Opin­ion: Con­gress needs to take a hard look at what went on at Trump's White House dur­ing the pan­dem­ic

Masks are com­ing off, restau­rants are fill­ing up again in­doors, and the US is, by all ac­counts, re­turn­ing to some sort of nor­mal-ish state.

But as the Covid-19 death toll slow­ly ticks up to the 600,000 mark, there’s a grow­ing con­sen­sus that at least some of those lives could’ve been saved. Where and how the past ad­min­is­tra­tion went wrong is easy to di­ag­nose as an arm­chair ex­pert, but Con­gress needs to be­gin what will like­ly be a gar­gan­tu­an and long process of ac­tu­al­ly sift­ing through the da­ta, in­ter­nal emails and de­ci­sion mak­ing to see what ex­act­ly hap­pened and what needs to be cor­rect­ed mov­ing for­ward.

With the help of the Free­dom of In­for­ma­tion Act, the pub­lic can now see a tiny glimpse of what some of the top health of­fi­cials in the Trump ad­min­is­tra­tion were do­ing at the height of the pan­dem­ic, and it isn’t pret­ty.

First and fore­most, the emails show how for­mer FDA com­mis­sion­er Steve Hahn lied to the pub­lic when he apol­o­gized for mis­s­peak­ing dur­ing a press con­fer­ence about how con­va­les­cent plas­ma would in­crease sur­vival. He didn’t mis­s­peak, his email shows he was plan­ning to note the 35% over­all in­crease in sur­vival all along.

And rather than of­fer­ing sup­port for what must’ve been a gru­el­ing sev­er­al months at the be­gin­ning of 2020 for those top ad­vi­sors like Deb­o­rah Birx and Hahn, se­nior Trump ap­pointees like Hope Hicks and Joe Gro­gan were in­stead push­ing their own agen­das, seek­ing fa­vors and mak­ing per­son­al ap­peals and de­mands — of­ten times for drugs like hy­drox­y­chloro­quine, which proved to be com­plete­ly in­ef­fec­tive.

And why was Katie Miller, the for­mer com­mu­ni­ca­tions di­rec­tor for Vice Pres­i­dent Mike Pence with no pub­lic health or med­ical ex­pe­ri­ence, telling Hahn what to look in­to ther­a­peu­tic-wise in April 2020?

Emails from a month pri­or to the Miller de­mand al­so show how celebri­ties with ac­cess to the top of­fi­cials (like Dr. Oz and Lau­ra In­gra­ham) were not on­ly grant­ed an au­di­ence but al­so mak­ing de­mands on how to run tri­als for hy­drox­y­chloro­quine.

Aaron Kessel­heim

And this is just the tini­est sliv­er of the ice­berg that Con­gress needs to look in­to and re­lease pub­licly, not on­ly for those who died of Covid-19 and their fam­i­lies, but for the next ad­min­is­tra­tion that has to deal with a sim­i­lar­ly mas­sive, time-sen­si­tive is­sue like this.

Tax­pay­er dol­lars shouldn’t be wast­ed on what celebri­ties think, par­tic­u­lar­ly dur­ing a pan­dem­ic.

Aaron Kessel­heim, pro­fes­sor of med­i­cine at Har­vard Med­ical School, put it best when he told me re­cent­ly, “I was most hor­ri­fied by the at­tempts by mem­bers of the Trump ad­min­is­tra­tion/Con­gress and celebri­ties to get fa­vors or make per­son­al ap­peals to the FDA Com­mis­sion­er, and to see such mi­nor, use­less stuff be el­e­vat­ed up to the high­est lev­els of the FDA.

“If com­mu­ni­ca­tions like this were more rou­tine­ly made pub­licly avail­able, then maybe such folks would feel less en­ti­tled to make them, and all of the peo­ple who re­ly on the FDA would bet­ter trust that cer­tain de­ci­sions were be­ing made on sci­en­tif­ic terms rather than po­lit­i­cal (or Dr. Oz’s!) in­ter­fer­ence,” he added.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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With few re­main­ing un­ap­proved drugs, re­searchers tell FDA its Un­ap­proved Drugs Ini­tia­tive is no longer ef­fec­tive

Back in May, the FDA decided to reverse a Trump-era decision to pull the agency’s controversial Unapproved Drugs Initiative, with the FDA citing “multiple legal and factual inaccuracies.”

But now a group of researchers from Harvard, funded by Arnold Ventures, raises new questions about why the UDI program might not be necessary in its current form.

Designed in 2006 as a way for the FDA to transition old drugs from unapproved to approved products, the agency sought to better ensure that unsafe products were removed from the market.

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