Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Shehnaaz Suli­man

Amid Shehnaaz Suli­man’s lengthy re­sume it could be easy to miss her stint lead­ing ear­ly-stage Alzheimer’s R&D at Genen­tech, where she over­saw a pro­gram for the ill-fat­ed crenezum­ab and ini­ti­at­ed one of the first pre­ven­tion stud­ies around the dev­as­tat­ing neu­rode­gen­er­a­tive dis­ease. But it is this ex­pe­ri­ence that she — af­ter think­ing long and hard about her next ca­reer move over the past months — will be lean­ing heav­i­ly on as the first pres­i­dent and COO of Alec­tor.

Re­turn­ing to the dis­ease area af­ter spend­ing some years ad­vis­ing and work­ing for sev­er­al com­pa­nies on oth­ers, most re­cent­ly as SVP of cor­po­rate de­vel­op­ment and strat­e­gy at Ther­a­vance, Suli­man sees rea­son to be com­pelled by Alec­tor’s pi­o­neer­ing work in im­muno-neu­rol­o­gy, which is fast ap­proach­ing a piv­otal test loom­ing next year.

“The field has evolved in terms of the so­phis­ti­ca­tion with which we are now able to both iden­ti­fy as well as cor­re­late bio­mark­ers with clin­i­cal out­comes,” she told End­points News.

That in­cludes the work that some of her old col­leagues from Genen­tech are now do­ing at De­nali, just down the road on Oys­ter Point Boule­vard in South San Fran­cis­co. At Alec­tor, their big idea is that ge­net­ic mu­ta­tions and the ag­ing process ac­cel­er­ate senes­cence or de­te­ri­o­ra­tion of the brain im­mune cells. Restor­ing a healthy im­mune sys­tem can ad­dress those is­sues — and with her ex­pe­ri­ence lead­ing clin­i­cal tri­als in mild-to-mod­er­ate Alzheimer’s “I al­most in­tu­itive­ly un­der­stood how this ap­proach could be a game-chang­er.”

In her new role Shehnaaz has broad re­spon­si­bil­i­ty over day-to-day op­er­a­tions in every­thing rang­ing from pre­clin­i­cal de­vel­op­ment to po­ten­tial com­mer­cial­iza­tion strat­e­gy. A key at­trac­tion for the job is to part­ner with Arnon Rosen­thal, founder and CEO, in fig­ur­ing out how to scale the or­ga­ni­za­tion while pre­serv­ing the agili­ty through which the biotech has cre­at­ed 14 can­di­dates and ush­ered four of them in­to the clin­ic with­in five years.

“Arnon is a tow­er­ing leader in the field of neu­rode­gen­er­a­tion and he has built an in­cred­i­ble team,” she said.

She now plans to help grow that team from 117 to be­tween 120 and 140 by the end of the year. And they have got­ten more ex­perts on board for the scale-up: Alec­tor an­nounced this morn­ing that Genen­tech vet Richard Scheller and Stan­ford pro­fes­sor Thomas Süd­hof, renowned neu­ro­sci­en­tists, will co-chair their strate­gic port­fo­lio ad­vice and re­view com­mit­tee. — by Am­ber Tong


Lara Sul­li­van

Lara Sul­li­van was deep in­to seed stage on­col­o­gy op­por­tu­ni­ties, just wrap­ping up a round for a stealth pre­clin­i­cal play­er when she came across the team at Pyx­is On­col­o­gy this sum­mer.

“I im­me­di­ate­ly rec­og­nized the trans­for­ma­tive po­ten­tial of Pyx­is’s nov­el bi­o­log­i­cal ap­proach­es built on the tech­nol­o­gy out of Tom Gajew­s­ki’s lab at Uni­ver­si­ty of Chica­go,” she told End­points News. “The en­thu­si­asm in the sci­en­tif­ic com­mu­ni­ty for Tom’s work com­bined with the horse­pow­er that was al­ready in place through the Se­ries A syn­di­cate of Long­wood, Leaps by Bay­er, Agent Cap­i­tal and Ipsen made it a no-brain­er to jump on board.”

