Over the last 10 to 15 years cocrystals have emerged as a new strategy that both originator and generic companies have embraced to generate value. On one side, the approval of new drug products containing a pharmaceutical cocrystal as drug substance has allowed for new and safer medicines. On the other side, pharmaceutical cocrystals have been used by generic companies to bypass intellectual property protection permitting the launching of generic versions of branded drugs earlier than expected, thus easing the public health budgets.

What has not yet gone mainstream is the tremendous potential that cocrystallization offers to overcome process chemistry challenges, such as complex purification and resolution processes, as well as the handling of unstable or difficult to manage intermediates, among others. It is the objective of this seminar to uncover and illustrate with practical examples how powerful cocrystals are when wisely used by the process chemist.

An update of the regulatory aspects that both the FDA and EMA make of pharmaceutical cocrystals will also be covered in this seminar.

Agenda (h 9.30 - 13)

• Introductions.- overview
• Solid forms in drug development.
• Cocrystals. A new player you have to count on.
• Cocrystals in process chemistry. Examples. Future.
• FDA and EMA updated position on cocrystals.
• Questions & Closing remarks.