Drug Target Review

SEPTEMBER 22, 2023

5 Organoids are recognised as New Alternative Methods (NAMs) in drug development. This recognition was codified by the United States Food and Drug Administration (FDA) in 2022 with the signing of the FDA Modernisation Act 2.0 This can aid in the development of safer, more effective therapeutic strategies. Front Genet.

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PPD

JANUARY 15, 2025

As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time.

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Clinical Trials Trials Clinical Research Drug Development 95

Drug Patent Watch

DECEMBER 11, 2024

Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.

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Pharmaceutical Companies Compliance Pharmaceuticals Drug Development 98

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

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PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Yet, today’s clinical research sponsors face significant challenges. These delays financially disrupt the potential of both current and future clinical research. With a median delay of 12.2

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PPD

JUNE 10, 2024

We are thrilled to announce that the PPD clinical research business of Thermo Fisher Scientific is getting a brand refresh! Our new visual identity will align more closely with Thermo Fisher’s style, while still retaining elements unique to our PPD clinical research business. Ready to unlock efficiencies?

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Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The global preclinical CRO market was estimated to be valued at US$5.7

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PPD

FEBRUARY 12, 2025

Its important for your clinical research organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.

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Clinical Supply Clinical Trials Drug Development Clinical Research 69

LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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Clinical Research Disease Research Clinical Trials 67

Fierce BioTech

JUNE 14, 2024

How AI Accelerates Clinical & Drug Development Timelines pesurya Fri, 06/14/2024 - 10:59 Wed, 09/11/2024 - 14:00 Resource Type Webinar Viswa Colluru, Ph.D. What Lies Ahead Speakers will discuss future opportunities to expand the application of AI in both clinical and drug development and where the industry is trending.

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Drug Development Clinical Research Drugs Research 52

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development. The rest of this blog will focus on the Clinical Trials Grants Program. The seven awardees included six early-stage trials (e.g.,

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Advarra

JUNE 27, 2023

This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively. The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy.

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Clinical Research Research Clinical Trials Trials 52

Conversations in Drug Development Trends

JULY 29, 2024

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. DEXA (Dual-Energy X-ray Absorptiometry) is the optimal method for accurately measuring body composition in clinical research.

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Clinical Research Research Clinical Trials Treatment 52

PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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Clinical Development Clinical Trials Clinical Research Trials 98

PPD

DECEMBER 19, 2022

PPD, Thermo Fisher Scientific ’s clinical research business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drug development industry. The opportunity to leverage new technologies in drug development (e.g.,

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Drug Target Review

DECEMBER 16, 2024

Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drug development. Opportunities in clinical research and drug development were not always easy to come by.

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Medical Schools Clinical Research Drug Development Trials 52

PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization.

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution.

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LifeSciVC

FEBRUARY 27, 2024

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC Patients and their care partners are at the center of our work in the life sciences industry – but at what point during the drug development process should companies start to engage these key stakeholders?

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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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PPD

FEBRUARY 10, 2025

A recent white paper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized.

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Clinical Trials Trials Clinical Research Research 52

Alta Sciences

JULY 5, 2023

How to Facilitate Your Ophthalmic Drug Development tchichekian Thu, 07/06/2023 - 01:11 HTML From Discovery to Market, We’ve Got You Covered. As a leading partner in ophthalmic drug development , Altasciences has an outstanding track record formulating, testing, and manufacturing ophthalmic products.

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Conversations in Drug Development Trends

JULY 9, 2024

The post Current Clinical Research Trends in GLP-1 (Glucagon-Like Peptide 1) Treatment appeared first on Worldwide Clinical Trials. By focusing on innovation, patient-centric solutions, and cross-functional collaboration, we aim to continue leading the charge in transforming the GLP-1 therapeutic landscape.

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Clinical Research Treatment Research Clinical Trials 52

PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Clinical Trials Trials Clinical Research Drug Development 98

PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. 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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PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

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Trials Clinical Trials Clinical Research Disease 98

Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

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Drug Development Disease Therapies Engineering 52

PPD

MAY 18, 2023

Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. There’s little time to lose.

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Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Conversations in Drug Development Trends

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

At Worldwide, we understand that every program is different, which means every drug development path forward will be unique. Rather than settling for an “off-the-shelf” approach, you deserve a team that actively seeks customized solutions tailored to your specific study.

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Quanticate

DECEMBER 4, 2020

Patient safety has been the primary focus of clinical trial design since 1947 when the Nuremberg code outlined the ethical guidelines for clinical research. Trials must be designed to avoid injury or suffering and patients must give consent and are free to leave the trial at any point.

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Clinical Trials Trials Clinical Research Drug Development 52

PPD

JULY 6, 2023

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints. How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves.

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PPD

MARCH 13, 2024

Due to overall efficiencies and a proactive risk mitigation approach to the cellular supply chain, timelines are continuously adhered to, allowing smooth cohort transitions and the potential to expedite drug development timelines.

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