Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Ex­change con­fer­ence with biotech and phar­ma in­dus­try in­sid­ers since be­fore the pan­dem­ic be­gan, it was no sur­prise many con­ver­sa­tions in­clud­ed Covid top­ics. Yet while vac­cines and treat­ments were dis­cussed, so too were the ef­fects on drug de­vel­op­ment, fed­er­al re­spons­es, health in­equities — and what to do now and next.

George Yan­copou­los

George Yan­copou­los, chief sci­en­tist and co­founder of Re­gen­eron, opened the con­fer­ence re­spond­ing to a ques­tion from Acor­da CEO Ron Co­hen about the spot­light on the in­dus­try dur­ing Covid and some of the “flak” bio­phar­ma has tak­en in the past.

“I hope so­ci­ety rec­og­nizes that the im­pact that dis­ease can have, mea­sured as it was in the pan­dem­ic in the tril­lions, in terms of eco­nom­ics – and not even able to cal­cu­late the loss of life and suf­fer­ing as­so­ci­at­ed,” Yan­copou­los said. “I hope that makes so­ci­ety re­al­ize that per­haps shouldn’t we be in­vest­ing more than $30 mil­lion, for ex­am­ple, for NIH fund­ing, but al­so in­vest­ing a lot more in this great in­dus­try to pro­tect our­selves against these cat­a­stroph­ic loss­es. I think we’re not do­ing enough.”

He at­trib­uted Re­gen­eron’s speed in de­vel­op­ing its ear­ly mon­o­clon­al an­ti­body treat­ment RE­GEN-COV — along with work by Pfiz­er, Mod­er­na, As­traZeneca and Eli Lil­ly — build­ing on the com­pa­nies’ decades of sci­en­tif­ic de­vel­op­ment and in­vest­ing. With much more need­ed, he point­ed out.

“We have to rec­og­nize none of the ex­ist­ing so­lu­tions for dis­ease and none of the ex­ist­ing so­lu­tions for cli­mate change will save us. We need new so­lu­tions,” he said, which will on­ly come from sup­port­ing next gen­er­a­tions of tal­ent and with in­vest­ments “at much larg­er scales than we are to­day.”

Rick Bright

For­mer BAR­DA chief Rick Bright al­so talked about the need to in­vest and im­prove not on­ly the cur­rent Covid re­sponse as it be­comes en­dem­ic, but al­so the im­por­tance of trust and truth in those ef­forts. Bright head­ed BAR­DA un­der Pres­i­dent Barack Oba­ma, join­ing in 2016, but was re­moved and re­as­signed to a low­er lev­el NIH job by the Trump ad­min­is­tra­tion in April 2020. Bright sub­se­quent­ly filed a whistle­blow­er com­plaint and tes­ti­fied be­fore Con­gress about the gov­ern­ment’s chaot­ic re­sponse to the pan­dem­ic.

“We hear a lot about the ero­sion of trust and to be trust­wor­thy we have to be hon­est,” he said. “… From the out­set of this pan­dem­ic, we didn’t have a lot of truth, hon­est­ly. So we need to make sure we’re not on­ly get­ting the truth out, but make sure we’re trans­lat­ing the truth to some­thing peo­ple can un­der­stand. When they see the de­vel­op­ment of a vac­cine or mon­o­clon­al an­ti­body ther­a­peu­tic, as George said they don’t re­al­ize that it’s been a decade worth of work. That was skipped over for a po­lit­i­cal rhetoric to say, ‘Hey, I made a vac­cine in a short pe­ri­od of time.’”

Tal Zaks

Al­so tak­ing the stage on a pan­el about per­son­al­ized med­i­cine was Tal Zaks, the for­mer chief med­ical of­fi­cer at Mod­er­na and Spike­vax Covid vac­cine de­vel­op­er, who is now a part­ner at Or­biMed.

While the ideas of per­son­al­ized med­i­cines and mass mar­ket vac­cines may seem in­con­gru­ent, Zaks not­ed that “all med­i­cine has al­ways been per­son­al­ized. We go to the doc­tor for treat­ment for our­selves, not our neigh­bor.”

In Covid-19 vac­cines and treat­ments, for ex­am­ple, per­son­al­iza­tion comes in­to play for im­muno­com­pro­mised peo­ple and some can­cer pa­tients who don’t re­spond as well and need spe­cif­ic, dif­fer­ent ther­a­pies. While costs, ben­e­fits and val­ue are fa­mil­iar top­ics in per­son­al­ized med­i­cine dis­cus­sions, Zaks said the po­ten­tial size of the pa­tient pool for per­son­al­ized med­i­cines is less im­por­tant to him than what they can de­liv­er.

“Rather than look at the rise of per­son­al­ized med­i­cine as some­thing that phar­ma went to be­cause they couldn’t make mon­ey else­where, I take a dif­fer­ent view. For me, the rea­son we’re talk­ing about per­son­al­ized med­i­cine is be­cause that’s what sci­ence has un­cov­ered,” he said. “… The world of sci­ence and the world of tech­nol­o­gy is open­ing up op­por­tu­ni­ties for us to un­der­stand pop­u­la­tions bet­ter — even in preva­lent dis­eases. If you talk to phar­ma to­day, they’re ac­tu­al­ly not shy­ing away from car­dio­vas­cu­lar dis­ease or neu­ro­log­i­cal dis­ease or di­a­betes. What they’re bring­ing to the fore is a much more nu­anced way of un­der­stand­ing those pop­u­la­tions and an in­di­vid­ual’s risk fac­tor.”

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Healthcare professionals give pharma company engagements middle-of-the-road reviews in a new survey. (Image: Shutterstock)

UCB, No­vo Nordisk, Gilead rank high­est among phar­mas for HCP cus­tomer ex­pe­ri­ence — sur­vey

When it comes to customer service to healthcare professionals, pharma companies’ overall average rating is, well, average. Its industry customer experience score of 59 is at the lower end of “good” (rated as scores from 51-75) in DT Consulting’s annual assessment out now.

Topping the list of individual pharma companies was UCB with a 66 score on the consultant’s proprietary “Customer Experience Quotient” or CXQ scale. Novo Nordisk and Gilead Sciences followed, tied for second at 65, while Boehringer Ingelheim and Johnson & Johnson’s Janssen tied for third with 64. Still, none of the top scores neared “excellent” territory of 76 or higher.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.