Am­gen adds 400 jobs in cen­tral Ohio as part of an ex­pan­sion of its pack­ag­ing op­er­a­tions

For drug­mak­ers look­ing to ex­pand the sup­ply chain, re­al es­tate near some of the in­dus­try’s biggest hubs can be pro­hib­i­tive­ly ex­pen­sive. But fur­ther afield, big drug­mak­ers like Am­gen can find a bet­ter deal — and now cen­tral Ohio is set to wel­come a new neigh­bor to town.

Ar­leen Pauli­no

Am­gen will in­vest $365 mil­lion in­to a new man­u­fac­tur­ing plant in New Al­bany, OH, 18 miles north­east of Colum­bus, to fur­ther its as­sem­bly and pack­ag­ing ca­pa­bil­i­ties for med­i­cines set to be dis­trib­uted in the US, the com­pa­ny said in a re­lease.

The site will en­com­pass 270,000 square feet, and Am­gen re­ceived sev­er­al tax breaks to open up shop in the up-and-com­ing New Al­bany In­ter­na­tion­al Busi­ness Park, in­clud­ing a 100% prop­er­ty tax abate­ment for 15 years.

The lo­ca­tion will al­low for a cen­tral lo­ca­tion for dis­tri­b­u­tion around the coun­try, SVP of man­u­fac­tur­ing Ar­leen Pauli­no said in a re­lease, and Ohio will of­fer both low op­er­at­ing costs and a grow­ing tal­ent pool. Am­gen cur­rent­ly has 25,000 em­ploy­ees across the world, 14,000 of which are based in the US.

Es­te­ban San­tos

“We are adding this ad­di­tion­al as­sem­bly and pack­ag­ing plant to our glob­al sup­ply chain net­work to sup­port the an­tic­i­pat­ed growth in de­mand for Am­gen med­i­cines,” Am­gen EVP of op­er­a­tions Es­te­ban San­tos said in a state­ment. “We plan to in­clude some of our most ad­vanced dig­i­tal au­toma­tion tech­nolo­gies in this new lo­ca­tion as we part­ner with the thriv­ing busi­ness com­mu­ni­ty of the Colum­bus re­gion to fur­ther ex­pand biotech­nol­o­gy re­gion­al­ly.”

VP of site op­er­a­tions San­dra Ro­driguez-Tole­do will move from Puer­to Ri­co to Ohio to over­see the new fa­cil­i­ty. One of its fea­tures is a heavy em­pha­sis on au­toma­tion, as it will fea­ture self-dri­ving ve­hi­cles to move ma­te­r­i­al from one place in the fa­cil­i­ty to an­oth­er and smart sen­sor to eval­u­ate the prod­ucts, as well us­ing da­ta-gath­er­ing tools to pre­dict quan­ti­ty and en­sure ef­fi­cien­cy.

“Our as­pi­ra­tion is to have the most ad­vanced as­sem­bly and pack­ing op­er­a­tion while we will cre­ate a fa­cil­i­ty that will lever­age the new tech­nol­o­gy that is in the mar­ket to be able to help ad­vance au­toma­tion,” Ro­driguez-Tole­do said in a call with End­points News.

The site is set to cre­ate 400 new jobs, and Am­gen has an agree­ment with Ohio State Uni­ver­si­ty, Pres­i­dent Kristi­na John­son said, to cre­ate an in­tern­ship pro­gram and oth­er ex­pe­ri­en­tial learn­ing chances.

The New Al­bany fa­cil­i­ty will sup­port Am­gen’s cur­rent en­vi­ron­men­tal stan­dards, as the com­pa­ny aims to be car­bon neu­tral by 2027. It will al­so sup­port the OneTen ini­tia­tive, which Am­gen is a part of along with com­pa­nies such as AT&T, Lowe’s and Gilead, to hire a mil­lion Black Amer­i­cans in­to well-pay­ing jobs by 2031.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.