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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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