A23 75N99225R00002 DRAFT.pdf

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CODE 18a. PAYMENT WILL BE MADE BY

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OFFEROR

ARPA-H

Washington, MD 20005 Suite 1200 West 1304 K Street NW NIH Advanced Research Projects Ag

Bethesda, MD CODE 16. ADMINISTERED BYCODE

X

X

541715

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% FOR:SET ASIDE:UNRESTRICTED ORARPA-H

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NORTH AMERICAN INDUSTRY

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INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75N99225R00002

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 95 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Washington, MD 20005 Suite 1200 West 1304 K Street NW

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

1,000

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

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DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

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SEE SCHEDULEX

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ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

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8(A)

NIH Advanced Research Projects Ag

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24.

AMOUNT

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UNIT PRICE

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UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Period of Performance: 03/01/2025 to 02/28/2030

1001 Technical & Administrative Labor - PWS 5.5.1 1 LO through 5.5.6 Product/Service Code: AN12 Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

1002 Laboratory Testing Services - PWS 5.5.2 1 LO Continued ...

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

ELAINE D. WONG

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

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27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

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ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

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RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

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FINALPARTIAL

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CORRECT FOR

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COMPLETE

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41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

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AMOUNT

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UNIT PRICE

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UNIT

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SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

1003 Travel - The Contractor shall obtain the 1 LO appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1. The Contractor shall obtain the

appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1.

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

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NAME OF OFFEROR OR CONTRACTOR

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75N99225R00002

1004 OPTIONAL - Clinical Trial Site Identification - 1 LO

PWS 5.5.7

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

Period of Performance: 03/01/2025 to 02/28/2026

2001 Technical & Administrative Labor - PWS 5.5.1 1 LO through 5.5.6

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

2002 Laboratory Testing Services - PWS 5.5.2 1 LO

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

2003 Travel - The Contractor shall obtain the 1 LO appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1. The Contractor shall obtain the

appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1.

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

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(A) (B) (C) (D) (E) (F)

75N99225R00002

2004 OPTIONAL - Clinical Trial Site Identification - 1 LO

Option Period 01 - PWS 5.5.7

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

Period of Performance: 03/01/2026 to 02/28/2027

3001 Technical & Administrative Labor - PWS 5.5.1 1 LO through 5.5.6

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

3002 Laboratory Testing Services - PWS 5.5.2 1 LO

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

3003 Travel - The Contractor shall obtain the 1 LO appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1. The Contractor shall obtain the

appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1.

(Option Line Item)

Product/Service Code: AN12

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75N99225R00002

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

3004 OPTIONAL - Clinical Trial Site Identification - 1 LO

Option Period 02 - PWS 5.5.7

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

Period of Performance: 03/01/2027 to 02/28/2028

4001 Technical & Administrative Labor - PWS 5.5.1 1 LO through 5.5.6

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

4002 Laboratory Testing Services - PWS 5.5.2 1 LO

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

4003 Travel - The Contractor shall obtain the 1 LO appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1. The Contractor shall obtain the

appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1.

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

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REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75N99225R00002

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

4004 OPTIONAL - Clinical Trial Site Identification - 1 LO

Option Period 03 - PWS 5.5.7

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

Period of Performance: 03/01/2028 to 02/28/2029

5001 Technical & Administrative Labor - PWS 5.5.1 1 LO through 5.5.6

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

5002 Laboratory Testing Services - PWS 5.5.2 1 LO

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

5003 Travel - The Contractor shall obtain the 1 LO appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. Additional guidance located in PWS

6.1. The Contractor shall obtain the

appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with

Federal Acquisition Regulation (FAR) 31.205-46, Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

7 95

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75N99225R00002

Travel Costs. Additional guidance located in PWS

6.1.

