President Donald Trump, left, listens as Moncef Slaoui, a former GlaxoSmithKline executive, speaks about the coronavirus in the Rose Garden of the White House, Friday, May 15, 2020, in Washington. (AP Photo/Alex Brandon)

Mon­cef Slaoui piv­ots from Mod­er­na's board to the helm of Pro­ject Warp Speed. His task: Overnight suc­cess

Bioreg­num Opin­ion Col­umn by John Car­roll

Mon­cef Slaoui stepped off Mod­er­na’s board of di­rec­tors on Fri­day and piv­ot­ed straight in­to the high pro­file role head­ing the Trump ad­min­is­tra­tion’s Pro­ject Warp Speed, where he’ll be in charge of ac­cel­er­at­ing Mod­er­na’s — and oth­ers — vac­cines to a rapid re­lease for a pan­dem­ic weary world.

The news be­came of­fi­cial mid-day Fri­day af­ter nu­mer­ous re­ports ear­li­er that he had been picked off the short list of can­di­dates.

Slaoui’s role on Mod­er­na’s board earned a com­pen­sa­tion pack­age val­ued at $490,000 last year, some­thing con­sumer ad­vo­cates quick­ly fixed on as a con­flict of in­ter­est. It’s un­like­ly that crit­ics will be sat­is­fied by Slaoui’s res­ig­na­tion, though Mod­er­na has al­ready done quite well for it­self with­out any added help from Slaoui. The biotech has ben­e­fit­ed ex­ten­sive­ly from ma­jor sup­port from BAR­DA and the NIH and will con­tin­ue to en­joy close con­tacts in Wash­ing­ton, in­clud­ing at the FDA.

As the lead de­vel­op­er in the US of a new vac­cine, Mod­er­na al­so of­fers the White House a Boston-based com­pa­ny that can po­ten­tial­ly pro­vide a US hero to re­solve the pan­dem­ic. So it’s like­ly Trump’s fa­vorite play­er with or with­out Slaoui’s in­volve­ment.

Mod­er­na CEO Stéphane Ban­cel is part of a small band of vac­cines ex­ecs who be­lieves it’s pos­si­ble to do some­thing that would have been con­sid­ered im­pos­si­ble at the be­gin­ning of the year: hus­tle a new vac­cine straight through a Phase I-III pro­gram in a mat­ter of months and come up with just enough piv­otal ef­fi­ca­cy and safe­ty da­ta to start dis­tri­b­u­tion in the fall.

While bil­lions of peo­ple ea­ger­ly want that, there’s al­so been some sig­nif­i­cant push­back from a va­ri­ety of ex­perts in the field who won­der if it’s re­al­ly fea­si­ble to be able to field a Covid-19 vac­cine in less than 2 years — in it­self some­thing of a mir­a­cle in a sec­tor where de­vel­op­ment can take years and some­times decades.

Slaoui’s po­si­tion will have al­ready been mold­ed by his board post. And it will fit neat­ly in­to the ad­min­is­tra­tion’s own view that they can make it hap­pen. Speak­ing at the White House to­day, he men­tioned see­ing un­pub­lished da­ta — pre­sum­ably Mod­er­na’s — that sug­gest­ed suc­cess is close at hand, ac­cord­ing to Politi­co.

“These da­ta made me feel even more con­fi­dent that we will be able to de­liv­er a few hun­dred mil­lion dos­es of vac­cine by the end of 2020,” he said.

We won’t have long to wait.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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