Bio­gen ex­ec Paul McKen­zie heads to CSL as COO; Pul­ma­trix CEO re­signs

Paul McKen­zie

→ Af­ter Bio­gen’s re­cent cat­a­stro­phe with ad­u­canum­ab, Paul McKen­zie, the com­pa­ny’s EVP for phar­ma­ceu­ti­cal op­er­a­tions and tech­nol­o­gy (and mem­ber of its ex­ec­u­tive com­mit­tee), jumped ship. He’s now head­ing to the Aus­tralia-based gi­ant CSL as its COO. His new job en­tails man­ag­ing CSL’s glob­al sup­ply chain. McKen­zie’s last day is May 29.

David Schi­lan­sky

→ French bio­phar­ma­ceu­ti­cal firm DBV Tech­nolo­gies an­nounced on Tues­day the de­par­ture of its deputy CEO and prin­ci­pal fi­nan­cial of­fi­cer, David Schi­lan­sky. Schi­lan­sky will re­main with the com­pa­ny through Au­gust 2019. While a search is un­der­way for a new CFO the role of deputy CEO will not be filled af­ter Schi­lan­sky’s de­par­ture. Shi­lan­sky has been with the al­ler­gy spe­cial­ist since 2011, at one point serv­ing as COO.

Robert Clarke

Pul­ma­trix CEO Robert Clarke stepped down from his po­si­tion on Thurs­day and will be im­me­di­ate­ly suc­ceed­ed by cur­rent CBO Ted Raad. Clarke will stay with the dry pow­der in­haler de­vel­op­er as an ad­vi­sor un­til Au­gust 14, 2019. Clarke was ap­point­ed CEO in 2012.

Ted Raad

Clarke said, “Af­ter fif­teen years at Pul­ma­trix grow­ing with the or­ga­ni­za­tion from Head of R&D to CSO and ul­ti­mate­ly to CEO, I’ve had the op­por­tu­ni­ty to see every as­pect of the com­pa­ny’s busi­ness. With the Pul­ma­zole pro­gram part­nered with Cipla Tech­nolo­gies, and a strong bal­ance sheet for fu­ture de­vel­op­ment, I be­lieve that the busi­ness is now head­ing in­to a promis­ing phase of its evo­lu­tion un­der Ted’s ca­pa­ble lead­er­ship.”

Michael Ca­vanaugh

→  Michael Ca­vanaugh will step up as in­ter­im CEO for Vi­tal­i­ty Bio­phar­ma and cur­rent con­troller and coun­sel of the com­pa­ny, Richard McKil­li­gan, will be pro­mot­ed to CFO and coun­sel. Ca­vanaugh will step in to re­place CEO and di­rec­tor Robert Brooke, who co-found­ed the com­pa­ny to pur­sue cannabi­noid pro­drugs.

Mi­ka Derynck

Amu­nix is fur­ther ex­pand­ing its ex­ec­u­tive team with the ap­point­ment of Mi­ka Derynck as CMO, Dar­cy Mootz as CBO and Yvonne Li as SVP of fi­nance. Ear­li­er this year, Amu­nix ap­point­ed Ang­ie You as CEO and brought on Fra­zier Life Sci­ences as a ma­jor­i­ty share­hold­er to fund and di­rect dis­cov­ery of nov­el pro­tein ther­a­peu­tics on its tech plat­form.

Ang­ie You

The new hires “bring a wealth of skills and ex­pe­ri­ences that will help ac­cel­er­ate the growth of the com­pa­ny,” said You “Their re­cruit­ment speaks to the promise of our Pro-XTEN plat­form in ad­dress­ing the key chal­lenge of on-tar­get, off-tu­mor tox­i­c­i­ty with T-cell en­gagers and cy­tokines.”

