In­ovio adds two to the lead­er­ship team; Adri­an Woolf­son is out at Sang­amo

→ En­trenched in a le­gal bat­tle with their man­u­fac­tur­er that’s ev­i­dent­ly block­ing them from mak­ing their Covid-19 vac­cine can­di­date, In­ovio is mak­ing some lead­er­ship changes. Gene Kim will be pres­i­dent of In­ovio Asia, while Mam­men (An­za) Mam­men jumps aboard the biotech as SVP, clin­i­cal de­vel­op­ment, and is slat­ed over­see de­vel­op­ment of In­ovio’s DNA vac­cine can­di­date INO-4800.

An ex-CFO at VGX Phar­ma­ceu­ti­cals, Kim had pre­vi­ous­ly been the CFO of AfreecaTV and video game de­vel­op­er We­Made En­ter­tain­ment, both South Ko­re­an com­pa­nies. And Mam­men, who re­tired from the US Army with the rank of colonel, spent more than 6 years at Vi­cal, be­com­ing their SVP, clin­i­cal de­vel­op­ment, and pri­or to that role, was an in­fec­tious dis­ease con­sul­tant and found­ing chief of the DoD’s pan­dem­ic warn­ing team at Fort De­t­rick, MD.

→ Start­ing Ju­ly 13, Far­go, ND-based plas­mid DNA man­u­fac­tur­er Alde­vron will change CEOs. Kevin Ballinger, who was “on the verge of be­ing a lif­er” at Boston Sci­en­tif­ic, will take the helm. He’s re­plac­ing Michael Cham­bers, who was named ex­ec­u­tive chair­man of the board at Alde­vron, which was found­ed on the cam­pus of North Dako­ta State Uni­ver­si­ty in 1998 by Cham­bers and John Bal­lan­tyne. Ballinger was EVP and glob­al pres­i­dent of Boston Sci­en­tif­ic’s largest di­vi­sion, in­ter­ven­tion­al car­di­ol­o­gy, for the past 9 years.

Ja­son Fontenot

→ An R&D split is un­fold­ing at Sang­amo, where EVP of R&D Adri­an Woolf­son, who had on­ly been with the Cal­i­for­nia biotech since Jan­u­ary 2019, has been shown the door. With a search un­der­way for a new head of de­vel­op­ment, Bio­gen vet Ja­son Fontenot — who has been Sang­amo’s SVP of cell ther­a­py — steps up to the plate as in­ter­im head of re­search. Be­fore join­ing Sang­amo, Fontenot was CSO at Im­mu­soft Cor­po­ra­tion and, pri­or to that, found­ed Im­mune Au­toma­ta Con­sult­ing. He spent 8 years at Bio­gen, where he was a group leader in im­munol­o­gy dis­cov­ery.

→ Men­tal health and psy­che­delics biotech ATAI Life Sci­ences has launched In­tro­Spect Dig­i­tal Ther­a­peu­tics, nam­ing David Keene pres­i­dent and CEO of the new plat­form. ”By us­ing a va­ri­ety of dig­i­tal bio­mark­ers, we stand to make treat­ments in­creas­ing­ly re­fined, ef­fec­tive, and — most im­por­tant­ly for men­tal health­care — in­di­vid­u­al­ized,” Keene said in a state­ment. Keene found­ed Everys­to­ry, which was lat­er re­named Dthera Sci­ences in 2016, and was their chief tech­nol­o­gy of­fi­cer, lead­ing de­vel­op­ment of what has been de­scribed as an AI-en­abled de­vice for Alzheimer’s dubbed DTHR-ALZ.

Robert Radie

Neu­rap­tive Ther­a­peu­tics — fo­cused on the treat­ment of pe­riph­er­al nerve in­juries — has brought on Robert Radie to take over the helm of the com­pa­ny as CEO and chair­man of the board. Radie has ex­pe­ri­ence run­ning op­er­a­tions as CEO at Zy­la Life Sci­ences, Trans­mol­e­c­u­lar and Topaz Phar­ma­ceu­ti­cals (ac­quired by Sanofi Pas­teur). In ad­di­tion, he’s held posts at Prest­wick Phar­ma­ceu­ti­cals, Mor­photek and Vi­curon Phar­ma­ceu­ti­cals.

Samuel Tong

→ The Lab­o­ra­to­ry for Ad­vanced Med­i­cine has wooed Samuel Tong as CEO of the com­pa­ny’s Chi­nese op­er­a­tions. Tong hops aboard from NAM­SA, where he served as VP and gen­er­al man­ag­er of the Asia Pa­cif­ic Re­gion. Pre­vi­ous­ly, he served in roles at QI­A­GEN, Ab­bott Vas­cu­lar and GE Med­ical among oth­ers.

→ Ef­fec­tive Ju­ly 30, Nicholas Green is suc­ceed­ing Rick Han­cock as pres­i­dent and CEO of Cal­i­for­nia-based CD­MO Avid Bioser­vices. Han­cock had been in­ter­im pres­i­dent and CEO for the past year. Green jumps to Avid af­ter 9 years as pres­i­dent and CEO of Ther­a­pure Bio­phar­ma, a com­pa­ny out of Mis­sis­sauga, On­tario that al­so in­cludes Ther­a­pure Man­u­fac­tur­ing. He was al­so pres­i­dent and CEO of Rho­dia Phar­ma So­lu­tions and was briefly the pres­i­dent of the phar­ma di­vi­sion at Codex­is.

