Luciana Borio (Susan Walsh/AP Images)

Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vet­ted by the Biden team to lead the FDA as com­mis­sion­er, Lu­ciana Bo­rio is now com­pil­ing quite the ré­sumé.

Bo­rio has now been named a ven­ture part­ner at Bob Nelsen’s ARCH Ven­ture Part­ners, and Nelsen told End­points News, “She will be in­volved in projects across the port­fo­lio, in­clud­ing on­go­ing projects in man­u­fac­tur­ing, clin­i­cal tri­als, gene ther­a­py and gene edit­ing, cell ther­a­py, and de­liv­ery. We are ex­plor­ing mul­ti­ple projects in in­fec­tious dis­ease, and next gen­er­a­tion man­u­fac­tur­ing.”

Bo­rio an­nounced her new role via tweet on Fri­day. The role will al­low her to show­case her FDA and Na­tion­al Se­cu­ri­ty Coun­cil-re­lat­ed ex­per­tise to ad­vance in­no­va­tion, sci­ence, and pub­lic health, Pfiz­er board mem­ber and for­mer FDA com­mis­sion­er Scott Got­tlieb, said.

Bob Nelsen

Nelsen and Bo­rio have worked close­ly in the past. He pre­vi­ous­ly told End­points News that he spent last spring in his Seat­tle home, talk­ing on the phone with Bo­rio about her work run­ning pan­dem­ic pre­pared­ness on the NSC, and fum­ing with her about the dire state of Amer­i­can man­u­fac­tur­ing. Those talks helped lead to the launch of Nelsen’s $800 mil­lion bi­o­log­ics man­u­fac­tur­ing start­up Re­silience.

Bo­rio, who pre­vi­ous­ly served as the FDA’s act­ing chief sci­en­tist and as VP at that non­prof­it in­vest­ment firm In-Q-Tel, serves as a se­nior fel­low for glob­al health at the Coun­cil on For­eign Re­la­tions for about the last year. Bo­rio did not re­spond to a re­quest for com­ment on whether she would keep that role at the CFR. She al­so serves as a mem­ber of CEPI’s sci­en­tif­ic ad­vi­so­ry com­mit­tee, where she pro­vides Covid-re­lat­ed guid­ance and work on the pub­lic-pri­vate part­ner­ship’s $3.5 bil­lion plan to re­duce the threat of fu­ture pan­demics and epi­demics.

And she played a hand in Pres­i­dent Biden’s race to nom­i­nate an FDA com­mis­sion­er, ac­cord­ing to one for­mer agency of­fi­cial.

Dur­ing the saga around the first ac­cel­er­at­ed ap­proval for Sarep­ta Ther­a­peu­tics’ DMD drug eteplirsen, Bo­rio — then FDA’s act­ing chief sci­en­tist — wrote to then-FDA com­mis­sion­er Robert Califf with fears that cur­rent act­ing com­mis­sion­er Janet Wood­cock “chilled sci­en­tif­ic de­bate with­in (the FDA Cen­ter for Drug Eval­u­a­tion and Re­view) and re­duced the lev­el of par­tic­i­pa­tion by the re­view team dur­ing the fi­nal stages of the de­ci­sion-mak­ing process.”

A for­mer se­nior FDA of­fi­cial said it was this dis­pute that led Wood­cock to push Bo­rio out of the FDA en­tire­ly, af­ter Bo­rio cir­cu­lat­ed an in­ter­nal memo con­cern­ing Wood­cock’s role with Sarep­ta. This for­mer of­fi­cial al­so said he thinks Bo­rio, who was vet­ted but ul­ti­mate­ly not nom­i­nat­ed to lead FDA, might have a hand in ic­ing Wood­cock’s fail­ure to land a nom­i­na­tion, too.

Ar­ti­cle up­dat­ed with com­ment from Bob Nelsen.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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RA Cap­i­tal-backed non-vi­ral gene ther­a­py start­up Sum­ma­tion Bio to shut down

As a string of new gene therapy startups aims to create treatments without the go-to shuttling method of an AAV virus, and as multiple gene editing biotechs look to do the same, one such startup is coming to a close.

Summation Bio, backed by at least $24 million in Series A funds, is “terminating operations” next month, per an employee’s LinkedIn profile update. (According to their LinkedIn profile, an employee said the company raised $60 million in the round.) Another employee took to the networking site last week to say the circumstances were “insurmountable,” noting that “despite all-out effort and error-free execution, the science, this time, was elusive.”

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San­doz plans to stay lo­cal af­ter No­var­tis sep­a­ra­tion, se­lect­ing new HQ in Basel

Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus.

The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024.

Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.”

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Bausch + Lomb to pro­mote three SVPs to ex­ec­u­tive team

Bausch + Lomb is making more executive change-ups, including the promotion of three of its senior VPs that will report directly to CEO Brent Saunders.

Earlier this year, Saunders returned to lead Bausch + Lomb and its roughly 12,000 employees after originally running the company from 2010 to 2013.

Bausch + Lomb said Thursday that Luc Bonnefoy, John Ferris and Yang Yang — the leaders of its surgical, consumer and vision care businesses, respectively — will join the executive management team and report directly to Saunders. It also said that Joseph Gordon, head of global consumer, surgical and vision care, is now a strategic advisor to Saunders.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Far­al­lon says it's won all de­sired board seats from Ex­elix­is af­ter share­hold­er vote

Less than two months after Farallon Capital Management launched a proxy fight to gain control of three seats on cancer biotech Exelixis’ board, it got what it wanted at the company’s annual shareholder meeting.

The hedge fund said Wednesday that preliminary results at Exelixis’ annual shareholder meeting elected all three of Farallon’s candidates to the board: Tom Heyman, Dave Johnson and Bob Oliver.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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