ADAPT CRO Sources Sought.docx

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

The following are the minimal requirements for ARPA-H to effectively support the ADAPT program’s evolutionary clinical trial.

1) The following services are required to support the evolutionary clinical trial:

a) ADAPT Program Phase 1 Stage I: Clinical trial establishment (8 months):

i. Regulatory affairs and compliance

ii. Clinical trial planning

iii. Clinical trial protocol management

iv. Clinical trial site identification and selection

v. Clinical trial site initiation and activation

vi. Patient recruitment

b) ADAPT Program Phase I Stage II and Phase II: Clinical trial management and oversight (60 months):

i. Patient recruitment and retention

ii. Patient enrollment target of 500+ patients across 8+ trial sites

a. Enrollment of patient cohort with demographics representative of the cancer types investigated in ADAPT- breast, colon, and lung cancers

iii. Clinical trial site management

iv. Clinical monitoring

v. Drug logistics

vi. Drug safety management

vii. Biomarker testing

viii. Biomarker integration

ix. Biological sample collection and processing including but not limited to patient blood and tumor biopsies

x. Biological sample distribution including but not limited to transfer of patient blood and tumor biopsies to testing labs

xi. Data management

xii. Data auditing

xiii. Regulatory requirements and compliance

xiv. Study file and document management

xv. Quality control

xvi. Communication with trial sponsors

xvii. Site closeout

xviii. Transfer of clinical trial data to ADAPT TA3 performers

2) Data Format & Transmission

a. All clinical trial data should be in a consistent machine-readable data format.

b. Vendor will provide all deliverables in a timely manner to recipients designated by ARPA-H, potentially including TA3 performers contracted by ARPA-H (e.g., for the purposes of transferring data into the ADAPT program treatment and analysis platform).

c. Vendor will ensure deliverables are transmitted or otherwise made available in a manner that is compliant with all appropriate security and privacy standards (e.g., via Secure File Transfer Protocol or download from secure platform).

III. Specific Questions:

1) Historical patient population data

a. Where available and as allowable, the following demographic information from trials performed at the respondent organization in the past 2 years should be provided by cancer type (breast, lung, colon). The Vendor should follow the OMB approved race and ethnicity categories.

i. Age,

ii. Sex,

iii. Gender,

iv. Race/ethnicity,

v. Clinical profile (e.g., immunocompromised, presence of chronic conditions),

vi. Median Income

vii. Location treatment was provided, including state and city

b. Description of the Vendor’s catchment area (city, county, state, region, country, etc.)

c. Describe the timeliness for patient enrollment in past trials including breast, lung, and colon cancer patient populations with an emphasis on traditionally hard-to-reach groups. Provide metrics if possible (e.g., average time to go from pre-screening to consent).

2) Do you have experience working with next generation clinical trials specific to adaptively designed and biomarker driven evaluations of molecularly targeted agents and immune therapies in selected patient subsets? If yes, please elaborate on this experience.

3) Innovative trial initiation and management:

a. Describe timelines from your previous trials including initiation of clinical trial sites and timeline to provide initial clinical and research trial data back to sponsor.

b. Describe experience you have with managing clinical trials of various designs including decentralized, pragmatic, adaptive, randomized, ‘N of 1’ trials, and/or umbrella trials. Please provide the number of engagements you have had working with each type of trial.

c. Do you have experience working with next generation clinical trials specific to adaptively designed and biomarker-driven evaluations of molecularly targeted agents and immune therapies in selected patient subsets? If yes, please elaborate on this experience.

d. Describe your expertise, experience, and provide examples of using and innovating on clinical data (e.g., EHR, imaging, pathology data, clinical trial management systems, and medical data standards).

e. Describe your experience and provide examples of working with tumor biology measurement technologies (e.g., blood-based circulating tumor DNA/RNA/methylome, single cell, bulk tumor ‘omics and spatial profiling technologies). Please detail capabilities for rapid sample collection and disbursement. Also, describe your past experience managing diverse data collection and sharing from different laboratory vendors of sequencing, etc.

4) Sponsor engagement:

a. Do you allow for transparent access to your clinical systems (e.g., operational and patient data)?

b. Please describe your processes to ensure real-time responsiveness, and real-time access to data to support decision making processes.

c. What process do you employ to facilitate sponsor review of clinical study data?

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) Provide a rough order of magnitude (ROM) estimate or cost range of the annual cost to perform the requirement in Section II. Please provide two (2) ROMs: one (1) for Phase I Stage I and one (1) for Phase I Stage II / Phase II. Please break out the estimates per task, rather than per patient.

l) 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 3:30 pm (Eastern) on May 29, 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 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.