Glob­al CRO Parex­el woos out­sourc­ing vet­er­an Jamie Mac­don­ald to the helm

Top-10 CRO Parex­el is bring­ing in an ex­pe­ri­enced hand to take the helm.

Co-founder Josef von Rick­en­bach — a fa­mil­iar face in the out­sourc­ing world — is step­ping up to con­cen­trate on the chair­man’s spot af­ter guid­ing the com­pa­ny for the past 35 years. And he’s be­ing re­placed in the CEO suite by Jamie Mac­don­ald, who not so long ago head­ed INC Re­search be­fore its merg­er with in­Ven­tiv and re­brand­ing as Sy­neos.

CROs have un­der­gone a sea change over the past decade, with pri­vate eq­ui­ty step­ping in to dri­ve a glob­al con­sol­i­da­tion of the in­dus­try. Last year proved to be par­tic­u­lar­ly chal­leng­ing to Boston-based Parex­el, which had built up a glob­al or­ga­ni­za­tion of some 19,000 staffers. Pam­plona Cap­i­tal end­ed up buy­ing the com­pa­ny out for $5 bil­lion af­ter a re­or­ga­ni­za­tion cost more than a thou­sand jobs, dri­ven by some painful can­cel­la­tions the year be­fore.

Josef von Rick­en­bach

For von Rick­en­bach, one big trend he’s been grap­pling with has been cen­tered around Big Da­ta: “mak­ing sure that the ef­fi­cien­cies and the op­por­tu­ni­ties that are com­ing down the pike as a re­sult of the avail­abil­i­ty and use of Big Da­ta — that we get that right.”

Mac­don­ald sees his job now as build­ing on the CRO’s strengths.

“What we have is a tech back­bone, a strong ba­sis in Asia, da­ta and an­a­lyt­ics,” says the new CEO, who jok­ing­ly notes that he is now on day two-and-half at Parex­el. Key con­cerns re­main the same: “Are we se­lect­ing the right drug and the most ap­pro­pri­ate pro­to­col, putting them in­to the right hands in sites and in­ves­ti­ga­tors.”

“There is,” he added, “some­thing to be said for fo­cus.”

So will Parex­el and its new own­ers at Pam­plona buy some­thing new to fo­cus on?

Could be.

“We cer­tain­ly have the ca­pa­bil­i­ty to ac­quire cer­tain as­sets,” says Mac­don­ald, who sound­ed most in­ter­est­ed in adding ca­pa­bil­i­ties rather than buy­ing mar­ket share through M&A. Mak­ing a big­ger com­pa­ny out of a peer-to-peer al­liance did not sound like his sweet spot at all.

Both von Rick­en­bach and Mac­don­ald not­ed that as the Big Phar­ma side of the busi­ness grows more and more sat­u­rat­ed on the CRO side, there is added po­ten­tial on the biotech side of the busi­ness. Small and mid-sized com­pa­nies have en­joyed huge in­creas­es in fi­nanc­ing sources in re­cent years, while op­er­at­ing with a busi­ness mod­el that en­cour­ages — if not out­right re­quires — out­sourc­ing clin­i­cal tri­al work.

An­oth­er big area of op­por­tu­ni­ty: Asia, says the chair­man, and in par­tic­u­lar Chi­na.

Parex­el is like­ly to con­tin­ue to see some of its biggest growth in Chi­na, adding re­searchers as well as clients as the bio­phar­ma busi­ness booms — dri­ven by less ob­struc­tive de­vel­op­ment reg­u­la­tions as well as plen­ty of new fund­ing.

It’s a fast-chang­ing world in the CRO in­dus­try. And Mac­don­ald will have a big say on how that plays out.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Mike Bloomberg (AP IMAGES)

Mike Bloomberg joins a grow­ing cho­rus of De­mo­c­ra­t­ic pres­i­den­tial can­di­dates threat­en­ing to go af­ter drug patents

As the mayor of New York City, Mike Bloomberg had a few modest ideas about lowering prescription drug prices in the Big Apple that gained little traction. Now on the campaign trail on a faint hope of clinching the Democratic presidential nomination, the billionaire has some bigger plans — including one that would alter the patent system central to the biopharma business.

In a barebones drug pricing plan posted on Monday, Bloomberg came out blasting President Donald Trump for failing to deliver his promise to lower drug prices, and then making misleading claims about them. The price of over 3,000 drugs still increased at a rate five times higher than inflation in the first six months of 2019, he wrote.

J&J's Spra­va­to gets no love from NICE, jeop­ar­diz­ing its prospects in the UK

UK’s cost-effectiveness watchdog NICE is taking the same track laid out by ICER — J&J’s pharmaceutical version of the hallucinogenic anesthetic ketamine, Spravato, is low value for money. On Tuesday, the agency refused to endorse the therapy for inclusion as a reimbursable drug on the UK’s National Health System.

Cognizant of the myriad of approved antidepressants that often don’t work, EU regulators endorsed J&J’s low-dose, nasal-spray formulation of ketamine last month for treatment-resistant depression.

Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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