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Synergy in Action

11th Annual Scientific Meeting

Includes Joint Scientific Session with ASENT
17 – 19 February, 2015   //   The Fairmont, Washington DC, USA

Distinguished Poster Award Recipient:

Stress-induced IV Alcohol Self-Administration Behavior: A Human Experimental Model for Stress-cue Reactivity and Risk for Alcohol Use Disorder (Stangl)

All Poster PDFs and Abstracts are available at the end of the second day.

Day 1 (17 February 2015)

Presidential Welcome S Romano
slides slides
video
Forming and Utilizing Integrated Clinical Trials Databases to Advance Insights in Treatments for Cognition in Schizophrenia and Alzheimer’s Disease Chairs:
L Alphs
G Haynes 
J Severe 
  Session Overview J Severe
slides 
slides
video
  Database of Cognitive Training and Remediation Studies (DoCTRS): Goals, Value, Potential  
  Trials and Tribulations: Personalizing Cognitive Treatment in Schizophrenia T Wykes
slides slides
video
  Hurdles and Solutions Encountered with DoCTRS S Morris
slides
slides
video
  Large Integrated Databases in Alzheimer’s Disease  
  Data Sharing and Models in Pre(Non)-Competitive Space in Addressing Unmet Medical Needs – Critical Path Institute’s Alzheimer’s Drug Development Tool V Sinha
slides
slides
video
  Lessons from the Development and Regulatory Evaluation of a Clinical Trial Simulation Tool for Alzheimer’s Disease K Romero
slides
slides
video
  Impact of Varying Data Quality on Statistical Analysis of Integrated Datasets E Andraca-Carrera
slides
slides
video
  Panel Discussion All Speakers
video

Working Group Dinners

 
  Assessment of Abuse Liability in Drug Dependent Subjects Chairs:
M Sokolowska
B Setnik
M Klein
Working Group Slides:
slides
Schoedel
Report Back
slides slides
  Addressing Methodological Challenges in International CNS Clinical Trials Chairs:
R Keefe
A Kalali
Working Group Slides:
slides
slides
Report Back

slides slides
  Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs Chairs:
J Rabinowitz
N Schooler
Report Back

slides slides
  Behavioral and Psychiatric Symptoms in Dementia Chairs:
L Ereshefsky
D Miller
L Pani 
Report Back

slides slides
  Biomarkers in Schizophrenia Chairs:
S Potkin
D Goff
Report Back

slides slides
  Cognitive Assessment in AD and Its Precursors Chairs:
H Posner
P Harvey
Working Group Slides:
slides
Cosentino
slides
Schneider
Report Back
slides slides
  Identifying/Reducing the Effects of Non-Adherence in Clinical Trials Chairs:
T Shiovitz
E Bain

Report Back
slides slides
  Implementing Innovations in CNS Trials Chairs:
G Sachs
M Detke
Working Group Slides:
slides
slides
  Suicidal Ideation and Behavior Assessment Chairs:
M Stewart
P Chappell

L Alphs
Working Group Slides:
slides
slides
Report Back

slides slides

Day 2 (18 February 2015)

Parallel Sessions

 
Session A: Adaptive Design in the Real World: Implications for Neuroscience Clinical Studies Chairs:
J Kando
R Marcus
  Introduction J Kando 
R Marcus
slides 
slides
  Overview of Adaptive Design Methodology V Dragalin
slides slides
video includes session introduction
  Review of Obstacles, Barriers, Problems and Logistical Issues with Adaptive Design Studies J Quinlan
slides slides
video
  Bayesian Adaptive Trial Design: A New Approach for Phase 2 Clinical Trials in Alzheimer’s Disease A Satlin
slides slides
video
  BMS-927711 for the Acute Treatment of Migraine: A Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial R Marcus
slides slides
video
  Adaptive Design in Phase 2: Potential Treatment for Insomnia Disorder M Moline
slides slides
video
  When is Adaptive Design Useful in Neuroscience T Parke
slides
slides
video
  Q & A and Panel Mediated Discussion  S J Wang*
All Speakers

