From Academic Discovery to Clinical Trials: Transitional Priorities
Moving a drug from academic discovery to clinical trials is one of the most critical phases in pharmaceutical development. Academic research often focuses on understanding disease mechanisms and identifying potential targets
Got Sleep? How to Sleep Better at Night
Poor sleep can affect heart health, blood sugar control, memory, learning, mood, productivity, and relationships. Over time, chronic sleep problems raise the risk of serious health conditions and increase health care costs. This week we discuss ways to sleep better at night.
How to REMS – A Practical Regulatory Guide
Risk Evaluation and Mitigation Strategies, or REMS, are required by the FDA for certain drugs with serious safety concerns. The goal of a REMS program is to ensure that the benefits of a drug outweigh its risks.
Regulatory Pathways FDA and EMA – Are You Prepared for Ongoing AI Supervision?
Regulatory pathways in the United States and Europe are becoming more complex. The FDA and the EMA continue to raise expectations for data quality, transparency, and oversight. At the same time, regulators are expanding their use of advanced digital tools, including artificial intelligence, to review submissions, monitor compliance, and identify risk.
Clinical Trial Optimization
Clinical trials are the backbone of drug development. They provide the evidence needed to show that a product is safe and effective. They also represent one of the largest investments a pharmaceutical company will make