Randy Schatz­man jumps to the helm of an­oth­er start-up; No­vo Nordisk vet lands top post at Macrophage Phar­ma

In biotech, long-term sur­vival in the ex­ec­u­tive ranks can de­pend a lot on the qual­i­ty of your con­nec­tions in the ven­ture/in­vest­ing side of the busi­ness.

Randy Schatz­man Bolt Bio­ther­a­peu­tics

So when Randy Schatz­man ex­it­ed Alder af­ter tak­ing the com­pa­ny from con­cep­tion to the thresh­old of a like­ly ap­proval for a new mi­graine ther­a­py, it was his re­la­tion­ship with long­time back­ers that led him to his new job as CEO of Bolt Bio­ther­a­peu­tics, an­nounced this week.

Con­nec­tions at No­vo and an­oth­er in­vestor asked him to check out the Red­wood City, CA start­up, which has been work­ing on what they call “im­mune-stim­u­lat­ing an­ti­body con­ju­gates” to turn cold tu­mors hot — a pop­u­lar theme in the on­col­o­gy field.

He was im­pressed with the tech­nol­o­gy and the team of about 35, which he ex­pects to see dou­ble in size in the next 18 to 24 months. But the big move will be the shift to the clin­ic in Q1 2020, which is right around the cor­ner now. Fund­ing as al­ways will be a key con­sid­er­a­tion for the start­up, but Schatz­man al­ready knows just how com­mit­ted the syn­di­cate is — which helps con­sid­er­ably.

“I think I got some in­sights, build­ing a com­pa­ny from scratch to the com­mer­cial en­vi­ron­ment,” Schatz­man tells me. So he’ll stay fo­cused on the fun­da­men­tals: tech and clin­i­cal de­vel­op­ment plans, re­cruit­ment, fi­nanc­ing and mak­ing sure he has a rock-sol­id board back­ing him.

Schatz­man’s ad­vice for oth­er CEOs: Hav­ing a “board that is row­ing in the same di­rec­tion,” he says. 

He’s grab­bing an oar to help set the tem­po. — John Car­roll

Michael Slater Syn­log­ic

→ A few months af­ter Syn­log­ic — a pi­o­neer in reengi­neer­ing non-path­o­gen­ic bac­te­ria in­to med­i­cines — inked a col­lab­o­ra­tion with Gink­go Bioworks, it’s ap­point­ed Richard Riese as CMO and Michael Slater as head of reg­u­la­to­ry af­fairs. Riese most re­cent­ly served as the vice pres­i­dent, clin­i­cal de­vel­op­ment at Al­ny­lam and was pre­vi­ous­ly at Alex­ion. Slater was the head of reg­u­la­to­ry af­fairs and, lat­er, de­vel­op­ment op­er­a­tions at Mer­ri­mack Phar­ma­ceu­ti­cals, where he helped lead the com­pa­ny to the 2015 US ap­proval of Onivyde for the treat­ment of metasta­t­ic pan­cre­at­ic can­cer. Slater has held var­i­ous stints, in­clud­ing at Mil­len­ni­um Phar­ma­ceu­ti­cals, Ani­ka Ther­a­peu­tics and Bio­gen. In ad­di­tion, the com­pa­ny an­nounced that CFO Todd She­gog will be hit­ting the ex­it to pur­sue oth­er op­por­tu­ni­ties. 

Richard Riese Syn­log­ic

→ Paris-based Step Phar­ma — an au­toim­mune-fo­cused biotech on the cusp of ush­er­ing its first oral nu­cleotide syn­the­sis in­hibitor tar­get­ing CTPS1 to the clin­ic — has wooed for­mer Zealand Phar­ma CSO An­drew Park­er as CEO, suc­ceed­ing Ge­of­froy de Rib­ains. Park­er an­nounced his res­ig­na­tion from Zealand in ear­ly Au­gust af­ter a three-year stint with the com­pa­ny. Dur­ing his time at Zealand, Park­er helped as­sem­ble a pre­clin­i­cal pipeline of ion chan­nel block­ers, GLP-1 as­sets and a com­ple­ment C3 in­hibitor. Pri­or to that, he was gen­er­al part­ner and sci­en­tif­ic di­rec­tor of life sci­ences in­vest­ment com­pa­ny Eclo­sion2 & Cie SCPC. Park­er’s pre­vi­ous stints in­clude roles at As­traZeneca, John­son & John­son and Op­sona Ther­a­peu­tics

