D-COHRe Strategic Partnership Solicitation.pdf

Strategic Partnership Solicitation for Decentralized Clinical Operations for

Healthcare and Research (D-COHRe)

U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response

Office of Biomedical Advanced Research and Development Authority Division of Research, Innovation, and Ventures (DRIVe)

Washington, DC 20201

June 20, 2023 (Original Solicitation Posted Date) June 28, 2024 (Revised via Amendment 005)

Decentralized Clinical Operations for Healthcare and Research

(D-COHRe) Strategic Partnership Solicitation

1. Overview

1.1. Background

The COVID-19 pandemic necessitated new models of healthcare to curb the pandemic and empower patients due to resource limitations across the entire healthcare sector. This included the establishment of pop-up clinics, drive-through testing sites, test-to-treat programs, and an increase in utilization of decentralized care, such as telemedicine, retail clinics, and wellness apps and physiological monitors. As the clinical demand for medical countermeasures remained high (e.g., point of care diagnostics, vaccines, antivirals, etc.), the public health emergency (PHE) also daylighted the need for clinical trial modernization, a shift from centralized clinical studies to an ability to rapidly validate and distribute broad sets of medical countermeasures1 (MCMs) in the clinical settings for which they were designed. Although this shift towards patient-centric care and use of decentralized care facilities has become the norm, the pivot with conducting clinical studies in such clinical settings, has not readily been adopted.

Millions of Americans do not have immediate access to a primary care physician2 and instead rely on non-traditional healthcare. Retail pharmacies delivering such services are increasingly accessible, within miles of most Americans3 and telemedicine has seen a greater than 30x increase in usage since before the pandemic and it is projected to continue to grow allowing patients to get the care they need closer to their home4. This sets the foundation for the ability to enhance clinical trial research capabilities leveraging the existing decentralized healthcare infrastructure utilized by Americans every day. The vision is that such decentralized care facilities, i.e., retail pharmacies, telemedicine providers, urgent care clinics, etc., can be the future of clinical studies, allowing MCM developers to easily recruit, enroll, and retain participants for clinical studies where they are seeking care today. This solicitation provides a mutually beneficial opportunity for BARDA to partner with healthcare service organizations to leverage and enhance decentralized care capabilities in order to ultimately conduct clinical research expeditiously with participants directly in the settings for which they are seeking care, enhancing the Nation’s ability to prepare and respond to future PHEs.

1.2. Introduction

The Office of Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S Department of Health and Human Services (HHS) is issuing a Strategic Partnership Solicitation to establish partnerships with organizations providing decentralized healthcare services (i.e., retail pharmacies, telemedicine, urgent care, mobile health clinics) or with Clinical Research Organizations (CROs) that have decentralized capabilities (i.e., decentralized sites, virtual

1 Medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency. www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures 2 Characteristics of Americans With Primary Care and Changes Over Time, 2002-2015 | Ethics | JAMA Internal Medicine | JAMA Network 3 Black LI, Adjaye-Gbewonyo D. Urgent care center and retail health clinic utilization among adults: United States, 2019. NCHS Data Brief, no 409. Hyattsville, MD: National Center for Health Statistics. 2021. DOI: https://dx.doi.org/10.15620/cdc:106463 4 Lucas JW, Villarroel MA. Telemedicine use among adults: United States, 2021. NCHS Data Brief, no 445. Hyattsville, MD: National Center for Health Statistics. 2022. DOI: https://dx.doi.org/10.15620/cdc:121435.

http://www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures http://www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2757495 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2757495 https://dx.doi.org/10.15620/cdc:106463 https://dx.doi.org/10.15620/cdc:121435 enrollment, remote monitoring) in order to establish sustainable decentralized clinical trial research infrastructure and execute decentralized clinical trials (DCTs). These partnerships will be part of the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program, which is focused on establishing and maintaining strong decentralized clinical research capabilities to support medical countermeasure (MCM) development and the execution of more efficient and relevant clinical research on MCMs, especially during future Public Health Emergencies (PHEs).

1.3. Objectives

The D-COHRe program will establish partnerships, through BARDA’s Other Transaction Authority (OTA5), with organizations or CROs already successfully leading decentralized clinical research studies and whom have access to healthcare delivery through decentralized means (i.e., retail pharmacies, telemedicine, urgent care, mobile health clinics).

The goal through these partnerships is to initially build internal capability to enhance decentralized care and clinical research jointly with BARDA and to allow for access to such DCT sites in order to assess medical countermeasures, during and outside a PHE.

