Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s lat­est projects is head­ed to Har­vard.

Re­silience, a com­pa­ny start­ed with the goal of es­tab­lish­ing it­self as a “one-stop-shop” for com­pa­nies look­ing to scale man­u­fac­tur­ing, in­clud­ing for hard-to-de­vel­op cell and gene ther­a­pies, is less than a year old. Fri­day, it an­nounced a five-year R&D deal with Har­vard Uni­ver­si­ty that in­cludes $30 mil­lion to de­vel­op bi­o­log­ics, in­clud­ing vac­cines, nu­cle­ic acids and cell and gene ther­a­pies.

Lee Ru­bin

Re­silience will fund re­search fo­cused on cer­tain ther­a­peu­tics and bio­man­u­fac­tur­ing tech­nolo­gies in the uni­ver­si­ty’s labs. New com­pa­nies are ex­pect­ed to arise out of this re­search as well, the com­pa­ny said. One spin­out, dubbed Cir­cle Ther­a­peu­tics, has al­ready been cre­at­ed, and will car­ry for­ward Har­vard bi­ol­o­gist Lee Ru­bin’s work on skele­tal mus­cle stem cells for use in in vit­ro cell ther­a­pies. That aca­d­e­m­ic project is led by staff sci­en­tist Feodor Price.

“For six decades since the dis­cov­ery of the satel­lite cell, it has not been pos­si­ble to ex­pand ther­a­peu­tic num­bers of satel­lite cells in vit­ro, un­til we made re­al head­way on it at Har­vard,” Ru­bin, a pro­fes­sor of stem cell and re­gen­er­a­tive bi­ol­o­gy, said in the press re­lease. “We’re tru­ly ex­cit­ed for the pos­si­ble ther­a­peu­tic im­pact of our in­no­va­tions.”

Ru­bin’s lab has pre­vi­ous­ly re­ceived sup­port from the Blavat­nik Bio­med­ical Ac­cel­er­a­tor. The hope is that with ad­di­tion­al fund­ing, the team will be able to fast-track the tech­nol­o­gy to treat pa­tients. Re­silience and Har­vard have asked for calls for pro­pos­als to iden­ti­fy oth­er projects to be fund­ed at Har­vard, and Re­silience will get op­tions to li­cense the tech­nol­o­gy com­ing from the projects.

Isaac Kohlberg

“This re­search al­liance with Re­silience will help sup­port bio­med­ical in­no­va­tion at Har­vard,” Isaac Kohlberg, Har­vard’s chief tech­nol­o­gy de­vel­op­ment of­fi­cer, said. “Col­lab­o­rat­ing to both ad­vance Har­vard sci­ence and place aris­ing tech­nolo­gies with ded­i­cat­ed new ven­tures, we can pro­vide yet an­oth­er valu­able source of sup­port and in­dus­try ex­per­tise to trans­la­tion­al bio­med­ical re­searchers across Har­vard’s schools as they seek to im­pact hu­man health for the bet­ter.”

In Ju­ly, Re­silience shelled out $110 mil­lion to buy a lentivi­ral vec­tor man­u­fac­tur­ing site in Durham, NC. As a part of the deal, blue­bird and spin­off 2sev­en­ty will still have ac­cess to the LVV man­u­fac­tur­ing for the pipeline pro­grams. Re­silience and 2sev­en­ty are col­lab­o­rat­ing on its emerg­ing pipeline.

Be­fore that, Re­silience picked up CD­MO Ol­o­gy Bioser­vices, a Flori­da CD­MO that has part­nered with the De­part­ment of De­fense on a Covid-19 an­ti­body. It’s al­so es­tab­lished it­self in Cana­da, af­ter a pair of deals. One gave it $163 mil­lion in spend­ing from Prime Min­is­ter Justin Trudeau’s ad­min­is­tra­tion, and the sec­ond was an agree­ment with Mod­er­na to make mR­NA for the drug­mak­er’s Covid-19 vac­cine.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.