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Background Analysis: Science Board to FDA to Hear CBER Program Subcommittee Report and Information about the Patient Affairs Initiative; Advise FDA on Leveraging its Tools and Authorities– APR 23, 2018 (SBFDA)

Announcement

The Science Board to the US Food and Drug Administration (FDA) will meet on Monday, April 23, 2018 to hear a report from the Center for Biologics Evaluation and Research (CBER) Program Review Subcommittee; hear about the FDA’s Patient Affairs Initiative; and discuss how the Agency can leverage its existing tools and authorities, and work with stakeholders, to better address the complex scientific, public health, and technology challenges it faces today.

Background

CBER Programs

CBER regulates a variety of diverse and complex biological products, both investigational and licensed, including: allergenics, blood and blood components, certain medical devices and tests, gene therapy, human tissues and cellular products, vaccines, and xenotransplantation products. As part of regulating these products, CBER Scientists may also conduct a variety of mission-related programs, including research into evolving technology and science that pertain to the safety, potency, and efficacy of new biological products. At the upcoming meeting, the Science Board will hear a report from the CBER Program Review Subcommittee.

FDA’s Patient Affairs Initiative

In 2017, the FDA launched the Patient Affairs Staff (PAS). PAS works in close collaboration with the Medical Product Centers, the Office of External Affairs (OEA), and other FDA offices to complement and support FDA’s ongoing patient engagement efforts. Specifically, PAS focuses on the following key areas:

·      Creating and assisting with public and private collaborations and partnerships with external groups of patients to discuss topics around medical product development and regulatory policies

·      Coordinating cross-cutting programs and activities to leverage best practices and enhance patient engagement

·      Facilitating consistent cross-Center policy-making and common standards to enhance integration of patient perspectives into the regulatory and scientific process

·      Building a framework for hosting and maintaining a shared database of patient engagement information

·      Providing navigation services to triage inquiries from patients and patient organizations

·      Establishing a centralized point of entry into the FDA for patients and their advocates (existing FDA interactions will not be affected)

·      Enhancing the Agency’s external communication platform to create awareness of FDA’s patient engagement activities and regulatory processes

Patient Engagement Collaborative (PEC)

In 2017, the FDA and the Clinical Trials Transformation Initiative (CTTI) created a new workgroup with patient advocacy organizations to talk about patient engagement at the FDA. The Patient Engagement Collaborative (PEC) provides an ongoing forum to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions. PEC is being led by the PAS.

European Medicines Agency (EMA) Patient Engagement Cluster

The FDA and the EMA created a working group on patient engagement called the FDA/EMA Patient Engagement Cluster. The FDA/EMA Patient Engagement Cluster joins a series of currently existing EMA/FDA clusters. The cluster allows FDA and EMA to share best practices involving patients along drug and biologic regulatory life-cycles.

FDA Patient Council

The Patient Council is designed to bring together all FDA Centers and Offices to better coordinate and integrate the role of patient perspectives in regulatory decision-making over the total product lifecycle.

Science Board Recommendations

The Science Board will discuss how the FDA can leverage its existing tools and authorities, and work with stakeholders, to better address the complex scientific, public health, and technology challenges it faces today. It is likely that the FDA will pose specific questions to the Science Board; these questions will be posted in meeting material or will be presented at the meeting.

What’s Next?

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none


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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.