"Should companies spend the money to manufacture inhouse or should they contract it to an outside vendor? What factors should be weighed—and how are they weighted—in the decision-making process? What structures and systems must a company have in place to effectively manage one or more contract manufacturing organizations? Is it safe for a patient community? Can a company have it both ways and why would it? This session addresses the manufacturing aspect of outsourcing and aims to cover some of the more complex issues such as safety and FDA oversight."

Objective1:Explore the complexities between outsourcing or in-house manufacturing, and address common problems with each scenario.

Objective2:Share best practices in the decision-making process for products currently under distribution.

Objective3:Explain how different variables were evaluated to achieve the final outcome for products currently under distribution.