JOFOC.SMARTT.NONBIOLOGICS.2015.2.18.nir.tm.nd_Redacted.pdf

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

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

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

U.S. Department of Health and Human Services (DHHS) National Institutes of Health (NIH) National Heart, Lung, and Blood Institutes (NHLBI) Office of Management (OM) Office of Acquisitions (OA) COAC Services Branch (CSB)

b. Sponsoring organization.

National Heart, Lung, and Blood Institute Division of Lung Diseases (DLD)

c. Project Officer information.

• Project Officer name.

Timothy M. Moore, M.D., Ph.D.

DLD, NHLBI, NIH

• Mailing address.

National Heart, Lung, and Blood Institute Division of Lung Diseases 6701 Rockledge Drive, Room 10178 Bethesda, MD 20892-7952

• E-mail address.

mooretm@nhlbi.nih.gov

• Telephone number.

301-435-0222 or 301-435-0220

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The primary purpose of this acquisition is to award follow-on contracts to continue supporting the existing NHLBI, Science Moving towArds Research Translation and Therapy (SMARTT) Program. SMARTT assists translation to the clinic of novel synthetic, natural, or biologic therapeutic interventions arising in the scientific community for the treatment of heart, lung, and blood diseases. SMARTT provides resources to investigators in the areas of preclinical and clinical-grade production and testing for biologics, non-biologics and small molecules, and in the conduct of pharmacology and toxicology studies. In addition, SMARTT provides regulatory assistance to investigators wishing to conduct early stage clinical trials. SMARTT consists of: two Production Facilities (PFs) for biologics, and non-biologics and small molecules; a Pharmacology and Toxicology Center (PTC); and a Coordinating Center (CC) that provides consulting, manufacturing, preclinical study and early phase clinical trial design, administrative and regulatory expertise.

An essential component of a successful, pre-clinical research therapeutics development program is cohesion and coordination of the component tasks required to advance an entity from proof-of-concept to investigational new drug (IND) filing. This program offers a unique link between NHLBI extramural investigators and IND-enabling research services. As such, the program provides relative swiftness in translating basic science to clinical usage by providing timely, integrated service delivery and the objective of this acquisition is to continue to make these services readily available to the NHLBI investigative community.

In the initial sixty months of the program, the non-biologics and small molecules production facility participated in establishing the program, developing research plans and fulfilling requests for manufacturing of drug substance and drug product.

The objective of the non-biologics and small molecules production facility during the 36-month extension will be to complete existing non-biological manufacturing; initiate activities for investigators with approved research plans; and provide guidance with regarding to investigators, the coordinating, and/or the NHLBI, as necessary.

b. Project background.

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 (FDA) to approve an IND application. These processes can be expensive and are unfamiliar to many academic scientists.

In November of 2010, the NHLBI allocated $32 million dollars; competed and awarded four cost-reimbursement contracts to provide tailored pharmacology and toxicology testing, manufacturing services, and regulatory support to investigators in order to expedite the transition of their discoveries to the clinic. Contracts were awarded to two PFs (one for biologics and one for non-biologics and small molecules); a PTC; and a CC for a five year period of performance.

The table below lists the awardees and the estimated total amounts initially negotiated:

Contractor Contract # Estimated Total Amounts

SMARTT Biologics Production Facility:

Advanced Bioscience Laboratories

HHSN268201100014C $9,003,863

SMARTT Non-Biologics and Small Molecules: SRI International

HHSN268201100015C $5,897,735

SMARTT Coordinating Center: Research Triangle Institute

HHSN268201100016C $5,223,305

SMARTT Pharmacology and Toxicology Center: SRI International

HHSN268201100017C $11,508,730

SMARTT has been approved by the NHLBI Director for an extension of 36 months in order to continue providing services for existing SMARTT protocols/research projects and to support those scientific review board (SRB)-approved applications for which initial project plans have been developed. This extension is essential to advance active projects to IND filing, launch meritorious projects that have been found acceptable for support but have yet to begin because of capacity issues (i.e. those in the “queue,”) and to keep the SMARTT program viable for other NHLBI translational programs to leverage.

See items 5.b. and 9. for other facts supporting the use of other than full and open competition.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

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

b. Project description.

SMARTT facilitates the movement of novel molecular entities and concepts from the laboratory to the clinic for proof-of-principle clinical trials. The SMARTT program is designed to assist translation to the clinic of novel synthetic, natural, or biologic therapeutic interventions, arising in the scientific community for the treatment of heart, lung, and blood diseases. SMARTT will help Institutions bridge the gap between discovery and clinical testing, so that efficient translation of promising discoveries may take place.

The Non-Biologics and Small Molecules PF supports 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 supports translational research and provide services as a US FDA-defined current good manufacturing practice production facility for non-biological and small molecule therapy products (drug substance and drug products). The Non-Biologics and Small Molecules PF participates with the NHLBI and the other SMARTT contractors to evaluate and prioritize requests for service based on their ability to fulfill scientifically meritorious request.

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

Provide the following information:

• Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

New requirement Follow-on Other (specify): ______________________

• Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number.

https://www.nhlbismartt.org/

c. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.)

3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1(a)(2).

This acquisition is conducted under the authority of section 4202 of the Clinger- Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor.

SRI INTERNATIONAL

333 Ravenswood Avenue Menlo Park, CA 94025-3493P

b. Nature of the acquisition and proposed unique qualifications of the contractor.