Partners will have individual opportunities to rapidly expand their decentralized services (i.e., sites, virtual recruitment/enrollment, monitoring along continuum of care) to enhance capabilities and better prepare for use of DCTs to respond to future health threats. The D-COHRe program will enable the establishment and growth of a strong decentralized capability for healthcare delivery organizations to support decentralized clinical studies for medical countermeasure development and to deliver enhanced models of decentralized healthcare. The objectives for the D-COHRe partners will be to:

1. Identify and address challenges in successfully implementing DCTs.

2. Catalyze and create lasting sustainable business models for DCTs beyond BARDA support.

3. Create capability for BARDA to evaluate products in real-world environments.

Objectives 1 and 2 will be addressed through capability build and program management activities in the Statement of Work (SOW). Objective 3 concerns three types of clinical studies that can be executed under this OTA as Option Line Items Specifically, these include:

• Product Development: Clinical validation of medical countermeasures (e.g., drug, biologics or device candidates) in real world environments to support regulatory submissions of those products.

• Product Adoption and Utilization: Generation of new evidence of use of MCM products, such as diagnostics, wearables, software, devices, vaccines, therapeutics, and clinical management approaches in decentralized real-world environments to support clinical value.

5 These will be individual Agreements with each Partner. This will not be a consortium, where Partners may be expected to engage with one another.

• Clinical Trial Innovation: Pilot and/or validation of novel processes, enablers, or supportive technologies to enhance decentralized clinical research to gain a body of evidence to be used in future clinical studies of medical countermeasures.

D-COHRe partners will maintain and scale internal capabilities for decentralized care and clinical research, beyond the period of performance of the D-COHRe Agreement. The goal is to overcome challenges currently faced by DCT organizations to support sustainable models.

Qualitative and Quantitative data will be collected during the partnership and analyzed to demonstrate continued success and impact of DCTs.

2. Administrative Overview

2.1 Respondent Eligibility Requirements

All responsible sources capable of satisfying the requirements for a D-COHRe partnership, are eligible to submit a proposal. Respondents are requested to address the following eligibility requirements in accordance with Section 4.1, Technical Proposal, item 3:

Managing Conflicts of Interest An organizational conflict of interest (OCI) may result when factors create an actual or potential conflict of interest on an instant contract (or agreement), or when the nature of the work to be performed on the instant contract (or agreement) creates an actual or potential conflict of interest on a future acquisition. In the latter case, some restrictions on future activities of the awardee may be required. Respondents must disclose if any individual member of their proposed team (including any potential sub-recipient or consultants) has provided professional consulting services to BARDA within the last three years. Adequate information must be provided at the time of proposal submission, about the services rendered. A determination will then be made whether a respondent has a conflict of interest and whether an appropriate mitigation plan is feasible. If this relationship is determined to create a conflict of interest that cannot be mitigated, then the individual or entity will be ineligible to be a part of the proposal. Further, any individual or organization who has provided direct professional consulting services to BARDA in support of this specific D-COHRe program is ineligible to respond (note this does not include engagement from interested organizations in the form of responses to RFI’s, etc.). This requirement applies to all subagreements or teaming arrangements in support of D- COHRe.

If professional consulting services are currently, or have been, provided to any BARDA program(s) by a member of a proposed team, the proposal must include:

• The name of the program office receiving the support,

• The agreement number,

• Identification of proposed team member (e.g., sub-awardee, consultant) providing the support, and

• A proposed OCI mitigation plan.

Salary Rate Limitation HHS is bound by applicable appropriations laws which direct that HHS funds cannot be used to pay extramural salaries at a rate in excess of Executive Level II ($221,900 as of

January 2024). Accordingly, USG funds appropriated to HHS and received by the partner cannot be used to pay salaries in excess of the federal Executive Level II salary.

It is important to note that this does not limit the amount of salary a partner may compensate an individual, rather it limits the amount of salary that can be paid to an individual using HHS funds.

Registration with System for Award Management Prior to award, a successful entity must possess an active and valid registration in the federal System for Award Management (SAM) at the following link:

https://sam.gov/content/entity-registration and should use NAICS code 541714 Research and Development in Biotechnology (except Nanobiotechnology).

Accounting System The respondent must demonstrate the ability to maintain an accounting system that is capable of tracking the expenditures of USG funds and investments of those funds given the financial requirements of this Agreement consistent with Generally Accepted Accounting Principles (GAAP) or equivalent standards.

2.2 Agreement Structure and Intent to Execute Multiple Agreements

BARDA anticipates issuing multiple Agreements under this Strategic Partnership Solicitation for D-COHRe. Partners will not be required to collaborate, share data or other resources with each other. Each organization is encouraged to establish appropriate teams (i.e., subagreements) to meet the requirements of this solicitation, including possibly partnering with other awarded partners under this solicitation.

