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Day 1: Tuesday 21 February 2012

8:30 National Mental Health Research to Policy Forum:  
        Are Clinical Trials of New Treatments for Chronic CNS Diseases Early Enough and Long Enough?
        
Co-chairs: Reuven Ferziger MD, Larry Ereshefsky PharmD, BCPP, Ron Manderscheid, PhD
                            Welcome and Objectives: Session Chairs
                            Part 1: Framing the Issues
                               The Public Health Opportunity: Robert Heinssen, PhD
                               The Policy Question: Howard Goldman, MD, PhD 
                               The Scientific Challenge: Ravi Anand, MD 
                               When Science Meets Policy: Helena Kraemer, PhD
                            Part 2: Policy Stakeholders Perspectives
                               Policy Perspective: Howard Goldman, MD, PhD
                               R&D Perspective: Alan Breier, MD
                               Regulatory Perspectives
                                   Psychiatry: Thomas Laughren, MD
                                   Neurology: Russell Katz, MD
                            Discussion
                            Part 3: Research Stakeholder Perspectives
                            NIMH Perspective: Robert Heinssen, PhD
                            Designing Prodromal and Long-Term Clinical Trials: Helena Kraemer, PhD
                            Ongoing Trial Examples:
                                   Schizophrenia: Alan Breier, MD
                                   Alzheimer's Disease: Ravi Anand, MD
                                   Schizophrenia Discussant: Stephen Marder, MD
                            Discussion
 11:15  Forum Adjourns

11:15 Arrival Light Luncheon Buffet

12:30 8th Annual Scientific Meeting
          Welcome from the President:  Larry Alphs, MD, PhD
Session 1: Augmentation Strategies-Focus on Depression, Methodology, and Regulatory Perspective
               Co-chairs: Amir Kalali MD, Jill Rasmussen MD
                           Introduction: Jill Rasmussen, MD
                           Background, Concepts and Definitions: Amir Kalali, MD
                           Antidepressant Augmentation: Acceleration and Enhancement Strategies
                             Sidney Kennedy, MD, FRCPC
                           Current Example 1: Geoffrey Dunbar, MD
                           Current Example 2: James Youakim, MD
                           Current Example 3: Erik Buntinx, MD
                           Discussion
                           Regulatory Forum
                              FDA: Thomas Laughren, MD
                              EMA - Karl Broich, MD
                           Panel Discussion
                              Schizophrenia: Stephen Marder, MD
                              Bipolar: Charles Bowden, MD
                              Cognition: Richard Keefe, PhD
                              Discussant: Sidney Kennedy, MD, FRCPC
5:00 PM Session Adjourns

6:00-7:00 Reception

7:00-9:00 Session 2: Working Group Dinners

                           WG1: Adaptive Design
                                    
Chair: Virginia Haynes, PhD
                           WG2: Biomarkers
                                     Chair: Hank Riordan PhD
                           WG3: Deferred to later meeting
                           WG4: Negative Symptoms
                                    
Co-Chairs: Stephen Marder MD, David Daniel MD
                           WG5: Suicidal Ideation and Behavior Assessment
                                     Co-Chairs: Adam Butler, Michelle Stewart PhD
                           WG6: Signal Detection
                                     Co-Chairs: Amir Kalali MD, Larry Ereshefsky, PharmD, BCPP
                           WG7: Assessing Abuse Liability Potential
                                     Co-Chairs: Michael Klein PhD, Mark Ammann PharmD, Heddie Martynowicz MS
                           WG8: Metric-based Measurement to Assess Cognitive Outcome in AD Trials?
                                      Co-Chairs: Holly Posner MD, Philip Harvey PhD
End of Day One

Day 2: Wednesday 22 February 2012

8:15 Working Group Updates
8:30 Session 3: Defining Clinically Meaningful Effect for the Design and Interpretation of RCTs
                           
Chairs: Richard Keefe PhD, Andrew C. Leon PhD
                            Introduction and Objectives: Session Chairs
                            Consumer Perspective: James McNulty, Ab, ScB

                            Discussion
                            Payers Perspectives: Rob Epstein, MD
                            Discussion
                            Health Care Economist Perspective: Shelby Reed, PhD 
                            Discussion 
                            Investor Perspective: Juan Sanchez
                            Discussion 
                            Regulatory Perspective and Discussion Panel
                               Thomas Laughren, MD
                               Karl Broich, MD

