04_Sample_TORFPs_A_and_B.pdf

RFP# 75N95021R00003

Attachment 4

Sample Task Order A

NCATS Scientific and Technical Support Services

Sample Task Order A, 3D Tissue Bioprinting Support

Contract Number: N/A PRISM Task Order: N/A

NOTE: The following sample task order is intended to assess the Offeror’s capabilities to execute projects of similar scope and size under task orders issued under the contract resulting from this solicitation. Although the sample task order will NOT be issued at the time of contract award, your response will be evaluated in accordance with Section M of the Solicitation.

A. Task Order Title

3D Tissue Bioprinting Support

B. Task Order Technical Areas

This Task Order (TO) is to provide support for NCATS Automation Research Services, task area 2.1.5 of the Parent Contract Statement of Work (SOW).

C. Task Order Period of Performance

5/1/2021 – 4/30/2022

D. Contract and Task Order Numbers Designation

On all correspondence submitted under the contract, the Contractor agrees to clearly identify the parent IDIQ contract and task order numbers as follows:

Contract Number: N/A Task Order Number: N/A

E. Task Order Price

1. The total fixed price of this task order is $TBD.

2. Upon delivery and acceptance of the services described in SECTION F, Statement of Work, of this task order, the Government shall pay to the Contractor the following price.

F. Statement of Work

See Sample Task Order A SOW, attached.

G. Reporting Requirements and Deliverables

1. Task Order Master Plan

2. Project Plan

Line Description of Service Total ($) 0001 3D Tissue Bioprinting Support TBD

Contract No. 75N95020##### Task Order No. 75N95020F00001

3. Monthly Task Order Updates

4. Task Order Final Report

5. Other Deliverables as requested

H. Contracting Officer’s Representative (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this task order:

TBD

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this task order; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this task order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this task order; (5) otherwise change any terms and conditions of this task order; or

(6) sign written licensing agreements.

The Government may unilaterally change its COR designation.

I. Invoice Submission/Contract Financing

The Contractor shall submit invoices in accordance with the Parent Contract.

J. Attachments

Attachment 1 – SOW

Sample Task Order A - SOW

Sample Task Order A: 3D Tissue Bioprinting Support

Task Order Statement of Work

Background

The 3D Tissue Bioprinting Laboratory (3DTBL) was formally established as part of the Early Translation Branch (ETB) within NCATS in 2018. Prior to that, ITRB had acted as an incubator for the group dating back to 2013 and the acquisition of our first bioprinter at NCATS. Although no longer part of ITRB, the branch is still responsible for providing extensive technical and logistical support to the laboratory. The objective of the 3DTBL at NCATS is to generate 3D tissues that closely resemble the architecture and function of native human tissues, in multi-well plate platforms for disease modeling and drug screening. The laboratory produces and validates a portfolio of normal and disease tissues and develops quantitative assays that enable the screening of compounds for their ability to rescue a disease phenotype. The contractor will provide support for all activities pertaining to the 3DTBL in addition to exploring novel technologies and techniques as this is a rapidly changing field.

1. Technical Requirements

1.1 3DTBL Program Support

The contractor will provide support for all activities that the laboratory is currently engaged in including, but not limited to, the following:

• The development of biofabrication protocols to produce human normal and disease tissues with native-like architecture and function.

• Morphological, physiological, and pharmacological validation of the biofabricated tissues using an array of technologies, including microscopy, histology, gene sequencing, and others.

• The development of quantitative assays that enable compound testing in 3D cellular disease models.

• Screening libraries of compounds using biofabricated tissues for drug discovery.

• Integration of 3D tissue models into the NCATS drug discovery pipeline.

• The development of a framework for the sharing of validated protocols and data as a readily available resource for the scientific community in the spirit of open science and the FAIR principles.

1.2 3DTBL Biofabrication Support

The 3DTBL currently focuses on producing 3D tissue models using tissue biofabrication techniques. Tissue biofabrication integrates advances in tissue engineering technologies and cell biology. Rapid, scalable, and reliable biofabrication of architecturally and physiologically defined functional human tissues in multiwell plate format for drug testing involves the integration of five emerging technologies.

