Durham, North Carolina

 5th December 2019

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All PHUSE Single Day Events are FREE to members. To become a member click here. Registrations per company are limited to 20% of maximum attendance.

 

Theme:

New Pathways to Approval

 

Description:

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.

 

Location:

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

 

Agenda:

Time Presentation Speaker(s)
8.30–9.15 Registration and Light Breakfast
9.15–9.30 Welcome Russ Helms,
Rho
9.30–10.00 Does the FDA Need a Reboot? Chris Decker,
d-wise
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,
FDA

Via video conference

11.30–12.00 Representing Master Protocols: What Can and Can't be Done Using the CDISC Trial Model Diane Wold,
CDISC
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,
Merck
1.45–2.15 Clinical Trial of the Future: Technology-driven Innovation in Clinical Research David Hall,
Rho
2.15–3.00 Coffee Break
3.00–3.30 New Data Pathways: Mobile and Wearable Devices Eric Harvey,
MMS
3.30–4.00 Panel Discussion and Closing Remarks

Moderator:
Jeff Abolafia,
Rho

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.

 

Sponsors:

     

 

 

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


Hotels:

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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