GSK and J&J alum Vi­jay Red­dy to take con­trol of R&D at Tmu­ni­ty; An­drew Hirsch ex­its Agios for CEO job at C4 Ther­a­peu­tics

Vi­jay Red­dy

Vi­jay Red­dy was seek­ing a re­turn to the US when he left his role as CMO at Lon­don-based Au­to­lus this sum­mer. Philadel­phia is that land­ing spot, as the T cell im­munother­a­py play­er Tmu­ni­ty has put him in charge of R&D.

Red­dy ar­rives at the Penn spin­out with plen­ty of Big Phar­ma bona fides af­ter de­vel­op­ing the CAR-T cell clin­i­cal pro­gram at Au­to­lus. Tmu­ni­ty’s new chief R&D of­fi­cer was a se­nior di­rec­tor and led ear­ly clin­i­cal de­vel­op­ment at J&J sub­sidiary Janssen from 2013-16, and from 2009-13, he was GSK’s med­ical di­rec­tor, can­cer re­search and clin­i­cal de­vel­op­ment.

Si­mona King

Tmu­ni­ty al­so added to their lead­er­ship team by se­lect­ing Si­mona King as their CFO. A near­ly 20-year vet of Bris­tol My­ers Squibb in var­i­ous fi­nan­cial roles, King just had a brief run as VP, fi­nance and as­sis­tant trea­sur­er at Emer­gent BioSo­lu­tions.

Co-found­ed by CAR-T in­ven­tors Carl June and Bruce Levine, Tmu­ni­ty has racked up $231 mil­lion in to­tal fund­ing.

An­drew Hirsch

→ Com­plet­ing a 4-year run as CFO at Agios, An­drew Hirsch has made the jump to CEO of pro­tein degra­da­tion pi­o­neer C4 Ther­a­peu­tics. Hirsch takes the helm at an­oth­er biotech af­ter a brief tenure as pres­i­dent and CEO of Bind Ther­a­peu­tics, where he spent 4 years over­all. C4 just pen­ciled in $100 mil­lion for an IPO and back in June, the biotech raked in a $170 mil­lion raise, $150 mil­lion of that from a Se­ries B round. Hirsch suc­ceeds An­drew Phillips, who bolts af­ter 2 years on the job.

→ Mary­land-based Cavo­Gene Life­Sciences, whose lead pro­gram for ALS is slat­ed for clin­i­cal tri­als by ear­ly 2022, has a new CEO with Daniel Jor­gensen now at the helm. A for­mer se­nior di­rec­tor at Pfiz­er, Jor­gensen was the phar­ma gi­ant’s first vac­cine de­vel­op­ment team leader, and he al­so served as glob­al clin­i­cal leader for azithromycin. Else­where, he’s been CMO and SVP, clin­i­cal de­vel­op­ment at Poly­Medix and VP, clin­i­cal re­search for AM­AG Phar­ma­ceu­ti­cals.

Jim Caggiano

→ Ex-Den­dreon CEO Jim Caggiano is back at the helm of an­oth­er biotech, this time at Targazyme, an im­munother­a­py and stem cell trans­plan­ta­tion out­fit in San Diego us­ing en­zyme-based plat­form tech­nolo­gies. Be­fore Caggiano’s tenure at Den­dreon, the for­mer US Army of­fi­cer was pres­i­dent of Valeant Phar­ma­ceu­ti­cals and al­so held po­si­tions at Al­ler­gan for more than 5 years.

→ No doubt get­ting a boost from Ake­bia’s Phase III vadadu­s­tat fail last week, rox­adu­s­tat de­vel­op­er Fi­bro­Gen has plucked Big Phar­ma vet Per­cy Carter from Janssen for the new­ly-cre­at­ed CSO post. Carter was pre­vi­ous­ly Janssen’s glob­al head of dis­cov­ery sci­ences, and pri­or to that, he spent near­ly 20 years at Bris­tol My­ers Squibb in sev­er­al roles, name­ly head of dis­cov­ery and head of dis­cov­ery chem­istry & mol­e­c­u­lar tech­nolo­gies.

Rachel Humphrey

→ Young on­col­o­gy com­pa­ny Black Di­a­mond Ther­a­peu­tics, which col­lect­ed over $200 mil­lion for their IPO in Jan­u­ary, has locked in Rachel Humphrey as CMO. Humphrey is tak­ing over from Karsten Witt, who has been serv­ing as act­ing CMO along with his du­ties as the com­pa­ny’s SVP of clin­i­cal de­vel­op­ment. Humphrey brings to the ta­ble ex­pe­ri­ence from a long list of roles at Cy­tomX Ther­a­peu­tics — where she served as CMO — Eli Lil­ly, As­traZeneca, Mi­rati Ther­a­peu­tics, Bris­tol My­ers Squibb and Bay­er.

