration, and accountability of study drugs. - Ability to monitor and enforce that relevant clinical site staff completes annual human subjects training; as well as training for staff of subcontracted clinical and laboratory centers in procedures for implementing and conducting specific protocols. - Ability to create and maintain relational databases that can be used across each clinical trial; requiring creative programming capabilities and database management expertise. - Ability to provide repositories for biological samples and the ability to support ancillary studies that may develop from the parent clinical studies. - Ability to obtain and conduct analyses of published and unpublished literature on the use of identified drugs in identified populations is required in pharmacoepidemiology research. Interested organizations that believe they possess the capabilities necessary to undertake this project should submit four (4) hard copies of their capability statement, addressing the areas above. 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 November 26, 2007. 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 2 HARD COPIES. See NUMBER NOTE 25. Responses should be no more than 15 pages. These pages exclude resumes.