There aren’t enough viruses.
At least, there are not enough engineered ones, the viral vectors used in gene therapies such as Novartis’ CAR-T based Kymriah, to whack a nucleic acid into a cell.
Vector manufacturing is not only harder, but demands higher biosafety levels, wandering as it does into a territory notorious for impeding the availability of products: GMO regulation. If we can unblock the manufacturing logjam, we’ll also have to fix the regulations.
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When the coronavirus pandemic struck Europe, the regulatory stranglehold on viral vectors hit home with a vengeance.
Related on the SLP
Burdening trials of COVID-19 vaccines with environmental risk assessments and applications for GMO release was hardly likely to bring a public health benefit, but in the absence of clear law, Member States were unsure as to whether such products could even be made available for emergency use, to meet a patient’s special needs, or on a compassionate basis.
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While media and politics dwells on crops and livestock, they have largely ignored the plight of GM medicines. Yet forcing potentially life-saving treatments for cancer and cardiovascular disease through the same regulatory mill as blight-resistant potatoes is simply deterring product development in the face of patient need.
