2007 Mid-Year Conference
Wednesday, May 21st, 2014
Related Publications |
|
NR Schooler, AH Kalali, L Alphs, R Anand, G Awad, M Davidson, S Dubé, L Ereshefsky, G Gharabawi, AC Leon, JP Lepine, SG Potkin, A Vermeulen What is Causing the Reduced Drug-Placebo Difference in Recent Schizophrenia Clinical Trials and What Can be Done About It? Schizophrenia Bulletin 2008, Vol. 36, No. 3; |
|
Day 1 (17 September 2007) |
|
| Welcome | G Gharabawi |
| Global Clinical Trials: Opportunities and Challenges | Co-chairs: J Rasmussen L Ereshefsky |
| Summary of Issues Session on Global Clinical Trials Part I | L Ereshefsky slides |
| Overview of Opportunities and Challenges to Global Clinical Trials | J Rasmussen slides |
| EUROPEAN VIEWPOINT | |
| Introduction | C Sampaio slides |
| Regulatory Issues and Concerns on Safety and Efficacy Data Obtained From CNS Global Trials: Focus on Neurology | C Sampaio slides |
| Issues and Concerns on Safety and Efficacy Data Obtained From Global Trials for Anxiety | JP Lepine slides |
| Case Study: Differences in Trial Design/Conduct and Results from Regional Clinical Trials | R Kahn slides |
| Issues and Concerns on Safety and Efficacy Data Obtained From Global Trials for Alzheimer’s Disease | R Anand |
| ASIAN VIEWPOINT | |
| Introduction: Role of ICH E-5 Guidelines and New Strategies for Global Drug Development | L Ereshefsky |
| Regulatory Issues and Concerns on Safety and Efficacy Data Obtained From CNS Global Trials: View from Japan | Y Uyama slides |
| Update on Clinical Development and Regulatory Approval Issues in China | BP Chan |
| BIOLOGICAL AND POLICY FACTORS THAT MAY INFLUENCE STUDY RESULTS | |
| Setting the Stage: Identified and Theoretical Issues to Consider – Factors that Influence Data Quality | B Edwards slides |
| Metrics Used for Site Selection in Global Clinical Trials | A Kalali |
| Biological Differences Between Regions (Response Polymorphisms) | K-M Lin slides |
| Regional Policy and Procedural Issues that Influence Clinical Trial Results | S Richter slides |
| SUMMARY OF SESSION | R Mahmoud |
| Final Comments | G Gharabawi |
| Dinner Talk: “The ‘TeGenero incident’ and its effect onCRO approaches to Phase I work” | J Lambert |
Day 2 (18 September 2007) |
|
| WHAT IS CAUSING THE REDUCED DRUG-PLACEBO DIFFERENCE IN OUR RECENT SCHIZOPHRENIA TRIALS AND WHAT CAN WE DO ABOUT IT?” What Is Causing the Reduced Drug-Placebo Difference in Recent Schizophrenia; Aaron S. Kemp; Schizophrenia Bulletin (free access) | Co-chairs: N Schooler A Kalali |
| INTRODUCTION | N Schooler A Kalali |
| NATURE OF THE PROBLEM | |
| Historical Perspective on Drug-Placebo Differences: Implications for Future Trial Design | L Alphs slides |
| Reduced Drug Placebo Differences: Evidence from Recent Phase III Trials | S Potkin slides |
| What Have We Learned from Conducting Clinical Trials in Depression? | S Dube |
| SEARCH FOR THE CAUSES | |
| Identifying the Nature of the Problem: The Use Of PK/PD Modeling to Understand Changes in Drug-Placebo Differences | A VerMeulen slides |
| Possible Causes of Diminishing Drug-Placebo Responsiveness | A Kalali N Schooler |
| ROUNDTABLE: POTENTIAL SOLUTIONS TO THE DIMINISHING DRUG RESPONSE DILEMMA | |
| Roundtable Discussants | Anand, Ereshefsky, Gharabawi, Leon, Lepine |
| Round 1: Site Profiles | L Ereshefsky |
| Round 2: Patient Profile | R Anand |
| Round 3: Enhanced Assessment Procedures: Implications for Sample Size Requirements | A Leon |
| Round 4: Study Design | G Gharabawi |
| SUMMARY OF SESSION | N Schooler A Kalali |
| Adjourn | G Gharabawi |
4th Annual Scientific Meeting
Wednesday, May 21st, 2014
Day 1 (25 February 2008) |
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| Welcome | G Gharabawi slides video |
| SESSION I: Addressing Controversies Surrounding Antidepressant Black Box Warnings | Co-chairs: AC Leon RJ Baldessarini |
| Identifying the Issues and Case Study | AC Leon slides video |
| Overview of Clinical Perspectives | RJ Baldessarini slides video |
| Statistical Issues: Meta-Analytic Approaches to Safety Data | S-L Normand slides video |
| Panel Discussion video |
AC Leon R Baldessarini SL Normand |
| Consumer Perspective on Black Boxes | J McNulty slides video |
| Legal Implications of a Black Box Warning | N Chayet video |
| Audience Q&A video |
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| The Regulatory Basis for a Black Box Warning | T Laughren slides video |
| Panel Discussion video |
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| Summary of Session | R Baldessarini |
| Dinner Debate: Views on the Evolving Relationship Between Journal Editors and Authors: Is a Two-Tiered Approach for Industry and Academic Authors Beneficial? | Chair: R Keefe |
| Summary of Dinner Debate | A Breier slides J Kane W Carpenter |
Day 2 (26 February 2008) |
