New ap­proach­es to de-risk­ing ear­ly drug de­vel­op­ment

End­points News talked with bio­phar­ma lead­ers at Mer­ck, Sanofi, Catal­ent, Take­da, and J&J about their ef­forts to im­prove R&D ef­fi­cien­cy

The bio­phar­ma in­dus­try as a whole is spend­ing more mon­ey than ever on drug R&D, but the pay­back on pro­duc­tiv­i­ty keeps shrink­ing. On a longterm ba­sis, that’s un­sus­tain­able for the in­dus­try and has to change. We spoke with sev­er­al of the lead­ing ex­perts in clin­i­cal tri­al de­sign and drug de­vel­op­ment to see what they’re do­ing to pick the right can­di­dates for clin­i­cal de­vel­op­ment and how they’re re­vamp­ing projects to achieve ap­provals as ef­fi­cient­ly as pos­si­ble.

Af­ter all, most of a drug’s de­vel­op­ment costs come late in the process. Run­ning the kind of clin­i­cal tri­als need­ed to sup­port an ap­proval are ex­pen­sive, and if they fail, all cap­i­tal in­vest­ed is lost.

Much of the prob­lem is based on an in­com­plete un­der­stand­ing of bi­ol­o­gy and an­i­mal stud­ies of­ten seem to con­fuse the is­sues more than they pro­vide fresh in­sights to re­searchers.

We know that stick­ing with an­i­mal stud­ies for ba­sic pre­clin­i­cal guid­ance will lim­it over­all suc­cess rates in the clin­ic to on­ly 5% to 10%. But the em­pha­sis right now is more on evo­lu­tion than rev­o­lu­tion. Or­gan-on-a-chip tech­nol­o­gy can en­hance pre­clin­i­cal work, just as col­lab­o­ra­tions among CROs and de­vel­op­ers have been re­lied on to iden­ti­fy pre­ferred dosages and de­liv­ery meth­ods.

But you al­so have to keep things sim­ple, to make sure that you don’t over­com­pli­cate your mol­e­cule, mak­ing it im­pos­si­ble to pro­duce at a rea­son­able cost.

And through­out all the changes chron­i­cled in this ar­ti­cle, you will hear of case af­ter case where large com­pa­nies have been strip­ping down in­te­ri­or walls to al­low for more part­ner­ing with in­ves­ti­ga­tors of all stripes, whether in the in­dus­try, gov­ern­ment or acad­e­mia.

In this field, bor­ders are in­creas­ing­ly mean­ing­less ob­sta­cles to change. Sci­en­tists and de­vel­op­ers in North Amer­i­ca, Eu­rope and Asia are look­ing glob­al­ly for the best so­lu­tions to this im­mense prob­lem. Fail­ure is not an op­tion, as NASA might phrase it. These days, when you’re do­ing a moon shot of your own, you need to use every im­por­tant re­source avail­able, wher­ev­er it is, to avoid a fail­ure to launch.

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