Peer Re­view: For­mer FDA Com­mish Califf will split his time be­tween Ver­i­ly and Duke

→ Af­ter a lit­tle over a year and a half at Al­pha­bet’s Ver­i­ly, neu­ro­sci­en­tist Dr. Thomas In­sel is join­ing the mys­te­ri­ous com­pa­ny’s ex­o­dus of tal­ent and call­ing it quits. In­sel ran the Na­tion­al In­sti­tute of Men­tal Health pri­or to his gig at Ver­i­ly. These days you can find him as the pres­i­dent and co-founder at a start­up called Mind­strong Health, which “has de­vel­oped and patent­ed a bio­mark­er pan­el that mea­sures brain func­tion from in­ter­ac­tion pat­terns cap­tured pas­sive­ly and con­tin­u­ous­ly from hu­man-com­put­er in­ter­faces found in ubiq­ui­tous mo­bile tech­nol­o­gy.”

Robert Califf

En­ter­ing the Ver­i­ly realm is Robert Califf. The ex-FDA com­mis­sion­er pre­vi­ous­ly worked with Ver­i­ly head An­dew Con­rad be­fore to head­ing up the agency. He’s al­so back at Duke Uni­ver­si­ty. “Af­ter con­clud­ing what has been an amaz­ing ex­pe­ri­ence as FDA Com­mis­sion­er, I’m ex­cit­ed to turn to a new ca­reer with Ver­i­ly and Duke Uni­ver­si­ty,” says Califf in his Ver­i­ly blog post.

→  Al­most ex­act­ly four years af­ter be­ing named per­ma­nent chief sci­en­tif­ic of­fi­cer at Bio­gen, Spy­ros Ar­ta­va­nis-Tsakonas has qui­et­ly left the com­pa­ny. The cell bi­ol­o­gy spe­cial­ist has been a pro­fes­sor at Har­vard Med­ical School since 1999. And now he’s head­ed back with fund­ing from Bio­gen on new re­search in­to neu­rode­gen­er­a­tive dis­eases. The big biotech gets an op­tion on li­cens­ing new tech from his lab in ex­change for the fund­ing.

→  For­mer Sarep­ta CEO Chris Garabe­di­an has won $15 mil­lion from some loy­al back­ers at Per­cep­tive Ad­vi­sors to es­tab­lish Xon­toge­ny, which promis­es to guide biotech star­tups through the first crit­i­cal stage of de­vel­op­ment lead­ing to proof-of-con­cept da­ta. Garabe­di­an is run­ning the show and he’s now re­cruit­ing a team.

Patrick Am­stutz has made the jump from in­ter­im CEO to the re­al deal. Am­stutz helmed Mol­e­c­u­lar Part­ners af­ter Chris­t­ian Zahn left the job late last year.

Ox­itec CEO Ha­dyn Par­ry is join­ing the moth­er ship. Par­ry has been bumped up to VP of cor­po­rate de­vel­op­ment, Eu­rope, the Mid­dle East, and Africa for In­trex­on. Look for Mark Carnegie-Brown to be in charge of Ox­itec as the new CEO.

→  Is­rael’s Al­co­bra said that CEO Yaron Daniely is step­ping down to head up the tech trans­fer arm at He­brew Uni­ver­si­ty.

Cy­tomX is shuf­fling the deck, with Bob Goetz ex­it­ing the CFO po­si­tion of the South San Fran­cis­co, CA-based biotech to “pur­sue new op­por­tu­ni­ties.” De­ban­jan Ray is now the new CFO and head of cor­po­rate de­vel­op­ment. “De­ban­jan has been in­stru­men­tal to Cy­tomX’s busi­ness suc­cess, in­clud­ing struc­tur­ing and ex­e­cut­ing col­lab­o­ra­tions that have re­sult­ed in more than $300 mil­lion in up­front and mile­stone pay­ments to date and to­tal po­ten­tial deal val­ue in ex­cess of $5 bil­lion,” said CEO Sean Mc­Carthy.

→ Ac­tini­um CEO Kaushik J. Dave and Chief Tech­nol­o­gy Of­fi­cer Dra­gan Ci­cic have both re­signed from the com­pa­ny

 

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantiating reforms to the advisory committee process at the agency.

Short on examples, Cavazzoni said at a BIO event aired on Monday that some recent adcomms show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Paul Burton, incoming Moderna CMO (J&J/file photo)

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

The FDA is offering a fuller account of what went wrong at Emergent BioSolutions’ Covid-19 manufacturing facility in Baltimore, where the cross contamination of J&J and AstraZeneca vaccines led to the discarding of about 75 million vaccine doses.

CBER director Peter Marks released a memo on Saturday with new specifics, making clear up front that no vaccine manufactured at this plant has been distributed for use in the US yet.

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