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| SESSION II: Patient Reported Outcomes: New Approaches Using Item Banks and Computerized Adaptive Assessments | Co-chairs: G Awad slides videoN Schooler video |
| Objectives and Introduction | N Schooler G Awad |
| Overview of the NIH PROMIS Roadmap Initiative | W Riley slides video |
| Patient Reported Outcomes: Use in Psychiatry and Neurology: Experience with PROMIS and Neuro-QOL | D Victorson slides video |
| Patient Reported Outcomes in the Experiences of Participating in Clinical Trials Study (EPICS) | J Weissman slides video |
| Application Of New Patient Reported Outcome Measures and Methods in Psychiatry and Neurology Clinical Trials | D Revicki slides video |
| FDA Perspective: Regulatory Perspective on New Approaches to Endpoint Measurement | L Burke slides video |
| Industry Perspective: Item Banks and Computerized Adaptive Assessment | R Morlock slides video |
| General Discussion | G Awad |
| Summary of Session | N Schooler |
| SESSION III: Methodological Challenges in Clinical Trials to Develop Devices for CNS Indications | Co-chairs: R Keefe S Lilienfeld |
| Objectives and Introduction | S Lilienfeld slides video |
| FDA Perspective: The Role of Basic Science in the Design of Clinical Trials of CNS Devices | V Krauthamer slides video |
| General Statistical Challenge for CNS Devices – A Regulatory Perspective | G Campbell slides video |
| Clinical Trail Methodology Challenges Faced in Evaluating a Medical Device for Diagnosis and Medication Response Monitoring: Regulatory Issues Encountered | M Teicher video |
| Clinical Trial Methodology Challenges in a Device Used in Chronic Neurological/Psychiatric Disorders |
S Brannan slides video |
| Clinical Trial Methodology and the Study of Medical Devices in Major Depression |
M Demitrack slides video |
| Panel and General Discussion video |
S Lilienfeld M Teicher M Demitrack S Brannan |
| SUMMARY OF SESSION | R Keefe S Lilienfeld |
Day 3 (27 February 2008) |
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| SESSION IV: Strategies For Using Data From Large Clinical Trials To Develop Public Health Policy | Co-chairs: L Alphs R Ferziger |
| Introduction and Objectives | R Ferziger slides video |
| Designing Clinical Research to Inform Mental Health Policy | P Wang video |
| Value of Research Analysis on the Comparative Cost Effectiveness of Antipsychotic Drugs | D Meltzer video |
| National Comparative Effectiveness Policy: The Case for Antipsychotic Drugs | D Polsky slides video |
| The Changing Landscape of Stakeholders and Collaborators in Psychiatry Clinical Trials | H Goldman |
| Panel Discussion video |
R Ferziger D Meltzer M Schoenbaum J McNulty R Manderscheid D Regier S Gottlieb |
| SUMMARY OF SESSION | R Ferziger |
| SESSION V: Methodological Challenges in Neuropathic Pain Trials Assessments | Co-chairs: R Anand P Marchettini |
| Introduction and Objectives | R Anand |
| New Approaches to Nosology, Diagnosis, and Treatment of NP | R Anand |
| Challenges in the Nosology, Diagnosis and Treatment of NP | P Marchettini slides video |
| Pharmaceutical Industry Perspective and Developing Treatments for NP | J Messina slides |
| Limitations of the New Definition of Neuropathic Pain | D Bouhassira slides video |
| Roundtable Discussion video |
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| Alternative Approaches to Nosology and Diagnosis of Neuropathic Pain: Perspective of a Neurologist | J Serra slides video |
| Regulatory Concepts of NP: An EU Perspective | C Sampaio slides video |
| Roundtable Discussion video |
|
| Closing Remarks | L Alphs video |
| Adjourn | |
2009 National Mental Health Research-to-Policy Forum
Wednesday, May 21st, 2014Interface of Mental Health Research and Policy in the Era of National Health Reform
(click presenter name to access slides)
Welcoming Remarks
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Introduction to the 2009 National Mental Health Research-to-Policy Forum
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Which Outcomes Matter: Apprasing the Infrastructure for Mental Health Policy Network
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Wiser Not Well: The Influence of Research on Mental Health Policy
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Capabilities and Unmet Needs for Conducting Mental Health Policy Research: Raising the Bar For Scientific Investment from Treatment Outcomes to Public Health Impact
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A CALL TO ACTION
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Mental Health Policy in the Era of National Health Reform
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ADDRESSING THE FUTURE: What Do Health Policy Decision Makers Need from Mental Health Policy Researchers?
