At­las-backed Dyne taps Joshua Brumm as CEO; Sekar Kathire­san woos car­di­ol­o­gist to gene edit­ing start­up

Ro­mesh Sub­ra­man­ian’s new biotech start­up, Dyne Ther­a­peu­tics, which is us­ing oligonu­cleotides to de­grade RNA re­spon­si­ble for dis­ease has brought on Joshua Brumm as pres­i­dent and CEO. Sub­ra­man­ian will now take on the CSO role af­ter launch­ing the biotech as en­tre­pre­neur-in-res­i­dence at At­las Ven­ture. Brumm makes the leap af­ter a stint as COO and CFO of Kalei­do Bio­sciences, where he led the com­pa­ny’s IPO and helped bring its lead pro­gram in­to Phase II de­vel­op­ment. Pri­or to Kalei­do, Brumm was the COO and CFO at Ver­sar­tis. His oth­er pre­vi­ous roles span Phar­ma­cyclics, ZEL­TIQ Aes­thet­ics, Pro­te­olix, Cit­i­group Glob­al Mar­kets and Mor­gan Stan­ley

Sekar Kathire­san has wooed a vet­er­an car­di­ol­o­gist and sea­soned biotech en­tre­pre­neur to his mis­sion to pro­tect the world from heart dis­ease via gene edit­ing. An­drew Bellinger is the new CSO at Verve Ther­a­peu­tics, tak­ing up the same role he oc­cu­pied at Lyn­dra, a biotech he co-found­ed based on drug de­liv­ery tech in­vent­ed by Bob Langer. He will now di­rect the re­search and trans­la­tion­al skills ac­crued there (and Co­coon Biotech be­fore that) to safe­ly ed­it genes to low­er the risk of coro­nary artery dis­ease.

“In my car­di­ol­o­gy prac­tice, I’ve seen first­hand the lim­i­ta­tions of our present-day ap­proach to car­dio­vas­cu­lar dis­ease,” Bellinger, who sees pa­tients at Brigham and Women’s Hos­pi­tal, said in a state­ment. “With Verve, we have a pro­found op­por­tu­ni­ty to change the dy­nam­ic of health­care de­liv­ery for peo­ple liv­ing with or at risk for coro­nary artery dis­ease — con­fer­ring life­long re­sis­tance with a gene-edit­ing treat­ment giv­en once in life.”

Jnana Ther­a­peu­tics has brought on Al­ny­lam vet Car­o­line Stark Beer as CBO in search of new part­ners for its SLC trans­porter tech, which has spawned treat­ments for in­flam­ma­to­ry and neu­ro­log­i­cal dis­eases. Dur­ing her time at Al­ny­lam, Stark Beer served in a va­ri­ety of po­si­tions, in­clud­ing vice pres­i­dent and head of busi­ness de­vel­op­ment — where she helped fa­cil­i­tate part­ner­ships and li­cens­ing deals with Sanofi Gen­zyme and Re­gen­eron. Pri­or to her time at Al­ny­lam, Stark Beer held roles at Am­i­cus Ther­a­peu­tics and Bain & Com­pa­ny.

→ Fol­low­ing re­cent big changes at Vor Bio­phar­ma — the ap­point­ment of Robert Ang as CEO, the com­pa­ny’s re­cent move in­to an in­te­grat­ed head­quar­ters in Cam­bridge, MA and a $42 mil­lion Se­ries A round — the biotech has en­list­ed two more cell ther­a­py ex­perts to the team. Sadik Kas­sim and Tirtha Chakraborty have been named chief tech­nol­o­gy of­fi­cer and VP of re­search, re­spec­tive­ly. Kas­sim joins the com­pa­ny af­ter a stint as ex­ec­u­tive di­rec­tor at Kite Phar­ma and pre­vi­ous roles at Mus­tang Bio, No­var­tis (where he con­tributed to the BLA and MAA fil­ings for Kym­ri­ah), the Na­tion­al Can­cer In­sti­tute and Janssen. Chakraborty joins the com­pa­ny from Sana Biotech­nol­o­gy, where he served as VP of cell ther­a­py re­search. Pri­or to his time at Sana, Chakraborty was the head of hema­tol­ogy at CRISPR Ther­a­peu­tics and served a stint at Mod­er­na Ther­a­peu­tics