• Operation of bioprinters with precise XYZ control to reproducibly fabricate tissues with defined 3D spatial geometries.

• Creation of novel tools and printing techniques for RegenHu, Cellink and other tissue printers to help facilitate the development of multiple cell type 3D structures.

• The use of equipment to perform histology on printed tissues, from preparing to measuring the samples using such equipment as:

o The Leica BOND RXm Processing Module and Control Kit o The Thermo Scientific PrintMate Cassette Printer, Slide Printer, Cryostat, Tissue

Processor with Embedding Station, Microtome, Slide stainer with cover-slipper and other assorted histology based peripheral devices o The Lecia Aperio VERSA 200 Brightfield and Fluorescence slide scanner

• The use of Biomaterials and biocompatible hydrogels to support the 3D structure of tissue-embedded cells.

• The use of traditional 3D printing capabilities to create support scaffolds and prototype parts to facilitate biofabrication.

• The ability to obtain cells from patients, including human iPSCs and primary cells.

• The utilization of imaging techniques that allow quantitative measurements in both 3D.

Specific experience required with the operation and maintenance of the Leica TCS SP8 Spectral Confocal and Multiphoton system, and the Molecular Devices ImageXpress and PerkinElmer Opera Phenix high content imaging platforms.

• Incorporating Machine Learning (ML) and AI methods that enable effective analysis and knowledge extraction from the 3D data obtained via imaging and other quantification techniques.

1.3 3DTBL Research and Development Support

The contractor will also provide support for additional research areas, both established and emerging, within the 3DTBL, including but not limited to:

The development and execution of high throughput screens (HTS) using spheroids and organoids, including the use of optical clearing techniques for improved visualization and assay miniaturization to allow for 1536 imaging well plate screening.

The development of Microphysiological Systems (MPS), which utilize the application of microfluidics in organs-on-chips to enable the efficient transport and distribution of nutrients and other soluble cues throughout the viable 3D tissue constructs. This also includes the addition of different forces on multi-cellular models to induce some behavior, essentially turning complex 3D systems into 4D systems.

Research and development activities related to engineering the necessary physical platforms to support such complex tissue models, such as advanced plate design which provides both open access to allow for tissues to be biofabricated through the use of a bioprinter while at the same time enabling perfusion of these tissues through incorporating active microfluidic channels.

2. Project Management

2.1. The Contractor shall provide overall project management to coordinate and integrate activities for the Task Order, including but not limited to:

• Provide a Project Plan with sufficient detail to enable project monitoring at intervals directed by the Task Order (e.g., weekly, monthly, or on an activity/milestone basis). The final Project Plan will be available no later than 30 calendar days after the effective date of any Task Order award. The Plan shall be developed in accordance with best practices and address task requirements, key personnel, process, procedures, timing, and risk.

• Identify a lead individual who will serve as a point of contact for NCATS with respect to Task Order progress.

• Provide sufficient project management staff to ensure management and monitoring of all Task Order activities.

• Provide effective communications with the Contract Program Management Office (CPMO) including regular reports and meetings, as well as exception reporting when there is a significant deviation from the Project Plan.

• Arrange a meeting schedule that enables attendance by key personnel, and others as required for the Task Order. Examples of meetings and teleconferences required in Task Order award(s) include:

• Alert the CPMO to a significant deviation from the Project Plan within 24 hours and have key personnel available for an ad-hoc team meeting no later than 24 hours after the notification. The Project Plan shall be updated when it significantly deviates from actual Task Order progress.

2.2 Task Order Initiation Meeting: Before the start of any tasks, plan for and participate in an Initiation Meeting to review the Task Order requirements and timelines, discuss Task Order technical plans/Project Management Plan and approaches, and identify any anticipated problems/obstacles to completing the Task Order requirements.

2.3 Progress Review Meetings: Conducted in intervals directed by the Task Order.

Sample Task Order B

NCATS Scientific and Technical Support Services

Sample Task Order B, ASPIRE Program Support

Contract Number: N/A PRISM Task Order: N/A

NOTE: The following sample task order is intended to assess the Offeror’s capabilities to execute projects of similar scope and size under task orders issued under the contract resulting from this solicitation. Although the sample task order will NOT be issued at the time of contract award, your response will be evaluated in accordance with Section M of the Solicitation.

