Philip Krause will take his 11 years of in­sight from the up­per ech­e­lons of the FDA — es­pe­cial­ly dur­ing pan­dem­ic vac­cine nods — and ap­ply it to an Aus­tralian biotech that wants a sec­ond chance at se­cur­ing ap­proval in the US, par­tic­u­lar­ly as it looks to bounce back from a nixed No­var­tis deal.

The for­mer sec­ond-in-com­mand for vac­cines lead­er­ship at the FDA de­part­ed un­der murky cir­cum­stances last fall when he and Mar­i­on Gru­ber, di­rec­tor of the reg­u­la­tor’s Of­fice of Vac­cines Re­search & Re­view, re­port­ed­ly were miffed by the fed­er­al ad­min­is­tra­tion’s side­step­ping of the FDA on mat­ters of Covid-19 boost­er shots.

Now, Krause will pro­vide reg­u­la­to­ry lessons to Mesoblast as a board mem­ber. The move comes at a crit­i­cal junc­ture for the Aussie drug de­vel­op­er as it looks to win over the FDA for its cell ther­a­py to treat chil­dren with steroid-re­frac­to­ry acute graft ver­sus host dis­ease (SR-aGVHD). The FDA re­ject­ed the drug, remestem­cel-L, on the grounds that a sin­gle-arm, open-la­bel study was not enough in an Oc­to­ber 2020 de­ci­sion.

The agency want­ed a ran­dom­ized tri­al, but Mesoblast ap­plied af­ter a sin­gle-arm study showed sta­tis­ti­cal­ly sig­nif­i­cant ben­e­fit on the pri­ma­ry goal against a his­tor­i­cal con­trol rate in a phase III study. Reg­u­la­tors con­vened an ad­vi­so­ry com­mit­tee to dis­cuss the ap­pli­ca­tion, and the study de­sign was dif­fi­cult for some mem­bers to en­dorse since par­ents and pe­di­a­tri­cians would be re­luc­tant to place chil­dren in a place­bo arm.

Since then, the biotech has said it’s been in a “well-es­tab­lished process with FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search.” The biotech is tee­ing up for a re­sub­mis­sion of the ther­a­py.

“Mesoblast has now gen­er­at­ed sub­stan­tial new da­ta that it be­lieves es­tab­lish the rel­e­vance of the pro­posed po­ten­cy as­say mea­sur­ing remestem­cel-L’s in vit­ro an­ti-in­flam­ma­to­ry and im­munomod­u­la­to­ry ac­tiv­i­ty to the in vi­vo clin­i­cal ef­fect of the prod­uct in the Phase 3 tri­al in chil­dren with SR-aGVHD, in­clud­ing sur­vival and bio­mark­ers of in vi­vo ac­tiv­i­ty,” the com­pa­ny said last month in its lat­est quar­ter­ly re­port.

As a new­ly mint­ed board mem­ber, Krause did not mince words on the cen­tral role he thinks he can play in Mesoblast’s path to mar­ket.

“I be­lieve I can make a sub­stan­tial con­tri­bu­tion at this very im­por­tant time in the com­pa­ny’s tran­si­tion to­wards com­mer­cial­iza­tion,” the 30-year FDA vet­er­an said in a state­ment.

Krause, who was in­volved in vac­cines de­lib­er­a­tions dur­ing the height of the pan­dem­ic, joins Mesoblast as it al­so looks to re­bound from a failed $1.2 bil­lion deal with No­var­tis in which the biotech test­ed the aGVHD drug in ven­ti­la­tor-de­pen­dent Covid-19 pa­tients with acute res­pi­ra­to­ry dis­tress syn­drome.

The No­vem­ber 2020 deal flunked with­in weeks as the da­ta safe­ty mon­i­tor­ing board rec­om­mend­ed they no longer en­roll new pa­tients and wrap the tri­al ear­ly be­cause it was un­like­ly to meet a 30-day mor­tal­i­ty re­duc­tion goal. Twelve months lat­er, No­var­tis ditched its col­lab­o­ra­tor.

But, as it ap­pears to go at Mesoblast, there’s a sec­ond try at every­thing. Last month, the biotech chalked up the con­tin­u­ing need for new Covid-19 ther­a­pies due to new vari­ants and still high num­bers of pa­tients on ven­ti­la­tors.

Af­ter talks with the FDA, Mesoblast will con­duct an­oth­er tri­al in this pa­tient pop­u­la­tion — peo­ple with mod­er­ate or se­vere ARDS due to the pan­dem­ic dis­ease — and that could pave the way for an emer­gency use nod, a route that Krause has fa­mil­iar­i­ty with around the Covid-19 jabs.

Al­so on the dock­et is a new Phase III tri­al in the US for rexleme­stro­cel-L in pa­tients with chron­ic low back pain. That study may sup­port ap­proval sub­mis­sions in the US and EU, Mesoblast said last month. Don’t fret, Mesoblast al­so wants to give the cell ther­a­py an­oth­er shot in chron­ic heart fail­ure af­ter a Phase III flop in De­cem­ber 2020.

For Krause, this isn’t the first biotech he’s linked arms with since leav­ing FDA HQ. He be­came a strate­gic ad­vi­sor at Ad­ju­vance Tech­nolo­gies in Jan­u­ary, a lit­tle-known Lin­coln, NE biotech work­ing on whoop­ing cough and shin­gles vac­cines.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.