An­drew Park­er

“The com­pa­ny has made sig­nif­i­cant progress in op­ti­miz­ing se­lec­tive CTPS1 in­hibitors and ex­plor­ing the role of CTPS1 in au­toim­mune dis­eases. My role will be to de­sign and im­ple­ment a plan to trans­late the phe­nom­e­nal sci­en­tif­ic progress made to date in­to a clin­i­cal pipeline,” not­ed Park­er.

No­vo Nordisk vet Søren Bre­gen­holt is tak­ing up his first CEO post at Macrophage Phar­ma in Eng­land to steer the start­up through ear­ly ef­forts of ap­ply­ing its Es­terase Mo­tif Tech­nol­o­gy. CRT Pi­o­neer Fund, Agla­ia On­col­o­gy Fund II, No­vo Hold­ings and M Ven­tures had pooled to­geth­er £9 mil­lion back in 2017 for the ESM plat­form, which gen­er­ates small mol­e­cule drugs that in­duce tran­scrip­tion­al re­pro­gram­ming of mono­cytes and macrophages. The lead pro­gram tar­gets p38 MAPK. While Bre­gen­holt brings fresh ex­pe­ri­ence in im­muno-on­col­o­gy from a brief CBO stint at IO Biotech, he is al­so talked with un­lock­ing ESM’s po­ten­tial in oth­er dis­eases.

Søren Bre­gen­holt Macrophage

→ Ready to stake a bold claim in the nascent field of RNA mod­i­fi­ca­tion, Ac­cent Ther­a­peu­tics has wooed sea­soned deal­mak­er Shak­ti Narayan to be­come its CEO. Narayan, who most re­cent­ly served as CBO of Tan­go Ther­a­peu­tics, was cred­it­ed for lead­ing the biotech’s “trans­for­ma­tion­al” col­lab­o­ra­tion with Gilead, which was worth up to $1.7 bil­lion. Hav­ing spe­cial­ized in on­col­o­gy busi­ness de­vel­op­ment from Genen­tech to J&J, he will now team up with Ac­cent pres­i­dent and CSO Robert Copeland in pluck­ing the most promis­ing in­hibito­ry small mol­e­cule drugs (block­ing RNA-mod­i­fy­ing en­zymes) in their dis­cov­ery pipeline.

→ Months af­ter Night­star’s $800 mil­lion sale to Bio­gen, Ak­ou­os has scooped Gre­go­ry Robin­son as CSO, lever­ag­ing his ex­per­tise in both gene ther­a­py and rare dis­ease trans­la­tion­al re­search. While Robin­son had fo­cused on reti­nal dis­or­ders at Night­star (and CNS dis­eases be­fore that at Ag­ilis Bio­ther­a­peu­tic), he will now turn his at­ten­tion to sen­sorineur­al hear­ing loss. Al­so join­ing the C-suite is Michael McKen­na, a co-founder of Ak­ou­os, who’s ex­pand­ing his role to full-time CMO. A neu­ro­to­log­ic sur­geon at Mass­a­chu­setts Eye and Ear, McKen­na con­tributed years of re­search on in­ner ear drug de­liv­ery that was key to Ak­ou­os’ cre­ation.

Si­mon Rus­sell Ome­icos

→ Ger­man car­dio­vas­cu­lar and oph­thal­mol­o­gy biotech Ome­icos has named Si­mon Rus­sell chief busi­ness of­fi­cer as it ap­proach­es clin­i­cal proof-of-con­cept and dose con­fir­ma­tion for its atri­al fib­ril­la­tion pro­gram, OMT-28. Rus­sell spent the ear­li­er years of his ca­reer climb­ing the ranks at As­traZeneca and No­var­tis, end­ing as glob­al com­mer­cial leader for the Swiss phar­ma gi­ant’s ill-fat­ed canakinum­ab. He has since made the trek to biotech and is now an en­tre­pre­neur in res­i­dence at the Basel Area ac­cel­er­a­tor Base­Launch, co-found­ing his own com­pa­ny just weeks be­fore join­ing Ome­icos in Berlin. “Ome­icos has a very promis­ing ther­a­peu­tic plat­form tar­get­ing one of na­ture’s most im­por­tant cell-pro­tec­tive path­ways,” Rus­sell said of its syn­thet­ic epoxy eicosanoid analogs.

