Does biopharma support the Califf nom for FDA? Yeah, whatever

Now that Pres­i­dent Joe Biden has drug his heels as long as pos­si­ble in se­lect­ing a new FDA com­mis­sion­er, we’re set to wel­come the new boss — same as the old boss.

Janet Wood­cock, whose pub­lic lega­cy may now boil down to the ap­proval of an un­proven Alzheimer’s drug and whose in­dus­try lega­cy cen­ters on putting the agency in sync with the largest drug de­vel­op­ers, is set to step aside as Robert Califf makes his way back to the helm. And the in­dus­try large­ly ap­pears to think that’s just fine.

We asked our read­ers what they thought about the move — which Wash­ing­ton in­sid­ers be­lieve is large­ly a slam dunk giv­en the last vote in Califf’s fa­vor. And 58% of­fered a quick and em­phat­ic thumbs up. True, right at 1 in four were not hap­py about the move. But with an­oth­er 18% lined up among the un­de­cid­eds, it’s clear he won’t face much if any crit­i­cism from in­sid­ers, who most­ly like him fine.

Califf, notes one sup­port­er, ‘knows what he is do­ing. FDA is in a good place and does not need rein­vent­ing. He will have to avoid Bio­gen like is­sues, but that is not hard.’

A key mo­ment in his past ex­pe­ri­ence run­ning the FDA oc­curred when Califf let Wood­cock move ahead with her con­tro­ver­sial OK for Sarep­ta’s still ex­per­i­men­tal Duchenne MD drug. Af­ter de­lay­ing the start of its con­fir­ma­to­ry tri­al, Sarep­ta will need more than 9 years to see through its post-ap­proval study. Bio­gen al­so gets 9 years. And no one is look­ing for the FDA to make things much hard­er for the av­er­age drug de­vel­op­er.

Califf will al­ways look a lit­tle lack­lus­ter com­pared to Scott Got­tlieb, a dy­nam­ic com­mish who al­so helped spot­light the re­volv­ing door be­tween the FDA and in­dus­try by leap­ing straight to Pfiz­er’s board. Califf is jump­ing in from Ver­i­ly. But he got his aca­d­e­m­ic cred at Duke, and he gets a lot of sup­port for that alone.

— He’s the clear best op­tion among some not-great can­di­dates (aside from Scott Got­tlieb, who ap­par­ent­ly was not in­ter­est­ed in the job).

‘We need an FDA head and there isn’t any­one else who seems bet­ter,’ notes an­oth­er read­er.

Oth­ers find that hard to be­lieve.

— This is a crit­i­cal time in the FDA’s fu­ture and it is time for new blood.

‘Too close­ly con­nect­ed to in­dus­try and cur­rent gov­ern­ment,’ writes an­oth­er in a com­ment re­peat­ed­ly echoed among the crit­ics.

That in­sid­er knowl­edge, though, can cut both ways with this crowd.

— Prag­mat­ic leader with an ex­cel­lent un­der­stand­ing of the clin­i­cal de­vel­op­ment process and a true com­mit­ment to in­no­va­tion for pa­tients that im­prove pa­tient out­comes.

— Thought­ful, ded­i­cat­ed, great per­spec­tive, trained as a clin­i­cian and clin­i­cal re­searcher, so he sees the field of ther­a­peu­tic de­vel­op­ment from a won­der­ful per­spec­tive. Cares about peo­ple and pub­lic health, does not view him­self as a ‘reg­u­la­tor’. He has all the right skills to lead FDA back to a trust­ed po­si­tion of lead­er­ship and pub­lic ser­vice in these fraught times of pub­lic opin­ion.

But the praise was large­ly mut­ed:

— Good enough con­sid­er­ing the al­ter­na­tives.

At this point, just mak­ing a choice and clear­ing up any un­cer­tain­ty will be re­as­sur­ing to a large seg­ment of in­dus­try lead­ers. And what­ev­er Janet Wood­cock does next, her dom­i­nant spir­it will con­tin­ue to in­flu­ence events at the FDA.