Ali Fat­taey

Ali Fat­taey is now lead­ing can­cer me­tab­o­lism play­er MetaboMed as their CEO. His pre­de­ces­sor, co-founder Si­mone Bot­ti, is mov­ing to a se­nior po­si­tion at an undis­closed Eu­ro­pean VC. Fat­taey pre­vi­ous­ly led ther­a­peu­tics dis­cov­ery and de­vel­op­ment at Sci­pher Med­i­cine and was the pres­i­dent and CEO at Curis. He start­ed his ca­reer at Onyx Phar­ma­ceu­ti­cals as VP, re­search.

→ Some hard times have be­fall­en DBV Tech­nolo­gies, whose peanut al­ler­gy skin patch was re­buffed in a CRL from the FDA in Au­gust. Now, a cou­ple of ex­ecs have head­ed for the ex­its with CFO Ramzi Be­na­mar and CCO Kevin Trapp walk­ing out the door of the French biotech. Sébastien Ro­bitaille will be fill­ing in as CFO on an in­ter­im ba­sis ef­fec­tive Oct 2. The Ipsen vet, who start­ed out at DBV 5 years ago as SVP, group con­troller and in­for­ma­tion sys­tems, was pro­mot­ed to chief of staff to CEO Daniel Tassé a year ago.

Mol­ly Hen­der­son

Mol­ly Hen­der­son is re­sign­ing from her role as CFO at Prince­ton, NJ biotech Ad­vax­is, ef­fec­tive Sept 25, to be­come CFO at Uro­Gen be­gin­ning the fol­low­ing week. Pres­i­dent and CEO Ken­neth Berlin will func­tion as in­ter­im CFO un­til her re­place­ment is found. Ad­vax­is has had a rough go of it with its ill-fat­ed Am­gen part­ner­ship and mul­ti­ple FDA holds on their lead as­set ax­al­imo­gene.

→ Else­where at Uro­Gen, Pol­ly Mur­phy has tak­en on the role of CBO and Ja­son Smith will be gen­er­al coun­sel and chief com­pli­ance of­fi­cer. Mur­phy and Smith are both Pfiz­er alums: Mur­phy spent 12 years in a se­ries of VP roles at the phar­ma gi­ant and was most re­cent­ly their VP for ear­ly com­mer­cial de­vel­op­ment in the on­col­o­gy busi­ness unit, while Smith logged 11 years at Pfiz­er, the last 4 of those as their chief coun­sel, on­col­o­gy. Be­fore that, Smith was le­gal lead for the North Amer­i­can re­gion of Pfiz­er Es­sen­tial Health.

Rosh Dias

→ Back in May, Spruce Bio­sciences in­tro­duced Samir Gharib as their CFO, and there’s an­oth­er change at the San Fran­cis­co biotech’s C-suite with Rosh Dias com­ing in as CMO. Be­fore join­ing Spruce, which tar­gets rare en­docrine dis­or­ders and re­vealed pos­i­tive Phase II da­ta a year ago with lead can­di­date tildac­er­font, Dias — a No­var­tis vet — spent the last year in the same role at In­di­v­ior. From 2015-18, he was Am­gen’s VP, glob­al sci­en­tif­ic af­fairs. In oth­er Spruce de­vel­op­ments, ex-Bio­Marin CFO Dan Spiegel­man was added to their board of di­rec­tors.

→ Forg­ing ahead in Phase III of their Covid-19 vac­cine and rank­ing No. 2 on our list of the 29 vac­cine play­ers, Mod­er­na has tapped Michael Mul­lette as man­ag­ing di­rec­tor, Cana­da. Af­ter near­ly 2 decades at Sanofi, with the last 2 years as gen­er­al man­ag­er and coun­try chair for Sanofi Cana­da in Mon­tre­al, Mul­lette came to Mod­er­na in Au­gust as VP, mar­ket ac­cess, and he will car­ry on in that role in ad­di­tion to his new ap­point­ment.

Mike Spi­garel­li

→ Rais­ing $16 mil­lion in a Se­ries B last week in an ef­fort to “de­moc­ra­tize” bi­o­log­ics, Seat­tle-based Lu­men Bio­science has giv­en the nod to Mike Spi­garel­li to be their CMO. Spi­garel­li is com­ing off 4 years as VP, med­ical af­fairs for di­ag­nos­tics com­pa­ny Im­mu­cor.

