HCB News: How are gene and cell therapies different from radiopharmaceutical therapies, like the emerging theranostic agents used in nuclear medicine?
FG: Gene therapies make a change to the gene, as mentioned previously, by adding, removing or changing part of the genetic material of the patient. Cell therapies use patient or donor cells to activate a cellular response against a disease.

Nuclear medicine, including radiopharmaceuticals and theranostics, uses radioactive particles bound to carrier molecules. Theranostics are treatments, which is a change from traditional nuclear medicine which was primarily used for diagnostic purposes. Theranostics are radioactive treatments which identify and target cancer cells, resulting in cell death. This is a different type of science and is most often used to treat a variety of cancer types.
Theranostics and cell and gene therapies are very innovative and important in treating a number of life-threatening conditions. But you can see that they are very different in how they work to alter the trajectory of the disease.

HCB News: Why is infrastructure such a critical component to improving access to gene and cell therapies?
FG: Cell and gene therapies are unlike most traditional or even complex specialty medications. These new treatments involve very specific manufacturing, taking cells or biologic material directly from patients or donors. The final product is individualized for one patient’s treatment, and that product must be delivered and administered to that one patient in a very specific and timely manner. Initially, after manufacturing, the product is volatile and must be handled with care, which is where sophisticated logistics and tracking become critically important.

Moreover, these therapies are often stored at extremely cold temperatures, some requiring temperatures such as negative 190 Celsius or below. This requires special handling and safety precautions for logistical or clinical teams handling the product or treating the patient. Product delivery to the exact site of care and ensuring the patient is present at the right time is critical- it’s the old pharmacy saying – “get the right drug to the right patient at the right time”- magnified infinitely for these products. Finally, tracking patient response and outcome over time is another piece of infrastructure that is important for these extremely high cost, yet often incredibly effective, treatments.

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