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

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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SEC calls out lit­tle Ther­a­peu­tic­sMD for its in­sid­er con­tacts with an­a­lysts to boost share price, then halt rout

Back in May 2017, following an FDA rejection, TherapeuticsMD saw its share price plummet to the lowest levels in two years. The little Florida biotech eventually found its way back to the good side of regulators, scoring a curious OK a year later for its therapy preventing vaginal pain during sex. But the SEC is now accusing it of selectively disclosing nonpublic information in attempts to manipulate its stock.

In two instances in June and July of 2017, TherapeuticsMD allegedly violated the Regulation Fair Disclosure rule by sharing material information with certain sell-side analysts and not the public, resulting in a more favorable stock move than otherwise would be expected.

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Therapists Marcela Ot'alora and Bruce Poulter are trained to conduct MDMA-assisted psychotherapy. In this reenactment, they demonstrate how they help guide and watch over a patient who is revisiting traumatic memories while under the influence of MDMA. (Photo: Multidisciplinary Association for Psychedelic Studies)

MD­MA, now in Phase III, shows promise as a PTSD treat­ment

The first time Lori Tipton tried MDMA, she was skeptical it would make a difference.

“I really was, at the beginning, very nervous,” Tipton said.

MDMA is the main ingredient in the club drug known as ecstasy or molly. But Tipton wasn’t taking pills sold on the street to get high. She was trying to treat her post-traumatic stress disorder by participating in a clinical trial.

After taking a dose of pure MDMA, Tipton lay in a quiet room with two specially trained psychotherapists. They sat next to her as she recalled some of her deepest traumas, such as discovering her mother’s body after Tipton’s mother killed two people and then herself in a murder-suicide.

Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin Bio Ventures and UBS Oncology Impact Fund in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.