In the wake of the BIA 10-2474 tragedy, in July 2017 the EMA updated their guideline on safety in first-in-human studies: \’Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.\’ This sweeping new guideline suggests an evolving approach in Europe to patient safety in first-in-human studies, but it may reflect a changing global perspective as well. The guideline went into effect in February 2018, and its impacts on various aspects of early clinical trial design and execution are beginning to be realized. The full impacts of this guideline are still uncertain. Meanwhile, drug developers continue to prioritize patient safety by remaining scientifically focused while working to bring much-needed treatments expeditiously to patients with unmet medical needs.

Dr. Michael Rothenberg has been at Genentech since January 2015 and is a Safety Science Medical Director in Early Development Safety, where he supports several molecule teams in early clinical development. Dr. Rothenberg received his MD PhD (Biochemistry) from UCSF in 2005 and then moved to Stanford University where he completed a residency and fellowship (Internal Medicine, Gastroenterology & Hepatology) as well as a postdoctoral research fellowship (Regenerative Medicine & Stem Cell Biology). He remains on faculty at Stanford as an Adjunct Assistant Clinical Professor of Medicine. He is passionate about science and drug development. In his spare time, he enjoys spending time with his family, traveling, and open water (and pool) swimming.