Alan List, new Precision BioSciences CMO, in 2019 (Diane Bondareff/AP Images for Moffitt Cancer Center)

Eli Lil­ly-part­nered biotech taps star in­ves­ti­ga­tor Alan List as CMO — a year af­ter he re­signed from Mof­fitt over Chi­na scan­dal

Af­ter lay­ing low for more than a year fol­low­ing a scan­dal that led to his ouster, for­mer Mof­fitt Can­cer Cen­ter CEO Alan List has emerged in the front­lines of biotech.

An ex­pert in hema­tol­ogy and on­col­o­gy drug de­vel­op­ment known as a lead in­ves­ti­ga­tor for Cel­gene’s block­buster Revlim­id, List is swap­ping “clin­i­cal tri­als con­sul­tant” for the chief med­ical of­fi­cer ti­tle at Pre­ci­sion Bio­Sciences — a Eli Lil­ly-part­nered biotech boast­ing a new gene edit­ing ap­proach to cell and gene cor­rec­tion ther­a­pies.

Chris Heery

He re­places Chris Heery, who’s leav­ing “to pur­sue oth­er op­por­tu­ni­ties.”

“Over the past 12 months, Alan has been in­ti­mate­ly in­volved in our clin­i­cal strat­e­gy to de­vel­op our lead al­lo­gene­ic CAR T ther­a­py, PB­CAR0191, as well as the de­sign of our clin­i­cal pro­gram for PB­CAR19B, our next gen­er­a­tion, stealth cell pro­gram,” Pre­ci­sion CEO Matt Kane said in a state­ment.

Kane him­self has an­nouc­ned that he will be leav­ing his role as soon as a suc­ces­sor is iden­ti­fied.

That’s not all the changes List will be step­ping in­to. While Servi­er has been part­nered on those pro­grams, Pre­ci­sion si­mul­ta­ne­ous­ly re­vealed that they’re get­ting full rights to the two ther­a­pies back af­ter the French com­pa­ny de­cid­ed to drop it — a “strate­gic de­ci­sion” to shift fo­cus. In ex­change, Pre­ci­sion is pay­ing $1.25 mil­lion in cash and waiv­ing $18.75 mil­lion in earned but as-yet un­paid mile­stones. Servi­er is still en­ti­tled to mile­stones and roy­al­ties.

Matt Kane

With a trio of clin­i­cal drug can­di­dates tar­get­ing CD19, CD20 and BC­MA, the biotech is fo­cus­ing ini­tial­ly on in­di­ca­tions like non-Hodgkin lym­phoma, B-cell acute lym­phoblas­tic leukemia and mul­ti­ple myelo­ma.

For 11 years, List was a top ex­ec at Flori­da’s Mof­fitt Can­cer Cen­ter, the third-largest can­cer cen­ter by pa­tient vol­ume in the US. But in late 2019, he re­signed for vi­o­lat­ing con­flict of in­ter­est rules re­gard­ing his work in Chi­na, mak­ing an ex­it along­side sev­er­al re­searchers who got swept up in an NIH-di­rect­ed crack­down on per­ceived threats of aca­d­e­m­ic es­pi­onage and re­lat­ed com­pli­ance is­sues.

List, the high­est-rank­ing ex­ec af­fect­ed by that purge, open­ly over­saw a long­stand­ing part­ner­ship with Tian­jin Med­ical Uni­ver­si­ty Can­cer In­sti­tute and Hos­pi­tal and was ap­point­ed the sci­en­tist in chief Tian­jin Tais­han Can­cer Hos­pi­tal’s Trans­la­tion­al Re­search In­sti­tute in 2016. But he was fault­ed for fail­ing to dis­close his per­son­al deal­ings in Chi­na, in­clud­ing an ap­pli­ca­tion to the Thou­sand Tal­ents pro­gram, awards and con­tracts from one of the Tian­jin in­sti­tu­tions, and a per­son­al bank ac­count.

An in­ter­nal in­ves­ti­ga­tion con­clud­ed that he was paid at least $85,000 through­out that pe­ri­od.

The whole or­deal sparked de­bates around the fair­ness or wis­dom of cast­ing all US-Chi­na col­lab­o­ra­tions in a sus­pi­cious light, es­pe­cial­ly as most aca­d­e­m­ic re­search is of lit­tle fi­nan­cial val­ue and in­sti­tu­tions don’t al­ways lay down clear rules on dis­clo­sure. In fact, sci­en­tif­ic ex­changes with Chi­na were of­ten en­cour­aged; Mof­fitt’s col­lab­o­ra­tion with the Tian­jin uni­ver­si­ty goes back years.

In any case, List will now be turn­ing a new page at Pre­ci­sion, over­see­ing the fruits of a genome edit­ing plat­form, dubbed AR­CUS, that came from a group of North Car­oli­na sci­en­tists look­ing to hack DNA us­ing a syn­thet­ic en­zyme.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

Luisa Salter-Cid, Pioneering Medicines CSO (Credit: Bristol Myers Squibb via Twitter)

Luisa Salter-Cid joins long­time Bris­tol My­ers col­lab­o­ra­tor Paul Bion­di at Flag­ship's new drug brew­ery

Paul Biondi is gaining a familiar research chief at his corner of Flagship Pioneering.

The ambitious VC — famous for bold platform plays such as Moderna — said Luisa Salter-Cid is joining Pioneering Medicines as CSO, with the mandate of leveraging the platforms of various Flagship portfolio companies to conceive new treatments.

The two had crossed paths at Bristol Myers Squibb, where Biondi brought in a series of new drugs throughout his prolific business development stretch while Salter-Cid worked her way up the ladder to become head of immunology, small molecule immuno-oncology and genomics discovery.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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