Allen Melemed

Eli Lil­ly vet Allen Melemed has been named CMO of Chimerix, which six years ago found it­self at the cen­ter of a hur­ri­cane of pub­lic anger over its ini­tial re­fusal to pro­vide their lead ex­per­i­men­tal drug to a dy­ing child. Be­fore his move to the Durham, NC-based biotech, Melemed was a Dis­tin­guished Med­ical Fel­low and se­nior di­rec­tor of reg­u­la­to­ry af­fairs on­col­o­gy, North Amer­i­ca at Lil­ly. Among the on­col­o­gy med­i­cines he worked on in his 20-plus years at the phar­ma gi­ant is Verzenio, which just last week showed pos­i­tive re­sults in a Phase III tri­al for pa­tients with high risk hor­mone re­cep­tor/HER2 neg­a­tive breast can­cer.

→ An­oth­er Eli Lil­ly vet, Thane Wet­tig, is head­ed to San Fran­cis­co bio­phar­ma Fi­bro­Gen as their chief com­mer­cial of­fi­cer. Pri­or to Fi­bro­Gen, which just had its lead drug rox­idu­s­tat for ane­mia ac­cept­ed for re­view by the EMA, Wet­tig had been the chief com­mer­cial of­fi­cer and meta­bol­ic fran­chise leader at Intar­cia Ther­a­peu­tics. Be­fore then, Wet­tig was at Lil­ly for near­ly 28 years, leav­ing as VP of glob­al mar­ket­ing, strat­e­gy and al­liance man­age­ment for Lil­ly Di­a­betes.

Robert Jor­dan

→ Res­pi­ra­to­ry in­fec­tion-fo­cused Meis­sa Vac­cines has re­cruit­ed Robert Jor­dan as their VP of R&D af­ter a short tenure as Vir’s di­rec­tor of vi­rol­o­gy. Jor­dan al­so had a hand in the dis­cov­ery and de­vel­op­ment of an­tivi­ral ther­a­pies, most no­tably remde­sivir, when he was di­rec­tor of bi­ol­o­gy for Gilead. Be­fore his time at Gilead, he was di­rec­tor of vi­rol­o­gy at Siga Tech­nolo­gies.

Josefin-Beate Holz has been named CMO at RNA epi­ge­net­ics play­er Storm Ther­a­peu­tics. Holz makes her way to the Uni­ver­si­ty of Cam­bridge spin­out af­ter be­ing an in­de­pen­dent clin­i­cal ad­vi­sor since 2015. Her lead­er­ship ex­pe­ri­ence in­cludes tenures at Abl­ynx, GPC-Biotech, Gilead, Bris­tol My­ers Squibb, OSI Phar­ma­ceu­ti­cals (ac­quired by Astel­las) and LEO Phar­ma.

Com­pass Path­ways, the Lon­don men­tal health start­up backed by Pe­ter Thiel which grabbed $80 mil­lion in fund­ing back in April, has wel­comed Trevor Mill as chief de­vel­op­ment of­fi­cer. Mill joins Com­pass af­ter be­ing SVP, head of glob­al safe­ty and reg­u­la­to­ry sci­ences with Bio­gen. He was al­so Pfiz­er’s head of reg­u­la­to­ry strat­e­gy, phar­mather­a­peu­tics, and spent 12 years over­all at the phar­ma gi­ant.

Ter­ri Young

→ With its SER-109 pro­gram in Phase III de­vel­op­ment for re­cur­rent C. diff, and try­ing to work its way back in­to the mix af­ter 30% of its work­force was let go in ear­ly 2019, mi­cro­bio­me play­er Seres Ther­a­peu­tics has named Ter­ri Young EVP, chief com­mer­cial and strat­e­gy of­fi­cer, ef­fec­tive June 29. Young is leav­ing Sage Ther­a­peu­tics, where she was VP glob­al com­mer­cial strat­e­gy. The GSK vet al­so spent time in lead­er­ship at Bris­tol My­ers Squibb as VP and gen­er­al Man­ag­er, car­dio­vas­cu­lar.

Reina Ben­abou

→ Just a week af­ter plug­ging in Will Kane as chief com­mer­cial of­fi­cer, New Haven, CT phar­ma BioX­cel Ther­a­peu­tics has brought in Reina Ben­abou as SVP and chief de­vel­op­ment of­fi­cer. Ben­abou, who joins BioX­cel af­ter be­ing SVP & CMO at Cog­nivue, has a Big Phar­ma back­ground that in­cludes stints at No­var­tis (VP & world­wide med­ical head for the neu­ro­science fran­chise) and Pfiz­er (head of glob­al med­ical prod­uct eval­u­a­tion).

