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Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics - industry day presentations

General Information

Document Type:MOD
Posted Date:Feb 16, 2018
Category: Special Studies and Analyses - Not R&D
Set Aside:N/A

Contracting Office Address

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States


IndustryDay_2018_Questions_submitted_in_advance IndustryDay_2018_AlanWilliams IndustryDay_2018_AzadehShoaibi MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for their Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. The FDA is seeking sources to determine the availability and capability of businesses capable of providing the required services. All business sources are encouraged to submit capability statements including small business concerns. The following information is provided to assist the FDA in conducting Market Research to identify potential sources for this effort. The RFI is to help the FDA understand the industry best practices and technical solutions capable of providing the full range of services described in this RFI and the draft SOW. The associated North American Industry Classification System (NAICS) Code is-518210- Data Processing, Hosting, and Related Services; Small Business Size Standard is $32.5 million. BACKGROUND The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, tobacco products, our nations food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines, devices, products, and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. As part of its mission, the FDA conducts monitoring of the safety of regulated products. In response to the FDA Amendments Act of 2007 (FDAAA 2007) with the goal to build an active post-market risk identification and analysis system, the FDA established the Sentinel System and built a national electronic data system for monitoring the safety of FDA-regulated medical products. Sentinel is a distributed database system consisting of numerous data partners who retain operational control over their data; the Sentinel contract was awarded to the Harvard Pilgrim Health Care Institute (HPHCI) in 2014 which set up a coordinating center to manage, receive, and process FDA questions in the form of queries and return summary results back to the FDA. The FDA Center for Biologics Evaluation and Research (CBER) uses the Sentinel System to conduct some of its epidemiological studies as part of its regulatory responsibilities. Within the Sentinel System, CBER has established 1) the Post-licensure Rapid Immunization Safety Monitoring (PRISM) System to conduct active post-market vaccine safety and effectiveness studies; 2) the Blood Safety Continuously Active Network (BloodSCAN) to carry out active post-market safety evaluation of blood components and products; and 3) Surveillance of Tissues and Advanced Therapies (STAT) to perform active post-market safety evaluation of tissues, cellular therapies, gene therapies, and other advanced therapeutics. In September 2017, FDA/CBER awarded two separate ~one-year contracts to IMS Government Solutions, Inc to launch a new pilot initiative within the CBER Sentinel Program called the Biologics Effectiveness and Safety (BEST) Initiative. The primary goals of the two initial contracts were 1) to develop a pilot system using electronic health record (EHR) data sources, the Observational Medical Outcomes Partnership (OMOP) Common Data Model, and Observational Health Data Sciences and Informatics (OHDSI) tools to conduct regulatory studies; and 2) to develop improved automated adverse events data collection and analysis techniques by using methods such as machine learning, artificial intelligence, natural language processing and others to conduct more sophisticated surveillance and automated adverse event reporting for blood and blood-derived products. CBER plans to continue to develop additional active post-market risk identification and analysis systems as part of the Biologics Effectiveness and Safety (BEST) Initiative in the Sentinel Program by using new data sources, enhanced capabilities and expanded infrastructure with the goal of providing deliverables in a more cost-effective, efficient, and timely manner for all biologic products. CBERs BEST Initiative will build additional capacity for: 1) Data, tools and infrastructure for surveillance of biologics; and, 2) New, innovative approaches to conduct automated adverse event reporting for biologic products to include approaches and applications such as machine learning, artificial intelligence, natural language processing and others. BIOLOGICS EFFECTIVENESS AND SAFETY (BEST) OBJECTIVES AND SCOPE The primary goal of the future contract is to expand and enhance the current CBER capabilities with respect to data sources, infrastructure, methods, and tools and to conduct surveillance and epidemiologic studies that promote CBERs Office of Biostatistics and Epidemiologys (OBE) mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics. This contract builds and expands upon activities undertaken as part of previous FDA collaborative studies for biologic product safety and effectiveness such as the Sentinel contract awarded to the HPHCI in 2014 and the contract awarded to IQVIA (formerly known as QuintilesIMS) in 2017. The objectives of this contract are to (i) build operational infrastructure and provide FDA with indirect access to large-scale United States (U.S.) health care data including administrative and claims as well as electronic health records (EHR) data sources using a distributed data model and network which would require the use of a common data model (CDM), (ii) the capability and capacity to run queries and observational studies on the data sources for CBER-regulated biologic products, and (iii) develop semi-automated processes for medical chart review to augment manual review of charts. The contractor shall provide a quality-checked and rapidly expanding distributed data network and a structured CDM that can accommodate granular clinical data in all care settings for blood, blood products, vaccines, tissues, and advanced therapeutics. Also, availability of longitudinal data for a large U.S. population and ancillary clinical data such as demographics, health care utilization, laboratory test results, blood transfusion, and geographic distribution are desirable characteristics for the data network of claims and EHR sources. The CDM requires to include a large library of clinical data elements with the capacity to expand the clinical data library and incorporate Information Standard for Blood and Transplant-128 (ISBT-128) and Codabar coding systems (a standard terminology for medical products of human origin). The Contractor shall develop the tools and methods needed to conduct population-based safety and effectiveness studies of CBER-regulated biologics using a distributed network of databases and provide scientific expertise to design and execute simple and complex queries as well as execute complex epidemiologic studies in a timely manner. Also, the contractor shall develop semi-automated capabilities to validate clinical outcomes and exposures to reduce or replace manual medical chart review. Overall, the contractor shall provide the capability and capacity in terms of data sources, tools and scientific expertise and operational management to run queries and observational studies in the form of simple and complex queries as well as complex epidemiologic