Can the new CEO at Genen­tech main­tain a tra­di­tion of ground­break­ing R&D?

Bill An­der­son

Dur­ing the 6 years that Ian Clark man­aged Genen­tech as its CEO, he nev­er lost sight of the sin­gu­lar mis­sion he had at the big Roche sub­sidiary. Like Pas­cal So­ri­ot be­fore him, and now Bill An­der­son com­ing in af­ter his de­par­ture at the end of this year, job 1 at Genen­tech is keep­ing the phar­ma gi­ant’s unique­ly pro­duc­tive R&D op­er­a­tion fo­cused on big new prod­ucts.

That job pro­file hasn’t changed one bit. This is what Roche’s Daniel O’Day, CEO of Roche’s phar­ma di­vi­sion, had to say on Clark’s re­place­ment at the helm:

We are con­fi­dent that (An­der­son) will nur­ture Genen­tech’s unique cul­ture and build up­on a lega­cy of pur­su­ing ground­break­ing sci­ence to find the next break­throughs for pa­tients.

When Roche seized com­plete con­trol of Genen­tech in 2009, the con­sen­sus view was that the rigid and some­what un­for­giv­ing Swiss men­tal­i­ty of the own­er would ex­tin­guish the cre­ative en­vi­ron­ment that helped make Genen­tech a world leader in can­cer R&D. Its own Basel-based re­search group, pRED, was head­ed in­to a painful re­or­ga­ni­za­tion that has yet to pro­duce the kind of new prod­ucts ex­pect­ed of it. But the feared demise of Genen­tech, gRED, didn’t hap­pen, which is one key rea­son why Clark was able to launch 11 new drugs in his 6-year tenure as CEO, in­clud­ing the close­ly watched PD-L1 check­point pi­o­neer Tecen­triq.

Ian Clark

Like Clark, An­der­son is a long­time com­mer­cial play­er. He joined Genen­tech from Bio­gen 10 years ago as VP of sales and mar­ket­ing for im­munol­o­gy. I asked for an in­ter­view, but Genen­tech’s PR con­tacts thought we should give it a few weeks be­fore set­ting any­thing up.

An­der­son, though has talked about what makes Genen­tech a spe­cial place to work.

It starts with tech­ni­cal ex­cel­lence, he said in a pre­sen­ta­tion at MIT, in a com­pa­ny where all man­agers are ex­pect­ed to have a deep un­der­stand­ing of their field. Man­age­r­i­al charis­ma and an abil­i­ty to wrig­gle out of a sit­u­a­tion can not sub­sti­tute for tech­ni­cal ex­cel­lence.

Here’s the rest of the list of val­ues:

-Fact-based ap­proach
-Speak­ing in plain Eng­lish
-Trust­ing over your idea to your peers
-Keep­ing com­mu­ni­ca­tion per­son­al
-Dis-ing the trap­pings
-Hu­mil­i­ty and be­ing wrong
-Check­ing your ego at the door
-Hard work
-Col­lab­o­ra­tion and con­flict
-The true mis­sion of com­pa­nies…and Genen­tech

Clark, So­ri­ot and now An­der­son all had some im­pos­si­bly big shoes to fill. CEO Art Levin­son be­came a leg­end in his own time as the out­sized chief of a com­pa­ny that was rev­o­lu­tion­iz­ing can­cer treat­ment. So­ri­ot went on to be­come CEO of As­traZeneca, and now Clark is sup­pos­ed­ly “re­tir­ing” at a time his CV and ex­pe­ri­ence give him dibs on one of the top jobs in the in­dus­try — or any kind of biotech role he’d care to pur­sue.

That’s some­thing that will be worth watch­ing, even though the Genen­tech job clear­ly no longer com­mands the same high pro­file that it once had.

In the mean­time, it’s up to An­der­son now to pro­tect the gold­en goose in Roche’s op­er­a­tion, which has played a fran­chise role in coun­ter­ing gener­ic com­pe­ti­tion as it los­es con­trol of some big mar­kets.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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