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

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.