Institute for International Research

Monday, January 21, 2008

B1: AM Workshop: FFD 101: Fundamentals of Formulation & Forced Degradation

8:30 Registration and Morning Coffee
9:00 Workshop Begins
10:30 30-Minute Networking & Refreshment Break
12:30 Networking Luncheon for Morning Workshop Speakers and Participants

The design and utilization of formulation and forced degradation studies is not well-defined for large molecules. It is imperative to have a working knowledge of the fundamentals to be able to interpret and advance your FFD strategies. Once there is an understanding of the fundamentals, experiments can be designed successfully and efficiently. This workshop is a must-attend for all those who are new to formulation and stability science, or who want a refresher course on the topic.

9:00 Part One: Understand the Chemistry and Formulation Considerations in Biomolecules

• Different biological formulations and general challenges
  
• What are the formulation considerations that you need in designing your formulation?
  
• What stress factors will impact formulations?

9:45 Part Two: Introduction to Forced Degradation Techniques and Their Application in Formulation Development

Forced degradation techniques are commonly used in formulation development. Studies under stressed conditions may help to understand candidate major degradation pathways and to provide stability information for product development.

• Over view commonly used forced degradation techniques in protein pharmaceutics and formulation development
  
• Use forced degradation techniques to establish major degradation profiles
  
• Develop strategies to improve formulation in shortened timeline
  
• Determine if accidental exposure to conditions other than those specified are deleterious to the product
  
• Evaluate which specific parameters may be the best indicators for product stability

Ning Li, PhD, Principal Scientist, PFIZER INC, PHARMACEUTICAL SCIENCE-GLOBAL BIOLOGICS

11:00 Part Three: Understand Photostability Forced Degradation Testing

• Master key concepts of ICH Q1B and Q5C photostability requirements for improved compliance
  
• Explore current available options in commercial photostability testing equipment, light sources and measurement
  
• Leverage practical considerations including sample presentation when conducting photostability testing

Allen F. Zielnik, Chemistry Senior Consultant, ATLAS MATERIAL TESTING TECHNOLOGY LLC

11:45 Part Four: Practical Tips for Working with the FDA to Meet their Expectations

• Improve compliance by being better prepared for FDA submissions
  
• What does the FDA want to see in a submission?
  
• Uncover how much information is too much to include in your submissions
  
• Setting FDA allowable limits for impurities in your biomolecule

Timothy K. Hayes, VP, Analytical Chemistry, Quality and Regulatory Affairs, PROMETIC BIOTHERAPEUTICS

Andrew C. Chang, PhD, Executive Director, PHARMANET CONSULTING, PHARMANET DEVELOPMENT GROUP, INC, and
Former Associate Director for Policy and Regulation, Division of Hematology, CBER, FDA

B2: PM Workshop:Vaccine Formulation & Stability Strategies

12:30 PM Workshop Registration
1:30 Workshop Begins
3:00 30 Minute Networking & Refreshment Break
5:00 Workshop Concludes; Evening Reception begins

The vaccine development industry has seen considerable growth in the past ten years. Thanks to significant advances in basic research, manufacturing and characterization technologies, the biomedical industry is experiencing a paradigmatic shifts, broadening our understanding of vaccines to include therapeutic and other immunomodulatory effects, in concert with traditional preventative functions. As such, many companies are investing more efforts and money into expanding their vaccine research and development groups. This workshop is designed to explore the fundamentals of vaccine development – "from bench to bedside."

Part I: Introduction- The Global Significance of Vaccines & Different Types Available

Humanitarian and socio-economic overview of the impact of vaccination on the human species, from prehistory to the third millennium.

Vaccine types to be covered:

• Immunotherapy
• Recombinant protein-based vaccines and adjuvants
  
• Sub-cellular vaccines (non-live, but cellular derived)
  
• Live vaccines and the distinct technology surrounding that process
  
• DNA Vaccines
  
• Therapeutics, adoptive approaches and immunomodulators

Part II: Industrial Considerations for Vaccine Design & Engineering

• Disease target and antigen selection
  
• Product development overview – Identifying the fast-track and planning your product
  
• Vaccine types
  
• The adjuvant and its partnership with delivery technology
  
• Analytical and process technologies are advantageous specifically to vaccines
  
• Accelerated formulation design
  
• Stability and Forced Degradation Studies

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