SB_Sources_Sought_PTN_1-3-24_1.pdf

SOURCES SOUGHT ANNOUNCEMENT

Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network (PTN)

75N94024R00008

Synopsis:

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources to perform a potential requirement; (2) whether they are small businesses; 8(a) small businesses, veteran owned small businesses; woman owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification system (NAICS) code for the potential acquisition. Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a small business set aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The requirement is assigned a code of 541715 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1,000 employees or less.

Background:

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides direct support for clinical research and clinical research networks that focus on particular diseases or public health issues. One of the goals of NICHD is to conduct research to better understand the effects and effectiveness of pharmaceuticals on maternal and child health. This initiative will ensure that NICHD is able to access quickly and efficiently experts with the ability to support studies relating to pediatric drug and device development.

The NICHD is seeking for small businesses capable of designing, conducting and overseeing the clinical, scientific, and technical aspects of pediatric drug development, including, but not limited to, pre-clinical studies, formulations development, and Phase 1-3 pediatric clinical trials.

Purpose and Objectives:

The purpose of this initiative will be to recompete a Pediatric Trials Network (PTN) with experts knowledgeable in pediatric drug development, who through their knowledge and experience, can design, conduct and manage pre- clinical and pediatric clinical trial activities in various pediatric therapeutics areas. This "Network" will support NICHD pediatric drug development activities, primarily, but not limited to, trials that can achieve the objectives of the Best Pharmaceuticals for Children Act (BPCA), which was reauthorized in 2022 to improve labeling information for drugs used to treat children. NICHD anticipates the clinical studies conducted by the Network will focus on the pharmacokinetics (PK), pharmacodynamics (PD), safety and efficacy of therapeutics (drugs and devices) used in children.

Under the current contract, over 150 drugs/therapeutics and 50 conditions/indications have been prioritized.

*46 clinical trials have been sponsored and/or co-sponsored by the NIH, and Clinical Study Reports (CSRs) for 26 of these trials have already been submitted to the FDA for a potential label change, with 19 label changes as of November 2023.

Therefore, the BPCA Program is planning to continue with the current infrastructure approach. Over the life of the contract NICHD anticipates the need to initiate activities in approximately five (5) to ten (10) therapeutic areas with multiple therapeutic approaches for each therapeutic area. These activities will require multiple scientific and clinical investigators with expertise in various disease areas such as Infectious diseases, Treatment of neonatal diseases, Acute Care, Obesity related pharmacology, Lactation related pharmacology, and Training in clinical pharmacology.

Under this requirement, NICHD anticipates the need to initiate approximately 10-15 NEW clinical trials throughout the life of the contract involving more than 75 clinical research sites. The PTN is responsible for protocol development, central Institutional review board (IRB) management, and clinical site management and monitoring.

A data coordinating center (DCC) will be awarded under a separate contract that will provide 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 initiative.

Project Requirements:

Small businesses that believe they possess the capabilities necessary to undertake this project must demonstrate and document the following in their capability statements, the ability to: manage a complex, clinical "Network" of approximately 30 on-going pediatric clinical trials/projects and up to 10 additional new trials/projects added yearly with approximately 15 clinical study sites, per clinical trial; 2) develop pediatric formulations; 3) provide researchers who possess experience in pediatric drug development; 4) coordinate diverse clinical trial activities with other contractors, including the DCC and the NICHD repository; 5) design, perform and analyze results of pediatric clinical trials (both domestically and internationally); and 6) identify and subcontract with investigators/clinical sites who will recruit 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 demonstrated evidence of their ability to provide 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 both in the US and abroad.

• Evidence of experience in managing special complexities associated with the design and conduct of multiple and concurrent 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. Respondents should state their understanding and experience with the informed consent exemption process.

• Evidence of knowledge and experience in producing new pediatric-friendly formulations according to Good Manufacturing Practice (GMP) standards.

• Experience conducting clinical trials in accordance with Good Clinical Practice (GCP) standards 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.

• Experience conducting pediatric clinical trials under regulatory rigorous requirements including Investigative New Drug (IND) applications.

• An understanding of the resources and expertise needed for pediatric clinical trial simulation for PK/PD, safety and efficacy trials.

• Evidence of personnel and services capable of performing statistical analyses of pediatric clinical 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.

• 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. Demonstrate the need to ensure that pediatric-friendly formulations are manufactured in accordance with 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 the DCC in order 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.

Anticipated Period of Performance:

The Government expects to award an Indefinite Delivery Indefinite Quantity (IDIQ) contract in 2024 with an ordering period of eight (8) years.

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 Sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this Notice. This notice is for information purposes only.

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).

Responses and Capability Statements:

Interested Small Businesses that believe they possess the capabilities necessary to undertake this project should submit an electronic copy of their capability statement addressing the areas listed above to the attention of Elizabeth Osinski, Contracting Officer, (E-mail: eo43m@nih.gov) and Alice Pagán, Contracting Officer (E-mail: alice.pagan@nih.gov).

Please state clearly in the subject line of the email that it is in response to the Sources Sought notice no.75N94024R00008. Please limit responses to 20 pages or less, exclusive of resumes. Electronic capability statements should be received by the Contracting Officers by 4:30 PM Eastern time on January 18, 2024. Respondents must submit their capability statement via electronic submission only.

Capability statements must identify the 1) organization name, address, point of contact, contact phone number, and email address; 2) Small Business status of the organization, NAICS code along with DUNS number, size and type of business (e.g., 8(a), HUBZone, etc.). No phone calls will be accepted. The designated NAICS code for this effort is 541715 and the size standard is 1,000 employees or less.