Clinical Development & Regulatory


Clinical Development & Regulatory, Monday 11 July 2022

last published: 20/May/22 23:45

Clinical Development & Regulatory, Tuesday 12 July 2022


Organizer Opening Remarks


Chair Opening Remarks

Emil Kakkis

Keynote Address: Drug Development in the 21st Century - The use of primary disease activity biomarkers to establish efficacy

Keynote speaker to be announced

Keynote Address: Reserved for FDA Commissioner

Katherine Capperella
Clinical Development & Regulatory

Fireside Chat: Diversity in clinical trials – Description pending

Sponsored by Janseen
Michael Murphy
Clinical Development & Regulatory

Endpoints - where are we now and how does the development process need to evolve?

Clinical Development & Regulatory

VIDEO: Updates from FDA

FDA representative to be announced
Irina Antonijevic
Clinical Development & Regulatory

Importance of Natural History studies and real world data to support clinical and biomarker development

Will Maier
Clinical Development & Regulatory

Effective use of rare disease RWE for external controls in drug development

Kristin Van Goor
Clinical Development & Regulatory

Retrospective 6 years out from the Cures Act - where are we on Patient Experience Data & Updates from FDA on Real World Evidence

last published: 20/May/22 23:45



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