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Detailed Agenda
Day 1
Wednesday, 19 February 2020
10:30 am
Onsite registration opens
1:00 pm
Welcome from the President
Carla Canuso
1:15-4:10
Session 1:
Unresolved problems in neuroscience drug development:
1:15-2:40
Drugs with abuse potential: Should they be used to treat psychiatric disorders?
Chair: Walter Dunn
Discussants:
Jerry Sanacora
Charlie Nemeroff
Raye Litten
2:45-4:10
Are current digital measures ready for prime time?
Chair: Phil Harvey
Discussants:
Elektra Papadopoulos
Greg Strauss
4:10-4:25
Break
4:25-6:00
Concurrent Working Groups Session A
(
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Working Group session objectives/details
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6:00-7:00 pm
Welcome Reception
Day 2
Thursday, 20 February 2020
7:30 am
Onsite registration
Continental Breakfast
8:15
Andrew C. Leon Distinguished Career Award
Carla Canuso
Steve Marder
8:30-12:15 pm
Session 2:
Enhancing drug development through artificial intelligence (AI) and machine learning (ML)
Chairs:
Adam Butler
Larry Alphs
Saeed Ahmed
8:30
Introduction: Improving clinical trials with modern techniques
Larry Alphs
8:40
What is artificial intelligence?
Saeed Ahmed
9:10
Discussion
9:20
Machine learning: Psychiatry and neurology
Joe Geraci
9:40
Discussion
9:50
Using AI/ML to differentiate drug and placebo responders in mood disorders: Offering the opportunity for enhanced patient selection
Jane Tiller
10:10
Discussion
10:20
AI-enabled digital phenotyping as a vehicle for improved subject measurement for clinical trial qualification and tracking of change during intervention
Dennis Wall
10:40
Discussion
10:50
Break
11:05
Regulatory considerations when utilizing AI and ML applications in the design and execution of a CNS clinical trial
David Millis
11:25
Panel Discussion
Speakers
12:10
Summary
12:15 pm
Session Adjourns
12:15-1:45
Annual Business Meeting / Luncheon
All attendees welcome
2:00-5:30
Parallel Sessions
2:00
Session 3A:
Is there a fundamental rethinking in the way we plan clinical trials? The estimand change in mindset
Chairs:
Pilar Lim
Michael Davis
Steve Brannan
Introduction
Pilar Lim
2:05
Introduction to the ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials”: A clinical perspective
Florence Butlen-Ducuing
2:25
Discussion
2:35
Putting the ICH E9(R1) Guidance into practice – A multi-disciplinary collaboration
Elena Polverejan
2:55
Discussion
3:05
Regulatory implications of the draft ICH E9(R1) Guidance
Robert Temple
3:25
Discussion
3:35
Break
3:50
Selection of estimands in a phase 2-3 trial: Examples from major depression disorder
Zimri Yaseen
4:15
Discussion
4:25
Panel and regulatory discussion
Facilitator:
Michael Davis
Panelists:
Speakers
James Hung
Craig Mallinckrodt
Michael O'Kelly
Mark Walton
5:25
Summary
Michael Davis
5:30
Session 3A Adjourns
2:00-5:30
Session 3B:
Studying the brain-gut axis in psychiatry and neurology
Chairs:
Jill Rasmussen
Ron Marcus
Introduction
Jill Rasmussen
2:10
Microbiome and schizophrenia and bipolar disorder
Bob Yolken
2:30
Discussion
2:40
Microbes, brain and behavior- Focus on depression
Ted Dinan
3:00
Discussion
3:10
Microbiome and Alzheimer's disease
Miia Kivipelto
3:30
Discussion
3:40
Break
3:55
Microbiome and Parkinson's disease
Peter LeWitt
4:15
Discussion
4:25
Regulatory considerations for microbiome based therapeutics
Paul Carlson
Luca Pani
4:45
Discussion
4:55
Panel Discussion
Facilitator: Ron Marcus
Speakers
5:25
Summary
5:30
Session 3B Adjourns
5:45-7:30 pm
Poster Session/Reception
(
Poster Guidelines and Submission Form
)
End of Day 2
Day 3
Friday, 21 February 2020
7:00
Onsite Registration
7:30-9:15 AM
Working Groups Session B (Breakfast)
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Working Group session objectives/details
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9:30
Session 4:
Role of reward processing assessment as a tool in drug development
Chairs:
Larry Ereshefsky
Raimund Buller
Introduction
Raimund Buller
Larry Ereshefsky
9:45
The biology of reward processing and relationships to circuits and symptoms associated with psychiatric and neurological diseases
Diego Pizzagalli
10:15
Discussion
10:25
Reward processing in psychiatry
Greg Strauss
10:45
Discussion
10:55
Reward processing in neurological disorders: Focus on Parkinson's disease
Masud Husain
11:15
Discussion
11:25
Break
11:45
Reward processing in drug development trials
Stephane Pollentier
12:05
Discussion
12:15
Regulatory view on use of reward processing in patient segmentation and as a marker for treatment response
Tiffany Farchione
EU- Pending
12:35
Panel and Audience Discussion
Larry Ereshefsky
Raimund Buller
1:10
Summary
1:15
Meeting Adjourns
Ramy Mahmoud
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