Af­ter clos­ing the gap on new hires, FDA could face an ex­o­dus of top reg­u­la­tors

The FDA is look­ing to strength­en its work­force us­ing new au­thor­i­ties grant­ed un­der the 21st Cen­tu­ry Cures Act, ac­cord­ing to a re­port sent to Con­gress ear­li­er this month. And they’ll need all the help they can get.

Af­ter dig­ging in and re­duc­ing the num­ber of open jobs in the past year, FDA lead­ers say that 40% of se­nior ex­ecs will be el­i­gi­ble to re­tire next year — leav­ing the agency sus­cep­ti­ble to a ma­jor top-lev­el tran­si­tion pe­ri­od at a time the hunt for top tal­ent has nev­er been more in­tense.

Scott Got­tlieb

The Cures Act grant­ed FDA the au­thor­i­ty to stream­line the hir­ing process for cer­tain sci­en­tif­ic, tech­ni­cal and pro­fes­sion­al po­si­tions, and al­lows the agency to pro­vide high­er salaries to en­sure the agency can com­pete with in­dus­try and acad­e­mia.

“This au­thor­i­ty will al­low us to bet­ter build and main­tain the high­ly tal­ent­ed work­force need­ed to meet the chal­lenges of to­day’s rapid ad­vances in sci­ence, med­i­cine, and tech­nol­o­gy,” FDA Com­mis­sion­er Scott Got­tlieb writes in the open­ing of the re­port.

Ac­cord­ing to Got­tlieb, FDA has been us­ing the hu­man re­sources au­thor­i­ties grant­ed un­der Cures since Feb­ru­ary 2018 but has “on­ly be­gun to tap its po­ten­tial.”

In the years lead­ing up to Cures en­act­ment, FDA strug­gled to fill hun­dreds of va­can­cies in its re­view di­vi­sions, of­ten cit­ing a drawn out hir­ing process and low salaries com­pared to in­dus­try as ma­jor hur­dles in at­tract­ing new tal­ent, es­pe­cial­ly in emerg­ing sci­en­tif­ic and tech­ni­cal ar­eas.

How­ev­er, with­in the last two years the num­ber of va­can­cies at the Cen­ter for Drug Eval­u­a­tion and Re­search has come down from more than 900 in May 2016 to 650 in Ju­ly 2017.

Cures Im­ple­men­ta­tion

Since Cures‘ pas­sage in 2016, FDA says it has been work­ing to­wards im­ple­ment­ing its new hir­ing and HR au­thor­i­ties.

Ac­cord­ing to the agency, some of those ef­forts in­clude cre­at­ing a staffing team to iden­ti­fy can­di­dates for “hard-to-fill” sci­en­tif­ic po­si­tions, de­vel­op­ing process­es to re­duce time to hire to less than 80 days and de­sign­ing a new al­ter­na­tive pay struc­ture for 38 oc­cu­pa­tions that is more com­pet­i­tive than un­der the agency’s ear­li­er au­thor­i­ties.

FDA says it is still work­ing on com­plet­ing new poli­cies and pro­ce­dures around hir­ing but says that it made its first two hires us­ing Cures au­thor­i­ties in ear­ly 2018 and ex­pects to fill ad­di­tion­al po­si­tions in the com­ing months.

Aside from salary lev­els and lengthy hir­ing times, FDA says that its swelling size has con­tributed to the chal­lenge of fill­ing open po­si­tions. In the last decade, FDA says its staff has more than dou­bled from 8,000 em­ploy­ees to ap­prox­i­mate­ly 17,000 to­day.

“The need to rapid­ly re­cruit high­ly skilled and ex­pe­ri­enced staff has been a chal­lenge for the agency,” FDA writes.

An­oth­er ma­jor chal­lenge FDA faces in main­tain­ing its work­force is the sheer num­ber of staff who will be­come el­i­gi­ble to re­tire in the com­ing years.

Ac­cord­ing to the re­port, staff turnover is cur­rent­ly around five per­cent each year, con­sis­tent with oth­er fed­er­al agen­cies, but may soon spike as a grow­ing num­ber of staff be­come el­i­gi­ble for re­tire­ment.

As of 2017, FDA says that 13.3% of its staff are el­i­gi­ble to re­tire, and by 2019 the agency says that more than 40% of se­nior lead­er­ship will be el­i­gi­ble to re­tire.

In an­tic­i­pa­tion of the com­ing de­par­tures, FDA says it is work­ing to de­vel­op suc­ces­sion plan­ning strate­gies, though spe­cif­ic strate­gies have yet to be de­ter­mined.

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 for more in­for­ma­tion. 

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D re­or­ga­ni­za­tion in­side Sanofi is con­tin­u­ing, more than a year af­ter the phar­ma gi­ant brought in John Reed to head the re­search arm of the Paris-based com­pa­ny.

Sanofi said in a state­ment that it is cut­ting its re­search ranks by 466 in France and Ger­many while drop­ping new, in-house car­di­ol­o­gy drug re­search. Ex­ist­ing car­dio pro­grams will go for­ward, says Sanofi, but the pipeline is be­ing cut off at the dis­cov­ery source. The phar­ma gi­ant, long known as a lag­gard in R&D, in­tends to com­mit more of its re­sources to the 4 re­main­ing R&D fo­cus­es: can­cer, im­munol­o­gy, rare dis­eases and vac­cines.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”