FDA ex­e­cutes an abrupt about-face as sole-source con­tract for ex-agency chief Mark Mc­Clel­lan draws the spot­light

Mark Mc­Clel­lan

Af­ter nom­i­nat­ing Scott Got­tlieb for FDA com­mish last year, Mark Mc­Clel­lan, his for­mer boss at the agency, of­fered a warm en­dorse­ment for the move.

“(Got­tlieb) knows how to get things done in a pol­i­cy en­vi­ron­ment, work­ing with not just peo­ple in Wash­ing­ton, but in­dus­try, pa­tient groups and all kinds of stake­hold­ers on im­por­tant pub­lic health ini­tia­tives,” Mc­Clel­lan told the cam­pus pa­per at Duke, where he is di­rec­tor of the Duke-Mar­go­lis Cen­ter for Health Pol­i­cy.

That close re­la­tion­ship raised a few eye­brows, though, when the FDA re­cent­ly set up a con­tract where Mc­Clel­lan’s cen­ter was the sole al­lowed bid­der. Mc­Clel­lan’s role as a board mem­ber of phar­ma gi­ant J&J al­so came in­to the harsh spot­light.

From the re­quest for pro­pos­al:

The pri­ma­ry ob­jec­tive of this ef­fort is to pro­vide sup­port­ing re­search, iden­ti­fy key is­sues, and con­vene ap­pro­pri­ate sub­ject mat­ter ex­perts to help in­form ma­jor ini­tia­tives for process im­prove­ment and reg­u­la­to­ry sci­ence re­lat­ed to FDA com­mit­ments un­der the 2018 reau­tho­riza­tion of the Pre­scrip­tion Drug User Fee Act (PDU­FA VI) and the 21st Cen­tu­ry Cures Act leg­is­la­tion.

Politi­co raised some point­ed crit­i­cism, as did the Wash­ing­ton Post.

Jer­ry Avorn

“It frankly makes no sense that the on­ly place you could go from this is the Duke cen­ter run by a drug com­pa­ny ad­vo­cate,” Jer­ry Avorn, a pro­fes­sor of med­i­cine at Har­vard Med­ical School, told the Post. “The very fact that they could have thought this was a good idea, even to the point of pub­lish­ing the re­quest for pro­pos­al, is im­por­tant be­cause of what it re­flects about the de­ci­sion-mak­ing process with­in FDA and the ad­min­is­tra­tion.”

And then, yes­ter­day, the FDA sud­den­ly did an about face, say­ing that they had be­come aware of oth­er groups that could of­fer a ri­val bid. A spokesper­son sent this state­ment:

Since post­ing our orig­i­nal sole source award an­nounce­ment on­line, we have be­come aware of oth­er or­ga­ni­za­tions who be­lieve that they can sub­mit a com­pet­i­tive pro­pos­al to con­duct the need­ed re­search and re­lat­ed ac­tiv­i­ties. As a re­sult, FDA has de­cid­ed to change the an­nounce­ment from a sole source award to an open com­pet­i­tive grant.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.