James Mack­ay has wooed a for­mer col­league from Ardea Bio­sciences to help ex­pand the clin­i­cal port­fo­lio of his new start­up, Aris­tea. Ni­har Bhak­ta jumps to the CMO po­si­tion from Gos­samer Bio, where he was a project team leader. At San Diego-based Aris­tea he will keep a laser fo­cus on in­flam­ma­to­ry dis­eases, start­ing with a lead drug from As­traZeneca cur­rent­ly in Phase II. His pri­or ex­pe­ri­ence spans Roche and Bris­tol-My­ers Squibb.

→ An­ti­calin pro­tein-based drugs fo­cused Pieris Phar­ma­ceu­ti­cals had some change-ups to its lead­er­ship team with the ad­di­tion of Hit­to Kauf­mann as SVP and CSO and the an­nounce­ment of the de­par­ture of Al­lan Reine, SVP and CFO. In this new role, Kauf­mann will be re­spon­si­ble for the com­pa­ny’s drug dis­cov­ery, pro­tein en­gi­neer­ing and bio­man­u­fac­tur­ing ac­tiv­i­ties, while over­see­ing al­liance man­age­ment and serv­ing as site head for its Ger­man R&D fa­cil­i­ty. Kauf­mann held a stint at Sanofi be­fore hop­ping over to the Boston, Mass­a­chu­setts-based com­pa­ny. His pri­or ex­pe­ri­ence spans roles at Boehringer In­gel­heim and at the Wal­ter and Eliza Hall In­sti­tute in Mel­bourne. Pieris in­tends to ini­ti­ate a search for a new CFO as Reine will be pur­su­ing an­oth­er busi­ness op­por­tu­ni­ty. Up­on Reine’s res­ig­na­tion, Tom Bu­res, the com­pa­ny’s vice pres­i­dent of fi­nance, will serve as trea­sur­er and prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer.

Ab­Cellera has ex­pand­ed its ex­ec­u­tive team with the ad­di­tions of An­drew Booth as CFO and Tryn Sti­mart as gen­er­al coun­sel. Booth makes the jump from the com­pa­ny’s board of di­rec­tors and brings ex­pe­ri­ence to the role from his pre­vi­ous stint at STEM­CELL Tech­nolo­gies as vice pres­i­dent of in­stru­men­ta­tion, CFO and CMO. Sti­mart draws from ex­pe­ri­ence from his roles at Gib­bons PC, Finnegan, Coo­ley and Womble Bond Dick­in­son, where he has rep­re­sent­ed clients from Gilead, Take­da, Ge­vo, Sunovion and Ap­tal­is

Gil McVean Ge­nomics

→ Da­ta sci­ence com­pa­ny Ge­nomics — which was found­ed in 2014 by four pro­fes­sors out of the Uni­ver­si­ty of Ox­ford — has brought on one of its founders, pro­fes­sor of sta­tis­ti­cal ge­net­ics Gil McVean, as chief in­for­ma­tion of­fi­cer of the com­pa­ny. McVean is a found­ing di­rec­tor of the Big Da­ta In­sti­tute (BDI) and brings ex­pe­ri­ence from his time as head of bioin­for­mat­ics and sta­tis­ti­cal ge­net­ics at Ox­ford’s Well­come Cen­tre for Hu­man Ge­net­ics to the ta­ble. 

→ Af­ter bank­ing €12M to de­vel­op a drug for mul­ti­ple sys­tem at­ro­phy (MSA) — tar­get­ing tox­ic pro­tein ag­gre­ga­tion — in June, Ger­man biotech MODAG has ap­point­ed Jo­hannes Levin as CMO. Levin brings ex­pe­ri­ence in MSA along with a back­ground in pro­tein ag­gre­ga­tion. He re­cent­ly led a clin­i­cal MSA study with pro­fes­sor Armin Giese, CSO of MODAG — the find­ings were pub­lished in The Lancet Neu­rol­o­gy. In his new role, Levin will be re­spon­si­ble for ad­vanc­ing the com­pa­ny’s lead can­di­date, an­le138b, in­to the clin­ic.