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| PERSPECTIVES |
Stepping Into the Data Gap: NAMI’s Grading the States
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Synthesis and Comment
|
| * Slides not released |
2008 Autumn Conference
Wednesday, May 21st, 2014
Related Publications |
|
| M Heo, AC Leon Trial designs likely to meet valid long-term Alzheimer’s disease progression effects: learning from the past, preparing for the future Journal of Biopharmaceutical Statistics. 2010 Jul;20(4):787-802.PMID: 20496206 |
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Day 1 (6 October 2008) |
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| President’s Welcome | G Gharabawi video |
| SESSION I: Current Understanding of Disease Progression in Alzheimer’s Disease | Chair: R Mohs Co-chair: G Grossberg |
| Introduction and Objectives | R Mohs slides |
| Understanding Disease Progression in Alzheimer’s Disease | H Feldman* |
| Long-Term Studies in Patients with AD: Do Currently Completed Long-Term Studies in AD Provide Evidence of a Disease Progression Effect? | M Sano slides video |
| SESSION II: Imaging, CSF and Plasma Biomarkers: Their Role in Alzheimer’s Disease | Chair: S Potkin slides videoCo-chair: G Small |
| Process of Amyloid Aggregation: What’s Toxic? | C Glabe slides video |
| Amyloid Imaging Markers for Monitoring Clinical Trials | G Small slides video |
| Qualification of the Analytical and Clinical Performance of CSF Biomarkers for Use in the ADNI Study | L Shaw slidesvideo |
| Structural and Functional Imaging as Biomarkers: Tools for Proof of Concept, Trials and Gene Discovery | S Potkin slides video |
| Genetics of Alzheimer’s Disease: How will we use genetic information to develop therapies? | J Hardy slides video |
| Panel Discussion: The Role Of Biomarkers and Genetics in the Future Diagnosis and Treatment of Alzheimer’s Disease | video S Potkin G Small J Hardy L Shaw |
| SESSION III: Trial Designs Likely to Meet Valid Long-Term Disease Progression Effect: Learning from the Past, Preparing tor the Future | Chair: R Anand Co-chair: S Romano |
| Introduction and Objectives | G Grossberg slides |
| The Use of MRI to Measure Degeneration and Progression: Lessons Learned from MS | D Arnold slides video |
| An Industry Viewpoint on Clinical Trials Designs for Disease Modification in Alzheimer’s Disease: Challenges | S Romano slides video |
| An Industry Viewpoint on Clinical Trials Designed for Demonstrating Disease Progression in Alzheimer’s Disease: Current Approaches | M Ryan slides video |
| An Academic Viewpoint on Clinical Trial Designs for Disease Modification in Alzheimer’s Disease: Challenges | R Bullock slides video |
| Panel and Audience Discussion | video R Anand M Ryan D Streiner S Romano R Bullock |
Day 2 (7 October 2008) |
|
| SESSION IV: Clinical Endpoints in Alzheimer’s Disease Progression | Chair: G Gharabawi Co-chair: P Tariot |
| Introduction and Objectives | G Gharabawi |
| Clinical Endpoints in Long-Term Studies in AD: Cognition | L Schneider* |
| Clinical Endpoints in Long-Term Studies in AD: Behavior | P Tariot video |
| Clinical Endpoints in Long-Term Studies in AD: Daily Functioning | C Petrie slides video |
| Panel and Audience Discussion | video L Schneider P Tariot G Gharabawi |
| SESSION V: Regulatory Views on Trial Designs Likely to Meet Valid Long-Term Disease Progression Effect | Chair: R Anand Co-chair: H Feldman |
| Dementia: A European Regulatory Perspective – Challenges, Opportunities, Requirements | K Broich slides video |
| Establishing Claims for Long Term Therapeutic Benefit for Alzheimer’s Disease, Including Disease Progression: A US Regulatory Perspective | R Mani slides video |
| Establishing Claims for Long Term Therapeutic Benefit for Treatment of Alzheimer’s Disease, Including Disease Progression: A European Academic Regulatory Reviewer’s Perspective | C Sampaio slides video |
| Panel Discussion | video R Anand H Feldman K Broich R Mani C Sampaio |
| SESSION VI: Statistical and Outcomes Issues in Alzheimer’s Disease Progression Trials | Chair: A Leon slides videoCo-chair: D Streiner |
| From Symptomatic Effect to Disease Modifying Effect: A Statistical Methodology Overview in Alzheimer’s Disease Trials | R Zhang slides video |
| The Design and Analysis of Alzheimer’s Disease Trials with a Delayed Start Period | G Sethuraman slides video |
| Panel and Audience Discussion | video R. Zhang G. Sethuraman A. Leon D. Streiner |
| SESSION VII: Payers/Policy Issues in Alzheimer’s Disease Progression Trials | Chair: G Gharabawi Co-chair: L Jonsson |
| Payers Perspective on Results of Clinical Trials in Alzheimer’s Disease | L Jonsson slides video |
| US Perspective on Alzheimer’s Disease Outcomes Measurement | L Frank slides video |
| Panel and Audience Discussion | video L Jonsson L Frank R Anand C Petrie |
| Summary of Meeting | G Gharabawi |
| Adjourn | |
| * Presentation materials have not as yet been released for publication in this forum. | |