12:00-2:00 ISCTM Annual Business Meeting Luncheon

2:00 Session 3 Continues
                           What are the Statistical Methods for Determining a Clinically Meaningful Effect
                           The Special Case of Clinically Meaningful Similarity: Andrew C. Leon, PhD
                           Discussion 
                           Determining How Effective a Treatment Will Be for a Single Patient: Helena Kraemer, PhD
                           Discussion 
                           How to Determine Benefit in a Clinical Trial (incorporating risk and benefit): Ellen Frank, PhD
                           Discussion 
                           Comments: Ken Davis, MD
                           Focused Discussion Panel
                              Steven Romano, MD
                              Helena Kraemer, PhD
                              Ellen Frank, PhD
                              Richard Keefe, PhD
                              Andrew C. Leon, PhD
 5:00 PM Session Adjourns

6:00-8:00 Joint Poster Session/Reception with ASENT

End of Day Two

Day 3: Thursday 23 February 2012
Joint Scientific Session with ASENT 
8:00   Welcome from ISCTM and ASENT Presidents Robert Hamill MD, Richard Keefe PhD
8:10   Session 4:  Challenges and Opportunities in Pediatric Drug and Device Development 
                               for Neuro-Psychiatric Diseases: A Cross-Disciplinary Symposium

                               Chairs: Atul Mahableshwarkar MD, Steven Romano MD, Richard Keefe PhD
                                             Jill Rasmussen, MD, Shaun Comfort MD, Bennett Lavenstein, MD
                          Session Objectives: Atul Mahableshwarkar, MD
                          Introductory Remarks: Thomas Insel, MD
                 
                          Therapeutics and the Developing Nervous System: Epilepsy as a Model:
                             Gregory Holmes, MD
                          Specific Consideration for Development in Children and Adolescents: 
                             Depression as a Model: John March, MD, MPH                                
                          Discussion                           
                          Unique Challenges in Pediatric Drug and Device Development
                          Drug Development Example: ADHD: David Michelson, MD
                          Device Development Examples: Vargal Nerve Simulation and Deep 
                             Brain Stimulation: Bennett Lavenstein, MD             
                          Discussion                            
                          Regulatory Perspective
                                    US FDA: Pharmaceutical: Tiffany Farchione, MD
                                    US FDA: Devices: Kristen Bowsher, PhD
                                    PMDA: Yoshiaki Uyama, PhD
                                    EMA Perspective: Karl Broich, MD
                          Discussion Panel                

12:00-1:00 Luncheon

Session 4 Continues

                               Breakout Groups

                                  1: Specific Challenges, PK/PD, Potential for Longer Term Effects
                                      Expert: John March, PhD
                                      Regulatory Representative: Tiffany Farchione, MD
                                      Facilitators: Richard Keefe, PhD, Jill Rasmussen, MD
                                  2: Animal Models for Diseases, Drugs and Devices
                                      Expert: Gregory Holmes, MD
                                      Regulatory Representative: Yoshiaki Uyama
                                      Facilitators: Michael Rogawski, MD, Douglas Feltner, MD
                                  3: Pediatric Outcomes and Scales
                                      Expert: Joe Horrigan, MD
                                      Regulatory Representative: Peter Como, MD
                                      Facilitators: Shaun Comfort, MD, Atul Mahableshwarkar, MD
                                  4: IRB and Ethics
                                      Experts: Joan Conry, MD; Barbara Karp, MD
                                      European Regulatory Representative: Karl Broich, MD
                                      Facilitators: Steven Romano, MD, Bennett Lavenstein, MD

                               Plenary Report Back           
                               (Each presentation segment will be followed by a Panel Response and Discussion)    
                                  Group 1 Report: Specific Challenges, PK/PD, Potential for Longer Term Effects
                                  Group 2 Report: Animal Models for Diseases, Drugs and Devices
                                  Group 3 Report: Pediatric Outcomes and Scales
                                  Group 4 Report: IRB and Ethics

