Clinical Development & Regulatory

 

Clinical Development & Regulatory, Monday 11 July 2022

last published: 20/May/22 23:45
 

Clinical Development & Regulatory, Tuesday 12 July 2022

08:30

Organizer Opening Remarks

08:35

Chair Opening Remarks

Emil Kakkis
08:40

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

Keynote speaker to be announced
09:35

Keynote Address: Reserved for FDA Commissioner

Katherine Capperella
Clinical Development & Regulatory
11:55

Fireside Chat: Diversity in clinical trials – Description pending

Sponsored by Janseen
Michael Murphy
Clinical Development & Regulatory
12:15

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

Clinical Development & Regulatory
12:35

VIDEO: Updates from FDA

FDA representative to be announced
Irina Antonijevic
Clinical Development & Regulatory
15:15

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

Will Maier
Clinical Development & Regulatory
15:35

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

Kristin Van Goor
Clinical Development & Regulatory
15:55

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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