Edgardo Hernandez (via Linkedin)

Eli Lil­ly pro­motes Edgar­do Her­nan­dez to head its man­u­fac­tur­ing op­er­a­tions as 19-year vet O'Neill hits the ex­it

Myles O’Neill

Edgar­do Her­nan­dez is be­ing pro­mot­ed to fill the shoes of Myles O’Neill, who’s leav­ing the top man­u­fac­tur­ing post at Eli Lil­ly af­ter a 19-year run at the com­pa­ny.

“Myles added to the strong foun­da­tion of Lil­ly man­u­fac­tur­ing through his lead­er­ship of nu­mer­ous pro­duc­tiv­i­ty ini­tia­tives, the ini­ti­a­tion of our new site in North Car­oli­na and, most re­cent­ly, by suc­cess­ful­ly nav­i­gat­ing the chal­lenges of man­u­fac­tur­ing dur­ing the glob­al pan­dem­ic,” not­ed CEO Dave Ricks on the chang­ing of the guard.

Now Her­nan­dez will be a di­rect re­port to Ricks as the phar­ma gi­ant fol­lows up on plans to ex­pand the port­fo­lio.

One of his biggest tasks will be as­sum­ing re­spon­si­bil­i­ty for the sup­ply of Eli Lil­ly’s an­ti­body cock­tail for Covid-19, one of the few ther­a­pies to make it across the EUA line so far at the FDA. Just days ago the US gov­ern­ment inked a $210 mil­lion deal to buy a min­i­mum of 100,000 dos­es of bam­lanivimab (LY-CoV555) 700 mg and ete­se­vimab (LY-CoV016) 1400 mg to­geth­er. And there’s an op­tion for 1.1 mil­lion more dos­es through No­vem­ber 25.

The gov­ern­ment had al­ready con­tract­ed to buy 1,450,000 dos­es of bam­lanivimab alone, with more than 1 mil­lion dos­es de­liv­ered and 450,000 ad­di­tion­al dos­es due by March 31.

Her­nan­dez earned his bach­e­lor’s de­gree in chem­i­cal en­gi­neer­ing from the Uni­ver­si­ty of Puer­to Ri­co – Mayaguez and his mas­ter’s in chem­i­cal en­gi­neer­ing from North Car­oli­na State Uni­ver­si­ty. Be­fore mov­ing to Lil­ly 16 years ago, he did a stint at Pfiz­er.

His ca­reer at Lil­ly has in­clud­ed roles in en­gi­neer­ing ser­vices and man­u­fac­tur­ing strat­e­gy, as well as man­u­fac­tur­ing site-head roles in Puer­to Ri­co, France, and the Unit­ed States. “He cur­rent­ly over­sees Lil­ly’s par­enter­al and de­vice man­u­fac­tur­ing net­work, as well as the com­pa­ny’s glob­al sup­ply chain ac­tiv­i­ties. Her­nan­dez will as­sume his new role on May 2, 2021.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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