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.

Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMedO

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Francis Collins, NIH director (Sean Zanni/Patrick McMullan via Getty Images)

NIH kicks off Covid-19 vac­cine, mon­o­clon­al an­ti­body re­search net­work

The NIH today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV-2, the virus that causes infection with Covid-19.

The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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