H1 Blog

JUNE 7, 2023

Clinical trial success is a key factor for pharma companies when designing and recruiting patients into trials. In a recent article in Clinical Leader , Randy Krauss, head and executive director of metrics, analytics, and performance, Merck & Co.,

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Drug Target Review

FEBRUARY 10, 2025

In just two years, CTMC has advanced eight therapies into clinical trials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies.

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Cytel

DECEMBER 29, 2023

Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial design to advice on regulatory submission to clinical data best practices, and so much more — all written by our many expert authors.

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Cytel

DECEMBER 19, 2022

Adaptive clinical trial topics are frequently explored in Perspectives on Enquiry and Evidence. Here are some of our most-read articles on adaptive clinical trials of 2022.

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Agency IQ

FEBRUARY 2, 2024

In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs.

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Cytel

MAY 5, 2023

As clinical trials become more complex, simulation-guided design approaches are crucial.

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Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. ” About Ascletis.

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Labcorp Drug Development

APRIL 17, 2023

In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an … The post Alcohol-related liver disease: Inherent Challenges and Strategies for Successful Clinical Trial Conduct appeared first on Insights From Our Labs to Yours.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

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Drug Target Review

AUGUST 28, 2024

The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.

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Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. How do they stack up? Other therapeutic areas include cell and gene therapy.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Let the CRO know any key outcomes from each.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

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Cytel

NOVEMBER 6, 2023

The first-in-human trial, which aims to show the safety and tolerability of a new drug, is a major milestone for any drug development project.

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Alta Sciences

MARCH 21, 2024

Top 5 Scientific Resources in CNS Clinical Trials blussier Thu, 03/21/2024 - 18:09 HTML CNS Center of Excellence Resource Library Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

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Conversations in Drug Development Trends

FEBRUARY 6, 2023

When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Read the full article! Guidance in this area is much needed.

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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Drug Target Review

JULY 18, 2023

This article is the second part of my interview with Olivia Cavlan, Chief Corporate Development and Strategy Officer at Alchemab Therapeutics Ltd, this time exploring the AI applications in personalised medicine, and the evolving landscape of drug development.

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Vial

APRIL 10, 2024

This article provides a comparative overview of Vial and IQVIA. Positioned as a technology-centric CRO, Vial aims to revolutionize clinical research by delivering faster, superior, and more cost-effective clinical trial outcomes. Vial stands out from IQVIA in several key aspects.

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Cytel

MARCH 13, 2023

And despite initial hesitancy in the clinical trials space, simulation-guided design has revolutionized, and will continue to transform, the landscape of clinical trial development. Many industries have long since adopted the practice of modeling and simulating experimental scenarios.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Drug Target Review

MARCH 17, 2025

Hopes for the Phase IIb trial Donello discusses the key outcomes he hopes to see in the Phase IIb VITALIZE study of zelquistinel for major depressive disorder (MDD). With over 25 years of experience in the pharmaceutical industry, Donello has been instrumental in drug discovery and development.

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Cytel

DECEMBER 27, 2022

Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new opportunities for efficient and flexible clinical trials. Here are some of our most-read articles on Bayesian methods in 2022. Bayesian topics are frequently explored in Perspectives on Enquiry and Evidence.

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Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. However, research and clinical trials of BiTEs in solid tumours, including NSCLC, are still in the early phases. 2024;347:122676. BMC Cancer.

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The Pharma Data

DECEMBER 29, 2020

The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China.

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Agency IQ

FEBRUARY 12, 2024

Furthermore, the Consortium would also work to develop standardized approaches to nonclinical testing as well as a set of standardized analytical methods, which could be used to assess product quality and manufacturing processes and controls.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

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The Pharma Data

NOVEMBER 26, 2020

The EGM resolved on amendment of § 4 (share capital) and § 5 (number of shares) of the Articles of Association for the purpose of enabling the directed issue of shares and warrants, as resolved by the Board of Directors on 27 October 2020 subject to the approval by the EGM. § LUND, Sweden , Nov. LUND, Sweden , Nov. sammanläggning 1:25 ).

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

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Vial

APRIL 24, 2024

Introduction In a landscape where many contract research organizations (CROs) are available, Vial is breaking through with its promise to deliver on its vision to empower scientists to cure all human diseases by reimagining clinical trials.

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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By geographical region, the global CRO services market in 2023 was dominated by North America.

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The Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial.

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The Pharma Data

SEPTEMBER 15, 2020

Enrolling study subjects, setting up patient randomization and managing drug supply are critical to the success of a clinical trial. During her medical practice, Seredina worked in clinical research as an investigator. Konneh is currently responsible for strategic development at Strategic Alliances and marketing at S-Clinica.

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Agency IQ

APRIL 12, 2024

Not only are assays useful tools for characterizing products early in development; they can also be used to set “benchmarks,” allowing sponsors to verify that the lots of the product used during clinical trials and eventually, for commercial distribution, continue to adhere to the same standards specified in the original product’s design.

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