2. STSS 3.0 SOW.pdf

NCATS Scientific and Technology Support Services

Statement of Work

Contents

1. Introduction, Background and Purpose

1.1. Introduction and Background

1.2. Objective

1.3. Scope of Work

2. Specific Task Areas

2.1 Task Area 1 – Program Management Office (PMO) Support

2.2 Task Area 2 – Scientific and Technology Operations Services

2.3 Task Area 3 – Scientific Support Services

2.4 Task Area 4 – Scientific Platform Services

2.5 Task Area 5 – Data Science Services

1. Introduction, Background and Purpose

1.1. Introduction and Background

The objective of the NCATS Scientific and Technology Support Services (STSS) contract is to provide comprehensive support for the integrated scientific environment supporting the National Center for Advancing Translational Sciences (NCATS), one of the 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). This environment consists of the scientific and technology systems (both physical and virtual) that advance the scientific mission of NCATS. STSS also provides the technical and scientific subject matter expertise that permits full exploitation of the environment to support NCATS scientists and collaborators.

NCATS is transforming translational science to get more treatments to more patients more quickly.

NCATS relies on the power of data, new technologies and teamwork to develop, demonstrate, and disseminate innovations that reduce, remove, or bypass costly and time-consuming bottlenecks in translational research.

The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Rather than targeting a particular disease or area of fundamental science, NCATS focuses on what is common across diseases and the translational process.

The Center conducts and supports research on both the scientific and operational aspects of translation to lead to more predictive and successful development of new medical interventions, such as drugs, diagnostics, and medical devices, for all human diseases.

NCATS programs and initiatives span the translational science spectrum, which covers each stage of research. These stages include basic research, preclinical research, clinical research, clinical implementation, and public health. The translational process is multi-directional, starting at any stage and potentially going directly to any other stage. NCATS scientists typically do not conduct basic research. However, insights gained from the Center's studies can inform basic research. At all stages of the spectrum, NCATS develops new approaches, demonstrates their usefulness, and disseminates the findings.

Significantly, NCATS is at the forefront of automated biomedical experimentation, replacing hours of time-consuming basic laboratory work with systems and robots capable of conducting experiments with a fraction of the resources. This technology can both cut costs and increase productivity, which acts as a multiplier effect on research efficiency and raw output.

By design, NCATS' efforts complement and empower those of other NIH ICs, academic scientists, the private sector, and the nonprofit community. By emphasizing collaboration, innovation, deliverables and team science, the Center serves as a catalyst to enable others in the translational research ecosystem to work more effectively.

Nearly every NCATS initiative is completely dependent on secure, collaborative platforms as the foundation for the center to meet its administrative and scientific objectives. The integrated scientific environment at NCATS – the integrated physical and virtual environment - is most accurately considered to be a laboratory instrument itself. This intelligent instrument is greater than the sum of its parts, which includes the physical environment, all the connected information acquisition, storage, and processing systems, laboratory control systems, data services (cloud and on-premises), and software. Although support for the integrated scientific environment is organizationally located in the Information Technology Resources Branch, the environment is a scientific resource, not an IT resource. NCATS does not arbitrarily segregate IT from non-IT in the support of its scientific mission, nor does it treat the horizontally and vertically integrated systems that comprise the scientific and technical infrastructure as a mere aggregation of disparate devices.

1.2. Objective

The objective of the NCATS Scientific and Technology Support Services (STSS) contract is to provide comprehensive support for the integrated scientific environment supporting NCATS. This environment consists of the scientific and technology systems (both physical and virtual) that advance the scientific mission of

NCATS. STSS also provides the technical and scientific subject matter expertise that permits full exploitation of the environment to support NCATS scientists and collaborators.

The STSS contract provides task

• Maintenance and operation of the NCATS scientific environment.

• Cutting edge integration and automation of laboratory devices.

• Cutting edge integration, control, and automation of the laboratory environment with information systems.

• Generation, acquisition, processing, management, and reporting of data and information generated by or acquired through the operation of the NCATS integrated scientific environment.

• Installation, configuration, operation, and maintenance of all components of the NCATS integrated scientific environment, to include platform services, analytic environments, data services, laboratory instrumentation and equipment, and all supporting IT.

• Security across all dimensions (systems, platforms, devices, data, and users).

• User support, to include subject matter expertise, scientific support, training, application support, and service desk.

1.3. Scope of Work

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the following services as defined in this SOW except for those items specified as government furnished property and services:

• Scientific and Technology Operations Services

• Scientific Support Services

• Scientific Platform Services

• Data Science Services

2. Specific Task Areas

2.1 Task Area 1 – Program Management Office (PMO) Support

The NCATS Program Management Office (PMO) responsible for the inherently governmental functions relative to this contract resides within NCATS. The Contractor shall provide PMO support for the overall administration of the contract and development, tracking and management of all work orders issued under this contract. The Contractor’s PMO support staff shall work in coordination with designated federal staff; and be responsible for performing all the non-inherently governmental activities associated with administration of this contract. The Contractor shall serve as the primary liaison to government stakeholders and designated federal staff such as the Contracting Officer (CO), the designated Contracting

Officer’s Representative (COR), Federal task leads (FTLs)/points of contact (POCs), administrative officers, etc.

