Sarep­ta Ther­a­peu­tics CMO Gilmore O’Neill will take over as CEO and pres­i­dent of CRISPR biotech Ed­i­tas Med­i­cine on June 1.

But al­ready in the hours since be­ing an­nounced, O’Neill has been hear­ing from his net­work on who could po­ten­tial­ly be the new CMO at the gene edit­ing com­pa­ny he’s about to helm. Lisa Michaels was fired from the med­ical chief post in ear­ly Feb­ru­ary, with­out pub­lic ex­pla­na­tion, as part of a re­build­ing of the C-suite.

Hir­ing a new CMO will be one of O’Neill’s top pri­or­i­ties when he takes over the C-suite posts from ex­ec­u­tive chair Jim Mullen, who was in the post for the past 14 months, the two said in a joint in­ter­view with End­points News. The pair know each oth­er well and will have few kinks to work out in the tran­si­tion pe­ri­od be­cause of their pri­or time to­geth­er at Bio­gen in the aughts, where Mullen was CEO and O’Neill held var­i­ous VP and SVP posts.

“The com­pa­ny hasn’t been as crisp on ex­e­cu­tion as it just needs to be, should be, has to be,” Mullen said of the lead­er­ship tran­si­tion. Ed­i­tas’ shares $ED­IT were down about 5.5% Thurs­day morn­ing. As ex­ec­u­tive chair, he’ll spend more time on “in­vestor de­vel­op­ment, think­ing about some pol­i­cy de­vel­op­ment, look­ing over the hori­zon at the days when we may start to com­mer­cial­ize prod­ucts.”

Jim Mullen

Busi­ness de­vel­op­ment and cap­i­tal rais­ing will be ad­di­tion­al fo­cus­es on “day one,” O’Neill said. His pre­de­ces­sor said Ed­i­tas has “not been as ac­tive or as pro­duc­tive on the busi­ness de­vel­op­ment front” as it could have been. The biotech will look to shore up ex­per­tise via part­ner­ing on its en­gi­neered NK cell pro­grams be­cause of the space’s “uber com­pet­i­tive” and ex­pen­sive na­ture, Mullen said. In­bound in­ter­est is al­so flow­ing in from drug de­vel­op­ers look­ing to pair up their ther­a­peu­tics with Ed­i­tas’ edit­ing ma­chin­ery and tech, he added.

O’Neill was al­so look­ing for a new part­ner over the past few months. His job search was laser-fo­cused on CEO posts.

“Ed­i­tas jumped off the page at me just as an enor­mous­ly ex­cit­ing op­por­tu­ni­ty. Why? The tech­nol­o­gy. It has un­lim­it­ed, re­al­ly, po­ten­tial and then the com­pa­ny it­self there [is] dif­fer­en­ti­at­ed core ex­per­tise in the com­pa­ny around nu­cle­as­es en­hance­ments, around guide RNA chem­istry and de­sign, as well as ex­pe­ri­ences with dif­fer­ent de­liv­ery method­olo­gies,” O’Neill said.

He in­her­its a nine-year-old biotech found­ed with the po­ten­tial to be a pi­o­neer in the CRISPR field. The com­pa­ny was born out of the sci­ence from CRISPR and gene edit­ing lead­ers Feng Zhang, George Church, J. Kei­th Joung and David Liu.

But the com­pa­ny has had on­ly a few clin­i­cal tri­al da­ta re­leas­es since en­ter­ing hu­man stud­ies. The com­pa­ny pre­sent­ed some ini­tial da­ta on ED­IT-101 for Leber con­gen­i­tal amau­ro­sis, a rare ge­net­ic vi­sion-loss dis­or­der, in Oc­to­ber 2021. And this week, the biotech said it be­came the first to test a CRISPR gene edit­ing med in vi­vo in a pe­di­atric pa­tient with ED­IT-101. Ed­i­tas be­gan test­ing ED­IT-101 in Ju­ly 2019 with part­ner Al­ler­gan, but Ab­b­Vie ditched the deal in Au­gust 2020.

Al­so this year, Ed­i­tas will be­gin test­ing its sec­ond pro­gram, ED­IT-301, in pa­tients with sick­le cell dis­ease and in an­oth­er study in pa­tients with trans­fu­sion-de­pen­dent be­ta tha­lassemia.

O’Neill has been CMO and EVP of R&D at Sarep­ta since June 2018, where he’s con­tributed to the Cam­bridge, MA biotech’s gene ther­a­pies for Duchenne mus­cu­lar dy­s­tro­phy, Amondys and Vyondys. Ed­i­tas al­so tout­ed O’Neill’s work on Bio­gen’s spinal mus­cu­lar at­ro­phy drug Spin­raza and MS ther­a­pies Ple­gridy and Tec­fidera.

He’s the third new CEO since 2019. Mullen took over in Feb­ru­ary 2021, when Cyn­thia Collins de­part­ed fol­low­ing a two-year stint af­ter Ka­trine Bosley’s ex­it in Jan­u­ary 2019. Mul­ti­ple oth­er sci­ence and med­ical chiefs have packed up their bags in re­cent years, too.

“The first thing to start with on long-term vi­a­bil­i­ty is to have some­body that’s younger, which prob­a­bly doesn’t nec­es­sar­i­ly in­clude me,” Mullen jok­ing­ly said.

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.

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.

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.