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5th Annual Formulation & Forced Degradation

January 21 - 23, 2008 | Manchester Grand Hyatt, San Diego, CA

Main Conference: Day Two

Main Conference: Day Two

Wednesday, January 23rd, 2008

8:15Morning Coffee
8:45

Chair's Recap of Day One

David Lechuga-Ballesteros, PhD, Senior Director R&D, ARIDIS PHARMACEUTICALS

Dr. Ian C. Boulton, Former Development Scientist, Formulation & Stability, SANOFI-PASTEUR,
President and Chief Scientific Officer, THE IMAGO GROUP

9:00

Case Study: Formulation and Forced Degradation Considerations in Vial and Dual Chamber Cartridge and/or Syringe

Susan W.H. Martin, PhD, Prinicipal Scientist, PFIZER, PHARMACEUTICAL, R&D-GLOBAL BIOLOGICS

9:30

Case Study:When Correlations Fail-Understand the Differences between Differential Scanning Calorimetry and Real-Time Stability

David Sek, Scientist II, WYETH BIOPHARMA

10:00

Case Study: Structure and Stability Changes of Human IgG1 Fc as a Consequence of Methionine Oxidation

Dingjiang Liu, PhD, Principal Scientist, Department of Protein Formulation, Amgen

10:3030 Minute Networking & Refreshment Break
11:00

Case Study: Use of Biophysical Characterization Techniques for Forced Degradation Studies to Support Formulation Development

Tim Kelly, PhD, Vice President, Biopharmaceutical Development, KBI BIOPHARMA, INC.

11:30

Implementation of a flexible yet cGMP complaint Stability Program for Phase I, II and III Studies

Nanda K. Subbarao, PhD, Senior Consultant, BIOLOGICS CONSULTING GROUP

12:30Luncheon
1:45

Therapy Time for Biomolecular Development Challenges!  

Bring your own case study! Faciliated by the conference co-chairs, attendees are encouraged to bring forth their own formulation and forced degradation challenge(s) and the audience will help with the sharing of suggested solutions.  This session promises to be highly interactive and one of the highlights for getting the best real tips!

 

2:45Afternoon Tracks Begin

Track A: Formulation Track

Track B: Forced Degradation/Analytical Track

Track C: New Generation Application of Innovative Drug Delivery Technology

2:45

Case Study: Leverage Novel Excipients in the Design of Stable Formulations for Inhalable Biopharmaceuticals

David Lechuga-Ballesteros, PhD, Senior Director R&D, ARIDIS PHARMACEUTICALS

Case Study: Isomerization of Aspartic Acid and Its Potential Impact on Other Quality Attributes

Christopher J. Roberts, PhD, Assistant Professor, Department of Chemical Engineering, UNIVERSITY OF DELAWARE

Controlled Drug Delivery Systems that Overcome the Mucus Barrier

Justin Hanes, PhD, Oncology Director of Therapeutics, THE INSTITUTE FOR NANOBIOTECHNOLOGY, JOHNS HOPKINS UNIVERSITY

3:15

Case Study: Scale-Up of Formulations for the Big Picture for Better Process Design

Victor Lee, Associate Director, Manufacturing and Equipment Engineering, TEVA PARENTERAL MEDICINES

Modeling and Predicting Aggregation Kinetics for Biopharmaceuticals

Christopher J. Roberts, PhD, Assistant Professor, Department of Chemical Engineering, UNIVERSITY OF DELAWARE

Advances in Ophthalmic Drug Delivery: Topical Treatment Options – Are We There Yet?

Hovhannes J. Gukasyan, PhD, Worldwide Pharmaceutical Sciences, Research Science & Technology Formulations, PFIZER GLOBAL R&D

3:45

Panel Discussion: Orthogonal Methods and Characterization Technologies To Characterize Degradants and Aggregates

Panelists:

Dingjiang Liu, PhD, Principal Scientist, Department of Protein Formulation, Amgen

Elizabeth M. Topp, PhD, Professor of Pharmaceutical Chemistry, UNIVERSITY OF KANSAS

Qin Chin Zou, PhD, Research Scientist, ELI LILLY AND COMPANY

4:15Conference Concludes


Event Sponsors

  • Atlas Material Testing Technology

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