1. PhUSE Computational Science Working Groups
Solutions Through Collaboration

2. What is PhUSE?
Pharmaceutical Users Software Exchange Mission: Provide platform for creating & sharing ideas, implementing tools & standards around data, and exploring innovative methods and technologies

3. Paradigm Shift FDA Sponsors EMA Vendors PMDA CROs SDOs Academia
The Computational Science Collaboration shifts the problem solving paradigm in the drug development and regulatory space. The current paradigm is often reactive. Industry waits for regulatory agencies to release new guidance or legislation and sponsors, CROs, vendors, etc. react with different processes and/or toolsets to address the same challenge. Or, SDOs release a new standard and industry and regulators react with different approaches or practices to implement the same standard. The Computational Science Collaboration brings regulatory agencies, sponsors, CROs, SDOs, vendors, and academia together in an open, pre-competitive space to proactively and collaboratively address unmet needs.
SDOs
Academia

4. Computational Science Collaboration
Mission: To provide an open, transparent, and collaborative forum in a non-competitive environment in which Academia, Regulators, Industry, and Technology providers can address computational science needs in support of product development and regulatory review, ultimately bringing safe and effective products to those who need them.

5. CS Collaboration Framework
Working Groups
Symposium
Computational Science Collaboration

6. CS Working Groups Over 30 active projects
Steering Committee
Optimizing Use of Data Standards
Emerging Technologies
Standard Scripts for Reporting and Analysis
Non-Clinical Roadmap and Implementation
Semantic Technology
Over 30 active projects

7. CS Working Group Objectives
Non-Clinical WG: Improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner.
Optimizing Use of Data Standards: Identify specific gaps that prevent FDA and industry from optimizing the use of data standards by collaborating to close these gaps
Semantic Technology: Investigate how formal semantic standards can support the clinical and non-clinical trial data life cycle from protocol to submission

8. CS Working Group Objectives
Standard Scripts WG: Establish a platform for the collaborative development of program code to be used as analytical tools for clinical trial research, reporting, and analysis
Emerging Technologies WG: Provide a forum identifying new opportunities for recognizing and leveraging new or emerging technologies and computational tools or under-utilized existing technologies.

10. CSS 2016 FDA and PhUSE co-sponsoring the event Upcoming Dates
Event Date: March 13-15
Registration Opened Monday!
Call For Posters; January 15
Early Bird Registration: January 29
Register early! Only room for 300 attendees

11. CSS 2016 Agenda Sunday Night: Opening Session NEW ACTIVITIES!
Welcome and Working Group Overview
Working Group Breakout Sessions
NEW ACTIVITIES!
Collaborate Scripting Session (CSS)
Semantics 101 Workshop

12. CSS 2016 Agenda FDA State of the Union
The PhUSE CSS Collaboration – Getting Involved and Getting it Done: A Regulatory Perspective
Steve Wilson, Dr.PH, CAPT., USPHS Director of Division of Biometrics III, CDER, FDA
eStudy Guidance – How Much Do You Know?
FDA Representative – TBC
Data Integrity Overview: What CDER is Seeing with SDTM, ADaM and SEND
Reviewers Guides: State of Affairs: SDRG, ADRG and Non-Clinical SDRG

13. CSS 2016 Agenda Working Group Breakout Sessions
Monday Afternoon
Tuesday Morning
Monday evening Poster Session
Networking
Snacks and Drinks
Conference closes on Tuesday at 4 pm

14. CS Collaboration Activities
Computational Science Symposium: Annual working meeting
March 2016 in Silver Spring, MD:
Exploring European CSS in 2016…
PhUSE CS Dashboard: Overview of active projects
PhUSE Catalog of WG Deliverables: Finalized work packages
PhUSE WG Deliverables Under Review: Draft work packages available for public review

15. Get Involved and Join the Collaboration
Need more information? Visit the PhUSE Wiki more detailed working group and project information
Ready to join? Working Group Leads or join a Working Group Mailing List
Have an idea? Submit a new project request today!
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