Durham, North Carolina

 5th December 2019

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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, basket protocols, continuous drug development and historical cohorts instead of placebo.



Rho Inc.
2635 E NC Hwy 54
Durham, NC 27713



Time Presentation Speaker(s)
8.30–9.15 Registration and Light Breakfast
9.15–9.30 Welcome Russ Helms,
9.30–10.00 Does the FDA Need a Reboot? Chris Decker,
10.00–10.30 The Power of Sharing Clinical Data: Developing an External Control Arm for Registration Mike Litzsinger,
Project Data Sphere
10.30–11.00 Coffee Break
11.00–11.30 Guidance for Industry – Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Bioligics

Lee Pai-Scherf,

Via video conference

11.30–12.00 Representing Master Protocols: What Can and Can't be Done Using the CDISC Trial Model Diane Wold,
12.00–1.00 Lunch Break
1.00–1.15 PHUSE Updates Chris Hurley,
PHUSE Americas Director
1.15–1.45 Quality-based Drug Development – Traditional Versus Non-traditional Clinical Trials in the Context of 21st Century Novel Clinical Research Srinivasa Rao M & Cheryl Simon,
1.45–2.15 Clinical Trial of the Future: Technology-driven Innovation in Clinical Research David Hall,
2.15–3.00 Coffee Break
3.00–3.30 New Data Pathways: Mobile and Wearable Devices Eric Harvey,
3.30–4.00 Panel Discussion and Closing Remarks

Jeff Abolafia,

Panel Mebmers:
All Speakers


SDE Chairs:

Jeff Abolafia, Rho

Ramesh Ayyappath, ICON

If you have any questions, or require any information, please contact one of the SDE Chairs.






If you are interested in sponsoring this event, click here.


Courtyard by Marriott Durham Research Triangle Park

Residence Inn by Marriott Durham Research Triangle Park

Comfort Inn Research Triangle Park

Extended Stay America -Durham -Research Triangle Park -Hwy 54

La Quinta Inn & Suites by Wyndham Raleigh/Durham Southpoint

Hilton Garden Inn Raleigh-Durham/Research Triangle Park


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