Arndt Rolfs

→ There’s a change at the top at Ger­man rare dis­ease biotech Cen­to­gene. Arndt Rolfs de­cid­ed to step down as CEO, ef­fec­tive Tues­day, and Big Phar­ma vet An­drin Os­wald will re­place him start­ing Dec. 1. Os­wald, the del­e­gate for Covid-19 vac­cines and im­munother­a­pies for the fed­er­al gov­ern­ment of Switzer­land, re­cent­ly spent 4 years with the Bill & Melin­da Gates Foun­da­tion as di­rec­tor of life sci­ence in­dus­try en­gage­ment and part­ner­ships. He was al­so a busi­ness in­te­gra­tion ex­ec at GSK and di­vi­sion head of vac­cines & di­ag­nos­tics at No­var­tis.

Rolfs will stay as an ad­vi­sor dur­ing the tran­si­tion. Cen­to­gene and Evotec an­nounced an ex­pan­sion of their part­ner­ship in Au­gust that tar­gets Gauch­er dis­ease, the most com­mon lyso­so­mal stor­age dis­or­der.

João Sif­fert

→ Not even a month af­ter ex­it­ing stage left from a tee­ter­ing Abeona Ther­a­peu­tics, João Sif­fert is now at the helm of San Diego start­up De­sign Ther­a­peu­tics, which launched with a $43 mil­lion round in March and is geared to­ward de­gen­er­a­tive dis­eases brought about by nu­cleotide re­peat ex­pan­sions. Sif­fert, who was al­so Abeona’s head of R&D and CMO, was the head­lin­er in a mass ex­o­dus at the gene ther­a­py biotech that in­clud­ed 5 board mem­bers. Sif­fert will al­so be a board mem­ber at De­sign Ther­a­peu­tics, which was co-found­ed by Pratik Shah and Aseem Ansari and has a lead pro­gram that tar­gets Friedre­ich’s atax­ia.

→ In the process of de­vel­op­ing pro­grams for pem­phi­gus vul­garis and celi­ac dis­ease, Ger­man biotech Topas Ther­a­peu­tics has tapped Klaus Mar­tin as CEO, a tran­si­tion that ac­tu­al­ly took place in Au­gust af­ter the res­ig­na­tion of Timm Jessen but was re­leased nonethe­less this week. Mar­tin was pres­i­dent of Toron­to-based Apo­bi­ologix the last 2 years be­fore mak­ing the move to Topas. Among his oth­er stops, he was al­so CSO of Pol­phar­ma Bi­o­log­ics and led busi­ness de­vel­op­ment & li­cens­ing and port­fo­lio man­age­ment dur­ing his 8 years at San­doz.

→ Two new C-suite ex­ecs are on board at Vac­citech, the Ox­ford T cell vac­cine and im­munother­a­py play­er co-found­ed by Sarah Gilbert, with Meg Mar­shall com­ing on as CMO and Geor­gy Egorov as CFO. Mar­shall has con­sult­ed at Vac­citech since June and has held clin­i­cal re­search di­rec­tor­ships at Pfiz­er, Kite and Ky­owa Kirin. Egorov bounces to Vac­citech from Ex­sci­en­tia, an AI drug dis­cov­ery com­pa­ny al­so based in Ox­ford, spend­ing 2 years as their CFO and as a board mem­ber.

Chris­tine Heenan

→ Noubar Afeyan’s Flag­ship Pi­o­neer­ing has brought Chris­tine Heenan on board as se­nior part­ner and chief com­mu­ni­ca­tions of­fi­cer. A for­mer speech­writer and se­nior pol­i­cy an­a­lyst in the Clin­ton ad­min­is­tra­tion, Heenan found­ed and is pres­i­dent of the Claren­don Group, which has ad­vised the Broad In­sti­tute, the Bill and Melin­da Gates Foun­da­tion and Har­vard. Heenan has con­nec­tions to Har­vard, serv­ing as the uni­ver­si­ty’s VP of pub­lic af­fairs and com­mu­ni­ca­tions from 2008-15.