NOTE 2: The ASPIRE Reduction-to-Practice Challenge, https://ncats.nih.gov/aspire/2020Challenge, is separate and distinct from this sample task order. The Challenge is focused on the extramural community, whereas the work described in this task order supports NCATS intramural programs in building the foundational, industrial-scale platform that no single awardee under the Challenge could build.

A. Task Order Title

ASPIRE Program Support

B. Task Order Technical Areas

This Task Order (TO) is to provide support for NCATS Automation Research Services, task area 2.1.5 of the Parent Contract Statement of Work (SOW).

C. Task Order Period of Performance

5/1/2021 – 4/30/2022

D. Contract and Task Order Numbers Designation

On all correspondence submitted under the contract, the Contractor agrees to clearly identify the parent IDIQ contract and task order numbers as follows:

Contract Number: N/A Task Order Number: N/A

E. Task Order Price

1. The total fixed price of this task order is $TBD.

2. Upon delivery and acceptance of the services described in SECTION F, Statement of Work, of this task order, the Government shall pay to the Contractor the following price.

Line Description of Service Total ($) 0001 ASPIRE Program Support TBD https://ncats.nih.gov/aspire/2020Challenge

Contract No. 75N95020##### Task Order No. 75N95020F00001

F. Statement of Work

See Sample Task Order B SOW, attached.

G. Reporting Requirements and Deliverables

1. Task Order Master Plan

2. Project Plan

3. Monthly Task Order Updates

4. Task Order Final Report

5. Other Deliverables as requested

H. Contracting Officer’s Representative (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this task order:

TBD

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this task order; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this task order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this task order; (5) otherwise change any terms and conditions of this task order; or

(6) sign written licensing agreements.

The Government may unilaterally change its COR designation.

I. Invoice Submission/Contract Financing

The Contractor shall submit invoices in accordance with the Parent Contract.

J. Attachments

Attachment 1 – SOW

Sample Task Order B - SOW

Sample Task Order B: ASPIRE Program Support

Task Order Statement of Work

Background

It is rapidly becoming recognized across the translational science community that there are significant opportunities for bringing artificial intelligence and automation to bear on medicinal chemistry. Briefly, this may expand the repertoire of chemical reaction types utilized in medicinal chemistry, enable the degree of chemical space explored during medicinal chemistry campaigns, and bring a systematic approach to structure-activity studies. The NCATS initiative called A Specialized Platform for Innovative Research Execution (ASPIRE) aims to integrate automated synthetic chemistry (ASC), artificial intelligence, and biological testing into a modular platform to design and build new chemical structures. Through this platform, scientists will apply new ASC techniques and testing capabilities to accelerate the development of new therapeutics. Put simply, ASPIRE is driven by the goal of bringing technologies to the chemistry laboratory that match those of biology in a high-throughput screening environment. The goal is to build a fully automated modular platform for both intramural and extramural collaborators to access;

including the ability to incorporate custom modules developed within a standardized framework to introduce new ASC techniques and testing capabilities.

1. Technical Requirements

The ASPIRE intramural program was officially launched in 2018 and is now entering a critical phase to essentially build not only a fully integrated translational science focused automated platform but an entire ecosystem of chemistry development. This will require several strategically aligned ASPIRE workstreams for which NCATS requires contract support:

Chemistry Analytical/Purification Biology

Automation – Development & Support

Informatics

Consumables

Tech Advancement

Sample Task Order B - SOW

It is important to note due to the overall goal of ASPIRE being a fully integrated and ultimately autonomous platform that none of these areas can exist outside the program for it to succeed.

Although there are already automation, informatics, biology, and other groups within NCATS the functional areas proposed here are all intended to be closely incorporated within the ASPIRE framework to provide the necessary cohesion to achieve the goal of creating a next generation autonomous translational research laboratory.

1.1 ASPIRE Automation

The contractor will provide support for all activities related to ASPIRE Automation, including but not limited to the following tasks:

• Develop a Laboratory Dashboard providing means for both automated and manual experiment submission management and tracking.

