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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

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

Thursday 2 December 2021  
7:00-7:45am EST Registration / Safety Measures Check-in   
8:00am EST Introduction Carla Canuso
Kari Nations
  Early Phase Trials Session 1 – Proof of Mechanism Studies Andrew Krystal
Daniel Umbricht
  Early Phase Trials Session 2 – Proof of Concept Studies Daniel Umbricht
Andrew Krystal
  Early Phase Statistical Considerations Craig Mallinckrodt
  Regulatory Perspectives on the Use of Digital Health Technologies in CNS Drug Development Mike Davis

  Learning Lab Breakout A: Study Design Group Assignment (lunch provided)  
  Late Phase Trials Session 1 – Moving from Early Phase to Late Phase Drug Development: Determining and Confirming Therapeutic Potential Bruce Kinon

  Late Phase Trials Session 2 – Clinical Trials: When Design Dreams meet Clinical Reality 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 (lunch provided)  
2:30pm EST Meeting adjourns  

Faculty and preceptors (Bios and Disclosures Linked to Names)
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, Cyclerion Therapeutics
Andrew Krystal, MD, University of California, San Francisco
Craig Mallinckrodt, PhD, Cortexyme
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

Faculty and Preceptor Disclosures

COVID Safety Measures:
We will adhere to the safety guidelines of our host facility. Vaccination required. Rapid antigen tests will be administered upon entry. Face mask and social distancing requirements will follow local guidelines.

Questions? Email info@isctm.org