Brett Zbar to lead life sci­ences in­vest­ing at Gen­er­al At­lantic; Michael Ka­vanaugh plans re­tire­ment as Cy­tomX pro­motes Genen­tech vet Mar­cia Belvin

Brett Zbar

→ Growth eq­ui­ty firm Gen­er­al At­lantic has reeled in Brett Zbar as man­ag­ing di­rec­tor to lead its new life sci­ences fo­cus. Zbar hops aboard from Fore­site Cap­i­tal where he served as man­ag­ing di­rec­tor and ad­vised on the boards of com­pa­nies such as Kin­nate Bio­phar­ma, ORIC Phar­ma­ceu­ti­cals and Sig­nant Health among oth­ers. Pri­or to his role at Fore­site, Zbar was a part­ner at Ais­ling Cap­i­tal.

Michael Ka­vanaugh has an­nounced his re­tire­ment ef­fec­tive Dec. 1 as CSO, head of re­search and non-clin­i­cal de­vel­op­ment of Cy­tomX. Ac­cord­ing to the re­lease, he’s tran­si­tion­ing to an ad­vi­so­ry role. Ka­vanaugh had been with the on­col­o­gy biotech since 2015 af­ter hold­ing the same ti­tles at Five Prime Ther­a­peu­tics. VP of on­col­o­gy re­search Mar­cia Belvin, who came to Cy­tomX 2 years ago, has been pro­mot­ed to SVP, head of re­search. Belvin pre­vi­ous­ly held mul­ti­ple po­si­tions lead­ing can­cer pro­grams and pre­clin­i­cal pipeline teams dur­ing 13 years at Genen­tech and got her start at Ex­elix­is.

→ Co-found­ed by Har­vard pro­fes­sor Kevin Eggan, who start­ed a new chap­ter this week lead­ing R&D at Bio­Marin, Q-State Bio­sciences has tapped Paul Medeiros to helm the start­up as pres­i­dent and CEO.

Paul Medeiros

Medeiros, who cut his teeth at Mer­ck in the ear­ly 1990s and then moved on to Scher­ing-Plough, heads to Q-State from his gigs as pres­i­dent at both Im­bri­um Ther­a­peu­tics and Green­field BioVen­tures. From 2011-18, Medeiros was SVP, cor­po­rate and busi­ness de­vel­op­ment at Mundiphar­ma In­ter­na­tion­al.

Naveed Shams

Naveed Shams is re­plac­ing David Rod­man as CSO of Dutch biotech Pro­QR, whose RNA ther­a­pies look to treat ge­net­ic eye dis­eases. Shams hails from oph­thal­mol­o­gy-fo­cused San­ten, where he spent more than a decade in a num­ber of ca­pac­i­ties — in­clud­ing pres­i­dent and CEO for a time — leav­ing as their chief sci­en­tist and head of glob­al R&D. Shams al­so was in­stru­men­tal in the de­vel­op­ment and ap­proval of Lu­cen­tis while he was Genen­tech’s head of oph­thalmic med­ical af­fairs.

Re­na­to Skerlj

Re­na­to Skerlj is now on board as pres­i­dent and CEO of San Diego-based RNA-me­di­at­ed dis­ease biotech Ex­pan­sion Ther­a­peu­tics, suc­ceed­ing co-founder Kevin For­rest, who had been at the helm since its launch in Jan­u­ary 2018.  One of the sci­en­tif­ic founders at X4 Phar­ma­ceu­ti­cals, Skerlj was al­so the com­pa­ny’s CSO, co-in­vent­ing its lead drug ma­vorix­afor. He was al­so a drug dis­cov­ery and de­vel­op­ment ex­ec at Lyso­so­mal Ther­a­peu­tics, and be­fore that, he led small mol­e­cule dis­cov­ery at Gen­zyme.

→ Jerusalem im­munother­a­py com­pa­ny KAHR has tapped Bryan Jen­nings as CFO and Aron Knicker­bock­er as a di­rec­tor. Jen­nings has made the CFO rounds at such biotechs as Pep­ti­log­ics, Ra­tio­nal Vac­cines and ChemomAb, and is a 20-year Mor­gan Stan­ley vet. Knicker­bock­er re­signed from his CEO post at Five Prime last Sep­tem­ber, with Tom Civik tak­ing over that top spot in April. Knicker­bock­er al­so co-found­ed and was chair­man and CEO of ra­dio­phar­ma­ceu­ti­cal play­er Rayze­Bio.

