No­var­tis and Genen­tech push for clar­i­ty from FDA on how dis­ease pro­gres­sion mod­els can be used for reg­u­la­to­ry de­ci­sions

As com­pa­nies con­tin­ue their search for new drugs for de­bil­i­tat­ing dis­eases that progress over years and are no­to­ri­ous­ly tough to crack (think Alzheimer’s dis­ease), the FDA is ig­nit­ing a wider con­ver­sa­tion on how and when the bio­phar­ma in­dus­try might be able to use spe­cif­ic mod­els in their de­vel­op­ment pro­grams.

The con­cept of dis­ease pro­gres­sion mod­els dates back for decades, and the FDA pre­vi­ous­ly cre­at­ed a li­brary of dif­fer­ent mod­els for dis­eases of pub­lic health im­por­tance, like Alzheimer’s, obe­si­ty and Parkin­son’s dis­ease.

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