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

5004 OPTIONAL - Clinical Trial Site Identification - 1 LO

Option Period 04 - PWS 5.5.7

(Option Line Item)

Product/Service Code: AN12

Product/Service Description: HEALTH R&D

SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH

Period of Performance: 03/01/2029 to 02/28/2030

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

DEPARTMENT OF HEALTH & HUMAN SERVICES

Advanced Research Projects Agency for Health

Section C – Description/Specifications/Work Statement

Performance Work Statement Contract Research Organization (CRO) Support Services for the ADAPT Program

1.0 Description of Services/General Information

1.1 Mission Office and Objective

The Advanced Research Projects Agency for Health (ARPA-H) Scalable Solutions Office (SSO) requires Contract Research Organization services to support its ADvanced Analysis for Precision cancer Therapy (ADAPT) program. The ADAPT Program mission is to revolutionize cancer treatment by developing new adaptive strategies using biomarkers to target the evolution of metastatic cancer to improve patient survival. The program manager and performers will conduct trials to examine how a tumor’s behavior changes and will then use the results to match each patient with the best available therapy.

1.2 Scope

The Contractor will provide Contract Research Organization support services for a linked evolutionary clinical trial undertaken in breast, colon, and lung cancers in support of ARPA-H staff and its performers. Examples of required management and research support services include, but are not limited to, systems, data and tools to assist in the effective data management and biological assay testing requirements for its clinical research program. This PWS supports the requirements to complement and support ARPA-H’s mission. ARPA-H will select entities to perform technical areas (“TA”) TA1, TA2, and TA3 referenced below in a solicitation separate from this PWS. For more information, please see the attached ARPA-H- MAI-24-01-03, Amendment 02 document. The Contractor will support these TA performers by conducting the tasks outlined in this PWS.

To meet these requirements, the Contractor shall provide the specialized knowledge, skill sets, data, and services articulated in this contract PWS.

1.3 ADAPT Program Background: Technical Areas

Due to significant advancements in tumor measurement and analysis techniques, tremendous opportunities exist to develop biomarkers that improve drug selection for patients.

These innovations will enable the identification of optimal drug targets and treatment strategies for individual patients. The ADAPT Program is comprised of three interconnected TAs, outlined below and in Figure 1:

• TA1 – Therapy Recommendation

Techniques: Develop data-driven methods that determine resistant cancer traits, discover new predictive biomarkers of drug response, and guide optimized treatments based on a tumor’s genetic and phenotypic traits. TA1 comprises three sub-TAs including:

o TA1.1: Multi-Modal Data Fusion: Combine information from multi-modal data types to create a unified representation of tumor data that offers a more comprehensive and accurate understanding than any single data source alone.

o TA1.2: Resistant Trait Modeling: Develop tumor evolution models that increase number and precision at which resistant traits are discovered and that enable identification of new treatment strategies of targeting resistance traits.

o TA1.3: Biomarkers that Predict Drug Response: Develop and test multi-modal biomarkers that will be implemented within an evolutionary clinical trial (TA2).

• TA2 – Evolutionary Clinical Trial: Design a trial that adjusts drug treatments based on how the tumor evolves during multiple sequences of therapy. TA2 comprises three sub-TAs including:

o TA2.1: New Tumor Measurement Technologies: Collect a broad diversity of temporal tumor measurements from the evolutionary clinical trial (TA2.2) for resistance trait identification and predictive biomarker development in TA1.

o TA2.2: Evolutionary Trial Protocol: Develop a centralized, modular, open-source protocol design capable of responding to tumor changes in near-real-time.

o TA2.3: Evaluation of TA1 Biomarkers: Test and integrate predictive biomarkers and adaptation of subsequent lines of therapy into the evolutionary trial based on data collected from prior treatments.

Figure 1. The ADAPT Program’s TA1, TA2, and TA3 will jointly develop, test, share, and iteratively refine predictive biomarkers and new treatment regimens.

This cycle enables a new approach in the treatment of cancer patients where data rapidly, consistently, and accurately informs patient care.

• TA3 – Treatment & Analysis Platform: Create open-source collaboration space for developing, analyzing, and sharing data, models, and trial protocols between researchers and clinicians.

ARPA-H will select entities to perform TA1, TA2, and TA3 referenced above in a solicitation separate from this PWS.

