FDA ROADMAP - PREDICTIVE TOXICOLOGY

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A Six-Part Framework for New or Enhanced FDA Engagement in the Science of Toxicology

FDA’s Working Group recommends a six-part framework for new or enhanced FDA engagement in the science of toxicology.

1. Organizing Committee

FDA has formed a senior-level Toxicology Working Group to (1) foster enhanced communication among FDA product centers and researchers and (2) leverage FDA resources to advance the integration of emerging predictive toxicology methods and new technologies into regulatory safety and risk assessments.[pic 3]

Working Group activities include:

• discussions around and review of ongoing FDA research;
• access to internal databases to leverage data and identify gaps in the current testing paradigms, where newer methods are critical to mitigate uncertainty;
• development of context of use examples; and
• acceptance of newer toxicology methods (e.g., criteria for incorporating more predictive models in regulatory risk assessment).

These activities will help identify areas where research is needed and may reduce duplication of efforts inside and outside FDA.

1. Training

Continuing ongoing education in new predictive toxicology methods is essential for FDA regulators. To this end, FDA’s Toxicology Working Group has established an Agency-wide education calendar of events and a Toxicology Seminar Series to introduce concepts of new toxicology methodologies and updates in toxicology-related topics.[pic 4]

Developing and maintaining a cutting-edge capacity in this complex field touches on a broad range of skills. FDA will work to ensure that a wide range of disciplines, expertise, and individuals are engaged in developing or adopting appropriate predictive toxicology methods and technologies. Additionally, FDA will continue to make training in new test methods available during the development process so that

regulators understand the basis of these methodologies before they are integrated into regulatory application.

1. Continued Communication[pic 5]

FDA will continue to reaffirm its commitment to and support for incorporating data from newly qualified toxicology methods into regulatory submissions and that it encourages discussions with stakeholders as part

of the regulatory submission process. FDA product centers will encourage sponsors to submit a scientifically valid approach for using a new method early in the regulatory process and to engage in frequent communication with the Agency. Such interactions are essential to ultimately ensuring that new toxicology methods can be used in regulatory risk assessments.

1. Collaborations[pic 6]

FDA will continue its long practice of fostering collaborations across sectors and disciplines nationally and internationally. An example is the DARPA/FDA/NCATS Partnership that was formed to develop in vitro microphysiological systems, also known as organs on a chip. FDA considers these types of partnerships pivotal to identifying the needs, maintaining momentum, and establishing a community to support delivery of new predictive toxicology methods.

1. Research[pic 7]

FDA’s research programs will identify data gaps, such as understanding the concordance between animal and human responses (i.e., biomarkers of toxicity) and understanding how the performance of these markers and their interpretation may vary across different organ systems and species and within human populations (i.e., precision medicine). FDA supports intramural and extramural research to ensure that the most promising technologies are identified, developed, validated, and integrated into the product pipeline.