PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

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Conversations in Drug Development Trends

MARCH 1, 2024

To help determine if a master protocol could be a good fit for your study, check out this white paper for a more comprehensive overview of the appropriateness of master protocols in different contexts. Here are some relevant factors below: What Are the Advantages of a Master Protocol? Contact us.

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Conversations in Drug Development Trends

APRIL 4, 2024

The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies. Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research.

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Conversations in Drug Development Trends

MARCH 12, 2024

For a more in-depth look at biomarkers, check out our white paper. Based on previous studies, a single marker may be insufficient, and therefore, research points to the need for a “composite biomarker” made up of multiple markers meaningfully combined to inform the current disease state.

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PPD

OCTOBER 2, 2024

A recent white paper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants.

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Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

We recently published a white paper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study. At Worldwide, our early phase team has conducted these studies for over 20 years, gaining invaluable experience and insights into best practices for an AME study.

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Conversations in Drug Development Trends

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Conversations in Drug Development Trends

NOVEMBER 21, 2023

At Worldwide, we deliver full-service clinical development to support drug approval and commercialization. We thought, thousands of drugs haven’t been researched for thousands of other indications, so how can we disrupt the model?

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Conversations in Drug Development Trends

AUGUST 14, 2024

Recent Advancements in Biomarker Research The latest advancements in biomarker research have further elevated the biomarker’s role in disease diagnosis, treatment, and monitoring. However, at Worldwide, we have a proven track record of successfully utilizing biomarkers in oncology development.

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PPD

MARCH 21, 2024

When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. A number of strategies can be adopted to put the needs of the child at the center of the study.

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PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Ready to fuel more efficient drug development?

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PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) Download our white paper The post The Power of Bespoke Hybrid FSP/FSO Solutions appeared first on PPD.

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Clinical Trials Clinical Development Trials International 52

PerkinElmer

FEBRUARY 18, 2021

Eckelt conducted 23 hour-long, 1:1 interviews over five months in 2020 to gather market insights on how the top 20 Pharma are increasing productivity, efficiency, and speed of drug discovery in the short and long-term. A PerkinElmer White Paper offers a detailed look at the findings. Small molecules are making a comeback.

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Conversations in Drug Development Trends

MARCH 1, 2023

The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. See how to unlock the full power of your CRO partner in our white paper, Optimal Outcomes in Clinical Research and Product Development.

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The Pharma Data

OCTOBER 16, 2020

This week’s round up features a digital solution for adapting clinical trials to ease the burden on the clinical research industry and an in vitro model that mimics the human airway epithelium using a newly developed technology platform. BetterLife conducts patient centric study via a fully remote clinical trial.

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PPD

JULY 9, 2024

Drug developers need to staff RA teams that can handle regular lifecycle maintenance ebbs and flows across lifecycle maintenance tasks, and plan for a workload that sometimes requires senior-level expertise, while at other times is much more suited to support staff. However, completing this work is only half the challenge.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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The Pharma Data

DECEMBER 28, 2020

Dr. Hofstein completed his postdoctoral training and research in the Department of Neurobiology at Harvard Medical School. Dr. Russell has managed all aspects of the drug development and regulatory approval processes for oncology and non-oncology drug candidates. Hofstein received his B.Sc. from the Harvard T.H.

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The Pharma Data

SEPTEMBER 9, 2020

Receive expert-led insight from Dr. Heiner Oberkampf, Head of Data Governance at OSTHUS and learn how to: Digitally transform a drug development strategy. Develop a fully automated environment to significantly boost research efforts. Download Your Copy.

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