JOFOC.SMARTT.CC.2015.2.25-NR_Redacted.pdf

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

Science Moving towArds Research Translation and Therapy (SMARTT), Coordinating Center (CC) – Program 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 the proposed extension 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 coordinating center participated in establishing the program, developing governance and request for services submission and evaluation processes, a program manual of procedures, project and program metrics, customer satisfaction surveys, clinical development plan and gap analysis templates, monthly reporting procedures, information technology infrastructure and maintenance, meeting management processes and deliverables, marketing plans, slide presentations and dynamic metrics reporting.

The objective of the Coordinating Center during the 36-month extension will be to continue managing and coordinating the organizational aspects of the SMARTT Program, delivering regulatory affairs support services to SMARTT investigators, administering subcontracts and responding to ad hoc requests from NHLBI staff.

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 on page 3 lists the awardees and the estimated total amounts initially negotiated:

Contractor Contract # Estimated Total Amounts

SMARTT Biologics Production Facility:

Advance 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 now 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.

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 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.

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), Coordinating Center (CC) – 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 Coordinating Center supports SMARTT by providing program specific operational, regulatory affairs, infrastructure and other logistical/administrative support. The CC consults and provides preclinical study and early phase clinical study design support, and administrative and regulatory expertise. The CC will continue monitoring and coordinating the organizational aspects of the SMARTT Program.

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)(1).

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(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

RESEARCH TRIANGLE INSTITUTE

3040 Cornwallis Road

RESEARCH TRIANGLE PARK NC 27709-2194

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

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

Base Option 1 Option 2 Total

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

$991,868 $892,682 $803,413 $2,687,963 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.

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). Furthermore, the SMARTT program continues to receive between 7-11 new requests for services per quarter, but decisions to advance meritorious projects are on hold. 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.

During the past three years, the government has been investing approximately $1,000,000 per year on the regulatory support services only provided by this contractor per year to support program initiation, including the development of governance procedures, processes for proposal receipt and review, program and project management procedures and metrics, a website, marketing plans and deliverables, a manual of procedures, and administrative procedures plus reports and related deliverables.

The unique qualifications of the current contractor are that they are the governing body of the SMARTT program. RTI possess SMARTT program specific knowledge and expertise needed to manage the interrelatedness and complexities of the workflows associated with an electronic application process and active SMARTT projects, the provisions of IND-enabling regulatory affairs support specific to SMARTT applications for services, coordination and collaboration with other SMARTT contractors.

Transitioning the governing body of the SMARTT program to another contractor would cause a three to six months delay for all SMARTT facilities and projects while SMARTT activities, website availability, and current projects are fully migrated to the new contractor. The estimated cost for transitioning SMARTT to another new contractor is estimated at $1,025,933.

Lastly, the current contractor is bound by Non-Disclosure Agreements that prohibits them from sharing intellectual property belonging to an investigator and protects the current contractor from having to share proprietary information and/or trade secrets

See item 9.

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 the Federal Business Opportunities on January 27, 2015 for 15 days notifying business of the Government’s intent to award a contract to Research Triangle Institute so that they may continue as the Coordinating Center for the SMARTT program. There were no additional submissions from interested parties received by the expiration date, February 11, 2015.

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. The predetermination of the quantity, timelines and study types the biologics facilities will be manufacturing for cannot be predetermined. 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 HHSN268201100016C 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 was posted in the Federal Business Opportunities on January 7, 2015 for 15 days inviting small businesses to submit capability statements for the requirement. One response from a small business was received. The capability statement was reviewed by an NHLBI subject matter expert. He determined that the contract would not be capable of transitioning the requirement without causing significant delays to ongoing projects.

Transitioning the programs to another contractor for 36 months would be an additional cost to the Government and not the best value to the Government.

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.

Research Triangle Institute has been the Coordinating Center contractor since 2010. They have successfully coordinated all activities pertaining to the establishment of the SMARTT program.

They have effectively managed all the complexities brought on by the uniqueness of the multiple activities previously identified, which occur in investigational drug development.

Since inception, NHLBI has obligated a total of $4,839,917 to support all activities related to establishing the SMARTT program and coordinating essential activities. This includes and is not limited to developing a program web site, MOP, supporting activities through to IND filing processing requests for services, regulatory support, and developing project plans.

Awarding a contract to RTI International to continue as the SMARTT CC and preserve the integrity of the science, is the best value for the Government.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Rho Federal Systems Division, Inc. 6330 Quadrangle Dr. Chapel Hill, North Carolina 27517 DUNS 362726007; NAICS 541712 (Small Business)

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 developed de novo 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