Ben Pais
Seminars
Accurate dosimetry translation from animal models to humans is crucial for the safe and effective clinical application of targeted radiopharmaceuticals. This workshop delves into the methodologies, challenges, and best practices in extrapolating dosimetric data, ensuring that preclinical findings reliably inform human therapeutic strategies.
- Investigating a novel treatment approach in early phase clinical studies with the true theranostic pairs 61/67Cu-NU101 and 61/67Cu-NU201
- Comparing various extrapolation techniques and assessing their accuracy and applicability
- Review real-world examples where dosimetric translation informed clinical dosing, highlighting both successes and areas for improvement
- Leveraging in vivo (PET) and ex vivo biodistribution
- Dosimetry and scaling to human doses
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Outcome – Review the RWE for dosimetry informed clinical dosing – what went wrong, what could be improved and design an ideal phase zero trial.
Step inside a candid, forward-looking conversation with the field’s scientific leaders as they dissect what the data has – and hasn’t – told us about radiopharmaceuticals heading into 2026. Challenge
assumptions, explore inflection points, and put your questions directly to the experts shaping the next wave of innovation, regulation, and clinical design
- Which scientific assumptions about radiopharmaceutical behavior have held up under clinical data through 2026 – and which are now clearly incomplete or wrong?
- Are current pharmacokinetic and dosimetry models sufficiently predictive for decision-making, or are we still over-relying on empirical iteration in the clinic?
- What is needed in the field to continue investment and movement?
- What lessons from recent late-stage programs should be influencing how we design first-in-human studies today?
- Does existing regulatory paradigms adequately reflect the unique risk–benefit calculus of radiopharmaceuticals, or is misalignment now a rate-limiting step?
- Which manufacturing and supply-chain constraints are a fundamentally scientific problem – and which require more infrastructural changes?
- Looking ahead, what scientific bottleneck is most likely to determine winners and failures in radiopharmaceuticals beyond 2026?
