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As clinical trials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinical trial management. Get in touch.
The journey of cell and gene therapies from preclinical discovery to clinical trials is complex and challenging, impacting every team member involved, from researchers in the lab to patients receiving treatment. These digital platforms are designed to manage and automate critical trial processes, especially related to drug management.
Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.
Primary Endpoint and Clinical Results The HYPERION trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of time to clinical worsening (TTCW). The STELLAR trial, presented at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23),
The IDeate-Prostate01 trial marks a significant advancement in the B7-H3 ADC development program and underscores the shared commitment of both companies to addressing difficult-to-treat cancers. Study Design and Objectives The Phase 3 IDeate-Prostate01 study is a randomized, multicenter, open-label clinical trial.
From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.
Promising areas for AI implementation When discussing the most transformative AI applications in drug discovery, Sujeegar identifies a particularly ambitious goal: developing AI models that can simulate human pharmacokinetics and pharmacodynamics (PK/PD) using only preliminary laboratory data.
Related groups OASIS Consortium Carpenter-Singh Lab Health and Environment Sciences Institute (HESI) Related news A marriage of microscopy and machine learning Roughly a third of drug candidates fail in the first phase of clinical trials, often due to unanticipated toxic effects that weren’t apparent in animal tests.
It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. The result?
Our approach, grounded in Good Laboratory Practice (GLP) and honed through thousands of studies, ensures that even the most subtle toxicological indicators are reliably detected. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.
SRP-001 has already moved beyond the laboratory. South Rampart Pharma has completed its Phase 1 clinical trial, demonstrating strong safety, tolerability and pharmacokinetics. The next milestone is a Phase II trial, aiming to begin in 3Q2025, evaluating SRP-001 in acute pain following third molar extraction (wisdom tooth removal).
& Researchers at the Broad Institute and The Jackson Laboratory have used prime editing, a precise and versatile form of gene editing, to correct the root cause of AHC in mice. The technology has already been successfully tested in a clinical trial for another rare genetic disease.
Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. NHP-C cardiomyocytes offer a more predictive and ethical platform, especially for drugs intended to advance from animal testing to first-in-human trials. National Research Council.
Importantly, unlike other MCL1 inhibitors that have raised concerns about cardiovascular side effects in early-stage clinical trials, BRD-810 acts quickly within cancer cells and is eliminated from the body in animal models within a few hours. This rapid clearance minimizes the drug’s potential impact on healthy cells.
Optimizing Tube Labeling for Improved Efficiency The tube labeling process starts with the generation of an Excel file generated from our Laboratory Information Management System (LIMS), which contains a list of unique IDs and sample information. This file is then imported into an MS App interface to create the user request.
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The organization has honored Liu for the development of the gene editing platforms base editing and prime editing, which can correct the vast majority of known disease-causing genetic variations and have already been used in at least 15 clinical trials, with life-saving results.
Based on a technology developed by Broad Institute core member David Liu’s laboratory, the treatment is the first in a series of new medicines being tested to treat rare diseases by repairing patients’ particular genetic misspellings. Of the 19 base editing and prime editing clinical trials underway now, more are taking place outside the U.S.
The two companies have signed a Memorandum of Understanding (MoU) to provide comprehensive support and resources to Japanese drug-discovery startups, helping them bring their innovations from laboratory benches toward eventual global delivery of new medicines.
Jude Children’s Research Hospital and lead investigator of the CLEVER (MK-1654-004) and SMART (MK-1654-007) clinical trials, emphasized the significance of this development. Key results from the CLEVER trial include: A 60.5% Octavio Ramilo, Chair of the Department of Infectious Diseases at St.
Designed to better manage risk, patient safety, and data integrity in clinical trials, the updated guideline is expected to be adopted by regulatory authorities worldwide. Read on to explore how ICH E6 (R3) may affect your ongoing and future trials—and use the following 10 critical categories of questions to assess your readiness.
The approval, granted on the basis of promising results from the ongoing Phase 1/2 LINKER-MM1 trial, targets a subset of patients who have exhausted at least four prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
The goal is to transform laboratory discoveries into clinically relevant therapies that can reach patients faster and more efficiently. Notably, over 80% of Bayer’s major global multi-center clinical trials now include study sites in China, spanning early-phase development to late-stage pivotal trials.
Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.
For the former, clinicians extract a patient’s cells, engineer them in a laboratory, and then infuse them back into the body. One recent Duchenne muscular dystrophy trial saw such outcomes at high doses, illustrating the trade-off between sufficient gene delivery and immune risk.
Food and Drug Administration (FDA) granted approval to ENFLONSIA in early June 2025 based on compelling results from two pivotal clinical trials: the Phase 2b/3 CLEVER trial and the Phase 3 SMART trial. In these trials, ENFLONSIA not only met its primary efficacy endpoints but also showed a favorable safety profile.
Still, while these developments provide cause for hope, each drug or vaccine faces a variety of challenges, ranging from financial incentives for clinical trials to the difficulty of discovering new antimicrobials that pass safety and efficacy tests. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.
Dozens more clinical trials, based upon similar gene-editing technologies, are now underway. Cas9 is also being used in a number of ongoing clinical trials for everything from HIV to protein folding disease and lymphoma. Therapeutics The first Cas13-based clinical trial was approved in 2024.
FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. label of WINREVAIR based on compelling new evidence from the Phase 3 ZENITH trial. risk score of 9 or greater.
Inside the FutureHouse laboratory. Learning requires trial, error, and revision. Outside of purely intellectual domains, the more trial and error cycles we can perform in a given time, and the more accurate the error signals, the better we'll learn. Photo by Xiaofan Fang. Intuitively, this makes sense.
This skillset, shared by Oncley and several others who later become key fixtures in Cohn’s laboratory, proved invaluable to wartime efforts when it became clear that many protein purification experiments would require extensive modification of instruments to work at scale. Curious researchers from external laboratories often attended.
Josh’s work at the Marine Biological Laboratory unlocked the potential of utilizing an endogenous protein to make a single alphabet change on RNA (RNA editing), a process that was precise, reversible and had druglike characteristics. (Academic specializing in RNA editing).
Are you in early-stage clinical trials, or are you gearing up for commercial launch? A CDMO should have a mature data integrity program in place, especially in the laboratory. How do you approach the CDMO selection process to ensure the best outcome for your startup? Your timeline will significantly impact your CDMO requirements.
The approval is supported by data from KEYNOTE-689, a pivotal Phase 3 trial that evaluated KEYTRUDA in this patient population. Based on these trial results, KEYTRUDA as a key component of this regimen shows tremendous potential to enable patients to live longer without disease recurrence and hopefully improve their overall prognosis.”
Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. ” Nobody really knows without trying it out in the laboratory.
At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.
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Whether you're navigating your first trial or scaling a growing pipeline, see how a purpose-built lab model can help you move smarter and faster. Whether you're navigating your first trial or scaling a growing pipeline, see how a purpose-built lab model can help you move smarter and faster.
Clinical trials: Clinical trials have demonstrated the safety and potential efficacy of hexasodium phytate in reducing hydroxyapatite crystallization in patients undergoing hemodialysis, providing a basis for its use in treating calciphylaxis.
This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. The SELECT trial set out to understand whether the drug has similar effect on patients without diabetes. As of mid-2024, this includes at least 650 Phase I-IV trials, with about 430 of those already ongoing.
AI/ML methods Thus far we have constructed, trained, assessed, and implemented more than 40 clinical AI models for care quality assessments, clinical trial enrollment, information retrieval from EHR systems, risk stratification, and more.
Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. Incyte expects multiple pivotal trial readouts this year, along with proof-of-concept data for several pipeline candidates. You can unsubscribe at anytime. Registered in England and Wales. TechTarget, Inc.s
Over two decades ago, as a NIDA grantee, I and my colleagues at Brookhaven National Laboratory and SUNY-Stony Brook used PET neuroimaging to show the recovery of lost dopamine transporters in the striatum of people with methamphetamine use disorder after prolonged abstinence.
Despite including guidance on confirmatory trials and FDAs authority to require them, the Agency decided to publish an additional guidance focused solely on how it is interpreting the authority to require that such trials be underway prior to accelerated approval or within a specified time period after the date of accelerated approval.
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