Attachment B - Task Order 1 SOW.pdf

CBER BIOLOGICS EFFECTIVENESS AND SAFETY (BEST) COMMUNITY ENGAGEMENT AND

DEVELOPMENT INITIATIVE (CEDI) TASK ORDER

STATEMENT OF WORK

1. INTRODUCTION

2. OBJECTIVES

3. Key Personnel

4. Task Description(s)

4.1 Task 1: TASK ORDER MANAGEMENT AND GOVERNANCE

4.1.1 Kick-Off Meeting

4.2 Task 2: MEETINGS AND WORKSHOPS

4.2.1 DEVELOP, COORDINATE, HOST AND CONVENE MEETINGS OR WORKSHOPS

4.2.1 MEETING SUMMARIES, DRAFT PUBLICATIONS OR WHITE PAPERS

4.3 Task 3: Identify and complete at least one methods development project

4.3.1 COORDINATE AND/OR CONDUCT METHODS DEVELOPMENT IN EPIDEMIOLOGICAL,

INFORMATICS AND RELATED AREAS

4.3.2 DRAFT METHODS PUBLICATIONS

4.4 TASK 4: TRAINING, OUTREACH AND ENGAGEMENT

4.4.1. CONDUCT TRAINING FOR FDA STAFF ON BEST

4.4.2. CONDUCT OUTREACH AND ENGAGEMENT OF THE BEST USER, STAKEHOLDER AND

RESEARCH COMMUNITIES

4.5 TASK 5: MANAGEMENT PLAN

4.5.1 TASK ORDER MANAGEMENT PLAN

4.5.2 ORGANIZATION AND MANAGEMENT PROCEDURES

4.5.3 RISK MANAGEMENT

5.1 PUBLICATIONS AND POSTINGS

5.2 PERIOD OF PERFORMANCE

Project Title: The CBER Biologics Effectiveness and Safety (BEST) Community Engagement and Development Initiative (CEDI) Task Order

1. INTRODUCTION

In September 2017, CBER launched the Biologics Effectiveness and Safety (BEST) initiative, an expansion of the CBER Sentinel System, to specifically address the unique characteristics of CBER-regulated biologic products. BEST is an active surveillance and evidence generation system that can support commitments of the Prescription Drug User Fee Act VI and 21st Century Cures Act of 2016. Two primary goals of BEST were 1) to develop a pilot system using electronic health records (EHR),some claims data sources, methods and tools to rapidly conduct queries, epidemiological studies and surveillance of biologics; and 2) to use innovative approaches such as artificial intelligence and natural language processing to automate adverse event reporting by detecting and mining biologic product adverse events in EHRs for use in populating individual case safety reporting forms for submission to the FDA. CBER awarded contracts aligned with the two primary goals and continues efforts to develop and expand its growing network of biologics active postmarket risk identification and analysis systems by using new data sources, enhanced capabilities and innovative approaches with the goal of providing deliverables in a more cost-effective, efficient, and timely manner.

This request seeks to provide FDA with the support of one or more organizations or entities to serve in a convening role to work collaboratively with FDA staff to plan, develop, coordinate, host and convene BEST user community building activities such as meetings, workshops, training, projects and/or related support activities. This effort shall require conducting training and outreach to share information and educate FDA staff and external stakeholders on the BEST infrastructure, capabilities and applications that serve FDA and stakeholder needs, to the extent possible. The proposed FDA work may be conducted or coordinated under a number of possible organizational structures and arrangements. The convener may be an academic or similar organization and have their own business staff and subject matter experts such as epidemiologists, bioinformaticians, clinical experts, programmers and others who are experienced in conducting safety and effectiveness studies for drugs and biologics as well as related areas such as statistics, clinical studies, supercomputing, artificial intelligence, natural language processing, machine learning, modeling, patient input sciences, benefit-risk assessment, etc.

2. OBJECTIVES

The primary goal of this Contract is to provide FDA with the support of a convener organization to work collaboratively with FDA staff to convene meetings or workshops; coordinate or conduct methods development activities; conduct training and outreach to educate FDA staff and external stakeholders. To this end, this task order includes the following program tasks:

• Task 1: Establish Task Order Management and Governance

• Task 2: Develop, coordinate, host and convene at least four meetings

• Task 3: Identify and complete at least one methods development project

• Task 4: Conduct at least two training, outreach and engagement sessions

• Task 5: Generate Management Plan

• Task 6: General Risk Management Registry

• Task 7: Publish and post documents

3. Key Personnel

The follow personnel are considered key personnel by the government:

• Principle Investigator

• Project Manager

• Physician

• Epidemiologist II

• Epidemiologist III

4. Task Description(s)

The following tasks constitute the performance of work expectations for BEST support.

