Cel­gene vet Jack­ie Fouse grabs the reins of a Vivek Ra­maswamy vant-up

Jack­ie Fouse has land­ed.

A lit­tle more than four months af­ter Fouse said she was “re­tir­ing” as pres­i­dent of Cel­gene, she’s back run­ning her own biotech as ex­ec­u­tive chair­man of Der­ma­vant, one of sev­er­al new “vants” that Roivant chief Vivek Ra­maswamy has kicked in­to play over the last three years.

Fouse wrapped up her fi­nal lap at Cel­gene a few days ago, end­ing a 3-month leg as a com­pa­ny ad­vis­er to see out her tran­si­tion from the big biotech, which has per­haps the busiest deal­mak­ing group in the in­dus­try.  She moves from a top job at a bell­wether com­pa­ny to a start­up with a few ad­vanced ther­a­pies in the clin­ic. And she tells me that the part­ner­ing work she did at Cel­gene will help her get start­ed on her new job as ex­ec­u­tive chair­man.

Der­ma­vant is a pri­vate start­up, so we aren’t get­ting any de­tails on the pay pack­age. But if Ra­maswamy’s re­cent hires are any in­di­ca­tion, it like­ly in­cludes a hefty slice of eq­ui­ty with po­ten­tial to pay off with a few suc­cess­es in the clin­ic.

For Ra­maswamy, who’s been ramp­ing up a line­up of new com­pa­nies, a high-pro­file hire like Fouse fits per­fect­ly in­to a strat­e­gy to build cred­i­bil­i­ty quick­ly by woo­ing some note­wor­thy fig­ures to run his com­pa­nies. He did that just a few months ago with the move to bring in David Hung to run Ax­o­vant, fo­cused on Alzheimer’s and de­men­tia, not long af­ter Hung com­plet­ed the $14 bil­lion sale of Medi­va­tion to Pfiz­er.

“Over the past three years, I have come to the con­clu­sion that qual­i­ty of lead­er­ship and per­son­nel will be the most im­por­tant de­ter­mi­nants of suc­cess for Roivant over the long run,” Ra­maswamy told me. “In three years, it is my hope that Der­ma­vant will be one of the lead­ing com­pa­nies in the world in de­vel­op­ing tru­ly in­no­v­a­tive treat­ments for med­ical der­ma­to­log­ic con­di­tions, as op­posed to fol­low­ing the his­tor­i­cal path of ‘derm-fo­cused’ com­pa­nies that have sought to sell re­for­mu­la­tions or al­ter­na­tive­ly-brand­ed ver­sions of drugs that have been around for many decades. We hope to build not on­ly a world-class de­vel­op­ment team at Der­ma­vant, but al­so a lead­ing com­mer­cial or­ga­ni­za­tion in the field of med­ical der­ma­tol­ogy.”

These days, when you hear a se­nior bio­phar­ma ex­ec at a top-20 com­pa­ny is re­tir­ing, it’s of­ten just a pre­lude to a new job at a biotech start­up, where an eq­ui­ty stake can pay off in ways that a ca­reer of­ten can’t.

In a pre­view to to­day’s news, I got a chance to ask Fouse a few ques­tions by email. Here’s what she had to say about the move.

JC: I would safe­ly say that every­one in the in­dus­try has been look­ing to see where you’d land af­ter Cel­gene. I’m go­ing to as­sume you had some choic­es on your next role. Was there one key, de­cid­ing fac­tor that steered you to Der­ma­vant?

JF: What I found most com­pelling about Der­ma­vant was the com­pa­ny’s mis­sion, name­ly of­fer­ing in­no­v­a­tive so­lu­tions to press­ing un­met needs in med­ical der­ma­tol­ogy. I think the ther­a­pies in de­vel­op­ment at Der­ma­vant have strong mech­a­nis­tic ra­tio­nales and I have been im­pressed with what the Der­ma­vant and Roivant teams have done up to now to put to­geth­er a pipeline of late stage, in­ter­est­ing as­sets and con­tin­ue to ad­vance their de­vel­op­ment. The com­bi­na­tion of the clin­i­cal and med­ical skills of the ex­ist­ing Der­ma­vant team and those of the Roivant non-clin­i­cal, reg­u­la­to­ry and busi­ness de­vel­op­ment teams have de­liv­ered a great ex­ist­ing pipeline for Der­ma­vant.

JC: You’ve got a cou­ple of drugs in the pipeline. Do you plan on more deals and is an IPO on the hori­zon? In short, what are you go­ing to do with the com­pa­ny now? What’s your man­date?

JF: We have no plans for an IPO in the near term. The com­pa­ny is ful­ly fund­ed and sup­port­ed by Roivant to pur­sue all of its cur­rent and fu­ture de­vel­op­ment pro­grams at full speed. My im­me­di­ate man­date is to rapid­ly build the pipeline fur­ther through the right sort of part­ner­ships, while ad­vanc­ing the three drugs which are in the com­pa­ny’s pipeline to­day. My long-term ob­jec­tive at Der­ma­vant is to scale a com­pa­ny from the ear­ly stages of its growth in­to an in­dus­try leader in an im­por­tant and ne­glect­ed ther­a­peu­tic area.

JC: And fi­nal­ly, what’s the one thing you learned at Cel­gene that will be most help­ful in this new role?

JF: At Cel­gene I was re­spon­si­ble for man­ag­ing a port­fo­lio of cor­po­rate part­ner­ships through the com­pa­ny’s dis­trib­uted re­search and de­vel­op­ment mod­el. I learned how to man­age those re­la­tion­ships and de­liv­er mu­tu­al­ly ben­e­fi­cial so­lu­tions that served the needs of our part­ners. At Der­ma­vant, I in­tend to do the same thing as the com­pa­ny forms new part­ner­ships with oth­er com­pa­nies work­ing in med­ical der­ma­tol­ogy.

In a fol­lowup, she not­ed:

I should al­so add that at Cel­gene the dis­trib­uted R&D mod­el and port­fo­lio of part­ner­ships was a joint con­struc­tion across our ear­ly re­search team, name­ly Tom Daniel who I think you know, and BD team led by George Golumbes­ki along with oth­ers and me when I was CFO, head of hem/onc and COO. Team ef­fort, not just my su­per­vi­sion.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Martin Shkreli (Photo by Drew Angerer/Getty Images)

Mar­tin Shkre­li re­ceives life­time in­dus­try ban, forced to re­turn al­most $65M in prof­its af­ter an­ti­com­pet­i­tive scheme

Martin Shkreli will have to find a new nickname.

A federal judge banned the former biotech CEO and “Pharma Bro” from the drug industry on Friday, ordering him to pay nearly $65 million in illicit profits. Shkreli was convicted of securities fraud in 2017 and is currently serving a seven-year prison sentence, though he originally gained notoriety for raising the price of the antiparasitic drug Daraprim from $13.50 to $750 in 2015.