DCOHRe 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

Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Strategic Partnership Solicitation

1. Overview 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 patients 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 patients directly in the settings for which they are seeking care, enhancing the Nation’s ability to prepare and respond to future PHEs.

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

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 pharmacies, telemedicine, urgent care, mobile health clinics, etc.) or with Clinical Research Organizations (CROs) that have decentralized capabilities (i.e. decentralized sites, virtual enrollment, remote monitoring, etc.). Through an Other Transaction Authority (OTA) mechanism, partnerships with such organizations will be established to enhance innovation with decentralized care capabilities in order to execute more efficient and relevant clinical research in these decentralized clinical settings. The Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program will initially establish a strong decentralized clinical research capability to support medical countermeasure development and utility.

Through BARDA’s Other Transaction Authority, each partner will initially build internal capability to enhance decentralized care and clinical research jointly with BARDA to validate, pilot and implement new products, technologies and approaches intended for remote and/or decentralized use, with the agility needed during a PHE. Partnerships will focus on enhancing and encouraging decentralized research capabilities, while also increasing the capability to deliver enhanced models of decentralized healthcare (e.g. access to distributed clinical sites, ability to conduct virtual recruitment/enrollment capabilities, ability to monitor along the continuum of care, etc.). Beyond the initial build of internal capability under the partnership, additional capability builds may be added, based on programmatic needs. This capability will allow for the conduct of three types of clinical studies that may be executed through the partnership:

• Product Development: Clinical validation of new products and technologies focusing on studies to support regulatory activities in real world environments

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

• Clinical Trial Innovation: Pilot and/or validation of novel processes, enablers, or supportive technologies to enhance decentralized clinical research

Objectives

BARDA is seeking to substantially improve the collective ability of the United States Government (USG) and private organizations to respond to future PHEs by establishing public-private partnerships between BARDA and decentralized healthcare providers.

Specifically, BARDA is seeking to achieve the following objectives:

• Stimulate and accelerate expansion of decentralized clinical study capabilities across the private sector; better position decentralized care services to have impact for PHE preparedness and response

• Clinically validate products and technologies intended for use in decentralized settings in those real-world environments

• Generate evidence to increase use and impact of products and technologies intended for use in decentralized settings

• Pilot and/or validate novel clinical trial processes, enablers, or supportive technologies that could increase use of decentralized clinical settings in the validation of any MCMs, including vaccines and medicines

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-awardees 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 ($212,100 as of fiscal year 2023). 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 https://sam.gov/content/entity-registration 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 partnership consistent with Generally Accepted Accounting Principles (GAAP) or equivalent standards.

2.2 Intent to Execute Multiple Agreements

BARDA anticipates making multiple awards under this Strategic Partnership Solicitation for D- COHRe using Other Transactions (OT). BARDA anticipates that each agreement under the OTA will have initial funding of up to $2 million based on the availability of funds to support innovation towards the capability enhancements of decentralized care and clinical research.

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).

Each agreement under the OTA will have a 5-year Base period of performance, with multiple Option line items. Each Option line item will have a period of performance of up to 5-years, and will support continued activities for capability growth as well as the execution of clinical research studies, based on the availability of funds. Overall period of performance may be revised by mutual agreement. The total ceiling for all OT awards resulting from this solicitation will be up to $100 million in aggregate, exclusive of resource sharing.

The Base and Option Period(s) line items can use any available agreement type, depending on various factors, to include fixed price, expenditure based, milestone based or any other type determined to be of best interest to the government to support:

• Capability building to support decentralized clinical studies

• Clinical studies for product development

• Clinical studies for product adoption and utilization

• Clinical trial innovation

More information on these areas can be found in Section 3.

2.3 Submission Overview & Instructions

All correspondence and proposals should be submitted to the BARDA Division of Research Innovation and Ventures (DRIVe) Head of Acquisitions & Partnerships, Matt McCord, via email to LaunchOfficeContracting@hhs.gov. This call for Proposals will close on June 1, 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.

Submissions received by July 25, 2023, at 5:00PM EST may be evaluated for potential award by the end of the fiscal year, September 30, 2023.

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.

mailto:DRIVe.OTA@hhs.gov

3. Technical Overview

3.1 Capability Building and Clinical Study Types

BARDA is committed to jointly working with D-COHRe partners to clinically evaluate products and their adoption into healthcare models nationwide. These partners are expected to have current or planned capabilities to conduct decentralized clinical research. D-COHRe will execute clinical studies through the partnerships for product development, product adoption and utility, and clinical trial innovation as well as continued capability building to enable the clinical studies. The Base period includes up to $2 million, exclusive of resource sharing, for an initial capability build to support the development of decentralized infrastructure. It is anticipated that this will be completed within a 1 year timeframe from the date of award in order to be ready to conduct clinical studies.

