May 2016

Table of Contents

may16-cover 

Cover Story

The Therapeutic Promise of Genome Editing: In My Lifetime?

By T. Oliver Chao, Ph.D., Sanofi
Genome editing has potential to advance human health with several different approaches.. 

Guidance Comments Summaries

EMA Draft Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins

Comments from the AAPS Ligand Binding Assay Bioanalytical Focus Group and the Therapeutic Product Immunogenicity Focus Group

Professional Development

Building a Consulting Business: A Practitioner's Perspective

By Panos P. Constantinides
Building a consulting business takes experience, advance preparation, and marketing yourself, for starters.