5th Annual Scientific Meeting
Tuesday, May 20th, 2014
Poster Awardees |
||
| “Knowing When a Drug is Not Going to Work in Bipolar Depression”: Absence of Early Improvement as a Predictor of Later Non-Response in 3,369 Patients From 10 Placebo-Controlled Acute Trials J Calabrese |
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| Regional and Temporal Differences in Use of Doctorate Level MADRS Raters in Bipolar Depression Trials D Daniel |
||
Related Publications |
||
|
AC Leon |
||
Day 1 (3 March 2009) |
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| President’s Welcome | G Gharabawi slides |
|
| SESSION 1: Development of Treatments for Bipolar Depression SUMMARY OF SESSION |
Chairs: R Baldessarini E Vieta |
|
| Introduction and Objectives | E Vieta | |
| Bipolar Versus Unipolar Depression | R Baldessarini slides video |
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| Challenges to Design of Treatment Trials for Bipolar Depression: An International Perspective | E Vieta slides video |
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| Methodological Challenges in Short-term Treatment Trials for Bipolar Depression | M Tohen slides video |
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| Methodological Challenges in Long-term Treatment Trials for Bipolar Depression | J Calabrese slides video |
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| Panel and General Discussion: Treatment Trials for Bipolar Depression | C Bowden slides video |
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| Session Discussion – Q&A | video |
|
Day 2 (4 March 2009) |
||
| SESSION 2: Improving Methodology of RCTs for PTSD SUMMARY OF SESSION |
Chairs: A Leon L Davis |
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| Introduction to Session | L Davis video |
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| National Priorities for PTSD RCT Research | T O’Leary slides video |
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| Consideration of PTSD Nosology and Pathophysiology in Targeting the Study Population, Intervention, and Outcomes | L Davis slides video |
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| Psychotherapy Methodological Issues: Choice of Comparison Group | A Suris slides video |
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| Methodology for Evaluating Moderators of PTSD Treatment | A Leon slides video |
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| Methodological Challenges for Secondary Prevention Trials in PTSD | T Neylan slides video |
|
| Session Discussion – Q&A | video |
|
| SESSION 3: Recent FDA Decisions on Approval of Antipsychotics: A Redefinition of Risk – Benefit Assessment? SUMMARY OF SESSION |
Chairs: L Alphs R Anand |
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| Introduction: Objectives of Session | R Anand* |
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| Active Controls in Antipsychotic Trials: Why Have Them? | A Kalali slides video |
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| The Role of Active Controls for Risk-Benefit Analysis in Antipsychotic Clinical Trials: Clinical/Academic Considerations | J Lieberman slides video |
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| Discussion video |
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| Challenges and Implications of Use of Active Controls in Risk-Benefit Analysis in CNS Clinical Development Programs: An Industry Perspective | L Alphs slides video |
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| Implications of Use of Active Controls in Risk-Benefit Analysis in CNS Clinical Development Programs: Statistical Considerations | A Leon slides video |
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| Regulatory Policy Considerations on Risk-Benefit Assessment in CNS Clinical Trials and Benefit Challenges Identified in Recent New Drug Applications for Antipsychotic Drugs | T Laughren* |
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| Requirements on Medicinal Products in the Treatment of Schizophrenia – European Perspective | K Broich slides video |
|
| Summary | R Anand | |
| Poster Session | View All Poster Abstracts | |
Day 3 (5 March 2009) |
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| Welcome from ASENT and ISCTM Presidents video |
R Porter L Alphs |
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| SESSION 4: Methodological Issues in Examining Cognition Across the CNS Spectrum SUMMARY OF SESSION |
Chairs: R Keefe S Rao |
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| Introduction: Cognition as an Under-Explored Aspect of Multiple Disorders | R Keefe slides video
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| Cognitive Profiles, Assessment Challenges, and Efforts Towards Advancement in Selected Example Disorders | ||
| Schizophrenia: MATRICS and Beyond | M Green slides video |