For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.

Al Sandrock (Biogen via Youtube)

Two years after Al Sandrock jumped from CMO to the top post in R&D — and just months after the hyper-controversial approval of the experimental Alzheimer’s drug aducanumab (Aduhelm) — Sandrock is planning to step out of his long career at Biogen.

Late Monday evening the big biotech put out word that Sandrock, a longtime fixture in the company after a 23-year stint, is hitting the exit.

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The US Securities and Exchange Commission has launched a probe into claims that Cassava Sciences, an Austin-based drug developer, manipulated data key to its case for its experimental Alzheimer’s drug simufilam, the Wall Street Journal reported Wednesday.

The report comes just two days after Cassava in an SEC filing revealed that ‘certain government agencies’ had asked the biotech for documentation. It wasn’t clear which agencies were inquiring or what information they sought, and Cassava went out of its way to say the requests weren’t accusations of wrongdoing.

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A cell containing smallpox viruses, as captured by transmission electron microscopy

Smallpox was declared eradicated  in 1980 by the World Health Organization, after an effort to vaccinate the globe. But several vials labeled as the disease were found at a Pennsylvania vaccine research facility belonging to Merck, when a laboratory worker was cleaning out a freezer.

There’s no indication that anyone was exposed to the vials, the CDC told CNN in an email. The lab worker was wearing gloves and a face mask, and the FBI is now investigating.

A few weeks after Jennifer Doudna introduced CRISPR/Cas9 genome editing to the world, one of her old students decided to take the central part of the biology-altering invention and kill it.

CRISPR/Cas9, as the name implies, is a two-part system: a string of letters called a guide RNA, that says where to cut the DNA. And an enzyme, Cas9, that does the cutting. Often compared to molecular scissors, it was the first system that allowed researchers to cut DNA with ease and precision, promising potential cures for genetic diseases such as sickle cell and cystic fibrosis.

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Frank D’Amelio, Pfizer CFO

Frank D’Amelio, Pfizer’s legendary chief financial officer of the last 15 years, would often say his job was about understanding the ‘rhythm of the numbers.’ Now — as the company’s on track to drum up the largest single-year sales for a medical product ever — he’s hitting the exit on a high note.

D’Amelio is retiring from his position as CFO and executive vice president of global supply, Pfizer revealed Wednesday. CEO Albert Bourla has already begun an external search for his successor, and D’Amelio will stay on board through the transition.

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Francis deSouza, Illumina CEO (Kevin Dietsch/Getty Images)

Ahead of expected objections by European regulators Wednesday to its deal to acquire Grail, Illumina defended itself in papers submitted to the agencies Tuesday.

Illumina is anticipating a formal bloc objection to the $8 billion Grail buyout, it said in a briefing document for EU competition authorities, and tried to preempt the move by asserting the deal is not anti-competitive. It’s an argument Illumina has used previously, but it’s unclear whether or not the new brief will prove persuasive.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Following an oral explanation held at the November meeting of the EMA’s human medicines committee, Biogen received ‘a negative trend vote’ on its marketing application for its controversial Alzheimer’s drug aducanumab, the company said Wednesday morning.

The setback is just the latest in a string of negatives — from an anemic launch to rejection of coverage from the VA — since the surprising June approval of the drug by the FDA that led to multiple resignations from an advisory committee that unanimously rejected it.

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Albert Bourla, Pfizer CEO (AP Images)

If you thought Pfizer was raking it in with megablockbuster sales of its BioNTech-partnered Covid-19 vaccine — last projected at $36 billion for 2021 — think again.

As the pharma giant sends off its EUA submission for its antiviral pill to the FDA, the Washington Post, New York Times and others are reporting that the US government is planning a $5 billion contract to purchase 10 million courses of the treatment, dubbed Paxlovid.
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