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Synergy in Action

8th Annual Scientific Meeting

plus 2012 ISCTM National Mental Health Research-to-Policy Forum
21 – 23 February, 2012   //   Washington DC, USA

The 8th Annual Scientific Meeting was dedicated to our dear friend and colleague, Andrew C. Leon.

Poster Awardees:

The Relationship Between Urine Cannabinoid Concentration and Choice Reaction Time in Chronic Marijuana Users
Boyd AF, Morgan DW, Goddard SG, Gray KM
Severity Rating in Restless Legs Syndrome: Validation of the RLS-6 Scales
Kohnen R
Feasibility of Assessing the Pragmatic vs. Explanatory Design of a Clinical Trial
Bossie CA, Hulihan JF, Alphs L
(All poster abstracts are available for public viewing. Link found at end of Day 2)
Related Publications:
Defining A Clincally Meaningful Effect for the Design and Interpretation of RCTs
Innovations in Clinical Neuroscience, May-June 2013 (ISCTM Supplement # 1)
Keefe R

Day 1 (21 February 2012)

2012 ISCTM National Mental Health
Research-to-Policy Forum
Are Clinical Trials of New Treatments for Chronic CNS Diseases Early Enough and Long Enough?
R Ferziger
R Manderscheid
L Ereshefsky
SUMMARY
Introduction Session Chairs
slides slides
video
Part 1: Framing the Issues  
  What Do Policy Makers Need Treatment Researchers to Tell Them About Schizophrenia and Alzheimer’s Disease? 

Epidemiology and Policy Goals for Treatment Research in Alzheimer’s Disease and Schizophrenia

H Goldman/
R Manderscheid
slides slides
video
  Schizophrenia Perspective R Heinssen
slides slides
video
  Alzheimer’s Disease Perspective R Anand
slides slides
video
  Methodological Challenges H Kraemer
slides slides
video
Part 2: Responses  
  Industry Perspective A Breier
slides slides
video
  FDA Perspective on Early Treatments and Long-Term Outcomes for Schizophrenia T Laughren
slides slides
video
  FDA Perspective on Early Treatments and Long-Term Outcomes for Alzheimer’s Disease R Katz
slides slides
video
  Panel Discussion video
Part 3: Current and Future Research  
  Current and Future Trials: Schizophrenia A Breier
slides slides
video
  Current and Future Trials: Alzheimer’s Disease R Anand
slides slides
video
  Methodology Discussant H Kraemer
slides slides
video
  Panel Discussion video
Summary and Next Steps R Ferziger
R Manderscheid
L Ereshefsky
ISCTM 8th Annual Scientific Meeting  
President’s Welcome and Tribute to Andrew C. Leon L Alphs
slides slides
video
Session 1: Augmentation Strategies-Focus on Depression, Methodology and Regulatory Perspective Chairs:
A Kalali
J Rasmussen
  Introduction J Rasmussen
slides slides
video
  Background, Concepts and Definitions A Kalali
slides slides
video
  Antidepressant Augmentation: Acceleration and Enhancement Strategies S Kennedy
slides slides
video
  Current Example 1: Case Study – Add-On Trials in Depression G Dunbar
slides slides
video
  Current Example 2: Focus on Depression Methodology and Regulatory Perspective J Youakim
slides slides
video
  Current Example 3: Early Onset of Response in Treating MDD E Buntinx
slides slides
video
  Panel Discussion video
Regulatory Forum  
  FDA T Laughren
slides slides
video
  EMA K Broich
slides slides
video
  Regulatory Panel Discussion video
  Focused Panel Discussion video
  Schizophrenia S Marder
  Bipolar C Bowden
  Cognition R Keefe
  Discussant S Kennedy
Session 2: Working Group Dinners (See Next day for Report Back Summaries)  

Day 2 (22 February 2012)