Sang­amo has se­lect­ed Bet­ti­na Cock­roft as the com­pa­ny’s SVP and CMO. Cock­roft draws from ex­pe­ri­ence from her time at Cy­tokinec­tics, where she was re­spon­si­ble for the clin­i­cal de­vel­op­ment of fast skele­tal mus­cle tro­ponin ac­ti­va­tors in dis­eases such as amy­otroph­ic lat­er­al scle­ro­sis and spinal mus­cu­lar at­ro­phy. In her new role, Cock­roft will shift fo­cus to gene-edit­ing pro­grams, in­clud­ing one for he­mo­phil­ia A part­nered with Pfiz­er. In ad­di­tion, Cock­roft has served as CMO of Au­ris Med­ical and pre­vi­ous­ly worked at Mer­ck Serono, No­var­tis Con­sumer Health and Menar­i­ni Ricerche

As­cle­tis Phar­ma — a com­pa­ny that paved the way in de­vel­op­ing and com­mer­cial­iz­ing Chi­na’s first home-cul­ti­vat­ed he­pati­tis C drug — has an­nounced that its CFO Lin­di Tan is de­part­ing. Tan’s de­par­ture comes weeks af­ter the Hangzhou-based biotech lost Zhengqing Li, a for­mer top Mer­ck ex­ec who jumped to the com­pa­ny as its CMO and pres­i­dent of R&D just months pri­or to help ex­tend its glob­al reach.

→ Sev­en years in­to a tu­mul­tuous tenure at Te­va — in which he was charged with down­siz­ing and clos­ing out man­u­fac­tur­ing op­er­a­tions while the com­pa­ny faced a probe in­to gener­ic drug price hikes in the US — Car­lo de No­taris­te­fani, EVP of glob­al op­er­a­tions, is step­ping down to re­tire.  Er­ic Drapé has been cho­sen as his suc­ces­sor and will be based out of the com­pa­ny’s glob­al head­quar­ters in Is­rael. Drapé joined the com­pa­ny in 2014 and has since served var­i­ous roles, in­clud­ing as EVP and chief qual­i­ty of­fi­cer and SVP, tech­ni­cal op­er­a­tions ster­iles, res­pi­ra­to­ry and bi­o­log­ics. No­taris­te­gani’s ex­it comes in the wake of two oth­er top ex­ec ex­its — CFO Michael Mc­Clel­lan and EVP glob­al brand and com­mu­ni­ca­tions Iris Beck-Cod­ner.

→ Af­ter it was an­nounced last week, in a sur­prise twist, that Akcea pres­i­dent Sarah Boyce along with her two top ex­ec col­leagues, CEO Paula Soteropou­los and COO Jef­frey Gold­berg were leav­ing the Io­n­is spin­off, Boyce has found a new home at Avid­i­ty Bio­sciences. The com­pa­ny is work­ing on an­ti­body-oligonu­cleotide con­ju­gates (AOCs), and as their new CEO Boyce will draw from ex­pe­ri­ence from her pre­vi­ous stints at Io­n­is, For­est Lab­o­ra­to­ries, Alex­ion Phar­ma­ceu­ti­cals, No­var­tis On­col­o­gy, and Roche.

→ Back in Ju­ly, AM-Phar­ma raised $113 mil­lion from a Eu­ro­pean syn­di­cate to help fund its planned Phase III tri­al in pa­tients with sep­sis-as­so­ci­at­ed acute kid­ney in­jury. Now the com­pa­ny is ex­pand­ing its lead­er­ship team with the ap­point­ments of Ju­liane Bern­holz as COO and Kristie Bass as VP clin­i­cal op­er­a­tions. Bern­holz will draw up­on ex­pe­ri­ence from her roles at Janssen, Sanofi, No­var­tis and Acte­lion. Bass tran­si­tions to her new po­si­tion af­ter serv­ing as se­nior di­rec­tor of project de­liv­ery at CRO PRA Health Sci­ences and di­rec­tor, project man­ag­er at PPD. Both Bern­holz and Bass will move from the US to the Nether­lands.

