Newsletter | September 26, 2024

09.26.24 -- How Subject Matter Expertise Is Driving Industry Innovation

Targeted Medicines: Enhancing Efficacy, Safety, And Regulatory Success

With targeted medicines, understanding individual patient characteristics is key to maximizing efficacy and safety. By tailoring treatment regimens, organizations can bridge the gap between preclinical research and clinical development, ensuring regulatory success and improved patient outcomes.

 

When Transcriptomics Meets Drug Repurposing

Drug repurposing, once a niche strategy, is gaining traction thanks to transcriptomics. By analyzing gene expression patterns, researchers can rapidly identify new uses for existing drugs, reducing development time and costs. This approach holds immense potential for addressing unmet medical needs.

 

How New Technology Is Reshaping Pharmacovigilance And Patient Safety

Cutting-edge technologies are revolutionizing how we monitor and ensure patient safety. Join an expert panel discussion as they explore how AI, machine learning, and other innovations are streamlining processes, enhancing accuracy, and empowering safety and clinical teams to make data-driven decisions.

 

Getting The CAPA Framework Right The First Time

Fear of CAPAs is a common misconception. While they're regulatory necessities, they're also powerful tools for improving quality and efficiency. Let's explore a structured approach to implementing a robust CAPA framework that benefits both your business and patients.

 

Smart Steps to Managing Your TMF Audit Trail

Navigating the complex world of TMF audits can be daunting. But with a well-structured audit trail, you can ensure compliance, streamline inspections, and protect your clinical trials. Discover essential strategies for building a robust audit trail that empowers your TMF.

 

Improving Access And Support For Cell And Gene Therapies

Although cell and gene therapies (CGTs) are potentially transformative, their effectiveness is undermined by difficulties with patient access and support, high costs, and a complex pathway to treatment. Understand the patient access problems that are inherent with CGTs and the benefits of data collection and integrated patient support hubs.