Panelists:

Christopher A. Rhodes, Ph.D., President & CEO, Drug Delivery Experts

Athan Kulioulos, MD, Ph.D., Tufts University

Lisa Carelli, Director of Pharmaceutics, Pharmatek (Moderator)

The popularity of peptide therapeutics has increased significantly in recent years. It is estimated that by 2018, the global Peptide therapeutics market is expected to pass $25 billion. The success of most peptide drugs is dependent upon the delivery of the biologically active form to the site of action. Therefore the development of a stable formulation is a necessary step for each new peptide therapeutic. While the number of peptide therapeutics in development grows, experience with formulation and manufacture of peptides is limited. This seminar will concentrate on key considerations for a successful peptide development program. Topics will include:

• Key differences between peptide and small molecule development projects
• Analytical methods development for peptides, including the importance of orthogonal methods
• Routes of administration and formulation development strategies, including solutions, suspensions and lyophilization.
• Formulation approaches to avoid degradation and ensure chemical and physical stability

The panel will cover such topics as:

• Market trends for peptides
• API synthesis and scale-up
• Moving from discovery to development and ultimately into the market.
• Process development and scale-up considerations for manufacturing