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ASCPT 2023 Annual Meeting
Translating Clinical Pharmacology for All
The ASCPT 2023 Annual Meeting will be held as an in-person event with an online component, March 22-24, at the Hyatt Regency in Atlanta, GA. Registrants for the in-person meeting will enjoy reuniting with friends and colleagues face-to-face, with more time to network. View the Preliminary Program for details on the Pre-Conference event and three days of robust content planned for the 2023 Annual Meeting.
Register Today!
Meeting Dates
Online Network & Community Experience (NCE): TBD
ASCPT Annual Meeting: March 22-24, 2023 | Hyatt Regency - Atlanta, GA
ASCPT 2023 Pre-Conference
Advancing the Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) in Clinical Pharmacology and Translational Research
Tuesday, March 21, 2023, 9:00 AM – 5:30 PM
Co-Sponsored by the IQ Consortium
Chairs:
- Paulien Ravenstijn, PhD
- Karen Yeo, PhD
- Jing Liu, PhD
Additional Organizing Committee Members:
- Mariam Ahmed, PhD
- Pooja Manchandani, PhD
- Anuradha Ramamoorthy, PhD
- IQ RWE Workgroup: Rui Zhu, PhD, and Cyrus Ghobadi, MD, PhD
RWD and RWE have been routinely used in epidemiology, clinical practice, and post approval regulatory decisions. Despite the fact that there have been published examples and new regulatory guidelines in recent years, there remains a lack of general understanding on RWD and RWE and how this approach can be applied in clinical pharmacology and translational research.
This Pre-Conference experience will include state of the art presentations from a diverse panel of experts from academia, industry, and regulatory, access to presentations on selected case studies reflective of current practices for RWE/RWD in drug development, an interactive workshop to reinforce learnings of applications of RWE/RWE in drug development, poster presentations submitted by participants, and forward-looking panel discussion from global representatives.
Who Should Attend?
This Pre-Conference will be of significant interest to clinical pharmacologists and modeling communities in industry, regulatory, and academia as it has widespread application throughout.
Learning objectives:
- To introduce the basics of RWD and RWE
- To provide education on the data source, quality and analytics involved in generation of RWE from RWD
- To discuss the necessary framework for application of RWD and RWE application in the scope of clinical pharmacology, translational research, drug development and approval
Tentative Schedule
| Start time |
End time |
Title |
Speaker |
| 9:00 am |
9:10 am |
Opening & Welcome |
Karen Rowland Yeo |
| 9:10 am |
9:35 am |
Lecture 1: Introduction of RWD and RWE and advancing utilization of RWD and RWE in clinical pharmacology and translational research – academia perspective |
Almut Winterstein |
| 9:35 am |
10:00 am |
Lecture 2: Advancing utilization of RWD and RWE in clinical pharmacology and model-informed drug development – industry perspectives |
Brian Corrigan |
| 10:00 am |
10:25 am |
Lecture 3: Advancing their utilization in clinical pharmacology – regulatory perspectives |
Qi Liu |
| 10:25 am |
10:50 am |
Lecture 4: Real world data sources, quality, and analytics considerations for generating RWE |
Jeff Barrett |
| 10:50 am |
11:00 am |
Break |
|
| 11:00 am |
12:30 pm |
Real case studies demonstrating the application of RWD/RWE in drug development for various scenarios.
- Special populations
- DDI
- Disease progression modeling
- Translational research/ Reverse translation
- Totality of evidence for drug approvals
|
Rui Zhu
Cyrus Ghobadi
Samira Jamalian
TBD
|
| 12:30 pm |
1:30 pm |
Lunch and Posters |
All |
| 1:30 pm |
2:45 pm |
Hands-on Workshop – Drug X: Breakout groups |
All, and breakout facilitators |
| 2:45 pm |
3:30 pm |
Cross-group learnings from breakout groups |
Moderator: Paulien Ravenstijn |
| 3:30 pm |
3:45 pm |
Coffee Break |
|
| 3:45 pm |
4:30 pm |
Panel discussion with presenters and panelists from academia, industry, EMA, FDA, WHO on the vision/future of RWE/RWD in clinical pharmacology, translational research and drug development and approval; data quality & data standards |
Moderator: Jing Liu
Panelists: TBD
|
| 4:30 pm |
4:35 pm |
Wrap up |
Jing Liu |
| 4:35 pm |
5:30 pm |
Posters and Refreshment |
All |
Interested in being an ASCPT 2023 Partner?
Contact Lisa Infelise to find out more about year-round partnership opportunities.
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