Explore the Agenda
8:00 am Morning Registration & Breakfast
8:55 am Chair’s Opening Remarks
Advancing Preclinical Models to Generate More Human-Relevant Evidence & Better Predict Clinical Performance
9:00 am Keeping the Patient in Mind: Building Preclinical Evidence That Better Supports Translation into Humans
- Work backwards from the intended patient population and clinical setting to determine which preclinical questions need to be answered before progressing an RLT towards human studies
- Interrogate where preclinical models accurately reflect human disease and where they fall short, using complementary evidence to strengthen confidence in translation
- Apply lessons from previous RLT development to generate preclinical evidence that better informs clinical study design, treatment delivery and the successful progression of next-generation candidates into patients
9:30 am Building Preclinical Models that Better Recapitulate Human RLT Biology to Improve Prediction of Clinical Performance – Reserved for AstraZeneca
- Selecting models that reproduce clinically relevant target expression, heterogeneity & tumor biology to generate more representative preclinical data
- Identifying where conventional xenografts misrepresent human disease to avoid overestimating candidate performance
- Defining the characteristics required of a predictive model to support higherconfidence candidate progression
10:00 am Fireside Chat: How Much Preclinical Evidence Is Enough?: Defining a Fit-for-Purpose Preclinical Package to Progress RLTs Towards IND
- Benchmark contrasting approaches to preclinical development to determine the level of evidence required to progress confidently towards the clinic
- Determine which studies generate decision-critical evidence versus where additional data adds time, cost, & complexity without strengthening the development case
- Balance toxicology, biodistribution, dosimetry, pharmacology, & model selection to build a robust package proportionate to the candidate and development stage
- Leverage early FDA engagement to clarify expectations, ask the right scientific questions, & establish a more predictable path towards IND
10:30 am Morning Break & Networking
Understanding Radiobiology to Translate Radiation Dose into Therapeutic Response & Maximize Treatment Effect
11:30 am Understanding Radiobiological Drivers Beyond Absorbed Dose to Strengthen RLT Candidate Selection
- Interrogate cellular uptake and target-specific biology to understand how biological characteristics influence therapeutic response beyond absorbed dose alone
- Leverage knockout and knock-in models alongside in vitro and in vivo validation to establish target-specific effects and strengthen confidence in the underlying biology
- Integrate imaging and therapy studies throughout preclinical development to connect biological response with candidate performance and inform progression towards the clinic
12:00 pm Connecting Subcellular Localization & Radiation Quality to Better Predict Therapeutic Potency
- Understand how subcellular localization changes biological response, even when absorbed dose appears comparable at the organ or tissue level
- Examine how the type and range of radiation interact with localization to influence therapeutic effect and normal-tissue toxicity
- Integrate localization, radiation biology, and dosimetry to improve prediction of the therapeutic window during translation
12:30 pm Roundtable Discussion: Harnessing Short-Lived Alpha Emitters to Maximize the Therapeutic Benefit of Combination Strategies
- Understanding how short, high-intensity alpha irradiation alters tumor biology to identify opportunities for synergistic combination therapies
- Combining alpha therapy with immunotherapy & other treatment modalities to enhance anti-tumor response beyond RLT alone
- Optimizing isotope half-life, treatment timing, & sequencing to maximize the therapeutic benefit of combination strategies
1:00 pm Lunch Break & Networking
Advancing Dosimetry to Define the Therapeutic Window, Guide Candidate Selection, & Inform Clinical Dosing
2:00 pm Comparing Dosimetry Considerations Across Alpha & Beta Emitters to Inform Therapeutic Development
- Benchmark the current state of therapeutic radiopharmaceutical dosimetry to understand what can reliably be measured today & where critical uncertainties remain
- Examine current regulatory expectations & the limitations of existing dose thresholds to determine what evidence is needed for therapeutic radiopharmaceutical development
- Explore the path towards more standardized dosimetry approaches that can better connect absorbed dose with clinical outcomes & inform therapeutic development
2:30 pm Roundtable Discussion: Connecting Macro & Micro Dosimetry to More Accurately Characterize Tumor & Healthy-Tissue Radiation Exposure
- Identifying what whole-organ absorbed dose fails to capture to reveal important differences in radiation exposure
- Accounting for heterogeneous radionuclide distribution at tissue & cellular levels to understand where average dose may mask localized dose variation
- Applying microdosimetry where greater resolution is needed to more accurately characterize the dose delivered to tumor & healthy tissue
3:00 pm Integrating Dosimetry, PK & Biodistribution to Improve Human Dose Prediction & Inform Clinical Progression
- Combining imaging-derived kinetics, PK & biodistribution data to build more robust human dose predictions
- Accounting for species differences in distribution, clearance, & organ kinetics to improve extrapolation from animals to humans
- Quantifying uncertainty in predicted tumor & organ doses to determine when estimates are reliable enough to support clinical progression
3:30 pm Afternoon Break & Networking
Strengthening Safety Prediction to Characterize Toxicity & Maximize the Achievable Therapeutic Window
4:30 pm Defining the Non-Clinical Safety Strategy for Next-Generation Radiopharmaceuticals
- Navigate differences in non-clinical safety requirements across regulatory regions to understand what evidence is needed to progress towards FIH
- Tailor the safety strategy to the target, modality, and radioconjugate profile, rather than applying a one-size-fits-all toxicology package
- Identify the remaining safety uncertainties after IND-enabling studies and determine where additional evidence is needed to better predict clinical risk
5:00 pm Improving RLT Safety & Reducing Off-Target Toxicity Through Tumor- Selective Targeting
- Identify biomarkers preferentially expressed on malignant versus healthy cells to strengthen tumor selectivity & minimize normal-tissue exposure
- Leverage molecular imaging to characterize target expression & tumor uptake and inform suitability for therapeutic development
- Translate diagnostic targeting insights into therapeutic radiopharmaceutical strategies to improve specificity & reduce off-target toxicity
- Apply lessons across prostate, breast, & bladder cancer to demonstrate how tumorselective targeting can support safer therapeutic development