• Develop custom ACS related hardware, including supporting peripheral devices, and facilitate integration with existing and new automated platforms.

• Develop hardware drivers including API implementation for external control and monitoring.

• Responsible for system hardware monitoring/telemetry and operation metrics (for standalone and automated systems).

• Develop, operate, and maintain custom Automation Scheduling and Error recovery software which is capable of both manual and automated operation o Must provide the capability to actively monitor events in real time and to control the provided scheduling software through external applications o Must allow multiple processes to run in parallel o Must allow the programmatic launch of new processes o Must be asynchronous in operation o Must provide the capability to communicate with external applications to coordinate tasks and record results including such endpoints to a variety of cloud storage options (AWS, Google Cloud Platform (GCP), Azure, etc.), databases (AWS RDS, NoSQL, PostgreSQL, Oracle, etc.), distributed office applications (Office 365, Google Sheets, etc.), open standard messaging protocols such as Advanced Messaging Queuing Protocol (AMQP) and machine-to-machine connectivity protocols such as MQ Telemetry Transport (MQTT) (often referred to as the ‘Internet of Things (IoT)’) o Must be able to incorporate AI/ML driven experimentation

• Reaction DB interfacing and UI development (in partnership with ASPIRE Informatics) o Reaction ontology framework for experiment annotation.

o Annotated reaction database (electronic Laboratory Notebook (eLN) + external sources) o Implement bidirectional eLN API interfaces.

o Develop reaction templating schema, ideally hardware and scale agnostic.

o Develop a hardware specification schema incorporating scale and chemical compatibility.

1.2 ASPIRE Informatics

The contractor will provide support for all activities related to ASPIRE Informatics, including but not limited to the following tasks:

• Reaction Knowledge Base/Dashboard development o Reaction Analytics platform o Technology gap analysis o Reaction development management

• Explore opportunities to connect with other knowledge bases e.g. Biology Knowledge Base/Dashboard

• Molecular Design Suite (QSAR/Structure-based)

• Retrosynthetic platform evaluation and implementation

• Synthesis Route Planning incorporating multiple modes o Manual o Automated o Reaction screening

• eLN data annotation including both internal and external resources

• Technology-aware reaction ontology framework for chemistry experiment annotation

(photo, high pressure, flow, others)

• Reaction templating schema and DB development

1.3 ASPIRE Consumables

The contractor will provide support for all activities related to ASPIRE Consumables, including but not limited to the following tasks:

• Establish supply chain management for all consumables o Chemicals, labware, biological reagents, etc.

o Examples of this include allocating and managing storage, supply chain management, barcode specifications, inventory tracking systems and technologies (e.g. 2D-barcodes, RFID, micro-GPS, etc.).

• Define and implement positive tracking standards (i.e. barcode and track everything)

• Establish a real time inventory system for chemicals (building blocks)

• Partner and integrate with existing NCATS groups involved with heavy consumable management such as Automation, Compound Management, Analytical Chemistry, Biology and Building Services

• Daily curation of all inventory

• Providing automated means to access inventory data to enable externally driven real-time experiment initiation based upon the availability of resources present on the ASPIRE platform

1.4 ASPIRE Chemistry

The contractor will provide support for all activities related to ASPIRE Chemistry, including but not limited to the following tasks:

• Establish chemistry synthesis benchmarks and continuously track improvements

• Test chemical synthesis and isolation platforms

• Develop system for standardizing all chemical transformation of the automation platform

• Partner with purification to establish robust transfer modalities and standards

• Pilot project chemistry

• Test, develop and integrate new chemistry synthesis technologies on the automation platform

• Participate in organic synthetic chemistry research programs, including medicinal chemistry programs

• Synthesis of compounds using standard synthetic techniques, and advanced synthetic instrumentation, to develop probe molecules against biological targets

• Liaising with analytical chemists, compound management, informaticians, engineers, and assay biologists to design, plan, and implement chemistry synthesis-based research programs that align with the goals of DPI