Initial Funding:

BARDA anticipates that each agreement under the OTA will have initial funding for program management and yearly data analytics. In addition, up to $2 million is available to support the capability build for innovation towards the enhancements of decentralized care and clinical research, and the creation of sustainable models that help solve challenges organizations face in delivering DCTs. Resource sharing, including cash and in kind (e.g., personnel or equipment) contributions are strongly encouraged, have no limit, and are in addition to the BARDA funding to be provided under the resultant award(s). BARDA also anticipates providing additional funding for program management and data analytics activities. The total ceiling for all Agreements resulting from this solicitation will be up to $100 million in aggregate, exclusive of resource sharing.

Agreement Structure:

Each agreement will be structured with a 5-year base period of performance (PoP). The base PoP will include program management activities. In addition, the initial award will include line items for the Capability Build and data analytics with their own respective PoPs. Option line items based on availability of funds, will support future annual data analytics, potential additional Capability Builds, and the conduct of clinical studies. Each Option line item may have a period of performance of up to 5-years. However, overall period of performance may be revised by mutual agreement. The Base and Option line items can use any available https://sam.gov/content/entity-registration agreement type, depending on various factors, to include fixed price, expenditure based, milestone-based, cost sharing, or any other type determined to be of best interest to the government. An example of the line item structure of an Agreement may be the following:

• Line Item 1: Program Management

• Line Item 2: Data Analytics

• Line Item 3: Capability Build

• Option Line Item 4: Data Analytics (future years)

• Option Line Item 5: Additional Capability Build

• Option Line Item 6: Clinical Research Study

Concurrent with the Base period, Options may be executed to conduct clinical studies and/or conduct additional capability builds. In addition, if a clinical study requirement arises which could potentially be executed by more than one partner resulting from this solicitation, BARDA reserves the right to seek competitive responses to such requirements prior to executing an Option.

2.3 Submission Overview & Instructions

All correspondence and proposals should be submitted via email to LaunchOfficeContracting@hhs.gov. This call for Proposals will close on December 9, 2024, at 12:00PM EST, beyond which no proposals will be accepted, unless otherwise revised or superseded by a subsequent amendment to this solicitation. We highly encourage early submissions as opportunities may close based on available funding.

All proposals will be kept confidential, to the extent permissible under law, and be reviewed pursuant to the criteria established in this solicitation. Any interested parties that respond to this solicitation will be deemed a respondent.

3. Technical Overview

3.1 Program Management

This will entail the entire scope of management of the Agreements, which will include Agreement administration, technical management of activities within the SOW, coordination and management with partners subrecipient agreements, regulatory support as may be needed for certain clinical studies, financial management of the Agreement, and liaising to the US Government on the OT.

Specifically, we envisioned a dedicated program manager to provide oversight and coordination of the Agreement and directly communicate with the Government, respond to inquiries and ensure timely delivery of all deliverables required (see Appendix D) under the Agreement.

3.2 Data Analytics

3.2.1 Decentralized Clinical Trial Gap Analysis and Enhancement & Sustainability Plan

Identify current business and technical challenges with the conduct of DCTs within your organization and team partners. Provide a report on these challenges and a 5-year plan for mailto:DRIVe.OTA@hhs.gov addressing these challenges such that there can be a sustainable model at the end of the period of this OTA. Describe how the current capability build (see 3.3) and other activities may assist in addressing these challenges.

3.2.2 Qualitative and Quantitative Metrics & Reports for Decentralized Trials

Qualitative and quantitative analysis on the sustainability of DCTs will be conducted and reported under the OT. The goal is to show an improvement in DCT capabilities over time which support a sustainable model. Reported metrics should reflect all the decentralized clinical research conducted by the organization, not just limited to BARDA mission space. This can include metrics from other studies conducted outside the OTA such as Phase 1, 2, 3, 4, pivotal studies, real world use studies, post-clearance/approval/authorization studies, clinical utility studies, etc. If reporting on studies not funded by BARDA, then it is expected that information may be blinded, de-identified from participants and/or study sponsor, etc.

Reports generated should reflect summary of data from last reporting period or baseline and quantify change for each metric. It is desired for reporting to occur on the level of each individual study. BARDA will be able to provide additional information during negotiations on how to categorize the information as well as a Data Dictionary Guide for D-COHRe. It is anticipated that the following metrics will be of interest, but this may be adjusted through conversations with the Agreement partner:

• Cost of decentralized clinical trial cost compared with comparable standard trial costs

• Diversity of Participant population recruited and enrolled

• Diversity of clinical sites, including regional footprint, locations, and diversity of environment

• Time to first Participant enrolled from study kickoff (i.e., startup time) and time to complete enrollment, based on number of patients

• Patient engagement and healthcare utilized

• Use of decentralized technologies and types of Participant data (e.g., EHR, eCOA, ePRO

• Participant data relevant to satisfaction during and after decentralized clinical studies

(which can include participant engagement, support, re-engagement efforts)

• Assessment of the current the regulatory framework and guidance (e.g., FDA) for DCTs being leveraged and implemented and any regulatory challenges.

