Strengthening Preclinical Packages for FDA Radiopharmaceutical Approval

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, discusses the evolving landscape of radiopharmaceutical development based on his twenty-plus years of experience in academia and industry. His central message is the critical need to bridge the gap between preclinical research and clinical success by utilizing patient-derived xenograft (PDX) and other clinically relevant models.

Vera argues that the industry must move beyond simplistic models that only evaluate high and low target expression, as these can lead to overestimating a drug's potential. He emphasizes, "I think it is time to move on from only evaluating radiopharmaceuticals in a model that has high target expression and lower target expression, and really move to clinically relevant models that will actually, assess your radiopharmaceutical and not overestimate any of the features that you are looking in a radiopharmaceutical.”

By incorporating these advanced models into preclinical packages for the FDA, researchers can provide a much stronger proof of concept that more accurately predicts clinical outcomes. Vera explains that these models are invaluable for identifying the right patient populations and expanding existing assets into new therapeutic indications.

While oncology remains a primary focus, he highlights the potential for radiopharmaceuticals in treating infectious diseases and rheumatoid arthritis. Ultimately, Vera advocates for a more rigorous, model-based approach to ensure that preclinical developments translate directly into clinical success.

Transcript:

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

I'm Denis Beckford Vera. I am the head of radiopharmacology at Champion Oncology. Being twenty-plus years in the radiopharmaceutical field, combined between the academia and the industry, so I truly believe the patient-derived xenograft and overall clinical relevant models, will really bridge the gap between preclinical development of radiopharmaceutical and clinical development. I think it is time to move on from only evaluating radiopharmaceuticals in a model that have high target expression and lower target expression, and really move to clinically relevant models that will actually, assess your radiopharmaceutical and not overestimate any of the features that you are looking in a radiopharmaceutical. That will really translate directly into clinical outcome and success. So that's what I really think. So we have to really work, and this is a message to the field, to really work on including more and more of these clinically relevant models in preclinical development of radiopharmaceutical in the packages that we provide to the FDA as a proof of concept. Basically strengthen very much our proof of concept, that we are closer to a clinical outcome that we are really expecting. The same for if you are a little bit late in the process. This is very relevant to choose patient populations well. You are able to choose a variety of, these models within a disease with the characteristics that you are looking for in your patient population. So by evaluating the radiopharmaceutical in the patient population, you generate a strong proof of concept to then apply into the clinic, for instance, for an asset that has been already in the clinic used for a specific indication. Now you can move into a different indication if you are strong, if you assess these radiopharmaceuticals in those clinically relevant models and apply the right numbers, the right designs, and the right studies. That's what I think. Radiopharmaceuticals can be applied to many diseases. Like infectious diseases, there is a lot of success there. Also, probably even for diagnostics a lot. So not just beyond oncology also, for instance, for disease like rheumatoid arthritis as well, have been some development. And I think because you have the capability to see what you treat, and then you probably basically, everything that you can kill, for instance, with other type of modality, there is a high probability that you can also use this very, very powerful payload, very specific, to also treat it as well. So I do think so.