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ISAL 2025 | Logistical challenges associated with the implementation of FPM into AML clinical practice
Anthony Letai, MD, PhD, Dana-Farber Cancer Institute, Boston, MA, comments on the biggest logistical hurdles in incorporating functional precision medicine (FPM) into routine clinical practice for acute myeloid leukemia (AML). He highlights the biggest hurdles as regulatory challenges, as well as the necessity to operate on viable patient samples, which creates shipping and storage hurdles. This interview took place at the 19th International Symposium on Acute Leukemias (ISAL XIX) in Munich, Germany.
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Transcript
Honestly, the biggest logistical hurdle, I would say at this point, is purely regulatory. These assays that we’re producing are novel and they’re complex, both of which get in the way of regulatory approval, because regulatory approval of our assay will be sort of the first regulatory approval of that type of assay. So it meets with challenges like standards that exist are really for different types of assays than for ours...
Honestly, the biggest logistical hurdle, I would say at this point, is purely regulatory. These assays that we’re producing are novel and they’re complex, both of which get in the way of regulatory approval, because regulatory approval of our assay will be sort of the first regulatory approval of that type of assay. So it meets with challenges like standards that exist are really for different types of assays than for ours. And part of the job that we have is just education of regulators and scientists and clinicians in general about the utility of these systems and how they differ from prior assays. Of course, there’s other logistical hurdles such as we need to operate on viable patient samples. So a fixed or a flash-frozen sample will not do. So shipping and storage conditions are particularly important for this type of assay, even more important than for a genomic assay where there’s multiple different types of fixation or storage that would be compatible with a typical omics assay.
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Disclosures
Scientific Advisory Board: Flash Therapeutics, Zentalis Pharmaceuticals; Advisor: Curie.Bio.
