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Biologics Effectiveness and Safety (BEST) Initiative: Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Biological Products - 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: Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Biological Products. 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. Sentinel and BEST 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 and CBER uses the Sentinel System to conduct some of its epidemiological studies as part of its regulatory responsibilities. 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 records (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 efforts to develop and expand its 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 capabilities and 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. Electronic Health Records Post-Market Observational Data Large insurance claim databases have been the standard for large scale epidemiologic studies, including the safety of CBER-regulated products assessed within Sentinel over the past decade. The implementation of EHR systems among USA Hospitals and other healthcare providers has expanded almost 10-fold since 2008, with approximately 85% of current facilities using some form of EHR. EHRs contain both structured text (e.g. visit date, initial diagnosis, lab results) and unstructured narrative text (e.g. admission notes, discharge summaries, ancillary notes, radiology reports). EHR data offers richness of content and an embedded ability to validate mined data by further examination of the online record within the originating institution. Complex text mining algorithms are needed to leverage the information in the unstructured narrative of EHRs. Artificial intelligence systems (AI) were first described in the 1950s as rule-based systems and have evolved into procedures that are in common use today including Natural Language Processing (NLP). Examples of further evolution of AI include Machine Learning (ML) and Statistical Learning procedures which make use of data algorithms based on a learning dataset and neural networks and deep learning which incorporate simple machine -learned concepts into complex algorithms. CBER-Regulated Products The BEST program is intended to provide greatly improved adverse event recognition, data accuracy, cost effectiveness, and safety reporting for CBER-regulated products. The techniques employed will also allow for improved post-market effectiveness studies based on many of the same advantages. In addition to identifying well-qualified applicants to serve in a Coordinating Center role, BEST anticipates the development of individual task orders based on specific CBER product areas; including Blood and blood products, and tissues, advanced cellular and gene-based therapies, vaccines, CBER-regulated devices. CBER-regulated cellular and gene therapy products include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, including hematopoietic stem cells and adult and embryonic stem cells. Because patient populations are limited, the exposure to these advanced therapies can also be difficult to detect in regular administrative or EHR databases. CBER also has a unique and expanding program of medical device review, including devices integral to the manufacture of licensed biologic products such as blood, tissues, and cell and gene therapies. The recent universal implementation of unique device identifier codes (UDI) will help to support future studies of the adverse events that may be related to devices that are used during the biologics manufacturing process (e.g. devices to screen donated blood for infectious agents, blood warmers, or apheresis devices). Any of these devices may contribute to the development of adverse patient outcomes. Contract Rationale CBER is initiating this contract action as part of its Sentinel Biologics Effectiveness and Safety (BEST) initiative, in a continuing effort to address postmarket risk identification challenges and evaluation of effectiveness unique to its regulated biologic products. CBERs Sentinel BEST initiative expands our work beyond current partners (Harvard Pilgrim Health Care Institute and its data partners) to provide CBER with new data sources; common data models (CDMs); tools and methods; and infrastructure, with the goal of providing deliverables in an efficient, timely, and cost-effective manner. Overall, the CBER BEST system is being built to enhance safety, surveillance, and effectiveness studies around three defined needs: 1) Development and evaluation of improved standard AE data including collection, analysis, and surveillance methods for all other CBER-regulated products, including vaccines, blood and blood products and advanced therapies and devices; and 2) Development and piloting of innovative new approaches to obtain postmarket safety and effectiveness data for all CBER-regulated products. These methods will include approaches and applications such as query tools, robotics, machine learning, artificial intelligence (AI), and natural language processing (NLP). These tools will also be applied to mining of EHR and similar electronic records for text content that may reflect unexpected adverse events related to use of CBER-regulated products. The scope of this contract will also include pilot studies of automated or semi-automated methods for post-market data collection and direct electronic submission to the FDA Adverse Event Reporting System (FAERS) and the Vaccine Adverse Event Reporting System (VAERS) adverse event databases. With this solicitation, CBER is seeking coordination, scientific, and data resource capacity-building to address the need for advanced, innovative approaches to obtaining postmarket data from EHR and other electronic health records for safety and effectiveness studies of CBER-regulated biologic products. The advanced tools to be applied include: query tools, robotics, machine learning, artificial intelligence (AI), natural language processing (NLP) and others yet to be determined. This effort will also include the development of procedures to automatically transmit safety-related data to the FDA adverse event databases (FAERS and VAERS) in alignment with