Kris­ti­ina Vuori

Vivek Ra­maswamy’s gene ther­a­py play­er Ax­o­vant has pro­mot­ed Parag Meswani to CCO, bump­ing him up from his pre­vi­ous po­si­tion of SVP, com­mer­cial strat­e­gy & op­er­a­tions. Meswani spent 13 years at Bio­gen and then led brand strat­e­gy for Lux­tur­na as head of US mar­ket­ing and di­ag­nos­tics for Spark Ther­a­peu­tics. Mean­while, Ax­o­vant has al­so brought Kris­ti­ina Vuori on to the board of di­rec­tors. Vuori is pres­i­dent of the San­ford Burn­ham Pre­bys Med­ical Dis­cov­ery In­sti­tute in San Diego.

Greg Patrick is re­tir­ing as CFO at Rockville, MD biotech Su­per­nus Phar­ma­ceu­ti­cals, which forked over $300 mil­lion in April for US WorldMeds’ CNS port­fo­lio. James Kel­ly is step­ping in to re­place Patrick, who is stick­ing around as an ad­vi­sor to fa­cil­i­tate the tran­si­tion. Kel­ly, who got his ca­reer go­ing at Janssen in the 1990s, had been the long­time CFO of Van­da Phar­ma­ceu­ti­cals be­fore mak­ing his way to Su­per­nus. Kel­ly is al­so a Bio­gen vet who was al­so VP, con­troller at Med­im­mune.

Yvette White-Wig­gins

Yvette White-Wig­gins is re­tir­ing from the Biotech­nol­o­gy In­no­va­tion Or­ga­ni­za­tion (BIO) af­ter 18 years, the last 4 as their CFO. Her suc­ces­sor is Steve Jasko, who has been CFO at the Howard Hugh­es Med­ical In­sti­tute and the TB Al­liance. Be­fore these CFO roles at not-for-prof­its, Jasko spent 6 years with Cel­gene and was a fi­nance di­rec­tor at Mer­ck.

→ The search is un­der­way for a new CFO at Lon­don-based Si­lence Ther­a­peu­tics af­ter the siR­NA biotech an­nounced that Rob Quinn will be leav­ing in Jan­u­ary 2021 “to take up a new po­si­tion.” Quinn, a GSK vet, had been with Si­lence with 2017.

Sarah Noon­berg

Launch­ing last year with ARCH and Third Rock con­tribut­ing large­ly to the $191 mil­lion haul, Maze Ther­a­peu­tics has en­list­ed Sarah Noon­berg as CMO. Noon­berg comes to Maze af­ter rel­a­tive­ly brief CMO stays at Nohla Ther­a­peu­tics and Prothena Bio­sciences. Pri­or to those posts, she led glob­al clin­i­cal de­vel­op­ment at Bio­Marin, spear­head­ing a port­fo­lio that in­cludes the gene ther­a­py for he­mo­phil­ia A, val­rox, which was giv­en a stun­ner of a re­jec­tion by the FDA in Au­gust.

Re­lief Ther­a­peu­tics, the Swiss biotech whose lead com­pound avip­tadil is be­ing de­vel­oped by Neu­roRx and has been iden­ti­fied as a promis­ing Covid-19 drug, has re­cruit­ed Jack We­in­stein as CFO and trea­sur­er. We­in­stein has pre­vi­ous biotech ex­pe­ri­ence from Cat­a­lyst Phar­ma­ceu­ti­cals, where he was their CFO, trea­sur­er and VP of busi­ness de­vel­op­ment.

Aled Williams

→ De­vel­op­ing anti­gen-spe­cif­ic poly­mers to treat au­toim­mune dis­eases, Uni­ver­si­ty of Basel spin­out Polyneu­ron has locked in Aled Williams as CBO. Williams’ Big Phar­ma lead­er­ship ex­pe­ri­ence is vast — a lit­tle As­traZeneca here, some No­var­tis there, along with a dash of Pfiz­er, Roche and Bris­tol My­ers Squibb — but he comes to the Swiss biotech from a spell as chief com­mer­cial of­fi­cer at Vec­tivBio. Be­fore that, Williams was chief com­mer­cial of­fi­cer and head of pa­tient ac­cess for Ther­a­chon.

→ UK-based Achilles Ther­a­peu­tics, which pulled to­geth­er a $121 mil­lion megaround last year for their work with neoanti­gens in cell ther­a­pies, has named one of their founders, Karl Peg­gs, as CMO. Peg­gs, who hits the ground run­ning in his new re­spon­si­bil­i­ty on Jan. 4, 2021, is pro­fes­sor of trans­plant sci­ence and can­cer im­munother­a­py at UCL Can­cer In­sti­tute and sci­en­tif­ic di­rec­tor of the Blood and Trans­plant Re­search Unit at the Na­tion­al In­sti­tute for Health Re­search (NIHR).