3.3 Capability Build

BARDA is committed to jointly working with D-COHRe partners to address challenges associated with sustainability of decentralized clinical studies and demonstrating the value of DCTs to support product evaluation, adoption, or clinical trial preparedness for future PHEs.

Partners are expected to have current capabilities to execute and lead decentralized clinical studies. The capability build is an opportunity for D-COHRe partners to improve their DCT capabilities and mitigate challenges, through direct funding. It is anticipated that while address challenges of decentralized research that the capability build may also have an anticipated effect of enhancing innovation with in decentralized clinical studies. Some examples of what partners may want to address through a capability build are the following, noting that this list is not meant to be inclusive:

• Enabling greater research access to communities or special population (e.g., pediatrics, elderly, rural populations)

• Building or enhancing capability to conduct clinical research end to end within the organization, without having to issue a subagreement to a CRO

• Creating ability to conduct clinical research to support regulatory path activities

• Implementing ability to monitor participants longitudinally

• Improving data collection and/or interoperability across the continuum of care by establishing clinical trial experience in multiple care locations and acuity levels.

• Integration of new remote health monitoring system, and desire to conduct clinical value assessment

• Establishing partnerships with payers/providers to support reimbursement for new models of care

• Expansion to include new modality of decentralized care (e.g., drone delivery, mobile vans)

• Establishing partnerships with new entities to access underserved populations for care or trial recruitment.

• Establishing and hiring employees to manage clinical studies

• Upgrading software and systems to allow digital data integration from Participant wearables

• Building a team of digital, social media, diversity & inclusion experts to enhance clinical trial outreach and enrollment, etc.

The BARDA funding for the capability build component of the agreement may not be used for physical infrastructure such as the construction, alteration, or repair of buildings, structures, or other real property. Instead, the focus should be on ways to improve and enhance capabilities in (e.g., staffing, business infrastructure, training, modernizing. The initial capability build should be completed within a 1-year timeframe from the date of award. However, the effects of the capability build should be sustainable such that the implementation of these changes can be maintained for the 5 years of the PoP and beyond, without additional USG funding to enhance ability to conduct decentralized clinical research. For example, hiring personnel or paying for 1 year of annual data services may not be considered appropriate if there is not a means to continue to support these changes beyond 1 year.

3.4 Clinical Research

There are 3 types of studies that may be executed under this Agreement. Although the ability to conduct all 3 studies is not required, it is considered highly desirable. Experience in executing DCTs is required and should be elaborated on in the technical proposal. Of particular interest is experience in conducting trials relevant to BARDA’s mission space (e.g., infectious disease, burns, radiation injury). Partners should describe their approach and current ability to conduct the 3 types of studies. If capabilities will be developed under the Agreement, then please describe the innovative solutions that will address current and anticipated future challenges frequently encountered during DCTs (for example, but not limited to: patient access, recruitment and retention, data acquisition, technical/digital tools, regulations, etc.)

o Product Development: Clinical validation in of medical countermeasures (e.g., drug, biologics or device candidates) in real world environments Support regulatory path activities of new and emerging classes of MCMs designed for use in decentralized settings or that could benefit from the incorporation of decentralized approaches for product evaluation.

• Product Adoption and Utilization: Generation of new evidence of use of MCM products, such as diagnostics, wearables, software, devices, vaccines, therapeutics, and clinical management approaches in decentralized real-world environments o Increase use and availability of products in decentralized settings or decentralized clinical research to provide significant expanded clinical value, including for PHE preparedness.

• Clinical Trial Innovation: Pilot and/or validation of novel processes, enablers, or supportive technologies to enhance decentralized clinical research to gain a body of evidence to be used in future medical countermeasures clinical studies.

o Risk reduction to implementing decentralized clinical trial innovations at larger scale, including in design, execution and analysis; publication of results to widely disseminate evidence to support implementation of approach by others;

Greater insight for BARDA to inform the design of future clinical trials and studies.

Examples of such clinical studies can be found in Appendix A and B.

4. Resource Capabilities Partners are required to have a broad footprint in the US (or intend to expand more nationally within a reasonable timeframe under the agreement) with established capabilities in decentralized clinical care and/or research, and a commitment to continue to enhance such capabilities as part of their organization’s business model.

It is also desired for partners to have prior experience in conducting and managing clinical studies internally. Successful respondents will possess the ability to provide the majority of services and capabilities needed for end-to-end execution of a clinical trial (e.g., clinical protocol development, trial conduct, data collection and analysis). Successful respondents must have established clinical sites and delivery care platforms to enable rapid and easy access to diverse participant populations. Agility along with the ability to quickly activate and scale studies will also be essential for maintaining a readiness posture for response during a PHE is desirable.

