The top 10 bio­phar­ma CROs in the world—mid-2017 edi­tion

Huddled with five employees in a tiny Chapel Hill house, Quintiles Transnational founder Dennis Gillings began breaking down the many things drug companies needed done when testing in humans and started doing them much more reliably than his clients could, and with that, gave rise to the modern CRO industry. The year was 1982 and the company has dominated clinical outsourcing for the 35 years since.

Now, after a wave of consolidation in the CRO space has transformed countless smaller competitors into a handful of big public players, the company is still out front, but it no longer enjoys a vast gulf between it and the rest of the pack vying for a piece of biopharma's massive R&D budget.

To keep pace and stay in front, Quintiles engineered a big M&A deal of its own, but it had nothing to do with typical CRO work. QuintilesIMS is the brand now thanks to last year's merger with IMS Health — the largest vendor of physician prescribing data, which biopharma companies use to price and market drugs.

Ari Bousbib is QuintilesIMS’ CEO, the position he held at pre-merger IMS Health. Bousbib was not a shoo-in choice to lead the combined firm. Tom Pike had been the CEO at Quintiles since 2012, successfully taking the reins of the company from an enigmatic founder and ramped up its main Research and Development Solutions business. In 2016 the workhorse division accounted for 65% of the combined company's revenue, yet IMS insisted Bousbib — a highly regarded executive who made his name over a 14-year stint at aerospace and building giant United Technologies Corp — be installed as CEO and chairman as a condition of the merger. Pike retired rather than take a diminished role at QuintilesIMS.

Bousbib's emergence at the top is a sign pointing where the industry is headed. “Traditional CRO services have become commodities,” says Jason Monteleone, president of Pivotal Financial Consulting, who has advised CRO boards on M&A transactions. So big players are looking for new ways to stand out.

QuintilesIMS wants to compete in what it describes in regulatory filings as a $130 billion market opportunity completely outside of clinical development. It ranges from collecting so-called Real-World Evidence to sales force training, while mining billions of healthcare transactions for lucrative signals. In these areas and the traditional clinical work it has a sizeable but shrinking advantage against the only other truly global, can-do-pretty-much-everything CROs in the world: PPD, Parexel, Icon, PRA Health Sciences, Covance, and the soon-to-be rebranded INC Research/inVentiv Health.

The payoff comes from following a drugmaker’s molecule from early clinical R&D on through to commercialization, selling ever more expensive arrangements each step of the way — without assuming the risk endemic to drug development. The promise of the new CRO services — which grew as Big Pharma and a booming group of biotechs looked to outsource the clinical work — is that the harmonization of disparate data is finally possible, leading to clients' clinical trials recruiting faster,  their drug products positioned better for both regulators and the commercial opportunity that might come later. And if it reaches market? Collect, analyze, and act on even more data.

It's a tall order. Lab testing giant LabCorp turned heads by acquiring Covance in 2015. It added Chiltern earlier this summer for $1.2 billion in order to expand its clinical offerings. INC Research, founded in 1998 with roots in neurology trials, closed their $7.4 billion merger with the commercial-focused inVentiv Health this month.

Is there more M&A in the works? Monteleone is leaning towards no — at least at the top end of the market — unless a non-traditional player comes in like LabCorp did with Covance.  “Most likely we'll see strategic deals like PRA Health Sciences's acquisition of Symphony Health,” he adds, where the Raleigh-based CRO acquired a healthcare data and analytics provider. The mid-tier market, a few of which we name in our list below, is always ripe for action.

Two CROs in the top 9 — PPD and BioClinica —  are private, making a definitive ranking here impossible, so our proxy is the valuation paid recently by their primary owners.

There are no comparable metrics for the CROs listed in the #10 position, but after asking several industry sources their opinions who belonged there, we've added a few contenders.

We’ll update this entire list again in the fall, when surely, the names and places will have changed.

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UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Ted Love. HAVERFORD COLLEGE

Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.


Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.


Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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Ab­b­Vie touts new da­ta for Hu­mi­ra suc­ces­sor; Gilead inks dis­cov­ery deal

→ Ab­b­Vie is tout­ing new pos­i­tive da­ta com­par­ing their ag­ing block­buster Hu­mi­ra with their hoped-for block­buster upadac­i­tinib. Over 48 weeks a larg­er pro­por­tion of pa­tients tak­ing the ex­per­i­men­tal drug ex­pe­ri­enced clin­i­cal re­mis­sion than in the con­trol arm with Hu­mi­ra. Their drug brought in $20 bil­lion last year, top­ping the scales in the num­ber 1 slot.

→ Gilead has turned to Van­cou­ver-based Ab­Cellera for its lat­est dis­cov­ery deal. Ab­Cellera will use its know-how in “sin­gle-cell screen­ing of nat­ur­al im­mune sources” to find an­ti­body can­di­dates for Gilead to pur­sue in the in­fec­tious dis­ease field. The deal in­cludes an up­front and mile­stones.

Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

The Wash­ing­ton Post man­aged to whip up the quick­est in­dus­try con­sen­sus I’ve ever seen that one of its re­porters was pur­vey­ing overblown non­sense with a sto­ry that Pfiz­er was sit­ting on da­ta sug­gest­ing that En­brel could be an ef­fec­tive treat­ment for Alzheimer’s. 

In cov­er­ing that bit of an­ti-Big Phar­ma fan­ta­sy — there are lots of rea­sons to go af­ter phar­ma, but this piece was lu­di­crous — I not­ed com­ments in the sto­ry from some promi­nent peo­ple in the field crit­i­ciz­ing Pfiz­er for not pub­lish­ing the da­ta. I sin­gled out Rudy Tanzi at Har­vard and then ap­plied some added crit­i­cism for the things he’s done to hype — in my opin­ion — high­ly ques­tion­able as­sump­tions. You can see it in the link.