The CDDF is pleased to share the key takeaways from our live webinar series – “AI and Big Data AI in Drug Development: Transparency and Risk Assessment” held on 16 June 2026. This webinar included a lecture by Dr. Weida Tong (FDA) followed by a 30-minute Q&A discussion moderated by Ruth Plummer and Fergus Sweeney (CDDF).
KEY TAKEAWAYS
- AI is already embedded and aiding the regulatory approval process.
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- DILI tool highlighted as an exemplar.
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- International collaboration between regulatory agencies with annual meetings is evaluating and ensuring safe and appropriate use “TREAT” criteria (Trustworthiness, Reproducibility, Explainability, Applicability, Transparency).
- There are various potential modes/uses of AI in this space – the following 4 “A”s of AI, with the first 2 in regular use aiding safe and efficient assessment of new technologies:
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- Assistive
- Augmentative
- Autocratic
- Autonomous
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- Autonomous AI is a description of the future potential, with need for checks and balances discussed.
The webinar recording and presentation slides are available on the CDDF website.