Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition

Steve W. Baertschi is a Research Fellow, Eli Lilly and Company. Dr Baertschi’s research interests include impurity isolation/purification and structure elucidation, mechanisms of drug degradation reactive intermediates and drug-excipient interactions. Dr Baertschi has organized or chaired several scientific symposia on forced drug degration, photostability and impurity investigations and has published widely on the topics. Dr Baertschi received his degree in chemistry from David Lipscomb University, Nashvile, Tennessee and received his PhD in organic chemistry from Vanderbilt University, Nashville, Tennessee.

Karen M. Alsante is a Research Fellow, Pfizer PharmaTherapeutics Pharmaceutical Sciences in Groton, CT. Dr Alsante’s experience has included leading drug degradation/impurity isolation, solid state characterization as well as early analytical research activities starting in partnership with Discovery and progressing through development to Phase 2 clinical trials. Dr. Alsante organized and chaired several scientific conferences on forced drug degration, photostability and oxidation and has published extensively on these topics. Dr. Alsante received a BA with honors in chemistry from Holy Cross College in 1989 and her PhD in organic chemistry from Duke University in 1994.

Robert R. Reed, is Vice President, CMC and Technological Operations for Celsion Corporation overseeing the CMC, QA and Technical Operations functions. Dr Reed most recently was Vice President, Pharmaceutical Operations at XenoPort, Inc., and has over 20 years of experience across Celsion Corp., XenoPort, Inc, Merck & Company, Inc., and The Liposome Company, Inc., with extensive scientific and regulatory experience in the design and development of pharmaceutical products. Dr Reed holds a Ph.D. in Analytical Chemistry from The University of North Carolina at Chapel Hill and was the recipient of a 3 year NIH Postdoctoral Individual Award at Princeton University.