Bioreg­num Opin­ion Col­umn by John Car­roll

The FDA de­serves ku­dos for draw­ing a line in the sand over their re­view of Covid-19 vac­cines. They’ve made it clear — af­ter deep skep­ti­cism be­gan to ap­pear fol­low­ing the de­ba­cle over con­va­les­cent plas­ma — just what they will need to see be­fore hand­ing out an EUA, thus sav­ing the agency’s rep for en­forc­ing stan­dards es­sen­tial to main­tain­ing pub­lic trust in drugs.

That same in­tegri­ty, though, has gone miss­ing from the FDA’s stance on Bio­gen’s Alzheimer’s drug ad­u­canum­ab. De­spite a sta­tis­ti­cal analy­sis that high­lights the con­flict­ing na­ture of the Bio­gen $BI­IB da­ta, a post hoc dump­ster dive op­er­a­tion to find sup­port­ive da­ta and a move to shine up small co­hort re­sults as back­up proof of ef­fi­ca­cy, the FDA di­vi­sion re­spon­si­ble for Alzheimer’s chose to en­dorse adu for use among mil­lions of pa­tients.

We’ve been here be­fore. The Sarep­ta ap­proval lead­ing to mar­ket­ing au­tho­riza­tion — with a la­bel that clear­ly states their first, very ex­pen­sive, Duchenne MD drug re­mains ex­per­i­men­tal — is a per­ma­nent black eye when it comes to in­dus­try stan­dards. What fol­lowed just made it all much, much worse — and ap­pears to be about ready to hap­pen again in an in­fi­nite­ly larg­er pa­tient pop­u­la­tion.

At the time, as I found out fair­ly re­cent­ly, the FDA’s Janet Wood­cock re­peat­ed­ly told col­leagues that an ap­proval for Sarep­ta was a once-off de­ci­sion. She signed off on bio­mark­er da­ta from a tiny study one time. The next time Sarep­ta would have to do some­thing like a walk test with more boys. She want­ed re­al da­ta.

On­ly that nev­er hap­pened. What did hap­pen: The FDA reg­u­la­tors in charge adopt­ed the bio­mark­er da­ta on dy­s­trophin pro­duc­tion as a low bar for an ap­proval, and once they got a naysay­er out of the way who hand­ed out a CRL for their sec­ond app, the new reg­u­la­tors in charge waved it through.

So we shouldn’t con­sid­er this some sort of once-off just to give Alzheimer’s pa­tients a drug they can use un­til some­thing bet­ter comes along.

This is a prece­dent that can be used again and again, low­er­ing the bar on Alzheimer’s da­ta that oth­ers can jump over as well.

What else did we learn from Sarep­ta?

One, when you catch a ‘Hail Mary’ pass, there’s no need to do some­thing like ac­tu­al­ly meet FDA time­lines for a full piv­otal tri­al to con­firm the weak signs of ef­fi­ca­cy you’re see­ing. The biotech drug their heels on that for­got­ten front for years, and the FDA did noth­ing about it.

We see this sort of thing reg­u­lar­ly. Once a drug wins any kind of quick OK, it doesn’t al­ways just dis­ap­pear once the re­quired Phase III fol­lowup — in­evitably re­quir­ing years — turns out to be a flop.

An un­met med­ical need like Alzheimer’s is a ter­ri­ble thing. But when FDA stan­dards go in the trash bin on the way in­to an ad­vi­so­ry pan­el meet­ing, it hurts every­one — pa­tients and in­dus­try alike. If you de­stroy pa­tients’ trust in reg­u­la­to­ry de­ci­sions, as the FDA ap­pears de­ter­mined to do here, you un­der­mine all mar­ket­ed ther­a­peu­tics.

We’ll find out what the FDA pan­el thinks of ad­u­canum­ab lat­er to­day. Most drug de­vel­op­ers al­ready know that the FDA is be­ing pushed by po­lit­i­cal rea­sons here. The sci­ence sim­ply doesn’t back it up.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.