However, partners should anticipate maintaining a readiness capability to conduct clinical studies that integrates with the business model of their organization for the entire period of performance of the OT award. Concurrently with the Base period, Options may be exercised to conduct clinical studies and / or conduct additional capability building as outlined in Table 1. 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.

Table 1: Capability Building and Clinical Study Types Project Type Project Goal Purpose Approach Intended Outcomes

Capabilities Capability Building

Stimulate and accelerate expansion of decentralized clinical study capabilities within a commercial organization;

Better position decentralized care services to have impact for PHE preparedness and response

Partners would propose their capability needs to BARDA. Each partner may have different needs and therefore propose different solutions that best align with their priorities.

New infrastructure with added capabilities to better execute on decentralized clinical studies, with added benefit of enhanced preparedness and response to future PHEs as well as towards the organization’s business operations.

Clinical Studies

Product Development

Clinically validate products and technologies in real world settings using decentralized sites or approaches.

Partners would propose approaches to evaluate BARDA-specified products with a focus on decentralized care settings.

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

Generate evidence to increase use and impact of products and technologies in decentralized settings (e.g., quality improvement, pragmatic, health outcomes, RWE/RWD)

Partners would propose the investigational clinical approach, collect and analyze data from product use

Partners could also evaluate models (including use of technologies) for delivery of treatment/care in decentralized settings.

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 validate novel processes, enablers, or supportive technologies that increase use of decentralized clinical studies in the validation of any MCM, including vaccines and medicines.

Partners would propose approaches to validate a new process or technology (e.g.

virtual recruitment, blood draw, new device, etc.). These approaches would be evaluated in pilot studies and could be done with or without a product under development.

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 funding and design of future clinical trials and studies

Example Topics for Capability Builds and Clinical Study Examples can be found in Appendix A and B

3.2 Partnership Overview

In the event that multiple awards are executed resulting from this solicitation, 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.

It is not expected that every respondent will possess all the key capabilities at the time of responding to this solicitation. For example, not every organization will have access to diverse clinical site types, decentralized capabilities, or the ability to run clinical studies.

BARDA intends therefore, to support capability building that aligns with both the strategic future business priorities of the partner, as well with BARDA’s needs for decentralized clinical trial capabilities for pandemic preparedness. BARDA anticipates funding up to $2 million to complete the initial capability build, with the remainder of the project being funded by the partner via resource sharing under the OT award. Additional capability builds may be possible over the period of performance of the OT award.

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, ability to integrate new products, technologies, and models of care (such as wearables, home monitors, telehealth, etc.), have established data quality standards, have considered reimbursement models for services, and /or ability to capture real-world data for (near) real-time analysis. Crucial to the function of D-COHRe is the ability to have rapid and easy access to clinical sites, delivery care platforms and patients to conduct these studies. It is possible for these capabilities to be built as part of the initial capability build under the OT award.

The types of organizations listed below are representative but not exclusive of potential partners that may contribute to 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.

1) Telemedicine and/or Virtual Health Service Providers: Providing care to patients in a variety of ways including through concierge or specialty care, insurance or workplace coverage, subscription based or on-demand care, and/or virtual health by physicians, other healthcare providers, AI-powered bots or other delivery modes. Interest primarily in organizations who provide care outside the hospital or are not limited by use through a parent organization (i.e.

specific hospital system), although stand-alone ERs and/or urgent cares utilizing telehealth are of interest.

2) Retail Clinics and/or Mobile Clinics (Vans or pop-up sites): Proving care through physical or mobile clinic locations, including pharmacies, big box stores, grocery stores or community clinics addressing underserved areas via a mobile or temporary location, by care provided by physicians, nurse practitioners, physician assistants or any other type of provider. These locations may offer diagnostic tests performed at point of care, provide services for acute care and disease management, and can be connected to pharmacies to facilitate prescription fulfillment. Mobile laboratories or sites not-offering clinical care and treatment in addition to diagnostics are not of interest.

3) Urgent Care Clinics: Walk-in clinics, including stand-alone ERs, focused on the delivery of medical care for minor illnesses and injuries in a medical facility outside of a traditional hospital setting, including those that may be specialized for a patient population (e.g., pediatrics), temporal use (e.g., late night) or other factors. It is desired for these organizations to offer point of care diagnostic tests, acute care services, telemedicine platforms, and a means for patient follow up for coordinated longitudinal care or monitoring.

