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The rising impact of biomarkers in early clinical development

Drug Target Review

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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Future-proofing drug development with GenAI

Drug Target Review

It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. Because LLMs are trained on extensive, internet-scale datasets, they can learn to identify contexts linking words and language.

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How FSP Solutions Support Risk-Based Methodologies and Tech Innovation in Clinical Operations

PPD

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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The Power of Worldwide Networks in Data and Safety Monitoring Boards

Advarra

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

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Ladders to Cures (L2C) Accelerator

Broad Institute

As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. I’m a rare disease researcher. Visit broad.io/L2C2023

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Intellia Reports Positive 3-Year Phase 1 Data for Lonvo-z in Hereditary Angioedema

The Pharma Data

The most frequently reported adverse events during follow-up were infusion-related reactions (IRRs), which were predominantly grade 1 (mild) and resolved without further complications. This trial is no longer enrolling, and additional enrollment details will be provided in future announcements.

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Combination of Lunsumio and Polivy from Roche Significantly Extends Remission in R/R Large B-Cell Lymphoma

The Pharma Data

The SUNMO trial evaluated subcutaneous Lunsumio in combination with intravenous Polivy in comparison to R-GemOx, a standard salvage regimen for transplant-ineligible LBCL. CRS occurred in approximately 25% of patients, and less than 5% experienced Grade 2 or 3 events. With a median follow-up of 23.2