2.0 ACRONYMS

ACA Associate Contract Agreement ADAPT ADvanced Analysis for Precision cancer Therapy ARPA-H Advanced Research Projects Agency for Health CFR Code of Federal Regulations CLIA Clinical Laboratory Improvement Amendments COR Contracting Officer’s Representative CPM Contract Program Manager CSR Clinical Study Report CT Computed Tomography FDA Food and Drug Administration FFPE Formalin-fixed, paraffin-embedded GFE Government Furnished Equipment GFP Government Furnished Property H&E Hematoxylin and Eosin HHS Department of Health & Human Services IHC Immunohistochemistry IRB Institutional Review Board IVD In vitro diagnostic IT Information Technology LOI Letter of Intent MRI Magnetic Resonance Imaging MSR Monthly Status Report NDA Non-Disclosure Agreement ODC Other Direct Cost OSHA Occupational Safety and Health Administration PM Program Manager PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QP Qualification Plan SSO Scalable Solutions Office SOP Standard Operating Procedures TA Technical Area TDY Temporary Duty WES Whole Exome Sequencing

WSI Whole Slide Image

Unless otherwise defined within this PWS, “days” shall mean business days.

3.0 GOVERNMENT FURNISHED

3.1 Information

Performance on this contract may require the Contractor to access and use material and information such as studies, reports, and key data considered proprietary to ARPA-H or another Contractor, which is of such a nature that its dissemination or use, other than in performance of this effort, would be averse to the interests of the Government and/or others.

The Contractor will be required to sign a non-disclosure agreement (NDA) prior to commencement of the work. At the request of the Government, or on completion of the contract, the Contractor will immediately return any information provided by the Government.

3.2 Contracting Officer’s Representative (COR)

4.0 CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES

The Contractor shall provide all equipment, supplies, facilities, transportation, tools, materials, and other items and non-personal services necessary to perform Clinical Trial Data Management, and Contract Research support as defined in this PWS except for those items specified in Part 3.

5.0 REQUIREMENTS

5.1 Period of Performance

The contract will be one (1) 12-month base period with four (4) 12-month option years and may extend up to six (6) months past the last option period.

5.2 Place(s) of Performance

The tasks listed below will be performed at off-site locations including, but not limited to, the Contractor’s locations.

5.3 Hours of Operation

The Contractor must maintain an adequate workforce for uninterrupted performance of all tasks defined within this PWS. The Contractor may be responsible for required work during holidays, local, national or other emergencies or closings due to the nature of the requirement.

5.4 Observance of Legal Holidays

The list below are Federal holidays observed under this contract. This includes any other day/time designated by Federal statute, Executive Order, or Presidential Proclamation. The Contractor’s employees may be required to perform services on legal holidays and/or the day the United States Government observes that holiday if it falls on the weekend; the COR may direct the Contractor to work on these holidays for specific mission needs. The Contractor may follow its corporate policy for holiday leave.

• New Year’s Day, January 1

• Martin Luther King’s birthday, the third Monday in January

• President’s Day, the third Monday in February

• Memorial Day, the last Monday in May

• Juneteenth, June 19

• Independence Day, July 4

• Labor Day, the first Monday in September

• Columbus Day, the second Monday in October

• Veterans Day, November 11

• Thanksgiving Day, the fourth Thursday in November

• Christmas Day, December 25

5.5 Specific Task Areas

The following are the minimal clinical trial data management and contract research service requirements from ARPA-H to effectively support the ADAPT’s TA1, TA2 and TA3. The Contractor shall provide all management, scientific, expert, and support staff required to conduct contract activities in the Task Areas described below.

5.5.1 Task 1. Study Operations and Review

1. Conduct periodic review of study progress, data entry, and data quality upon request of the ADAPT PM and/or COR

2. Attend scientific progress review meetings at the request of the COR/ADAPT PM, provide required background material, record meeting minutes and take appropriate actions on recommendations.

3. Coordinate and collaborate with ADAPT PM and ADAPT program performers as defined in Attachment 4 Associate Contractor Agreement.

4. Collaborate with ADAPT performers on day-to-day operations including but not limited to: shipping and receiving biological specimens to/from ADAPT TA2 performers and biological assay vendors, and data collection and transfer to the ADAPT TA3 platform.

5. Coordinate with the ADAPT PM and/or COR regarding impediments to day-to-day operations (equipment or assay failures, software down time), and additional instances as referenced below.

5.5.2 Task Area 2. Biological Testing of Patient Samples

1. The Contractor shall negotiate and manage all financial and administrative matters related to the shipment, assay, and analysis of biological specimens as described in the requirement.

