Worldwide Clinical Trials

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

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Worldwide Clinical Trials

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

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Clinical Development Development Clinical Trials Clinical Trials 59

Pharmaceutical Technology

JUNE 9, 2023

Upstream Bio will use the funds to advance its UPB-101 into Phase II trials to treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). It is also preparing for a swift transition to Phase III development. It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.

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Outsourcing Pharma

APRIL 7, 2022

Experts from the Decentralized Trials and Research Alliance and Rafael Pharmaceuticals discuss progress and possibilities during Clinical Development Advances.

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FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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CTTI (Clinical Trials Transformation Initiative)

OCTOBER 15, 2024

The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making The post The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making appeared first on CTTI.

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Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Medical Xpress

APRIL 26, 2023

A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa.

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Worldwide Clinical Trials

JUNE 13, 2024

The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

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Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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Outsourcing Pharma

OCTOBER 10, 2024

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Under […]

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Clinical Trials Clinical Trials Trials Clinical Research 156

Outsourcing Pharma

JULY 12, 2023

Acasti Pharma, a late-stage biopharma company with drug candidates addressing rare and orphan diseases, has selected WuXi Clinical Development to conduct its STRIVE-ON phase 3 safety trial for GTX-104, a novel injectable nimodipine formulation for intravenous infusion (IV) that addresses high, unmet medical needs for aneurysmal subarachnoid haemorrhage (..)

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XTalks

OCTOBER 4, 2024

The push to increase diversity in clinical trials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 89

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. The Phase III VISIONARY trial enrolled 530 adults aged 18 to 65, with varying degrees of kidney function, and most were at risk of progressing to end-stage kidney disease.

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XTalks

NOVEMBER 7, 2024

Intra-Cellular Therapies recently announced that its schizophrenia treatment, lumateperone (brand name Caplyta), has met the primary endpoint in a late-stage clinical trial. The Study 304 withdrawal trial is part of Intra-Cellular’s post-marketing commitment to the FDA, a standard requirement for antipsychotic medications.

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Pharma Mirror

JUNE 8, 2022

The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine. According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the.

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XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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Pharma Times

SEPTEMBER 1, 2020

Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa

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XTalks

SEPTEMBER 16, 2024

Lung-MAP is a pioneering clinical trial designed to simultaneously test multiple treatments for non-small cell lung cancer (NSCLC) under a single, comprehensive “umbrella” protocol. Could you give us an overview of the Lung-MAP trial and its significance in the treatment of NSCLC?

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Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

OCTOBER 19, 2022

Yesterday, global provider of patient-centric data analytics, Phesi launched its AI-driven Trial Accelerator Platform, an integrated SaaS solution designed to enable clinical development personnel to leverage study and control arm data, so as to accelerate product development.

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Outsourcing Pharma

JANUARY 9, 2024

has announced a new intelligent automation technology applied across its clinical trials platform it hopes will cut standard trial build timelines by at least half. Medable Inc.

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Clinical Trials Clinical Trials Trials Clinical Development 107

BioTech 365

NOVEMBER 12, 2021

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments First Patients Dosed in Camsirubicin Phase 1b Clinical Trial in U.S.Validive® Phase 2b/3 VOICE Trial Cleared … Continue reading →

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STAT News

OCTOBER 13, 2022

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development. Continue to STAT+ to read the full story…

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XTalks

SEPTEMBER 25, 2024

Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, Clinical Trial Financial Management Medidata Alicia C.

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XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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BioTech 365

OCTOBER 3, 2021

Active Biotech: Tasquinimod clinical development in multiple myeloma advances into combination therapy following completion of the initial phase of the ongoing trial in the US Active Biotech: Tasquinimod clinical development in multiple myeloma advances into combination therapy following completion of … Continue reading →

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ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.

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XTalks

SEPTEMBER 12, 2024

Ryan Brown Regional Vice President Sales-Trial Landscape H1 Diversity in clinical trials is not just a regulatory box to check — it’s an ethical imperative and a scientific necessity. Incorporating SDOH data into trial planning ensures that studies are more inclusive and accessible to diverse populations.

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XTalks

SEPTEMBER 13, 2024

Diverse clinical trials are a matter of equity and essential for the validity and reliability of research outcomes. Historically, racial and ethnically minoritized groups or populations have been excluded from clinical trials, leading to a lack of data on how different demographic subgroups respond to treatments.

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XTalks

JANUARY 17, 2024

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.

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pharmaphorum

DECEMBER 2, 2022

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. With a fresh take on a data-driven trial strategy, sponsors can create a new path for trials that also accounts for potential risks.

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