→ Res­pi­ra­to­ry dis­ease-cen­tered ge­net­ic med­i­cines play­er Re­Code Ther­a­peu­tics has a tri­fec­ta of ap­point­ments with Mukul Agar­w­al, CBO; Vladimir Kharitonov, SVP, chem­istry, man­u­fac­tur­ing and con­trols (CMC); and Bran­don Wust­man, SVP, R&D. Agar­w­al heads to Re­Code af­ter a lit­tle over a year as VP, cor­po­rate de­vel­op­ment at Forty Sev­en, which Gilead bought in March for $4.9 bil­lion. Kharitonov had spent 20 years at Paci­ra Phar­ma­ceu­ti­cals, the last 10 as their VP of R&D. And Wust­man had been with the com­pa­ny as VP of R&D be­fore Re­Code joined forces with Tran­scrip­Tx in March. From 2002-14, he was se­nior di­rec­tor, pre­clin­i­cal bi­ol­o­gy at Am­i­cus Ther­a­peu­tics.

Mar­tin Madaus

→ Ex-Mil­li­pore chair­man, pres­i­dent and CEO Mar­tin Madaus is mak­ing his way to Feng Zhang’s CRISPR-based di­ag­nos­tics play­er Sher­lock Bio­sciences as COO. Madaus has been in­ter­im CEO and ex­ec­u­tive chair­man at Ul­tivue and Em­u­late Bio of late, and from 2014-19, he was chair­man and CEO at Or­tho Clin­i­cal Di­ag­nos­tics.

→ UK clin­i­cal AI com­pa­ny Sen­syne Health has tapped Michael Mac­don­nell as COO. Mac­don­nell cur­rent­ly heads Google Health as di­rec­tor of glob­al de­ploy­ment. Pri­or to his po­si­tion at Google Health, Mac­don­nell was at Google Deep­Mind and held roles at Ac­cen­ture, NHS Eng­land and Im­pe­r­i­al Col­lege Lon­don among oth­ers.

→ Long­time Mer­ck vet Ercem Atil­la­soy is on board at cell ther­a­py com­pa­ny AlloVir as chief reg­u­la­to­ry and safe­ty of­fi­cer. At Mer­ck Re­search Lab­o­ra­to­ries, Atil­la­soy was VP and ther­a­peu­tic area head of vac­cines and in­fec­tious dis­ease and VP, glob­al reg­u­la­to­ry af­fairs and clin­i­cal safe­ty. He ran Keytru­da’s first IND fil­ing for melanoma and was in­volved in the ap­proval of such med­i­cines as the Ebo­la vac­cine Erve­bo and the HPV vac­cine Gar­dasil.

Er­ic Kim­ble

Till­man Gern­gross’ new en­deav­or, Ada­gio Ther­a­peu­tics, has locked in Er­ic Kim­ble as chief com­mer­cial of­fi­cer and Ed Cam­pa­naro as SVP of clin­i­cal op­er­a­tions. Kim­ble and Cam­pa­naro worked at Cu­bist Phar­ma­ceu­ti­cals in VP po­si­tions at the same time – Kim­ble from 2004-13, and Cam­pa­naro from 2000-14. Be­fore Ada­gio, which fo­cus­es on an­ti­bod­ies as an av­enue to com­bat Covid-19, Kim­ble was the CCO at En­ta­sis Ther­a­peu­tics, while Cam­pa­naro was SVP of clin­i­cal op­er­a­tions at Ar­tu­gen Ther­a­peu­tics.

Ole­ma On­col­o­gy, work­ing on the de­vel­op­ment of tar­get­ed ther­a­pies for women’s can­cers, has made sev­er­al new ad­di­tions to its ex­ec­u­tive team with the ap­point­ment of Shane Ko­vacs as COO/CFO, Genen­tech vet Kin­ney Horn as CBO, and John Mo­ri­ar­ty as EVP, chief le­gal of­fi­cer. In ad­di­tion, Pamela Klein has been named CMO and David Myles has been pro­mot­ed to chief de­vel­op­ment of­fi­cer. Ko­vacs joins the com­pa­ny from Blue­Rock Ther­a­peu­tics (ac­quired by Bay­er), where he served as CBO and CFO. Horn held a 16-year stint at Genen­tech, while Mo­ri­ar­ty was most re­cent­ly EVP and gen­er­al coun­sel at Por­to­la Phar­ma­ceu­ti­cals.

Klein joins the com­pa­ny with ex­pe­ri­ence from Syn­dax Phar­ma­ceu­ti­cals and Genen­tech — where she most re­cent­ly served as VP, de­vel­op­ment — among oth­ers. Myles moves up to his new role af­ter serv­ing as Ole­ma’s EVP, drug dis­cov­ery and de­vel­op­ment.