2. The Contractor shall coordinate sample collection and handling protocols, and shipment of biological specimens (e.g., peripheral venous blood, tissue biopsies, FFPE, etc.) from points of collection at TA2 performer clinical trial sites (anticipated minimum of 33 trial sites within the Continental United States) to centralized biological testing laboratories. The Contractor shall direct and oversee transfer of custody of specimens from the performer to the laboratory, and subsequent shipment to biological assay companies. Protocols can include shipping a portion of the sample to multiple ADAPT performer laboratories.

3. Develop and implement standard operating procedures (SOPs) adaptable to each site where work is being performed and utilize such standard approaches at all sites in order to minimize variation in handling and processing of biological specimens, and train personnel who will be involved in collecting, handling, processing and shipping of biological specimens.

4. Inventory all samples. Pertinent data concerning the specimen donor and processing procedures shall be collected and accompany every biological specimen.

5. Ensure that adequate caution is maintained by employees working with materials that present a biological hazard, e.g., human tissues. Safety regulations detailed by the Occupational Safety and Health Administration (OSHA Standards – 29 CFR Part 1910.1030) shall be followed.

6. Arrange for onsite storage and/or safe shipment of biological specimens (on dry ice or other means as appropriate) to laboratories, for either immediate assays or storage.

The contractor shall store any remaining raw or processed samples (tissue, serum, DNA, RNA, etc.) not needed for biological assays until contract termination, at which time ARPA-H PM shall direct sample dispersal.

7. Specimens shall be stored within refrigerators/freezers/cryopreservation systems equipped with state‐of‐the‐art remote monitoring devices monitored 24 hours/day for failures. Contractor shall notify the COR and ADAPT PM of failures or other need for offsite storage. Ensure the relocation of specimens to appropriate backup refrigerators/freezers/cryopreservation systems when necessary. Monitor backup systems of all refrigerators/freezers/cryopreservation systems regularly.

8. Report to the ADAPT PM all irregularities, delays, losses, deteriorations, unplanned defrosting, accidents, mishandlings, errors, discrepancies and significant inefficiencies connected with any specimen collection, delivery or storage activity. When relevant, include in reports to the ADAPT PM the potential for sample degradation, length of time thawed, etc. Deliver reports within 24 hours of unexpected event.

9. Prior to conducting biological assays, the Contractor shall develop appropriate SOPs outlining the materials and methods, methods used to check sample quality, e.g.

electrophoresis for RNA and sequencing libraries, other samples or measures that will be used for quality assurance (QA) and quality control (QC) testing, and methods for recording, documenting and analyzing data.

10. The Contractor shall provide and conduct biological sample assays on the biological specimens at laboratories holding an active Clinical Laboratory Improvement Amendments (CLIA) certification, with a focus on data generation from assay platforms that can be used in a clinical setting as an in vitro diagnostic (IVD) test.

Performance of the below assays at a single laboratory is preferred. The Contractor is expected to be prepared to begin performance of biological assays within 30 days of contract award. An expected total of 1,700 patients will be enrolled over the performance of the contract by the ADAPT TA2 performer clinical teams, funded through ARPA-H. It is expected that patients will have an average of two tissue biopsies, upon which both whole exome sequencing and whole transcriptome sequencing will be performed (up to 6,800 tests across the 1,700 patients), and an average of five blood draws each, upon which both ctDNA and ctDNA methylome sequencing will be performed (up to 8,500 tests each, total of 17,000 tests across the 1,700 patients, with methylome sequencing including both whole genome and targeted assays), and up to 8,500 tests across 1,700 patients for the optional cfMeDIP-seq assay. Assays shall include but are not limited to:

a. Whole Exome Sequencing (WES) (data generated must include at least 100X coverage across at least 15,000 genes; IVD testing platform preferred) on tumor biopsy tissue

b. Whole Transcriptome Sequencing (data generated must include at least 50M paired-end reads per sample across at least 15,000 genes, IVD testing platform preferred) on tumor biopsy tissue

c. ctDNA sequencing (clinical assay; ≥500X coverage across a minimum of 500 genes, IVD testing platform preferred) performed on blood samples taken sequentially before, during and after treatments

d. ctDNA methylome sequencing targeted assay (research use/experimental) ≥500X coverage across a minimum of 500 genes, performed on blood samples taken sequentially before, during and after treatments

e. Optional, but preferred cfMeDIP-seq assay (research use/experimental) (≥500X coverage across a minimum of 500 genes), performed on blood samples taken sequentially before, during and after treatments.

