Durham, North Carolina

 5th December 2019

New Pathways to Approval


New pathways to approval – study/program designs that use methodologies other than traditional Phase I to III randomized trials. The FDA recently published a guidance about this, encouraging sponsors to use non-traditional approaches such as master protocols and basket protocols.



Does the FDA Need a Reboot? – Chris Decker, d-wise

The Power of Sharing Clinical Data: Developing an External Control Arm for Registration – Mike Litzsinger, Project Data Sphere

Guidance for Industry – Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics – Lee Pai-Scherf, FDA

Representing Master Protocols: What Can and Can't be Done Using the CDISC Trial Model – Diane Wold, CDISC

Quality-based Drug Development – Traditional Versus Non-traditional Clinical Trials in the Context of 21st Century Novel Clinical Research – Srinivasa Rao Mandava & Cheryl Simon, Merck

Clinical Trial of the Future: Technology-driven Innovation in Clinical Research – David Hall, Rho

New Data Pathways: Mobile and Wearable Devices – Eric Harvey, MMS


View the event brochure.






Photos of the day:


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