4) Contract or Clinical Research Organizations (CROs): Experienced organizations providing comprehensive services to support the design, execution, and analysis, of clinical research.

Organizations must have experience in executing hybrid or fully decentralized clinical studies and interest in further expanding decentralized capabilities, which may include virtual recruitment and enrollment of broad, diverse patient populations, remote study execution using community-based, mobile, or digital care models, home-based sample collection or patient monitoring or other methods of remote care delivery. Expertise in patient-centered study designs and use of patient-friendly study platforms are critical. Research experience involving pragmatic studies, patient generated data, observational and other real-world data is of interest.

3.3 Minimal Acceptable and Desired Technical Capabilities

Respondents must satisfy the below requirements to ensure adequate capability to conduct decentralized clinical research. It may be necessary to establish subagreements to form a team, in order to meet the requirements for an OT award. Table 2 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 (Base period). 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 2. Requirements Requirements Minimum Acceptable

Capabilities Desired Capabilities (Minimum

Acceptable Capabilities plus the following)

Equity and Diversity

Access to diverse patients Access to data on social determinants of health and demographic information from diverse populations.

Established pathways and protocols to reach/enroll underserved, at-risk, and diverse populations

Study Sites 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 patients

Patient engagement

Single care events or service engagement

Preventative care, acute care, and longitudinal care with tracking and data from multiple engagements with the patient or across health systems

Patient 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

At least 1 region (defined by census bureau*) in US, and in multiple states, with potential to expand

Present in all US 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

Exclusion Criteria

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

• Respondents interested in only advancing their own product, technology, or platform in a decentralized setting (e.g., technology developers, developers of specific MCMs, data management and integration)

• Respondents with capabilities limited to a single disease or therapeutic area with no viable pathway for expansion

• Respondents that have international clinical capabilities but no ability to conduct domestic clinical studies in the United States, which is critical to represent disease burden and healthcare practices in the US where the MCM will be utilized.

4. 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 5. Proposals that do not comply with the instructions outlined herein will not be considered for award.

Submissions will be reviewed each quarter as well as 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 USG”s 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)

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.

4.1 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 subagreements, 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.

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

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 subagreements/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 the proposed partnership with

BARDA, how this aligns with organization future business operations, and overview of current decentralized clinical trial capabilities.

5. Technical Approach: Provide a 10-15 page description of current decentralized capabilities and future vision for enhancing decentralized capabilities to support BARDA clinical studies.

a. Capability Build: The initial Base period will be focused on the capability build, see

Section 3 Technical Overview. Respondents should describe their approach to enhance capabilities and infrastructure for conducting decentralized clinical studies, see Appendix A.1 for examples as part of the initial Base period. Please describe how capability builds will be executed, including description of team members and their roles and responsibilities, new subagreements, implementation of technical approaches, licensing agreements, QA/QC if needed, etc. Also include clear deliverables that can be utilized to evaluate the successful integration of these new capabilities. Provide a detailed description of the current capability/infrastructure (s) selected, and the justification or reasoning for why this is critical for decentralized care and clinical trial research. Describe the qualitative and quantitative enhancement this will have on business operations, i.e. describe the current state and desired end state for decentralized capabilities. Describe the capabilities that would meet the “minimal requirements” in Table 2 and address if any of the proposed work would move towards meeting “Desired requirements”. Please provide the period of performance to conduct and implement the capability build as the goal is to complete this work within a 1 year period such that clinical studies would be possible thereafter. Also please 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.

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

b. Clinical Studies: Please describe the organization's current capabilities to conduct the 3 types of clinical studies described in Table 1: Product Development, Product Adoption and Utilization and Clinical Trial Innovation. Briefly describe current capabilities that could be leveraged to conduct these studies and what would be readiness state to conduct these types of studies after the Capability Build (Base period). Please describe any limitations that may affect the organization’s ability to conduct such clinical studies. Examples of clinical studies can be found in Appendix A sections 2-5.

c. Partnership/Business model: The ultimate goal of D-COHRe is to establish partnerships with organizations to enhance decentralized clinical care and clinical research capabilities. Please describe how this partnership aligns with organizational vision and how the work conducted under this OT award will support and enhance business operations outside of BARDA supported work. While the intent is to build capabilities that can be sustained for normal business operations supporting traditional decentralized healthcare, these capabilities should be able to translate to operations under a PHE. Please describe how the organization would be able to leverage these decentralized care and clinical research capabilities to respond to a PHE, should one occur.

