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Transparency Initiatives at Health Canada

janvier 4, 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy. As part of the Regulatory Transparency and Openness Framework (http://www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php),...

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Precision Medicine and the FDA

octobre 20, 2016

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

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

septembre 21, 2016

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

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

mai 24, 2016

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

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CIMT 2016 « Mechanisms of efficacy in cancer immunotherapy »

mai 20, 2016

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

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

mars 16, 2016

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

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The FDA Wants To Hear Patients’ Voices

janvier 27, 2016

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

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

mars 30, 2015

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

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Top Five Mistakes in Clinical Protocol Design

octobre 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...