1.5 ASPIRE Analytical/Purification

The contractor will provide support for all activities related to ASPIRE Analytical/Purification, including but not limited to the following tasks:

• Establish analytical and purification benchmarks

• Implement a fully automated purification workflow including compound registration

• Partner with chemists to establish a robust submission and material transfer mechanism

• Work with automation to implement a custom purification workflow on the ASPIRE platform

• Integrate current characterization/registration workflow for all synthesized molecules

Sample Task Order B - SOW

1.6 ASPIRE Biology

The contractor will provide support for all activities related to ASPIRE Biology, including but not limited to the following tasks:

• Partners with chemists to identify ways to improve automating biological assay development and implementation including the incorporation of AI/ML driven experimentation

• Collaboration with internal and external groups for Target Identification/Validation and Screening

• Support extramural ASPIRE efforts by collaborating and validating assays developed from external groups

• Work with staff on all aspects of the implementation of small molecule screening, including assay design, development and optimization, high-throughput screening (HTS), data analysis and follow-up studies in support of development of new pharmacological probes and target validation.

• Design, develop, and implement novel cutting edge assay approaches and technologies for the development of new disease relevant assays for screening.

• Integrate bioassay automation with other programs and instrumentation, particularly compound management, and informatics.

• Development of mass spectrometry-based assays for screening, and integration of required instrumentation with automation

• Perform confirmation assays and determine EC50/IC50 for primary active compounds in secondary and follow-up experiments

• Maintain mammalian cell lines, laboratory supplies including tissue culture room, and basic laboratory equipment.

• Operate liquid dispensing systems – for example: (Pintool, BioRaptor) and multimodal detectors/plate readers (Tecan Safire, EnVision, ViewLux, PHERAStar).

• Operate imaging-based plate readers, for example: (InCell, Opera Phenix, FDSS).

• Analyze the experiment results, organize data, and share with other components of the research team/program.

• Co-develop project plans; summarize and highlight the overall goal and course of action per project under the supervision of NCATS team leader and the principal investigator for each project; prepare assay descriptions and methods, and critical path flow chart.

1.7 ASPIRE Technology Advancement

The contractor will provide support for all activities related to ASPIRE Technology Advancement, including but not limited to the following tasks:

• Actively research and incorporate new advances in critical areas such as Reaction Screening and Optimization

• Survey current technologies in consultation with chemists to identify potential new scientific opportunities to pursue

• Scout and prioritize public space for opportunities related to all ASPIRE activities and report back to NCATS leadership those worth pursuing

• Conduct pilot tests and assess technology readiness for platform adoption

• Construction and execution of a technology integration plan with ASPIRE (or external partnerships)

2. Project Management

2.1. The Contractor shall provide overall project management to coordinate and integrate activities for the Task Order, including but not limited to:

• Provide a Project Plan with sufficient detail to enable project monitoring at intervals directed by the Task Order (e.g., weekly, monthly, or on an activity/milestone basis). The final Project Plan will be available no later than 30 calendar days after the effective date of any Task Order award. The Plan shall be developed in accordance with best practices and address task requirements, key personnel, process, procedures, timing, and risk.

• Identify a lead individual who will serve as a point of contact for NCATS with respect to Task Order progress.

• Provide sufficient project management staff to ensure management and monitoring of all Task Order activities.

• Provide effective communications with the Contract Program Management Office (CPMO) including regular reports and meetings, as well as exception reporting when there is a significant deviation from the Project Plan.

• Arrange a meeting schedule that enables attendance by key personnel, and others as required for the Task Order. Examples of meetings and teleconferences required in Task Order award(s) include:

• Alert the CPMO to a significant deviation from the Project Plan within 24 hours and have key personnel available for an ad-hoc team meeting no later than 24 hours after the notification. The Project Plan shall be updated when it significantly deviates from actual Task Order progress.

2.2 Task Order Initiation Meeting: Before the start of any tasks, plan for and participate in an Initiation Meeting to review the Task Order requirements and timelines, discuss Task Order technical plans/Project Management Plan and approaches, and identify any anticipated problems/obstacles to completing the Task Order requirements.

2.3 Progress Review Meetings: Conducted in intervals directed by the Task Order.