As the new CEO of the com­pa­ny, suc­ceed­ing Long­wood part­ner David Stein­berg, she will keep the team laser-fo­cused on the ear­ly pipeline while bring­ing in the right part­ners for the plat­form, which iden­ti­fies new tar­gets for can­cer im­munother­a­py from the tu­mor mi­croen­vi­ron­ment. CSO Ronald Herb­st, who joined in Oc­to­ber, has helped “set our sci­en­tif­ic strate­gies and rapid­ly at­tract tal­ent,” Sul­li­van said, and their biggest chal­lenge right now re­mains the tech­ni­cal one of pick­ing the right drugs for the right pa­tient pop­u­la­tions.

It has been a year since Sul­li­van left Spring­Works, the biotech she helped spin out of Pfiz­er with mid- to late-stage can­di­dates that didn’t make the cut for in­ter­nal de­vel­op­ment.

“I’ve al­ways felt strong­ly that great sci­ence de­serves the op­por­tu­ni­ty to de­clare it­self, and that at­tri­tion of great sci­ence (whether at dis­cov­ery or clin­i­cal stage) dri­ven by in­suf­fi­cient bud­get or in­ef­fi­cient op­er­a­tions is in­ex­cus­able,” she said.

With $22 mil­lion in Se­ries A fund­ing from deep pock­et­ed in­vestors and an ex­pe­ri­enced team in place, she is count­ing on Pyx­is to tack­le the chal­lenge head on. — by Am­ber Tong


→ More changes at com­ing at Bris­tol-My­ers Squibb. Just a day af­ter con­firm­ing BD chief Paul Bion­di’s de­par­ture, the phar­ma gi­ant said John Elick­er, EVP of cor­po­rate af­fairs and in­vestor re­la­tions, is set to re­tire by the end of March next year. His role will be split in­to two: Kathryn Met­calfe, the chief com­mu­ni­ca­tions of­fi­cer of CVS Health, has been poached to take on the lead in cor­po­rate af­fairs; 13-year vet­er­an Tim Pow­er is be­ing pro­mot­ed to head of in­vestor re­la­tions.

→ Fol­low­ing an FDA OK for its be­ta-tha­lassemia drug Re­blozyl, Ac­celeron Phar­ma has wooed Jay Back­strom, the CMO of its part­ner Cel­gene, to the new­ly cre­at­ed role of head of R&D. Back­strom moves as Cel­gene is be­ing in­te­grat­ed in­to Bris­tol-My­ers Squibb af­ter a $74 bil­lion ac­qui­si­tion. Back­strom’s pre­vi­ous stints span Pharmion, Mar­i­on Mer­rell Dow and Quin­tiles

James Burns

→  San-Diego-based Lo­cana — which launched ear­li­er this year based on ge­net­ic re­search from UC San Diego pro­fes­sor Gene Yeo’s lab — has tapped James Burns to run the com­pa­ny as CEO. Burns suc­ceeds Jef­frey Os­trove, who will con­tin­ue to serve as a board di­rec­tor. Burns joins af­ter a stint as CEO of Case­bia, lead­ing the team in de­vel­op­ing new CRISPR/Cas9 ther­a­peu­tics to treat blood dis­or­ders. Burns al­so brings ex­pe­ri­ence from his time at Sanofi-Gen­zyme to the role.

Leila Al­land

PMV Phar­ma has wel­comed Leila Al­land to the fold as CMO, help­ing push the p53 drug it re­ceived $74 mil­lion back in 2017 to test in hu­mans. Most re­cent­ly, Al­land served in the same role at Af­fimed and has pre­vi­ous­ly held stints at Tarve­da Ther­a­peu­tics, As­traZeneca, Bris­tol-My­ers Squibb, No­var­tis and Scher­ing-Plough