In support of the PMO, the Contractor shall effectively and efficiently manage cost, schedule, and performance under this contract by using integrated program management systems and processes across all aspects of performance and in a manner that yields cost savings and/or performance efficiencies throughout the execution of all work orders issued under this SOW.

The Contractor’s PMO support duties shall also include, but not be limited to, the following client services support activities:

• Performing liaison responsibilities that include, but not be limited to, gathering initial project requirements; developing work order plans and packages; providing ongoing technical and administrative support of active work orders, such as budget, travel approvals, ad hoc reporting, etc.; communicating and reporting.

• Assisting government stakeholders in defining their need.

• Facilitating submission of work orders and tracking their progress.

• Developing and maintaining standard work order templates, processes, and workflows; all elements of which shall be consistent with industry best practices and contract requirements.

• Documenting all management processes as well as recommending and implementing technologies/systems to ensure and support their execution.

• Obtaining the necessary approval prior to the adoption of any standard process or template.

The Contractor shall employ appropriate measures and safeguards required by the Contractor’s PMO support staff to accomplish its responsibilities. Upon request, the Contractor shall perform project evaluation to ensure that activities are on track, within budget, and above all, meet requirements.

Contract Management Plan: The Contractor shall prepare a Contract Management Plan to ensure that the Contractor’s staff (including any subcontractor’s staff) follow individual Project Plans established in support of the work performed under this SOW. The COR will closely monitor the cost and schedule of the work to minimize the potential for cost and/or schedule variance.

The Contractor shall follow the work process flow, methodology, procedures, deliverables and best practices that conform to the standards dictated by the Project Management Body of Knowledge (PMBOK)

Guide, and Project Management Life Cycle defined and published by the Project Management Institute

(PMI).

The Contract Management Plan shall include:

1. Detailing the understanding and approach that will be used to keep the project on track;

2. Ensuring risks are understood and managed;

3. Handling changes to scope, and

4. Communicating with stakeholders.

The Contract Management Plan shall be kept current and updated throughout the period of performance;

and shall address, but is not limited to, the following:

• Team organization and responsibilities

• Project execution

• Project constraints and assumptions

• Project schedule and milestones

• Project risks identification and management

• Budgeted costs

• Project monitoring

The Contractor shall submit a draft of the Contract Management Plan to the COR no later than fifteen (15) business days after the award of the contract. Following the timely receipt of comments from the COR, the Contractor shall submit a final version of the Contract Management Plan to the COR no later than fifteen (15) business days after award of the contract.

Monthly Activity and Financial Status Reports: The Contractor shall provide separate written Monthly

Activity and Financial Status Reports that monitor the progress, cost, schedule, quality assurance, configuration management, and security management as applicable to the work orders issued under this

SOW. The reports shall include, but are not limited to, progress updates on recruiting, outstanding administrative or technical issues, and cost projections. The Contractor shall provide other reports as requested by the COR.

Although the activity and financial status reports are due monthly, this shall not relieve the Contractor of the responsibility to pro-actively keep the Government informed of issues or problems as they occur

(including technical, cost, or schedule issues).

Reports in a computer-readable format of the Contractor’s staff leave schedules are required to enable the Government to be notified of anticipated absences and vacation schedules.

2.2 Task Area 2 – Scientific and Technology Operations Services The Contractor shall assist ITRB to deploy and continuously improve various research and engineering technologies; provide services for governance, change management, configuration management, capacity planning, performance management, disaster recovery, and availability management. The Contractor shall also work to improve technology service delivery to NCATS staff by documenting each service, aligning the service with industry best practices, and presenting that information to NCATS staff.

The contractor shall enable NCATS to offer its scientific projects an environment of simplified implementation, deployment, and operations with operational reliability. Through these services, the contractor shall enable NCATS scientific development teams to gain a self-service capability. The contractor shall provide for a four-tiered service model: Infrastructure as a Service (IaaS), Platform as a

Service (PaaS), Software as a Service (SaaS) and Data as a Service as well as providing Common Cloud

Engineering Support Services.

Examples of task orders that may be issued under this include but not limited to:

• Research and Research engineering Governance and Management Support

• Hosting, Cloud Computing and Engineering Support

• Cloud Brokering Services

• Cloud Engineering Support Services

The contractor shall employ effective and efficient strategies for research data management including software for data record keeping, analysis, sharing, and streamlining processes and protocols. The contractor shall customize, deploy, build, or procure and manage as appropriate software implementation for laboratory processes and data management including but not limited to:

• Collaborative sites and apps to streamline processes, protocols and enhance communication and collaboration within NCATS research laboratories

• Biospecimens and other sample inventory and tracking management systems

• Electronic Laboratory Notebooks (ELNs) to enable electronic documentation of experimental procedures performed in a laboratory and provide a secure method of storing/retrieving research data and enable customized templating, automated approvals, witnessing workflows, and sharing

