Brain Maps: Live 3D Imaging of Activity

Scientists at the Massachusetts Institute of Technology (MIT) and the University of  Vienna have developed a light-field laser imaging system that generates 3D movies of entire brains at a millisecond timescale to create a complete “living” brain map.  The research...

Assessing Safety Earlier in Drug Development

The objective of a recent survey by Cambridge Health Associates was to identify trends in safety biomarkers and their utilization in drug development.  Regardless of company size, recurrent themes for assessing drug safety in early preclinical development were noted....

US, Canada, and EU – Who wins the Drug Approval Race?

Both pharmaceutical industry and regulatory professionals acknowledge the importance of balancing timely access to new medicines with the need for thorough review of drug safety and efficacy data.  A new study, funded by the Pew Charitable Trusts (to be published in...

Potential Academic Contributions to Drug Development

Dr. Janet Woodcock (CDER, FDA) stated that for every 10 drugs that enter Phase I clinical trials, only 1 drug is approved.  The cost of bringing an innovative drug to market often requires a decade and a billion dollars of investment.  The paradigm where...

Drug Safety: IOM Pharmacovigilance Report

An Institute of Medicine (IOM) committee report, recommends that the FDA take proactive steps to continue monitoring drug safety after initial approval and throughout the market lifecycle.   Post-market evidence is far greater than what the FDA has when deciding upon...