Bob Nelsen

Re­silience has caught the eye of the Cana­di­an gov­ern­ment, which will in­vest $163M to boost mR­NA pro­duc­tion

Bob Nelsen’s Re­silience, with a mis­sion no less am­bi­tious than rewrit­ing the rules of drug man­u­fac­tur­ing, has raced off to a quick lead with just a year of life un­der its belt. The Cana­di­an gov­ern­ment likes what it sees, and plans to cut a healthy check to boost Re­silience’s Mis­sis­sauga fa­cil­i­ty.

The Cana­di­an Strate­gic In­no­va­tion Fund will spend $163 mil­lion will mod­ern­ize and ex­pand pro­duc­tion ca­pac­i­ty for new tech­nolo­gies such as mR­NA, the key com­po­nent of Pfiz­er/BioN­Tech and Mod­er­na’s vac­cine, at Re­silience’s site. The ex­pan­sion will add 205 new jobs in Mis­sis­sauga at a 136,000-square-foot fa­cil­i­ty that cur­rent­ly pro­vides fill-fin­ish man­u­fac­tur­ing.

Prime Min­is­ter Justin Trudeau and In­no­va­tion Min­is­ter François-Philippe Cham­pagne re­vealed the news in a press con­fer­ence Tues­day.

“The Gov­ern­ment of Cana­da’s top pri­or­i­ty is to pro­tect the health and safe­ty of Cana­di­ans,” Cham­pagne said in a state­ment. “To­day’s con­tri­bu­tion to Re­silience Biotech­nolo­gies Inc. is an­oth­er im­por­tant step to sup­port Cana­da’s lead­er­ship in the life sci­ences sec­tor and to build fu­ture pan­dem­ic pre­pared­ness. These in­vest­ments are al­so cre­at­ing well-pay­ing jobs and help­ing to grow Cana­da’s life sci­ences ecosys­tem as an en­gine for our eco­nom­ic re­cov­ery.”

An April ar­ti­cle in The At­lantic high­light­ed sev­er­al prob­lems that have con­tributed to the vac­cine short­age, with reg­u­la­tions be­ing at the top of the list. The gov­ern­ment has the abil­i­ty to reg­u­late drug prices and lim­its the num­ber of years for patent pro­tec­tion, mak­ing the coun­try a de­sir­able place to cre­ate a drug. There’s al­so a larg­er ap­petite for price-con­trol, as the gov­ern­ment is the largest buy­er of vac­cines.

On­tario has halt­ed ad­min­is­ter­ing As­traZeneca’s vac­cine as of Tues­day, af­ter 12 re­ports of blood clots in Cana­di­an pa­tients, with 3 peo­ple dy­ing. The province is ex­pect­ed to re­ceive an­oth­er 250,000 dos­es this week, the Toron­to Star re­port­ed.

The new fa­cil­i­ty will be able to man­u­fac­ture be­tween 112 mil­lion and 640 mil­lion dos­es of mR­NA vac­cines a year, an in­crease that Cham­pagne says will po­si­tion the coun­try to at­tract com­pa­nies to man­u­fac­ture dos­es both for its own coun­try and for ex­port. The move adds 50 co-op spots for young sci­en­tists to get their foot in the door.

Rahul Singhvi

Re­silience has made a num­ber of moves in its 7-month ex­is­tence. Founder Bob Nelsen was in­spired to cre­ate the start­up while sit­ting at home dur­ing the start of the Covid-19 pan­dem­ic, as there was plen­ty of news about vac­cines but not plan for the pro­duc­tion or sup­ply chain.

In April, his com­pa­ny picked up the Flori­da CD­MO Ol­o­gy Bioser­vices. In Feb­ru­ary, it ac­quired a 310,000 square-foot plant in Boston from Sanofi along with the 136,000 square-foot plant in On­tario. When those moves were made, CEO Rahul Singhvi said the com­pa­ny was just get­ting start­ed on build­ing op­er­a­tions up.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Robert Califf, FDA commissioner (Photo by Drew Angerer/Getty Images)

House com­mit­tee to in­ves­ti­gate FDA's re­sponse to on­go­ing drug short­ages

Republican leaders of the House Committee on Energy & Commerce sent a five-page letter yesterday announcing an investigation into the ongoing drug shortages that have rankled the US during the pandemic and the FDA’s response to it.

The letter, signed by Chair Cathy McMorris Rodgers (R-WA), explains how shortages have become more common over the past decade, while pointing to a report from the National Academies of Science, Engineering and Medicine finding that drug shortages have been “on the rise” over the past several decades and are lasting longer, with new drug shortages in the US seeing a 30% increase from 2021 to 2022.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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