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Agenda
MONDAY, MARCH 15TH, 2010: CONFERENCE, DAY ONE |
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| 8:00 | Registration & Morning Coffee |
| 8:30 | Conference Chairs’ Opening Remarks Karen Alsante, PhD, Research Fellow, PFIZER Steven Baertschi, PhD, Research Advisor Fellow, ELI LILLY & COMPANY |
FORCED DEGRADATION FUNDAMENTALS |
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| 8:45 | Regulatory Guidance and Best Practices for Conducting
Forced Degradation Studies |
| 9:45 | Develop a Greater Understanding of Drug Degradation
Chemistry to Avoid Potential Problems from the Start Dinos Santifianos, PhD, Principal Scientist, Analytical R&D, PFIZER |
| 10:30 | 30 minute networking & refreshment break |
| 11:00 | Experimental Approaches to Conducting Photostability
Stress Studies For Increased Testing Accuracy Rhonda A. Jackson, PhD, Principal Scientist, JOHNSON & JOHNSON |
| DEGRADANTS & GENOTOXICITY | |
| 11:30 | Develop Rational, Risk-Based Approaches to the
Application of Stress Testing as a Predictive Tool for
Potentially Genotoxic Impurities Christopher M. Riley, PhD, President, RILEY AND RABEL CONSULT ING SERVICES, LLC |
| 12:00 | Making Decisions Regarding Stress Degradation Studies
and Potentially Genotoxic Impurities Bernard A. Olsen, PhD, Consultant, OLSEN PHARMACEUTICAL CONSULTING |
| 12:30 | Luncheon |
| 1:30 |  A Catalytic Approach to Potentially Genotoxic Pyridine
Oxide Degradants to Enable Efficient Analysis of
Potential GenotoxinsLi Li, PhD, Senior Research Chemist, MERCK |
| 2:00 | Approaches for Understanding and Managing
Degradation Products that may be Genotoxic Alan P McKeown, PhD, Senior Principal Scientist, PFIZER |
| 2:30 | Strategies for Identifying and Controlling Potentially
Genotoxic Impurities that are Actual or Potential
Degradation Products in API and Drug Product Kevin L. Facchine, PhD, Structural and Degradation Chemistry, Chemical Development Analytical Sciences, GLAXOSMITHKLINE |
| 3:00 | 15 Minute Networking & Refreshment Break |
| DEGRADATION DATABASE & TECHNOLOGY DEVELOPMENTS | |
| 3:15 | Live Web Demo! Pharma D3 Degradation Database
Demonstration and Real Life Degradation Problem
Solving Strategy
Case Studies Session Leaders: Karen M. Alsante, PhD, Research Fellow, PFIZER Dinos Santafianos, PhD, PFIZER |
| 3:45 | In silico Prediction of Forced Degradation - Developing an Expert Computer System to Predict Degradation Pathways Session Leader: Nicole McSweeney, Project Team Senior User, Lhasa Limited, UK An introduction into the Background of the Project to create an in silico tool to predict Forced Degradation Pathways, Current Status, Future Plans, Data Sharing. |
| 4:15 | Explore Computer Tool Utilization to Elucidate
Degradation Pathways Faster and More Accurately Session Leader: Steven Baertschi, PhD, Research Fellow, ELI LILLY & COMPANY |
| 5:00 | Day One Concludes |
TUESDAY, MARCH 16TH, 2010: CONFERENCE, DAY TWO |
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| 8:00 | Morning Coffee |
| 8:30 | Conference Chairs’ Opening Remarks & Recap of Day One Karen Alsante, PhD, Research Fellow, PFIZER Steven Baertschi, PhD, Research Fellow, ELI LILLY & COMPANY |
| GROUNDBREAKING FORCED DEGRADATION ADVANCES | |
EXPLORE THE LATEST CASE STUDIES, TESTING ADVANCES, CONCEPTS AND BREAKTHROUGHS IN FORCED DEGRADATION TESTING |
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| 8:45 | Forced Degradation in Discovery to Guide Lead
Optimization and at the Discovery-Development
Interface to Identify Risks for Product Development Allen C. Templeton, PhD, Sr. Director, Basic Pharmaceutical Sciences, MERCK |
| PHOTO STABILITY | |
| 9:15 | Pitfalls to Avoid in Assumptions about Photosensitivity
of Drug Products to Improve Study Design Quality Robert A. Reed, PhD, Executive Director, CMC & Technical Operations, CELSION CORPORATION |
| 9:45 | Gaining Insight into Phototoxicity and
Photogenotoxicity Through the Use of Photostress
Studies Mark Kleinman, PhD, Manager, Early Phase Project Analysis and Degradation Chemistry, GLAXOSMITHKLINE |
| 10:15 | 30 Minute Networking & Refreshment Break |
| OXIDATIVE DEGRADATION | |
| 10:45 | Diving Deeper into the Chemistry of Radical Initiator
Models of Pharmaceutical Oxidation to Mitigate Risks of
Undesirable Actions Eric Nelson, PhD, Principal Scientist, JOHNSON & JOHNSON Michael Watkins, PhD, Senior Research Scientist, ELI LILLY & COMPANY |
| 11:15 | Towards Understanding Oxidative Degradation
Associated with Polysorbate Excipients Darren L. Reid, PhD, Senior Scientist, AMGEN, INC |
| 11:45 | Explore the Latest Advances in Parenteral Degradation
Studies Andreas Abend, PhD, Associate Director, MERCK |
| 12:15 | Lunch & Learn: Working Group Roundtables |
| 1:15 | Understanding the Impact of Excipients and Packaging
on the Stability of Solid and Sterile Liquid Dosage Forms Leonardo Allain, PhD, Research Fellow, MERCK SHARP & DOHME CORP |
| 1:45 | Development of an Automated Screen to Predict
Excipient-Induced Degradation in Solid Oral Dosage
Forms Pat Jansen, PhD, ELI LILLY & COMPANY |
| 2:15 | Accelerated Stability Assessment Program (ASAP): Using
Science to Set Expiry Dating for Solid Drug Product Kenneth C.Waterman, PhD, Research Fellow, PFIZER |
| 2:45 | Uncover the Degradation of Fraglitizar to Anticipate
Product Degradation for Improved Testing Accuracy Dan W. Reynolds, PhD, Manager, Chemical Development Analytical Sciences, GLAXOSMITHKLINE |
| 3:15 | The Forced Degradation Forum Concludes; Have a Safe Trip |