EMA of­fers method­olog­i­cal con­sid­er­a­tions for tri­als dur­ing Covid-19 pan­dem­ic

The Eu­ro­pean Med­i­cines Agency (EMA) on Wednes­day re­leased for con­sul­ta­tion a new draft guide­line on points that clin­i­cal tri­al spon­sors should con­sid­er on the im­pli­ca­tions of the coro­n­avirus dis­ease (Covid-19) on method­olog­i­cal as­pects of on­go­ing tri­als.

While not­ing that “it is not pos­si­ble to give gen­er­al ap­plic­a­ble ad­vice on how the dif­fer­ent as­pects re­lat­ed to the pan­dem­ic should be han­dled, as im­pli­ca­tions on clin­i­cal tri­als are ex­pect­ed to be man­i­fold,” the EMA’s Bio­sta­tis­tics Work­ing Par­ty calls on spon­sors “to pre-plan how sys­tem­at­ic de­vi­a­tions re­sult­ing from the mea­sures and in­di­vid­ual de­ci­sions re­lat­ed to the Covid-19 pan­dem­ic are cap­tured,” as well as to record such de­vi­a­tions and the re­lat­ed rea­sons for them.

The guid­ance comes as last week the EMA re­leased ini­tial guid­ance on con­duct­ing tri­als dur­ing the pan­dem­ic, in tan­dem with the FDA. Since then, Eli Lil­ly said it will de­lay most new study starts and pause en­roll­ment in most on­go­ing stud­ies. And Bris­tol My­ers Squibb said that for both on­go­ing and new stud­ies, no new sites will be ac­ti­vat­ed un­til 13 April – a date that could be ex­tend­ed. BMS al­so tem­porar­i­ly sus­pend­ed screen­ing, en­roll­ment and aphere­sis in its cel­lu­lar ther­a­py clin­i­cal tri­als.

In light of such paus­es, the EMA guide­line notes that spon­sors should col­lect a “suf­fi­cient amount of in­for­ma­tion on pan­dem­ic-re­lat­ed mea­sures and whether tri­al pa­tients or tri­al con­duct were af­fect­ed, as well as on the sub­pop­u­la­tions of ex­posed/non-ex­posed, and in­fect­ed/non-in­fect­ed pa­tients will be nec­es­sary to study the im­pact on the treat­ment ef­fect. Spon­sors should col­lect this in­for­ma­tion to the ex­tent fea­si­ble, and in a prag­mat­ic man­ner.”

In some cas­es, the guide­line says an in­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee may be nec­es­sary, par­tic­u­lar­ly to help spon­sors re-start usu­al tri­al op­er­a­tions, ad­just the tri­al sam­ple size and/or to deal with any po­ten­tial sources of bias.

Most im­por­tant­ly, pa­tient safe­ty is para­mount and at the heart of every de­ci­sion tak­en, re­gard­less of any po­ten­tial con­se­quences for an on­go­ing tri­al. Be­yond this, it is an eth­i­cal man­date to pro­ceed with a tri­al that has been start­ed as long as there is an op­por­tu­ni­ty that the ef­forts tak­en by pa­tients and physi­cians can ben­e­fit drug de­vel­op­ment and pa­tient care,” the guide­line adds.

Points to con­sid­er on im­pli­ca­tions of Coro­n­avirus dis­ease (COVID-19) on method­olog­i­cal as­pects of on­go­ing clin­i­cal tri­als

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Author

Zachary Brennan

managing editor, RAPS

A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Force 5 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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GSK's asth­ma bi­o­log­ic Nu­cala is one step clos­er to ap­proval in key chron­ic rhi­nos­i­nusi­tis pop­u­la­tion

Months after GSK’s Nucala cleared in a pivotal rare blood disorder study, the asthma biologic has scored in a late-stage trial in chronic rhinosinusitis patients with nasal polyps.

The British drugmaker on Friday disclosed data from the SYNAPSE study, which tested Nucala (also known as mepolizumab) against a placebo on top of standard-of-care in more than 400 patients, all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and required surgery due to severe symptoms and bigger polyps.

Servi­er bags an an­ti­body spe­cial­ist in its lat­est on­col­o­gy M&A deal with plans to add the plat­form tech

Whatever Servier learned about Symphogen during their 2-year development alliance must have significantly whetted their appetite for an acquisition.

Paris-based Servier announced Friday that it has struck a deal to buy out the antibody expert. The acquisition comes 2 years after Servier acquired Shire’s cancer business for $2.4 billion. They’ve been working with Symphogen on a slate of programs, including some favs – PD-1, LAG3 and TIM3 — where they are looking to differentiate themselves from the more prominent drugs in these niches.

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GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

→ Rip Ballou, who until very recently led vaccine research and development at GlaxoSmithKline, is joining the International AIDS Vaccine Initiative (IAVI) to lead its USAID-funded ADVANCE program. The program uses a network of researchers and institutions in Africa to help develop a vaccine for HIV. Ballou had worked at GSK since 2010 and has led global vaccine R&D since 2015. Prior to that he held posts at the Bill & Melinda Gates Foundation, a different post at GSK, Medimmune, and Walter Reed Army Institute of Research.  IAVI is led by Mark Feinberg, the former CSO of Merck Vaccines. 

Ahead of US IPO, Leg­end Biotech adds $150M, top-tier in­vestors to back CAR-T pipeline

Last month Nanjing Legend Biotech revealed that it sees, and was quietly planning for, a future as a public company in the US, separate but still tied to its former parent, Chinese CRO GenScript. It’s evidently a vision that enticed investors, drawing marquee names for a pre-IPO round.

The Series A fetched a whopping $150.5 million from Hudson Bay Capital Management, Lilly Asia Ventures, Vivo Capital, RA Capital Management and JJDC, the venture arm of J&J. The pharma giant has helped fund Legend’s CAR-T work with the $350 million upfront payment it handed over to partner on the lead BCMA program.

Aaron Royston, venBio

In­vest­ing in the time of coro­n­avirus: the good, the bad and the hope­ful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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FDA re­ports short­age of se­da­tion drug used for putting Covid-19 pa­tients on ven­ti­la­tors

The FDA on Thursday updated its list of drugs in shortage to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation.

The updated listings for five manufacturers note an increased demand for midazolam and may just be the beginning of what’s to come for other sedation drugs too.

Michael Ganio, senior director of pharmacy practice and quality at the American Society for Health-System Pharmacists, told Focus via email: “We have multiple reports of increases in purchases and utilization of sedatives like midazolam, fentanyl, and propofol to treat COVID-19 patients who require mechanical ventilation.”

Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.