For assays described in 5.6.2.10a, 5.6.2.10b, 5.6.2.10.c, and 5.6.2.10d, a 14 calendar day turnaround time is required from sample receipt to data distribution. For assay described in 5.6.2.10e, a 35 calendar day turnaround time is required from sample receipt to data distribution. Please see A23 Attachment 2a Assay Testing Requirements file for further details.

11. The contractor shall collect and send raw unprocessed biological assay data (FASTQ or BAM files) to TA3 performers as directed by ARPA-H and meeting the ADAPT program data requirements.

12. The Contractor will be responsible for any insurance company billing and reimbursements in coordination with TA2 performers, where relevant. Any biological assay test costs reimbursed to the Contractor by insurance companies will not also be paid by ADAPT.

13. The Contractor will maintain data use and confidentiality contracts with any external biological testing companies.

14. The Contractor will provide historical data from the assay platforms selected for independent validation of biomarker performance. Raw data is preferred.

15. The Contractor will maintain an inventory log of all specimens and provide tracking status of specimens and associated biological assay results in real time.

16. The contractor shall submit monthly reports to the ADAPT PM detailing ongoing QA/QC management efforts implemented in each laboratory. Reports shall include results from continual monitoring of defined quality performance metrics and analysis of blinded QA/QC samples (supplied by the contractor) assayed across biological test batches. Data used to calculate quality metrics shall be provided as requested.

17. The Contractor shall (within 1 week of data generation, with near real-time data transfer preferred) transfer raw and processed data and laboratory reports from biological assay laboratories or internal testing laboratories to ADAPT TA3 performers, and transfer clinical patient-facing reports produced by testing laboratories to ADAPT TA2 clinical investigators within 2 weeks of specimen collection (preferred), within 4 weeks (required).

18. The Contractor shall provide all equipment, supplies, systems, and personnel, in order to furnish services outlined above.

5.5.3 Task Area 3 Centralized Clinical and Research Data Management

1. The Contractor will work directly with ADAPT TA3 performers for data transfer and evaluation. Both clinical and research data (research data detailed in Task 2.11) from each patient should be collected and centralized with the Contractor. Clinical data to be collected and centralized by Contractor from ADAPT TA2 performers includes but

Figure 2. Data Collection and Transfer to TA3 Performer Cloud Platform. The Contractor will be responsible for tracking and collecting all data from ADAPT clinical trial sites. Clinical data, labs, and imaging (radiology, pathology) will be collected directly from sites, while data derived from biospecimens (molecular assays etc.) will be collected from the Contractor’s assay labs. The Contractor will coordinate with TA3 performers to transfer all data into the ADAPT Data Lake.

is not limited to electronic health records, blood panels/counts, hematoxylin and eosin (H&E) stains at time of diagnosis/biopsies and other relevant pathological tests for breast, lung and colon cancer from FFPE, as well as other pathological tests, radiological tests (computed tomography (CT), mammography, magnetic resonance imaging (MRI)), and other clinical data taken sequentially before, during, and after treatments.

2. The Contractor shall develop and implement SOPs adaptable to each ADAPT TA2 clinical trial site to support the transfer of data from TA2 sites to the Contractor and conversion of trial data into file types specified by the ADAPT program.

3. The contractor shall collect and send raw and any relevant processed imaging (whole slide images (WSI) from H&E, immunohistochemistry (IHC), other relevant pathological and clinical tests) and radiological imaging data to TA3 performers as directed by ARPA-H and meeting the ADAPT program data requirements.

4. The Contractor will assemble individual subjects' electronic health records and codify key treatment and outcomes data, including hospital or physician visit records, assessment of response to each therapy and time to progression, side effects and adverse drug events, pathology and radiological tests and reports, prescription or billing information, death certificates, etc. Have these records and certificates evaluated and coded and transferred to the ADAPT TA3 data lake. It is estimated that ~3,400-11,900 visit/clinical data records will be collected during the multiple contiguous lines of therapies on average for ADAPT patients.

5. The Contractor will develop or employ tracking systems that monitor the incoming flow of data, editing of data, back‐ups, and changing or modification of data that can be summarized into descriptive reports and/or databases.