4.1 Task 1: TASK ORDER MANAGEMENT AND GOVERNANCE

4.1.1 Kick-Off Meeting

The Contractor shall lead a kick-off meeting with the COR and Government staff within 10-calendar days of task order award by Telecon. The purpose of the kickoff meeting is to introduce the contractor staff to the Government and discuss the contractor’s approach to meeting the requirements of the TO SOW.

4.1.2 Establish the Community Engagement and Development Initative Coordinating Center

(CC)

The Contractor shall establish the CC with an appropriate governance structure including an Executive Committee of contractor appointees to provide leadership have their own business staff and subject matter experts such as epidemiologists, bioinformaticians, clinical experts, programmers and others who are experienced in conducting safety and effectiveness studies for drugs and biologics as well as related areas such as statistics, clinical studies, supercomputing, artificial intelligence, patient input sciences, benefit-risk assessment, etc.

within 30 days of award. The Contractor shall work collaboratively with the FDA CBER Office of Biostatistics & Epidemiology leadership team, the CBER Sentinel Team and FDA Staff as well as the other BEST Contractor Leadership Teams and Staff to complete the contract tasks, business requirements and deliverables.

Table 1: Task 1 Deliverables

4.2 Task 2: MEETINGS AND WORKSHOPS

A major objective of this contract is for CBER to obtain contractor support to develop, coordinate and convene public meetings or workshops and small non-public expert workgroup meetings on specific topics or challenges. In some cases, CBER may provide funds or co-sponsor funding through this contract to public meetings, especially those hosted by academic or research organizations and/or where there is no apparent or perceived conflict of interest. FDA CBER may require that its name be in the title of the meeting or workshop.

4.2.1 DEVELOP, COORDINATE, HOST AND CONVENE MEETINGS OR WORKSHOPS

Develop, coordinate, host and convene at least four meetings. The contractor shall develop content and framing of relevant discussion topics and items for meetings, including a meeting backgrounder document, and lead development of the agenda, meeting content and identify and secure speakers and presenters. The contractor shall serve as overall meeting coordinator, moderator and provide one or more presentations and convene three to six meetings a year with meeting sizes expected to range from 75 (small meeting) to up to about 250 participants (large meeting). The Contractor shall provide meeting resources including venue rental, audio-visual and webcasting support, research and development costs, supplies, administrative support, registration, as well as travel costs for out of town speakers and certain meeting participants and other miscellaneous items.

4.2.1 MEETING SUMMARIES, DRAFT PUBLICATIONS OR WHITE PAPERS

The contractor shall lead the effort to generate a draft summary of the meeting or workshop.

For meetings the contractor shall provide a draft manuscript, white paper, report or similar

Task Deliverable/Work Product Title Frequency: and Due date Delivered To

Task 1 3.1.1. Kick-Off Meeting Once : Within 10-calendar days of task order award

COR

Task 1

3.1.2 Establish the Community

Engagement and Development Initiative Coordinating Center

(CC)

Once : Within 30-calendar days of task order award

COR

document suitable for publication or FDA website posting summarizing the major outcomes.

FDA staff would be expected to contribute to generated documents (which may require an FDA disclaimer) and all documents must be submitted and cleared through the FDA Clearance process prior to journal submission, external review, public posting or disclosure.

Meeting Types and Topics

The contractor shall convene meetings or workshops to support BEST and related CBER programs that meet FDA needs and provide value to stakeholders including the community of BEST users, patients and the public. These may include but are not limited to smaller meetings;

public meetings or workshops; BEST contractors and Principal Investigators meetings; technical workshops; biologic product area-based workshops; issue-based meetings or workshops (e.g., real-world data, real-world evidence, etc; and others related to the CBER science-based public health mission. These meetings may include but are not limited to any of the following:

Annual BEST Meeting: A public meeting that assembles FDA staff, BEST Contractors, other government agencies and stakeholders from the public sector, private sector, academia, researchers, patients and patient advocates, and the public.

