BARDA D-COHRe Questions and Answers_6 Nov 23.pdf

Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Strategic Partnership Solicitation Questions Received & BARDA Answers 6 Nov 2023

# Solicitation Section Reference

Question BARDA Answer

1 General Is this opportunity to access funding from BARDA is open to companies located outside of the U.S.?

There is no general prohibition on awarding to companies located outside of the U.S.; however, please refer to the “Exclusion Criteria” in Section 3.3 Minimal Acceptable and Desired Technical Capabilities of the Solicitation:

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.

2 Section 1.3 - Bullet Point 2 The Objectives section of the RFP indicates that BARDA is seeking to achieve ‘Clinically validate products and technologies intended for use in decentralized settings in those real-world environments.’

• Please clarify whether BARDA will need to validate the products or technology OR it will be sufficient that the partner has already done this?

The goal is for the partner/respondent to develop decentralized clinical study capabilities that can be used to conduct future clinical studies under the partnership – such as clinically validating products to support regulatory indications. In this situation, BARDA will identify the product and work with the partner to conduct the clinical study.

It may be appropriate in the Technical section of your proposal to describe studies you have already

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

6 Nov 2023 performed. Section 4.1 Technical Proposal instructions item 5b of the Solicitation states, “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).”

3 Section 2.1 Respondent Eligibility Requirements

Would you consider opening this opportunity up for a NAICS code other than 541714 Research and Development in Biotechnology (except Nanobiotechnology?

Not being registered for the 541714 NAICs code does not prohibit the Respondent from responding to the Solicitation.

4 Section 2.2

Each agreement will have a 5-year Base period of performance and multiple Option line items whereby continued activities for capability growth may be supported.

• Would it be advisable therefore to detail the 5-year plan, but forecast what would be achievable in terms of capability growth if further funding was supported (i.e., over an 8-10- year period)?

• Please confirm that the 5-year base period includes the 1-year timeframe for initial capability build.

Section 3.1 Capability Building and Clinical Study Types of the Solicitation states, “...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.”

BARDA will evaluate proposals received per Section 5 Proposal Evaluation Criteria and Section 4 Proposal Preparation of the Solicitation. The guidance for how to propose your capability growth plan is outlined in the evaluation criteria and Table 2.

Yes, the 5-year base period includes the 1-year timeframe for initial capability build.

5 Section 3.1

During the Base period, options may be exercised to conduct clinical studies and / or conduct additional capability building (outlined in Table 1).

• Is it preferable to place equal focus in the proposal on the three types of clinical studies that may be executed through the partnership

The proposal should focus on the desired company objectives and capabilities to address the evaluation criteria in the solicitation. Section 5 Proposal Evaluation Criteria , Evaluation Criteria B Overall Scientific and Technical Merit, states “... BARDA will give preference to respondents that can address more

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

6 Nov 2023

(product development, product adoption and utilization, clinical trial innovation)?

than one clinical study area as described in Table 1.

Your proposal should address the capability of your organization to conduct all 3 clinical studies should there be a need for BARDA to execute one of these types of studies as an option under the Agreement.

See Section 4.1 Technical Proposal instructions in the Solicitation item 5b, “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.”

6 Section 3.3 - Table 2 With regard to the ‘Footprint/Use Regions,’ the RFP states the desired capabilities to be present in all US regions.

• Is this linked to having sites, patients and PI licensure to treat in all regions? Please clarify?

The Footprint/Use Regions is relevant to the ability of your organization to deliver decentralized clinical care and/or conduct decentralized clinical studies in those regions. In your proposal, please justify the ability of your organization to deliver healthcare and conduct studies in those regions which may include but is not limited to the site capacity, patient access, personnel, medical licensure, etc.

7 Section 3.3 - Exclusion Criteria

Please provide further details on the exclusion criteria ‘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).

• Please clarify whether Respondents may use the

$2M capability funding to create a new piece of technology to enhance patient and site experience to participate in a DCT?

• If “Yes”, would this need to be open source?

Please review Section 3.1 Capability Building and Clinical Study Types, Table 1 and Appendix A: Example Topics for Capability Builds and Studies.

Yes, it is reasonable for a Respondent to use the $2M to incorporate, build or develop a specific type of technology to improve decentralized clinical study readiness, however the Respondent itself should not be focused on technology development. There is no requirement currently for any technology developed by D-COHRe partners to be open source. In your proposal you should justify how the proposed funding

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

6 Nov 2023 for the capability build will enhance innovation and the organization's overall business model for decentralized clinical studies

As per Section 3.3. Exclusion criteria, “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),” would be considered non-responsive.

8 Section 4.2. Business Proposal; Part 2: Clinical Study Pricing (Options);

pages 15-16

Within the “Part 2 – Clinical Study Pricing” tab of Attachment 1, please confirm if Respondents can provide hourly rates across the 5-year Base Period of performance (Years 1 through 5) that include annual escalation factors.

Yes, Respondents can provide hourly rates across the 5-year Base Period of performance (Years 1 through 5) that include annual escalation factors. As stated in Section 4.2 Business Proposal, “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.”

9 General Does BARDA have a preferred eCOA platform/vendor?

BARDA doesn’t have a preferred eCOA platform as we do not dictate which vendors a partner selects, that is an internal business decision. Any choice, if selected, will be evaluated with the remainder of the proposal.

10 General Would it be possible to provide a copy of the OTA contract referenced in the solicitation materials that would govern this project?

We reserve the OTA draft until a company is invited to negotiate, then a draft will be made available, and both the offeror and Government will mutually negotiate terms and conditions.

11 Atch 1, Business Proposal Template

For Clinical Study Pricing spreadsheet (Labor Category column), are you asking for titles of the employees or Bureau of Labor Statistics occupation codes?

Generally, BARDA seeks company-specific titles

12 General Will a Program Evaluator be required for this solicitation?

BARDA cannot specify what category of personnel is required, outside of anything listed in the official solicitation, as that is an internal business decision the Respondent must make. If the Respondent elects to

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

6 Nov 2023 provide a Program Evaluator, it will be evaluated in accordance with the criteria in the solicitation

13 General We would like to know if BARDA's solicitations is for US decentralized healthcare services only or if this extends and includes international healthcare services (OCONUS) locations.

The solicitation on SAM.gov references exclusion criteria at Section 4.2. While there no prohibitions on international clinical studies, a responsive proposal must include the ability to conduct studies in the United States.

14 Budget Budget: The ceiling for the Capability Build budget is $2M. Are we correct that the Program Management and Data Analytics budget is separate and not inclusive of the $2M ceiling? Does the PM and Data Analytics PoP also start in year 1? Should that be budgeted for the 5 year OTA?

Correct, Program Management and Data Analytics funding are separate and not inclusive of the $2M ceiling. However, the D-COHRe program may have a limit on available funds for these activities; therefore, depending on the proposed costs BARDA may have to request a resource contribution or negotiate a reduced scope of work. The assumption is that PM and Data Analytics will start year 1 and will go for the full 5-year period of performance. Proposals should include a budget for the full 5 years of the OTA for these activities.

15 General Our company is trying to coordinate some of the proposed enhanced recruitment and retention activities around a currently running trial. If funded, when could we expect the funding to reach our company?

The initial award of the Capability Build, Program Management, and Data Analytics will be a combination of firm-fixed price and/or milestone-base payments. Therefore, partial payments will be made upon submission of an acceptable invoice after completing fixed-price or milestone-based events. The timing/events for payment can be determined during negotiations if the proposal is selected for award.