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| Multiple Sclerosis: Psychometric Considerations and Consensus Standards | R Benedict slides video |
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| Epilepsy: Cognitive and Behavioral Endpoints as Primary Outcome Variables | D Loring slides video |
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| Bipolar Disorder: Application of Cognitive Assessment Methods | K Burdick slides video |
|
| Structured Discussion | ||
| Regulatory Perspective: Neurological Conditions | R Katz | |
| Regulatory Perspective: Psychiatric Conditions | T Laughren | |
| Panel | R Benedict K Burdick M Green R Katz R Keefe T Laughren D Loring G Tucker |
|
| Summary and Recommendations | R Keefe S Rao |
|
| SESSION 5: Methodological Issues In Traumatic Brain Injury SUMMARY OF SESSION |
Chairs: A Faden slides videoT Macek |
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| Characterization and Changes in Civilian Populations | M Lovell slides video |
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| Characterization and Challenges in Military Populations | ||
| Studies of Acute mTBI in the Combat Arena | M Jaffee slides video |
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| Studies of Chronic Problems After mTBI | K Schwab slides video |
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| Methodological Issues and Translational Research in TBI | ||
| Mechanisms of Mild TBI | D Smith slides video |
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| Methodological Problems in TBI Trials | R Bullock slides video |
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| Discussion – Q&A video Discussion – Q&A (continued) video |
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| Summary | T Macek | |
| Dinner Symposium: Resource Allocation in Translational Neuroscience: Perspectives on Influencing the Pipeline | Chairs: R Ferziger K Clarence-Smith |
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| Tom Insel, MD, NIMH slides |
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| Janet Vergis, Janssen, A Division of Ortho-McNeil Janssen Pharmaceuticals slides |
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| Jonathan Fleming, Oxford Biosciences slides |
||
| Adjourn | ||
| * Presentation materials have not as yet been released for publication in this forum. | ||
2009 Autumn Conference
Tuesday, May 20th, 2014
Poster Awardees |
|
| Test-Retest Characteristics of the MATRICS Consensus Cognitive Battery in a 29-Site Schizophrenia Clinical Trial of Lurasidone Versus Risperidone K Fox |
|
| Differential Response to Treatment Across Countries in a Randomized Clinical Trial of Ziprasidone and Haloperidol in Patients With Bipolar Mania E Vieta |
|
Related Publications |
|
| Y Ando, A Hirakawa, Y Uyama Adaptive clinical trials for new drug applications in Japan European Neuropsychopharmacology: February 2011 (Volume 21, Issue 2)
V Dragalin T Park S Wang, J Wang, R O’Neill J Severe |
|
Day 1 (5 October 2009) |
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| SESSION 1: Adaptive Design for CNS Trials | Chairs: A Leon D Berry |
| President’s Welcome Overview, Rationale and Objectives of Session 1 |
L Alphs A Leon slides video |
| An Introduction to Adaptive Design and Adaptation | V Dragalin slides video |
| Adaptive Design Approaches in CNS Clinical Trials – A US Regulatory/Scientific Perspective | HM Hung SJ Wang video |
| Bayesian Adaptive Trials and How Such Designs Can Best Be Used in CNS Trials | D Berry slides video |
| Challenges and Solutions for Implementing Adaptive Design | T Parke slides video |
| Practical Considerations in Designing and Executing Early Phase Adaptive Trials: An Industry Perspective | R Lenz slides video |
| Session Discussion – Q&A | |
| Update on FDA Guidance for Adaptive Design* | SJ Wang |
| Update on EU Guidance for Adaptive Design | A Koch slides video |
| Regulatory Issues Related to Use of Adaptive Design in Japan | Y Ando slides video |
| Discussion Panel | A Leon Y Ando HM Hung A Koch SJ Wang video |
| Case Study 1 Facilitators: V Dragalin, T Parke, C Mallinckrodt slides |
D Berry R Lenz |
| Case Study 2 Facilitators: P Lim, V Sutton, Y Ando, G Sachs |
W Olson slides |
| Poster Session | View All Poster Abstracts |
Day 2 (6 October 2009) |
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| SESSION 2: Workshops |
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| Introduction | |
| Sources And Management of Placebo Effects in CNS Clinical Trials Plenary Session SUMMARY |
Chairs: A Kalali C Bowden slides slides |
| Assessing and Methodologies for Treating Suicidality in Trials with CNS Drugs Plenary Session |
Chairs: W Goodman L Greenhill slides video |
| Methodological Issues for Studying Negative Symptoms of Schizophrenia Plenary Session |
Chairs: S Marder D Daniel video |
| Challenges in Conducting Multi-Center Academic Trials Plenary Session |
Chairs: N Schooler J Severe slides video |
