Pfiz­er reshuf­fles top ranks with Al­bert Bourla as COO; In­tra-cel­lu­lar nabs No­var­tis vet An­drew Satlin as CMO

Al­bert Bourla

Pfiz­er has pro­mot­ed its In­no­v­a­tive Health chief Al­bert Bourla to the new role of chief op­er­at­ing of­fi­cer, where he’s been giv­en a spe­cial man­date to over­see the day-to-day ac­tiv­i­ty around prod­uct de­vel­op­ment, sales and strat­e­gy. This has been in­ter­pret­ed as CEO Ian Read’s way of anoint­ing his suc­ces­sor, al­though that is far from cer­tain. The move, which be­comes of­fi­cial on Jan­u­ary 1, trig­gered a reshuf­fle in the top ranks at Pfiz­er. John Young, who heads Pfiz­er Es­sen­tial Health, takes Bourla’s old job, while An­gela Hwang suc­ceeds Young.

→ New York-based In­tra-Cel­lu­lar Ther­a­pies has brought on An­drew Satlin as chief med­ical of­fi­cer. The biotech spe­cial­iz­ing in cen­tral ner­vous sys­tem dis­or­ders man­aged to raise $150 mil­lion ear­ly Oc­to­ber part­ly to fund the pre-launch and com­mer­cial ac­tiv­i­ties for lu­mate­per­one, their lead drug in schiz­o­phre­nia, claim­ing that safe­ty con­cerns brought up in March have been cleared. That’s great tim­ing for Satlin to join, they say, as the No­var­tis vet brings in­sight from be­ing the glob­al head of med­i­cine cre­ation strat­e­gy, neu­rol­o­gy busi­ness group at Ei­sai.

→ Dual Flag­ship Pi­o­neer­ing and Alex­ion vet Je­re­my Spring­horn has tak­en on the chief busi­ness of­fi­cer role at Cam­bridge, MA based Sy­ros Ther­a­peu­tics. As one of the in­ven­tors of Soliris, Sp­ing­horn will be re­spon­si­ble for busi­ness de­vel­op­ment and strate­gic plan­ning across the biotech’s $SYRS wide-ranged pipeline.

Macro­Gen­ics $MGNX, the biotech de­vel­op­ing mon­o­clon­al an­ti­body-based ther­a­peu­tics that just out-li­censed a PD-1 check­point drug to In­cyte, has named J&J re­tiree Jay Siegel to its board of di­rec­tors. Siegel spent the first two decades of his ca­reer as a reg­u­la­tor with the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search be­fore join­ing the Big Phar­ma in 2003, even­tu­al­ly tak­ing up R&D and reg­u­la­to­ry af­fairs roles.

→ In a boost to their con­sult­ing prac­tice, con­tract re­search or­ga­ni­za­tion Parex­el has re­cruit­ed three reg­u­la­to­ry/drug de­vel­op­ment staffers as their new vice pres­i­dents: Robert Is­er, VP of reg­u­la­to­ry con­sult­ing ser­vice; Bob (Bhard­waj) De­sai, VP of con­sult­ing, tech­ni­cal (on­col­o­gy); and Chang Lee, VP of con­sult­ing, APAC. To­geth­er, the trio brings ex­pe­ri­ence from the FDA and in­dus­try gi­ants such Pfiz­er and Ab­b­Vie — key sell­ing points as the CRO tries to prove it has much to of­fer out­side the lab.

Bay­er’s $BAYN head of con­sumer health Er­i­ca Mann is de­part­ing next March, and the com­pa­ny has tapped a long­time Nestlé ex­ec­u­tive to fill her shoes. Heiko Schip­per, who led the in­fant nu­tri­tion di­vi­sion while serv­ing as deputy ex­ec­u­tive vice pres­i­dent of Nestlé, will al­so join Bay­er’s board of man­age­ment.

Tony de Fougerolles, for­mer­ly chief sci­en­tif­ic of­fi­cer at Abl­ynx, is the new CEO of Ox­ford, UK-based Evox Ther­a­peu­tics. He takes over from co-founder Per Lundin, who will now fo­cus on be­ing COO. The young biotech aims to cre­ate a plat­form tech­nol­o­gy uti­liz­ing ex­o­somes — “foun­da­tion­al trans­porters in the hu­man body” — to cre­ate bio­ther­a­peu­tics, and fig­ures it could use some help from de Fougerolles, who has al­so helped ad­vance pipelines for Mod­er­na and Al­ny­lam.

Eu­gene Kennedy has been pro­mot­ed from VP of clin­i­cal and med­ical af­fairs to chief med­ical of­fi­cer at NewLink Ge­net­ics $NLNK, the biotech best known for its IDO in­hibitor that has gar­nered (though some­times lost) in­ter­est from big part­ners. His new role is an ex­pan­sion of his pre­vi­ous job, in­volv­ing the start of en­roll­ment in­to NewLink’s piv­otal tri­al of in­dox­i­mod com­bos for ad­vanced melanoma.

→ The small crew at Mus­tang Bio has found a new mem­ber in Bri­an Achen­bach, their new VP of fi­nance and cor­po­rate con­troller who will as­sume re­spon­si­bil­i­ties pre­vi­ous­ly held by in­ter­im CFO David Horin. His fi­nance and ac­count­ing ex­per­tise, last ex­er­cised at Ameri­gen af­ter stints at Con­va­Tec and My­lan, will be need­ed as the tiny biotech tries to tack­le gi­ants in the CAR-T field.

Bris­tol-My­ers Squibb’s Mike Burgess is leav­ing Big Phar­ma be­hind and be­com­ing pres­i­dent of re­search and de­vel­op­ment at Cana­da’s Turn­stone Bi­o­log­ics, where he will lead all R&D ac­tiv­i­ties. The role builds up­on Burgess’ ex­pe­ri­ence at BMS head­ing trans­la­tion­al re­search and can­cer de­vel­op­ment, af­ter stints at Roche and Eli Lil­ly. In a state­ment, Burgess ex­pressed con­fi­dence in the on­colyt­ic con­tender’s two-in-one can­cer vac­cine, which got a boost from Ab­b­Vie just last month: “Turn­stone Bi­o­log­ics is unique­ly po­si­tioned to de­liv­er break­through vi­ral-based im­munother­a­pies for pa­tients with can­cer. … I look for­ward to work­ing close­ly with Turn­stone’s ex­pe­ri­enced team and founders, who are dri­ven by sci­ence and in­no­va­tion, to bring these break­through med­i­cines to pa­tients.”

→ The Med­i­cines Com­pa­ny $MD­CO has brought Pfiz­er vet Geno Ger­mano on­to its board. Ger­mano most re­cent­ly was pres­i­dent of In­trex­on but left af­ter a short stint. Chair­man Fredric Es­hel­man, mean­while, is be­ing bumped up to ex­ec­u­tive chair­man.

CRISPR Ther­a­peu­tics an­nounced that Michael Tom­sicek, for­mer­ly of med­ical im­plant man­u­fac­tur­er Abio­med and Mer­ck-ac­quired phar­ma Cu­bist, will be­come its CFO. The news came on the same day the Swiss gene edit­ing com­pa­ny $CR­SP said it will team up with Cure­Vac to de­vel­op im­proved Cas9 mR­NA con­structs for in vi­vo gene edit­ing, to­geth­er with its joint ven­ture Case­bia.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.