Wende Chen

Ever­est Med­i­cines wel­comed Wende Chen as chief com­mer­cial of­fi­cer of the com­pa­ny. Chen will al­so serve as an op­er­at­ing part­ner for Ever­est’s found­ing in­vestor, CBC Group, for­mer­ly known as C-Bridge Cap­i­tal. He is tasked with de­vis­ing strate­gies for Ever­est’s port­fo­lio of drugs, in-li­censed from glob­al part­ners and tar­get­ed to Asian mar­kets. Pre­vi­ous­ly, Chen served as vice pres­i­dent of cor­po­rate af­fairs, mar­ket ac­cess and chan­nel man­age­ment at Roche Phar­ma Chi­na.

Wendy Winck­ler

→ Six months af­ter woo­ing Car­o­line Loew from Bris­tol-My­ers Squibb to the helm, Glympse Bio has re­cruit­ed an­oth­er Big Phar­ma vet to its quest for dis­ease-mon­i­tor­ing sen­sors. New CSO Wendy Winck­ler joins from the No­var­tis In­sti­tutes for Bio­med­ical Re­search, where she di­rect­ed next-gen di­ag­nos­tics projects. Spun out of Sangee­ta Bha­tia’s lab at MIT and backed by Arch as well as Po­laris, Glympse Bio is get­ting ready to en­ter the clin­ic with its tech, which both de­tects dis­eases (like NASH and can­cer) and mon­i­tor pa­tients’ re­sponse to drugs.

→ Leav­ing be­hind a 17-year ca­reer at DuPont, William Fee­hery is the new CEO of Cer­tara, a provider of mod­el-in­formed drug de­vel­op­ment, reg­u­la­to­ry sci­ence, re­al-world ev­i­dence and mar­ket ac­cess ser­vices. He re­places Ed­mun­do Mu­niz, who was cred­it­ed for cast­ing a glob­al vi­sion over the past five years that Fee­hery will see to fruition.

Chris­tine Bel­lon

Beam Ther­a­peu­tics made sev­er­al lead­er­ship ap­point­ments to strength­en its man­age­ment team. The gene edit­ing biotech says that Chris­tine Bel­lon has joined as se­nior vice pres­i­dent and chief le­gal of­fi­cer; Su­san O’Con­nor has joined as chief hu­man re­sources of­fi­cer; and Suzanne Flem­ing has joined as se­nior vice pres­i­dent, fi­nance. In ad­di­tion, the com­pa­ny an­nounced that Court­ney Wal­lace has been pro­mot­ed to se­nior vice pres­i­dent and head of busi­ness de­vel­op­ment and strat­e­gy.

Su­san O’Con­nor

Tetra Nat­ur­al Health, a sub­sidiary of Tetra Bio-Phar­ma, said that it had ap­point­ed sev­er­al in­di­vid­u­als to its new board of di­rec­tors. An­dre Ran­court will be­come chair­man, while Greg Dro­han, Guy Cham­ber­land and Richard Giguère al­so joined the board ef­fec­tive Wednes­day. The com­pa­ny al­so an­nounced the ap­point­ment of Chris MacLean as COO, who is al­so COO of Panag Phar­ma and will con­tin­ue to hold the po­si­tion.

→ On Tues­day, Tetra Bio-Phar­ma an­nounced the re­tire­ment of its CFO Bernard Lessard and post­ed the ap­point­ment of Sabi­no Di Pao­la as his re­place­ment, which be­came ef­fec­tive Wednes­day.

Bi­jan Ne­jad­nik is head­ing to San­Bio as CMO of the com­pa­ny, tasked with lead­ing reg­u­la­to­ry af­fairs for its re­gen­er­a­tive med­i­cines by lever­ag­ing his vast ex­pe­ri­ence ac­crued over a long ca­reer span­ning J&J, Jazz Phar­ma, Gale­na Bio­phar­ma and Eu­re­ka Ther­a­peu­tics. Damien Bates, who un­til Wednes­day served as CMO of the com­pa­ny, will con­tin­ue to be with the com­pa­ny and in­stead, hold the po­si­tion of se­nior ad­vi­sor.