Eli Wal­lace

→ Af­ter drop­ping their bid to re­claim Ei­dos af­ter three of­fer re­jec­tions, Neil Ku­mar-led Bridge­Bio Phar­ma has ap­point­ed Eli Wal­lace as the com­pa­ny’s CSO in res­i­dence for on­col­o­gy. Wal­lace joins the com­pa­ny af­ter a stint as CSO at Pelo­ton Ther­a­peu­tics, the can­cer biotech Mer­ck snapped up for $2.2 bil­lion. Pri­or to Pelo­ton, Wal­lace served in the med­i­c­i­nal chem­istry de­part­ment at Ar­ray Bio­Phar­ma — where he led re­search that pro­duced eight chem­i­cal en­ti­ties for the treat­ment of can­cer, in­clud­ing Mek­tovi.

Take­dapart­nered I/O play­er Shat­tuck Labs has ap­point­ed Casi DeY­oung as CBO. DeY­oung hops aboard af­ter serv­ing as COO at Im­mune­Sen­sor Ther­a­peu­tics. Pri­or to Im­mune­Sen­sor, DeY­oung was CBO of Mir­na Ther­a­peu­tics and had var­i­ous ex­ec roles at Rea­ta Phar­ma­ceu­ti­cals, EMD Phar­ma­ceu­ti­cals and Mer­ck KGaA

Julie Grant

Julie Grant and Bren­dan Dick­in­son have been pro­mot­ed to gen­er­al part­ner at Canaan Part­ners, the Sil­i­con Val­ley-based VC firm known for jump­ing in ear­ly. Grant joined in 2013 as an as­so­ciate, af­ter a stint at Genen­tech, while Dick­in­son start­ed in 2010. Grant is the fourth woman in the com­pa­ny to be­come GP.

Roche has a slew of up­com­ing changes to its board of di­rec­tors and cor­po­rate ex­ec­u­tive com­mit­tee. As an­nounced in Ju­ly 2018, An­dreas Oeri will re­tire from the board along with John Bell — their pro­posed suc­ces­sors are Jörg Duschmalé and CEO of Swiss Life Group Patrick Frost re­spec­tive­ly. In ad­di­tion, Clau­dia Böck­stiegel, the cur­rent head of le­gal of the di­ag­nos­tics di­vi­sion, will suc­ceed gen­er­al coun­sel Got­tlieb Keller, who is step­ping out and in­to re­tire­ment. An­nette Luther, cur­rent­ly gen­er­al man­ag­er of Roche Di­ag­nos­tics In­ter­na­tion­al, will take over for Keller as sec­re­tary to the board of di­rec­tors. 

→ Af­ter se­cur­ing FDA ap­proval for its con­tro­ver­sial lead drug El­zon­ris in use for blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm (BPD­CN), on­col­o­gy-fo­cused drug de­vel­op­er Stem­line Ther­a­peu­tics has pro­mot­ed Robert Fran­co­mano from the role of SVP, glob­al head of com­mer­cial med­ical af­fairs to that of CCO. Fran­co­mano has held po­si­tions at Bax­al­ta, Pfiz­er, GSK and As­traZeneca — where he played a role with­in the com­pa­ny’s breast can­cer fran­chise.  

→ Af­ter mak­ing its de­but on the Hong Kong Stock Ex­change with a $285 mil­lion IPO in Feb­ru­ary, CStone Phar­ma­ceu­ti­cals has brought on Shirley Zhao as gen­er­al man­ag­er for Greater Chi­na and head of com­mer­cial. Pre­vi­ous­ly, Zhao was the coun­try GM for Bris­tol-My­ers Squibb, where she spear­head­ed the launch for Op­di­vo, the first PD-1 in­hibitor to en­ter the Chi­nese mar­ket. Be­fore that, Zhao had the same job at Gen­zyme and Al­ler­gan

Fresh off a $114 mil­lion round led by Sam­sara and with big plans for its CAR-NK plat­form, Nkar­ta Ther­a­peu­tics has re­cruit­ed On­coMed vet Yvonne Li as SVP, fi­nance and for­mer On­cBio­Mune Phar­ma­ceu­ti­cals CMO Bri­an Bar­nett as SVP, clin­i­cal de­vel­op­ment.