d. Technical Capabilities: Please detail the specific partnerships, collaborations, resources, and infrastructure within the organization to meet the requirements of Table 2 and accomplish the work as outlined above for the Capability Build and Clinical studies. Letters of commitment and evidence of partnerships should be included in the appendix and do not count toward the page limit.

e. Facilities and Infrastructure: Please describe the current facilities and infrastructure available within the organization and across subagreements and partners to provide decentralized care and conduct clinical studies. This could include clinical sites for patient care, laboratory facilities, major equipment, quality systems, data management and integration systems, freezer, storage systems, safety monitoring, plans for management of adverse events, etc. Additionally, please describe the number of clinical trial operations personnel and their location (i.e., centralized to headquarters or. positioned at each decentralized site) as well as non-trial personnel who can participate in trial-related activities. Please explain 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.

6. Key Personnel: Provide a list of key personnel for the project (both within the organization and through subagreements/consultants with key roles), associated expertise, and https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices describe who will be responsible for the management and operations. Describe the roles and responsibilities of each individual and associated organizations and how they will contribute to work for both the capability builds and conducting clinical studies. 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 role, and expertise

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

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

e. Short bio and/or CV (appendix)

7. Team Organization: Please provide an organizational chart of all partners that will be considered part of the team and include this as an appendix. Also please provide a list of all subagreements and consultants and how team will work together to meet the requirements of this partnership. An organizational chart for the project with affiliations (who will report to whom) should be provided in the appendix. A communication and project plan should also be included as to how this partnership with BARDA will be managed to conduct the work proposed, both for capability builds and clinical trial execution. Include letters of intent or commitment or subagreements for any partners or stakeholders that are relevant to the proposed partnership in the appendix (does not count towards 25 page limit). Include confirmation of the commitments to the project (should it be funded) made by key collaborating organizations, agencies and alliance members in this part of the application. Any organization that is specifically named to have a significant role in carrying out the project should be considered an essential collaborator.

4.2 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 Capability Build Pricing (Base period). Provide cost proposal associated with the proposed capability build which must identify and support all cost elements to support the total proposed value. The total funding requested from BARDA shall not exceed $2M, 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. The cost elements described below are not intended to be a fully exhaustive list; however, not all of these elements may be relevant. BARDA reserves the right to request additional documentation as necessary to support the total proposed value. As per the below, please provide any justification to support costs in the template provided in an associated Word document.

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, 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 OT.

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 and justification of price reasonableness of all proposed equipment, materials and/or supplies. May provide vendor quotes, historical data, or catalog prices where necessary.

E. Travel. Explanation for the location and number of trips proposed under travel.

F. Subagreements and Consultants. Please provide a description of what work will be conducted by all proposed subagreement(s) or consultant(s) and how the subagreement (or consultant) was selected and determined to be reasonable for the project. Justification to support price reasonableness for proposed subagreeements and consultants is needed. Documentation can include, but is not limited to, detailed cost element breakdown, vendor quotes or Rough Orders of Magnitudes (ROMs), subagreements/consultant commitment letters, or a comparison of historical costs/prices for similar efforts.

G. Total Proposed Value. Total proposed value to include the requested BARDA funding amount plus any resource contribution from the partner.

H. Resource Contribution. Clearly indicate and describe the proposed Resource Sharing, which may consist of cash investment or in-kind contributions expressed in U.S. dollars. It is anticipated that the total proposed value to complete the capability build will exceed the $2M cap of BARDA funding; therefore, any proposed costs exceeding $2M will be considered resource contribution. Greater resource contributions will be considered favorably. If a teaming partner proposes contributing towards the Respondent’s cost share, then this contribution is part of the proposal, the partners cost share must be included in the Letter of Commitment or subagreement that will be shared as an appendix (see Technical Proposal).

Part 2: Clinical Study Pricing (Options). In the absence of a defined Clinical Study requirement at this time, provided under this solicitation, BARDA requests supporting documentation to understand future proposed pricing and forecast future budget requests. For Clinical Studies, BARDA requests the respondent provide labor categories and direct labor rates for personnel that will be involved in accomplishing the clinical studies. Anticipated personnel should include, but not be limited to, project manager, quality affairs, clinical operations, medical officer, physicians, and clinical PI.