Reliance on external organizations and subrecipients to execute clinical studies should be limited. The desire is to directly partner with clinical sites where participants may engage and seek care on a regular basis. Partners should be able to recruit diverse participants, i.e., racial/ethnic diversity, but also location (rural vs. urban), socioeconomic, education, disability and other measures of diversity. The desired capabilities (as described in Table 1) should comprise a core component of the respondent’s primary business operations or teaming operations. The partner’s internal capabilities should enable them to conduct most of a decentralized trial from end to end (i.e., serve as the prime contractor for clinical trial execution) rather than outsourcing niche/specialty services of DCTs. Partners should take a holistic look at what is needed to address the challenges of conducting DCTs and consider addressing this as part of the capability build or own internal activities.

Partners should, although not required, possess the ability to: integrate new products, technologies, and models of care (e.g., wearables, home monitors, telehealth, data platforms). Partners should utilize established data quality standards, as well as capture near to real-time data for analysis, but this should not be the primary focus of the partnership or the entire capability build. This is viewed as an attribute that will allow the organization to remain competitive and sustainable with conducting DCTs.

Additionally, evidence of established relationships with external organizations and subrecipients are desirable and will be considered more favorably than proposed or nascent relationships.

The types of organizations listed below are representative but not exclusive of potential partners for D-COHRe. This is not meant to be a comprehensive list and other organizations not listed may still meet the technical requirements for this solicitation and are encouraged to propose. Respondents should consider partnering with other organizations in order to establish collective complementary capabilities to fully address the requirements.

• Telemedicine and/or Virtual Health Service Providers

• Retail Clinics and/or Mobile Clinics (Vans or pop-up sites):

• Urgent Care Clinics

• Contract or Clinical Research Organizations (CROs):

• Site Management Organizations (SMO)

Please see additional descriptions in Appendix C for types of D-COHRe partners.

4.1 Minimal Acceptable and Desired Technical Capabilities

Respondents must satisfy the below requirements to ensure adequate internal capability to conduct decentralized clinical research from end to end, as described in Section 3.4 and below in Table 1. It may be necessary to establish additional subagreements to form a team, in order to meet the requirements for an Agreement or to enhance DCT capabilities.

However, preference will be given to those with already established subagreements. Table1 describes both the Minimum Acceptable Capabilities which will be the basis of evaluation, as well as Desired Capabilities, which represents optimal capabilities and could be the potential end state after the capability build activities. Proposals that do not meet the minimum acceptable capabilities will not be considered for award. It is anticipated that each respondent will possess unique and different capabilities and therefore a range of capabilities could be considered responsive.

Table 1. Requirements Requirements Minimum Acceptable

Capabilities Desired Capabilities (Minimum

Acceptable Capabilities plus the following)

End-to-End Trial Capabilities

Ability to execute DCTs through a hub and spoke model of diverse capabilities or with identified partners

Integrated healthcare sites into business operations that allow for more efficient execution of DCTs with less dependency on layers of subrecipient agreements.

Equity and Diversity

Access to diverse participants: demonstrated rural & urban/suburban locations, multiple races, ages, genders, ethnicities, and orientations

Access to data on social determinants of health and demographic information from diverse populations relevant to BARDA’s mission space Established pathways and protocols to reach/enroll underserved, at-risk, and diverse populations

Study Settings

Single decentralized setting (e.g., home only, mobile clinic only, etc.)

Multiple decentralized settings, (e.g., home, retail or mobile clinic, primary care, and hospital, if applicable) and ability to scale and expand to more sites or participants

Participant Engagement

Single care events or service engagement

Preventative care, acute care, and longitudinal care/follow-up with tracking and data from multiple engagements with the participant or across health systems

Participant Data

Discontinuous data, records or report for single events/encounter(s)

Longitudinal data spanning the continuum of care (e.g., healthy, sick, and follow-up encounters), which may involve access to and integration of multiple data types and sources, including digital health data

Technology and Workflow Integration

Use of at least one decentralized technology capability (e.g., wearable, home monitor, smartphone app, virtual recruitment)

Capabilities to continuously and easily integrate new technology into clinical workflow, research, data collection streams and EHRs.

