The as­so­ciate di­rec­tor of the Na­tion­al In­sti­tute of Health’s Of­fice of Leg­isla­tive Pol­i­cy and Analy­sis (OL­PA) is leav­ing her gov­ern­ment post to join CEO James Pey­er at Cam­bri­an Bio­Phar­ma.

Adri­enne Hal­lett made the an­nounce­ment via her LinkedIn pro­file Wednes­day morn­ing, link­ing to a state­ment from act­ing NIH di­rec­tor Lawrence Tabak.

In her role at OL­PA, Hal­lett over­saw and man­aged rep­re­sent­ing bio­med­ical re­search to Con­gress and pres­i­den­tial ad­min­is­tra­tions, on top of lead­ing 120 staff in ad­vanc­ing pol­i­cy goals, co­or­di­nat­ing re­spons­es to over­sight in­ves­ti­ga­tions and more.

Tabak’s state­ment not­ed Hal­lett’s work in Con­gress, tout­ing her record im­prov­ing NIH’s fed­er­al ap­pro­pri­a­tions by more than 40% since she start­ed work­ing for the agency in 2015.

“I want to thank Adri­enne for her ded­i­ca­tion to cul­ti­vat­ing NIH’s re­la­tion­ship with Con­gress over the past sev­er­al years,” Tabak said.

Be­yond that, Tabak added that Hal­lett played a crit­i­cal role as an ad­vi­sor to NIH brass as the agency im­ple­ment­ed sex­u­al ha­rass­ment re­port­ing re­quire­ments, new stan­dards re­lat­ing to pa­tient con­fi­den­tial­i­ty and ad­dressed struc­tur­al racism in bio­med­ical re­search.

Be­fore her time at NIH, she worked with the US Sen­ate’s ap­pro­pri­a­tions com­mit­tee for 14 years, mov­ing up to staff di­rec­tor on the La­bor, HHS, and Ed­u­ca­tion sub­com­mit­tee and lat­er a se­nior pol­i­cy ad­vi­sor be­fore mov­ing to NIH.

As for her new gig, she will be leav­ing for Cam­bri­an on Feb. 25 to be­come the biotech’s new VP of glob­al pol­i­cy and strate­gic ini­tia­tives.

Cam­bri­an CEO James Pey­er told End­points News that he first con­nect­ed with Hal­lett through a mu­tu­al friend.

“We start­ed talk­ing about a year ago,” Pey­er said, adding that Hal­lett will be work­ing with foun­da­tions, gov­ern­ment in­sti­tu­tions and oth­er groups for in­vest­ments in­to Cam­bri­an’s pipeline, along with long-term ob­jec­tives such as be­ing able to run more pri­ma­ry pre­ven­tion tri­als.

“Her job will be to help us fig­ure out how to run tri­als and how to find great part­ners,” Pey­er added.

This an­nounce­ment is the newest de­vel­op­ment for the com­pa­ny, less than two weeks af­ter un­wrap­ping Cam­bri­an’s newest pipeline com­pa­ny, Is­ter­ian Biotech, which is cur­rent­ly fo­cused on in­hibitor drugs for TG2, a hard-to-tar­get pro­tein that could have im­pact in the ex­tra­cel­lu­lar space.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.