Sen­ate com­mit­tee backs Scott Got­tlieb as next FDA com­mis­sion­er


Scott Got­tlieb has tak­en an­oth­er big step down the road to his con­fir­ma­tion as the coun­try’s next FDA com­mis­sion­er. The Sen­ate’s Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee vot­ed in fa­vor of his nom­i­na­tion Thurs­day morn­ing, with the law­mak­ers split­ting down par­ty lines.

The com­mit­tee vote — 14 to 9 in fa­vor — now shifts the fo­cus to the fi­nal Sen­ate vote, which should set up a quick swear­ing-in some­time in May, de­pend­ing on the leg­isla­tive ma­neu­ver­ing around high-pro­file is­sues like tax and health­care re­form.

Once the nom­i­na­tion does get to the Sen­ate floor, you can ex­pect to hear the same ba­sic ar­gu­ments for and against Got­tlieb.

“Dr. Got­tlieb has been through an ex­haus­tive vet­ting process,” not­ed Lamar Alexan­der (R-TN) this morn­ing. He’s agreed to re­cuse him­self from ac­tions re­gard­ing a long list of bio­phar­ma com­pa­nies he’s worked with, and re­ceived a clean bill of health on his ethics re­view. And Alexan­der was hap­py to en­dorse Got­tlieb’s work in the in­dus­try.

“If you’re go­ing to the hos­pi­tal for brain surgery you might want a doc­tor that knew some­thing about brain surgery,” he said. “I think we should step back and rec­og­nize that we need in our gov­ern­ment peo­ple with ex­pe­ri­ence in the types of in­dus­tries and agen­cies they’re in charge of.”

Pat­ty Mur­ray (D-WA), though, wasn’t hav­ing it. While she said she was en­cour­aged by Got­tlieb’s com­mit­ment to the gold stan­dard in drug R&D and post-ap­proval mar­ket sur­veil­lance of med­ical de­vices, he al­so pro­vid­ed fre­quent­ly vague an­swers to ques­tions, or sim­ply avoid­ed them

“I have grown in­creas­ing­ly con­cerned that he can lead the FDA in an un­bi­ased way,” said the Sen­a­tor. Got­tlieb used his pub­lic plat­form to sup­port com­pa­nies he has in­vest­ed in or held po­si­tions with. And she re­peat­ed ear­li­er ac­cu­sa­tions about Got­tlieb’s “un­prece­dent­ed” con­flicts of in­ter­est.

The De­moc­rats, though, don’t have the votes to stop the process.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Christos Kyratsous (via LinkedIn)

He built a MERS treat­ment in 6 months and then the best Ebo­la drug. Now Chris­tos Kyrat­sous turns his sights on Covid-19

TARRYTOWN, NY — In 2015, as the Ebola epidemic raged through swaths of West Africa, Kristen Pascal’s roommates sat her down on their couch and staged an intervention.

“Are you sure this is what you want to be doing with your life?” she recalls them asking her.

Pascal, a research associate for Regeneron, had been coming home at 2 am and leaving at 6 am. At one point, she didn’t see her roommate for a week. For months, that was life in Christos Kyratsous’ lab as the pair led a company-wide race to develop the first drug that could effectively treat Ebola before the outbreak ended. For Pascal, that was worth it.

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Left to right, top to bottom: Carl Gordon, Adam Stone, Peter Moglia, David Schenkein, Robert Nelsen, Carol Gallagher; Srinivas Akkaraju, Ray Debbane, Jim Flynn, Peter Kolchinsky, Thilo Schroeder, Brad Bolzon

UP­DAT­ED: The top 100 bio­phar­ma ven­ture in­vestors at the mega­bil­lions deal ta­ble

The VC crowd took a step back last year, but nevertheless maintained a furious pace of new investments in therapeutic tech platforms and biotech startups. And the top 100 players completely dominated the megabillions game.