Footprint/Use Regions*

Large, multi-regional US footprint in multiple states, with ability to scale as needed, including rural areas and harder-to-reach populations

Present in all US regions*. Able to scale and activate quickly in response to a PHE to multiple regions

Healthcare Providers

Access to Board-Certified Physicians, Nurse Practitioners, or Physician Assistants in at least one US region who will be involved in the proposed work and can provide care to study participants

Access to Board-Certified Physicians, Nurse Practitioners, or Physician Assistants in multiple US regions where partner has a footprint will be involved in the proposed work and can provide care to study participants

* https://www2.census.gov/geo/pdfs/maps-data/maps/reference/us_regdiv.pdf

4.2 Exclusion Criteria

The following submissions are non-responsive to the solicitation and will not be considered for award:

• interest in only advancing own product, technology, platform, or service (e.g., technology developers, developers of specific MCMs, data management and integration), without the capabilities to lead decentralized clinical trial operations from end-to-end

• intent to use the capability build to support regulatory approval of a product, technology, platform, or service

• operations limited to a single disease or therapeutic area with no viable pathway for expansion, lacking the capacity to conduct clinical studies relevant to BARDA’s mission space such as: infectious diseases, CBRN (chemical, biological, radiological, and nuclear), etc. (see medicalcountermeasures.gov)

• inability to conduct clinical studies in the United States

• inability to scale clinical trial capabilities

• inability to execute end to end clinical research through internal capabilities, inclusive of existing partnerships

5. Proposal Preparation Respondents must submit their Proposals in accordance with the instructions provided below.

Proposals will be evaluated against the stated criteria as described in Section 4. Proposals that do not comply with the instructions outlined herein will not be considered for award.

Submissions will be reviewed on a rolling basis as they are received where bandwidth permits.

All proposals received are handled as procurement information prior to award and in accordance with 41 U.S.C. § 2012. The Government will not disclose respondent proposal information prior to agreement award. The respondent must indicate any limitation to be placed on disclosure of information contained in the proposal as follows:

• Respondents that include in their proposals, data that they do not want disclosed to the public for any purpose, or used by the USG except for evaluation purposes, shall mark the title page with the following legend:

This proposal includes data that shall not be disclosed outside the United States Government (USG) and shall not be duplicated, used, or disclosed-in whole or in part-for any purpose other than to evaluate this proposal. If, however, an agreement is awarded to this Respondent as a result of-or in connection with-the submission of this data, the USG shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting agreement. This restriction does not limit the USGs right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or other identification of sheets]

• Respondent shall mark each sheet of data it wishes to restrict with the following legend:

Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal.

Classified proposals will not be accepted. All submissions must be Unclassified.

There are certain post-employment restrictions on former federal officers and employees, including special USG employees (Section 207 of Title 18, U.S.C.). If a prospective Respondent believes a conflict of interest may exist, the situation should be emailed to LaunchOfficeContracting@hhs.gov, prior to expending time and effort in preparing a proposal.

The appropriate HHS personnel will discuss any conflict of interest with prospective respondent.

The original proposal received by each respondent will be retained by ASPR pursuant to National Archives and Records Administration (NARA) General Records Schedule 1.1, Financial Management and Reporting Records (http://www.archives.gov/records-mgmt/grs.html).

http://www.archives.gov/records-mgmt/grs.html http://www.archives.gov/records-mgmt/grs.html

By engaging in this process, submitting a proposal to this solicitation, or entering into an agreement resulting from this solicitation, Respondents acknowledge that non-federal personnel may participate and provide input throughout the evaluation or agreement administration process. All non-USG personnel who support BARDA are strictly bound by appropriate non-disclosure and conflict of interest requirements. Respondents should not engage in any part of this process if they do not consent to the participation of non-federal consultants as described in this subparagraph.

5.1 Technical Proposal

Technical Proposals should not exceed 25 pages, excluding any supplemental information provided as appendices. Content that exceeds the 25-page limit will not be reviewed.

Additional supportive information (e.g., proposed subrecipients, letters of intent, publications, etc.) may be provided as part of an appendix and will not be considered part of the 25 pages.

The appendix must be indexed and easily trackable to the relevant section of the technical proposal. Any supportive information not clearly linked to the technical proposal, or that appears to be provided in an attempt to circumvent the 25-page limit, may not be reviewed. All files should be combined into a single searchable PDF file before submission.

The 25-page proposal should consist of the following information:

1. Cover Page: The follow information shall be provided on the first page of the technical proposal:

a. The words “Volume I: Technical Proposal;”

b. OTA solicitation number: Decentralized- Clinical Operations for Healthcare and

Research (D-COHRe) Partnerships

c. Title of proposal (descriptive of the work proposed and not a copy of the title of the solicitation)

d. Date of submission

e. Respondent and complete list of subrecipients/team members if applicable

f. Technical contact (name, address, phone, electronic mail address)

g. Administrative/business contact (name, address, phone, electronic mail address)

2. Table of contents: An alphabetical/numerical listing of the sections within the proposal, including corresponding page numbers.

3. Summary of Eligibility Requirements from Section 2.1: Respondent must provide a summary for how each of the eligibility requirements described in Section 2.1 will be satisfied. This portion of the submission should be kept to a maximum of one page. The summary of eligibility should stand on its own without the need for evaluators to do any external research outside of what is provided in the summary. Proper citations and supporting evidence are required. The information provided in the summary will be used to determine if the respondent satisfies the eligibility criteria. The USG reserves the right to address eligibility requirements in negotiations prior to award, as applicable.

