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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.