From big bio­phar­ma to biotech CEO, John Hous­ton’s R&D jour­ney high­lights a fast-chang­ing world

John Hous­ton spent close to 30 years in the ranks of two big bio­phar­ma R&D or­ga­ni­za­tions. There was a decade at GSK fol­lowed by 18 more years at Bris­tol-My­ers Squibb, where he built a re­sume around con­struct­ing their drug dis­cov­ery tech­nol­o­gy base and was cred­it­ed with a key role in de­vel­op­ing a range of ma­jor fran­chise drugs like Op­di­vo and Yer­voy.

Then about two years ago, in­stead of de­vel­op­ing new drugs, he was charged with lend­ing a hand at shut­ting down two big re­search sites in Seat­tle and Walling­ford, CT, while BMS set its sights on a new R&D cen­ter in Cam­bridge.

And he found that he didn’t like the re­struc­tur­ing world so much.

“I de­cid­ed it was not what I want­ed to do, to con­tin­ue to close sites and han­dle the tran­si­tion,” Hous­ton tells me. So he left Bris­tol-My­ers in the sum­mer of 2016, join­ing the mi­gra­tion out of the big com­pa­ny R&D world to see what else bio­phar­ma might have in store for him.

Ear­ly this year, that quest led to the CSO’s job at Arv­inas in New Haven, where the team is work­ing on new pro­tein degra­da­tion tech orig­i­nal­ly de­vel­oped in the lab of Yale’s Craig Crews. (“It was ex­act­ly the role I want­ed.”) And this morn­ing — fol­low­ing the de­par­ture of CEO Man­ny Litch­man for Mus­tang last spring — Hous­ton has been giv­en the helm as a new­ly mint­ed biotech CEO.

Hous­ton’s tran­si­tion high­lights the boom­ing op­por­tu­ni­ties of a fast-grow­ing US biotech in­dus­try, which has proven to be siren song for a le­gion of ex­pe­ri­enced bio­phar­ma R&D ex­ecs who’ve grown dis­en­chant­ed with their old roles, where re­struc­tur­ing is of­ten the or­der of the day. Hous­ton’s seen it all around New Haven, where new com­pa­nies like Bio­haven have sourced teams from Bris­tol-My­ers’ dis­card­ed op­er­a­tions.

“The ex­cite­ment of mov­ing in­to a biotech, where you can get things done quick­er and have an im­pact, is clear­ly an at­trac­tion,” says Hous­ton. In a start­up biotech, you’re not “weight­ed down by a de­ci­sion-mak­ing bu­reau­cra­cy. Al­so, you want to see new chal­lenges, add val­ue, and cre­at­ing the set­ting gives you a huge pos­si­bil­i­ty to do that.”

Hous­ton’s world now is dom­i­nat­ed by the 46 staffers at Arv­inas who are push­ing two lead drugs for an­dro­gen and es­tro­gen re­cep­tor degra­da­tion for prostate and breast can­cer from the pre­clin­i­cal ef­fort in­to the clin­ic. They’re work­ing on a pair of INDs — with the help of around 80 chemists spread out among WuXi and oth­er Asian con­tract re­search groups — and look­ing to get in­to the clin­ic at the end of 2018.

Hous­ton, who used to run neu­ro­sciences at Bris­tol-My­ers, is al­so more than a lit­tle thrilled to be set­ting up a pre­clin­i­cal pro­tein degra­da­tion pro­gram for tau, one of the key tar­gets in the Alzheimer’s world.

Some­where along the way now, Arv­inas Chair­man Tim Shan­non — a gen­er­al part­ner at Canaan — will look to see how best to arrange the next fundrais­ing for the com­pa­ny, which he says is fund­ed through Q2.

Arv­inas is a ven­ture-backed com­pa­ny, and ven­ture-backed com­pa­nies tend to fol­low a path where you con­cen­trate on deals (Arv­inas is part­nered with a cou­ple of the best: Genen­tech and Mer­ck)  and con­sid­er the pos­si­bil­i­ties of an IPO or a buy­out if the right of­fer comes along.

“The main fo­cus is to grow the com­pa­ny to the point where it can be seen as a valu­able med­ical pro­duc­ing or­ga­ni­za­tion,” says Hous­ton.

And he couldn’t be hap­pi­er.

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

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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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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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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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.

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.