4. Executive Summary: An abstract or synopsis (1-2 pages) of current DCT capabilities, proposed partnership with BARDA, the capability build and how the proposed work will address current DCT challenges and support a sustainable business model.

5. Scientific and Technical Approach: Provide a 10-15 page description that addresses the approach for maintaining DCT capabilities and the activities outlined in Section 3 and Section 4.

a. Program Management: Describe your approach to managing your team, supporting activities of the Agreement and liaising to the US Government. Proposal must include a dedicated program manager to provide oversight and coordination of the Agreement and directly communicate with the Government, respond to inquiries and ensure timely delivery of all deliverables required under the Agreement.

b. Data Analytics

i. Decentralized Clinical Trial Gap Analysis and Enhancement & Sustainability

Plan: Describe any work to date in identifying any current business and technical challenges with the conduct of DCTs within your organization and team partners. Provide a description of how you will develop a report on these challenges and a 5-year plan for addressing these challenges such that there can be a sustainable model at the end of the period of this OTA.

ii. Qualitative and Quantitative Metrics & Reports for Decentralized Trials:

Qualitative and quantitative analysis on the sustainability, utility, and benefits of DCTs. Describe what data may be accessible to report and analyze for BARDA on DCT metrics (see draft SOW), and what methods are proposed to capture and analyze such data.

c. Capability Build: Describe approach to enhance DCT capabilities and infrastructure to address the challenges associated with DCTs and develop a more sustainable business model. Describe the specific activities that will be conducted as part of the capability build and how these address existing challenges. Describe how these activities will be sustainable and integrated into the organization’s business model during the 5 years of the Agreement and beyond.

i. Propose clear, tangible deliverables that can be utilized to evaluate the successfulness of the capability build activities.

ii. Account for validation of capability builds, licensing agreements, QA/QC as needed as relevant to ensure integration of these activities into business practice.

iii. Explain who will be conducting the capability build – if this will occur within the prime organization or with existing subrecipients. If the latter, please explain how these will be accessible and integrated into the prime’s business activities for conducting DCTs.

iv. Describe roles and responsibilities of who will be conducting the work

v. Provide a Gantt and timeline of activities to conduct and implement the capability build. Note that it is desired that activities be completed in 1 year Describe how these capabilities will not only be sustained over the 5-year Base period of performance of the OTA but also how this work will integrate into business operations of the organization, beyond BARDA supported work.

vi. As the initial capability build will be limited to up to $2M of BARDA funding and will be accomplished in the 1st year, please also describe if there are additional capabilities that would be of interest to incorporate beyond year 1 or if funding should become available.

6. Resource Capabilities: The ultimate goal of D-COHRe is to establish partnerships with organizations to enhance decentralized clinical care and clinical research capabilities.

While the intent is to build decentralized capabilities that can be sustained for normal business operations, the capabilities should be able to translate to operations under a PHE. Additionally, trial experience and current network of partnerships should demonstrate an alignment with or an ability to support BARDAs mission. Please describe:

a. Clinical Studies: Please describe the organization's capabilities and experience to date in conducting each of the 3 types of clinical studies described in Section 3.4 and Appendix A and B. The description should include the following:

i. Current capabilities to conduct each of the 3 study types in a decentralized manner, from beginning to end. Examples of previous or current work should be provided as supporting evidence.

ii. Any potential limitations or gaps in capabilities that could impact your ability to execute each of these study types in a decentralized manner from beginning to end

iii. Plans to address potential limitations or gaps

iv. Ability to scale capabilities to regionally diverse locations and participant populations.

v. Readiness state to conduct these types of studies

vi. Existing partnerships and subrecipients that are required for execution of

Decentralized clinical studies.

vii. Future or pending partnerships to enhance decentralized clinical studies.

viii. Ability to access healthcare clinical sites where patients may seek care

b. Existing infrastructure and capabilities to conduct decentralized clinical studies and delivery healthcare

i. How the organization currently addresses the minimal requirements in Table

ii. Describe the current footprint and ability to have broad regional access and ability to scale.

iii. Describe the team in place (including external partners/subrecipients) and the organizational vision to achieve the work proposed under this solicitation as well as support and enhance business operations outside of BARDA supported work.

iv. How the organization would be able to leverage these decentralized care and clinical research capabilities to respond to a PHE, should one occur.

c. Facilities and Infrastructure:

i. Current facilities and infrastructure available within the organization and across subagreements to provide decentralized care and conduct clinical studies. This includes, but is not limited to, clinical sites for Participant care, laboratory facilities, major equipment, quality systems, data management and integration systems, freezer, storage systems, safety monitoring, plans for management of adverse events, etc.

ii. The number of clinical trial operations personnel and their location (i.e., centralized to headquarters or positioned at each decentralized site, or remote/hybrid) as well as non-trial personnel who can participate in trial-related activities.

iii. How your decentralized infrastructure addresses the draft guidance by FDA (see Decentralized Clinical Trials for Drugs, Biological Products, and Devices | FDA specifically, Section III.B and D.2).

