Advanced CNS Clinical Trials Course
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 |
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Early Phase Trials Session 2 – Proof of Concept Studies | Daniel Umbricht Andrew Krystal |
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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