Janet Woodcock and Francis Collins

Janet Wood­cock and Fran­cis Collins dish on lessons learned from the pan­dem­ic

With al­most 550,000 Covid-19 deaths in the US, it might seem hard to fath­om any sil­ver lin­ings from such a tragedy. But NIH di­rec­tor Fran­cis Collins and FDA act­ing com­mis­sion­er Janet Wood­cock did their best on Wednes­day to ex­plain what they’ve seen and learned and what the coun­try needs to do to pre­pare for the next pan­dem­ic.

For Wood­cock, who led the ther­a­peu­tics side of Op­er­a­tion Warp Speed be­fore re­turn­ing to lead the FDA, Covid-19 clin­i­cal tri­al in­ef­fi­cien­cies and a dearth of com­mu­ni­ty-based re­search in­fra­struc­ture sit atop her list.

While point­ing to her pub­li­ca­tion last month in Na­ture Re­views Drug Dis­cov­ery, she ex­plained how just 5% of the al­most 3,000 Covid-19 ther­a­peu­tic tri­als were ac­tu­al­ly ran­dom­ized and ad­e­quate­ly pow­ered to re­veal ac­tion­able da­ta.

“There was a tremen­dous amount of du­pli­ca­tion, and a lot of small tri­als that yield­ed tan­ta­liz­ing in­for­ma­tion that sent peo­ple off to use treat­ments that were not use­ful and po­ten­tial­ly harm­ful,” Wood­cock said at the Milken In­sti­tute event. “In a glob­al emer­gency we need to have more cen­tral co­or­di­na­tion be­cause we should re­al­ly ran­dom­ize the first pa­tient.”

On the lack of re­search in­fra­struc­ture, Wood­cock ex­plained how com­mu­ni­ties with­out aca­d­e­m­ic med­ical cen­ters or ad­e­quate­ly trained per­son­nel were stuck with­out any op­tions for en­rolling peo­ple in tri­als. “You can’t just build up in­fra­struc­ture ca­pac­i­ty in the mid­dle of a pan­dem­ic,” she said. “We had tens of thou­sands of peo­ple dy­ing from Covid and we couldn’t get enough pa­tients en­rolled in some tri­als.”

Collins, mean­while, point­ed to three lessons learned. The first is to en­sure NIH and the phar­ma in­dus­try main­tain its pub­lic-pri­vate part­ner­ship, known as AC­TIV, which bet­ter co­or­di­nat­ed and stream­lined bio­med­ical re­search re­sources for test­ing new and re­pur­posed com­pounds to treat Covid-19.

“If we can do it in two weeks, as we did with AC­TIV, we can prob­a­bly do it again and make these kinds of part­ner­ships,” Collins said.

Sec­ond­ly, he point­ed to the dis­con­nect in the clin­i­cal tri­al net­works in the US, not­ing Wood­cock’s com­ments. While he said the du­plica­tive and po­ten­tial­ly un­help­ful tri­als weren’t re­ceiv­ing funds from NIH, they may have been us­ing NIH-fund­ed in­fra­struc­ture.

“We can­not let this clin­i­cal tri­al ecosys­tem fall back in­to this scat­ter­shot ap­proach or we’ll be sor­ry. We need a much more rig­or­ous ap­proach. If we need­ed the ev­i­dence, we now have it,” Collins said.

And third­ly, he point­ed to the need for con­tin­u­ing NIH’s ven­ture cap­i­tal-like strat­e­gy used in its RADx com­pe­ti­tion to speed new Covid-19 tests to mar­ket.

“There’s a lot of tech­nolo­gies out there,” he added, not­ing the Shark Tank ap­proach may be bet­ter suit­ed for many of the ones in de­vel­op­ment, as op­posed to the NIH grant process, which can take more time.

Last­ly, both Wood­cock and Collins point­ed to the need to in­crease the di­ver­si­ty of clin­i­cal tri­als, which Collins not­ed was a heavy lift for some of the Covid-19 vac­cine de­vel­op­ers.

“The way in which bio­med­ical re­search works is con­t­a­m­i­nat­ed by struc­tur­al racism,” Collins said.

Wood­cock echoed that sen­ti­ment, ex­plain­ing how of­ten tri­als are run in dif­fer­ent coun­tries but they don’t nec­es­sar­i­ly re­flect the di­ver­si­ty of the US pop­u­la­tion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.