→ New York-based Phos­platin Ther­a­peu­tics, which has ob­tained ex­clu­sive li­cense to a fam­i­ly of com­pounds known as phos­phap­latins that may aid in treat­ing can­cer, has made Joseph O’Don­nell their in­ter­im CMO, and Ja­son Sum­ma has got­ten the call to be VP of clin­i­cal de­vel­op­ment. O’Don­nell has long been in acad­e­mia at Dart­mouth Uni­ver­si­ty’s Geisel School of Med­i­cine, where he start­ed teach­ing in 1978. A Bind and Mo­men­ta alum, Sum­ma was pre­vi­ous­ly on­col­o­gy di­rec­tor and clin­i­cal project sci­en­tist at Janssen.

→ Aus­tralian CRO Avance Clin­i­cal has cor­ralled Jor­gen Mould as a sci­en­tif­ic af­fairs spe­cial­ist. Mould was pre­vi­ous­ly with Mer­ck (KGaA) Health­care as an as­so­ciate med­ical man­ag­er and med­ical sci­ence li­ai­son, neu­rol­o­gy and im­munol­o­gy.

Aman­da Mur­phy

→ Cell en­gi­neer­ing ser­vice provider Max­Cyte has snagged Aman­da Mur­phy as CFO, suc­ceed­ing Ron Holtz — who has been pro­mot­ed to the po­si­tion of SVP and chief ac­count­ing of­fi­cer. Pri­or to Max­Cyte, Mur­phy was man­ag­ing di­rec­tor at BTIG and was part­ner and health­care an­a­lyst at William Blair & Com­pa­ny.

Brain­Storm Cell Ther­a­peu­tics — a de­vel­op­er of adult stem cell ther­a­pies for neu­rode­gen­er­a­tive dis­eases — has re­cruit­ed Bris­tol My­ers Squibb vet An­tho­ny Wa­claws­ki as EVP, glob­al head of reg­u­la­to­ry af­fairs. Dur­ing his 35 year stint at Bris­tol My­ers, Wa­claws­ki most re­cent­ly served as the com­pa­ny’s VP and head, reg­u­la­to­ry and phar­ma­ceu­ti­cal sci­ences, car­dio­vas­cu­lar, im­muno­sciences, fi­bro­sis and ge­net­i­cal­ly-de­fined class­es.

Henk Schur­ing

Prile­nia Ther­a­peu­tics, fo­cused on treat­ments for neu­rode­gen­er­a­tive and neu­rode­vel­op­men­tal dis­or­ders, has wel­comed Henk Schur­ing as chief reg­u­la­to­ry and com­mer­cial­iza­tion of­fi­cer. Schur­ing hails from Sanofi Gen­zyme, where he had a 21-year ca­reer and man­aged the rare nephro­log­i­cal dis­eases busi­ness and rare neu­ro­log­i­cal dis­eases busi­ness.

Paul Bavier has been ap­point­ed gen­er­al coun­sel at can­cer-fo­cused Velos­Bio, which racked up $137 mil­lion in a Se­ries B round a cou­ple months ago. Be­fore he set off for Velos­Bio, Bavier spent 3 years at Ave­dro as their gen­er­al coun­sel and chief com­pli­ance of­fi­cer. He al­so held sim­i­lar roles at Biodel from 2007-16 and was al­so their VP, cor­po­rate de­vel­op­ment.

Lau­rie Stelz­er

→ With Rich Hey­man now chair­man of the board and a $70 mil­lion Se­ries D in the hop­per, NJ-based PMV Phar­ma has brought in Robert Tick­tin as gen­er­al coun­sel. Tick­tin was pre­vi­ous­ly as­so­ciate gen­er­al coun­sel, cor­po­rate at Tesaro (and then GSK af­ter the buy­out). PMV Phar­ma, which tar­gets p53 mu­ta­tions, has al­so se­lect­ed Are­na Phar­ma­ceu­ti­cals CFO Lau­rie Stelz­er to the board of di­rec­tors as au­dit com­mit­tee chair.

Syg­na­ture Dis­cov­ery, a Not­ting­ham-based provider of drug dis­cov­ery and pre­clin­i­cal ser­vices, has reeled in Andy Mead as di­rec­tor and head of drug abuse and sub­stance use dis­or­ders at its in­te­grat­ed vivophar­ma­col­o­gy com­pa­ny, Re­naSci. Mead jumps aboard Syg­na­ture from So­sei Hep­tares, where he served as di­rec­tor of dis­cov­ery and trans­la­tion­al safe­ty. In ad­di­tion, he brings ex­pe­ri­ence from roles at Mer­ck, Pfiz­er and As­traZeneca among oth­ers.

