Tag: biomarkers

Clinical Research: Phase 1 - Phase 4

Premier Perspective on Biomarkers in Oncology

In this era of precision medicine, biomarkers play a critical role in the rational development of novel therapies. With advances in both our understanding of cancer pathophysiology and tumor profiling technology, biomarkers can now be used to provide – important insights at every stage of drug discovery and development. In this article, we explore the...

Clinical Research: Phase 1 - Phase 4

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy. Adaptive...

Consulting

Biomarker Trends: Advancing the Body’s Ability to Fight Cancer

As researchers seek to harness the human immune system to fight cancer, they’re looking at several emerging opportunities to expand use of biomarkers. Among them: Human leukocyte antigen typing. Microbiome analysis for determining risk of inflammatory complications with immune therapeutics. Tumor mutation burden, measured via whole genome sequencing, whole exome sequencing, or comprehensive gene panel...

Clinical Research: Phase 1 - Phase 4

4 Phases of Biomarker Method Validation in Rare Disease Research

Rare diseases present some unique obstacles for researchers that significantly contribute to the high cost of drug development. Fortunately, innovations in biomarker use have the potential to significantly cut back on these costs while improving data quality. However, before biomarkers can be used in this research, their associated collection, measurement, and evaluation methods must be validated. The key phases of biomarker...

Clinical Research: Phase 1 - Phase 4

Fit-For-Purpose: A Strategic Approach to Biomarker Method Validation for Rare Disease

Ensuring the integrity of your surrogate endpoints Rare disease studies present unique obstacles to drug developers, including small patient populations, slow disease progression, lack of prior clinical research, and uncertainty around validating biomarker measurements intended for use as surrogate endpoints. Our white paper describes a fit-for-purpose approach to validating bioanalytical methods in orphan drug trials....

Clinical Research: Phase 1 - Phase 4

Biomarker Method Validation in Rare Disease Drug Development

While drug discovery has seen major advances over the last few years — especially in the domain of rare disease research — the number of new drug approvals has not kept pace with increasing development costs. However, the innovative use of biomarkers has the potential to change that trend. Biomarkers in Rare Disease Research Biomarkers are objectively measurable characteristics...