Sentinel_Pre-Proposal_Forum_March_11.pptx

Sentinel Pre-Bid Forum March 11, 2019

Proposal Submission Information Contracting Officer – Matt Bucher Branch Chief, Scientific Support Branch

FDA/OAGS/DAP/SSB

Important Deadlines Final RFP Posted– March 25, 2019 Q&A Amendment – expected date of posting – approx. 15 April 2019 Submission deadline for Proposals – 4:00 PM (EST) 24 May 2019

Submitting Questions All Questions must be submitted to OAGS, Tara Hobson Tara.Hobson@fda.hhs.gov All Questions must be formally submitted in writing and sent to Tara Hobson via e-mail.

No verbal questions (after this meeting) will be accepted.

All Answers shall be posted to FBO via amendment to the RFQ Offerors will not be notified in the case of an amendment being posted, offerors are responsible for checking the FBO posting for any updates.

Section L: Submitting a Proposal All offerors must submit a proposal for the base IDIQ Proposals for the task orders are optional.

Offerors may submit a proposal for one, two or all three task orders.

Follow the instructions provided in Section L Naming Conventions Page Limits Technical Proposal outline Do not to exceed the specified Maximum Page Count.

Attachment 2 – Resource Data Table is to be submitted as part of Technical Proposal

Section L: Submitting a Proposal, Cont’d Past Performance questionnaires - not to exceed 2 per proposal PPIRS is acceptable/encouraged Past Performance questionnaires will be included in page limits.

Past Performance information will not be accepted by third party.

Resumes - not to exceed 2 pages per resume Resumes will be included in page limits.

SBA Subcontracting Plan will not be included in page limits

Section M: Evaluation Factors 4 separate evaluations will be conducted Base IDIQ Task Order 1 MMR, Pass/Fail Criteria Task Order 2 Task Order 3 Past Performance – must be submitted on the questionnaires provided in the Solicitation Past Performance questionnaires submitted may be used for more than one proposal.

Pricing Matrices provided must be used.

Failure to use the provided forms may result in the proposal being unacceptable and eliminated from consideration for award.

Section M: Base IDIQ All offerors must submit a proposal for the base IDIQ Technical Proposal – evaluation factors Factor 1 Technical Approach Factor 2 Program Management Plan Factor 3 Key Personnel Factor 4 Past Performance (Risk Assessment) Price Proposal – labor rates over the life of the IDIQ SBA Sub-contracting Plan – recommend using template provided.

Section M: Task Order #1 Operating Center Minimum Mandatory Criteria, Pass/Fail Proposal must receive a PASS on the MMC to have the Technical and Price evaluated for Task Order #1 award.

Factor 1, Access to Longitudinal Electronic Healthcare Data for at Least 100 Million Patients Factor 2, Access to Source Medical Records Technical Evaluation Factors Technical Approach Past Performance (risk assessment) Qualifications of Contractor Personnel – letters of commitment Experience with Distributed Data Networks Task Order Price use of pricing matrix provided is mandatory

Section M: Task Order #2 Innovation Center Technical Evaluation Factors Technical Approach Past Performance (risk assessment) Qualifications of Contractor Personnel – letters of commitment Task Order Price Proposal

Section M: Task Order #3 Community Building and Outreach Center Technical Evaluation Factors Technical Approach Past Performance (risk assessment) Qualifications of Contractor Personnel – letters of commitment Task Order Price Proposal

Attachments Attachments 1 – Glossary of Terms & References 2 – Resource Data Table 3 – FDA Non-Disclosure Form, sensitive information, non-public information, confidential information, and/or Controlled Unclassified Information (CUI) 4 – FDA Non-Disclosure Form, Information Technology Systems Security Contractor Non-Disclosure Agreement 5 – Past Performance Questionnaire 6 – Task Order #1 7 – Task Order #2 8 – Task Order #3 9 – Pricing Matrix 10 – Summary of Log of All Work Orders 11 – Work Order Tracker

Conclusion Award will be Best Value

Questions??

Sentinel Initiative Solicitation Pre-Proposal Forum March 11, 2019 Michael Nguyen, MD FDA Sentinel Program Lead Office of Surveillance and Epidemiology Center for Drug Evaluation and Research

Agenda Review solicitation preparation process Importance of Sentinel’s strategic plan How the strategic plan shaped the contracting strategy Contract implications Structural Operational Next steps and timeline

Sentinel Acquisition Timeline Q1 Q2 Q3 Q4 Initiated Acquisition Planning Process Request for Information Industry Day Market Research (18 total vendor meetings) 5-Year Strategic Plan Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Pre-Proposal Forum Draft Sentinel RFP

Consistent, Open, Standardized Market Research Approach Request for Information FDA has identified several areas of potential development for the Sentinel System. These include:

Maximally efficient chart review in a distributed database environment Enhanced leveraging of granular, potentially-unstructured data available in electronic health records (EHRs) and other data sources Improving operational efficiency and reducing system cost by separating production (i.e. fulfilling queries) from development (i.e. enhancing data architecture and statistical methods) We are particularly interested in understanding how new technologies (e.g., natural language processing, machine learning, blockchain) may enhance any of these areas of the Sentinel System. We also invite perspectives on the use commercially-available data compared to the use of Data Partners in the Sentinel System.

