FDA’s CDER un­veils de­tails of re­or­ga­ni­za­tion

The US Food and Drug Ad­min­is­tra­tion’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) on Thurs­day an­nounced the de­tails of a ma­jor re­or­ga­ni­za­tion, af­fect­ing near­ly one-third of CDER.

The pro­posed re­or­ga­ni­za­tion will im­pact the Of­fice of New Drugs, Of­fice of Com­pli­ance, Of­fice of Ex­ec­u­tive Pro­grams, and Of­fice of Com­mu­ni­ca­tions and has been sub­mit­ted to HHS, though still must be ap­proved by HHS and sub­mit­ted to Con­gress for con­cur­rence. The changes will be in ef­fect once ap­proval is re­ceived and the 30-day con­gres­sion­al no­ti­fi­ca­tion has lapsed, FDA said.

FDA al­so not­ed that the changes are not part of a sep­a­rate ef­fort re­lat­ed to the New Drugs Reg­u­la­to­ry pro­gram Mod­ern­iza­tion, which is a longer-term ef­fort in­clud­ing a broad­er re­or­ga­ni­za­tion of OND.

Of­fice of New Drugs (OND)

The changes an­nounced Thurs­day in­clude the cre­ation of a new Of­fice of Ther­a­peu­tic Bi­o­log­ics and Biosim­i­lars (OTBB) with­in OND, which will house pol­i­cy staff and sci­en­tif­ic re­view staff. The re­struc­tur­ing will al­so re­align staff from the OND Im­me­di­ate Of­fice to the new OTBB and will help in im­ple­ment­ing the reau­tho­rized Biosim­i­lar User Fee Act (Bs­U­FA II).

“OTBB will give biosim­i­lar and in­ter­change­able prod­uct re­view a stronger in­fra­struc­ture with re­sources to stream­line and ad­vance pol­i­cy de­vel­op­ment,” FDA said. “The in­creas­ing com­plex­i­ties and vis­i­bil­i­ty of this pro­gram re­quire a ded­i­cat­ed of­fice to ef­fi­cient­ly and ef­fec­tive­ly achieve cross-or­ga­ni­za­tion­al co­or­di­na­tion and col­lab­o­ra­tion.”

Of­fice of Com­pli­ance (OC)

The Of­fice of Un­ap­proved Drugs and La­bel­ing Com­pli­ance will house the Di­vi­sion of Com­pound­ed Drugs, for­mer­ly known as the Di­vi­sion of Pre­scrip­tion Drugs.

“This change will bet­ter re­flect our crit­i­cal work re­lat­ing to com­pound­ing pol­i­cy and over­sight, as the di­vi­sion will ab­sorb the func­tions of the for­mer Com­pound­ing and Phar­ma­cy Prac­tice Branch. It will es­tab­lish three new branch­es re­lat­ing to com­pound­ing pol­i­cy, reg­u­la­to­ry ac­tions, and op­er­a­tions – and re­align the Pre­scrip­tion Drugs Branch with a new Di­vi­sion of Un­ap­proved New Drugs, for­mer­ly the Di­vi­sion of Non-Pre­scrip­tion Drugs & Health Fraud. New branch names will bet­ter re­flect the di­vi­sion’s mis­sion and goals,” FDA said.

In ad­di­tion, the Of­fice of Man­u­fac­tur­ing Qual­i­ty (OMQ) will es­tab­lish a third drug qual­i­ty di­vi­sion with two branch­es for glob­al com­pli­ance. And the Of­fice of Drug Se­cu­ri­ty, In­tegri­ty, and Re­sponse will re­name its Di­vi­sion of Im­ports, Ex­ports, and Re­calls to the Di­vi­sion of Glob­al Drug Dis­tri­b­u­tion and Pol­i­cy to re­flect the agency’s re­spon­si­bil­i­ty in en­sur­ing the safe­ty and qual­i­ty of drug prod­ucts flow­ing in­to and out of the US.

Of­fice of Ex­ec­u­tive Pro­grams (OEP)

OEP is re­struc­tur­ing to ad­dress the grow­ing vol­ume and com­plex­i­ty of man­ag­ing CDER’s ex­ec­u­tive pro­grams.
“The OEP changes will es­tab­lish four staff groups with­in OEP’s Im­me­di­ate Of­fice fo­cus­ing on spe­cial projects, ex­ec­u­tive sec­re­tari­at mat­ters, leg­isla­tive ac­tiv­i­ties, and pro­gram man­age­ment and analy­sis – ab­sorb­ing the func­tions of the for­mer Di­vi­sion of Ex­ec­u­tive Op­er­a­tions. The re­struc­tur­ing will al­so es­tab­lish two branch­es with­in the Di­vi­sion of Ad­vi­so­ry Com­mit­tee and Con­sul­tant Man­age­ment to man­age and over­see ad­vi­so­ry com­mit­tee and con­flict of in­ter­est mat­ters,” FDA said.

Of­fice of Com­mu­ni­ca­tions (OCOMM)

OCOMM’s changes in­clude es­tab­lish­ing three branch­es with­in the ex­ist­ing Di­vi­sion of Drug In­for­ma­tion. OCOMM will al­so re­name two di­vi­sions to bet­ter re­flect their ex­pand­ed mis­sion. The Di­vi­sion of Health Com­mu­ni­ca­tions will be­come the Di­vi­sion of Pub­lic Ed­u­ca­tion and Out­reach, and the Di­vi­sion of On­line Com­mu­ni­ca­tions will be­come the Di­vi­sion of Dig­i­tal and On­line Com­mu­ni­ca­tion.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion. 

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

Covid-19 roundup: As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Forget 1 billion. AstraZeneca is now promising to supply 2 billion doses of Oxford University’s Covid-19 vaccine around the world per year.

Three new partners are coming on board to help reach that goal, as well as a broader vision to ensure access for nations that have been largely left out of the bargaining table.

CEPI — the coalition that’s been doling out grants to support other vaccine projects — is providing $383 million to support manufacturing of 300 million doses, while Gavi the Vaccine Alliance will chip in $367 million and be in charge of the procurement and distribution, a spokesperson told Wall Street Journal. A separate licensing agreement directs the Serum Institute of India to produce 1 billion doses for low- and middle-income countries, with the first 400 million due before the end of the year.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

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UP­DAT­ED: 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.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

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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