Ac­cept­ing the po­si­tion of CMO, Ne­jad­nik com­ment­ed, “I have been in­volved in the de­vel­op­ment of many new phar­ma­ceu­ti­cal drugs with a view to meet­ing un­met med­ical needs that lack ef­fec­tive treat­ment. San­Bio is a pi­o­neer in drug de­vel­op­ment for pa­tients suf­fer­ing cen­tral ner­vous sys­tem dis­or­ders. I un­der­stand that the de­vel­op­ment of SB623 has al­ready come close to the stage of prod­uct launch in Japan; tak­ing ad­van­tage of my past ex­pe­ri­ences, I will do my best to bring SB623 to pa­tients world­wide as soon as pos­si­ble.”

Christo­pher Heery

Christo­pher Heery stepped up as the new CMO of Pre­ci­sion Bio­sciences. Pre­vi­ous­ly, Heery served as CMO at Bavar­i­an Nordic. Chief de­vel­op­ment of­fi­cer, David Thom­son, com­ment­ed, “Chris brings a high­ly unique and sought-af­ter skill set to Pre­ci­sion Bio­Sciences. He has been a trans­la­tion­al clin­i­cal tri­al­ist at one of the world’s pre­em­i­nent re­search in­sti­tu­tions, NCI, where his first-in-hu­man im­munother­a­py clin­i­cal tri­als in­clud­ed a Phase I study of an an­ti-PD-L1 treat­ment (avelum­ab) that is now ap­proved for use in the Unit­ed States. Chris’s most re­cent ex­pe­ri­ence as Chief Med­ical Of­fi­cer at Bavar­i­an Nordic has giv­en him a strong un­der­stand­ing of reg­u­la­to­ry re­quire­ments, clin­i­cal tri­al over­sight, and lead­er­ship that will al­low him to play a key role in help­ing Pre­ci­sion Bio­Sciences build a suc­cess­ful clin­i­cal or­ga­ni­za­tion.”

→ Hav­ing re­cent­ly wrapped up a Phase I study for its neu­ro­pro­tec­tion drug, Barcelona’s Bionure is step­ping up its clin­i­cal game with a new leader. As CMO, Lu­cia Sep­tien will help fi­nal­ize and ex­e­cute Phase II plans for BN201, a po­ten­tial treat­ment for acute op­tic neu­ri­tis and mul­ti­ple scle­ro­sis. Sep­tien jumps from DBV Tech­nolo­gies, where she held the same role fol­low­ing pre­vi­ous stints at Pfiz­er, GSK and Ipsen.

An­tho­ny Pe­traglia

Geron is con­tin­u­ing to build its de­vel­op­ment team by adding two new se­nior lead­er­ship ap­point­ments. Ying Wan was an­nounced as vice pres­i­dent, bio­met­rics, while Patrick Mur­phy was an­nounced as vice pres­i­dent, man­u­fac­tur­ing. Both po­si­tions will sup­port the com­pa­ny’s late-stage clin­i­cal de­vel­op­ment, which in­cludes the “planned open­ing of the Phase III clin­i­cal tri­al of ime­tel­stat in low­er risk myelodys­plas­tic syn­dromes for screen­ing and en­roll­ment by mid-year 2019.”

Geo­cann an­nounced the ap­point­ment of An­tho­ny Pe­traglia as CMO of the com­pa­ny as well as chair­man of the sci­en­tif­ic and med­ical ad­vi­so­ry board. Pe­traglia is a neu­ro­sur­geon at Rochester Re­gion­al Health and serves as the ex­ec­u­tive di­rec­tor of the hos­pi­tal’s con­cus­sion pro­gram. In his new role, Pe­traglia will work close­ly with the com­pa­ny’s glob­al part­ner tech­nol­o­gy ex­change, in­clud­ing Zurich, Switzer­land-based Vesi­fact AG, as well as the or­ga­ni­za­tion’s sci­en­tif­ic and med­ical ad­vi­so­ry board com­prised of physi­cians, nurs­es and prod­uct for­mu­la­tors.

Am­ber Tong con­tributed re­port­ing

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 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.