CBER sets strategic priorities through 2025

Regulatory NewsRegulatory News | 19 March 2021 |  By 

Facilitating product development, conducting research, boosting preparedness against health threats and organizational excellence top the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) strategic goals for the next five years.
Those goals are detailed in CBER’s 42-page strategic plan, released Wednesday, and account for new legislation and scientific advances since the center’s previous interim plan for FY2017-2019. That legislation includes the 21st Century Cures Act, the FDA Reauthorization Act of 2017 and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. (RELATED: CBER strategic plan 2017-2019: Increase threat preparedness, improve international collaborations, Regulatory Focus 17 October 2016).
Each of the four goals is supported by a set of objectives and reflect CBER’s near-term priorities of addressing the COVID-19 pandemic, building a regulatory program for individualized or bespoke therapies, facilitating compliance for human cells, tissues and cellular and tissue-based products (HCT/Ps) and advancing manufacturing technologies for biologics.
“New scientific advances give us the opportunity to reduce the burden of disease by bringing patients safe and effective novel products to prevent and treat diseases. At CBER, a fundamental part of our missions and vision is helping to provide the scientific foundations and the regulatory framework that will maximally expedite the translation of new scientific advances into such benefits for individuals and for the public health,” writes CBER Director Peter Marks.
The goals, while reduced from six under the previous interim plan, reflect many of the same objectives:
Goal 1: Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology.
Goal 2: Conduct research to address challenges in the development and regulatory evaluation of medical products.
Goal 3: Increase preparedness for emerging threats and promote global public health.
Goal 4: Manage for strategic excellence and organizational accountability.
In a reflection of some of the advancements in technology since the previous strategic plan, the new document makes numerous references to cutting-edge tools such as artificial intelligence and machine learning, individualized and bespoke therapies and foresees more extensive application of real-world data and real-world evidence.
Under its first goal, CBER says it will work to integrate emerging science and technology into its policy development and continue to support interaction with stakeholders through its patient-focused drug development (PFDD) efforts and industry targeted initiatives like its Initial Targeted Engagement for Regulatory Advice (INTERACT) program. The center also says it will work to advance product evaluation using innovative statistical and epidemiological approaches and continue its risk-based approach to product oversight.
With its second goal, CBER says it will boost its support for nonclinical methods and models for evaluating medical products and improve its clinical evaluations by using innovative statistical, analytical and modeling approaches. While tackling emerging health threats is covered in the third goal as well, CBER says it will employ a “robust intramural research program … to proactively facilitate development of innovative medical products addressing a variety of public health challenges from rare genetic disorders to cancer while also providing rapid responses to emerging infectious diseases.”
The center’s third goal is to increase preparedness for emerging threats and promote global public health. In its previous strategic plan, preparedness against threats such as terrorism, pandemic influenza and emerging infectious diseases was listed as CBER’s first goal, with improving global public health through international collaboration following in second. CBER’s approach to this goal incorporates several lessons from the COVID-19 pandemic, including the need to rapidly scale up manufacturing, shorten supply chains, bolster manufacturing resilience and anticipate and mitigate shortages.
CBER’s fourth and final goal is to manage for strategic excellence and organizational accountability and focuses on building and maintaining the center’s workforce and ensuring accountability through effective resource management. Other facets of the goal include effective and proactive communication with internal and external stakeholders and to harmonize and modernize the center’s business operations.


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