| SESSION 3: Preparing for Medicine of the Future: Personalized Medicine: Its Opportunities/Challenges and How to Meet Them |
Chairs: L Alphs G Garibaldi |
| Introduction | G. Garibaldi slides video |
| Personalized Medicine in the Age of Genomics | S Potkin slides video |
| Optimizing the Approach to Personalized Medication: Selection of Indications, Study Populations and Endpoints | D Feltner slides video |
| Design and Statistical Challenges for Personalized Medicine and How to Meet Them | N Schork slides video |
| Identifying and Meeting Regulatory Challenges for Indications in Personalized Medicine (Materials submitted, but not presented) |
K Broich slides |
| Session Summary | L Alphs slides video |
| Adjourn | |
| * Presentation materials have not as yet been released for publication in this forum. | |
6th Annual Scientific Meeting
Tuesday, May 20th, 2014
Poster Awardees |
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| Do Recruitment Sources Impact Study Outcome: Assessment by Computer and Site-Based Raters B Kasuba, S Edman |
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| “Reporting Adverse Event Data From Clinical Trials of Antipsychotic Agents” I Turkoz |
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| Placebo Response Assessed by Site and Blinded Remote Centralized Raters in a GAD Trial J Williams |
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| All poster abstracts are available for public viewing. Link found at end of Day 1. | ||
Day 1 (22 February 2010) |
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| President’s Welcome | L Alphs | |
| SESSION 1: New Approaches to Assessing the Safety of Marketed Drugs – FDA, Industry and Academic Perspectives
|
Chairs:
S Marder |
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| Approaches to Safety Assessment: A Pharmacoepidemiological Perspective | P Wang* | |
| Current Approaches to Pharmaceutical Benefit-Risk Assessment | B Levitan | |
| Approaches to Marketing Medical Product Safety Assessment: An FDA Perspective | A McMahon (Racoosin) | |
| Panel and General Discussion | C Bowden
|
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| SESSION 2: Translational and Cultural Adaptation of Key Outcome Measures in International CNS Trials
|
Chairs:
A Kalali |
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| The Current Reality of Outcome Measures in International Clinical Trials: Should We Be Doing Things Differently? | A Kalali | |
| Challenges and Best Practices in Training and Monitoring Measurement of Psychopathology in Linguistically and Culturally Diverse Settings | D Daniel
|
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| Translating and Implementing Measures of Neurocognition in Eastern Europe and Asia | R Keefe | |
| Cultural Considerations of Functional Outcomes in Chinese and Other Cultures | P Harvey
|
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| Cultural Aspects of Outcome Measures – European and US Regulatory Viewpoints | K Broich
T Laughren
|
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| Discussant | R Anand | |
| Poster Session | View All Poster Abstracts
|
|
Day 2 (23 February 2010) |
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| ISCTM 2010 National Mental Health Research-to-Policy Forum: The Role of Comparative Effectiveness Research in Future Mental Health Policy Decision Making
|
Chairs:
R Ferziger |
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| SESSION 3a: The Role of CER in Future Mental Health Policy Decision Making | Chair:
D Steinwachs |
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| CER 2010: Overview and Critical Review of the Current Science and Politics of Comparative Effectiveness | B Luce | |
| Keynote Address: The Role of CER in Future Mental Health Policy Decision Making | M Rawlins | |
| Discussant | J Slutsky
|
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| Panel Discussion | M Schoenbaum D Shern |
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| Relating the Science of CER to Mental Health Policy and Clinical Care
|
Chair:
B Druss |
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| Locations, Populations and the Generalizability of Data for Policy Decisions in Mental Health | R Frank* | |
| Discussant | M Rawlins
|
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| Panel Discussion | J Parks K Broich D Jarvis |
|
| Hitchhikers Guide to System Comparative Effectiveness | S Leff
|
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| Panel Discussion | video
|
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| SESSION 3b: Comparative Effectiveness Trials in CNS Disorders: Rationale, Elements and Challenges | Chairs:
N Schooler |
|
| What Constitutes Comparative Effectiveness Research? NIH and Inferential Perspectives | C Bowden | |
| Key Issues in CER for Design and Analysis | T Ten Have | |
| Goals and Strategies of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Initiative | B Heinssen
|
