D1 75N95024Q00564_SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW)

September 4, 2024

GENERAL INFORMATION

Title of Project:

Portfolio Impact Analysis for the Therapeutic Development Branch (TDB), NCATS

Statement of Need and Purpose:

The Therapeutic Development Branch (TDB) in the intramural Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) was established to enable preclinical development through collaborative partnerships. In alignment with accomplishing the Center’s mission, the Branch needs to conduct a portfolio impact analysis, from its inception in 2010 to present. The goal is to capture key metrics and evaluate the program’s research outcomes, including analyzing the economic and other quantitative and qualitative impact measures on further research and development and healthcare. TDB requires the expertise of a firm capable of conducting such types of specialized impact analyses of novel therapeutics and related technologies. The results of this analysis will be used by Branch leadership to inform future research policy and priorities.

Background Information and Objective:

NCATS’ mission is to turn research observations into health solutions through translational science. The goal is to generate more treatments for all people more quickly. The TDB works to enhance the development, testing, and implementation of diagnostics and therapeutics for a wide range of diseases and conditions, with an emphasis on rare (typically genetic) and otherwise neglected (typically tropical infectious) diseases. Our goal is to conduct an unbiased, objective analysis of our research portfolio (comprising approximately 100 research partnerships since 2010) in order to determine the value generated by our program in developing novel therapeutics and enabling technologies, advancing translation and innovating healthcare for all.

This review is expected to provide in-depth qualitative and quantitative analyses of publicly-available information as well as structured interviews with collaborators and key partners. The detailed findings and feedback will inform our strategic plans and future priorities for the next 10- 15 years.

Period of Performance:

The period of performance is nine months from date of award.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Specific Requirements listed below. The

CSS 75N95024Q00564

Contractor will be required to work collaboratively with TDB staff in the performance of these requirements.

Specific Requirements:

• Design an appropriate survey instrument and relevant analysis model(s) to gather and analyze the necessary quantitative and qualitative information.

o The methods utilized must be appropriate for and compatible with analysis of various outcome measures related to preclinical and clinical research and development (R&D) in support of novel therapeutics and related biomedical technologies.

o The model(s) should be able to analyze the quantitative and qualitative data to be gathered, and address the direct, indirect and induced impacts of the R&D activities (e.g., Impact Analysis for Planning (IMPLAN)).

o Prior to launching the data collection phase, the survey instrument will be discussed with and agreed to by the TDB staff.

• Gather publicly-available data and conduct surveys / interviews with collaborators and key partners (estimated 100 nominated partners / projects) to gather the necessary information to be analyzed.

• Analyze the data with the appropriate analysis tool(s) and present the information in an acceptable format that clearly conveys the outcome of the survey with respect to the subject area.

• Generate a report and presentation slides to communicate the results in a manner appropriate for consumption by multiple audiences, including NCATS leadership, advisory groups, and the general public.

o The report and presentation must articulate the methods used, results obtained, and analyses generated.

• Generate impact stories / narratives based on the findings for up to four (4) exemplar drug development project case studies.

GOVERNMENT RESPONSIBILITIES

The Government shall provide the list of collaborators / partners for the analysis; will collaborate with the Contractor in the design of the survey questions; and will provide key background data and context on the nominated collaborators / projects.

DELIVERY OR DELIVERABLES

• Communication and Collaboration o The Contractor will participate in online briefings (estimated biweekly basis) for one hour per meeting, as needed, in addition to regular email communications.

• Written Reports and Data o Monthly written reports will provide updates on the progress of the data collection and analysis.

o A final written report containing the methods, raw data, and analyzed results from responses to the qualitative and quantitative survey questions. The report will focus on the contributions and impact of NCATS’ collaborative interactions in pursuit of therapeutic development (particularly for rare diseases) on the United States or other global economies.

o The final report will be provided in a publication quality format (PDF) as well as a searchable, editable format (Microsoft Word), including graphical representation of the analyzed data (e.g., pie charts, bar graphs, tables, etc.). Raw and analyzed data will be provided in a searchable, editable format (Microsoft Excel).

OTHER CONSIDERATIONS

Key Personnel:

• Key personnel engaged in the survey design, implementation and analysis should have advanced degree(s) in relevant fields, such as MPA, MBA or PhD in Public Policy or Economics.

• The key personnel must have extensive experience in designing and conducting economics and economic impact studies.

• Prior experience analyzing R&D outputs for preclinical and clinical-stage therapeutic candidates is preferred.

Data Rights and Confidentiality of Information:

Data rights will be governed by FAR Clause 52.227-14, Rights in Data-General. Under 52.227- 14(c)(1), the Contractor must obtain approval from the Contracting Officer to assert copyright in any data first produced in performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. Under 52.227-14(d)(2), the Contractor must obtain approval from the Contracting Officer to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract. In addition, the Contractor will keep all data and information, whether provided to the Contractor by NCATS or collected by the Contractor on behalf of NCATS, confidential.