Synergy in Action

Advanced CNS Clinical Trials Course

Jointly sponsored by ISCTM and ASCP
02 – 03 December, 2021   //   Raleigh, NC

A new, brief, intensive, interactive program for mid-career CNS clinical researchers who wish to expand and refine their trial design expertise

Registration is reserved for accepted applicants, faculty and preceptors only. Registration opens 21 June 2021.

Syneos Health Headquarters, room TBA
1030 Lync Drive
Morrisville, NC 27560
(approximately 3 miles from Raleigh-Durham International Airport)

Agenda at a Glance

Thursday 2 December 2021  
8:00am EST Introduction Carla Canuso
  Early Phase Trials Session 1 – Proof of Mechanism Studies Andy Krystal
  Early Phase Trials Session 2 – Proof of Concept Studies Daniel Umbricht
  Early Phase Statistical Considerations Craig Mallinckrodt
  Pre-Breakout Practical Considerations Kari Nations
  Learning Lab Breakout A: Study Design Group Assignment  
  Late Phase Trials Session 1 – Confirmatory Industry Trials Bruce Kinon
  Late Phase Trials Session 2 – Multi-center Academic Trials Lori Davis
5:15pm EST Session Adjourns  
5:30-7:30pm EST Dine-around with Faculty and Preceptors (optional)
Friday 3 December 2021  
7:00am EST Lite Breakfast with Faculty and Preceptors (optional – lite breakfast provided)  
8:00am EST Late Phase Statistical Considerations  Elena Polverejan
  Learning Lab Breakout B: Study Design Group Assignment  
  Group Discussion of Study Designs  
2:30pm EST Meeting adjourns  

Optional Activities
Thursday: Dine-around with Faculty and Preceptors
Friday: Lite Breakfast with Faculty and Preceptors

Topics such as Adaptive Designs, Regulatory Process, Biomarker Development and Validation, and Designing Multicenter Trials will be discussed during dinner and breakfast.
ISCTM will be in touch regarding dine-around opportunities and other details.

Faculty and preceptors:
Carla Canuso, MD, Janssen Research and Development
Lori Davis, MD, Tuscaloosa VA Medical Center
Michael Davis, MD, PhD, FDA
Don Goff, MD, NYU School of Medicine
John Kane, MD, The Zucker Hillside Hospital
Bruce Kinon, MD, Lundbeck
Andy Krystal, MD, University of California, San Francisco
Craig Mallinckrodt, PhD, Biogen
Stephen Marder, MD, Semel Institute at UCLA
Kari Nations, PhD, Syneos Health
Elena Polverejan, PhD, Janssen Research and Development
Bill Potter, MD, PhD, Independent expert (retired from NIMH, Lilly, and Merck)
Nina Schooler, PhD, SUNY Downstate Medical Center
Madhukar Trivedi, MD, University of Texas Southwestern Medical School
Daniel Umbricht, MD, xperimed LLC

Registration Fees
Academia/Government: $250
Industry: $500

Questions? Email