A New Expedited Review Designation: Regenerative Advanced Therapy

February 9, 2017

By Michelle Villasmil, Ph.D., RAC (U.S.), Regulatory Scientist One of the many changes brought by the 21st Century Cures Act...


Transparency Initiatives at Health Canada

January 4, 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy. As part of the Regulatory Transparency and Openness Framework (,...


Precision Medicine and the FDA

October 20, 2016

by Reshma Jagasia, Ph.D., Scientist “Doctors have always recognized that every patient is unique, and doctors have always tried to...


The Current Implementation of the Drug Supply Chain Security Act (DSCSA) Implementation Plan and Rare Disease Drugs

September 21, 2016

What is the Drug Supply Chain Security Act (DSCSA)? In November 2013 the Drug Quality and Security Act (DQSA) was...


CIMT 2016 – Rise of mRNA therapeutics, a relatively new class of treatment

May 24, 2016

The increase of titles related to RNA-based therapeutics and vaccines within the CIMT poster session compared to previous years, highlighted...


CIMT 2016 “Mechanisms of efficacy in cancer immunotherapy”

May 20, 2016

For 14 years now, the largest meeting in Europe focused on cancer immunotherapies, the CIMT Annual Meeting, gathers the knowledge...


Jump on the Development Safety Update Report (DSUR) Bandwagon!

March 16, 2016

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Canada. If you have an open Investigational New Drug application (IND) then...


The FDA Wants To Hear Patients’ Voices

January 27, 2016

The FDA Wants To Hear Patients’ Voices by Joanne McNelis, Ph.D., Scientist at Cato Research In September the FDA announced...


‘Inhibit the inhibitor’ – it’s all about PD-(L)1 inhibitors in cancer treatment

March 30, 2015

PD-1 and PD-L1 inhibitors are the hot topic in oncology drug development at the moment, as underscored by numerous speakers...


Top Five Mistakes in Clinical Protocol Design

October 9, 2014

By Lisa R. Sanders, Ph.D., R.A.C., Sr. Clinical Scientist II Almost a Holy Grail for the pharma/biotech world, the perfect...