Sat.Jan 13, 2024 - Fri.Jan 19, 2024

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Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance

Advarra

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Despite each stakeholders’ best efforts, there are persistent challenges regularly throwing studies off track and resulting in costly workarounds: Failure to achieve recruitment goals : About 20 to 50% of clinical trials will require “rescue”, where new sites are added

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Top 10 Clinical Trial Trends for 2024

XTalks

The field of clinical research will witness significant advancements in 2024. From the continuing trend of the rapid adoption of AI tools to the growing use of real-world evidence (RWE) in regulatory decision-making and a focus on enhancing data integrity, find out how clinical trials will evolve in 2024 to shape the future of medical research. Read on to learn about the top 10 clinical trial trends for 2024, and be sure to explore and join upcoming webinars about clinical trials at Xtalks. 1.

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January 17, 2024: In This Friday’s PCT Grand Rounds, Why Are Imaging Trials Different?

Rethinking Clinical Trials

Dr. Pamela Douglas (Photo: Erin Roth, Duke Health) In this Friday's PCT Grand Rounds, Pamela Douglas of Duke University will present "Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials." The Grand Rounds session will be held on Friday, January 19, 2024, at 1:00 pm eastern. Douglas is the Ursula Geller Professor of Research in Cardiovascular Diseases at Duke University and a past president of both the American College of Cardiology and the American Society of Echocardiograp

Trials 147
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Clinical trial will test novel inhaled TB vaccine

Drug Discovery World

A new study will compare whether giving tuberculosis vaccine by inhalation is better at protecting against tuberculosis (TB) than injection into the skin. The Jenner Institute at the University of Oxford is conducting the study using Bacille Calmette-Guérin (BCG), the current licensed vaccine against TB. As the natural route of infection with TB is through inhalation of droplets into the lungs, it is hoped that delivering BCG by the same route will be more effective at stimulating the immune sys

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?

XTalks

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their

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UK maintains status as an attractive destination for advanced therapy clinical trials

BioPharma Reporter

The Cell and Gene Therapy Catapult (CGT Catapult), an independent organization specialising in the advancement of cell and gene therapies, has revealed that the UK has remained an attractive destination for commercial trials, with this type of clinical trial accounting for 81% of trials in 2023 and 80% in 2022.

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January 16, 2024: Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study

Rethinking Clinical Trials

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study. The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulat

Trials 147
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Kyverna sets plans for IPO in test of biotech market

Bio Pharma Dive

The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.

Marketing 309
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Coya stretches lead drug’s development to Parkinson’s and dementia

Pharmaceutical Technology

Coya plans to file investigational new drug applications for COYA 302 in amyotrophic lateral sclerosis and frontotemporal dementia later this year.

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Rabies Is a Deadly, Unpredictable Threat. Here’s How to Protect Yourself.

AuroBlog - Aurous Healthcare Clinical Trials blog

A feral kitten in Omaha, Nebraska, tested positive for rabies in November 2023. It died of the raccoon variant of the virus, which is typically found only in the Appalachian Mountains.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Former Pfizer statistician found guilty of insider trading on Paxlovid trial results

Fierce Pharma

A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

Trials 142
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Novartis details first-line data for radiopharma drug Lutathera

Bio Pharma Dive

Phase 3 trial results showed Lutathera cut the risk of disease progression or death by 72% as initial treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs.

Drugs 296
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XNK Therapeutics’ Evencaleucel gains EMA recommendation

Pharmaceutical Technology

XNK Therapeutics has received scientific recommendation from the EMA's Committee for Advanced Therapies (CAT) for its product evencaleucel.

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Scientists Identify The Optimal Number of Daily Steps For Longevity, And It’s Not 10,000

AuroBlog - Aurous Healthcare Clinical Trials blog

Conventional wisdom would have us believe the journey to a long and healthy life begins with 10,000 steps. Each and every day. For those living a more sedentary lifestyle, it’s a goal that can take some effort to maintain. We’ve also known for some time it’s also almost certainly wrong.

Scientist 183
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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DDW Winter 2023/2024

Drug Discovery World

The DDW Winter issue asks whether AI can deliver better immunotherapies for cancer and includes expert predictions on what to expect from the sector in 2024, alongside a supplement looking at SLAS2024 and an exclusive guide exploring therapeutic antibodies. DDW Winter 2023/2024 The post DDW Winter 2023/2024 appeared first on Drug Discovery World (DDW).