video
Session B: Regulatory Guidelines and Methodological Approaches to Assess Prescription Drug Abuse and Misuse During CNS Drug Development  Chairs:
B Setnik
M Sokolowska
M Klein
  An Overview of the Regulatory Requirements for Assessing the Abuse Potential of CNS Active Drugs in Different Populations M Klein
slides slides
video
  Human Abuse Potential Study Design and Interpretation for CNS Active Drugs M Sokolowska
slides slides
video
  Statistical Considerations for Human Abuse Potential Studies L Chen
slides slides
video***
  Q & A and Panel Mediated Discussion S Calderon*
P Geoffroy*

video
  Methodological Approaches to Assess Dependence Potential in Clinical Trials S Ratcliffe
slides slides
video
  Evaluation of Dependence and Withdrawal in Clinical Trials and Human Dependence Study – Design and Considerations A Lerner
slides slides
video
  Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse and Dependence of CNS-Active Drugs in Patient and Post-Marketing Trials B Setnik
slides slides
video
  Q & A and Panel Mediated Discussion S Butler*
video
  Presentation of the Andrew C. Leon Distinguished Career Award R Keefe
slides 
slides
S Romano
slides 
slides
 
video
  Challenges in Developing Therapeutics in Partially Responsive and Treatment Resistant Depression – Where Do We Go From Here? Chair:
H Martynowicz
  Introduction to the CHMP MDD Guidance and How the EFPIA Position Was Formulated H Martynowicz
slides slides
video
  Clinical Perspective on Conducting Trials in Major Depressive Disorder J Kent
slides
slides
video 
  Clinical Perspective on Conducting TRD Studies H Eriksson
slides slides
video 
  Regulatory Perspective—CHMP K Broich
slides
slides
video 
  Advancing our Thinking About Partially Responsive MDD and TRD T Laughren
slides
slides
video 
  Panel Discussion J Kent
H Eriksson
K Broich
T Laughren
C Nelson
M Mathis
video
  Poster Session / Reception Poster PDFs and Abstracts

Day 3 (19 February 2015)

TBI Treatment Development Chairs:
G Ling
A Faden

R Ferziger

 Welcome from ISCTM and ASENT Presidents S Romano 
H Federoff
 
video
 Introduction A Faden
R Ferziger
slides 
slides
video
  State of Affairs  
  Traumatic Brain Injury State of the State G Ling
slides 
slides
video***
  State of the Science  
  Scientific Opportunities and Key Unknowns in TBI Research S Hinds
slides slides
video***
  TBI: Translational Issues and Opportunities 1 A Faden
slides slides
video
  TBI: Translational Issues and Opportunities 2 J Povlishock
slides
slides
 video
  Research at FDA on TBI Pathophysiology and Biomarker Development C Welle
slides slides
video
  Discussant D Hovda*
video
  State of the Pipeline  
  TBI Clinical Trials: Past, Present and Future D Hack
slides slides
video
  Reconceptualizing TBI Assessment and Clinical Trial Design G Manley
slides slides
video
  Regulatory Perspectives C Pena*
video
  Discussant and Moderator G Ling*
video***
  State of Investment
What Would it Take to Increase Public-Private Partnership in TBI Treatment Development?
M Anderson
slides 
slides
M Stebbins
S Romano
G Ling
R Ferziger
video
  State of Selected Treatment Targets
Reports from TBI Treatment Development Working Group Chairs:
 
  Neuroinflammation D Loane
slides
slides
video
  Biomarkers Development for TBI G Small
slides 
slides
video
D Smith
slides
slides
video
  TBI & Sleep Disorders M Yochelson**
video
E Wickwire**
video
  TBI – Neuropsychiatric Sequelae L Davis
slides
slides
video
  Post-Traumatic Headache: Opportunities and Challenges for Clinical Trials J Erickson**
video***
  Responses from Experts Panel and Open Discussion Panel
 video***
Meeting Adjourned  
* No slides presented
** Slides not released
*** Video not released