Tayler shebly

Company: Akouos Inc.

Job title: senior director cmc regulatory affairs

Seminars:

Panel Discussion: Establishing a Commercial-Ready CMC Checklist for Expedited Pathways 2:15 pm

Defining key sticking points to ensuring CMC and clinical development are aligned when a programme is under an expedited pathway Considerations for CMC-focused meetings with the regulators when moving through the clinic Laying out a commercial manufacturing plan upon receiving an expedited pathway designationRead more

day: Day 2 MANUFACTURING PM

TACKLING THE MOST PRESSING REGULATORY CMC CHALLENGES 9:00 am

Navigating regulatory expectations after process changes, including technical regulatory strategies for successful comparability assessments Taking advantage of all channels available for drug sponsors to interact with the regulators Identifying the commonly observed CMC-related issues that have potential to lead to a clinical hold Identifying common pitfalls related to product characterization and manufacturing process controls Leveraging…Read more

day: Workshop Day - track c