→ There are pro­mo­tions ga­lore at Coral Gables, FL-based Cat­a­lyst Phar­ma­ceu­ti­cals, the mak­er of Fir­dapse to treat adults with Lam­bert-Eaton myas­thenic syn­drome. Jef­frey Del Car­men gets the bump to chief com­mer­cial of­fi­cer af­ter ar­riv­ing at Cat­a­lyst in Au­gust 2018 as SVP of sales and mar­ket­ing. Del Car­men had pre­vi­ous­ly been VP of busi­ness de­vel­op­ment for Paragon Bio­sciences. Mean­while, Pe­te Cur­ry moves to VP of sales, and Maria Pan­dol­fo has been pro­mot­ed to VP of pa­tient ser­vices.

→ Af­ter re­cent­ly post­ing pos­i­tive in­ter­im da­ta for their Phase I tri­al, Cal­i­for­nia-based biotech Ad­verum Biotech­nolo­gies has added a new face to the team with the ap­point­ment of Heik­ki Jout­ti­järvi as VP, man­u­fac­tur­ing. Jout­ti­järvi hops aboard from Men­lo Ther­a­peu­tics, where he served as VP, tech­ni­cal op­er­a­tions. Pre­vi­ous­ly, Jout­ti­järvi served in roles at San­ten Phar­ma­ceu­ti­cal Com­pa­ny.

Syg­na­ture Dis­cov­ery, a Not­ting­ham-based provider of drug dis­cov­ery and pre­clin­i­cal ser­vices, has made a new ad­di­tion to its lead­er­ship team with the ap­point­ment of Paul Over­ton as SVP of busi­ness de­vel­op­ment. Over­ton joins the com­pa­ny from Eu­rofins, where he served as head of Eu­ro­pean sales, mar­ket­ing and key ac­count man­age­ment.

Tere­sa Bair

→ Can­cer-fo­cused Buf­fa­lo, NY bio­phar­ma Athenex has pro­mot­ed Tere­sa Bair to gen­er­al coun­sel and SVP, ad­min­is­tra­tion from her pre­vi­ous po­si­tion of SVP, le­gal af­fairs and ad­min­is­tra­tion. Be­fore mak­ing it to Athenex in 2015, Bair was a part­ner at Har­ris Beach.

→ Over at a dif­fer­ent Cat­a­lyst, Charles De­mocko has moved to Cat­a­lyst Bio­sciences to be­come SVP, reg­u­la­to­ry af­fairs. De­mocko had led Cy­tomX’s reg­u­la­to­ry af­fairs and qual­i­ty, and be­fore that, he was VP of reg­u­la­to­ry af­fairs at an ar­ray of com­pa­nies such as As­cendis, Kalo­Bios, No­vacea, Phar­ma­co­Fore, and Con­net­ics.

Nascent Biotech out of San Diego has as­signed Nav­paul Singh to the role of chief med­ical con­sul­tant for Covid-19 re­search, par­tic­u­lar­ly as it per­tains to their lead prod­uct, Pri­tu­mum­ab. “This op­por­tu­ni­ty with Nascent Biotech al­lows me to con­tin­ue my med­ical work in vi­ral in­fec­tions that are with us to­day and pos­si­bly in the fu­ture,” Singh said in a state­ment.

→ Cana­di­an CRO Al­ta­sciences — which pre­vi­ous­ly inked a deal with fel­low CRO WuXi last May — has en­list­ed Joseph Fran­cis­co as chief tox­i­col­o­gist. Fran­cis­co joins with ex­pe­ri­ence from his time at Charles Riv­er Lab­o­ra­to­ries, Seat­tle Ge­net­ics and Bris­tol My­ers Squibb.

Part­ner­ing with Roche’s Genen­tech on an im­muno-on­col­o­gy col­lab­o­ra­tion, Bi­cy­cle Ther­a­peu­tics has ap­point­ed Sir Kei­th Pe­ters chair­man of their sci­en­tif­ic ad­vi­so­ry board. Pe­ters, the emer­i­tus regius pro­fes­sor of physic at the Uni­ver­si­ty of Cam­bridge, was al­so on the board of med­ical ad­vis­ers to Mer­ck Re­search Lab­o­ra­to­ries and se­nior con­sul­tant in R&D for GSK.

Jane Was­man

→ Nat­ur­al killer im­munother­a­py play­er Cy­tovia Ther­a­peu­tics has added Leila Al­land and Jane Was­man to their board of di­rec­tors. Al­land, the cur­rent CMO at PMV Phar­ma, was pre­vi­ous­ly the CEO at Af­fimed and has held po­si­tions at such Big Phar­mas as As­traZeneca, Bris­tol My­ers Squibb and No­var­tis. Was­man, the chair of the board at Sel­l­as Life Sci­ences, al­so spent 15 years at Acor­da Ther­a­peu­tics.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

→ Accompanying the news that they just scored an $85 million Series C round, Laura Shawver-led Silverback Therapeutics has promoted two execs, with Valerie Odegard adding president to her CSO duties and Naomi Hunder moving to CMO. A Novo Nordisk alum, Odegard has been with the Seattle-based biotech since 2016 and the CSO the last 2 years. Before Silverback, she was VP of research at Juno Therapeutics.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”