Drug Target Review

JUNE 6, 2025

“Protocol development can be a complex and meticulous process,” he explains, “as it’s crucial to ensure that trial candidates meet the necessary inclusion criteria.” Prior treatments and patient histories often introduce variables that can affect outcomes, making thoughtful trial design essential for generating reliable data.

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Therapies Treatment Drug Development Clinical Development 100

PPD

OCTOBER 21, 2024

FSP solutions are widely used in biotech Biotech companies of any size can benefit from using a contract research organization (CRO) to fulfill trial-related functions and services. With FSO, all tasks for a clinical trial are outsourced. are outsourced.

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International Clinical Development Clinical Trials Clinical Research 87

New Drug Approvals

APRIL 11, 2025

2] History The efficacy and safety of fitusiran were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male participants with either hemophilia A or hemophilia B. [2] 2] [3] Names Fitusiran is the international nonproprietary name. [4] Fitusiran 1711.0g/mol, Fitusiran 1711.0g/mol,

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Clinical Trials FDA FDA Approval Trials 107

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Clinical Trials Trials Compliance International 98

PPD

JUNE 7, 2023

By partnering with a contract research organization (CRO) that understands the challenges of liver disease clinical trials — and the complexities of working with pediatric populations — you can drive your treatment forward. Partnership with an experienced CRO is essential to your trial’s success. Hispanic: 11.8%

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Trials Clinical Trials Clinical Research Disease 98

PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 98

Drug Target Review

APRIL 7, 2025

A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.

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Clinical Development Clinical Trials Clinical Pharmacology Trials 69

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. Clarification of Roles and Responsibilities The Roles & Responsibilities section was added to provide clearer expectations for all trial stakeholders.

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Clinical Trials Trials Clinical Research Government 88

Drug Target Review

JUNE 11, 2025

Clinical genomics, powered by NGS, enables more precise target validation, improved patient stratification and optimised trial design, ultimately aiming to increase PoS. Internally, the models learn to associate concepts, find patterns and relate text and images (or other modalities) so that they can be analysed in the same way.

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Drugs Clinical Trials Drug Development Pharmaceuticals 64

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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Drug Development Clinical Trials Compliance Trials 52

Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Previously, organizations had limited influence on the direction of basic research, clinical trial designs, and data ownership.

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Clinical Research Disease Research Clinical Trials 72

PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.

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Drug Development Clinical Trials Trials Drugs 52

Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Compliance Treatment 81

Drug Patent Watch

DECEMBER 30, 2024

Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan. Challenges and Opportunities Ethnic Bridging : Japan has historically required clinical trials to be conducted within the country to account for ethnic differences.

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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Drug Discovery Today

NOVEMBER 10, 2022

A team of surgeons and scientists from the UK, Sweden and Canada, funded by Rinri Therapeutics, has confirmed secure surgical access to the central core of the human cochlea The research, published in Scientific Reports, is critical to the first in-human trials of new cell, gene and drug therapies for the inner ear, and will assist with treatment for (..)

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International Research Therapies Trials 100

Conversations in Drug Development Trends

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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Trials Disease Clinical Trials Clinical Research 75

On Medicine

NOVEMBER 27, 2023

On the International Day of Persons with Disabilities , it is important to make sure that we think about ALL people with disabilities. The trial We are recruiting 66 educational settings and will involve 330 children and young people and their families. We will conduct the study at educational settings throughout the country.

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Trials International Research 92

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. Bock explained that the supply chain for clinical trials typically follows a linear model for traditional therapies, where manufacturing is separate from the clinic.

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Therapies Treatment Engineering Clinical Trials 64

Antidote

JUNE 22, 2023

Creating clinical trial marketing materials is a delicate balance — it's important to craft outreach that connects with patients and care partners, but it’s also important to adhere to the guidelines set out by the Food and Drug Administration (FDA) to receive the approval of the Internal Review Board (IRB).

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Clinical Trials Trials International FDA 59

PPD

FEBRUARY 10, 2025

Todays clinical trials rely on technologically sophisticated systems that require complex integrations to capture and process all manner of data across multiple sites, often spread throughout multiple countries or jurisdictions. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.

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Clinical Trials Trials Clinical Research Research 52

H1 Blog

APRIL 2, 2025

Leveraging Data for More Inclusive Research Clinical trial representation is more than just a regulatory requirementits a critical component of accessible healthcare. Ensuring that trial participants reflect the real-world patient population leads to more effective treatments and better health outcomes.

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Clinical Trials Trials International Research 52

The Premier Consulting Blog

JANUARY 14, 2025

Oncology Regulatory Affairs and Policy Program Advancing Oncology Decentralized Trials Multiple trial modernization initiatives Evaluate the benefits and challenges of decentralized trials to prioritize streamlined procedures for future trials. Provides the Oncology Dosing Toolkit.

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Clinical Trials Therapies FDA Trials 52

Drug Target Review

OCTOBER 30, 2024

Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. Further still, think about implanting these mini organs into the patient to restore lost function. Cell Stem Cell. 2013;13(6):734-44.

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Treatment Disease Clinical Trials Research 105

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.

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Clinical Research Trials Clinical Trials Research 69

On Medicine

MAY 17, 2023

Yet, what about those who took part in the trial? In recent years there has been an increasing call to let trial participants know the results of trials in which they have taken part. Back in 1995 only one person in every 27 was on a trial in cancer. The post Clinical Trials Day 2023: what about the trial participant?

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Clinical Trials Trials Research Hospitals 52

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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Clinical Research Research Clinical Trials Bioethics 52

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

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Treatment Trials Clinical Trials Drugs 69

Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry. The work environment.

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International Laboratories Science Molecular Biology 40

Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.

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Clinical Trials Trials Clinical Research Research 52

Advarra

JANUARY 13, 2023

This blog explores what it takes for an EAC/CEC to adequately support worldwide clinical trials. Having one set of adjudicators across the entire trial aids consistency of determinations and allows for a central decision-making framework. The Global Reach of EACs and CECs. Source: United Nations Conference on Trade and Development.

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Clinical Trials Regulations Trials International 52

Drug Target Review

DECEMBER 11, 2024

By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.

International 52

International Laboratories Drugs Pharmacokinetics 52

Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? In a study on cancer clinical trials, Pe et al. In a study on cancer clinical trials, Pe et al.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 52

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. As clinical trial design becomes more dynamic and adaptive, studies require more complex statistics and more specialized biostatisticians to ensure study data are relevant and scientifically valid.

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Trials Clinical Trials FDA Approval Therapies 52

H1 Blog

JULY 19, 2023

Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

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Clinical Trials Trials FDA Treatment 52

ASPET

JUNE 22, 2023

Clinical trials assessing the impact of Radiotherapy (RT) in combination with inhibitors of the DNA Damage Response Pathway (DDRi) and/or immune checkpoint blockade are currently ongoing. Nonlinear mixed effects modelling was performed followed by internal validation with Visual Predictive Checks (VPC).

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DNA Clinical Trials International Trials 100