7. Key Personnel: Provide a list of key personnel for the Agreement (including subagreements/consultants) who will be responsible for the management and operations of https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices the work proposed, highlighting how they will contribute both to the capability build and to clinical research conducted. Teams needing to hire a significant number of key personnel will be considered less favorably. We also strongly recommend having a dedicated project manager for the D-COHRe effort as well as a data manager for line item 2 of the SOW.

CVs or bios of personnel may be included in the appendix and does not count toward the page limit.

For each individual, please include the following:

a. Name

b. Organization

c. Expertise

d. Proposed role and contribution to the proposed work for the partnership

e. Proposed level of effort (as a percentage of full-time employment)

f. Short bio and/or CV (appendix)

8. Team Organization: Provide information on all partners to describe how the project will be staffed and managed. This information should reflect how the team will work together to meet the requirements of this partnership.

The following elements should be included:

a. Organizational chart illustrating all members of the project team, including consultants and any other personnel support provided through subagreements.

Team member affiliations should be clearly noted

b. List of consultants or other personnel provided via subagreements and supporting narrative to describe their role within the team.

c. Reporting structure and plans for managing and communication within the partnership, for the capability build, data analytics, and clinical trial execution,

d. List of all subagreements or commitments to the proposed project from key collaborators, encompassing any organization with a significant role in project execution. Supporting documentation such as contracts, letters of commitment, and letters of intent should be provided in the appendix and will not count towards the 25-page limit.

9. Statement of Work (SOW): Attachment 2 is provided as a SOW template for Section 1, Program Management and Section 2, Data Analytics. Both sections should be reviewed and redlined by the Respondent as necessary to align with their technical solution.

Additionally, Section 3, Capability Build shall be populated and submitted as part of the Technical Proposal.

5.2 Business Proposal

The business proposal shall be provided in two parts as instructed below and as desired via the Excel template provided in Attachment 1.

Part 1: Initial Pricing

1. Capability Build Pricing. Provide cost proposal associated with the proposed capability build which must identify and support all cost elements to support the total proposed value. Note that the total funding requested from BARDA shall not exceed

$2M for the Capability build, but partners are expected to absorb any additional costs through resource sharing. The respondent is requested to complete the capability build cost/price template provided in Attachment 1.

2. Program Management and Data Analytics Pricing. Provide cost proposal associated with the proposed program management and data analytics which must identify and support all cost elements to support the total proposed value. While there is no ceiling on the proposed price for these activities, BARDA has planned to fund this work per fiscal year, noting that the first year may require higher costs to establish the data reporting system. The respondent is requested to complete the cost proposal for program management and data analytics as a Microsoft Excel file in their preferred format. Respondent can reference the Statement of Work Template at Attachment 2 to assist with determining the appropriate proposed personnel and required deliverables.

3. Please provide justification as described below to support costs for the Capability

Build pricing and Program Management and Data Analytics pricing. BARDA reserves the right to request additional documentation as necessary to support the total proposed value. The below cost elements are not intended to be a fully exhaustive list; however, not all of these elements may be relevant.

A. Direct Labor Hours. Describe the employees, positions/labor categories, level of effort, and functions being performed in the proposed project. Provide basis of estimate and/or rationale for proposed skill mix and direct labor hours. Anticipated personnel should include but not be limited to, project manager, data manager, quality affairs, clinical operations, medical officer, physicians, clinical PI, etc. Costs should reflect what is needed to sustain capabilities for 5 years of the Base period of the Agreement.

B. Direct Labor Rates. Justification for estimated unburdened direct labor rates.

Documentation can include, but is not limited to, USG Forward Pricing Rate Agreements (FPRAs), pay stubs, accounting system data, historical costs/invoices under similar contracts, SEC filings on executive compensation, and a comparison of proposed rates to market indices/industry standards.

C. Indirect Labor Rates. Justification for estimated Fringe, Overhead, and General and Administrative (G&A) indirect labor rates: Documentation can include, but is not limited to, USG Forward Pricing Rate Agreements (FPRAs), detailed calculations, historical rates for similar efforts, and a comparison of proposed rates to market indices/industry standards.

D. Materials, Equipment, and Supplies. Briefly describe proposed materials, supplies, and equipment and how it will be used in the proposed project.

Explanation for the quantity…