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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Vas Narasimhan (AP Images)

Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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