Up­dat­ed: Al­ny­lam pro­motes long­time ex­ec Kevin FitzGer­ald to CSO; In­tel­lia Ther­a­peu­tics brings on Lau­ra Sepp-Loren­zi­no

Kevin FitzGer­ald Linkedin

Kevin FitzGer­ald has been with Al­ny­lam since 2005, and with his ex­pe­ri­ence of “lead­ing suc­cess­ful teams on de­liv­ery tech­nolo­gies, tar­get se­lec­tion, and pro­grams in clin­ic,” he’s been pro­mot­ed to CSO of the com­pa­ny.

“Our tech­nol­o­gy is at such an ex­cit­ing stage and there are so many ap­pli­ca­tions for pa­tients in need, pri­or­i­tiz­ing what we do first (and at times, what we do not do) will be a very im­por­tant chal­lenge,” said FitzGer­ald via email.

Al­ny­lam has come a long way from its in­cep­tion in 2002. Last Au­gust the com­pa­ny re­ceived the first and on­ly ever FDA ap­proval for the treat­ment of the polyneu­ropa­thy of hered­i­tary transthyretin-me­di­at­ed (hAT­TR) amy­loi­do­sis in adults with its RNAi ther­a­peu­tic, On­pat­tro (patisir­an) — a lipid com­plex in­jec­tion.  

“Dur­ing my time at Al­ny­lam, we have gone from RNAi is a cool and ex­cit­ing pos­si­bil­i­ty, to clin­i­cal proof of con­cept that the tech­nol­o­gy works ro­bust­ly in man, to a com­mer­cial com­pa­ny with an ap­proved RNAi ther­a­peu­tic prod­uct with sev­er­al oth­ers in Phase III tri­als,” said FitzGer­ald.

FitzGer­ald joined Al­ny­lam af­ter a stint at Bris­tol-My­ers Squibb. When asked why he de­cid­ed to hop on board with the com­pa­ny, FitzGer­ald said “It may sound made up, but from the very be­gin­ning I was look­ing for a tech­nol­o­gy that could change med­i­cine. One of my men­tors told me, ‘If you are go­ing to spend a lot of time, maybe years of your life… ded­i­cat­ed to work­ing on a prob­lem, make sure at the oth­er end of it, some­thing big is the re­sult.’ I saw RNAi as an evo­lu­tion­ary con­served mech­a­nism, that if we could har­ness it, had the po­ten­tial to change how we treat hu­man dis­ease. I be­lieved way back then, but af­ter all these years… and now an ap­proved prod­uct, I am more ex­cit­ed than ever and be­lieve we are at the cusp of re­al­iz­ing what RNAi ther­a­peu­tics could do for hu­man dis­ease.”

Kel­ley Bouch­er Linkedin

In ad­di­tion to FitzGer­ald’s pro­mo­tion, Al­ny­lam has ap­point­ed Kel­ley Bouch­er as the com­pa­ny’s se­nior vice pres­i­dent, chief hu­man re­sources of­fi­cer. Bouch­er has a back­ground of over 15 years of hu­man re­sources and tal­ent ac­qui­si­tion/man­age­ment ex­pe­ri­ence in the biotech sec­tor. Be­fore Al­ny­lam, Bouch­er had a stint at Abio­med. And be­fore that, she spent 10 years at Shire.

“This tran­si­tion, along with the ad­vance­ment of the Com­pa­ny’s ro­bust and di­verse pipeline, will be en­abled by con­tin­ued in­vest­ment in glob­al growth, scal­a­bil­i­ty, and peo­ple de­vel­op­ment,” Bouch­er said. “I hope to help fos­ter this growth by en­sur­ing that we are an em­ploy­er of choice and that we con­tin­ue to cul­ti­vate an in­clu­sive and di­verse cul­ture con­ducive to for­ward think­ing and in­no­va­tion.”