the FDA MedWatch reporting format. Data Considerations With respect to data sources, CBERs experience has been that EHR data or similar electronic sources of text-based or structured clinical data provide more usable patient information than administrative claims data for inpatient and outpatient settings. The availability of very large EHR datasets for study purposes does not currently compare with the availability of large collections of claims data, therefore EHR data capacity-building is also one of the goals of this contract. Similarly, data from different sources generally needs to be brought into a standardized format and nomenclature to be useful for large-scale studies. CBER wishes to gain experience with new common data models (CDM) that CBERs Sentinel program has not used in the past. Of particular interest to CBER is the Observational Medical Outcomes Partnership (OMOP) common data model that can accommodate EHR-sourced patient clinical data with the capability to expand the current vocabularies and domains to meet the specific needs for evaluation of CBER-regulated products. The OMOP CDM is based on the UMLS (Unified Medical Language System) which brings together multiple health and biomedical vocabularies and standards to enable interoperability between computer systems. The capabilities of BEST for safety surveillance of all CBER products can be improved by collecting data from all possible sources (administrative and EHR data), as well as mining clinical research data either from the biomedical literature, or from clinical trial data submitted to FDA. The combined public-private efforts from HL7 Regulated Clinical Research Information Management (RCRIM), CDISC (Clinical Data Interchange Standards Consortium), NCI, and the FDA led to the development of the BRIDG (Biomedical Research Integrated Domain Group) model. The BRIDG model links the CDISC data reporting (required by FDA for data submission) models with the HL7 RIM. Efforts are underway within FDA to harmonize the BRIDG model with the OMOP CDM. Such harmonization will enable linking the protocol driven clinical research artifacts to the post market active surveillance studies. Exploring different sources of data will provide more power to detect safety and effectiveness signals with more accuracy. Specific strengths of the OMOP CDM of interest to CBER include: The availability of user-friendly, open source tools and analytics that are used by researchers across the world; the availability of the OMOP tools both as an online platform and as standalone software; rapidly expanding use of OMOP within the medical/scientific community that helps to ensure its further expansion and longevity; ongoing efforts (within FDA and elsewhere) to harmonize the OMOP CDM with multiple other CDMs that were developed to support different phases of translational and clinical research; flexible capabilities to support expansion of data vocabularies and domains; support for rapid interactive analyses across appropriate data firewalls that do not include dependency on centralized data management. CBER also seeks to greatly improve the granularity of information available to define exposures to CBER-regulated products through this contract. Necessary improvements include access to electronic records that include ISBT-128 labeling codes for blood components and tissue products, NDC codes for drugs, and UDI codes for devices. 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. 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: The BEST objectives and scopes describes the high-level activities under which task orders may be released to obtain relevant infrastructure, data sources, and scientific expertise. 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 capabilities and experience to evaluate unstructured text data using artificial intelligence, natural language processing, machine learning and other methods to improve surveillance methods for biologics. 7. Describe approaches, methods and experience as mentioned above to conduct data mining of adverse events associated with biologic product exposure from medical records and utilize mined data to populate adverse event case reports to be submitted to FDA safety systems such as FDA MedWatch. 8. Describe ability to validate the delivery and accuracy rates of completed case report submissions to FDA. 9. Describe capabilities 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. 10. 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. 11. Describe ability 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. 12. Are there additional complementary activities that your company would suggest to fully support the FDAs stated objectives? 13. Please note any additional considerations, changes, additions, updates, or clarifications your company suggests critical to this procurement. 14. 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. 15. 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? 16. 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. 17. Describe how the company will accommodate simultaneous task orders that require multiple resources with specialized technical capabilities in support of the SOW requirements. 18. Please provide suggested / appropriate North American Industry Classification System (NAICS) code and rationale. 19. What contract vehicles would your company suggest in acquiring the services outlined in this document (GSA Federal Schedules, Government-wide Acquisition Contract (GWAC), OMB Best in Class Contracts, etc.)? 20. If a small business, demonstrate the firms capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting. 21. If a large business, identify the subcontracting opportunities that would exist for small business concerns; 22. Describe your usual contract type, terms and conditions; and 23. 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 FDA1194238. 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 15:11:43">Feb 02, 2018 3:11 pm Modified: <input type="hidden" name="dnf_class_values[procurement_notice][description][1][modified_on]" value="2018-02-16 15:22:07">Feb 16, 2018 3:22 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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