ROUNDTABLE BREAKOUT DISCUSSIONS

In this interactive session, audience members choose one of the breakout topics listed below and join the moderated discussion at hand. Participants are encouraged to share examples from their work, vet ideas with peers and ask questions of one another. This discussion is a relaxed, informal exchange amongst scientists and is not meant to be, in any way, a corporate or specific product discussion.

Topic: Process Control Justifications

Co-Moderators: Matthew Ravn, Ph.D., Senior Scientist III, GPRD Process R&D, Abbott

Robert Hughes, Ph.D., Chemical Development, Vertex Pharmaceuticals Inc.

• Success or failures in experimental models – pathway to file and do they provide regulatory flexibility?
• How does interpretation of QbD impact execution of Process Control Justficiations (PCJ)?
• PCJ experimental approaches - forward (process), backward (risk assessment) or somewhere in between?
• Success or failures on incorporation of PAT into PCJ and process validation.

Topic: Impurities and the Regulatory Environment

Moderator: Michelle Kenyon, DSRD, Genetic Toxicology, Pfizer Global Research and Development

• What type of impurity information (safety/quality) is being disclosed in regulatory submissions?
• How do we deal with differing regulatory views regarding impurities for global submissions?
• Are compound-specific PDEs being used/accepted to justify levels of impurities above the TTC?
• How is ICH S9 being applied for oncology products and is it generally accepted by regulators?

Topic: Control of Final Form

Moderator: Neal Anderson, Ph.D., President, Anderson’s Process Solutions

• Advanced technologies for detecting crystal polymorphs
• How much of a crystal polymorph is too much?
• What are the most relevant critical quality attributes?
• What/when to report about crystal polymorphs