Monique Levy

→ Us­ing an AI ap­proach to im­prove men­tal health, San Fran­cis­co-based Woe­bot Health has wel­comed Monique Levy as their chief com­mer­cial and strat­e­gy of­fi­cer. Levy, who has been on Google Health’s ad­vi­so­ry board, hails from Black­Thorn Ther­a­peu­tics, where she was their chief strat­e­gy of­fi­cer for the last year. She’s al­so been glob­al head of strat­e­gy, part­ner­ships and prod­ucts at iCar­bonX.

Daniel Vo­gel has moved in­to the CFO slot at UK-based Ge­nomics, who par­layed their analy­sis en­gine of more than 100 bil­lion da­ta points in­to a col­lab­o­ra­tion with Ver­tex for ge­net­ics and ma­chine learn­ing. Vo­gel jumps to Ge­nomics af­ter be­ing CFO at UK car buy­ing plat­form car­wow.

Meghan Rivera

→ Boston-based Ak­ili has named Meghan Rivera as chief mar­ket­ing of­fi­cer. In her new role, Rivera will be re­spon­si­ble for lead­ing mar­ket­ing and sales for the com­pa­ny’s first com­mer­cial prod­uct, En­deav­or­Rx. Rivera hails from AM­AG Phar­ma­ceu­ti­cals, where she ran the com­pa­ny’s women’s health busi­ness. In ad­di­tion, she pre­vi­ous­ly served at Boehringer In­gel­heim.

→ Women’s health-fo­cused Ovo­ca Bio has en­list­ed Christo­pher Wilt­shire as CBO and ex­ec­u­tive di­rec­tor of the board of di­rec­tors. Pre­vi­ous­ly, Wilt­shire served as non-ex­ec­u­tive di­rec­tor for the Dublin-based com­pa­ny’s board. Wilt­shire brings ex­pe­ri­ence from his roles at Hemath­er­ix, La Jol­la Phar­ma­ceu­ti­cal and Pfiz­er.

Lev­an Dar­ja­nia

→  Cannabi­noid-fo­cused Green Hy­gien­ics has pulled in Lev­an Dar­ja­nia as CSO. Pri­or to hop­ping aboard, Dar­ja­nia held roles at Take­da, Well­spring Bio­sciences, Cy­lene Phar­ma­ceu­ti­cals and Ver­ti­cal Bio­sciences.

→ Af­ter sign­ing on Tushar Shah to be CMO in May, Re­search Tri­an­gle phar­ma Liq­uidia Tech­nolo­gies has made Ger­ald O’Brien VP, pul­monary clin­i­cal de­vel­op­ment. A for­mer med­ical af­fairs di­rec­tor at As­traZeneca and Bay­er, O’Brien bolts to Liq­uidia af­ter a brief stint as VP, clin­i­cal de­vel­op­ment, pul­monary hy­per­ten­sion at Com­plexa.

Bri­an La­m­on

→ Bris­tol My­ers Squibb vet Bri­an La­m­on has moved on to pre­ci­sion med­i­cine-fo­cused Caris Life Sci­ences as their CBO. La­m­on spent 6 years at BMS in a hand­ful of ca­pac­i­ties, leav­ing the phar­ma gi­ant as their VP, de­vel­op­ment lead, gen­i­touri­nary (GU) ma­lig­nan­cies, on­col­o­gy de­vel­op­ment.

Bernard Coulie-led Pli­ant Ther­a­peu­tics, which amassed $144 mil­lion in an up­sized IPO in June, has cor­ralled Mike Ouimette as their gen­er­al coun­sel. Ouimette had been VP and as­sis­tant sec­re­tary of Por­to­la be­fore Alex­ion bought it for $1.4 bil­lion, and he was al­so se­nior cor­po­rate coun­sel and as­sis­tant sec­re­tary for Onyx Phar­ma­ceu­ti­cals.

→ For­mer Roche chair­man and CEO Franz Humer has been named ex­ec­u­tive chair­man at Neo­gene Ther­a­peu­tics, which en­joyed a $110 mil­lion launch in Sep­tem­ber with the help of Al­lo­gene co-founders Arie Bellde­grun and David Chang. Humer re­tired from Roche in 2014.

Je­re­my Levin

→ Ef­fec­tive Mon­day, Je­re­my Levin will take over as chair­man of Mel­bourne-based Opthea, fo­cused on reti­nal dis­eases such as wet AMD and di­a­bet­ic mac­u­lar ede­ma (DME). The Ovid CEO is al­so the cur­rent chair­man of BIO.

