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

Time: 2:15 pm
day: Day 2 MANUFACTURING PM

Details:

• 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 designation

Speakers:

Mi Jin Sr. Director of Downstream and Drug Product Development at Spark Therapeutics, with over 20 years’ experience in protein characterization, biologics and gene therapy manufacturing process Read more

Khandan Baradaran Khandan Baradaran, Ph.D., is Vice President and Global Head of Regulatory CMC at Ultragenyx Pharmaceutical. In this role she is responsible for multiple AAV gene Read more

Tayler shebly