The NHLBI SMARTT Program, which is constituted by the Production Facilities (PFs), the Pharmacology and Toxicology Center (PTC), a Coordinating Center (CC), and overall governance provided by a Steering Committee (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

Base Option 1 Option 2 Total

Months: 12 Months: 12 Months: 12 Months: 36

$1,185,045 $1,066,541 $959,887 $3,211,473 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

Each of the contractors participating in the SMARTT program has developed tailored project plans with the supported investigators that involve unique protocols and practices that are specific to their facilities. 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 entities or introducing new protocols or practices to other facilities would significantly delay and possibly even thwart the completion of ongoing projects.

As of December 29, 2014, 38 active projects are being supported encompassing near-full use of all PF, the PTC, and the regulatory assistance services provided through the CC.

Because project plans have been developed by the current contractors in collaboration with supported investigators, it is necessary to continue the SMARTT program under the same operating conditions using the current Manual of Procedures (MOP).

Lastly, additional pre-clinical research services requests are expected from the NIH Centers for Accelerated Innovations (NCAI), the NHLBI Vascular Interventions/Innovations and Therapeutic Advances Program (VITA), the Centers for Advanced Diagnostics and Experimental Therapeutics in Lung Diseases Stage II Program (CADET II), and NHLBI-supported SBIR/STTR grantees. Thus, the continued availability of the SMARTT Program for these programs to leverage will help maximize NHLBI’s return on investment in these early translational research programs.

The unique qualifications of the current contractor include but are not limited to the development of protocols specific to their facility and scientific approach, and are approved by the FDA. The contractor’s technical staff possesses the explicit knowledge and expertise needed to complete these already approved complex studies.

For example, one project will require 36 and 48 month stability study. The formulations for this study were developed two years ago and kept at controlled storage conditions (humidity and temperature). Transferring these samples to a different facility will comprise the sample quality, thus creating delays and incurring additional costs as the process is restarted from the beginning. Also, if material transfer has to occur, the methods developed by current contractor has to be revalidated, which is an additional cost to the Government. The revalidation will be a necessity due to inter-lab variations and regulatory requirements in such transfers. In addition, samples have been stored under controlled conditions for two years and there are only a limited amount of samples available. If these samples are lost in transit or a container breaks, it would be both a scientific and financial catastrophe for the project.

The remaining projects with approved research plans involve cGMP production of formulation. The current contractor has developed the formulations and has the knowhow and experience to smoothly translate into a cGMP production. Transferring the protocols and establishing the cGMP production in a new site will not benefit the government and may lead to loss of time and the previous investment. The loss may amount to tens of thousands of dollars.

See item 9. for other facts supporting the use of other than full and open competition.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A Presolicitation notice was posted in FedBizOpps on January 27, 2015 for 15 days. No additional inquiries or capability statements were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

This is a research and development requirement. It is impossible to pre-determine the quantities, timelines and project types that will be fulfilled by the non-biologics facility. The CO will use Cost Realism to determine cost reasonableness. The CO will perform an internal review of invoices of the contractor’s current contract number HHSN268201100015C in addition to requesting that the contractor submit current salary documentation and price quotes with their proposal.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

A Sources Sought Notice/Market Survey was posted in the Federal Business Opportunities (FedBizOpps) web site on January 7, 2015 for 15 days. No capability statements were submitted on the due date of January 22, 2015.

9. Any other facts supporting the use of other than full and open competition.

The proposed period of extension, 36 months, is minimally sufficient to allow ongoing work to be completed, including IND filings, and to allow for limited numbers of new projects to be initiated. New projects will be derived from proposals already under consideration, i.e. those that have been evaluated by the SMARTT SC and for which project plans can be prepared by the current contractors.

SRI International has been the contractor for the PF for non-biological and small molecules since 2010. They have managed exceptionally well through the technical complexities brought on by the uniqueness of each study and the unavoidable delays that often occur in research and development.

Since inception, NHLBI has obligated a total of $3,020,545.55 to support all activities related to pharmacology and toxicology testing NHLBI investigators. This includes costs incurred establishing the program, supporting activities through to IND filing processing requests for services, regulatory support, and developing project plans.

Awarding a contract to SRI International to continue as the SMARTT PF for non-biologics and small molecules in order to preserve the integrity of the science and comply with GLP standards, is the best value for the Government.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. “No other sources have expressed an interest in the proposed acquisition.”

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The NHLBI SMARTT Program provides a unique resources niche for investigators seeking to advance the development of promising interventions for clinical applications and has developed into a highly successful program both in terms of performance and output metrics. While it is anticipated that NHLBI will continue to provide mechanisms to foster pre-clinical research, other acquisitions and/or grant mechanisms to support pre-clinical research in the future may or may not include a SMARTT-like model. Therefore, it is anticipated that there will be no additional noncompetitive acquisition effort for this program beyond this planned 36 month extension.

Subsequent efforts to acquire pre-clinical research and development services in accordance with NHLBI mission-specific needs would be newly developed and no barriers to competition would be expected.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Timothy M. Moore, M.D., Ph.D.

DLD, NHLBI, NIH

Project Officer’s Immediate Supervisor

James P. Kiley, Ph.D.

Division Director, DLD, OD, NHLBI, NIH

Head of the Sponsoring

Program Office

James P. Kiley, Ph.D.

Division Director, DLD, OD, NHLBI, NIH

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Nora I. Rivera, Contracting Officer, CSB, OA, NHLBI, NIH

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting

Office

John C. Taylor, Director, OA, OM, NHLBI, NIH

Head of the Contracting

Activity

Diane J. Frasier, OALM, OM, OD,NIH

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive