Dennis Zaller, ROME Therapeutics CSO

ROME founder Rosana Kapeller re­cruits a CSO from the se­nior ranks of a ma­jor league R&D team

The phone call start­ed in­no­cent­ly enough.

Den­nis Za­ller, then the ex­ec­u­tive di­rec­tor for in­te­gra­tive sci­ences at Cel­gene/BMS, rang up Rosana Kapeller back in April to con­grat­u­late her on the $50 mil­lion Se­ries A for her new biotech, ROME Ther­a­peu­tics. The two had col­lab­o­rat­ed a few times when Kapeller worked for Nim­bus, and Za­ller, do­ing his due dili­gence, want­ed to see if the new start­up could be a fit for a new part­ner­ship.

But dis­cus­sions quick­ly mor­phed from a sim­ple how-do-you-do in­to some­thing else en­tire­ly — a job of­fer.

ROME an­nounced Wednes­day that Za­ller would be join­ing the biotech as chief sci­en­tif­ic of­fi­cer. So far, it’s the young com­pa­ny’s biggest hire to date.

Rosana Kapeller

“We had just start­ed our search, we had a group of in­di­vid­u­als we were do­ing our re­search for, we were just start­ing com­pil­ing the names,” Kapeller told End­points News. “And then the con­ver­sa­tion pro­ceed­ed in­to whether it would make sense ac­tu­al­ly for Den­nis to fi­nal­ly sam­ple the oth­er side in­stead of con­tin­u­ing to be on the big com­pa­ny side … it was re­al­ly like a to­tal con­ver­gence.”

“I knew some­thing in­ter­est­ing was bound to come out of this,” Za­ller added. “But I came away from it think­ing ‘Wow this is so in­ter­est­ing, I need to take a deep­er dive.’ And that’s where things land­ed.”

Za­ller is mak­ing the tran­si­tion to the biotech world af­ter rough­ly 30 years work­ing for Cel­gene and, pre­vi­ous­ly, Mer­ck in their drug dis­cov­ery out­fits. ROME boast­ed in its press re­lease that Za­ller had per­son­al­ly been a part of teams that ad­vanced near­ly three dozen mol­e­cules in­to the clin­ic.

The two re­called their first en­counter when Za­ller worked at Mer­ck sev­er­al years ago. Kapeller wouldn’t go in­to too much de­tail, but they were col­lab­o­rat­ing on an on­col­o­gy pro­gram that need­ed to show high se­lec­tiv­i­ty in its da­ta. Za­ller helped con­struct a plan that so im­pressed Kapeller, she kept in touch with him af­ter­wards.

Ul­ti­mate­ly, the key to that mu­tu­al ef­fort was the “truth-seek­ing” process, Za­ller said.

“One of the things that is sim­i­lar in the sci­en­tif­ic ap­proach I have with Rosana that came out of these in­ter­ac­tions is that we didn’t have a deal yet, but we both, as we went through this, re­al­ized it made no dif­fer­ence,” he said.

They fo­cused on: “What is the an­swer? Whether it’s good, whether it’s bad, let’s just do the right ex­per­i­ments and brain­storm it, be­cause the truth is all that mat­ters.”

Kapeller has brought with her sev­er­al for­mer col­leagues to fill out ROME’s lead­er­ship team, as she as­serts they all come with proven track records. Za­ller’s ad­di­tion to that ros­ter helps the biotech cre­ate a “high-per­form­ing cul­ture,” she said.

ROME fo­cus­es its re­search on a por­tion of the hu­man genome that for years has been de­scribed as “junk DNA,” or the 97% to 99% of ge­net­ic code that doesn’t code for pro­teins, known as the re­peatome. This seg­ment of the “junk” refers to about 60% of the genome that’s com­posed of re­peat­ed DNA el­e­ments and doesn’t code for pro­teins, Za­ller said.

Be­ing able to con­duct such stud­ies to try to treat can­cer and au­toim­mune dis­ease takes Za­ller back to ear­li­er in his ca­reer, he said, when he ran small­er lab­o­ra­to­ries where he was able to pro­vide an “in­tense fo­cus” on a small­er prob­lem rather than over­see­ing a large de­vel­op­men­tal op­er­a­tion.

And now, too, he gets to helm drug dis­cov­ery on that “oth­er side” in an emerg­ing field.

“This is still just the be­gin­ning,” Za­ller said. “Watch this space close­ly, be­cause it’s go­ing to be in­ter­est­ing.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months after Legend Biotech made the startling disclosure that founder and then-CEO Frank Zhang was placed under “residential surveillance,” its parent company revealed that he’s been formally arrested.

Zhang — who, since founding GenScript 18 years ago, has taken the CRO public and groomed Legend Biotech in-house until the J&J-partnered CAR-T player was mature enough for its own Nasdaq listing — is severing his final ties with both. He is resigning as board chair/non-executive director of GenScript and director of Legend.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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