BEST Contractors In-person Meeting: Participants will be limited to FDA contractors and collaborating organizations, other government and invited participants.

Below are additional topics for possible, general meeting and workshop topic areas:

CBER-regulated product areas: A public assembly with participation from specific regulated biologic product stakeholders and communities including manufacturers, academia, researchers, patients, and others.

Methods development topics: Focused presentations and discussions on methods development topic areas including but not limited to epidemiological, informatics, statistical and others to support BEST and related CBER programs.

Technology topics: Potential discussions of artificial intelligence, machine learning, natural language processing, supercomputing, computational sciences, next generation sequencing, modeling, systems biology and others.

Issue-based topics: Topics may range from real-world data, real-world evidence, RWD and RWE-generation, digital technologies, patient input science, clinical trial design, benefit-risk assessment, observational study design, and others.

For this task order, FDA is requesting at least four meetings/workshops, including the Annual BEST meeting and BEST Contractors.

Table 2: Task 2 Deliverables

4.3 Task 3: Identify and complete at least one methods development project

The Contractor shall engage the broader research and stakeholder community (or the “community”), and CBER Staff in methods development to advance the development of BEST to address regulatory questions and stakeholder needs, to the extent possible. This effort combines many activities of this contract that the Contractor shall coordinate including identifying and engaging the community of researchers and stakeholders, conducting workshops and meetings to identify areas of mutual interest and need with FDA and the community, and moving towards continual improvement and building of the BEST system methods, tools and infrastructure to advance the scientific field and address common areas of need and interest.

For this task order, FDA is requesting the identification and completion of at least one project for methods development in epidemiological, informatics and related areas.

4.3.1 COORDINATE AND/OR CONDUCT METHODS DEVELOPMENT IN EPIDEMIOLOGICAL,

INFORMATICS AND RELATED AREAS

The Contractor shall work collaboratively with FDA to identify methods development activities and projects in areas including but not limited to the following:

Possible epidemiological methods development areas may include: causal inference, prediction modeling, signal detection, confounding, bias, adjustment and weighting methods, Task Deliverable/Work Product Title Frequency: and Due date Delivered To

Task 2

3.2.1 Develop, coordinate, host

and convene at least four meetings

Four or more times and due 30 calendar days before the last day of the task order project’s period of performance

COR

Task 2

3.2.2 Draft manuscript, white

paper, report or similar document

Four or more times and due 10 calendar days before the last day of the task order project’s period of performance statistical methods in distributed networks, quantitative bias, generating phenotype and cohorts, and others.

Possible informatics methods development areas include: Establish temporality between events, observation periods for study populations, interoperability, application of artificial intelligence, machine learning and/or natural language processing, vocabulary and mappings, Use of Fast Healthcare Interoperability Resources (FHIR) and bulk FHIR, and others.

4.3.2 DRAFT METHODS PUBLICATIONS

The contractor shall lead the effort to generate draft manuscripts, white papers or similar documents suitable for publication or FDA website posting for each project or activity.

Authorship shall be agreed upon mutually with the FDA. FDA staff would be expected to contribute to generated documents (which may require an FDA disclaimer) and all documents must be submitted and cleared through the FDA Clearance process prior to journal submission, external review, public posting or disclosure.

Table 3: Task 3 Deliverables

4.4 TASK 4: TRAINING, OUTREACH AND ENGAGEMENT

The Contractor shall Conduct Training, Outreach and Engagement of FDA staff and the BEST stakeholder community to improve and advance BEST as a system that meets the needs of FDA and the community, to the extent possible. This includes training and development of FDA Staff throughout the contract period. The contractor shall conduct outreach and engagement of the

Task Deliverable/Work Product Title Frequency: and Due date Delivered To

Task 3

3.3.1 Coordinate and/or

Conduct Methods Development in Epidemiological, Informatics or Related Areas

Once COR

Task 3

3.3.2 Draft manuscripts, white

papers or similar documents suitable for publication or FDA website posting

Once and due 21 calendar days before the last day of the task order project’s period of future BEST user and research communities, first through identification, characterization;

gathering of stakeholder input and information through methods including but not limited to interviews, surveys, meetings and workshops; and then recommend approaches for the contractor and FDA to engage the stakeholder community and foster and encourage use of the BEST infrastructure for safety and effectiveness evaluations and surveillance, real-world evidence generation and other related activities. The contractor shall develop training for stakeholders and the research community range from a high-level presentation of concepts to more technical sessions for epidemiologists, clinicians, informaticists, and scientists from related life and health sciences areas and specialties.

