E18: Stability Studies: The Tools, Methods and Predictions During Each Stage of Pharmaceutical Development

One-Day Course 
Date is TBA; 8:30am – 5:00pm

Dr. Kenneth C. Waterman, FreeThink Technologies, Branford, CT
Dr. Peter Bonk, Reaction Analytics, Groton, CT

First, we will look at the nature of stability measurements and the meaning of shelf-life. We will emphasize the needs at each stage of pharmaceutical development. Accelerated models used to accurately predict stability appropriate for various storage conditions will be discussed, along with how to calculate error bars when using these types of predictions.  The discussions will include in-use stability and justification for acceptability after shipping excursions.

Scientists and Regulatory Affairs personnel wanting to understand the latest thinking in the science of stability would be the primary audience.

1. What is Stability
a.  Change: good going down; bad increasing
b.  Analytical methods
c.  Specification limits
d. Regulatory requirements
2. Early Stage Pharma
a.  Accelerated stability modeling
b.  Drug form/salt selection
     c.  Formulation development
d.  Fast to clinic for regulatory
3. Towards NDA/ANDA
a.  Stability comparisons
b.  Packaging selection
4. Stability Beyond ICH
a.  Excursion modeling
     b.  In use stability

Dr. Kenneth C. Waterman received his B.S. degree with honors in chemistry from UCLA, his Ph.D. in physical-organic chemistry from UC Berkeley and conducted post-doctoral studies in physical and photo-chemistry as an NIH research fellow at Columbia University.  Dr. Waterman worked 12-years at Polaroid (as a distinguished scientist) developing imaging products, then 13 years at Pfizer (as a Research Fellow) working on drug stability, drug delivery, biopharmaceutics and prodrugs.  He is the author of over 75 publications and was made an AAPS Fellow in 2011.  In 2011, he started FreeThink Technologies which both produces and licenses the accelerated stability software package ASAPprime® and is a CRO that has Connecticut-based laboratories specializing in stability for pharmaceuticals, generics, OTCs, nutraceuticals and consumer products.

Dr. Pete Bonk received his B.S. degree in Chemistry from the University of Michigan and his Ph.D. in organic chemistry from the University of Wisconsin.  Pete has worked at Dow Chemical, Abbott Laboratories, Rhodes Technologies (affiliated with Purdue Pharma) and CSCS Corp., a small CRO/CMO. Since 2014 Dr. Bonk has being consulting in the pharmaceutical and fine chemical industries, with a focus on process chemistry, cGMP compliance and training on Design of Experiments.