6. The Contractor shall design and maintain computer databases and associated reporting software, setting up and maintaining a multi‐user computer network with shared software and data backup capabilities. Provide adequate validation when new software is developed.

7. The Contractor shall utilize data management systems that meet the informational needs defined by ARPA-H and are compatible with ARPA-H standards and other existing and planned ARPA-H applications. These standards would include: secure data storage, including the secure protection of Protected Health Information (PHI), clear documentation of data organization, including e.g., file naming schema, folder structure, data dictionaries, etc., support for secure access and retrieval of data (programmatically via APIs or via other interfaces or timely and compliant deposition of data into ARPA-H-managed storage locations), common data standards for ingested clinical data and harmonization of clinical and research data collected during lines of treatment.

8. When applicable, computer-based systems shall be consistent with Code of Federal Regulations (CFR), Federal, and HHS informatics standards, relevant industry standards, as well as Federal regulations and standards to ensure the integrity, confidentiality, security and availability of data. Regulations and standards will be provided by the government. ARPA-H shall have access to data.

9. The Contractor may be requested to work with developing ARPA-H ADAPT infrastructure as needed for data ingest from TA2 clinical trial performers as well as

TA3 data platform and sharing performers. It is preferred if the Contractor provides access to already established datasets that include some or all of the data types being used for ADAPT performers for early model development of TA1 performers. Details on access to additional data types and numbers should be provided for evaluation.

10. Prepare, edit programs, edit data, and correct computer files where necessary.

11. Update files with follow‐up data, error corrections, etc. as directed by the COR or

ADAPT PM.

12. Develop and maintain internal record‐keeping procedures for assessing efficiency and quality of data collection, preparation, back‐up, and entry.

5.5.4 Task Area 4 Regulatory Submission Support and FDA Interface Coordination

The ADAPT program will work closely with TA1, TA2, and TA3 performers to develop biomarkers as in vitro diagnostics (IVDs) for clinical applications. To support this objective, the Contractor will:

1. Provide a plan that meets requirements to obtain regulatory approvals for a clinical test.

2. Draft or update existing SOP specifying how the Contractor will provide regulatory submission support and FDA interface coordination.

3. Provide technical and administrative support to ARPA-H staff and ADAPT program principal investigators in the preparation, assembly, review and submission of regulatory documents that may include clinical study reports (CSRs), Letter of Intent (LOI) and Qualification Plan (QP) for new biomarkers, pre-submission requests for IVDs, and pre-market notification 510(k)s. This shall include original and subsequent submissions as well as interim and annual reporting, when needed. Assure that submissions of regulatory documents and systems are in compliance with all applicable Federal regulations and guidance. Documents shall be submitted to the ADAPT PM and/or FDA in the standard, electronic format accepted by the FDA.

4. Assist ARPA-H staff in responding to inquiries and communications from the Food and Drug Administration (FDA) and other regulatory authorities, if warranted.

5. Participate in meetings and teleconferences with regulatory authorities and provide assistance to ARPA-H staff in preparing meeting materials.

6. Track and store information submitted to the FDA and other regulatory authorities (e.g., biomarker LOI, QP correspondence and submissions, 510(k)s) for ARPA-H-supported studies.

5.5.5 Task Area 5 General Logistical, Administrative and Technical Support

1. Attend bi-annual ADAPT program meetings in person and prepare and present briefings to ADAPT program performers at these meetings as directed by the ADAPT

PM.

2. Establish reliable electronic communication links with ARPA-H and ARPA-H clinical study sites, which permits sending e-mail and sharing word processor and data files.

Websites for protocol and program communication(s) shall be implemented with appropriate secured access. Maintain compatibility with standard software used by ARPA-H. Initiate conference calls for projects and protocols on an ongoing basis, as well as attend these calls and prepare/distribute minutes.

3. At specified intervals or as needed, prepare study status and study-specific performance reports for all ongoing ARPA-H ADAPT-supported clinical studies including, but not limited to sample tracking status, summary data reports from biological assays, data quality reports.

5.5.6 Task Area 6 Contract Transition-Out Plan

1. Develop a written transition-out plan to ensure the orderly transfer of all contract-generated data, documents and other materials to the Government and a successor Contractor.

