16th Annual Scientific Meeting

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 (View all Working Group session objectives/details)
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
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