The contractor shall provide most of the training sessions in the DC, Maryland and Virginia (DMV) area for FDA staff and the community in-person, to maximize interactions among participant. However, some training sessions may be conducted in other locations outside of the DMV area or as part of scientific, society, association meetings or large public meetings.

The contractor may use seminars, webinars or other media-based approaches to conduct training as well. FDA may require that training sessions be posted on its public website to promote broader dissemination of the information and perhaps further encourage use of the BEST infrastructure as a resource for use by the community.

4.4.1. CONDUCT TRAINING FOR FDA STAFF ON BEST

The contractor shall conduct and/or coordinate training of FDA staff on aspects of the BEST system including the data, data characterization, tools, methods, approaches to conducting research and applications of BEST for conducting evaluations of CBER-regulated product safety and effectiveness studies, surveillance, and methods development at least four times per year.

The contractor shall work with the CBER Sentinel Team to understand the training needs for CBER staff. Training shall be targeted to different groups of staff who may vary in their knowledge and understanding of areas such as active surveillance, epidemiological knowledge and the BEST system so training sessions should range from introductory sessions to more technical sessions. The size of FDA/CBER staff training sessions will vary for instance a general introductory session may be large have up to 75 or more participants, while more technical sessions may be smaller and have only approximately 20 participants.

4.4.2. CONDUCT OUTREACH AND ENGAGEMENT OF THE BEST USER, STAKEHOLDER AND

RESEARCH COMMUNITIES

The contractor shall identify and describe the community of stakeholders and potential users of the BEST infrastructure, their needs and how they may use the BEST system. The contractor shall gather and elicit information from the community (through discussions, interviews, meetings and workshops) on best approaches to improve the BEST system and infrastructure to better support FDA and the community; this effort may be undertaken during the second year of the contract and may take one year to complete. The Contractor shall identify potential projects or areas of mutual work for the stakeholder community and FDA. The contractor shall generate a report of the findings of these activities and provide recommendations of the strategies and approaches that FDA and the Contractor may use to engage the community and encourage use of BEST.

Training may range from introductory sessions providing a general overview of BEST and the BEST infrastructure and potential uses and applications to more technical training to epidemiologists, informaticians and others working regularly with BEST on the infrastructure as well as more in-depth methods, cohort and phenotype identification, complex study designs, and applied sessions.

As part of the contract and task orders FDA may provide funding for a Training Fellowship Program for Fellows to address regulatory questions relevant to FDA CBER products including methods, issues and product related topic areas. This is another area of outreach, training and development and another area where FDA and the stakeholder and research community can work jointly on projects of potentially mutual interest.

Table 4: Task 4 Deliverables

Task Deliverable/Work Product Title Frequency: and Due date Delivered To

Task 3 3.4.1 Conduct Training for FDA Staff on BEST

Four or more times and due 10 calendar days before the last day of the task order project’s period of performance

COR

Task 3

3.4.2 A report on the

community of stakeholders and BEST users including recommendations of the strategies and approaches that FDA and the Contractor may use to engage the community and encourage use of

BEST.

Once and due 21 calendar days before the last day of the task order project’s period of

4.5 TASK 5: MANAGEMENT PLAN

The contractor shall develop a Management Plan (MP) including a manual of policies and procedures (MOPP), that outlines practices, policies and processes for the administration, day-to-day operations, handling conflicts of interest, handling of contractor-to-contractor collaborations, and interactions with stakeholders including but not limited to other BEST or FDA Contractors, researchers, manufacturers, and other stakeholder communities.

4.5.1 TASK ORDER MANAGEMENT PLAN

As part of the MP the Contractor shall deliver a Task Order (TO) Management Plan. The TO Management Plan (TOMP) shall include a Work Breakdown Structure (WBS), which shall contain all of the work elements described in the Task Order. The WBS elements shall also illustrate the sequence, timeline, and resources required for each work package. Additionally, the TOMP shall include a schedule that details activities; dependencies and timeframes for meeting FDA objectives and deliverables; and an organizational chart identifying relationships, authorities, and responsibilities. The TOMP shall include a description of the management controls that the Contractor shall employ to meet the performance, cost, and schedule requirements; and other areas the Contractor deems relevant and important to the management of the Task Order. The Contractor shall ensure that activities are coordinated across task orders, if applicable, to promote cohesiveness among contracted activities.

