Jim Wang

Company: Regeneron

Job title: Vice President - Regulatory Affairs & Genetic Medicines

Bio:

Senior regulatory professional with more than 20 years of global experience managing full spectrum drug development, marketing applications, and regulatory approvals, including the approval of two major gene therapy products, Luxturna and Upstaza

Seminars:

Designing & Implementing a Robust Late-Clinical Stage Regulatory Action Plan 11:45 am

Reflecting on lessons learned preparing for and undertaking a BLA/MAA filing Top tips for data demonstration earlier in clinical development to support a marketing application Facilitating smooth translation of your therapy into a commercial-ready productRead more

day: Day 2 REGULATORY AM

Panel Discussion: A 101 in Expedited Programs for Gene Therapy 2:00 pm

Outlining the practicalities of gaining FDA expedited designations Criteria for designation and best practices with regulatory touchpoints Considerations for successful interactions with CBER reviewers  Common reasons for denial of RMAT applicationsRead more

day: Regulatory - PM