11/10/2026  |  Joanne S. Eglovitch  |  RAPS

https://www.raps.org/resource/fda-commissioner-touts-strong-interest-in-early-stage-trial-pilot.html 

Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas said there is significant public interest in its recently announced Expedited Investigational New Drug (IND) pilot at the Friends of Cancer Research (FOCR) annual meeting on Tuesday.

Diamantas said the agency has received more than 100 applications and will select six to eight sponsors to participate in the pilot. The participants will be chosen next month, he said.

Both Diamantas and National Cancer Institute (NCI) Director Anthony Letai discussed some of the efforts being made to make early-stage US trials more competitive with countries such as China and Australia and said they are looking forward to working together as partners in Operation TrialBlazer.

The expedited IND pilot is part of Operation TrialBlazer, which was launched in mid-June and features a series of measures designed to speed up drug development from the IND stage to late-stage clinical trials. In the Expedited IND pilot, qualified external institutions will collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for IND submissions to the FDA. (RELATED: HHS and FDA propose clinical trial reforms to expedite drug development, Regulatory Focus 23 June 2026)

Through these programs, FDA and NCI will be working together to streamline clinical research. FDA’s part in the effort is to accelerate early-stage, first-in-human clinical trials and to streamline IND applications while NCI’s role is to collaborate with cancer centers and researchers to streamline clinical trial activation timelines and improve patient enrollment in cancer studies.

11/11/2026  |  Doherty Institute

https://www.doherty.edu.au/articles/from-immune-discovery-to-clinical-trial-the-journey-of-a-covid-19-antibody/ 

How a promising antibody discovered in a person who recovered from COVID-19 progressed from the laboratory to a first-in-human clinical trial.

The COVID-19 pandemic highlighted the need for treatments that can be rapidly developed against emerging infectious diseases. One promising approach is the use of monoclonal antibodies, laboratory-made versions of the body’s natural immune defences that can help prevent or treat viral infections. Researchers from the University of Melbourne, WEHI and collaborating institutions spent five years developing one such antibody, PDI204, taking it from discovery in a person who recovered from COVID-19 through to a Phase I clinical trial in healthy volunteers. While the virus continued to evolve, the project provides valuable lessons for developing antibody therapies against future pandemic threats.

Finding the right antibody: learning from natural immunity
The journey began at the start of the pandemic, when a team of researchers at the University of Melbourne – including Professor Stephen Kent, Associate Professor Adam Wheatley, Associate Professor Jennifer Juno, and Dr Wen Shi Lee – studied a cohort of people who had recovered from COVID-19. After infection with SARS-CoV-2, the virus that causes COVID-19, a person’s B cells keep memory of the virus and can make antibodies against it. The team isolated these memory B cells from people who had recovered from COVID-19 and created a library of antibodies that could be used as potential treatments for SARS-CoV-2.

From a promising candidate to an antiviral treatment
Finding an antibody…

11/10/2026  |  Moe Alsumidaie  |  The Clinical Trial Vanguard

https://www.clinicaltrialvanguard.com/clinical-bellwether/the-1m-trial-is-real-so-is-the-question-it-cant-answer/ 

Meri Beckwith opened her post with a direct challenge: “A lot of the skepticism about AI x Bio boils down to ‘clinical trials are the expensive part and AI can’t help there.'” Then she dropped the number. Lindus Health ran an end-to-end, randomized Phase 2a drug trial in neurology for a total, all-in cost of $1 million, an order of magnitude below benchmarked comparables. The clinical trials community noticed. And then, almost immediately, it split.

One faction read the number as proof. The other read it as a provocation dressed up as evidence.

Both are right, which is what makes this moment worth examining carefully rather than celebrating or dismissing.

What One Million Dollars Actually Proves
The Lindus figure is real, and it deserves credit on its own terms. Getting a randomized controlled Phase 2a trial across the finish line for $1 million is not a rounding error or a semantic trick. For context, Phase 2 trials typically consume tens of millions of dollars in direct costs before a single interim analysis is unblinded. If Lindus genuinely compressed that by a factor of ten through AI-assisted site selection, protocol optimization, remote data capture, and automated monitoring, that is an operational achievement worth scrutinizing in detail.

But scrutiny is precisely what is missing from the current conversation.

The neurology indication is unnamed. The sponsor compound is unnamed. The endpoint design, the patient population size, the duration, the regulatory pathway, all absent from the public claim. That silence does not invalidate the…

11/10/2026 | Mayo Clinic | Newswise

https://www.newswise.com/articles/especialista-da-mayo-clinic-destaca-pesquisas-que-ampliam-as-op-es-de-tratamento-para-pacientes-com-c-ncer-de-bexiga-e-rim 

Cancers of the reproductive and urinary organs—known as genitourinary cancers—affect millions of people worldwide each year. Yousef Zakharia, M.D., a medical oncologist at Mayo Clinic, leads clinical research aimed at improving treatment outcomes for patients with kidney, bladder, and prostate cancer.

“We have made significant progress in cancer therapies,” says Dr. Zakharia, head of the Genitourinary Tumor Group at the Mayo Clinic Comprehensive Cancer Center. “There is still more work to be done, especially for patients whose disease stops responding to standard therapies. Clinical trials help us expand options and advance the field.”

Expanding treatment options for bladder cancer

For many years, cisplatin-based chemotherapy was the primary treatment for bladder cancer. Recently, researchers have identified newer therapeutic options that improve outcomes and are generally well-tolerated, including enfortumab vedotin—an antibody-drug conjugate—and the immunotherapy drug pembrolizumab.

Initially approved by the U.S. Food and Drug Administration for advanced disease, this combination is now being evaluated for use prior to surgery in patients with localized cancer—meaning the cancer has not spread to distant organs. Dr. Zakharia is a co-author of an international study examining this approach in patients with muscle-invasive bladder cancer—a condition where the cancer has grown into the bladder wall and typically requires surgery.

Based on the study’s findings, Dr. Zakharia…