Institute for International Research

Dear Colleague,

This annual conference brings together scientists involved with the development of biomolecules who are responsible for the design of the formulation and testing the stability.

What 10 Topics Were Most Cited by Scientists in Biomolecular Development?

1. Generate Accurate Prediction of Aggregation for Improved Formulation Development
2. Use Novel Excipients in the Design of Stable Formulations for Inhalable Biopharmaceuticals
3. Optimize Orthogonal Analytical Techniques for Degradant and Impurity Analysis
4. Develop Stability-Indicating Methods and the Relationship Between Forced Degradation and Stability-Indicating Assays
5. Understand the Differences between Differential Scanning Calorimetry and Real-Time Stability
6. Conduct and Determine the Phototstability of Biomolecules through Forced Degradation Studies
7. Scale-Up Formulations for the Big Picture for Better Process Design
8. Explore the Potential for Determining Leachables Using HPLC Multi-Detection Systems
9. Uncover Drug Delivery Advances and Techniques and How They Impact A Formulation
10. Detect and Predict Deamidation for Improved Protein Stability

Solution Oriented Sessions
This event is 100% focused on best practices on how to conduct the above 10 challenging topics. The speaking faculty provides solutions and strategies through case studies, best practices and interactive discussions in biomolecule development with lessons that you can implement in your lab.

Added Benefit!
This year, we are pleased to announce that FFD is co-located with the Drug Delivery Partnerships conference- the largest gathering of drug delivery professionals in the world. Gain access to recent trends in the drug delivery marketplace through networking at the evening receptions, access to the exhibit hall as well as optional sessions on drug delivery advances and technologies.

Please take a moment to review the agenda. We feel confident that you will experience a conference with innovative case studies and immersing interactive discussions to help you develop your Biomolecule more efficiently. If you are interested in bringing your group, take advantage of the early bird and team discounts. We look forward to seeing you in San Diego on January 21st!

Sincerely,

Tricia Carle,
FFD Event Director,
Institute for International Research

Valerie Bowling,
Managing Director,
Institute for International Research

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

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

Dear Analytical Scientist,

• What would you do if the FDA implemented Genotoxic Degradation guidelines tomorrow? Are you prepared to meet these guidances? Uncover the European Genotoxic Degradation guidances and what position the FDA is taking through presentations and case studies presented by Transform Pharmaceuticals and Pfizer R&D.
• Are you maximizing the usefulness of your forced degradation testing results when designing your formulation? Hear a two-part case study from Merck on what information to take away from forced degradation to value in your formulation and method.
• Are you certain that the orthogonal methods you are using to analyze forced degradation work are the most efficient? Are you leveraging the most effective combination of orthogonal methods? Grasp the benefits of improved orthogonal method utilization with case studies from Johnson & Johnson, Pfizer, and Arena Pharmaceuticals. Ask the experts during a panel discussion on the best orthogonal methods to implement when analyzing degradants.
• Do you want to discover faster ways to conduct forced degradation? Improve your forced degradation testing efficiencies by hearing case studies on high throughput and automated technologies presented by Pfizer, Novartis, and Purdue University.
• Do you have a pressing forced degradation challenge that you want to share? Bring forward your challenges during Therapy Time for Forced Degradation Testing and have the audience help you with the sharing of suggested solutions.

This is your chance to enhance your forced degradation knowledge with 12+ brand new case studies, and to engage in open dialogue with fellow analytical scientists through interactive breakout sessions, panel discussions, and therapy time.

IIR welcomes you to Forced Degradation 2008. Come and take advantage of this outstanding opportunity to hear and learn from the experts and develop relationships with other professionals in your field. WE look forward to greeting you in Baltimore!

Sincerely,

Tricia Carle
Conference Producer
Institute for International Research

Eric Nelson, PhD
Group Leader
Johnson & Johnson
Conference Co-Chairman

Alex Opio, PhD
Scientist
Pfizer, Inc.
Conference Co-Chairman