Neu­ro­crine Bio­sciences — which, back in Jan­u­ary, struck up a $1.8 bil­lion gene ther­a­py pact with Voy­ager Ther­a­peu­tics to snag the rights of four of their gene ther­a­py pro­grams — has wel­comed David Boy­er aboard as chief cor­po­rate af­fairs of­fi­cer. Boy­er makes the jump af­ter a stint at BGR Group as prin­ci­pal and head of the health & life sci­ences prac­tice. Pri­or to his role at BGR, Boy­er served as spe­cial as­sis­tant to the pres­i­dent for leg­isla­tive af­fairs un­der Pres­i­dent George W Bush, as­sis­tant com­mis­sion­er for leg­is­la­tion at the FDA and spe­cial as­sis­tant to the sec­re­tary at the US De­part­ment of Health and Hu­man Ser­vices. He’s al­so held po­si­tions at BIO and PhRMA.

→ Months af­ter strik­ing a re­verse merg­er deal with strug­gling His­to­gen­ics, Malvern, PA-based Ocu­gen has ap­point­ed San­jay Sub­ra­man­ian to the role of CFO. Sub­ra­man­ian joins the rare eye dis­ease-fo­cused biotech from the same po­si­tion at Ar­alez Phar­ma­ceu­ti­cals, where he helped the com­pa­ny close $350 mil­lion in fi­nanc­ing. Pri­or to his stint at Ar­alez, Sub­ra­man­ian held po­si­tions at Bausch Health Com­pa­nies and Gen­er­al Mo­tors.

Retrophin has tapped Pe­ter Heer­ma as CCO. Heer­ma will be in charge of the com­pa­ny’s com­mer­cial­iza­tion strat­e­gy for ap­proved prod­ucts and pre-com­mer­cial plan­ning of pipeline pro­grams, which in­cludes sparsen­tan — cur­rent­ly be­ing eval­u­at­ed in Phase III tri­als for fo­cal seg­men­tal glomeru­loscle­ro­sis and IgA nephropa­thy. But that group won’t in­clude fos­met­pan­tote­nate, the drug that its no­to­ri­ous founder Mar­tin Shkre­li co-in­vent­ed, af­ter it flopped in a piv­otal tri­al. Most re­cent­ly, Heer­ma was the glob­al prod­uct man­ag­er for on­col­o­gy and car­dio­vas­cu­lar prod­ucts at Am­gen and has al­so served roles at Ab­b­Vie and Ab­bott

→ UK-based VC and life sci­ences com­pa­ny, Ar­ix Bio­science — which re­cent­ly co-led a $63 mil­lion round for drug de­vel­op­er Imarahas an­nounced that their CFO, James Rawl­ing­son is hit­ting the ex­it. Rawl­ing­son is the cur­rent non-ex­ec­u­tive di­rec­tor and chair­man of the au­dit and risk com­mit­tee at Citibank UK. In ad­di­tion, the com­pa­ny’s group fi­nan­cial con­troller, Mar­cus Karia, has been pro­mot­ed to group fi­nance di­rec­tor.  

→ Neoanti­gen play­er PACT Phar­ma has wooed Tim Moore from Kite to run tech­ni­cal ops as the com­pa­ny’s pres­i­dent and chief tech­ni­cal of­fi­cer. The prospect of tack­ling sol­id tu­mors by hit­ting neoanti­gens that form a unique sig­na­ture on each — drew him to the new op­por­tu­ni­ty, Moore told End­points News