→ Af­ter David Main took the helm as pres­i­dent and CEO in Ju­ly, two more ex­ecs have joined Toron­to biotech Notch Ther­a­peu­tics, fo­cused on cre­at­ing al­lo­gene­ic T cell ther­a­pies from re­new­able stem cell sources. EVP, fi­nance and CFO Kam­ran Alam was in­ter­im CFO at In­ter­leukin Ther­a­peu­tics for a time af­ter the com­pa­ny merged with Aquinox Phar­ma­ceu­ti­cals, where he was an 8-year vet. Gre­go­ry Block, who steps in as SVP, cor­po­rate de­vel­op­ment, had just com­plet­ed a year-and-a-half run at Astel­las as their di­rec­tor of busi­ness de­vel­op­ment.

Mah­boob Rah­man

→ Mah­boob Rah­man, well-trav­eled in Big Phar­ma, has been in­stalled as CSO of Cy­to­Dyn, which hit a snag in Ju­ly to the tune of a refuse-to-file let­ter for its lead drug leron­limab in HIV. The drug is al­so in a Phase II tri­al for graft-ver­sus-host dis­ease and a Phase Ib/II tri­al for metasta­t­ic triple-neg­a­tive breast can­cer. An alum of Cen­to­cor/J&J, Pfiz­er and No­var­tis, Rah­man spent the last year as Mesoblast’s glob­al head of im­munol­o­gy de­vel­op­ment and phar­ma­covig­i­lance. He was al­so pres­i­dent and CMO at Glen­mark be­fore he made his way to Mesoblast.

→ Third Rock-backed Rheos Med­i­cines — fo­cused on the field of im­munome­tab­o­lism — has picked up Da­nia Rabah as CSO. Rabah hails from Bio­gen, where she served as head of drug dis­cov­ery in­cu­ba­tor, re­search and ear­ly de­vel­op­ment.

→ Cam­bridge, MA mi­cro­bio­me play­er Seres Ther­a­peu­tics con­tin­ues to fill out its lead­er­ship team, with David Ege join­ing as chief tech­nol­o­gy of­fi­cer and Jayne Gansler as chief peo­ple of­fi­cer. In April, Lisa von Moltke was named CMO of Seres, which mount­ed a Phase III come­back in the sum­mer for their C. dif­fi­cile pro­gram SER-109 af­ter a crush­ing Phase II fail. Ege held a va­ri­ety of posts at Mer­ck since 2003, ex­it­ing as the glob­al lead for dig­i­tal strat­e­gy in the phar­ma gi­ant’s man­u­fac­tur­ing di­vi­sion. A J&J and Gen­zyme vet, Gansler leaps to Seres from Ari­ad Phar­ma­ceu­ti­cals, where she was SVP, head of hu­man re­sources.

Behrad De­r­akhshan

→ Michael Car­ruthers and Behrad De­r­akhshan have head­ed to mus­cu­loskele­tal dis­ease-fo­cused Edge­wise Ther­a­peu­tics as CFO and CBO, re­spec­tive­ly, three months af­ter the Boul­der, CO biotech made an­oth­er C-suite move by bring­ing in CMO Kirsten Gruis. Edge­wise’s lead can­di­date, EDG-5506 for Duchenne and Beck­er mus­cu­lar dy­s­tro­phy, is in clin­i­cal de­vel­op­ment. Car­ruthers was CFO at 2 oth­er Boul­der com­pa­nies, Ar­ray Bio­Phar­ma and Ni­valis Ther­a­peu­tics, where he was al­so in­ter­im pres­i­dent. De­r­akhshan, an Alex­ion vet, was most re­cent­ly CBO at Vec­tivBio and led busi­ness de­vel­op­ment at Ther­a­chon from 2017-19.

