Ned Sharp­less is not play­ing with the FDA’s gold stan­dard — any more than Scott Got­tlieb did

Ned Sharp­less got a chance to out­line just what kind of act­ing FDA chief he’ll be in the wake of Scott Got­tlieb’s de­par­ture from the agency. And aside from a more con­ser­v­a­tive se­lec­tion of socks, he’s clear­ly plan­ning to adopt the ex­act same fash­ions laid down by his pre­de­ces­sor.

Ned Sharp­less. (DARR BEIS­ER/NA­TION­AL CAN­CER IN­STI­TUTE)

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In an all-hands-on-deck ad­dress to staffers, Sharp­less promised to fit the Got­tlieb mold per­fect­ly, vow­ing to main­tain the agency’s gold stan­dard on drug ap­provals while do­ing what he can to keep the copy­cats com­ing to help tamp down on drug costs.

So let me re­as­sure you, I am not plan­ning any rad­i­cal changes from what the FDA has been try­ing to ac­com­plish.

Bioreg­num Opin­ion Col­umn by John Car­roll

That’s a theme that will be mu­sic to the ears of the bio­phar­ma in­dus­try, which quick­ly swooned to Got­tlieb’s en­er­getic mes­sages on speed­ing ap­provals when­ev­er ap­pro­pri­ate while hold­ing the line on safe­ty and ef­fi­ca­cy stan­dards. The fu­ture of the FDA proved to be a huge is­sue at the start of Pres­i­dent Don­ald Trump’s term in of­fice, as Trump en­ter­tained some lib­er­tar­i­an no­tions that fright­ened the be­je­sus out of com­pa­nies that clear­ly want­ed a more re­cep­tive reg­u­la­to­ry ap­proach — with­out any reg­u­la­to­ry an­ar­chy that would de­stroy the val­ue of an FDA OK.

Sharp­less got right to it. His bot­tom line:

Nec­es­sar­i­ly, there will be course ad­just­ments as new facts emerge, but es­sen­tial­ly, I feel I am walk­ing in­to an or­ga­ni­za­tion on a good tra­jec­to­ry, and my main job is to fig­ure out how keep that go­ing.

Now how to do that:  let me sug­gest two guid­ing prin­ci­ples.

First, I be­lieve our ef­forts should re­ly on and be guid­ed by the sci­ence. As a re­searcher, I am used to let­ting da­ta dri­ve my de­ci­sion-mak­ing, and I know this has al­ways been the ap­proach at FDA.

Sec­ond, when wran­gling with the com­plex is­sues that face the agency, we will keep top of mind our mis­sion of pro­tect­ing and pro­mot­ing pub­lic health, and what that means to the Amer­i­can pub­lic.

So that’s what will steer my pri­or­i­ties as act­ing com­mis­sion­er: a com­mit­ment to sci­ence-based de­ci­sion-mak­ing and pri­or­i­tiz­ing our ef­forts for the ben­e­fit of the pub­lic health.

That mes­sage on con­ti­nu­ity ex­tends to the agency’s work hus­tling up less ex­pen­sive knock­offs.

I promise you, for ex­am­ple, that we’ll con­tin­ue our im­por­tant and suc­cess­ful work to in­crease com­pe­ti­tion and reign in pre­scrip­tion drug costs through ad­vances in our gener­ic drug and biosim­i­lars pro­grams

And we’ll con­tin­ue to do every­thing we can to make the de­vel­op­ment of new treat­ments and cures more ef­fi­cient across our med­ical prod­uct cen­ters, while en­sur­ing that we main­tain FDA’s gold stan­dard of safe­ty and ef­fi­ca­cy.

What could be more re­as­sur­ing to the in­dus­try, law­mak­ers and the pub­lic?

In­ter­est­ing­ly, Got­tlieb’s de­par­ture from the FDA was al­so marked by his in­sis­tence that the rank-and-file drug de­vel­op­ers of the world need­ed to do more to adopt the re­forms he had pushed, look­ing for faster, more ef­fi­cient ways to de­vel­op drugs. The chal­lenge for Sharp­less will be to see if he con­tin­ues that push as an in­dus­try train­er look­ing to get some out-of-shape de­vel­op­ers up to speed with the new or­der. And that means urg­ing reg­u­la­tors as well to get the lead out.

Scott Got­tlieb

Con­ti­nu­ity may sound like the ex­act right mes­sage here and now. But if that be­comes a con­ser­v­a­tive ap­proach to main­tain­ing stan­dards and tra­di­tions, plea­sure may soon be re­placed by an un­easy feel­ing that the FDA may once again be­come more of an ob­sta­cle and less of a part­ner. And that won’t be wel­come.

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.