Forced Degradation Studies
Agenda Day One
Tuesday, January 23rd, 2007
| 8:00 | Registration and Morning Coffee |
| 8:45 |
Chairperson's Opening Remarks Karen Alsante, PhD, Associate Research Fellow, Analytical R&D, Solid State Characterization, PFIZER GLOBAL RESEARCH AND DEVELOPMENT Steven W. Baertschi, PhD, Research Fellow, Analytical Sciences R&D, Chemical and Structural Characterization Team, ELI LILLY AND COMPANY Allen C. Templeton PhD, Associate Director, Pharmaceutical Analytical Chemistry, MERCK & COMPANY |
| 9:15 |
Out of the Box Academic Keynote! The Economics of New Drug Development Joseph A. DiMasi, PhD, Director of Economic Analysis, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT |
| 10:15 |
Method Development and Degradation Qualification Milton Abreo, Sr. Scientist, Preformulation, ALLERGAN, INC. |
| 10:45 |
Leveraging Force Stressed Studies to Predict Real Time Stability of Production Scale batches of a Solid Formulation Maria Teresa Cruañes, Group Leader, Pharmaceutical and Analytical Chemistry, MERCK & COMPANY |
| 11:15 | 15 Minute Networking and Refreshment Break |
| 11:30 |
Utilization of LC/MS - MS for Rapid and Accurate Prediction of Degradant Formation Rates in Pharmaceutical Formulations Jim Jiao, PhD, Senior Scientist, PFIZER |
| 12:00 |
Implementation of Thermal Desorption Mass Spectrometry for the Detection of Free Acid Impurities in Pharmaceutical Products Eric A. Kemp, MS, Research Chemist, MERCK & COMPANY |
| 12:30 | Luncheon |
| 1:30 |
Implementation of Quality by Design Tactics for Forced Degradation Studies Rhonda Jackson, Principal Scientist, Analytical Development, Drug Substance & Chemical Characterization Team, JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT |
| 2:15 |
Development of Quantitative Methods to Assess the Photolytic and Oxidative Stability of Pharmaceuticals in Solution and the Solid State Christian Schöneich, PhD, Professor and Chair, Department of Pharmaceutical Chemistry, THE UNIVERSITY OF KANSAS |
| 2:45 |
Wavelength-Dependent Photoisomerization of Montelukast Sodium Lee Klein, PhD, Senior Research Chemist, MERCK & COMPANY |
| 3:15 | 15 Minute Networking and Refreshment Break |
| 3:30 |
Out of the Box Keynote! Keynote Address on Overcoming Challenges with Billy Beane, General Manager of the Oakland A's |
| 5:00 |
Conference Concludes; Evening Reception Begins |
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