Just looking at the number of deals done by each of the top 100, OrbiMed came in at the top, with 20, followed by Alexandria (18), Perceptive (16) and the ubiquitous RA Capital at 16. It’s impossible to say exactly how much they invested in total — those numbers are only rarely provided — but it is clear from the numbers assembled by Chris Dokomajilar at DealForma who’s most likely to be found sitting at the table during the go-go days of biotech investing.

Dokomajilar tracked $14.06 billion in biotech venture investing last year, a dip from the frenzied pace of $16.02 billion in 2018 and more than $10 billion higher than he recorded for 2010, as the economy was recovering from a profound economic crisis.

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Rahul Ballal, Imara

As sick­le cell pa­tients find new op­tions, NEA-found­ed Imara pitch­es mid-stage al­ter­na­tive for $86M IPO

November 2019 proved to be a fruitful month for patients with blood disorders known as hemoglobinopathies. Within days, the FDA ushered two drugs for sickle cell disease and another for beta thalassemia to the market — livening up a barren field.

Imara, a relatively young plower, is riding on that enthusiasm as it shoots for an $86.25 million IPO.

Imara emerged from New Enterprise Associates’ orphan drug accelerator Cydan in 2016 as a single-product company. $77.3 million in private financing later IMR-687 remains the sole asset in its pipeline; the difference is the drug is now in Phase II for sickle cell disease, with topline data slated for later this year and two other mid-stage beta thalassemia studies lined up.

RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Beijing-based rare disease and oncology player has raised $98 million to help fund the expansion of its pipeline as well as a commercial portfolio.

CANbridge put out word Tuesday that the global private equity player General Atlantic joined forces with Chinese CRO Wuxi AppTec to lead the Series D, with both ready to chip in an extra $10 million each under the right conditions. The syndicate includes RA Capital Management, Hudson Bay Capital Management, YuanMing Prudence Fund and Tigermed.

Carol Robinson, Professor Dame Carol Robinson Research Group

UP­DAT­ED: Drug dis­cov­ery in HD: Ox­ford spin­of­f's mass spec­trom­e­try ap­proach scores fresh fund­ing

The technology used to detect explosives at airports — mass spectrometry — is being piloted as an engine for drug discovery.

Mass spectrometry is a tool designed to measure with profound accuracy the mass of a single molecule. Typically, mass spectrometers can be used to identify unknown compounds, to quantify known compounds, and to determine the structure and chemical properties of molecules.

UP­DAT­ED: Chi­na ap­proves flu drug be­ing tout­ed as a po­ten­tial coro­n­avirus treat­ment amid a rush of clin­i­cal stud­ies

One of the three drugs that China’s Ministry of Science and Technology has tapped as potential COVID-19 treatments to watch has notched its first Chinese OK — for the flu.

While there’s no proof yet that fapilavir, or favipiravir, is the cure that patients and physicians are yearning for, it stands out for a unique constellation of qualities. It’s been commercially available in Japan for several years (unlike Gilead’s experimental remdesivir) yet it’s new to China (unlike the malaria drug chloroquine phosphate). Perhaps more importantly, a domestic biotech — Zhejiang Hisun Pharma — owns the rights to manufacture and market the drug, preempting any concerns about patents.

FDA goes on high alert as coro­n­avirus rais­es threat to drug man­u­fac­tur­ing and clin­i­cal tri­als grind to a halt

The FDA isn’t quite sure just what the coronavirus outbreak in China will mean for the US pharma industry, but it has the potential to trigger a host of troublesome issues around the supply chain the country is directly plugged into.

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Warren Buffett, AP Images

War­ren Buf­fett gets a dou­ble take as the in­vest­ment pow­er­house set­tles on its first biotech in­vest­ment

Coke. American-Express. Apple. And Biogen?

Warren Buffet’s Berkshire Hathaway, which made itself into a symbol of rock-solid investment strategy, has revealed a stake in the big biotech as it takes on one of the biggest gambles in the industry.

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