Af­ter walk­ing away from a long ca­reer in Big Phar­ma last year — on­ly to bail from his start­up of choice on­ly 10 months lat­er — ex-Pfiz­er ex­ec Geno Ger­mano is back on the move.

Geno Ger­mano

The re­spect­ed bio­phar­ma chief has joined New York-based Elu­ci­da On­col­o­gy, a tiny Cor­nell spin­out work­ing on some fas­ci­nat­ing nanopar­ti­cle tech with ap­pli­ca­tions in can­cer. At Elu­ci­da, Ger­mano will serve as pres­i­dent and CEO — the first full-time post he’s tak­en up since his ab­bre­vi­at­ed stint at In­trex­on, the flashy syn­thet­ic bio start­up he ex­it­ed from last No­vem­ber.

Be­fore his stretch at the start­up, Ger­mano had been head of the glob­al phar­ma busi­ness at Pfiz­er when he was sud­den­ly the odd man out in a planned merg­er with Al­ler­gan (which ul­ti­mate­ly nev­er hap­pened). At Pfiz­er, he cul­ti­vat­ed a $14 bil­lion op­er­a­tion and over­saw a port­fo­lio of drugs span­ning sev­er­al ther­a­peu­tics ar­eas. He al­so worked at the top of Pfiz­er’s on­col­o­gy and spe­cial­ty care busi­ness units and di­rect­ed the in­te­gra­tion of in­dus­try gi­ant Wyeth af­ter the mas­sive $68 bil­lion ac­qui­si­tion.

Wyeth ap­pears to have a con­nec­tion to this new gig of Ger­mano’s. Af­ter all, Elu­ci­da’s ex­ec­u­tive chair­man is Robert Ess­ner, who was chair­man and CEO of Wyeth be­fore its merg­er with Pfiz­er in 2009.

Robert Ess­ner

“Geno’s con­sid­er­able ex­pe­ri­ence in the phar­ma­ceu­ti­cal in­dus­try makes him an in­valu­able ad­di­tion to the Elu­ci­da team. The back­ground and stature he brings to this piv­otal role will, with­out ques­tion, help our com­pa­ny ful­fil its goal of be­com­ing a leader in the world of pre­ci­sion med­i­cine on­col­o­gy,” Ess­ner said in a state­ment.

At Elu­ci­da, Ger­mano is join­ing an ef­fort to use ul­tra-small nanopar­ti­cals called C-dots for can­cer di­ag­no­sis and treat­ment. It’s hoped that these tiny par­ti­cles will aid in pre­ci­sion med­i­cine, tar­get­ing and pen­e­trat­ing can­cer cells to de­liv­er a range of can­cer-killing drugs, with the promise of un­used par­ti­cles and the drugs they car­ry safe­ly leav­ing the body through the re­nal sys­tem.

“My ca­reer is pred­i­cat­ed on a com­mit­ment to mean­ing­ful change and Elu­ci­da af­fords the op­por­tu­ni­ty to ex­plore the world of pre­ci­sion on­col­o­gy and, per­haps, push the bound­aries of its di­ag­nos­tic and ther­a­peu­tic ap­pli­ca­tions. I am ex­cit­ed to join this dy­nam­ic team,” Ger­nano 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.

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.