Biotech sci­en­tist/en­tre­pre­neur Saurabh Sa­ha makes an un­usu­al re­turn to the arms of a big — and ex­ces­sive­ly dis­creet — R&D group

Over the past few years we’ve seen a grow­ing ex­o­dus of R&D ex­perts out of big bio­phar­ma groups and in­to the rapid­ly grow­ing ranks of biotech star­tups. Now, one of the biggest play­ers in the on­col­o­gy field is get­ting at least one suc­cess­ful biotech sci­en­tist and en­tre­pre­neur to make an un­usu­al re­turn trip and come back in­to the fold of a ma­jor re­search or­ga­ni­za­tion.

Saurabh Sa­ha

This morn­ing Bris­tol-My­ers Squibb $BMY put out word that the com­pa­ny had hired Saurabh Sa­ha to run the trans­la­tion sci­ence group for the com­pa­ny, which is re­spon­si­ble for triag­ing pre­clin­i­cal work of in­ter­est and steer­ing the most promis­ing pro­grams to­ward the clin­ic.

Sa­ha — a 40-year-old Johns Hop­kins grad, where he worked in Bert Vo­gel­stein’s lab — once up­on a time la­bored in­side No­var­tis’ glob­al ops, be­fore leav­ing for a string of new jobs in biotech. Nine years ago he set up a trans­la­tion­al re­search and de­vel­op­ment or­ga­ni­za­tion called Bio­Med Val­ley Dis­cov­er­ies. Then his role as a ven­ture part­ner at the pro­lif­ic At­las Ven­ture led him to be­come chief med­ical of­fi­cer at Syn­log­ic, fol­lowed by a brief but wild­ly suc­cess­ful stint as CEO of Delinia.

Back at the be­gin­ning of this year Cel­gene stepped up with a $775 mil­lion deal to ac­quire Delinia — with $300 mil­lion of that in cash — just four months af­ter Sa­ha lined up a $35 mil­lion round to back a pre­clin­i­cal au­toim­mune drug that showed promise in con­trol­ling reg­u­la­to­ry T cells, restor­ing im­mune tol­er­ance and home­osta­sis.

Odd­ly, Bris­tol-My­ers has de­cid­ed to keep Sa­ha un­der wraps for this an­nounce­ment, not al­low­ing in­ter­views. That’s too bad, as com­pa­nies like Bris­tol-My­ers could use all the fresh, in­tel­li­gent faces it can get to per­suade in­vestors that there’s rea­son to be­lieve new stuff is com­ing along to whip up some ex­cite­ment.

As big bio­phar­ma of­fers re­peat­ed ev­i­dence of the kind of cash-con­strained, slow mov­ing en­vi­ron­ments that re­searchers have chafed against, high-risk biotechs with op­por­tu­ni­ty for rapid re­wards and cash wind­falls have of­fered a com­pelling bea­con for some high pro­file ex­ecs. What­ev­er Sa­ha’s rea­sons, any­thing he says that might per­suade sci­en­tists to re­con­sid­er that could on­ly ben­e­fit an in­dus­try where the trends have so far point­ed in on­ly one di­rec­tion.

That’s par­tic­u­lar­ly true for the trans­la­tion­al side of the busi­ness.

Sa­ha is stay­ing in the Boston area, where Bris­tol-My­ers is build­ing a new R&D cen­ter.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Bio­phar­ma ramps up lob­by­ing spend as drug pric­ing leg­is­la­tion nears

The top biopharma companies in the world collectively spent more than $40 million in just the first quarter of 2021 on lobbying Congress as part of preparations to stave off major drug pricing legislation that’s expected later this year.

Although the numbers are not dramatically higher than what the companies collectively spent in the first quarter of 2020, some like GlaxoSmithKline, Teva, Merck and Johnson & Johnson have already increased their quarterly lobbying spend in 2021 by about $1 million more each when compared to recent quarters in 2020.

Sushil Patel, Replimune

Ex­clu­sive: Genen­tech's for­mer Tecen­triq 'CEO' jumps ship to head up com­mer­cial at an on­colyt­ic virus play­er

Genentech has long been a headhunter’s paradise with biotechs shopping for top execs with premium résumés, so it’s not unusual to see some long-time employees jumping ship. Now, one of the commercial leads on the company’s oncology portfolio is leaving after a 20-year stint to try his hand at a tiny oncolytic virus biotech.

Sushil Patel, Genentech’s former global oncology franchise head for lung and skin cancer and rare/agnostic tumor types, will leave his post at the world’s first biotech to head commercial at a much smaller operation in Replimune, which is using oncolytic viruses to hunt solid tumors.

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