→ UK’s Pre­ci­sion­Life has ap­point­ed Si­mon Beaulah as SVP of health­care and head of US op­er­a­tions. Most re­cent­ly, Beaulah was di­rec­tor of health­care at Lin­gua­mat­ics and pri­or to that was at IDBS Health­care.

Alex Badam­chi-Zadeh

→ VC and growth eq­ui­ty firm SV has brought on Alex Badam­chi-Zadeh as se­nior as­so­ciate. Badam­chi-Zadeh hops aboard with ex­pe­ri­ence from Xilio Ther­a­peu­tics — where he helped guide the Kendall Square-based com­pa­ny through their $100.5 mil­lion Se­ries B fi­nanc­ing round — and LEK Con­sult­ing.

Dean Mitchell has been named chair­man of the board at Kin­nate, which just nabbed a $98 mil­lion Se­ries C in Au­gust. The GSK and Bris­tol My­ers Squibb vet is the for­mer pres­i­dent and CEO of Lux Bio­sciences and Al­phar­ma.

Blue­print Med­i­cines pres­i­dent and CEO Jeff Al­bers has joined the board of di­rec­tors at Kymera Ther­a­peu­tics. The new­ly pub­lic pro­tein degra­da­tion play­er al­so added Replimune CBO Pamela Es­pos­i­to to the board.

Bon­nie An­der­son

→ Af­ter pen­cil­ing in a $150 mil­lion IPO in June, For­ma Ther­a­peu­tics has re­cruit­ed Thomas Wig­gans to its board of di­rec­tors. Wig­gans is the for­mer chair­man and CEO of Der­mi­ra (ac­quired by Eli Lil­ly) and helped in the for­ma­tion of the Biotech­nol­o­gy In­dus­try Or­ga­ni­za­tion, now Biotech­nol­o­gy In­no­va­tion Or­ga­ni­za­tion (BIO).

Bon­nie An­der­son has been elect­ed to the board of di­rec­tors at Bruk­er Cor­po­ra­tion, a sci­en­tif­ic in­stru­ment man­u­fac­tur­er. An­der­son co-found­ed Ve­r­a­cyte in 2008 and is their chair­man and CEO.

Joseph Bow­er

→ UK-based GW Phar­ma­ceu­ti­cals has tapped ex-In­cyte and Cel­gene CFO David Grys­ka to be on their board of di­rec­tors. Grys­ka is al­so on the boards of Seat­tle Ge­net­ics, PDL Bio­Phar­ma and Aerie Phar­ma­ceu­ti­cals.

Joseph Bow­er has an­nounced his de­ci­sion to re­tire as chair­man of the board at or­tho­pe­dic-fo­cused Ani­ka Ther­a­peu­tics af­ter his term is up in 2021. Bow­er, a pro­fes­sor emer­i­tus at Har­vard Busi­ness School, has served on the board since 1993. Ani­ka is al­so bring­ing in Jack Hen­ne­man and Stephen Richard as new board mem­bers.

Ash­er Chanan-Khan

→ AAV-based gene ther­a­pies-fo­cused Pre­vail Ther­a­peu­tics has added William Car­son to its board of di­rec­tors. Most re­cent­ly, Car­son served as pres­i­dent and CEO of Ot­su­ka Phar­ma­ceu­ti­cal De­vel­op­ment & Com­mer­cial­iza­tion and draws from ex­pe­ri­ence from a stint at Bris­tol My­ers Squibb.

Sean Bo­hen

→ Hema­tol­ogy biotech Star­ton Ther­a­peu­tics has cho­sen Ken­neth An­der­son and Ash­er Chanan-Khan to sit on their board of di­rec­tors. An­der­son is di­rec­tor of the Jerome Lip­per Mul­ti­ple Myelo­ma Cen­ter and LeBow In­sti­tute for Myelo­ma Ther­a­peu­tics at Dana-Far­ber, while Chanan-Khan is a pro­fes­sor of med­i­cine at Mayo Clin­ic Can­cer Cen­ter in Jack­sonville.

→ Reti­nal gene ther­a­py com­pa­ny Gy­ro­scope Ther­a­peu­tics has brought on Sean Bo­hen to its board of di­rec­tors. Bo­hen is the for­mer CMO and EVP, glob­al med­i­cines de­vel­op­ment at As­traZeneca and pre­vi­ous­ly served as SVP of Genen­tech ear­ly de­vel­op­ment (gRED).

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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