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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Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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