Care about R&D strate­gies? Have we got a sum­mit for you

If there’s one un­der­ly­ing les­son I’ve learned watch­ing bio­phar­ma in ac­tion over the past 20 years or so, it’s that no R&D or­ga­ni­za­tion can rest on its lau­rels. Es­pe­cial­ly the larg­er ones. You’ve had a big suc­cess? Great. Now how do you plan to fol­low up on that? And how soon? Hit by fail­ure? What’s Plan B, C, D and E?

Lars Fruer­gaard Jør­gensen

And that’s the cen­tral mes­sage of my up­com­ing Eu­ro­pean Bio­phar­ma Sum­mit com­ing up next week. I’ll be talk­ing to 5 top bio­phar­ma ex­ec­u­tives about their next-gen game plans.

— No­vo Nordisk CEO Lars Fruer­gaard Jør­gensen and I have had a lot to talk about. Semaglu­tide has been the kind of suc­cess sto­ry any com­pa­ny likes to tell, es­pe­cial­ly now that it looks to make block­buster re­turns in fight­ing obe­si­ty — one of the tough­est nuts to crack in drug R&D his­to­ry. But we know that al­ready. What hap­pens now in R&D? The com­pa­ny has some am­bi­tious plans for build­ing the pipeline, and a clear strat­e­gy for where it wants to head. And there are even more plans for semaglu­tide in R&D.

Su­san Gal­braith

Su­san Gal­braith had a big role to fill when she took José Basel­ga’s job at As­traZeneca, fol­low­ing the top sci­en­tist’s trag­ic death. But com­ing from the trans­la­tion­al side of can­cer drug re­search, she’s top­ping a lengthy ca­reer in Big Phar­ma by fol­low­ing in­sights in­to the 2.0 gen­er­a­tion of can­cer drugs and com­bos. She has a lot to say, and I’m pay­ing close at­ten­tion. You should too.

John Tsai

— One of the key is­sues in any big de­vel­op­ment group is defin­ing risk. How do you em­brace the idea of a high-risk, high-re­ward pro­gram? For No­var­tis de­vel­op­ment chief John Tsai, that in­volves a “wild card” strat­e­gy we’ll be dis­cussing, where the phar­ma picks up a tough chal­lenge and goes in­to the clin­ic — know­ing that a win could de­liv­er a com­pa­ny-build­ing drug, but that suc­cess is far from se­cure. That’s one of sev­er­al things we’ll be talk­ing about No­var­tis’ de­vel­op­ment strat­e­gy.

Jean-François Tou­s­saint

— Then there’s mR­NA. You don’t even need to ex­plain it any­more. What start­ed out with a hand­ful of star­tups a decade ago has be­come the New, New Thing in bio­phar­ma now that the tech has de­liv­ered the top 2 vac­cines be­ing used to fight a pan­dem­ic. Of course, there’s a lot — and I mean a lot — that still has to be done to prove the full po­ten­tial. And there are def­i­nite­ly no guar­an­tees. I’ll be talk­ing with Jean-François Tou­s­saint, the head of glob­al R&D at Sanofi Pas­teur, which is in­vest­ing heav­i­ly in the field, and Sean Marett, a top ex­ec at BioN­Tech.

Sean Marett

One of the most in­ter­est­ing star­tups in the in­dus­try has been Centes­sa, as­sem­bled by the start­up crew at Medicxi. David Grainger played a big role in that com­pa­ny, and now he’s tak­en on the task of chief deal­mak­er as they con­tin­ue to build up the pipeline. Grainger and End­points News pub­lish­er Ar­salan Arif will be ex­plor­ing that in a one-on-one ses­sion.

David Grainger

And fi­nal­ly, my co-host for this year’s event, Sil­i­con Val­ley Bank’s Nooman Haque, will be wrap­ping up with an­oth­er look at the Eu­ro­pean biotech fi­nance land­scape with 3 top play­ers: Alex Pas­teur at F-Prime, Juli­ette Au­det from For­bion and Thomas Burt at Sofinno­va. These have been boom times in the glob­al biotech busi­ness — how is that play­ing out in Eu­rope?

It’s a packed pro­gram. If you’re in­to R&D strat­e­gy, or you’re grow­ing your own com­pa­ny, I hope you’ll join us on Oct. 12. You can look over the sched­ule and sign up here — at no cost — by hit­ting the link.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.