East­Gate Biotech has en­list­ed Bill Aba­jian to over­see the li­cens­ing and mar­ket­ing of their liq­uid in­sulin mouth rinse so­lu­tion for type 2 di­a­betes as COO. Aba­jian, who’s pre­vi­ous­ly helped Generex com­mer­cial­ize an oral in­sulin spray in de­vel­op­ing coun­tries, will con­tin­ue to fo­cus on that part of the world. “We are on the cusp of ma­jor li­cens­ing ini­tia­tives and the com­pa­ny needs to be stream­lined and fo­cused to max­i­mize share­hold­er val­ue,” he said, adding about East­Gate’s pink sheet stock: “The mar­ket re­ac­tion to our fun­da­men­tal sto­ry has been ex­treme­ly dis­ap­point­ing as share­hold­ers choose to fo­cus on the struc­tur­al risks of di­lu­tion in­stead of the po­ten­tial of the tech­nol­o­gy. We are about to change the par­a­digm on how a small biotech brings drugs to mar­ket.”

Ter­ry-Ann Bur­rell has hopped over to Beam Ther­a­peu­tics — a com­pa­ny found­ed by CRISPR trail­blaz­ers David Liu, Feng Zhang and J Kei­th Joung — af­ter a stint as man­ag­ing di­rec­tor at JP Mor­gan. Dur­ing her time at JP Mor­gan, Bur­rell helped ex­e­cute over $10 bil­lion in eq­ui­ty and eq­ui­ty-linked fi­nanc­ings and more than $50 bil­lion in M&A trans­ac­tions. Pri­or to that, Bur­rell worked in eq­ui­ty re­search at Cit­i­group, cov­er­ing spe­cial­ty phar­ma­ceu­ti­cals and gener­ics. 

Juha Lau­ren Kally­ope

Jernej Godec has joined VC firm At­las Ven­ture. Pri­or to hop­ping on board to At­las, Godec was the se­nior as­so­ciate at Ap­ple Tree Part­ners, in­volved in build­ing El­star Ther­a­peu­tics, an ATP-found­ed com­pa­ny de­vel­op­ing next-gen­er­a­tion of mul­ti­func­tion­al im­munomod­u­la­to­ry an­ti­bod­ies for can­cer, where he al­so served as a board ob­serv­er.

Kally­ope — fo­cused on iden­ti­fy­ing and pur­su­ing ther­a­peu­tic op­por­tu­ni­ties in­volv­ing the gut-brain ax­is — has wel­comed Juha Lau­ren aboard as CBO. Lau­ren joins the com­pa­ny af­ter a stint as se­nior di­rec­tor, busi­ness de­vel­op­ment and R&D strat­e­gy at Re­gen­eron, fo­cus­ing on deals with Al­ny­lam, blue­bird bio and In­tel­lia Ther­a­peu­tics. Lau­ren be­gan as a neu­ro­sci­en­tist, pub­lish­ing stud­ies in jour­nals in­clud­ing Na­ture and Neu­ron be­fore launch­ing his busi­ness ca­reer as a man­age­ment con­sul­tant with Ac­cen­ture.  

Tracey Franklin has been cho­sen as the chief hu­man re­sources of­fi­cer at Mod­er­na — a com­pa­ny de­vel­op­ing mR­NA ther­a­peu­tics and vac­cines. Franklin hops over af­ter a 15-year stint at Mer­ck, serv­ing as vice pres­i­dent, HR chief tal­ent and strat­e­gy of­fi­cer.