Summary and Next Steps
 

5:10 ISCTM 8th Annual Meeting Adjourns

Confirmed Presenters

Click here for biographical profiles
Larry Alphs, MD, PhD
Therapeutic Leader, Psychiatry, Janssen Pharmaceutical Companies
Mark Ammann, PharmD
President, Catalyst Regulatory Services, LLC
Ravi Anand, MD
Chief Executive Officer, Anand Pharma Consulting
Charles Bowden, MD
Nancy U. Karren Clinical Professor, Department of Psychiatry and Professor in the Department of Pharmacology, University of Texas Health Science Center at San Antonio
Kristen Bowsher, PhD
Electrical Engineer, Food and Drug Administration
Alan Breier, MD
Professor of Psychiatry, Chief, Department of Psychotic Disorders, Indiana University
Karl Broich, MD
Deputy Head of Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte)
Adam Butler
Associate VP, Client Services, United BioSource Corporation
Erik Buntinx, MD
Chief Executive Officer, Pharmaneuroboos N.V.
Shaun Comfort, MD
CMO, Adaptix Clinical Solutions, LLC
Joan Conry, MD
Neurologist, Children's Hospital Medical Center Sheikh Zayed Campus for Advanced Children's Medicine
David Daniel, MD
Senior VP, Chief Medical Officer, United BioSource Corporation
Ken Davis, MD
President and CEO, Mount Sinai Medical Center
Geoffrey Dunbar, MD
CMO, SVP, Clinical Development and Regulatory Affairs, Targacept, Inc.
Rob Epstein, MD, MS
President, United BioSource Corporation
President, Advanced Clinical Science & Research and Chief Clinical Research & Development Officer, Medco Health Solutions, Inc.
Larry Ereshefsky, PharmD, FCCP, BCPP
Chief Scientific Expert, Parexel International
Tiffany Farchione, MD
Medical Officer, Food and Drug Administration
Reuven Ferziger, MD
CNS Medical Affairs, Janssen Pharmaceutical Companies
Ellen Frank, PhD
Professor of Psychiatry and Psychology, University of Pittsburgh Medical Center
Howard Goldman, MD
Professor of Psychiatry, University of Maryland School of Medicine
Philip Harvey, PhD
Professor of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine
Virginia Haynes, PhD
Principal Research Scientist, Global Health Outcomes, Eli Lilly & Co
Robert Heinssen, PhD
Scientific Executive and Director of the Division of Services and Intervention Research, National Institute of Mental Health
Gregory Holmes, MD
Department Chair, Neurology, Dartmouth-Hitchcock Medical Center
Joseph P. Horrigan, MD
Assistant VP, Head of Medical Research, Autism Speaks
Thomas Insel, MD
Director, National Institute of Mental Health
Amir Kalali, MD
VP, Medical and Scientific Services, and Global Therapeutic Team Leader CNS, Quintiles Inc.
Barbara Karp, MD
Deputy Clinical Director, National Institute of Neurological Disorder and Stroke
Russell Katz, MD
Director, Division of Neurology, Center for Drug Evaluation and Research, US Food and Drug Administration
Richard Keefe, PhD
Professor, Departments of Psychiatry and Behavioral Sciences and Psychology, Duke University Medical Center
President, Neurocog Trials, Inc.
Sidney Kennedy, MD
Professor of Psychiatry and Psychiatrist-in-Chief , University Health Network, University of Toronto
Michael Klein, PhD
 US Food and Drug Administration - CDER- CSS
Helena Kraemer, PhD
Professor of Biostatistics in Psychiatry (Emerita)
Department of Psychiatry and Behavioral Sciences, Stanford University
Professor, Department of Psychiatry, University of Pittsburgh
Tom Laughren, MD
Division Director, Division of Psychiatry Products, Center for Drug Evaluation and Research, US Food and Drug Administration
Bennett Lavenstein, MD
Pediatric Neurologist, Children's Hospital Medical Center Sheikh Zayed Campus for Advanced Children's Medicine
Andrew C. Leon, PhD
Professor of Biostatistics in Psychiatry and Professor of Public Health, Weill Cornell Medical College
DeWitt Wallace Senior Scholar, Weill Cornell
Atul Mahableshwarkar, MD
Senior Medical Director, Takeda
Ron Manderscheid, PhD
Executive Director, National Association of County Behavioral Health and Developmental Disability Directors
John March, MD, MPH
Professor of Psychiatry and Psychology, Director Division of Neurosciences Medicine, Duke Clinical Research Institute
Stephen Marder, MD
Director, Department of Veterans Affairs, VISN 22 Mental Ilness Research, Education and Clinical Center;
Professor, Psychiatry, David Geffen School of Medicine, UCLA
Heddie Martynowicz, MS
Senior Director, Regulatory Affairs, Janssen Research and Development, LLC
James McNulty, AB/Scb
President, MMDDA-RI
David Michelson, MD
VP, Development for Neuroscience, Merck & Co.
Holly Posner, MD
Senior Director, Research and Development, Primary Care Busines Unit, Pfizer, Inc.
Jill Rasmussen, MD
Director, psi-napse
Shelby Reed, PhD
Associate Professor, School of Medicine, Duke University
Henry Riordan, PhD
SVP, Medical and Scientific Affairs, Worldwide Clinical Trials
Steven Romano, MD
SVP, Medicines Development Group Head, Primary Care Business Unit, Pfizer, Inc.
Juan Sanchez, MD
Analyst, Ladenburg Thalmann & Co.
Michelle Stewart, PhD
Director, Pfizer, Inc.
Yoshiaki Uyama, PhD
Director, Regulatory Science Research Division, Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA)
James Youakim, MD
Senior Director, Global Clinical Development, Otsuka
Click here for biographical profiles

Fifth Section

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