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| The NIMH RAISE Initiative. Two Parallel Approaches to a CER Question: | ||
| Case Study I | N Schooler
|
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| Case Study II | L Dixon
(H Goldman) |
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| Academic Discussant | D Meltzer | |
| NICE Discussant | M Rawlins | |
| Panel and Participants Discussion | ||
| Summary | ||
| Dinner Symposium: Industry/Academic Relationships: Continuing Collaboration in an Era of Evolving Standards | Chairs:
R Keefe |
|
| Principled Research in the Face of Conflicts of Interest | R McKinney | |
Day 3 (24 February 2010) |
||
| SESSION 4: Clinical Trials in the Prodromal Phase of Alzheimer’s Disease-Methodological Challenges and Clinical Outcomes
|
Chairs:
G Garibaldi M Davidson |
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| Challenges Faced when Identifying and Providing Prodromal Disease treatments: The Problems of Preserving Wellness | M Davidson | |
| Keynote Address: “Antecedent Biomarkers in Prodromal Alzheimer’s Disease – Now is the Time” | J Morris | |
| Clinical Correlations with Postmortem Findings: Clues to Identifying the Prodrome for AD-Age Matters | V Haroutunian | |
| How Recent Developments in Biomarkers Have Changed Clinical Trials Design-from the Perspective of the Trialist | R Schindler
|
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| Neuroroimaging as a Marker for Prodromal Treatment: Evidence, Value and Limitations | M Cantillon*
|
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| Clinical Trials in Prodromal AD: An Industry Viewpoint | R Anand
|
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| Prodromal Alzheimer’s Disease-EU Regulatory Point of View | K Broich | |
| Roundtable Discussion | video |
|
| Adjourn | ||
| * Presentation materials have not been released for posting. | ||
2010 Autumn Conference
Tuesday, May 20th, 2014
Poster Awardees: |
||
| Randomization Strategies for Clustered Clinical Syndromes: Effects on Statistical Power B Lebowitz, Y Wang, N Duan, CF Reynolds III, NM Simon, S Zisook, MK Shear |
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| Reconsidering the Criterion for Excluding Comorbid Substance Use Disorders from Clinical Trials for the Treatment of Depression L Davis |
||
| Methodological Challenges of Demonstrating Cognitive Improvements with Broad Spectrum Agents: A Novel Approach Y Geffen, M Davidson, M Hufford, RM Gendreau, S Rao, R.Zablocki, J Kranzler |
||
Day 1 (13 October 2010) |
||
| President’s Welcome | L Alphs slides video |
|
| S1: MATRICS Update and Beyond | Chairs: S Marder M Egan |
|
| Introduction | S Marder slides video |
|
| The MATRICS Approach to Measuring Cognition: Foundational Issues and Critical Decisions | M Green slides |
|
| Real-World Application of the MATRICS Consensus Cognitive Battery (MCCB) in Multisite Clinical Trials | R Keefe slides video |
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| Assessment of Functional Outcomes | D Velligan slides video |
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| Challenges in Drug Development for Cognitive Impairment Associated with Schizophrenia | M Egan* |
|
| Cognition in Schizophrenia: New Directions in Clinical Trials at NIMH | B Cuthbert slides |
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| Bridging the Gaps Between Animal Models, Human Neuroscience and Schizophrenia Clinical Trials: Rational Enhancement of Signal Detection | J Sweeney slides |
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| Cognitive Remediation as a Platform for Clinical Trials of Cognitive Enhancing Drugs in Schizophrenia | A Reichenberg slides |
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| Cognitive Assessment for Schizophrenia Clinical Trials in the Post-MATRICS Era | R Bilder slides |
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| Standardized Approach to Clinical Trials: Risks, Benefits, and a Working Model | S Koslow slides |
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| Exemplar Applications and Results From BRAINnet: What Are The Implications for Understanding, Modeling, Diagnosing and Treating Brain Disorders? | S Silverstein slides |
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| Regulatory Perspective MATRICS and Beyond: US Perspective | T Laughren video |
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| Regulatory Perspective MATRICS and Beyond: European Perspective | K Broich slides video |
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| Panel Discussion | Chair: M Egan videoPanelists: K Broich T Laughren R Keefe video |
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| Summary | S Marder video |
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| Poster Session | View All Poster Abstracts | |
Day 2 (14 October 2010) |
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| S2: Concurrent Workshops | ||
| Sources And Management Of Placebo Effects In CNS Clinical Trials | A Kalali L Ereshefsky slides (summary) |