→ Fo­cused on sep­sis-as­so­ci­at­ed acute kid­ney in­jury and in the midst of a Phase III piv­otal clin­i­cal tri­al, Dutch biotech AM-Phar­ma has wel­comed Maarten Kraan as CMO and Te­un van de Laar as VP, man­u­fac­tur­ing and sup­ply chain man­age­ment. Kraan has been around the R&D block with Bris­tol My­ers Squibb, Roche and As­traZeneca, pri­mar­i­ly in in­flam­ma­to­ry dis­eases, and most re­cent­ly led R&D at French phar­ma Pierre Fab­re Phar­ma­ceu­ti­cals. A 10-year vet of Mer­ck, van de Laar moves on to AM-Phar­ma from his post at Aduro Biotech as VP, CMC tech­ni­cal op­er­a­tions.

George El­dridge

→ Co-found­ed by Bob Langer and fo­cused on oral sus­tained-re­lease ther­a­pies, Wa­ter­town, MA-based Lyn­dra Ther­a­peu­tics has named George El­dridge as their CFO. El­dridge has been a CFO at a bushel of biotechs in the past, in­clud­ing Pro­teon Ther­a­peu­tics (his pre­vi­ous gig), Tar­gan­ta Ther­a­peu­tics and The­ri­on Bi­o­log­ics. This marks the third se­nior man­age­ment po­si­tion to be filled at Lyn­dra since Feb­ru­ary, with El­dridge join­ing chief tech­nol­o­gy of­fi­cer Örn Al­mars­son and CMO Richard Scran­ton.

→ Char­lottesville, VA-based Dif­fu­sion Phar­ma­ceu­ti­cals, look­ing to treat dis­eases where hy­pox­ia plays a big role, has re­cruit­ed Chris Gal­loway as CMO. A for­mer med­ical af­fairs di­rec­tor in Mer­ck’s im­munother­a­py di­vi­sion, Gal­loway has spent the last 2 years as se­nior med­ical di­rec­tor in crit­i­cal care for San Diego biotech La Jol­la Phar­ma­ceu­ti­cal.

David Ja­cobs

→ Swiss top­i­cal eye drug de­vel­op­er Oculis SA has brought on David Ja­cobs as chief de­vel­op­ment of­fi­cer of its US of­fice, where Sylvia Che­ung was ap­point­ed CFO last month. Ja­cobs had been VP, clin­i­cal de­vel­op­ment and med­ical af­fairs at Os­mot­i­ca Phar­ma­ceu­ti­cals for the last 3 years and held drug de­vel­op­ment roles at J&J, Dai­ichi Sankyo, Ap­tal­is Phar­ma­ceu­ti­cals and King Phar­ma­ceu­ti­cals.

→ Mereo Bio­Phar­ma has made a cou­ple of new per­son­nel moves with Chris­tine Fox as CFO and Hei­di Pe­tersen as SVP, reg­u­la­to­ry af­fairs. Start­ing in Jan­u­ary 2021, Fox will re­place in­ter­im CFO Michael Wyz­ga, who will stay on as a board mem­ber. A KP­MG vet, Fox had been group fi­nan­cial con­troller and trea­sur­er for Trav­el­port. Pe­tersen, who starts Nov. 2, has been in reg­u­la­to­ry af­fairs for 25 years and jumps over to Mereo from Kar­tos Ther­a­peu­tics. She’s al­so been a reg­u­la­to­ry ex­ec at Phar­ma­cylics and Im­mune De­sign, which was scooped up by Mer­ck in March 2019.

→ Af­ter rak­ing in $28.5 mil­lion to dive in­to Phase II ear­li­er this month, Sen­sei Bio­ther­a­peu­tics has named Anu Hoey as CBO. Hoey joins the com­pa­ny af­ter hav­ing served in roles at Sec­ond Genome, In­ven­ra, Ar­cus Bio­sciences and Sutro Bio­phar­ma.

→ While de­vel­op­ing the first blood-based test of ear­ly on­set Alzheimer’s dis­ease, Di­a­dem has plucked up Paul Kin­non as CEO. Paul jumps to the helm with stints at Pre­dic­tIm­mune, Transge­nom­ic, ZyGem and Life Tech­nolo­gies (now Ther­mo Fish­er) among oth­ers un­der his belt.