3 Standard Vendor Questions Discuss your capabilities and offerings in the following areas:

Availability of electronic health records, claims and claims linked to electronic health records Current or planned quality assurance processes for these data sources Ability to confirm health outcomes of interest through chart review or other means

Summary of Solicitation Process

STRATEGIC PLAN

D

EXTENSIVE MARKET RESEARCH

Transparent, standardized process, RFI C

INDEPENDENT ADVISOR

Acquisitions and contract review B

TWO PUBLIC MEETINGS

Industry Day, Pre-proposal forum A D C B A Culmination of >2 years of effort Publicly available

Key Messages from Strategic Plan Maintain and enhance the foundation of the Sentinel System, preserving FDA’s long term investment in Sentinel’s analysis tools and data infrastructure Diversify data sources, especially EHRs and claims linked to EHR Selectively incorporate advanced analytics Broaden touch points for participating in Sentinel’s development Establish a Sentinel scientific community and disseminate knowledge to improve public health

Executive Summary “In the next five years, FDA will focus its investment on innovations emerging from new data science disciplines, such as natural language processing and machine learning, and seek to expand its access to and use of electronic health records (EHRs). FDA will balance this forward-looking strategy by incorporating core gains from the prior decade that witnessed the creation of the largest and most advanced medical product safety surveillance system to date that includes the Sentinel Common Data Model, a quality-checked distributed network, and suite of state-of-the-art analysis tools. The strategy directs Sentinel to reach beyond its current boundaries while preserving capabilities and key accomplishments. By 2023, FDA envisions a more robust Sentinel System: a transformative, multi-purpose national data and scientific resource center for evidence-generation that a wide array of stakeholders use to inform all aspects of healthcare decision-making.”

https://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM629243.pdf

Evolving Sentinel Operating Model

Agenda Solicitation preparation process Importance of Sentinel’s strategic plan How the strategic plan shaped the contracting strategy Contract implications Structural Operational Next steps and timeline

From Strategic Plan to the Contract More than one type of center needed However, the same offeror may be awarded more than one task order if qualified and provides the best value to the government Diversify sources of expertise Seek innovation from both established and emerging fields Emphasize cross-disciplinary activities Enable specialization and differentiation Base plus option-years strategy provides government the requisite flexibility to extend or cease activities as needed Combination of task orders and work orders to enable contracting agility to rapidly initiate key projects and use resources in a timely fashion

Contract Implications: Structural

IDIQ Awardees Consists of >1 most highly qualified contractors who have been selected to compete for Sentinel task orders Selected based on IDIQ technical proposal, program plan, key personnel, past performance criteria Do not have to compete for every task order If not selected in the base year, will serve as “active reserve” for future task orders Operations Center Innovation Center Community Building and Outreach Center Task Order 2 Task Order 1 Task Order 3 Coordinating center for data partner network, infrastructure management, and data curation Conducts regulatory analyses Largest center Coordinating center for methods development Data science and advanced analytics Potential for >1 Innovation Center Coordinating center for community development Convening, hosting functions Knowledge dissemination Promotion of a national resource

Contract Stages

Submit Proposal IDIQ Evaluation Task Order Evaluation Award Do not need to compete for every task order PAG will select a pool of IDIQ vendors IDIQ pool may have >3 vendors Vendors will be evaluated on the ability to meet all IDIQ requirements Will base the evaluation on 4 criteria outlined in contract sections L and M FDA will select a vendor for each task order One vendor may win >1 task order

Vendor Vendor Vendor

OC

IC

CBOC

Example Contract Scenarios

Applies to IC Applies to OC and IC Applies to IC and CBOC Applies to OC, IC, CBOC Year 1 Years 2-5 Potential Scenario IDIQ Stage Selected Selected as IC Eligible for any task order Selected Not awarded OC or IC Eligible for any task order Not selected Not eligible Not eligible Selected Selected as OC Eligible for any task order Once in the IDIQ pool, vendors can compete for any future task order, but must meet requirements within the specific task order

Contract Implications: Operational Multiple interdependent operational groups Meeting requirements will often require collaborative effort between centers Introduces matrix management to the Sentinel System Increases FDA’s coordination responsibility Heightens need for communication, collaboration and transparency

Timeline

Pre-proposal forum Deadline to submit questions March 11 Final RFP Released Mar 25 Post RFP Amendments from Q&A Process April 15 Offeror proposals must be emailed by 4:00pm EST to Tara Hobson and Matt Bucher May 24, 2019 Start Award Draft RFP posted (request for proposal) March 4

21 days 61 days

Key References Request for Information, Dec 1, 2017 https://www.fbo.gov/index?s=opportunity&mode=form&id=ec59b8dbb36970e2912801aa2cfdd87d&tab=core&_cview=0

Industry Day, April 26, 2018 https://www.fbo.gov/index.php?s=opportunity&mode=form&id=043c30033350483ace5aad436a1ec20c&tab=core&tabmode=list&= image1.png image2.png image4.png image5.png image6.png image7.png image8.png image3.png