• Laboratory Information Management Systems (LIMS) to provide custom workflows and electronic forms within research team collaboration sites to replace tedious paper record keeping, and automate lab processes and protocols

• Create and implement a comprehensive data storage and management strategy to serve the increasing data storage needs of NCATS researchers

Examples of task orders that may be issued under this include but not limited to:

• Laboratory Systems Operations and Management

• On-prem and Cloud based Datacenter Operations and Management

• End User and Scientific Instrument Desktop Support

• Scientific and Systems Training Support

2.3 Task Area 3 – Scientific Support Services

NCATS requires contractor services with scientific laboratory research activities and laboratory management support across all NCATS laboratories. The contractor will be assisting in studies across various scientific disciplines, perform a variety of complex procedures and calibrate laboratory equipment, provide laboratory management support and training, and ensure compliance with safety procedures. NCATS also requires contractor services with scientific laboratory automation and equipment configuration, management, maintenance, and support across all NCATS laboratories. Examples of work performed within this task include but not limited to operating and performing maintenance and validation procedures on low volume liquid dispensation systems, such as Beckman Coulter BioRAPTRs, the CyBi well array-based liquid aspirator/dispenser systems used in compound library titration and compression, the Kalypsys pintool, LabCyte Echo acoustic liquid handlers and other off-line liquid handling systems

The objective of the 3D Tissue Bioprinting Laboratory (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. The contractor will also provide support for additional research areas, both established and emerging, within the 3DTBL.

The contractor shall provide scientific research support services. Activities under this task include scientific/technical writing and editing, graphic design, grants management, and outreach activities. In addition, the contractor may be required to present findings at meetings both inside and outside of the government. All information must be cleared by the task leader before being disseminated outside of

NCATS/NIH

Examples of task orders that may be issued under this include but not limited to:

• Laboratory Automation and Equipment Support

• 3D Tissue Bioprinting Support

• 3DTBL Program Support

• Scientific Research Program Support

2.4 Task Area 4 – Scientific Platform Services

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. To address the many scientific and operational opportunities for translational science, NCATS develops, demonstrates, and disseminates various scientific research tools and resources. NCATS also provides relevant expertise to the broader scientific community. One approach is through the continuous expansion of the Center’s Research Services Center (RSC) that enables efficiencies in all its translational research activities through automation and compound management.

NCATS’ automation engineers are not only responsible for the maintenance, operation and continuous improvement of the center’s laboratory, but also for continuous innovation in laboratory systems automation. For continuous improvement in laboratory instrumentation, automation and processes for high-throughput screening, and assay development and optimization, these staff members evaluate and implement novel technologies and methods, and develop custom solutions for hardware, software, and automation. Examples of task orders that may be issued under this area include but not limited to support for NCATS’ innovation in new and ongoing initiatives for advancing translational science, thus enabling

ITRB to act as a research and development incubator:

• Strategic Planning, Capability and Performance Management

• Strategic Systems and Project Analysis

• Logistical Operations Support

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. Examples of task orders that may be issued under this area include but not limited to providing support for all activities related to ASPIRE Automation:

• ASPIRE Informatics

• ASPIRE Consumables

• ASPIRE Analytical/Purification

• ASPIRE Biology

• ASPIRE Technology Advancement

2.5 Task Area 5 – Data Science Services

The Contractor shall provide expertise and assistance in bioinformatics, cheminformatics, and computational analysis in support of small molecule and genomic research being performed by NCATS

Investigators and within the Division of Pre-Clinical Innovation (DPI) Research Core Facilities (Informatics and Scientific Computing, Computational Chemistry and Biology, Statistics, High Throughput Screening, High Content Screening, Center for Regenerative Medicine, RNAi Screening, Toxicity Profiling, Pathway

Analysis, Medicinal Chemistry, Assay Development, Drug Repurposing). To that end, scientific programmers shall develop and implement computational tools for effective and efficient analysis of large-scale chemical biology and genomic data, to include small molecule profiling data, therapeutic development data, medicinal chemistry optimization, pathway analysis, drug combination screening, and high-throughput screening data. Since many NCATS laboratories have similar needs, Data Science solutions shall be developed as "generalized solutions" that can then be tailored to the specific needs of a specific NCATS Investigator's research program. Scientific programmers shall also develop solutions for the efficient management and analysis of experimental datasets. This includes development of software to capture information being generated by high-throughput instrumentation (e.g., chemical, bioassay, HTS, and HCS data).

Services under this task shall include specialized support in the areas of bioinformatics, high-throughput genomic sequencing, image analysis, computational and systems biology, and data analysis for both basic and clinical research projects. Tools shall include those for biomedical research experimentation, data management, sharing and analysis, data extraction, and algorithm development. Examples of task orders that may be issued under this area include but not limited to:

• Platforms, Applications and Pipeline Development

• Clinical Informatics Services

• Data Science and Data Engineering Services

• Cloud based High Performance Computing

• AI/ML Model Development, Governance and Management Services

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