Pre-clinical safety assessment activities: What every PM needs to know but was afraid to ask

This meeting will be held at the MBC Offices, located on the ninth floor of One Cambridge Center, Cambridge, MA 02142.

Topic Overview

Whether you come from a large pharmaceutical company or a small to mid size biotech company, as a project manager, the more you know about the drug development process the better you will be able to lead your team towards milestones. This month's PM Committee meeting will focus on the pre-clinical safety assessment activities needed to reach one of the major milestones that we often are focused on: reaching the IND Submission.

Join us to learn and share the knowledge that could distinguish you as a Project Manager.

Presenter

Peter J. Sausen, PhD, DABT , Vice President of Program Management Services at Covance Laboratories

Dr. Sausen received his doctorate in Toxicology from the University of Wisconsin-Madison in 1992. Following completion of a postdoctoral fellowship at the Chemical Industry Institute of Toxicology, Dr. Sausen was responsible for supporting preclinical development of cyclooxygenase-2 inhibitors at G.D. Searle and Company. He joined Eli Lilly and Company in 1997 and led the Nonclinical Safety Assessment group that was responsible for preclinical development programs in the areas of neuroscience, endocrine, inflammation, erectile dysfunction, and cardiovascular disease. In addition, Dr. Sausen was responsible for the conduct of nonclinical safety studies, and was the primary author of regulatory submission documents and responses to regulatory questions for the worldwide submission of Cialis. Dr. Sausen was one of the pivotal members of the Cialis team that defended the safety profile of Cialis to the FDA, CPMP, China CDE, Canada HBP and the MHLW in Japan. Dr. Sausen is currently the Vice President of Program Management Services at Covance Laboratories. In this role, he leads a group of senior scientists and professional project managers who assist clients with their drug development needs from preclinical safety assessment through clinical proof of concept studies.