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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

Social image: UCB