Manish Maski

Manish Maski

Company: Sanofi Genzyme

Job title: Head, Global Rare Nephrology Medical Affairs


Leveraging Real-World Evidence to Achieve FDA’s Full Approval of a Biologic 11:30 am

Employing cutting-edge use of real-world data to demonstrate long-term efficacy and safety Considering acceptable endpoints: what is an approvable change in eGFR? Innovative approaches to study design in phase IV trials to secure regulatory approvalsRead more

day: Day Two

Panel Discussion: Evolving Functional Endpoints: What is an Acceptable Change in eGFR? 2:40 pm

Identifying alternative functional outcomes earlier in disease progression to minimize time it takes to show appreciable change beyond eGFR Discussing acceptable changes in eGFR across multiple kidney diseases Regulatory considerations of functional endpoints: what is acceptable and approvable?Read more

day: Day One

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