Former FDA commissioner Scott Gottlieb (AP Images)

Got­tlieb op-ed: Man­u­fac­tur­ers need to ramp up pro­duc­tion of an­ti­bod­ies as 'Covid in­sur­ance pol­i­cy'

Af­ter Pfiz­er and BioN­Tech scored the FDA’s emer­gency use au­tho­riza­tion for their mR­NA-based Covid-19 shot late last week, hopes are high that one or more vac­cines could turn the tide on the pan­dem­ic. But vac­cines will take time to get in­to arms, and a for­mer FDA head is call­ing on drug­mak­ers to dou­ble down on mak­ing an­ti­body ther­a­pies as a “Covid in­sur­ance pol­i­cy” in the mean­time.

In a Wall Street Jour­nal col­umn penned less than 48 hours af­ter Pfiz­er-BioN­Tech’s EUA, for­mer FDA com­mish Scott Got­tlieb opined that man­u­fac­tur­ers have not in­vest­ed enough re­sources in­to stock­pil­ing an­ti­body ther­a­pies — es­pe­cial­ly from Re­gen­eron and Eli Lil­ly, which have al­ready re­ceived EUAs of their own — as a cru­cial back­stop in the US pan­dem­ic re­sponse.

The so­lu­tion? Con­tact bio­phar­ma man­u­fac­tur­ing plants to switch gears and pro­duce large quan­ti­ties of the Re­gen­eron and Lil­ly drugs. This, Got­tlieb said, was al­ways the best op­tion in his mind to re­duce the im­pact of the virus while a vac­cine was slow­ly rolled out to the mass­es.

“Sup­ply is se­vere­ly con­strained, and the two avail­able drugs must be ra­tioned, some­what ar­bi­trar­i­ly, be­cause the gov­ern­ment didn’t do every­thing pos­si­ble last spring to ramp up man­u­fac­tur­ing,” Got­tlieb wrote. “There is still an op­por­tu­ni­ty to in­vest in mak­ing more an­ti­bod­ies … there will be many pa­tients who need these med­i­cines.”

Got­tlieb laid out what would be a com­pli­cat­ed process for how the Re­gen­eron and Eli Lil­ly an­ti­body drugs could be pro­duced at a much greater scale than the 6 to 7 mil­lion dos­es avail­able next year. It would re­quire wide­spread li­cens­ing and tech trans­fer for both ther­a­pies but could help the US be bet­ter pre­pared for a harsh win­ter in 2021.

First, large man­u­fac­tur­ing plants can dip in to their re­serves of oth­er drugs al­ready on hand, which nor­mal­ly amounts to at least two years worth of sup­ply. This will avoid cre­at­ing a short­age of oth­er im­por­tant med­i­cines while the fa­cil­i­ties switch gears to pro­duc­ing Covid-19 an­ti­bod­ies.

While it would take around six months for a man­u­fac­tur­er to ful­ly switch mech­a­nisms to pro­duce the Re­gen­eron or Eli Lil­ly drug, do­ing so could pro­duce as many as 2.5 mil­lion dos­es in eight months, Got­tlieb said. The gov­ern­ment would then agree to buy the an­ti­body and stock­pile it at a worth­while price for the man­u­fac­tur­er, and Re­gen­eron or Eli Lil­ly would be paid to li­cense the drug.

The US gov­ern­ment would do well to in­vest in such a plan, Got­tlieb wrote, be­cause it could freeze some of the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent and store it away as a hedge against an­oth­er tough win­ter. Mak­ing the ac­tive in­gre­di­ent is the hard part, Got­tlieb said, but that API could stay frozen for three years. Thaw­ing it and turn­ing it in­to fin­ished drug would take less than a month.

While a ver­sion of this plan has al­ready tak­en place to get to the cur­rent an­ti­body drug ca­pac­i­ty of 6 to 7 mil­lion dos­es — Am­gen teamed up with Eli Lil­ly, and Roche worked with Re­gen­eron — Got­tlieb said that much greater stock­piles will be need­ed over the com­ing months.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.