More than four months af­ter Er­ic Lan­der, the fa­mous found­ing di­rec­tor of the Broad In­sti­tute of MIT and Har­vard, re­signed from his top White House spot af­ter bul­ly­ing staff, Pres­i­dent Joe Biden has nom­i­nat­ed Arati Prab­hakar to serve as the next di­rec­tor of the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy (OSTP), which is a Sen­ate-con­firmed po­si­tion.

Prab­hakar is the first woman, im­mi­grant, or per­son of col­or nom­i­nat­ed to serve as the di­rec­tor of OSTP, and if con­firmed, she would al­so take the role of As­sis­tant to the Pres­i­dent for Sci­ence and Tech­nol­o­gy.

Prab­hakar can im­me­di­ate­ly take up the sci­ence ad­vi­sor post, ac­cord­ing to Sci­ence, which first re­port­ed Prab­hakar’s new ap­point­ment last week. In be­tween Lan­der’s de­par­ture and yes­ter­day’s nom­i­na­tion, Biden had to scram­ble to find sci­en­tif­ic lead­er­ship, bring­ing for­mer NIH di­rec­tor Fran­cis Collins back from re­tire­ment to help. Biden still has yet to nom­i­nate Collins’ Sen­ate-con­firmed re­place­ment.

“Dr. Prab­hakar is a bril­liant and high­ly-re­spect­ed en­gi­neer and ap­plied physi­cist and will lead the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy to lever­age sci­ence, tech­nol­o­gy, and in­no­va­tion to ex­pand our pos­si­bil­i­ties, solve our tough­est chal­lenges, and make the im­pos­si­ble pos­si­ble,” Pres­i­dent Biden said in a state­ment. “I share Dr. Prab­hakar’s be­lief that Amer­i­ca has the most pow­er­ful in­no­va­tion ma­chine the world has ever seen. As the Sen­ate con­sid­ers her nom­i­na­tion, I am grate­ful that Dr. Alon­dra Nel­son will con­tin­ue to lead OSTP and Dr. Fran­cis Collins will con­tin­ue to serve as my act­ing Sci­ence Ad­vi­sor.”

Prab­hakar is a safe se­lec­tion for Biden as she was unan­i­mous­ly con­firmed by the Sen­ate to lead the Na­tion­al In­sti­tute of Stan­dards and Tech­nol­o­gy, which she led from 1993 to 1997. She al­so led DARPA more re­cent­ly, from 2012 to 2017.

At DARPA, ac­cord­ing to the White House, she es­tab­lished a new of­fice to spur nov­el biotech­nolo­gies and jump-start­ed the de­vel­op­ment of a rapid-re­sponse mR­NA vac­cine plat­form, mak­ing pos­si­ble the in­cred­i­bly fast roll­out of Covid-19 vac­cines. And that work may trans­late in­to help­ing out with the cre­ation of ARPA-H, which is just be­gin­ning to stand up un­der the NIH.

Born in In­dia and raised in Texas, Prab­hakar earned her PhD in ap­plied physics from the Cal­i­for­nia In­sti­tute of Tech­nol­o­gy in 1984 (where she was the first woman to earn a PhD in ap­plied physics).

“She is the right per­son at the right time to sup­port the U.S. in­no­va­tion ecosys­tem, im­prove trans­la­tion­al sci­ence, at­tract and re­tain di­verse tal­ent pools, and en­sure that in­vest­ments in re­search and de­vel­op­ment solve the re­al chal­lenges fac­ing the Amer­i­can peo­ple,” Sen. Maria Cantwell (D-WA), chair of the com­mit­tee that over­sees sci­ence pol­i­cy, said in a state­ment on the nom­i­na­tion.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”