→ CRISPR/Cas9 tech­nol­o­gy pi­o­neer In­tel­lia Ther­a­peu­tics wel­comed Lau­ra Sepp-Loren­zi­no as its new ex­ec­u­tive vice pres­i­dent and CSO. Sepp-Loren­zi­no joins the com­pa­ny af­ter a stint at Ver­tex Phar­ma­ceu­ti­cals as vice pres­i­dent, head of nu­cle­ic acid ther­a­pies, re­search lead­er­ship and a mem­ber of the ex­ter­nal in­no­va­tion team. Pri­or to Ver­tex, Sepp-Loren­zi­no de­vel­oped and im­ple­ment­ed the he­pat­ic in­fec­tious dis­ease strat­e­gy at Al­ny­lam and helped the com­pa­ny strength­en its RNA pipeline. Be­fore that, she spent 14 years at Mer­ck ad­vanc­ing RNAi as a nov­el ther­a­peu­tic modal­i­ty.

Ed­ward Con­ner Linkedin

Au­dentes, which is hop­ing to ri­val Sarep­ta Ther­a­peu­tics with its gene ther­a­py for DMD, has un­veiled new mem­bers of its se­nior ex­ec­u­tive team. The San Fran­cis­co-based com­pa­ny has hired for­mer Sang­amo ex­ec­u­tive Ed­ward Con­ner as CMO, and pro­mot­ed Ful­vio Mav­ilio to se­nior VP of trans­la­tion­al sci­ence. Mean­while, Au­dentes’ CMO Suyash Prasad and chief tech­nol­o­gy of­fi­cer John Gray are leav­ing the com­pa­ny.

Brent Hatzis-Schoch Black Di­a­mond

David Ep­stein-led can­cer up­start Black Di­a­mond Ther­a­peu­tics has an­nounced the ap­point­ment of Brent Hatzis-Schoch as COO and gen­er­al coun­sel of the com­pa­ny. Hatzis-Schoch has over 20 years of ex­pe­ri­ence in le­gal af­fairs at com­mer­cial and de­vel­op­ment-stage phar­ma­ceu­ti­cal and biotech­nol­o­gy com­pa­nies. He joins Black Di­a­mond af­ter stints at Ra­dius Health and Merz Phar­ma in Frank­furt, Ger­many. 

In ad­di­tion, Black Di­a­mond has made new ap­point­ments to its se­nior lead­er­ship team in prepar­ing to en­ter its lead pro­gram in­to the clin­ic next year. These ap­point­ments in­clude: Karsten Witt — who was in­volved in the clin­i­cal de­vel­op­ment of NSCLC drug Tarce­va — as se­nior vice pres­i­dent of clin­i­cal de­vel­op­ment, Nigel Wa­ters as vice pres­i­dent of pre­clin­i­cal de­vel­op­ment, As­traZeneca vet Carl Cook, vice pres­i­dent of clin­i­cal op­er­a­tions — cred­it­ed for lead­ing piv­otal stud­ies for Ires­sa — and Mer­sana vet San­na Be­lorusets as vice pres­i­dent of fi­nance.

The com­pa­ny was launched last De­cem­ber and ear­li­er this year, the com­pa­ny had raised $85 mil­lion in a Se­ries B round, bring­ing the funds raised by the first com­pa­ny out of Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel to $105 mil­lion. 

Jo­han­na Merci­er Linkedin

Gilead chief Daniel O’Day has been mak­ing quite a few changes to his ex­ec­u­tive team and now he’s ax­ing his EVP of world­wide com­mer­cial ops chief Lau­ra Hamill — who ar­rived less than a year ago from Am­gen and will be re­ceiv­ing $1.75 mil­lion in sev­er­ance up­on her for­mal de­par­ture from the com­pa­ny Ju­ly 1 — and bring­ing Jo­han­na Merci­er on board. The 10-year Bris­tol-My­ers vet has been cap­tain on large mar­kets in the US, Eu­rope and Japan. Merci­er will tack­le Gilead’s HIV mar­ket — which has faced heavy crit­i­cism for the price of its drugs — and its cell ther­a­py pipeline.

“She is a tal­ent­ed leader with a deep un­der­stand­ing of the phar­ma­ceu­ti­cal in­dus­try, across ther­a­peu­tic mar­kets and ge­o­gra­phies,” not­ed O’Day, “as well as a proven abil­i­ty to in­put the com­mer­cial per­spec­tive in­to de­vel­op­ment strate­gies.”

