The UK’s RE­COV­ERY tri­al, a plat­form study eval­u­at­ing sev­er­al po­ten­tial treat­ments for Covid-19 us­ing the NHS’ net­work of hos­pi­tals, has proven one of the most suc­cess­ful pan­dem­ic en­deav­ors, like­ly sav­ing hun­dreds of thou­sands of lives. Its cre­ators want to tack­le oth­er dis­eases in a sim­i­lar man­ner, and they’ve se­cured some Big Phar­ma cash to get start­ed.

Led by RE­COV­ERY mas­ter­mind Mar­tin Lan­dray, the non­prof­it Pro­tas launched Mon­day with $6.8 mil­lion from Sanofi. The goal is to de­sign and de­vel­op cost-ef­fec­tive large scale clin­i­cal tri­als across a wide range of dis­eases, part­ner­ing with phar­ma com­pa­nies, clin­i­cal sites, aca­d­e­m­ic in­sti­tu­tions and pa­tient groups along the way.

“As we have seen dur­ing the re­cent pan­dem­ic, large ran­dom­ized clin­i­cal tri­als are crit­i­cal for the prop­er as­sess­ment of pos­si­ble treat­ments,” Lan­dray said in a state­ment. “The sit­u­a­tion is not [unique] to the pan­dem­ic; there are many oth­er com­mon and oth­er life-threat­en­ing dis­eases… where bet­ter treat­ments are need­ed to re­duce the huge bur­den on pa­tients and the NHS.”

In ad­di­tion to the Sanofi part­ner­ship, Pro­tas has al­so won an NHS grant for an undis­closed sum. The non­prof­it ex­pects to be­gin de­sign­ing its first tri­als in 2023.

RE­COV­ERY is large­ly cred­it­ed with dis­cov­er­ing how dex­am­etha­sone, a cheap cor­ti­cos­teroid, can lessen the risk of death in hos­pi­tal­ized Covid-19 pa­tients. Lan­dray and his team de­liv­ered the re­sult ear­ly on in the pan­dem­ic, launch­ing the study back in March 2020, giv­ing hos­pi­tals a tool to fight the most se­vere Covid-19 cas­es.

The tri­al al­so showed the Re­gen­eron/Sanofi mon­o­clon­al an­ti­body and the rheuma­toid arthri­tis drug Actem­ra worked in the same pa­tients, while find­ing oth­er treat­ments like hy­drox­y­chloro­quine and con­va­les­cent plas­ma were not ef­fec­tive.

Giv­en the bal­loon­ing costs of con­duct­ing clin­i­cal stud­ies, Pro­tas now wants to ex­pand the method­ol­o­gy to oth­er com­mon dis­ease ar­eas — its launch state­ment lists heart, lung and res­pi­ra­to­ry dis­ease, arthri­tis, can­cer, de­pres­sion and de­men­tia as ar­eas of in­ter­est. Lan­dray and his team plan to de­sign their own stud­ies from scratch, fo­cus­ing on clin­i­cal tri­als’ most es­sen­tial as­pects.

Some phar­ma com­pa­nies can even spend hun­dreds of mil­lions of dol­lars on a sin­gle drug can­di­date, but Pro­tas hopes its ef­forts to stream­line R&D will lead to more drugs be­ing de­vel­oped at a frac­tion of their cur­rent costs. And work­ing as a non­prof­it will make the stud­ies both more af­ford­able and im­prove their qual­i­ty, Pro­tas says.

Mak­ing plat­form stud­ies the norm is an idea that has been float­ed be­fore, par­tic­u­lar­ly by Lan­dray him­self. In a Feb­ru­ary 2020 ar­ti­cle in NE­JM, Lan­dray wrote how phar­ma com­pa­nies were in­creas­ing­ly turn­ing to re­al-world ev­i­dence to cut costs, re­ly­ing on that “myth” in­stead of ran­dom­ized stud­ies.

But by fo­cus­ing on­ly on the es­sen­tials, Pro­tas is hop­ing to re­verse the trend and re­mind the in­dus­try of the “mag­ic” be­hind ran­dom­iza­tion.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.