Stability Studies in Pharmaceutical Development

Wei Pan, Ph.D. RAC, Senior Manager, Catalent Pharma Solutions

Dr. Pan is currently a senior manager in the development and clinical services business unit in the Research Triangle Park, NC facility.  She received her Ph.D. in inorganic chemistry from University of Miami.  She also has a Regulatory Affair Certification by the Regulatory Affair Professional Society (RAPS) with a focus on the analytical CMC requirements to support different regulatory filings (IND, NDA and ANDA).  Dr. Pan has over 14 year of pharmaceutical industry experience.  She joined Catalent Pharma Solutions (then Magellan Laboratories) in 1999.  She has worked in the analytical CMC areas including preformulation, method development, method validation, release and stability testing of drug substances and drug products of a variety of dosage forms.  In her current role as a senior manager, she is responsible to manage the stability group and the product ventures group in RTP.  The RTP facility is the center of excellence for stability testing designated by Catalent Pharma Solutions.

Kathy Waddle, Director, Stability QC Biology, Catalent Pharma Solutions

Kathy Waddle is the Director of Stability, Quality Control, and Biology for Catalent Pharma Solutions in the development and clinical services business unit in the Research Triangle Park, NC facility.

She has a Master degree in Pharmaceutical Chemistry from the Medical College of Virginia, Virginia Commonwealth University. With over 25 years in the pharmaceutical industry, Kathy has previously worked at Eli Lilly, Burroughs- Wellcome, and Sphinx Pharmaceutical. She joined Catalent in 1994. In her current role she is responsible for the stability, quality control, microbiology, bioassay and biosafety departments at the Catalent RTP facility.