Pas­cal Tou­chon Co­gen

Atara Bio­ther­a­peu­tics CEO Isaac Ciechanover made a sur­prise de­ci­sion to leave the com­pa­ny in Jan­u­ary and it’s been an­nounced Tues­day that No­var­tis vet Pas­cal Tou­chon will of­fi­cial­ly join the com­pa­ny June 24. At No­var­tis, Tou­chon worked with­in on­col­o­gy as glob­al head, cell & gene and as a mem­ber of the on­col­o­gy ex­ec­u­tive com­mit­tee, where he was in charge of the glob­al roll­out of Kym­ri­ah. Pre­vi­ous­ly, Tou­chon has worked at Servi­er, Sanofi and Glaxo.

Isaac Ciechanover Atara

Ciechanover has joined the board of SQZ Biotech­nolo­gies, a cell ther­a­py biotech prep­ping a clin­i­cal en­try. “SQZ’s in­no­v­a­tive cell ther­a­py plat­form and the ther­a­peu­tics the com­pa­ny is cre­at­ing have great promise for pa­tients and can im­pact mul­ti­ple dis­eases,” he said. “Cou­pled with their ad­vances in ef­fi­cient cell ther­a­py man­u­fac­tur­ing, this is a tru­ly unique op­por­tu­ni­ty, and I am en­thu­si­as­tic about be­ing a part of the team at this piv­otal stage.”

Di­et­mar Berg­er Atara

Af­ter hop­ping out of Atara Bio­ther­a­peu­tics, Di­et­mar Berg­er has joined Sanofi. Berg­er will be the head of de­vel­op­ment and will over­see the com­pa­ny’s clin­i­cal port­fo­lio across all ther­a­py ar­eas and help the com­pa­ny bring trans­for­ma­tive new med­i­cines to pa­tients. Pri­or to join­ing Atara, Berg­er was the head of de­vel­op­ment for Genen­tech’s hema­tol­ogy and on­col­o­gy unit and is cred­it­ed with play­ing a lead role for top pro­grams like Gazy­va, Cotel­lic, Ale­cen­sa, Tecen­triq and Hem­li­bra. And be­fore Genen­tech, he was at Bay­er and Am­gen for over 16 years.

Jef­frey Sprouse Linkedin

Sanofi CSO John Reed is shift­ing away from ma­jor league part­ners like Re­gen­eron and Al­ny­lam to fo­cus on the com­pa­ny’s own on­col­o­gy pipeline.

Howard Federoff Linkedin

Ju­ve­nes­cence’s new ven­ture, Sou­vien Ther­a­peu­tics — which is cre­at­ing in­no­v­a­tive med­i­cines to ad­dress neu­rode­gen­er­a­tive dis­eases by tar­get­ing the epi­ge­net­ic un­der­pin­nings of neu­rode­gen­er­a­tion — an­nounced two new ap­point­ments. Jef­frey Sprouse — who led pre­clin­i­cal pro­grams at both Pfiz­er and Lund­beck — will join the com­pa­ny as its CEO and Howard Federoff — pro­fes­sor of neu­rol­o­gy at the Uni­ver­si­ty of Cal­i­for­nia, Irvine, Col­lege of Med­i­cine and for­mer CEO of UCI Health Sys­tem — as its chair.

Matthew Har­baugh Mallinck­rodt

→ While Mallinck­rodt Phar­ma­ceu­ti­cals re­cent­ly up­dat­ed plans for its spin-off com­pa­ny, it al­so put a full man­age­ment team in place. Matthew Har­baugh, cur­rent pres­i­dent of Mallinck­rodt’s spe­cial­ty gener­ics busi­ness and for­mer CFO of the com­pa­ny is pro­ject­ed to be­come pres­i­dent and CEO of the new com­pa­ny up­on com­ple­tion of the sep­a­ra­tion. Er­ic Slusser — who has for­mer­ly served as CFO for com­pa­nies such as Ex­press Scripts, Gen­ti­va Health Ser­vices and Cen­tene Cor­po­ra­tion —  is pro­ject­ed to serve as CFO. In ad­di­tion, the an­tic­i­pat­ed board of di­rec­tors of the new spe­cial­i­ty gener­ics com­pa­ny will con­sist of nom­i­nat­ed in­de­pen­dent chair­man James Su­lat — who has served as CEO of both Maxy­gen and Mem­o­ry Phar­ma­ceu­ti­cals — and nom­i­nat­ed chair of the au­dit com­mit­tee of the new board of di­rec­tors Michael Atieh — who was the for­mer ex­ec­u­tive vice pres­i­dent and CFO of Oph­thotech Cor­po­ra­tion.

