Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of di­ver­si­ty in clin­i­cal tri­als has per­sist­ed de­spite decades of ini­tia­tives to try to turn the tide.

In a re­cent re­view of 17 years of clin­i­cal tri­als, drug­mak­er GSK found that there were some mis­match­es be­tween the de­mo­graph­ics of its US-based tri­als and how preva­lent dis­eases were in those pop­u­la­tions.

The re­sults, the com­pa­ny says, will help GSK and oth­ers de­sign stud­ies that bet­ter rep­re­sent epi­demi­o­log­i­cal rates with­in races and eth­nic­i­ties.

In the study, UK-based GSK looked at da­ta from its drug tri­als span­ning 2002 to 2019 and re­viewed more than 100,000 US-based par­tic­i­pants in 495 tri­als. The re­sults were pub­lished Mon­day in Clin­i­cal Tri­als: Jour­nal of the So­ci­ety for Clin­i­cal Tri­alsThe re­view com­pared tri­al en­roll­ment to US de­mo­graph­ics and to the share of each de­mo­graph­ic group rep­re­sent­ed in a dis­ease pop­u­la­tion, as some racial and eth­nic groups are dis­pro­por­tion­ate­ly af­fect­ed by cer­tain dis­eases.

The re­sults were mixed. The com­pa­ny found that in tri­als for asth­ma drugs, Black/African Amer­i­cans made up 22.6% of par­tic­i­pants — ex­ceed­ing the 13.4% they rep­re­sent in the US pop­u­la­tion, as well as the 17% share of asth­ma pa­tients com­prised by Black/African Amer­i­cans.

How­ev­er, in HIV tri­als, en­roll­ment of Black/African Amer­i­can par­tic­i­pants was at 35.1%, high­er than cen­sus lev­els of 13.4%. But it was sig­nif­i­cant­ly low­er than the 55.3% share the group rep­re­sents among HIV pa­tients.

In COPD, 2.1% of Asians are im­pact­ed, ac­cord­ing to epi­demi­ol­o­gy da­ta — but GSK stud­ies had on­ly 0.4% rep­re­sen­ta­tion. His­pan­ics/Lati­nos were al­so un­der­rep­re­sent­ed — on­ly 4.5% of par­tic­i­pants in GSK’s COPD tri­als iden­ti­fied as His­pan­ic/Lati­no, but ac­cord­ing to epi­demi­ol­o­gy da­ta, they make up 6.5% of the dis­ease pop­u­la­tion.

The study al­so found that across phar­ma­ceu­ti­cal tri­als, Asians and par­tic­i­pants who marked they were of more than one race were the least rep­re­sent­ed. For vac­cine tri­als, the most well-rep­re­sent­ed group was non-His­pan­ic whites, while the least rep­re­sent­ed group was In­dige­nous.

GSK said that by the end of 2022, all of its clin­i­cal tri­als had a “di­ver­si­ty plan” in place to make sure that the racial and eth­nic groups most im­pact­ed by a dis­ease were en­rolled in the tri­al.

The com­pa­ny says that they are al­so now im­ple­ment­ing “glob­al cul­tur­al com­pe­ten­cy train­ing” to 15,000 clin­i­cal tri­al staffers “to build trust, en­hance dis­ease aware­ness and pro­vide ap­pro­pri­ate­ly tai­lored in­for­ma­tion.”

The lack of di­ver­si­ty in tri­als is not on­ly on GSK’s radar.

In De­cem­ber, the Gov­ern­ment Ac­count­abil­i­ty Of­fice re­leased a re­port that found cer­tain racial and eth­nic groups, as well as ado­les­cents, old­er adults, women, low-in­come in­di­vid­u­als and in­di­vid­u­als from rur­al com­mu­ni­ties, “re­main con­sis­tent­ly un­der­rep­re­sent­ed in can­cer clin­i­cal tri­als” — de­spite at­tempts to rec­ti­fy those gaps.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”