2. Effect a smooth transfer of all databases and electronic systems, data, information and other files, documents and materials required under the contract to the Government and/or the successor Contractor, in coordination with ARPA-H. Transfer shall be completed electronically.

[Optional] 5.5.7 Task Area 7. Clinical Trial Site Identification

1. Provide assistance to TA2 performers to identify clinical trial sites with high patient enrollment for ADAPT, and with a high diversity of patients.

2. Assess sample and data collection capabilities for the ADAPT trial sites identified.

3. Develop and implement procedures to monitor recruitment rates and develop and help implement backup methods to adapt sites and enrollment strategies to increase recruitment if the ADAPT trial enrollment goals and diversity metrics are not met.

4. Attend Quarterly meetings with COR/ADAPT PM to assess clinical trial recruitment and enrollment metrics and timetables.

6.0 ADMINISTRATIVE REQUIREMENTS

6.1 Travel and Other Direct Costs

Contractor travel is required to perform the tasking of this PWS. Work will be performed in Contractor facilities. Travel requirements include travel to bi-annual ARPA-H ADAPT meetings; however, local Temporary Duty (TDY) and daily commuting will not be reimbursed.

All travel requires COR approval/authorization prior to incurring costs and commencement of travel. The Contractor shall be reimbursed for travel to provide support as approved by the COR. The Contractor shall obtain the appropriate approval(s) electronically to the COR designated official prior to finalizing any travel arrangements. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with Federal Acquisition Regulation (FAR) 31.205-

46, “Travel Costs”. Requests for approval of costs in excess of maximum per diem rates in accordance with the procedures contained in FAR 31.205-46(a)(3) must be submitted to the Contracting Officer for final approval prior to commencement of travel.

All Other Direct Costs (ODCs) associated with this contract shall be approved in writing by the COR prior to incurring costs. The Contractor may be required to procure software, licenses, or materials to perform the tasking of this PWS. The Contractor may be required to incur the cost of incidental items, including, but not limited, to the following: meeting and training supplies, copying and mailing. In addition, attendance at workshops or symposiums for training purposes not directly in support of this PWS is not permitted. Training directly in support of this PWS may be permitted on a case-by-case basis only with COR approval prior to any costs being incurred.

The Contractor shall invoice MONTHLY with description to include invoice performance period, short description of services completed, and any other information required by the COR after email submittal of Monthly Status Report to the Contracting Officer and COR. The report shall include other ODC items, such as software or licenses, should be itemized to include Title, whether it’s a License, Duration/Frequency of the item (yearly, monthly, one-time cost, etc.), Maintenance, Quantity, and any other pertinent information to include identifying the task the ODC supports. The financial report shall show travel charges shown per person, contain location and dates, and items must be identified by subject (i.e., meals, rental car, and airfare requirements.) Receipts for all single travel expenses of $75 or more shall accompany the report. All travel expenses for this contract must comply with FAR 31.205-46 “Travel costs”, FAR 52.232-25, and this PWS. Reference Part 7 for additional invoice details.

6.2 Conflict of Interest

The Contractor shall notify the Contracting Officer of any suspected conflict of interest and provide the plan to mitigate or eliminate the conflict to the satisfaction of the Government.

6.3 Performance

The Contractor shall provide Clinical Trial Data Management and Research support services delivered by high-quality, highly qualified, team oriented, cost conscious, innovative professionals dedicated to the development, implementation and maintenance of ADAPT programs and services. The Contractor shall function as a coordinated support team to assist ADAPT staff in performing the tasks listed herein. The Contractor shall provide personnel off-site support, as needed, during normal operations and during surges, special situations, and unforeseen events and requirements. The Contractor shall be able to provide the entire portfolio of services across the contract and the have the capability and resources to provide for rapid ad-hoc surge support as may be required by this PWS.

6.4 Non-Personal Service Statement/Inherently Government Functions Contractor employees performing on this contract will be controlled, directed, and supervised at all times by management personnel of the Contractor. Contractor management will ensure that employees properly comply with the work standards outlined in this agreement. Contractor employees will perform their duties independent of, and without the supervision of, any Government official. The tasks, duties, and responsibilities set forth in this contract may not be interpreted or implemented in any manner that results in any Contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S.