studies, methods (semi-automated processes for medical chart review, link health care data of mothers and their infants, link claims and EHR data) and devise a Management Plan to manage the contract and produce milestones and deliverables according to the specified schedule. The proposed FDA work may be conducted under a number of possible organizational structures and arrangements. The data holder(s) or other organization(s) may have their own team of epidemiologists, subject matter experts, bioinformaticians, programmers and others who are experienced in conducting post-market pharmacoepidemiological safety and effectiveness studies for drugs and biologics. Alternatively, the contractor may work with other organization(s) or academic partner(s) which has its own team or may assemble its own team of such experts, and that organization may serve as a Coordinating Center to manage the work. See Attachment 1, Draft IDIQ SOW. It is anticipated that this requirement will result in the award of an Indefinite Delivery/ Indefinite Quantity (IDIQ) contract. Place of Performance: Contractors facility. An Industry Day is scheduled for February 12, 2018. See attachment 2 for further information. The respondents shall furnish sufficient technical information necessary for the Government to determine the capability of the respondent at meeting the requirement of this initiative identified above. The methodology must ensure that the offeror has the capacity to take part in a large-scale implementation of the initiative. The BEST objectives and scopes describe the high-level activities under which task orders may be released to obtain relevant infrastructure, data sources, and scientific expertise. Though the target audience is small businesses all interested parties may respond. Responses are limited to fifteen (15) numbered pages on 8.5 inch by 11-inch paper. At a minimum, responses shall include the following: 1. Provide a brief corporate profile of your company to include the following: a) Business name b) DUNS number c) CAGE code d) Business address e) Business website f) Business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB) g) Number of employees in your organization h) Point of contact name i) Mailing address (if different from business address) j) Phone number k) Email address 2. The Draft SOW describes the high-level task areas under which task orders may be released to obtain specific scientific computing engineering and technical support services. The representative technologies described in the SOW are not comprehensive; they are intended to provide an overall understanding of the depth, breadth, and technical sophistication of the technologies employed by the FDA scientific community and the level of expertise and capabilities sought by the FDA under the anticipated contract. With that in mind, are the task areas and the capabilities required clear? 3. Demonstrate capabilities and experience to assemble the support infrastructure to integrate the data sources, tools and methods, and scientific expertise together into a coordinated fashion to carry out safety surveillance and effectiveness studies of biologics. 4. Describe possible data sources available to the offeror such as patient-centered health care data including electronic health records and claims data for a large representative US population. 5. Describe tools, approaches, methods that can be used to conduct analyses of patient groups exposed to biologics vs. control groups, to build appropriate patient populations or cohorts for observational study purposes, database characterization, effect estimation. Ability to conduct a range of analyses including simple queries to complex epidemiologic studies. 6. Describe capability and experience to assemble scientific expertise and experts with pharmacoepidemiology experience in biologics such as bioinformaticians, biostatisticians, epidemiologists, clinicians with experience in biologics, computer programmers, project managers, and others. 7. Describe processes and procedures to provide database management and architecture, data security and sharing in a distributed database environment and use of de-identified patient health information consistent with federal government requirements and regulations. 8. Demonstrate capabilities and experience to provide the necessary business and administrative support to build, operate, and maintain a coordinating center for many of the items listed above. These support services include but are not limited to program management, program support, project management, contract, legal, and budget support, and related services. 9. Are there additional complementary activities that your company would suggest to fully support the FDAs stated objectives? 10. Please note any additional considerations, changes, additions, updates, or clarifications your company suggests critical to this procurement. 11. Please provide a short narrative explaining how your company would approach providing the range of highly specialized, highly technical services to the FDA. If applicable, describe how the approach has proven successful in past efforts that are similar to this one in size, scope, and complexity. 12. What recommended performance and customer satisfaction measures and indicators would give the FDA adequate ability to monitor the quality of the services provided under the anticipated contract? 13. If your company identified any gaps in the described objectives and scopes, please describe any relevant projects where your company provided the service or support identified and what complementary scientific objectives were achieved. 14. Describe how the company will accommodate simultaneous task orders that require multiple resources with specialized technical capabilities in support of the SOW requirements. 15. Please provide suggested / appropriate North American Industry Classification System (NAICS) code and rationale. 16. What contract vehicles would your company suggest in acquiring the services outlined in the Draft SOW (GSA Federal Schedules, Government-wide Acquisition Contract (GWAC), OMB Best in Class Contracts, etc.)? 17. If a small business, demonstrate the firms capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting. 18. If a large business, identify the subcontracting opportunities that would exist for small business concerns; 19. Describe your usual contract type, terms and conditions; and 20. Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the Statement of work. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before February 26, 2018 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1194037. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Attachment: 1. Draft IDIQ SOW 2. Industry Day Information 3. Draft labor categories Added: <input type="hidden" name="dnf_class_values[procurement_notice][description][1][added_on]" value="2018-02-02 15:08:24">Feb 02, 2018 3:08 pm Modified: <input type="hidden" name="dnf_class_values[procurement_notice][description][1][modified_on]" value="2018-02-16 15:19:37">Feb 16, 2018 3:19 pm Track Changes The purpose of this amendment is to provide the industry day presentations and extend the response due date to February 26, 2018 by 13:00 hours Central Time in Jefferson, Arkansas

Original Point of Contact

POC Nicholas E Sartain, Phone: 870-543-7370

Place of Performance

Contractors facility, United States
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