Durham, North Carolina
5th December 2019
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.
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.
2635 E NC Hwy 54
Durham, NC 27713
||Registration and Light Breakfast
||Does the FDA Need a Reboot?
||The Power of Sharing Clinical Data: Developing an External Control Arm for Registration
Project Data Sphere
||Guidance for Industry – Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Bioligics
Via video conference
||Representing Master Protocols: What Can and Can't be Done Using the CDISC Trial Model
PHUSE Americas Director
||Quality-based Drug Development – Traditional Versus Non-traditional Clinical Trials in the Context of 21st Century Novel Clinical Research
||Srinivasa Rao M & Cheryl Simon,
||Clinical Trial of the Future: Technology-driven Innovation in Clinical Research
||New Data Pathways: Mobile and Wearable Devices
||Panel Discussion and Closing Remarks
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
How Do I Join the PHUSE Society?
There are two easy ways to join PHUSE:
1. Register online.
2. Contact firstname.lastname@example.org for group membership applications or for invoicing arrangements.