Schol­ar Rock — fo­cused on dis­eases in which pro­tein growth fac­tors play a fun­da­men­tal role — has brought George Nomikos in­to their com­pa­ny as vice pres­i­dent, head of med­ical re­search, mus­cle fran­chise. In this new role, Nomikos will be the med­ical lead for the SRK-015 pro­gram in Spinal Mus­cu­lar At­ro­phy (SMA) as well as fu­ture clin­i­cal pro­grams in the mus­cle fran­chise. Pri­or to jump­ing on board, Nomikos served as the se­nior med­ical di­rec­tor, glob­al med­ical lead for the BI­IB054 clin­i­cal pro­gram for Parkin­son’s at Bio­gen. Nomikos’ pre­vi­ous clin­i­cal work con­tributed to the ap­proval of an­ti­de­pres­sant vor­tiox­e­tine and the ac­cep­tance of the drug la­bel up­dates in the US and EU. His oth­er stints in­clude roles at Sage Ther­a­peu­tics, Take­da, Astel­las Phar­ma, Am­gen and Eli Lil­ly

Kevin Duffy has hopped from Mer­ck and on­board to North­west Bio­ther­a­peu­tics — de­vel­op­ing DC­Vax im­mune ther­a­pies for sol­id tu­mor can­cers, such as Glioblas­toma mul­ti­forme (GBM) — as vice pres­i­dent, med­ical af­fairs and ex­ter­nal col­lab­o­ra­tions. At Mer­ck, Duffy served as re­search sci­en­tif­ic di­rec­tor for the past five years in the Keytru­da pro­gram. Pri­or to his work at Mer­ck, Duffy served in var­i­ous roles, in­clud­ing as re­gion­al sci­en­tif­ic man­ag­er for on­col­o­gy and car­dio­vas­cu­lar ther­a­peu­tics at As­traZeneca.

→ While its lead prod­uct can­di­date, losmapi­mod, is cur­rent­ly in a Phase IIb tri­al to in­ves­ti­gate its po­ten­tial use in fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy (FSHD), Ful­crum Ther­a­peu­tics has ush­ered in Pamela Strode as their se­nior vice pres­i­dent, reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance. Strode jumps to the com­pa­ny af­ter a stint in the same role at Epizyme, where she di­rect­ed mul­ti­ple US fast track and US/EU or­phan drug des­ig­na­tions. Strode for­mer­ly served at Bris­tol-My­ers Squibb, Boehringer In­gel­heim and Cerulean Phar­ma.

→ While col­lab­o­rat­ing with Jazz Phar­ma­ceu­ti­cals in de­vel­op­ing PF743, a re­com­bi­nant crisan­tas­pase, and PF745, a re­com­bi­nant crisan­tas­pase with half-life ex­ten­sion tech­nol­o­gy, Pfenex has an­nounced the ap­point­ment of Steve Kay to its sci­en­tif­ic ad­vi­so­ry board. Kay cur­rent­ly serves as the Di­rec­tor of the Uni­ver­si­ty of South­ern Cal­i­for­nia (USC) MESH Acad­e­my, the Di­rec­tor of the USC Michel­son Cen­ter for Con­ver­gent Bio­science, and is a Provost Pro­fes­sor of Neu­rol­o­gy, Bio­med­ical En­gi­neer­ing and Bi­o­log­i­cal Sci­ences at the Keck School of Med­i­cine of USC.

Eva-Lot­ta Al­lan Ale­ta

Ale­ta Bio­ther­a­peu­tics has made some new ad­di­tions to its board of di­rec­tors, with the ap­point­ments of Mark Leucht­en­berg­er as ex­ec­u­tive chair­man and Eva-Lot­ta Al­lan as non-ex­ec­u­tive di­rec­tor. Leucht­en­berg­er present­ly serves as the in­ter­im CEO at Brook­lyn Im­munoTher­a­peu­tics and Al­lan is the cur­rent non-ex­ec­u­tive di­rec­tor for Tar­go­v­ax and Crescen­do Bi­o­log­ics, as well as chair­man of C4X Dis­cov­ery.

Lyra Ther­a­peu­tics — a biotech fo­cused on de­vel­op­ing med­i­cines to tar­get ear, nose and throat (ENT) dis­eases — has wel­comed Gen­zyme vet, Ann Mer­ri­field, to its board of di­rec­tors. Pre­vi­ous­ly, Mer­ri­field served as the CEO of Patho­Genetix.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.