Luciana Borio (Susan Walsh/AP Images)

UP­DAT­ED: 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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.