Cytel

JANUARY 15, 2024

After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen challenging market dynamics and a drop-off in activity. Every one of us working in clinical development has felt this slowdown, but as we begin 2024, there is reason for optimism.

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FDA Law Blog: Drug Discovery

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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Conversations in Drug Development Trends

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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Cytel

NOVEMBER 8, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director, Blackstone Life Sciences When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Conversations in Drug Development Trends

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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Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.”

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SCIENMAG: Medicine & Health

AUGUST 3, 2023

The Access to Advanced Health Institute Receives $18 Million Award to Develop a Temperature Stable, Single-Dose Chikungunya RNA Vaccine Through a Phase 1 Clinical Trial Credit: Delaney Brown Photography The Access to Advanced Health Institute Receives $18 Million Award to Develop a Temperature Stable, Single-Dose Chikungunya RNA Vaccine Through a Phase (..)

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Cytel

MAY 30, 2024

Written by David Kerr, Bill Coar, and Kent Koprowicz Data monitoring committees (DMCs) review data from ongoing clinical trials to make recommendations regarding trial conduct based on risk-benefit and other criteria, and are an essential component to ensuring the integrity and safety of many clinical trials.

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Alta Sciences

JUNE 21, 2024

Simpler Clinical Development From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. Ready for a simpler drug development journey? At Altasciences, we connect the dots, so you don’t have to. WATCH THE VIDEO.

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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?

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

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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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Drug Discovery Today

JANUARY 20, 2022

Cambridge and Wetherby, UK, 18 January 2022: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms announces that the next pre|CISION™ drug candidate, AVA3996, has been selected for pre-clinical development (..)

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Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

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Cytel

APRIL 5, 2024

Written by Sydney Ringold, Customer Success Manager, and Kevin Trimm, Chief Product Officer In an ever-changing clinical development environment, sponsors face many challenges when designing clinical trials. Both options can be utilized to effectively design a trial, but which approach is best?

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Cytel

MAY 5, 2023

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

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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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Cytel

MAY 14, 2024

Here, we discuss how KOLs can shape clinical trials, best practices for working with KOLs, and key considerations and potential challenges. The challenge, however, is how to use KOLs wisely — they are often clinicians first and researchers second, and their time is in high demand.

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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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PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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Cytel

JANUARY 13, 2023

Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase clinical trials. Yet there are also many strategic uses of Bayesian methods in late-phase clinical trial design, which can help generate more effective, efficient, and ethical clinical trials.

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Drug Discovery Today

JULY 28, 2020

Cancer Research UK, the University of Southampton and Touchlight Genetics, a London based biotechnology company, today (Wednesday) announce a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC).

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Cytel

JANUARY 22, 2024

Here, I share ways to save time and limit costs on your way to clinical trials. However, such guidelines do not tell you when different studies are ideally run or how to best prioritize between studies.

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Cytel

NOVEMBER 6, 2023

For this edition of the Industry Voices series, Ulrika Andersson, the new Director of Drug Development with the Therapeutics Development Team, discusses the route to the first-in-human clinical trial, planning nonclinical studies, and how to approach regulatory guidelines.

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Cytel

OCTOBER 30, 2023

The past two decades have seen the adoption of great innovation in clinical trial design. Statisticians have risen to the challenge by proposing a myriad of solutions to the ever more complex questions being posed by the trial team.

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Cytel

JANUARY 6, 2023

You may have heard that our clinical trial strategy platform Solara® won the Fierce Life Sciences award for Technology Innovation , so let’s take a closer look at simulation-guided design and what it enables clinical trial sponsors to do.

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PPD

SEPTEMBER 19, 2023

Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

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Cytel

APRIL 22, 2024

Kyle Wathen, Vice President, Scientific Strategy & Innovation One of the pivotal metrics considered when designing a clinical trial is the study’s probability of success, which can be measured in several ways. Adler, Director, Global Product Engagement, and J.

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Cytel

NOVEMBER 20, 2023

Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. Before diving headfirst into the guidelines, read on for tips to help you understand the essential regulatory requirements leading up to first-in-human clinical trials.

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Cytel

AUGUST 28, 2023

A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drug development and helps ensure that new therapies are safe, effective, and of high quality.

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Labcorp Drug Development

JANUARY 17, 2023

The potential of such immunotherapies to address untreatable malignancies … The post 4 emerging trends to watch in immunotherapy clinical trials appeared first on Insights From Our Labs to Yours.

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thought leadership

JUNE 27, 2023

In recent years, Australia has emerged as a leading destination for conducting clinical trials , attracting pharmaceutical, biotech, medical device/diagnostic companies, and research organizations globally.

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Cytel

NOVEMBER 29, 2022

Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as oncology and rare diseases, and in addressing clinical development challenges for COVID-19 drugs, devices, and biologics.

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Cytel

JANUARY 12, 2023

Statistical methods have long been fundamental to drug development, and advancements in the last few decades in computing power have opened the door to more widespread use of Bayesian methods in clinical trials. Interest in Bayesian methods is growing – in particular due to what these approaches enable.

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Cytel

APRIL 2, 2024

Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct based on risk-benefit. DMCs are an essential component to ensuring the integrity and safety of clinical trials. New draft guidance published by the U.S.

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