In­com­ing Ver­tex CEO Resh­ma Ke­wal­ra­mani has se­lect­ed her re­place­ment as CMO, choos­ing to pro­mote a mem­ber of the R&D team to the post. Car­men Boz­ic, who joined the com­pa­ny last May from Bio­gen, has been named EVP, Glob­al Med­i­cines De­vel­op­ment and Med­ical Af­fairs to­day and gets to add the new ti­tle of CMO next April as Ver­tex cau­tious­ly trans­fers the reins to a new CEO who much to prove in or­der to win over some skep­ti­cal an­a­lysts. Boz­ic’s first job at Ver­tex was lead­ing clin­i­cal de­vel­op­ment of the com­pa­ny’s cys­tic fi­bro­sis and al­pha-1 an­tit­rypsin de­fi­cien­cy pro­grams, as well as clin­i­cal op­er­a­tions across the pipeline. In ad­di­tion, Nia Tat­sis, Ver­tex’s SVP, glob­al reg­u­la­to­ry af­fairs, is tak­ing over as head of reg­u­la­to­ry, ef­fec­tive im­me­di­ate­ly. 

→ Just a lit­tle more than 3 years af­ter Michael Ehlers took the job as glob­al head of R&D for the now deeply trou­bled Bio­gen, he’s jump­ing ship. CEO Michel Vounatsos has ap­point­ed CMO Al San­drock, a chief ar­chi­tect of the drug­mak­er’s deeply flawed pipeline strat­e­gy, as his re­place­ment. Ehlers will go on to a new ca­reer op­por­tu­ni­ty as a ven­ture part­ner and CSO at Ap­ple Tree, which comes with a CEO job at a gene ther­a­py start­up named Lime­light Bio. In ad­di­tion, Vounatsos named Alphonse Galdes ex­ec­u­tive vice pres­i­dent, phar­ma­ceu­ti­cal op­er­a­tions and tech­nol­o­gy.

→ For­mer FDA Com­mis­sion­er Robert Califf and his inim­itable mus­tache will be on proud dis­play as he makes his way to Al­pha­bet to take a full-time role as head of med­ical strat­e­gy and pol­i­cy across the Google Health and Ver­i­ly units, come mid-No­vem­ber. 

→ Ther­a­peu­tic pro­tein man­u­fac­tur­er AGC Bi­o­log­ics has ap­point­ed Jef­frey Mow­ery as site head/gen­er­al man­ag­er of the com­pa­ny’s Copen­hagen, Den­mark fa­cil­i­ty. He will work with his col­leagues in Seat­tle to com­bine the com­pa­ny’s glob­al ca­pa­bil­i­ties. Mow­ery’s pre­vi­ous stints in­clude Juno Ther­a­peu­tics, Lon­za and Genen­tech.

PhRMA has named Jen­nifer Bryant as EVP of pol­i­cy and re­search, suc­ceed­ing Lori Reil­ly who was re­cent­ly ap­point­ed COO. Bryant has been with PhRMA for 13 years and most re­cent­ly served as SVP of pol­i­cy and re­search. Pri­or to her time at PhRMA, Bryant served as vice pres­i­dent at health­care con­sult­ing firm, The Lewin Group and worked at the Blue Cross Blue Shield As­so­ci­a­tion.

Opti­nose has hired Michael Richard­son as VP, busi­ness de­vel­op­ment to beef up its port­fo­lio of po­ten­tial treat­ments for ear, nose and throat. As the com­pa­ny be­gins to mar­ket its Xhance nasal spray for nasal polyps, Richard­son will eval­u­ate new op­por­tu­ni­ties to sup­port long-term growth, the com­pa­ny said. He joins from a com­mer­cial role at Prince­ton Bio­phar­ma.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Samantha Truex (file photo)

Bruce Booth and Saman­tha Truex's lat­est ven­ture aims just above Hu­mi­ra

In 2000, about a year after the first trial data on Humira came out, a Japanese team identified a new gene that appeared to prevent GI cancer in mice: gasdermin, they called it, after the particular proteins it expressed.

Over the next decade-and-a-half, scientists found five more genes in the same family – often identified as gasdermin A, B, C, D, E and F – and yet their purpose baffled scientists. Mutations in A appeared to make mice bald (alopecia), but deleting it had no effect. Mutations in F and A were linked to deafness. Mutant E caused human cells to self-destruct.

FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back — this time flunk­ing fu­til­i­ty test — as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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