Additionally, BARDA requests estimated indirect labor rates, to include fringe, overhead, or G&A, for the respondent in performing future clinical studies. Justification for these rates is requested using the following methods: USG Forward Pricing Rate Agreements (FPRAs), detailed calculations, historical rates for similar efforts, evidence of commercial rates, or a comparison of proposed rates to market indices/industry standards. Proposed personnel, direct labor rates, and indirect rates can match, in whole or in part, the cost elements proposed under the capability build, as necessary. The documentation provided under this part will not be binding; however, it will be used as a basis for determining budgets for future clinical study requirements. Please reference Attachment 1 for a template to submit the documentation requested under this part.

5. Proposal Evaluation Criteria As stated in Section 3.3 above, respondents that fall within the Exclusion Criteria will not be considered for award and will not be evaluated further. Proposals will need to stand on their own merit and will not be evaluated against each other as they will not be proposed in accordance with a common set of proposed activities. Each proposal will be evaluated against the defined evaluation criteria. All responsive proposals will be evaluated against the following evaluation criteria considered of equal merit, listed below.

A. Resource Capability The proposed resource capabilities demonstrate the ability to achieve minimal acceptable capabilities as outlined in Table 2. The ability to achieve the desired capabilities considerations will be taken into consideration, especially regarding what is achievable with current organizational capabilities and what will be achievable at the end of the capability build. The current partnerships within the team demonstrate the capabilities needed to accomplish the proposed capability build and future clinical studies. There is clear evidence of being able to quickly activate subagreements, as necessary, to meet the requirements. All existing partnerships and agreements as well as planned or future relationships are clearly outlined particularly for equipment, user/patient engagement, decentralized sites, healthcare delivery, data management systems and data sources as appropriate. In addition, respondent demonstrates that enhancing decentralized clinical care and research is already a core strategic priority for the organization. Current existing partnerships will be viewed more favorably over developing relationships. Proposals that do not demonstrate the ability to achieve the desired minimal acceptable capabilities will be deemed “unacceptable.”

B. Overall Scientific & Technical Merit The proposed approach is viable, realistic, and capable of satisfying the minimal acceptable requirements outlined in Table 2 and demonstrates the ability to address the multiple study areas outlined in Section 3. The proposal includes substantial scientific/development rationale with supporting preliminary use cases, experience, and/or data as well as ability to address new diseases, users/patients and technology.

Preference will be given to organizations that already have multiple desired capabilities outlined in Table 2, particularly a broad footprint in the US with established clinical care and/or decentralized clinical research.

BARDA will give preference to respondents that can demonstrate approaches and capabilities to address special populations of interest to BARDA, including: children, pregnant women, the elderly and persons with compromised immune systems as well populations underrepresented in scientific research as outlined-https://diversity.nih.gov/about-us/population-underrepresented. Furthermore, BARDA https://diversity.nih.gov/about-us/population-underrepresented will give preference to respondents that can address more than one clinical study area as described in Table 1.

A sound proposal will clearly define all necessary activities, identify and address all major risks, and propose planned mitigation efforts for identified risks. Proposals that do not demonstrate the ability to achieve the minimal acceptable capabilities will be deemed “unacceptable.”

C. Personnel Capability The proposed personnel capabilities demonstrate the ability to meet the technical requirements as outlined in Table 1 and Table 2 and include, but not limited to expertise in program management, clinical study operations and management, regulatory affairs, and medical experts as necessary for experimental, observational and interventional clinical studies. Personnel demonstrate experience in integrating new and diverse health technology into business operations and ideally into decentralized clinical studies, expertise in the harmonization, analysis and assessment of various health data types including electronic health records, clinical data and wearable/app data, and expertise in evaluating models of healthcare in clinical settings outside the hospital as appropriate.

Existing personnel will be viewed more favorably over personnel that may need to be hired. Proposals that do not demonstrate the ability to achieve the minimal acceptable capabilities will be deemed “unacceptable.”

Submissions will be evaluated against the above listed criteria and assigned a rating of either Acceptable or Unacceptable as defined below. The Respondent(s) whose submission(s) appear(s) to offer the best value to the USG will be selected and further engaged with the intent to mutually agree to terms during negotiation and execute an Agreement.

Acceptable: An “Acceptable” submission is characterized as follows:

Proposal meets the minimal acceptable capabilities and indicates an acceptable approach for the three evaluation criteria.

Unacceptable: An “Unacceptable” submission is characterized as follows:

Proposal does not meet the minimal acceptable capabilities and contains one or more deficiencies with the three…