Ex-Pfiz­er ex­ec Geno Ger­mano joins nanopar­ti­cle start­up Elu­ci­da On­col­o­gy as CEO

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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Glax­o­SmithK­line moves malar­ia vac­cine pro­duc­tion to In­dia; Nevakar bags Eu­ro­pean part­ner and nine-fig­ure deal

GSK is shifting production of its malaria vaccine to a Covid-19 vaccine developer in India.

Wednesday’s move to Bharat Biotech was made as part of efforts to battle the deadly fever, as GSK’s vaccine is the first to prove effective in combating the disease. Bharat will take over manufacturing of the protein part of the vaccine while GSK continues developing the adjuvant portion of the shot.

The vaccine is currently being piloted in regions of Ghana, Kenya and Malawi under the Malaria Vaccine Implementation Program. More than 500,000 children have received the first dose since the pilots were initiated by the three countries in 2019.

Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.