June Al­menoff Linkedin

Red­Hill Bio­Phar­ma — a bio­phar­ma­ceu­ti­cal com­pa­ny fo­cused on gas­troin­testi­nal dis­eases — has ap­point­ed June Al­menoff as its first CSO. Al­menoff has served in var­i­ous roles, in­clud­ing stints at Fu­riex and GSK. At Fu­riex — ac­quired by Ac­tavis, now Al­ler­gan — Al­menoff worked as pres­i­dent and CMO of the com­pa­ny where the lead prod­uct, Viberzi, was ap­proved by the FDA in 2015 for the treat­ment of ir­ri­ta­ble bow­el syn­drome with di­ar­rhea (IBS-D).

John Renger Cerev­el

Cerev­el ther­a­peu­tics ex­pands their ex­ec­u­tive team with three new ap­point­ments, which in­clude John Renger as CSO, Kathy Yi as CFO and Ken DiP­i­etro as chief hu­man re­sources of­fi­cer.

Kathy Yi Cerev­el

“Cerev­el Ther­a­peu­tics was pur­pose-built to fo­cus on the unique needs of peo­ple im­pact­ed by dev­as­tat­ing ner­vous sys­tem dis­eases—a mod­el that is at­tract­ing busi­ness lead­ers with di­verse back­grounds from across the in­dus­try,” said Tony Coles, ex­ec­u­tive chair­man of Cerev­el Ther­a­peu­tics. “John, Kathy, and Ken each have a proven track record in their re­spec­tive ar­eas of ex­per­tise and will be in­stru­men­tal in ac­cel­er­at­ing our pur­suit of lead­ing-edge so­lu­tions that can mean­ing­ful­ly im­pact pa­tients’ lives.”

Ken DiP­i­etro Cerev­el

MiMedx — a com­pa­ny spe­cial­ized in wound care — has adopt­ed a com­pre­hen­sive plan — de­vel­oped by the com­pa­ny’s largest share­hold­ers, Pre­science Point Cap­i­tal Man­age­ment — to re­fresh the com­po­si­tion of its board of di­rec­tors. This comes af­ter the com­ple­tion of the com­pa­ny’s au­dit com­mit­tee’s in­de­pen­dent in­ves­ti­ga­tion in­to al­leged wrong­do­ing by the pri­or se­nior man­age­ment team and en­gage­ment of BDO USA as the com­pa­ny’s new in­de­pen­dent reg­is­tered pub­lic ac­count­ing firm.

“It is time to be­gin the Board tran­si­tion and re­fresh­ment process. […] With the Au­dit Com­mit­tee’s in­ves­ti­ga­tion com­plete and a plan to re­fresh the Board in place, the Com­pa­ny is now in a po­si­tion to fo­cus on its fu­ture and en­hance its busi­ness, for the ben­e­fit of all stake­hold­ers,” said Charles Evans, chair­man of the board.

M. Kath­leen Behrens Wilsey Linkedin

The com­pa­ny says that un­der the plan, “six new di­rec­tors, in­clud­ing MiMedx’s new CEO, Tim­o­thy Wright, would be added to the board. The re­fresh­ment plan in­cludes the ap­point­ment of three of Pre­science Point’s nom­i­nees, in­clud­ing M. Kath­leen Behrens Wilsey, as the new chair­woman of the board, as well as K. Todd New­ton, who is ex­pect­ed to be­come the chair­man of the au­dit com­mit­tee af­ter the com­pa­ny’s 2019 an­nu­al meet­ing of share­hold­ers. Oth­er ap­point­ments/nom­i­na­tions for elec­tion to the board in­clude Richard Bar­ry and James Bier­man.

 


An ear­li­er ver­sion of the sto­ry did not in­clude ap­point­ments at Black Di­a­mond Ther­a­peu­tics

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US,UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as also known as ‘Cozy Bear,’ that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.