Scott Got­tlieb aced his con­fir­ma­tion hear­ing, vow­ing to main­tain R&D gold stan­dard

Scott Got­tlieb – April 5, 2017 Zach Gib­son/Get­ty Im­ages


Sen­ate De­moc­rats didn’t waste any time in rais­ing their ob­jec­tions to Scott Got­tlieb as the next FDA com­mis­sion­er.

Sen­a­tor Pat­ty Mur­ray (D-Wash­ing­ton) start­ed her re­marks at Got­tlieb’s con­fir­ma­tion hear­ing this morn­ing voic­ing her con­cerns about “whether you can with­stand po­lit­i­cal pres­sure” in main­tain­ing an un­bi­ased, sci­ence-based ap­proach in main­tain­ing the gold stan­dard on safe­ty and ef­fi­ca­cy re­views of new drugs.

Mur­ray com­plained that sen­a­tors had on­ly days to re­view Got­tlieb’s “un­prece­dent­ed fi­nan­cial en­tan­gle­ments” in the phar­ma in­dus­try — with dozens of drugs from the com­pa­nies he’s worked with head­ed to the FDA — as well as more than 800 list­ed pub­li­ca­tions which “raise con­cerns about po­ten­tial con­flicts of in­ter­est.”

Scott Got­tlieb this morn­ing on Capi­tol Hill at his nom­i­na­tion hear­ing. (CRED­IT: C-SPAN/End­points News)

Got­tlieb, though, came pre­pared to re­but those sug­ges­tions, mak­ing promis­es to main­tain an in­de­pen­dent FDA com­mit­ted to find­ing new ef­fi­cien­cies at the agency while mak­ing sure that all the new prod­ucts the agency ap­proves are safe and ef­fec­tive, meet­ing the agency’s long-term gold stan­dard on R&D.

“I’ve seen the im­por­tance of the FDA’s work as both a doc­tor and a pa­tient,” Got­tlieb, a can­cer sur­vivor, said in his open­ing state­ment. He added that his in­vest­ments and en­deav­ors were aimed at im­prov­ing health­care in the US. Some have worked, oth­ers didn’t and many oth­ers are still in de­vel­op­ment.

Re­gard­less of those ties, he vowed to be an “im­par­tial and in­de­pen­dent ad­vo­cate for the pub­lic health” main­tain­ing a rig­or­ous ap­proach to re­view­ing drugs. “We’re at an in­flec­tion point in bio­med­ical sci­ence,” he added, and the chal­lenge at the FDA will be get­ting the most bang for its reg­u­la­to­ry bucks.

“We should re­ject the false di­choto­my that it all boils down to a choice be­tween speed and safe­ty.” Bet­ter ef­fi­cien­cy and safe­ty are both pos­si­ble, he said, while main­tain­ing the gold stan­dard. And he added that “it’s in­cum­bent on us to have a world class work force,” hir­ing the best for reg­u­la­to­ry work, which Sen­a­tor Lamar Alexan­der not­ed was Got­tlieb’s pick as his most im­por­tant chal­lenge.

Got­tlieb al­so helped soothe any in­dus­try con­cerns that he might want to come in as an abra­sive re­former, work­ing at odds with staff.

“I think every­thing is a bot­tom-up ap­proach in the agency,” he told the law­mak­ers. “The ideas re­al­ly need to come from the ca­reer staff in the cen­ters.” That’s go­ing to be a chal­lenge as the agency re­cruits re­place­ments for a line­up of se­nior agency of­fi­cials who are due for re­tire­ment.

Got­tlieb promised to bring best prac­tices to those ar­eas in the FDA that have been lag­ging. There’s been an “un­even adop­tion” of the break­through drug pro­gram, he added, which now re­quires broad adop­tion.  The prospec­tive com­mis­sion­er al­so said that while he was not crit­i­cal of Phase III, there is a pos­si­bil­i­ty with new tech­nol­o­gy to com­press Phase II and Phase III in­to an adap­tive de­sign.

And, as ex­pect­ed, he rel­ished the prospect of tack­ling a slew of com­plex gener­ics await­ing an ap­proval at the FDA. Many drugs are sold at high prices, he said, but should be sub­ject to com­pe­ti­tion.

A few days ago Got­tlieb care­ful­ly de­lin­eat­ed ties to some two dozen bio­phar­ma com­pa­nies he’s been work­ing with over the past eight years of the Oba­ma ad­min­is­tra­tion. He’s worked with Glax­o­SmithK­line, Ver­tex and Bris­tol-My­ers, so you can check the box on in­dus­try con­flicts of in­ter­est that De­moc­rats will con­demn.

Among Got­tlieb’s oth­er lines of work, the for­mer deputy FDA com­mis­sion­er penned a se­ries of ar­ti­cles on bio­phar­ma for Forbes, and the Dems have been giv­ing them a close look. Two pieces float­ed to the top of the read­ing list. One cen­tered on his pro­pos­al to move re­spon­si­bil­i­ty for iden­ti­fy­ing the opi­oid sup­pli­ers who were break­ing the law from the DEA to HHS. The oth­er dealt with his crit­i­cism of the REMS pro­grams, which set up post-mar­ket­ing safe­ty pro­grams to lim­it risks seen in cer­tain drugs.

Add it all up, says Sher­rod Brown (D-Ohio), and you find some­one who will “roll over for his Big Phar­ma friends,” as The Hill re­ports.

Re­pub­li­cans, though, were large­ly con­tent to lim­it their com­ments to praise for the nom­i­nee and his three young daugh­ters, who were seat­ed be­hind the can­di­date. And it’s the Re­pub­li­cans who have the votes to make this hap­pen.

The in­dus­try, mean­while, has made it clear that af­ter hear­ing some of the ideas backed by oth­er com­mis­sion­er can­di­dates like Jim O’Neill – who’s sug­gest­ed ap­prov­ing drugs as soon as they’re de­ter­mined safe — Got­tlieb is the best can­di­date by far. In a snap poll of qual­i­fied End­points News sub­scribers, 87% of the 580 who reg­is­tered an opin­ion backed Got­tlieb’s nom­i­na­tion.

So you can ex­pect most peo­ple in bio­phar­ma to keep their fin­gers crossed for Got­tlieb.

Bot­tom line: Got­tlieb came well pre­pared for every ques­tion, care­ful not to step be­yond the bound­aries of the com­mis­sion­er’s job when in­vit­ed to com­ment on Oba­macare. His an­swers were pol­ished and prac­ticed, leav­ing lit­tle room for un­ex­pect­ed at­tacks. And he de­flect­ed crit­i­cism eas­i­ly, promis­ing to avoid any po­ten­tial con­flicts of in­ter­est.

Bar­ring a last minute sur­prise, Got­tlieb’s con­fir­ma­tion as the next FDA com­mis­sion­er is all but guar­an­teed.

Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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