FDA-wide modeling and simulation
Dear all:
I would like to share a recent meeting recording. You can learn the application
and research in modeling and simulation across all FDA centers (CBER, CDER,
CDRH, CFSAN, CTP, CVM, NCTR and ORA).
8:30
Welcoming Remarks
- Chief Scientists RADM Denise Hinton
8:45
Overview of ModSim WG & Accomplishments
- Tina Morrison, Chair, ModSim WG
9:05
Reports from each ModSim Interest Groups
- Big Data: Christopher Ellis, CDER
- Chemical Models: Patra Volarath, CFSAN
- Mechanistic Models: Maziar Kakhi, CDER
- Physics Models: Pras Pathmanathan, CDRH
- Risk Assessment: Annie Lumen, NCTR
- Statistical Models and Applications: Tomas Drgon, ORA
10:15
NETWORKING BREAK
10:45
Modeling Initiatives at FDA Centers
3-in-5 format (three slides in 5 mins)
* Specific strategic priorities for your Center around M&S
* What has changed in the last 5 years?
* What do you anticipate in the next 5 years?
- CBER: Richard Forshee
- CDER: Yaning Wang
- CDRH: Tina Morrison
- CFSAN: Jane van Dorn
- CTP: Kausar Riaz Ahmed
- CVM: Marilyn Martinez
- NCTR: Huixiao Hong
- ORA: Tomas Drgon
11:45
LUNCH on your own
12:30
Reports from ModSim Implementation Teams
- Communications Plan: Ryan Ortega
- Successes & Opportunities for M&S: Pras Pathmanathan
12:50
Avicenna Alliance Update and Engagement with ModSimWG
- Dr. Markus Reiterer, International WG Leader
1:00
Keynote Presentations
1. Dr. Keith Meintjes on Simulation Governance (confirmed)
2. Dr. Markus Reiterer on Critical Thinking (confirmed)
* The Role of Critical Thinking in the Assessment in Computer Modeling
and Simulation
3:00
NETWORKING BREAK
3:30
Round-table Discussion about ModSim WG
* Real-world evidence for model generation and validation
* Machine learning applications
* Digital transformation
* CDER text mining and natural language processes WG
* In silico clinical trials
* Ideas for other implementation teams
4:30
Wrap-up
* Part 1 Recording: https://collaboration.fda.gov/p81lvh7qzth/
* Part 2 Recording: https://collaboration.fda.gov/p8nxta18f86/
* Part 3 Recording: https://collaboration.fda.gov/p3pn29t4jjp/
Yaning Wang, Ph.D.
Director
Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Phone: 301-796-1624
Email: [email protected]
Disclaimer: The contents of this message are mine personally and do not
necessarily reflect any position of the Government or the Food and Drug
Administration.