Formulation & Forced Degradation Strategies for Biomolecules

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Home»Events»Formulation & Forced...Event Overview»Agenda Day One

Formulation & Forced Degradation Strategies for Biomolecules

The only conference tying analytics into formulation
considerations and delivery techniques!

March 19 - 21, 2007 | Hilton San Diego Mission Valley, | San Diego, CA

Agenda Day One

Tuesday, March 20th, 2007

This is just a snapshot of the FFD Agenda Day One.
For full details please download our brochure.

8:00 | Registration and Morning Coffee

8:30 | Chair's Opening Remarks

Jerry J. Lewis, MBA., PhD,
Senior Research Advisor,
ELI LILLY AND COMPANY

Vu Truong-Le, PhD,
VP of Research and Development,
ARIDIS PHARMA

8:45- 9:15 | State of the Industry:
Regulatory Requirements for Successful Product Development

The 2007 event kicks off with the regulatory requirements for successful product development and delves into the most pertinent questions such as:
• Understand when your formulations and analytical methods should be validated
• Uncover how to work through regulatory misconceptions
• Explore how others in the industry are dealing with regulatory considerations
• Conduct sucessful forced degradation studies to meet regulatory requirements

This is an Open Session.
Please contact Tricia Carle
tcarle@iirusa.com
for more information on participating.

Your choice of morning sessions. Please feel free to mix and match sessions to individualize your learning experience.

	Track A: Phases and Stages- Key Formulation Approaches for Successful Development	Track B: Design and Master Forced Degradation Strategies for Large Molecules
9:25	Implementing Biophysical and Thermodynamic Analyses into Formulation Development Rob Simler, PhD, Staff Scientist, GENZYME CORPORATION	Case Study! Investigating Potential Degradation Pathways of Recombinant Glycoproteins John Harrahy, PhD, Staff Scientist II, GENZYME CORPORATION
10:00	Challenges in the Development of a High Concentration Formulation Jamie Moore, PhD, Associate Scientist, GENENTECH	Photostability and Forced Degradation – Understanding Equipment and Techniques Allen F. Zielnik , BS, Chemistry Senior Consultant, ATLAS MATERIAL TESTING TECHNOLOGY
10:30	30 Minute Networking and Refreshment Break
11:00	Special Considerations in Liquid vs. Lyophilized Formulations Feroz Jameel, PhD, Principal Scientist, AMGEN	Case Study! Aggregation of Human Monoclonal Antibody during Formulation Development: A Structural Analysis by Vibrational Spectroscopy Tiansheng Li, PhD, Sr. Principal Scientist, Department of Pharmaceutics, AMGEN
11:30	Structural Studies as a Screening Tool in Optimization of Protein Purification Processes Prathima Acharya, PhD, Sr. Scientist, Analytical & Formulation Development, DIOSYNTH BIOTECHNOLOGY	Panel Discussion Improve Degradation Pathway Study Design Moderator: Jerry J. Lewis, MBA., PhD, Senior Research Advisor, ELI LILLY AND COMPANY Panelists: Tiansheng Li, PhD, Sr. Research Scientist, Department of Pharmaceutics, AMGEN John Harrahy, PhD, Staff Scientist II, GENZYME CORPORATION Allen F. Zielnik, BS, Chemistry Senior Consultant, ATLAS MATERIAL TESTING TECHNOLOGY
12:00	Networking Luncheon
1:30	Case Study! Confronting the Challenges of Formulation Development, Physical Characterization and Analytical Evaluation of PEGylated Peptides Owen Van Cauwenberghe, PhD, Sr. Research Scientist and Team Leader, ELI LILLY AND COMPANY
2:00	Case Study! Extrapolation of Results from Forced Degradation Studies to Practical Formulation Development Byeong S. Chang, PhD, President, INTEGRITY BIOSOLUTION
2:30	Case Study! The Impact of Drying Method on the Stability of Proteins and Vaccines Ahmad M. Abdul-Fattah, PhD, Scientist, AMGEN Michael J. Pikal, PhD, Department of Pharmaceutical Sciences, UNIVERSITY OF CONNECTICUT Vu Truong-Le, PhD, VP of Research and Development, ARIDIS PHARMA
3:00	30 Minute Networking and Refreshment Break
3:30	Case Study! Different Degradation Pathways in Liquid and Lyophilized Formulations Jim Mo, PhD, Research Fellow, PFIZER INC.
4:00	Panel Discussion Improve Communication between Analytical and Formulation Scientists Moderator: Byeong S. Chang, PhD, President, INTEGRITY BIOSOLUTION Panelists: Anna-Maria Hays Putnam, PhD, Research Scientist II, Analytical and Formulations Development, AMBRX Rebecca A. Sendak, PhD, Associate Director of Bioanalytical Development, GENZYME CORPORATION Please contact Tricia Carle, tcarle@iirusa.com, for more information on participating.
4:45	Day One Concludes