Last year Sue Dil­lon and Karyn O’Neil left J&J to launch fledg­ling Aro Bio­ther­a­peu­tics, and now the com­pa­ny has wel­comed Scott Green­berg as VP, busi­ness de­vel­op­ment and al­liance man­age­ment. Green­berg joins Aro af­ter a stint as VP, head of op­er­a­tions at Roivant Sci­ences. Pri­or to that, Green­berg spent more than a decade at Cel­gene — now swal­lowed by Bris­tol-My­ers in a $74 bil­lion deal — and Gold­man Sachs.

Sean Khozin

→ Ex-FDA of­fi­cial Sean Khozin has made the leap to join Janssen R&D as their glob­al head of da­ta strat­e­gy. Khozin was the for­mer as­so­ciate di­rec­tor for the FDA On­col­o­gy Cen­ter of Ex­cel­lence and found­ing di­rec­tor of the agency’s In­for­ma­tion Ex­change and Da­ta Trans­for­ma­tion (IN­FORMED). Khozin al­so found­ed SKMD, where he was CMO, and Hel­loHealth

Parex­el — which re­cent­ly part­nered up with Vivek Ra­maswamy’s Roivant-spawned Data­vant to em­brace re­al world ev­i­dence — has snatched up some reg­u­la­to­ry pros from the US and UK to join its team. All four will serve as tech­ni­cal vice pres­i­dents. The ad­di­tions in­clude: Mark Birse, for­mer MHRA deputy di­rec­tor of in­spec­tion, en­force­ment and stan­dards di­vi­sion; Philip Crook­er, drug de­vel­op­ment at­tor­ney; Lynne En­sor, who served as FDA act­ing deputy di­rec­tor of the of­fice of process and fa­cil­i­ties; and Yuex­ia Li, most re­cent­ly the FDA deputy di­rec­tor of the of­fice of pro­gram and reg­u­la­to­ry op­er­a­tions.

→ San Fran­cis­co start­up Verge Ge­nomics has ap­point­ed Thomas Large, the cur­rent CEO and co-founder of Blue Oak Phar­ma­ceu­ti­cals, and James Sum­mers, for­mer VP of neu­ro­science re­search at Ab­b­Vie, to its sci­en­tif­ic ad­vi­so­ry board. 

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.

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.

Endpoints News

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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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UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Ku­ra co-founder heads to Asian mul­ti-na­tion­al as biotech eyes the goal posts for lead drug

Six years after Kura Oncology snagged a farnesyl transferase inhibitor from J&J and leapt straight into clinical development, one of the biotech’s founders is leaving to start a new chapter in his career.

CMO and development chief Antonio Gualberto is exiting the company, and Kura — led by longtime biotech entrepreneur Troy Wilson — is on the hunt for a replacement. Wilson credited the CMO for some key biomarker work, including the discovery of the CXCL12 pathway as a target of their lead drug tipifarnib. Those biomarkers are being relied on to define the patient population most likely to benefit from the drug.

FDA waves Epizyme's $186K rare can­cer drug through to mar­ket — now get ready for the sec­ond act

After winning the hearts of the expert panel convened by the FDA despite a bleak in-house review and a checkered development history, Robert Bazemore has steered Epizyme to its first-ever OK for a rare cancer drug.

The approval in epithelioid sarcoma sets tazemetostat, now Tazverik, up nicely for a quick expansion to follicular lymphoma — a much bigger indication for which the biotech has just submitted an NDA.

2019 a 'trans­for­ma­tive year' for phar­ma M&A. Is that a good thing?

Big Pharma keeps getting bigger.

Fueled by the mega-mergers between Bristol-Myers Squibb and Celgene and between Allergan and AbbVie, the industry last year saw $350 billion worth of M&A, according to the new year-end report from the consultants at PwC.  That’s a more than 50% increase on 2018.

“I kind of look at 2019 as a transformational year,” report author Glen Hunzinger told Endpoints News. 

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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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