  Working Group 1 Report Back: Adaptive Design – Haynes (Presented by Ginger Haynes) slides slides
video
  Working Group 2 Report Back: Biomarkers – Riordan (Presented by Hank Riordan) slides slides
video
slides SUMMARY
  Working Group 3 Report Back: Negative Symptoms – Marder/Daniel (Presented by Stephen Marder) slides slides
video
slides SUMMARY
  Working Group 4 Report Back: Suicidal Ideation and Behavior Assessment -Butler/Stewart (Presented by Adam Butler) slides slides
video
  Working Group 5 Report Back: Signal Detection – Kalali/Ereshefsky (Presented by Amir Kalali) slides slides
video
  Working Group 6 Report Back: Assessing Abuse Liability Potential – Klein, Ammann, Martynowicz (Presented by Marta Sokoloska) slides slides
video
  Working Group 7 Report Back: Metric-Based Measurement to Assess Cognitive Outcome in AD Trials? Posner/Harvey
(Presented by Holly Posner)
slides slides
video
slides SUMMARY
SESSION 3: Defining Clinically Meaningful Effect for the Design and Interpretation of RCTs Chairs:
R Keefe
AC Leon
  Introduction and Objectives R Keefe
slides slides
video
  Consumer Perspective J McNulty
(presented by
R Keefe)
slides slides
video
  Payer Perspective R Epstein
slides slides
video
  Health Care Economist Perspective S Reed
slides slides
video
  Investor Perspective J Sanchez
slides slides
video
  Regulatory Perspective and Discussion Panel T Laughren
slides slides
video
K Broich
slides slides
  The Special Case of Clinically Meaningful Similarity AC Leon
(presented by
G Haynes)
slides slides
video
  Determining How Effective a Treatment Will Be for an Individual Patient H Kraemer
slides slides
video
  How to Determine Benefit in a Clinical Trial (Incorporating Risk and Benefit) E Frank
slides slides
video
References
(referenced by Kraemer and Frank)
  Comments (Davis) followed by Focused Discussion Panel K Davis
S Romano
H Kraemer
E Frank
R Keefe
video
Joint Poster Session / Reception with ASENT View All Poster Abstracts

Day 3 (23 February 2012)

ISCTM / ASENT Joint Scientific Session  
  Welcome from ISCTM and ASENT Presidents R Keefe
R Hamill
Session 4: Challenges and Opportunities in Pediatric Drug and Device Development for Neuro-Psychiatric Diseases: A Cross-Disciplinary Symposium Chairs:
A Mahableshwarkar
S Romano
R Keefe
J Rasmussen
S Comfort
B Lavenstein
  Session Objectives A Mahableshwarkar
slides slides
  New Treatments for Neurodevelopmental Disorders T Insel
(presented by
J March)
slides slides
video
  Therapeutics and the Developing Nervous System: Epilepsy as a Model G Holmes
slides slides
video
  Experimental Medicines Development in Children and Adolescents J March
slides slides
video
  Panel Discussion video
Unique Challenges in Pediatric Drug and Device Development  
  Developing New Psychiatric Drugs With a Pediatric Indication – A Case Study D Michelson*
  Devices, Children and Regulations: A Historical Perspective with Contemporary Problems B Lavenstein
slides slides
video
  Panel Discussion video
Regulatory Perspective  
  US FDA: Pharmaceutical T Farchione
slides slides
video
  US FDA: Devices K Bowsher
slides slides
video
  PMDA Y Uyama
slides slides
video
  EMA K Broich
slides slides
video
  Panel Discussion video
Session 4 Breakouts – Report Back Summaries  
  Specific Challenges, PK/PD, Potential for Longer Term Effects
(Presented by John March)
J March
T Farchione
R Keefe
J Rasmussen
slides slides
video
  Animal Models For Diseases, Drugs and Devices
(Presented by Doug Feltner)
G Holmes
Y Uyama
M Walton
D Feltner
slides slides
video
  Pediatric Outcomes and Scales
(Presented by J Horrigan)
J Horrigan
Peter Como
S Comfort
A Mahableshwarkar
slides slides
video
  IRB and Ethics J Conry
B Karp
S Romano
B Lavenstein
slides slides
video
Summary and Next Steps S Romano
Meeting Adjourns  
* Materials have not been released.