Or­chard $OR­TX. Seres $MCRB. Ret­roSense (ac­quired by Al­ler­gan). With sev­er­al high pro­file ex­its un­der their belt, 4BIO Cap­i­tal is out to find more trail­blaz­ers to back in the drug R&D world.

The VC shop has raised $50 mil­lion in the first close of what it hopes to be a $150 mil­lion sec­ond fund at the end of next year. With a fo­cus on ad­vanced ther­a­pies — cell and gene ther­a­py, RNA-based ther­a­py, tar­get­ed ther­a­py, and the mi­cro­bio­me — they will de­vote 60% of the fund to Eu­ro­pean deals from their perch in Lon­don, while spread­ing the rest be­tween Japan and the US, go­ing in­to the Mid­west and the South for promis­ing ideas that might not have re­ceived as much love as those com­ing out of Boston.

Al­to­geth­er, 8 to 12 pri­vate com­pa­nies will re­ceive in­vest­ment from 4BIO Ven­tures II.

“With the gap in re­al com­mer­cial de­vel­op­ment of ad­vanced ther­a­pies over the last 20 years, there’s a lot of pro­grams, par­tic­u­lar­ly here in Eu­rope, that aca­d­e­mics have been sol­dier­ing on, on a shoe­string bud­get, push­ing their ideas and thoughts to a point where they can be in the clin­ic with­in a year, par­tic­u­lar­ly if they don’t suf­fer from the bot­tle­neck of man­u­fac­tur­ing,” Owen Smith, di­rec­tor of in­vest­ment, told End­points News.

While many suc­cess­es in ad­vanced ther­a­pies have been lim­it­ed to rare con­di­tions, main­ly of the reti­na, liv­er and bone mar­row — 4BIO wants to start tak­ing these cut­ting edge ap­proach­es to slight­ly more main­stream ap­pli­ca­tions, man­ag­ing part­ner Dmit­ry Kuzmin said.

“Our am­bi­tion for…Fund II is to try and bring these in­to what we jok­ing­ly call medi­um rare con­di­tions, and ba­si­cal­ly where we have to tack­le with treat­ing tens of thou­sands of pa­tients on a reg­u­lar ba­sis,” he said.

Hav­ing been at the fore­front of ad­vanced ther­a­pies in­vest­ment since 2010, the team of 9 (bol­stered by a 6-mem­ber ad­vi­so­ry board) is clear about just the kind of fron­tiers it’s keen on tack­ling in each of the fields it’s watch­ing, Kuzmin added.

That means gene ther­a­py in the brain, as well as ways to tone down, crank up or turn off gene ther­a­pies (4BIO has pre­vi­ous­ly in­vest­ed in op­to­ge­net­ics start­up Ret­roSense, but there’s al­so chemo­ge­net­ics, ther­mo­ge­net­ics, mag­ne­to­ge­net­ics, and so on).

With­in cell ther­a­py, 4BIO is look­ing for sol­id clin­i­cal and man­u­fac­tur­ing op­er­a­tions that can de­liv­er con­sis­tent and durable re­spons­es; for tar­get­ed ther­a­py it’s most in­ter­est­ed in pro­tein degra­da­tion and vi­ral ap­pli­ca­tions; and “ra­tio­nal en­gi­neer­ing” is the key word for their mi­cro­bio­me bets.

The LPs, which in­clude the Chil­dren’s Min­neso­ta among a group of fam­i­ly of­fices and in­sti­tu­tion­al in­vestors, have man­dat­ed a third of the fund be re­served to launch new star­tups.

Kuzmin en­vi­sions most­ly seed-stage and Se­ries A rounds, with the oc­ca­sion­al Se­ries B — and the more ad­vanced in clin­i­cal proof-of-con­cept, the bet­ter. “Our ide­al project is clear­ly a for­ma­tion deal that’s al­ready in the clin­ic,” he summed up.

Ex­pect some more de­tails soon on the com­pa­nies they reck­on are push­ing through the med­i­cines of to­mor­row as the first two in­vest­ments get un­der way.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.