Government, overseeing work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Subpart 7.5 and

37.1 of the FAR. The Government will perform the inspection and acceptance of the deliverables provided.

All services described in this PWS are non-personal services and the Contractor shall not perform any inherently Government functions. As defined by FAR 37.104, Nonpersonal services contract means a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees. Specifically, the Government shall not perform the following to the individual Contractor personnel: supervise, rate performance, determine who or how tasks should be performed, and direct, schedule or critique on a continuous basis. Further, the Government shall not perform actions that would intervene in the Contractor’s chain of command, require out of scope work, require performance of inherently governmental actions or any actions that may result in competitive advantage or create organizational conflicts of interest including individual conflicts of interest, and solicit or accept gifts from Contractor personnel.

If concerns persist, contact the Contracting Officer with details of the concern for direction.

6.5 Subcontracting

Subcontracting with other Contractors, or subject matter experts or consultant services, for the efforts defined within this PWS to provide the technical capabilities needed to perform identified requirements within this contract is allowable. When providing subcontractors and/or consultants, the Contractor is fully responsible for their performance and cost reporting. The Contractor shall provide the manpower required to manage all subcontracts and consultant efforts and to monitor subcontractor activities to the appropriate level of detail required to assure timely deliverables. A report on the performance of subcontractors shall be included as part of the required Monthly Status Report deliverable.

6.6 Training

The Contractor shall ensure all personnel are adequately trained prior to supporting ADAPT.

The Contractor is generally expected to maintain the professional qualifications and certifications of its personnel through on-going training. Unless specifically authorized, the Contractor shall not directly bill the Government for any training that is not required by the Government.

6.7 Expectation

The Contractor is expected to attract, hire, and retain a quality work force, with minimal turnover, to perform the tasks of the PWS.

6.7.1 Contract Program Manager

The Contract Program Manager (CPM) is the single point of contact for the COR with overall responsibility for this contract to manage all programmatic matters and is responsible for managing the day-to-day operation while performing the Program Manager tasks. The CPM duties include but are not limited to, technical progress, problems, program performance, schedule, cost, resources, other program-related matters, ensures the Contractor team is comprised of highly skilled personnel to fulfill the tasks and complete deliverables during the performance period, assures team’s performance and support is of high quality and providing on-time delivery of products to the Government and recognizes areas for internal improvement and develops plans for implementing the improvements. CPM requires experience in a supervisory capacity in planning, developing, and executing clinical trial management efforts for the organization. Experience in establishing strong working relationships with R&D program managers as well as organization leadership; tracking contract efforts to rapidly identify and resolve potential and new problems; identifying and resolving administrative and contractual issues related to a support services contract is required. Demonstrates creativity, foresight, initiative, and mature judgment in anticipating and solving unprecedented problems. The CPM or alternate shall be available during normal business hours, Monday thru Friday except Federal holidays.

6.8 Additional Support

Additional in scope support may be requested as Government requirements demand during the period of performance. The Government will provide reasonable notice for additional support in which the Prime will be required to provide notice of qualified candidate(s) with a brief summary of the relevant experience to the quotation for the additional support or a plan to provide notice of support within 14 calendar days of Government notice of need(s).

6.9 Non-Disclosure Agreement

All Contractor personnel shall be required to sign ARPA-H non-disclosure agreements. During the performance of the contract, Contractor personnel may be exposed to or required to use Government information, as well as proprietary information belonging to other Contractors. The Contractor shall ensure that both prime and subcontractors use said information only to meet the requirements of this contract. The Contractor (to include subcontractors) shall not disseminate proprietary information or place said information at risk of disclosure. If Contractors are replaced during the performance of this contract, then new Contractor employees shall sign the NDA Form upon beginning work.

6.10 Data Rights

FAR 52.227-17 shall govern rights regarding data delivered and/or first produced in the performance of this contract. With respect to this data, the Government shall have, and the contractor hereby grants the Government unlimited rights. Additionally, the Government shall have, and the contractor hereby assigns the Government, copyright to any such data.

The Contractor shall not use, release, reproduce, prepare derivative works from, distribute, or publish any data first produced in the performance of this contract, nor authorize others to do so, except for purposes of performing under this contract or with written permission of the Contracting Officer. The Contractor may use data for internal research purposes only with written notification to the Contracting Officer.