GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

Rip Bal­lou

Rip Bal­lou, who un­til very re­cent­ly led vac­cine re­search and de­vel­op­ment at Glax­o­SmithK­line, is join­ing the In­ter­na­tion­al AIDS Vac­cine Ini­tia­tive (IAVI) to lead its US­AID-fund­ed AD­VANCE pro­gram. The pro­gram us­es a net­work of re­searchers and in­sti­tu­tions in Africa to help de­vel­op a vac­cine for HIV. Bal­lou had worked at GSK since 2010 and has led glob­al vac­cine R&D since 2015. Pri­or to that he held posts at the Bill & Melin­da Gates Foun­da­tion, a dif­fer­ent post at GSK, Med­im­mune, and Wal­ter Reed Army In­sti­tute of Re­search.  IAVI is led by Mark Fein­berg, the for­mer CSO of Mer­ck Vac­cines. 

→ As we re­port­ed yes­ter­day, Sue Desmond-Hell­mann has been elect­ed to Pfiz­er’s board of di­rec­tors along­side a ver­i­ta­ble who’s-who that in­cludes Co­ca-Co­la CEO James Quincey and for­mer FDA chief Scott Got­tlieb. Desmond-Hell­mann was CEO of the Bill & Melin­da Gates Foun­da­tion from 2014 un­til she an­nounced her de­par­ture in De­cem­ber, and be­fore sign­ing on there, was chan­cel­lor of the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co. In her 14-year tenure at Genen­tech, she led the de­vel­op­ment of two land­mark can­cer drugs, Avastin and Her­ceptin.

Lo­cana, which con­cen­trates on an RNA-tar­get­ing gene ther­a­py plat­form, has ap­point­ed Mic­ah Mack­i­son as its CBO. Mack­i­son leaves As­sem­bly Bio­sciences, where he was SVP, cor­po­rate de­vel­op­ment & strat­e­gy since 2015. He had been at a cor­nu­copia of bio­phar­ma play­ers be­fore As­sem­bly: H. Lund­beck A/S, as head of cor­po­rate strat­e­gy and se­nior di­rec­tor, new ven­tures; Ova­tion Phar­ma­ceu­ti­cals, as di­rec­tor, cor­po­rate de­vel­op­ment and M&A; and fi­nan­cial roles at Eli Lil­ly and Pfiz­er.

Mic­ah Mack­i­son

Jesse Mc­Cool has been pro­mot­ed to CEO of Cy­to­vance Bi­o­log­ics, a CD­MO that de­vel­ops and man­u­fac­tures ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) from both mam­malian cell cul­ture and mi­cro­bial fer­men­ta­tion. He re­places Yan Wang, who is step­ping down from the in­ter­im CEO post. Mc­Cool, who was pre­vi­ous­ly chief tech­nol­o­gy of­fi­cer at Ok­la­homa City-based Cy­to­vance, al­so held po­si­tions at Lon­za and Mas­co­ma Corp.

Owl­stone Med­ical gets a breath of fresh air as it wel­comes Neil Tween as its CFO. Owl­stone is the de­vel­op­er of Breath Biop­sy, which acts as a breath­a­lyz­er to mea­sure chem­i­cals in the breath for ear­ly dis­ease de­tec­tion and pre­ci­sion med­i­cine. Tween jumps to Owl­stone from GW Phar­ma­ceu­ti­cals, where he was VP and group fi­nan­cial con­troller. He al­so spent time at Jagex and De­loitte.

Neil Tween Owl­stone

→ Seneca Bio­phar­ma has made some new changes to its lead­er­ship team. The com­pa­ny wel­comed Matthew Kalnik as pres­i­dent and COO and Dane Saglio as CFO. In ad­di­tion, Seneca pro­mot­ed Thomas Hazel — who joined the com­pa­ny in 1998 — to the new po­si­tion of SVP of re­search and de­vel­op­ment. Kalnik joins the com­pa­ny from An­ti­dote Ther­a­peu­tics and held po­si­tions at Pfiz­er and Nabi Bio­phar­ma­ceu­ti­cals. Pre­vi­ous­ly, Saglio served as the CFO of Re­gen­eRx Bio­phar­ma­ceu­ti­cals.

→ AAV gene ther­a­py de­vel­op­er Stride­Bio has added Mar­itza McIn­tyre to its ex­ec­u­tive team as chief de­vel­op­ment of­fi­cer. McIn­tyre brings more than 20 years of ex­pe­ri­ence in the in­dus­try to the Re­search Tri­an­gle-based biotech. The for­mer pres­i­dent of Ad­vanced Ther­a­pies Part­ners, she al­so held VP po­si­tions at Bam­boo Ther­a­peu­tics and Re­genxbio, and was al­so chief of the gene ther­a­py branch at the FDA.

→ Af­ter a short stint at Gy­ro­scope Ther­a­peu­tics, Lau­ra Ro­ca-Alon­so has made the leap to CBO at the AI drug dis­cov­ery biotech e-ther­a­peu­tics. She was Gy­ro­scope’s di­rec­tor of busi­ness de­vel­op­ment, and be­fore that, she had a num­ber of roles at Si­lence Ther­a­peu­tics, most re­cent­ly as VP, head of cor­po­rate de­vel­op­ment.

Mar­itza McIn­tyre

→ Chi­na-based bi­o­log­ics de­vel­op­er and man­u­fac­tur­er CMAB Bio­phar­ma has tapped Ye Shi as the head of qual­i­ty. Be­fore mak­ing the leap to CMAB, Shi served as deputy gen­er­al man­ag­er and qual­i­ty as­sur­ance di­rec­tor at QILU Phar­ma­ceu­ti­cal. In ad­di­tion, Shi held posts at the PDI Com­pa­ny and Im­munomedics.

Joseph Mc­Crack­en has hopped aboard Lu­mos Phar­ma‘s board of di­rec­tors. Mc­Crack­en brings ex­pe­ri­ence from stints at Roche, Genen­tech and Aven­tis Phar­ma­ceu­ti­cals. In ad­di­tion, the com­pa­ny has tapped its CEO Rick Hawkins as chair­man of the board.

→ For­mer pres­i­dent of Pfiz­er On­col­o­gy Gar­ry Nichol­son has joined NextCure‘s board of di­rec­tors. In ad­di­tion, board mem­ber Tim­o­thy Shan­non will be step­ping down from his po­si­tion.

Kim Popovits, for­mer CEO of Ge­nom­ic Health, is join­ing the board of di­rec­tors of se­quenc­ing com­pa­ny 10x Ge­nomics.  Popovits al­so serves on the boards of Kiniksa Phar­ma­ceu­ti­cals and MyoKar­dia.

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.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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