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Synergy in Action

2025 Advanced CNS Clinical Trials Course

Jointly sponsored by ISCTM and ASCP
11 – 13 June, 2025   //   Raleigh, NC

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

APPLY HERE

Questions? Email info@isctm.org