Antibody 124
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Tr1x, a new biotech, joins ‘Treg’ chase with $75M fundraise

Bio Pharma Dive

The startup is focusing on immune cells called Tr1 cells, which it claims could be important in treating autoimmune conditions like graft-versus-host disease.

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Takeda gains US FDA approval for HYQVIA to treat CIDP

Pharmaceutical Technology

Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.

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MTaI urges Finance Ministry to reduce customs duty on certain medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

Even as the central government is expected to present its interim budget for 2024-25 in less than three weeks, the Medical Technology Association of India (MTaI) has urged the Union Finance Ministry to reduce the customs duty on certain devices. “India’s current tariff duty structure on medical device imports is very high.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Does CNS Drug Development Need to Evolve to Include Objective, Longitudinal and Broad-Spectrum Data?

XTalks

To date, the lack of objective longitudinal measures in central nervous system (CNS) clinical studies has resulted in less than 6 percent of drugs in this space making it to market. Many of the validated cognitive assessments today are paper based, introducing the potential for bias and limiting ethnic and geographic diversity in clinical studies. Additionally, blood biomarkers only provide a snapshot in time and do not provide insight into cognitive function.

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FDA widens approval of Vertex’s CRISPR medicine to treat beta thalassemia

Bio Pharma Dive

The agency’s decision to expand use of Casgey, which won a landmark OK for sickle cell disease in December, comes more than two months ahead of schedule.

Medicine 306
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BridgeBio secures $1.25bn for genetic therapy development

Pharmaceutical Technology

BridgeBio Pharma has secured strategic financing of $1.25bn from Blue Owl Capital and CPP Investments for genetic therapies.

Genetics 246
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Ayush Ministry to amend D&C Act to add French Homoeopathic Pharmacopoeia in Second Schedule

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.

Cosmetics 148
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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After row with Hungary and Poland, Pfizer sues Romania over missed COVID vaccine payments

Fierce Pharma

Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. | Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. The lawsuit marks the latest move in Pfizer’s campaign to press countries to honor COVID-19 vaccine contracts inked by the European Commission in May 2021.

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Bayer signals ‘significant’ layoffs in plan to shrink bureaucracy

Bio Pharma Dive

The company said it has secured agreement from labor representatives in Germany for job cuts that will shed “many managerial employees.

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FDA approves Vertex’s gene-edited therapy for beta thalassemia

Pharmaceutical Technology

The US FDA has approved Vertex's CASGEVY, a gene-edited cell therapy, to treat transfusion-dependent beta thalassemia.

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Parexel, JFCR ink agreement to accelerate access to oncology clinical trials in Japan

AuroBlog - Aurous Healthcare Clinical Trials blog

Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, and the Japanese Foundation for Cancer Research (JFCR), the first and leading non-profit cancer research organization in Japan, has announced a strategic alliance to accelerate access to oncology clinical trials in Japan.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Osimertinib Resistance and EGFR Mutations in NSCLC Treatment

Bioengineer

The presence of the T790M mutation during first or second-generation EGFR-TKI treatments is observed in 50-60% of patients. This mutation hinders the drug’s binding to the mutant EGFR protein. Osimertinib, however, can covalently bind to the T790M and cysteine-797 (C797) residue at the protein’s ATP binding site, overcoming resistance mechanisms.

Genome 119
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Gene therapy biotech Jaguar spins out manufacturing company

Bio Pharma Dive

Called Advanced Medicine Partners, the new company will offer specialized cell and gene therapy manufacturing services to biotech and pharma clients.

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Synendos set to study endocannabinoid inhibitor for neuropsychiatric conditions

Pharmaceutical Technology

The endocannabinoid inhibitor SYT-510 will be investigated in healthy patients to assess its safety, tolerability, and pharmacokinetics.

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Deadly ‘Zombie Drug’ Believed to Contain Human Bones Wreaks Havoc in West Africa

AuroBlog - Aurous Healthcare Clinical Trials blog

A new drug called kush is wreaking havoc in west Africa, particularly in Sierra Leone where it is estimated to kill around a dozen people each week and hospitalise thousands.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.