Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of an­a­lysts at Glob­al­Da­ta tracked 322 bio­phar­ma com­pa­nies — biotechs, phar­mas, CROs and such — re­port­ing on the trou­ble Covid-19 has caused for their clin­i­cal de­vel­op­ment plans.

Slight­ly more than half — 179 — are US op­er­a­tions, with about 1 in 4 scat­tered through­out Eu­rope and in Cana­da. And the dis­rup­tions are clus­tered around mid-stage de­vel­op­ment, though a hefty num­ber of late-stage de­rail­ments may well blunt the stream of ap­provals down the road.

“The ma­jor­i­ty of dis­rupt­ed clin­i­cal tri­als are in Phase II, at 44.8%, fol­lowed by Phase I with 26.1%, Phase III with 21.7%, and Phase IV with 7.4%,” says Brooke Wil­son, as­so­ciate di­rec­tor, tri­als in­tel­li­gence at Glob­al­Da­ta. “Of these tri­als, 12% are specif­i­cal­ly Piv­otal/Reg­is­tra­tional, giv­ing an in­di­ca­tion that there will be an im­pact on reg­u­la­to­ry ap­provals in the fu­ture.”

Glob­al­Da­ta al­so con­clud­ed that:

(T)he ma­jor­i­ty of dis­rupt­ed clin­i­cal tri­als — 67.3% — were due to the sus­pen­sion of en­roll­ment. The de­layed ini­ti­a­tion of planned tri­als fol­lows at 18.4%, then, fi­nal­ly, 14.4% of tri­als are cur­rent­ly be­ing im­pact­ed due to slow en­roll­ment. With­in the 14.4% of tri­als af­fect­ed by slow en­roll­ment, 20.7% of these are specif­i­cal­ly due to the avail­abil­i­ty of sites and in­ves­ti­ga­tors.

The big fo­cus now will be how fast the de­vel­op­ers can move these de­layed tri­als along, or re­place them with fresh ef­forts. Reg­u­la­to­ry groups on both sides of the At­lantic have been help­ing out with new rules that al­low tri­als to con­tin­ue, when pos­si­ble, with home drug de­liv­ery and at-home mon­i­tor­ing and the use of telemed­i­cine a more com­mon fea­ture.

Al­so of note, while we’ve seen plen­ty of ev­i­dence of wide­spread dis­rup­tion, a host of bio­phar­ma com­pa­nies have been ramp­ing up new work on drugs and vac­cines for Covid-19, strik­ing a whole new set of deals and di­vert­ing re­sources to new pro­grams. So it’s not a ze­ro-sum game.

Glob­al­Da­ta has been track­ing more than 700 drugs — from dis­cov­ery through piv­otal pro­grams — linked to Covid-19. “There are now over 2,000 clin­i­cal tri­als glob­al­ly – 398 of these clin­i­cal tri­als are for chloro­quine or hy­drox­y­chloro­quine and 22 of these tri­als are for remde­sivir,” the com­pa­ny re­port­ed a week ago. “There are al­so over 583 com­pa­nies and in­sti­tu­tions dri­ving pro­phy­lac­tic and cu­ra­tive in­no­va­tion.”

So­cial: Get­ty Im­ages

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

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.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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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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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.

Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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