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.”

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2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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