Description:
The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety and efficacy of drugs, biologics, medical devices, tobacco products, and our nation’s food supply. The 2007 Food and Drug Administration Amendments Act (FDAAA) required FDA develop an active risk identification and analysis system to monitor and analyze post-market performance of regulated medical products including drugs, vaccines, and other biologics. FDA established the Sentinel Initiative in 2009, a multiyear effort to build a system to evaluate safety of medical products with respect to health outcomes utilizing claims and administrative data from large health insurance companies.

In its continuing effort to develop and enhance the Sentinel Initiative, the Center for Biologics Evaluation and Research (CBER) initiated a new program called the Biologics Effectiveness and Safety (BEST) Sentinel Initiative in 2017, and CBER competed and awarded two one-year contracts to one vendor. The purpose of BEST is to expand CBER’s capabilities by providing additional data sources, such as electronic health records (EHR), and infrastructure in a more cost-effective, efficient, and timely manner. The BEST Program is part of CBER’s growing and evolving network of post-market safety and effectiveness systems within the Sentinel Initiative. 

To continue the work of the BEST Program after the initial one-year contracts expire, CBER seeks to identify vendors that have the capability and capacity to provide large sources of patient data, enhanced tools, and infrastructure to expand and enhance the current post-market surveillance system. CBER is announcing an Industry Day to be held on February 12, 2018 from 1 pm to 5 pm at the White Oak campus in Silver Spring, MD. The purpose of the Industry Day is for CBER to publicly communicate its requirements and provide an opportunity for the vendors to ask questions. Specifically, CBER will discuss an overview of its requirements and needs to build additional capacity for: 1) biologics post-market near real-time safety and effectiveness surveillance, 2) access to large sources of clinical patient-centered data particularly EHR, and 3) innovative approaches to conduct surveillance utilizing sophisticated query tools, machine learning, artificial intelligence, and natural language processing. 

The Industry Day will start with presentations by CBER representatives. CBER representatives will then present and answer questions that have been submitted by participants in advance. Next, vendors will have the opportunity to ask any additional questions during the Question and Answer session.

Advanced registration is required to attend the meeting, and on-site registration will not be available. Registered participants can attend the meeting in-person or via Webcast remotely. Registered participants may submit preliminary questions to [email protected] (Subject line: Industry Day 2018) by February 2, 2018. All questions and answers will be provided to all attendees and will be publicly available after the event. In addition, a transcript of the event will be provided publicly sometime after the event.

Date and Time of event: Feburary 12, 2018, 1-5 PM

Attendance registration period: January 16, 2018 to February 9, 2018

Registration period to submit questions: January 16, 2018 to February 2, 2018

Location:
U.S. Food and Drug Administration
10903 New Hampshire Ave.
White Oak, Building 31 (Great Room)
Silver Spring, MD 20993

Webcast Address: https://collaboration.fda.gov/industryday2018/ 

Backup Date: February 16, 2018 in case of inclement weather

Registration:
To register for the Industry Day, please visit the following Website: https://www.eventbrite.com/e/industry-day-2018-tickets-41093453626. Due to space limitation, we ask that each vendor bring no more than 5 representatives to the event for in-person attendance although Webcast attendance is available to as many registered attendees from each vendor. Persons interested in attending this Industry Day must register. Please provide complete contact information for each attendee including name, position title, affiliation, mailing address, email address, and day time telephone number. If you need special accommodation due to a disability, please contact Ms. Loni Warren or Sherri Revell at 240-402-8010 or [email protected] no later than February 2, 2018.

ResourcesForYou

• Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics
• Biologics Effectiveness and Safety (BEST) Initiative: Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Biological Products
• Biologics Effectiveness and Safety (BEST) Initiative Industry Day Meeting Agenda