In the News
ICH E6 R2 – Best practices for implementing a more formal risk management process
Volker Hack and Brian Barnes discuss how to undertake a well-balanced approach that applies critical thinking and implements lessons learned.
Biotech Booms in the Yangtze River Valley
Daniel Burch looks at the forces shaping the course of biotech growth in China.
Overcoming challenges in immunogenicity method development for peptide therapeutics
Heather Myler, Robert Kernstock and Janine Micheli discuss the unique challenges of peptide ADA assays.
A study of leachable silicone oil in simulated biopharmaceutical formulations
A team of PPD Laboratories GMP lab employees write about the potential effects of leachable silicone oil on large-molecule APIs and the need to establish a robust analytical method to detect and quantify the substance.
PPD’s Evidera acquires RWE provider Medimix
Medimix provides a real-world evidence service offering that includes access to patient-level data, data analytics and visualization capabilities.
Going global in biopharma regulatory affairs
Alistair Davidson, Patricia Hurley and John Watkins discuss the growth of international products and the ensuing need for regulatory harmonization.
Holding out hope
Stephen Peroutka talks about the challenges related to assessing and evaluating depression.
Applying for an EU marketing authorisation: A pharmacovigilance perspective
David Hillman and Clare Ryder outline the pharmacovigilance activities that a prospective marketing authorization holder will need to accomplish in advance of and throughout the application process.
FDA’s oncology clinical trial makeover
Pat Mann, Kirsten Messmer and Luis Arthur Pelloso provide an overview of new FDA guidances related to oncology drug development.