Sam Whit­ing

→ Sam Whit­ing has breezed in­to Ver­sant-backed South San Fran­cis­co on­col­o­gy play­er Tem­pest Ther­a­peu­tics, which is de­vel­op­ing their small mol­e­cule pipeline to treat tu­mors, as EVP and CMO. Whit­ing, who was in clin­i­cal re­search ear­ly in his ca­reer at Fred Hutch, was with Calithera since 2016 and had been their SVP of clin­i­cal de­vel­op­ment pri­or to his ar­rival at Tem­pest.

→ Speak­ing of Ver­sant-backed biotechs, neu­rore­gen­er­a­tion start­up Pipeline Ther­a­peu­tics has hand­ed the CFO reins to Pe­ter Slover. He’s an alum of 2 oth­er biotechs in the San Diego area — at Sophiris Bio, where he was their CFO since 2013, and be­fore that at Anadys Phar­ma­ceu­ti­cals, where he was VP, fi­nance and op­er­a­tions among sev­er­al man­age­ment roles dur­ing his 8 years.

Erin Cowhig

→ Erin Cowhig has been named as the first chief peo­ple of­fi­cer of Cam­bridge, MA drug dis­cov­ery pi­o­neer Nim­bus Ther­a­peu­tics, which chose 4 new tar­gets for its pipeline in June. Cowhig has left Ver­tex, where she had 2 sep­a­rate tenures in hu­man re­sources. Sand­wiched in be­tween, Cowhig was se­nior di­rec­tor, tal­ent ac­qui­si­tion and tal­ent man­age­ment at Agios.

→ Ef­fec­tive last Fri­day, Jen­nifer Chien has stepped aside as chief com­mer­cial of­fi­cer of Pitts­burgh-based Krys­tal Biotech “to pur­sue an­oth­er op­por­tu­ni­ty.” A group of mem­bers from the com­mer­cial team will fill in while the search gets un­der­way for her re­place­ment. Chien is a Sanofi alum who joined Krys­tal in Jan­u­ary.

Moya Daniels

→ San Diego re­gen­er­a­tive med­i­cine de­vel­op­er His­to­gen has se­lect­ed Moya Daniels as EVP and head of reg­u­la­to­ry, qual­i­ty and clin­i­cal op­er­a­tions. Daniels makes the move af­ter be­ing SVP of GMP qual­i­ty at San­Bio. She’s al­so held po­si­tions in reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance at Or­chard Ther­a­peu­tics, Fate Ther­a­peu­tics and Osiris Ther­a­peu­tics.

→ David Crist has been ap­point­ed VP of sales at Boston-based Aveo On­col­o­gy, whose NDA sub­mis­sion for tivozanib — a vas­cu­lar en­dothe­lial growth fac­tor re­cep­tor ty­ro­sine ki­nase in­hibitor (VEG­FR-TKI) to treat re­lapsed or re­frac­to­ry re­nal cell car­ci­no­ma — was ac­cept­ed for fil­ing in June af­ter re­peat­ed re­buffs and is now un­der re­view with an ac­tion date of March 31, 2021. Pri­or to Aveo, Crist was gen­er­al man­ag­er of hema­tol­ogy on­col­o­gy US fran­chise at ar­genx.

Hol­ly Vance

→ Seat­tle-based Ne­oleukin Ther­a­peu­tics, whose lead can­di­date NL-201 is a de no­vo IL-2/IL-15 ag­o­nist for can­cer, has named Hol­ly Vance their gen­er­al coun­sel. Vance was pre­vi­ous­ly as­so­ciate gen­er­al coun­sel for the Bill and Melin­da Gates Foun­da­tion, lend­ing guid­ance to the foun­da­tion’s Strate­gic In­vest­ment Fund.

→ Phar­maEssen­tia has tapped Ray­mond Ur­ban­s­ki as head of clin­i­cal de­vel­op­ment and med­ical af­fairs for its US sub­sidiary. Ur­ban­s­ki hops aboard af­ter stints at GT Bio­phar­ma — as CMO and pres­i­dent — Mannkind and My­lan.

