Craig Crews has in­cu­bat­ed some no­table biotech com­pa­nies this cen­tu­ry, and hun­dreds of thou­sands of blood can­cer pa­tients have ben­e­fit­ed from a med­i­cine with roots in his Yale lab.

His lab’s dis­cov­er­ies, par­tic­u­lar­ly in in­duced prox­im­i­ty and pro­tein degra­da­tion, have spawned biotech com­pa­nies such as Pro­te­olix, Arv­inas and Hal­da Ther­a­peu­tics, which was bought last year by John­son & John­son for $3.05 bil­lion. But while those were suc­cess­es, the cre­ation process was clunky — a se­ries of one-off jour­neys with sep­a­rate lead­er­ship teams.

Now, 31 years in­to his tenure, Crews has de­vel­oped a lead foot when it comes to biotech en­tre­pre­neur­ship. He’s spent the past few se­mes­ters con­struct­ing a lean­er mod­el that he hopes will sprout many med­i­cines and enough ear­ly-stage M&A ex­its to sup­port an ever­green pipeline of risky projects. He’s formed a hold­ing com­pa­ny, Quar­ry, and an op­er­a­tions com­pa­ny with a shared lead­er­ship team to run mul­ti­ple biotech star­tups at the same time.

Bar­clay But­ler, deputy com­mis­sion­er for op­er­a­tions and chief op­er­at­ing of­fi­cer in the FDA's of­fice of op­er­a­tions, will re­tire in the com­ing months, ac­cord­ing to an email to staff from FDA Com­mis­sion­er Mar­ty Makary that was re­viewed by End­points News.

But­ler's deputy, Melanie Keller, will take over both of his roles on April 6, ac­cord­ing to Makary's email. She has spent the last two decades at the NIH and FDA.

An FDA spokesper­son con­firmed the change. Ac­cord­ing to the FDA's web­site, But­ler over­sees "man­age­ment of busi­ness pro­grams and op­er­a­tions across the FDA en­ter­prise lev­el, in­clud­ing hu­man re­sources and fa­cil­i­ties."

But­ler took the dual op­er­at­ing roles last March af­ter serv­ing for a decade in the De­fense Health Agency and in the De­part­ment of De­fense.

John Crow­ley, CEO of the trade group BIO, says he still sup­ports FDA Com­mis­sion­er Mar­ty Makary even af­ter a se­ries of reg­u­la­to­ry de­ci­sions on his watch have caused frus­tra­tion and con­ster­na­tion among the biotech in­dus­try.

In an in­ter­view with End­points News on Tues­day, Crow­ley said the FDA “needs to con­tin­ue to suc­ceed” and that re­spon­si­ble reg­u­la­to­ry risk is crit­i­cal to fos­ter­ing a healthy ecosys­tem for drug de­vel­op­ers, par­tic­u­lar­ly for rare dis­ease treat­ments. He hasn’t seen as much of that.

“Some of the de­ci­sions have been head-scratch­ers.” Crow­ley said. “We need some sharp re­view and fo­cus, but the pat­tern here has been trou­ble in the rare dis­eases, par­tic­u­lar­ly in cell and gene ther­a­py.”

UCB is team­ing up with Chi­nese biotech An­ten­gene to de­vel­op a T cell en­gager in Am­gen's are­na, along­side bub­bling com­pe­ti­tion from As­traZeneca, Mer­ck and oth­ers.

The Bel­gian phar­ma is step­ping in­to the CD19xCD3 space in a pact with An­ten­gene that fea­tures $60 mil­lion up­front and $20 mil­lion in near-term mile­stones. The biotech could col­lect an­oth­er $1.1 bil­lion across de­vel­op­ment, reg­u­la­to­ry and sales mile­stones un­der the deal