IN8bio has snagged Alan Roe­mer as chair­man of its board of di­rec­tors. Roe­mer helped in launch­ing Roivant Sci­ences and Ax­o­vant Sci­ences and served as the CFO of Ax­o­vant. Pri­or to that, he served in roles at Ze­los Ther­a­peu­tics and Phar­mas­set (ac­quired by Gilead).

Paul Sekhri and Alan Moses are the lat­est mem­bers of Is­raeli mi­cro­bio­me drug dis­cov­ery play­er Bio­mX as Erez Chi­movits and Yaron Bres­ki step down. Sekhri has helmed eGe­n­e­sis since Jan­u­ary 2019, while Moses re­tired from No­vo Nordisk in 2018 af­ter 14 years in var­i­ous po­si­tions, in­clud­ing glob­al CMO.

John Crow­ley

→ Pompe dis­ease treat­ment ad­vo­cate John Crow­ley has joined the board of di­rec­tors at genome edit­ing out­fit In­tel­lia Ther­a­peu­tics. Crow­ley has been chair­man and CEO at Am­i­cus Ther­a­peu­tics since 2005.

→ Seat­tle-based Lu­men Bio­science, which raked in $16 mil­lion in a Se­ries B and re­ceived a $4 mil­lion grant from the US Army Med­ical Re­search & De­vel­op­ment Com­mand in Sep­tem­ber to fight GI in­fec­tions in Covid-19 pa­tients, has brought on Mark Lit­ton to sit at the board of di­rec­tors. Lit­ton has been the COO at Athi­ra Phar­ma since last sum­mer.

→ St. Louis biotech Im­munopho­ton­ics has made Jonathan Knowles a mem­ber of their board of di­rec­tors. The for­mer head of re­search at Roche, Knowles has chaired the boards at Im­muno­core and Adap­ti­m­mune.

Ann Miller

→ Fo­cused on en­zyme ther­a­peu­tics to fight meta­bol­ic and kid­ney dis­or­ders, Al­lena Phar­ma­ceu­ti­cals has added Ann Miller to their board of di­rec­tors. A Mer­ck, Am­gen and Ei­sai alum, Miller was more re­cent­ly the VP of mar­ket­ing at Sanofi.

J&J vet Eliz­a­beth Cer­mak has added an­oth­er board ap­point­ment to her ré­sumé. Cer­mak joins Mol­e­culin Biotech while cur­rent­ly serv­ing on the boards of Que On­col­o­gy and Clarus Ther­a­peu­tics as well. Cer­mak for­mer­ly served as world­wide VP per­son­al prod­ucts fran­chise and VP pro­fes­sion­al sales & mar­ket­ing dur­ing her 25-year stint with J&J and pre­vi­ous­ly served as CCO and EVP at POZEN (now Ar­alez Phar­ma­ceu­ti­cals).

George Mont­gomery

→ Red­wood City, CA biotech Ash­vattha Ther­a­peu­tics, de­vel­op­ing hy­drox­yl den­drimer ther­a­peu­tics from tech­nol­o­gy li­censed from Johns Hop­kins, has elect­ed George Mont­gomery to their board of di­rec­tors. Mont­gomery is al­so a board mem­ber at Lu­men Bio­science and a man­ag­ing di­rec­tor at WestRiv­er Group.

→ Af­ter team­ing up with Mer­ck to study its CD47 block­er ALX148 in com­bi­na­tion with Keytru­da to treat head and neck squa­mous cell car­ci­no­ma (HN­SCC) late last month, ALX On­col­o­gy has formed a sci­en­tif­ic ad­vi­so­ry board with Kei­th Fla­her­ty, Charles Baum and Kipp Weiskopf. Fla­her­ty is a pro­fes­sor of med­i­cine at Har­vard Med­ical School and co-founder of Loxo On­col­o­gy be­fore the com­pa­ny was snatched up by Eli Lil­ly. Baum is the cur­rent CEO and board mem­ber of Mi­rati Ther­a­peu­tics, while Weiskopf is a co-founder of ALX.

→ Af­ter bag­ging Tony Ver­non as non-ex­ec­u­tive chair­man of its board of di­rec­tors last month, glob­al med­ical de­vices com­pa­ny CMR Sur­gi­cal has picked Bill Mc­Comb as non-ex­ec­u­tive di­rec­tor. Mc­Comb climbs aboard with a 14-year stint un­der his belt from J&J and served as com­pa­ny group chair­man of J&J’s or­tho­pe­dic and neu­ro­log­i­cal med­ical de­vices busi­ness. In ad­di­tion he served as pres­i­dent at Mc­Neil Con­sumer Health­care and at Or­tho Women’s Health & Urol­o­gy.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $1 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.