The TOMP shall address all the action items from any Kickoff Meetings and other follow-on meetings, as appropriate. The Contactor shall update the TOMP when re-planning any activities. Changes to the TOMP are subject to approval of the COR. The contractor shall devise a plan for the governance of the program that will include governance structure, relationships and responsibilities, policies and procedures that will be followed by all the parties involved in terms of governing the program. FDA is not obligated to fund any project within the Master Plan and reserves the right to issue Work Orders for projects not listed in the Master Plan.

The Contractor shall work collaboratively with the FDA to develop and finalize the BEST project plans and the TOMP, and update components as needed to reflect the individual task order (ITO) activities. The Contractor shall work with the FDA to identify and meet all required review, approval and standard processes that comply with all relevant institutional, federal, state, and local laws and regulations to conduct the work such as Institutional Review Boards (IRB), data and information technology security such as Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA) and any others identified in the ITO. These procedures (i.e. the MP) shall address at a minimum the following:

information collection, handling, sharing, ownership, and security; management and tracking, consensus definitions, transfer, and sharing considerations for summaries.

4.5.2 ORGANIZATION AND MANAGEMENT PROCEDURES

The contractor shall schedule and facilitate (to include agendas, notes, minutes, action items) meetings with FDA CBER personnel to ensure smooth operations. These meetings shall include administrative and budgetary telecons monthly telecons for executives/leaders of the contract and FDA CBER, as well as workgroup meetings for specific task orders every two weeks. The contractor will prepare and submit monthly progress and financial reports

4.5.3 RISK MANAGEMENT

The Contractor shall identify and report for resolution to the Government any issues that prevent the Contractor from performing the work in any Task Order that the Contractor is unable to resolve independently. For each Task Order, the Contractor shall document and report the risks and opportunities within a risk registry. The Contractor shall maintain the risk registry and provide it to the COR on a monthly basis.

The risk registry shall contain, at a minimum, unless otherwise specified in the ITOs:

• Issue Number: a sequential numbering of all issues;

• Severity: assessment of issue severity i.e., likelihood and consequences

(High/Medium/Low)

• Date Found: – date that issue was identified by the Contractor;

• Duration: number of days that issue has been open;

• Status: representing issue status as open or closed. The Contractor shall maintain a complete list of all issues – no issues typically should be deleted from the Contractor’s delivered list;

• Title: short description of issue;

• Updated: date for updated status;

• Details: narrative description of activities that have been completed to resolve issue;

• Assigned To: identify Government POC or Contractor that is assigned to resolve the issue;

• Solution or Workaround: description of the actions and activities taken to resolve or mitigate issue the issue.

Table 5: Task 5 Deliverables

Task Deliverable/Work Product Title Frequency: and Due date Delivered To

Task 5 3.5.1 Task Order Management Plan (TOMP)

Once: 30 calendar days after the Award

Task 5

3.5.2 Administrative and

budgetary telecons monthly telecons for

Every two weeks COR

5. TASK ORDER ADMINISTRATION

5.1 PUBLICATIONS AND POSTINGS

The contractor shall provide drafts of documents, presentation materials (e.g., presentation slides and posters), and manuscripts. In addition, the contractor shall share summary data findings and interpretation of findings in the context of the data and tools used. Details of the collaboration will be determined on a task order basis.

Deliverables may be posted by FDA to the BEST website after clearance by FDA, the prime contractor, and subcontractors. The Parties agree this is a multi-site program and any publications as a result of studies shall be a multi-site publication coordinated by the prime contractor, subcontractors, FDA/CBER/OBE, and other involved sites. Authorship and other matters relating to publications shall be determined at the task order level. FDA may require outreach, training materials, and any other documents and deliverables to be posted on the BEST web pages in the spirit of transparency and community building.

5.2 PERIOD OF PERFORMANCE

Base Year One year from the time of award executives/leaders of the contract and FDA CBER, as well as workgroup meetings for specific task orders

Task 5

3.5.3 Maintain risk registry

Once per month