Presol.Notice.SMARTT.Non-Biologics SmallMolecules.pdf

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

HHS-NIH-NHLBI-CSB-HL-2016-13-NIR

Science Moving towArds Research Translation and Therapy (SMARTT), Non-Biologics & Small Molecules Production Facility (PF) – Program Extension (Follow-on)

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO

AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the Division of Lung Diseases intends to negotiate and award a single cost reimbursement contract without providing for full and open competition to SRI International in Menlo Park, California to continue supporting the SMARTT Program for the production and testing of novel therapeutics to treat heart, lung, and blood diseases. The award would extend Non-Biologics and Small Molecules Production Facility services for an additional 36 months and allow the facility to complete research projects in progress and initiate activities for investigators with approved research plans. The award will have a base period of 12 months and two option periods of 12 months each option period.

SMARTT website: https://www.nhlbismartt.org/

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541712 with a Size Standard of 500.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-78, December 24, 2014. This acquisition is conducted under the procedures as prescribed in FAR subpart 15—contracting by Negotiations at an amount exceeding the simplified acquisition threshold ($150,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

DESCRIPTION OF REQUIREMENT

In support of the SMARTT Program investigators, the Non-Biologics and Small Molecules PF will complete production of non-biological and small molecules therapeutics for existing protocols and begin providing services to investigators with approved research plans. The Non-Biologic and Small Molecules PF will: 1) participate in the Steering Committee (SC), and subcommittees as necessary, and attend SC meetings and participate in teleconferences, 2) provide, maintain and update a Manual of Procedures (MOP), 3) issue customer satisfaction surveys to investigators to evaluate the quality, acceptability, and timeliness of the product and service provided, 4) maintain and provide updates to the CC as needed, 5) produce scalable clinical and/or research grade non-biologic and small molecule therapeutic products, in accordance with Good Manufacturing Practices (GMP), as defined by the Food and Drug Administration (FDA), and applicable Federal and State regulations, for use by investigators studying a heart, lung or blood topic, 6) prepare and ship products, in accordance with the MOP and Federal and State guidelines, upon completion of GMP production and testing, 7) maintain product-related inventories in a secure and confidential manner, 8) monitor facilities to ensure quality control of product production and accuracy and completeness of production data, and maintain and make available for review, as necessary, records of monitoring activities, and 9) prepare materials for and participate in site visits to the contractor’s https://www.nhlbismartt.org/ facilities and ensure that up-to-date versions of all required certifications, inspections, and assurances are available for review during site visits.

Background The National Heart, Lung, and Blood Institute (NHLBI) has made many contributions to translational research through support of investigator-initiated research and development of targeted programs.

However, it has been recognized that translation of basic science discoveries to clinical application has barriers at different points along the translational pipeline. Pre-clinical development is the first step in turning discoveries into cures. Nonclinical studies and drug substance manufacturing need to comply with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) in order for the U.S.

Food and Drug Administration to approve an Investigational New Drug (IND) application. These processes can be costly and are unfamiliar to many academic scientists.

To bridge the gap that exists in moving scientific discoveries to clinical application, the NHLBI established and supports a Science Moving towArds Research Translation and Therapy (SMARTT) program for the production and testing of novel therapeutics to treat heart, lung, and blood diseases. This program serves NHLBI investigators and consists of: 1) a Production Facility (PF) for biologics; 2) a PF for non-biologics and small molecules; 3) a Pharmacology & Toxicology Center (PTC); and 4) a Coordinating Center (CC). SMARTT provides consulting, manufacturing, pharmacology and toxicology testing; preclinical and early phase clinical study design support, and administrative and regulatory expertise. The CC monitors and coordinates the organizational and regulatory aspects of the SMARTT Program. The PTC conducts pharmacology and toxicology testing of potential biologic, non-biologic, and small molecule therapeutics. The PFs support translational research. The PFs evaluate and prioritize requests for service based on their ability to fulfill the request. The biologic, non-biologic and small molecule products are primarily intended for clinical use within the United States. Products may be released by the PF for clinical use only under an Investigational New Drug (IND) issued by the US Food and Drug Administration (FDA).

In November of 2010, the NHLBI awarded four contracts to establish the SMARTT Program to provide tailored pharmacology and toxicology testing, manufacturing services, and regulatory support to investigators to expedite the transition of their discoveries to the clinic. Contracts were awarded to two PFs for biologics, and non-biologics and small molecules; a PTC; and a CC for a five year period of performance.

The current contracts are as follows:

1) HHSN268201100014C, SMARTT Biologics Production Facility

2) HHSN268201100015C, SMARTT Non-Biologics & Small Molecules Production Facility

3) HHSN268201100016C, SMARTT Coordinating Center

4) HHSN268201100017C, SMARTT Pharmacology & Toxicology Center

In December 2014, the SMARTT Program was approved for an extension (follow-on) of 36 months to continue providing services in support of existing and new SMARTT protocols/research. This extension is needed in order to continue supporting active projects to IND filing, launch projects that have been found acceptable for support but have yet to begin, and to keep the SMARTT Program available for other NHLBI translational programs to leverage.

As of December 29, 2014, 38 active projects are being supported encompassing use of all PF, the PTC, and the regulatory assistance services provided through the CC. The active projects have been developed under the current contracts. In addition, the SMARTT Program continues to receive between 7-11 new requests for services per quarter from NIH/NHLBI funded investigators.

