A11 ADAPT CRO RFI 09192024.pdf

Advanced Research Projects Agency for Health (ARPA-H) Business Innovation Division (BID)

Sources Sought – ADAPT Contract Research Organization Services

I. Background

The intent of this Sources Sought notice is to gauge industry interest, capabilities, relevant experience, and cost information to support Advanced Research Projects Agency for Health (ARPA-H) Resilient Systems Office (RSO). The mission of ARPA-H is to accelerate better health outcomes for everyone by supporting the development of high-impact solutions to society’s most challenging health problems.

The RSO objective seeks to support the procurement of Contract Research Organization (CRO) services for the ADvanced Analysis for Precision cancer Therapy (ADAPT) program.

Specifically, ARPA-H is looking for CRO services to support a single evolutionary clinical trial that will enroll patients with metastatic breast, lung, and colon cancers. This trial will adjust drug treatments based on tumor evolution during multiple sequences of therapy. The CRO service will establish and coordinate clinical trial efforts across multiple ADAPT performers in different geographical locations, allowing for clinical interventions and tumor biology assessments in real time.

II. Requirements

Please see Attachment RFI04 Performance Work Statement Tasks DRAFT ADAPT CRO

Please note this is a draft copy of the tasks within the Performance Work Statement (PWS) and is subject to change prior to solicitation released, if issued.

III. Specific Questions:

1) Please provide feedback on any tasks areas that are unrealistic or require clarification. Please provide tasks and subtasks that require clarification on or appear unrealistic in chronological order, to include the feedback.

2) Please provide general feedback on the task and subtask areas of the PWS. Please provide feedback on tasks and subtasks in chronological order.

3) Please indicate if your company can perform some or all the tasks of the PWS. If your company can perform some of the tasks, please list the tasks in chronological order.

Alternatively, please indicate which tasks will be performed by subcontractor or teaming arrangements. If your company indicates that it can perform a task, please summarize methodologies, procedures, or actions taken to perform the task.

4) Please provide a rough order of magnitude (ROM) estimate or cost range of the total cost to perform the tasks in the draft PWS. The estimated effort for this requirement is a total enrollment of 1,700 patients across a 5-year period. Patients will have an average of two tissue biopsies each with whole exome sequencing and whole transcriptome sequencing performed on both biopsies. An average of five liquid biopsies per patient will be sampled across the span of the contract, each of which will undergo ctDNA and ctDNA methylome sequencing (8,500 total ctDNA and 8,500 total ctDNA methylome tests across the 1,700 patients; with ctDNA methylome sequencing including both whole genome and targeted assays).

IV. Sources Sought Response Format:

Responses will be evaluated solely for market research purposes only. Consequently, the Government is primarily interested in Qualified Sources providing specific technical details indicating how that source can meet the Government’s needs. Interested parties, at a minimum, should provide the following information:

a) Name of Company and Point(s) of Contact

b) Address, Telephone Number, Fax Number, and Email Addresses(s) of POC

c) Vendor Cage Code & UEI

d) Possess an active sam.gov account

e) The anticipated NAICS Code for this effort is 541715 Research and Development in the Physical, Engineering, and Life Sciences (Except Nanotechnology and Biotechnology). Indicate if your company has or is performing under this NAICS code.

f) Identify business size (e.g. large or small), & applicable Socioeconomic Categories and standard size in relation to the proposed NAICS Code, 541715 if under socioeconomic category(s).

g) Concise technical description of the offeror’s capabilities (including systems compatibility) to support Section II Requirements above. Indicate which services can be provided directly from your company or would be subcontracted, and indicate which vendor(s) each service would be sourced from. Include experience performing clinical research management over a multi-year period (2 or more years).

h) Provide a response to Section III Specific Questions.

i) Provide in this response a list (of at least 2) Government contracts/task orders supported currently or during the past 36 months with a brief description of the services provided for the same or similar type of work.

j) Provide in this response any active contracts or agreements with the Government (e.g., GWAC, GSA schedule, BPA, etc.) that may be utilized for this requirement. Include the Government point of contact (name, title, phone and email).

k) Indicate if your company would respond to the Request for Proposal (RFP) as a prime or subcontractor and how long the company would need to respond to a Request for Proposal.

m) Indicate how quickly your company would be able to begin performance of the required tasks (e.g.

within XX days of contract award).

V. Response to this Sources Sought Notice should be single-spaced, 12-point font and 1-inch margins, inclusive of charts, graphs, or other illustrations. All responses to this notice must be UNCLASSIFIED and must be received electronically no later than 6:00 pm (Eastern) on September 26, 2024. Submit responses to steven.snyder@arpa-h.gov and cc elaine.wong@arpa-h.gov. Requests received after the due date will not be considered or responded to. When submitting a response, please use “ADAPT CRO Sources Sought Notice” in the email subject line. Any responses submitted through different channels or to a different email address will not be considered. The Government will NOT acknowledge receipt of submissions or provide feedback. The Government will review the responses to assess relevance and potential performance capabilities.

VI. Disclaimers and Important Notes This announcement contains all information required to submit a response. Submission of a response is entirely voluntary and is not required to propose to a subsequent solicitation. This Sources Sought Notice is issued solely for information and planning purposes; it does not constitute a formal solicitation for proposals. ROM estimates provided by the Contractor in response to this notice is non-binding and is mailto:steven.snyder@arpa-h.gov used for information purposes only. No solicitation exists; therefore, do not request a copy of the solicitation. If a solicitation is released in the future, it may be synopsized on a Federal Business Opportunities website. It is the responsibility of any potential offerors/bidders to monitor this site for release of any solicitation or synopsis. The Government will NOT provide reimbursement for costs incurred in responding to this notice. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

To the maximum extent possible, please submit non-proprietary and non-personal identifiable information. If company proprietary information is submitted, it must be appropriately and specifically marked. It is the submitter’s responsibility to clearly define to the Government what is considered proprietary data. Any proprietary information should clearly be labeled as “Proprietary”. The Government will not publicly disclose proprietary information or cost data obtained as a result of this notice.

Submissions may be reviewed by Government personnel and support contractors bound by appropriate non-disclosure agreements.