2025 Advanced CNS Clinical Trials Course
A brief, intensive, interactive program for mid-career CNS clinical researchers who wish to expand and refine their trial design expertise
APPLY by 5 MARCH – See below
Location:
Syneos Health Headquarters, room TBA
1030 Sync Drive
Morrisville, NC 27560
(approximately 3 miles from Raleigh-Durham International Airport)
Housing: On own
Agenda at a Glance
Wednesday 11 June 2025 | ||
1:00-1:15pm EDT | Registration Check-in / Meet & Greet | |
1:15pm | Introduction | Larry Alphs Judith Jaeger Kari Nations |
1:30pm | Early Phase Trial Design: Session 1 – Regulatory Considerations and Research Goals | Luca Pani |
2:15pm | Early Phase Trial Design: Session 2 – Proof of Mechanism/Clinical Concept (PoM/PoC) Clinical Trials | Gerard Sanacora |
3:15pm | Early Phase Trial Design: Session 3 – Proof of Mechanism/Clinical Concept (PoM/PoC) Clinical Trials | Seth Hopkins |
4:15pm | Early Phase Trial Design: Session 4 – Statistical Considerations | Ginger Haynes |
5:00pm | Session Adjourns | |
6:30-8:30pm | Group Welcome Dinner | |
Thursday 12 June 2025 | ||
8:00am EDT | Welcome Day 1 Recap Early Phase Q&A |
Larry Alphs Judith Jaeger Kari Nations Early phase faculty |
9:00am | Breakout Session: Early Phase Trial Design Work Group | |
11:15am | Later Phase Trial Design: Session 1 – Regulatory Considerations and Research Goals | Luca Pani Ni Khin |
12:00pm | Break / Lunch served | |
12:15pm | Later Phase Trials Session 2 – Demonstration/Confirmation of Therapeutic Potential (Working lunch) | Stephen Brannan |
1:15pm | Later Phase Trials Session 3 – Demonstration/Confirmation of Therapeutic Potential | Lori Davis |
2:15pm | Later Phase Trial Design: Session 4 – Statistical Considerations | Elena Polverejan |
3:15pm | Break | |
3:30pm | Small Group Discussions – Session I: Special Later Phase Content | |
4:30pm | Small Group Discussions – Session II: Special Later Phase Content | |
5:30pm | Session adjourns | |
6:30-8:30pm | Dine-Around with faculty and preceptors (at local restaurants) | |
Friday 13 June 2025 | ||
7:00am EDT | Lite Breakfast and Dine-Around Discussions with Faculty and Preceptors (optional – lite breakfast provided) | |
8:00am EST | Welcome Day 2 Recap Early Phase Q&A |
Larry Alphs Judith Jaeger Kari Nations Later phase faculty |
9:00am | Breakout Session: Later Phase Trial Design Work Group | |
11:00am | Break | |
11:15am | Group Presentations/Discussion of Study Designs/Review Committee Simulation (lunch provided) | |
2:30pm | Closing Remarks | |
3:00pm | Meeting Adjourns |
Faculty and preceptors (Bios and Disclosures Linked to Names)
Larry Alphs, MD, PhD, Larry Alphs Consulting
Stephen Brannan, MD, CNS Clinical Consulting
Carla Canuso, MD, Janssen Research and Development
Anita Clayton, MD, DLFAPA, IF, University of Virginia
Lori Davis, MD, Birmingham VA Medical Center
Ginger Haynes, PhD, Eli Lilly
Nanco Hefting, PharmD, H. Lundbeck A/S
Rebecca Hendrickson, MD, PhD, VA Puget Sound Health Care System
Seth Hopkins, PhD, Otsuka Pharmaceutical Development & Commercialization
Judith Jaeger, PhD, CognitionMetrics
Anzalee Khan, PhD, The Nathan S. Kline Institute for Psychiatric Research
Ni Khin, MD, Neurocrine Biosciences
Stephen Marder, MD, UCLA
Kari Nations, PhD, University of Texas at Austin
Luca Pani, MD, University of Miami / University of Modena
Elena Polverejan, PhD, Johnson & Johnson
Gerard Sanacora, MD, PhD, Yale University
Nina Schooler, PhD, SUNY Downstate Health Sciences Center
Faculty and Preceptor Disclosures
Questions? Email info@isctm.org