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From Endpoint news yesterday:

Fresh turmoil inside Novartis’ revamped CAR-T organization as top exec jumps ship

by john carroll
March 30, 2017 12:37 PM EDT
Updated: March 31, 2017 06:07 AM



There’s more tur­moil to re­port from in­side No­var­tis’ CAR-T camp.

On Fri­day Karen Walker will leave a se­nior po­si­tion in charge of CMC/man­u­fac­tur­ing of CAR-Ts for No­var­tis in ex­change for a new po­si­tion she’s tak­ing at Seat­tle Ge­net­ics, End­points News has learned.

Walker — the VP Global Head Cell and Gene Ther­a­pies Tech­ni­cal De­vel­op­ment and Man­u­fac­tur­ing at No­var­tis — was one of three se­nior execs put in charge of the cell and gene ther­apy ini­tia­tive at the com­pany last fall, ac­cord­ing to sources close to the com­pany, after a bruis­ing re­struc­tur­ing over the sum­mer in which the unit was chopped up and ab­sorbed in­side a huge R&D or­ga­ni­za­tion. Samuele Butera was put in charge of the com­mer­cial/busi­ness as­pect of the group while David Leb­wohl han­dles clin­i­cal ops.

“Karen Walker will join Seat­tle Ge­net­ics as Vice Pres­i­dent of Global Qual­ity in mid-April,” con­firmed a spokesper­son for Seat­tle Ge­net­ics.

I con­tacted Eric Al­thoff, a spokesper­son for No­var­tis, Wednes­day night, but after ac­knowl­edg­ing my query he did not fol­low up. Al­thoff has de­clined to re­spond to a fol­lowup query.

No­var­tis has been bleed­ing tal­ent through­out its global or­ga­ni­za­tion for the past year. Walker’s de­par­ture, though, comes at a par­tic­u­larly crit­i­cal stage for No­var­tis, just days after the pharma giant gained a pri­or­ity re­view for CTL019, putting it on a short path to per­haps the first his­toric ap­proval for a CAR-T.

Last sum­mer End­points broke the story about No­var­tis’ re­or­ga­ni­za­tion in CAR-T, which led the group’s top exec, Usman ‘Oz’ Azam, to leave No­var­tis. About 120 staffers were also ter­mi­nated as the sep­a­rate group was pulled back into the R&D struc­ture.

No­var­tis has kept up a neck-and-neck race with Kite on the lead pro­gram, which has its own pi­o­neer­ing CAR-T headed to the FDA.

Man­u­fac­tur­ing in this field is crit­i­cal. To make this ther­apy, physi­cians ex­tracts cells from can­cer pa­tients and then reengi­neer them with a chimeric anti­gen re­cep­tor to guide them to at­tack can­cer cells. The re­vised cells are then in­jected back into pa­tients. To be com­pet­i­tive, a com­pany has to prove not only that they know how to make the ther­apy, they also have to be able to turn it around quickly for use.

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