Fubao Wang
Company: Prime Medicine
Job title: Senior Vice President, Head of Regulatory Affairs
Seminars:
Chair’s Closing Remarks 3:15 pm
day: Conference Day Two
Panel Discussion: Exploring Recent Guidance on Platform Technologies to Clarify Frameworks for Approaches Used Across the Cell & Gene Field 2:00 pm
Considering what should be included on a platform basis or potentially excluded from a CMC, non-clinical, or procedural basis Enhancing the developmental process and efficiency by understanding the versatility of platform technologies and clarifying guidance on approaches Leveraging standardized systems to expedite the production of several cell and gene therapy productsRead more
day: Conference Day Two
Chair’s Opening Remarks 8:50 am
day: Conference Day Two
Panel Discussion: Navigating Various Assigned Designations like Orphan, Prime, & More to Clarify Criteria & Distinctions 1:45 pm
Breaking down criteria for different platform designations to streamline decisions on the most suitable designation for your therapy Emphasizing specific advantages of certain designation allocations to rationalize plans for application Tackling challenges in applying for platform designations to streamline the application and approval processRead more
day: Conference Day One
Industry Leaders Fireside Chat: Insights from Leading Experts on Overcoming Current & Future Regulatory Challenges in the Cell & Gene Therapy Field 9:00 am
What are the key obstacles challenging the cell and gene space now? Where will the cell and gene space be in 5 years, and how will this impact the regulation of these treatments? How can service providers assist biopharma in paving the way forward?Read more
day: Conference Day One