→ Matthew Pat­ter­son is lend­ing a hand on the board of di­rec­tors to both PureTech Health — which late last month was gun­ning for a Nas­daq de­but — and on­col­o­gy play­er Vor Bio­phar­ma. Pat­ter­son is strate­gic ad­vi­sor to Au­dentes, the com­pa­ny he co-found­ed and helmed un­til the Astel­las ac­qui­si­tion closed in Jan­u­ary.

Mark Cor­ri­g­an

→ Af­ter bring­ing in Bud Brigham as a board mem­ber last month, Austin im­muno-on­col­o­gy com­pa­ny Perseus Hold­ings has giv­en Mark Cor­ri­g­an a seat at the board of di­rec­tors. Cor­ri­g­an was re­cent­ly CEO of Cor­re­vio and pres­i­dent of R&D at Tremeau Phar­ma­ceu­ti­cals.

→ Dig­i­tal health com­pa­ny Ar­i­ana Phar­ma has brought on Kia Mote­sharei to its board of di­rec­tors. Cur­rent­ly, Morte­sharei serves as SVP of busi­ness de­vel­op­ment & cor­po­rate strat­e­gy with Akcea Ther­a­peu­tics. In the past, he held roles at Mer­ck KGaA, Dyax, Gen­fit and Ac­tivX.

→ De­vel­op­ing ther­a­pies to re­pair dam­aged tis­sues, Pitts­burgh-based Noveome Ther­a­peu­tics has cho­sen Michelle Berrey and An­na­maria Kausz to be on the board of di­rec­tors. Berrey, the ex-CEO of Chimerix, is now a sci­en­tif­ic ad­vi­sor for Vi­iV/GSK. Kausz has been CMO at Al­lena Phar­ma­ceu­ti­cals since 2015.

Gi­na Con­syl­man

→ John McHutchi­son-led As­sem­bly Bio­sciences, which part­nered on its hep B drugs with BeiGene in Ju­ly, has made Gi­na Con­syl­man a mem­ber of their board of di­rec­tors. A Bio­gen and Ve­rastem vet, Con­syl­man is Iron­wood Phar­ma­ceu­ti­cals’ SVP and CFO.

→ Gilead-part­nered Vi­en­na-based im­munother­a­py com­pa­ny Hookipa has made the ad­di­tion of Jean-Charles So­ria to its board of di­rec­tors. So­ria is a pro­fes­sor of med­i­cine and med­ical on­col­o­gy at the Uni­ver­si­ty of Paris-Saclay and cur­rent­ly serves as di­rec­tor gen­er­al of the Gus­tave Roussy Can­cer Cen­ter.

→ Gre­go­ry Berk has been added to the board of di­rec­tors at can­cer-fo­cused In­flec­tion Bio­sciences out of Dublin. Berk is a long­time CMO at such biotechs as Vedantra Phar­ma­ceu­ti­cals, Ve­rastem and Sideris Phar­ma­ceu­ti­cals.

Tanya Lewis

→ On­colyt­ic im­munother­a­py de­vel­op­er Replimune out of Woburn, MA, has ap­point­ed Tanya Lewis to the board of di­rec­tors. Lewis, a long­time reg­u­la­to­ry ex­ec, is Karyopharm’s EVP, chief reg­u­la­to­ry strat­e­gy and strate­gic op­er­a­tions.

→ Bi­cy­cle Ther­a­peu­tics has in­creased the mem­ber­ship in their sci­en­tif­ic ad­vi­so­ry board. It now in­cludes Uni­ver­si­ty of Penn­syl­va­nia pro­fes­sor Gar­ret FitzGer­ald, Ar­se­nal­Bio CSO Jane Gro­gan, Can­cer Re­search UK chief clin­i­cian Charles Swan­ton and Cae­tano Reis e Sousa of the Crick In­sti­tute.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.