Purpose and Objectives The purpose of the Non-Biologics and Small Molecules PF is to support the SMARTT Program by producing and testing novel therapeutics to treat heart, lung, and blood diseases. In addition to evaluating and prioritizing request for services, the Non-Biologics and Small Molecules PF will continue to support translational research and provide services as a US FDA-defined current good manufacturing practice production facility for non-biological and small molecule therapy products. The Non-Biologics and Small Molecules PF will complete production of non-biologics and small molecules therapeutics of existing protocols and initiate activities on approved application with already developed research plans.

Period of Performance The Government intends to negotiate one (1) cost-reimbursement contract for a base period of 12 months and two 12-month option periods. The approximate date of award is March 2, 2016.

Other Important Considerations

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the incumbent’s unique technical ability to complete existing and approved projects without compromising the scientific integrity of the projects, causing transitional delays, and incurring additional cost to the Government. A market research was conducted as prescribed in FAR Part 10—Market Research. The sources sought notice published in the FedBizOpps on January 9, 2015, HHS-NIH-NHLBI-CSB-RDSS-HL-2016-13-NIR, Science Moving towArds Research Translation and Therapy (SMARTT), Non-Biologics & Small Molecules Production Facility (PF) – Program Extension (Follow-on).

The NHLBI SMARTT Program, which is constituted by the PFs, the PTC, a CC, and overall governance provided by a SC, functions as a single entity to meet its objective of advancing promising new therapeutics into clinical applications for heart, blood, lung, and sleep disorders. A key feature of the program is that it can efficiently coordinate the multi-level tasks being performed by individual contractors to accomplish the greater goal of advancing an investigator’s concept to IND filing. As such, the investment into this program by NHLBI is yielding more output e.g. numbers of INDs, than would be predicted to occur if investigators had to seek out the necessary IND-enabling services on their own.

SMARTT is an accessible platform for NHLBI investigators to utilize pre-clinical resources when their science is ready; 70% of SMARTT-supported projects derive directly from NHLBI grants. In addition, SMARTT is an educational asset where Investigators learn how to effectively engage in early translational research by being active participants with the contractors to develop project plans and interact with the FDA on important regulator issues. SMARTT has developed into a truly collaborative Public-Private Partnership where the contractors, NHLBI Staff, and investigators all work together to provide the time and resources needed to advance each potential therapy to first-in-human exposure.

Open communication lines between contractors that otherwise compete for pre-clinical research customers has resulted in streamlined development paths and conservation of resources.

The inception of the SMARTT Program required a 12 month phase-up period for key activities to be designed. For example, request for services applications, a format for feasibility assessment and customer satisfaction surveys for products and services, an electronic database for use in capturing information conveyed to and from groups associated with the studies, a secure and password-protected Internet web site with pages for each of the program facilities (PFs and PTC), site visits to ensure that program facilities (PFs and PTC) continually possesses all required certifications, inspections, and assurances, development of a Manual of Procedures (MOP), the development of the program marketing plan and marketing of the program to the research community, all had to be developed before any research support could be provided to investigators. Due to the iterative nature of IND-enabling research, and due to the time needed to develop a functional cohesion in operations between the participating contractors, performance metrics used for SMARTT indicate the program was only maturing after the first 30 months.

However, performance metrics for the past 20 months reveal that SMARTT is now highly functional as a service entity for NHLBI investigators, and the IND output has gone from a single IND filed in February 2013 to a predicted IND filing of 13 applications by November, 2015, with an additional 6 INDs that could be filed within the first year of a Program extension.

As the contractor for the SMARTT Program’s Non-Biologics and Small Molecules PF, SRI International has developed tailored project plans with the supported investigators that involve unique protocols and practices. In addition, project plans are designed to be coordinated with the protocols and practices of the other participant contractors so that efficiency of time and money can be obtained. Transfer of protocols and practices to other facilities would jeopardize the integrity of the science.

The proposed period of extension, 36 months, is minimally sufficient to allow ongoing work to be completed by the Non-Biologics & Small Molecules PF, including IND filings, and to allow for limited numbers of approved projects with already developed project plans, to be initiated. Awarding a contract to SRI International to continue as the SMARTT Non-Biologics and Small Molecules PF and preserve the integrity of the science, is the best value for the Government.

Other SMARTT Program extension related notices include:

1) HHS-NIH-NHLBI-CSB-HL-2016-11-NIR

Science Moving towArds Research Translation and Therapy (SMARTT), Coordinating Center (CC) – Program Extension (Follow-on)

2) HHS-NIH-NHLBI-CSB-HL-2016-12-NIR

Science Moving towArds Research Translation and Therapy (SMARTT), Biologics Production Facility (PF) – Program Extension (Follow-on)

3) HHS-NIH-NHLBI-CSB-HL-2016-14-NIR

Science Moving towArds Research Translation and Therapy (SMARTT), Pharmacology & Toxicology Center (PTC) – Program Extension (Follow-on)

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. A determination by the Government not to compete this proposed contract solely within the discretion of the Government. This notice expires on Tuesday, February 11, 2015 at 8:30 a.m. Eastern.

Contact Information: Nora I. Rivera, Contracting Officer at riverani@nhlbi.nih.gov or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Suite 6030, Bethesda, MD 20892-7902. Faxes will not be accepted.

mailto:riverani@nhlbi.nih.gov