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| Methodological Issues for Studying Negative Symptoms of Schizophrenia | S Marder D Daniel video |
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| Health Information Technology and Electronic Medical Records: What Are the Scientific and Policy Priorities for the Field of CNS Clinical Research? | J Davis R Ferziger |
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| Questionable Data: Recognition and Resolution | G Sachs J Severe slides (Colton) slides (summary) video |
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| Mitochondrial Systems as Targets for Development of Novel Pharmacological Interventions for CNS Disorders Session Summary |
C Bowden A Nierenberg slides (summary) |
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| Suicidality Assessment in Clinical Trials: Methodological and Technical Challenges | A Butler M Stewart slide (Mathis) slides (summary) |
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| Session 3: DSM-5: Implications for Clinical Trials | Chairs: N Schooler R Hirschfeld |
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| Introduction | N Schooler video |
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| Implications of DSM-5 Mood Disorders for Future Treatment Efficacy Trials | J Fawcett slides video |
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| Schizophrenia and Psychotic Disorders in DSM-5 | J Bustillo slides |
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| Regulatory Perspectives from FDA and EMEA | M Mathis slides K Broich slides |
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| Public Perspective | J McNulty video |
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| General Discussion | R Hirschfeld | |
| Meeting Adjourns | ||
| * Materials have not been released. | ||
7th Annual Scientific Meeting
Tuesday, May 20th, 2014
Poster Awardees |
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| The Virtual Reality Functional Capacity Assessment Tool (VRFCAT): A New Co-Primary Cognitive Measure for Schizophrenia Drug Trials K Fox, S Ruse, V Davis, R Pietrobon, P Harvey, R Krishnan, R Keefe |
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| Neurocognitive Performance and Self-Reported Sedation Following Administration of Lorazepam J Yen-Revollo, ABoyd, D Morgan, D Loring, K Meador |
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| All poster abstracts are available for public viewing. Link found at end of Day 2 | ||
Day 1 (21 February 2011) |
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| President’s Welcome | L Alphs slides video |
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| SESSION 1: Do Clinical Results to Date Suggest that Drug Development Based on the Amyloid Hypothesis of Alzheimer’s Disease Is Dead? SESSION SUMMARY |
Chairs: R Anand L Ereshefsky D Feltner |
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| Introduction | L Ereshefsky slides R Anand L Ereshefsky video |
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| The Amyloid Hypothesis of AD: A Critical Reappraisal of its Origin and Genetic Basis | R Anand slides |
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| Pre-clinical Models of Alzheimer’s Disease: Does the Evidence Predict Success of Aß Modifying Therapies | F LaFerla slides video not released |
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| Progress in biomarker research in AD: Summary of findings from ADNI initiative | H Soares slides video |
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| Overview of Recent Clinical Trials: Ways Forward | L Schneider materials not released |
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| Unexpected Results from A Γ-Secretase Inhibitor for Alzheimer’s Disease: Implications for The Amyloid Hypothesis | D Henley slides video |
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| Panel | video |
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| Designing the Next Generation of Disease – Modifying Trials In AD ‐ Moving Forward | G Grossberg slides video |
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| Under What Circumstances Would a Biomarker/Surrogate Measure be Accepted as a Primary Efficacy Variable? | R Katz slides video |
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| What is Required to Accept a Biomarker as Primary Outcome Measure – an EU Regulatory Perspective | K Broich slides video |
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| Panel | video R Anand K Broich L Ereshefsky G Grossberg R Katz F LaFerla L Schneider |
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| Working Group Dinner Sessions | ||
| WG1: Adaptive Design | ||
| WG2: Suicidal Thinking and Behavior Assessment | Summary | |
| WG3: Placebo | ||
| WG4: Mitochondrial Systems | Summary | |
| WG5: Negative Symtoms | Summary | |
| WG6: Biomarkers | ||
Day 2 (22 February 2011) |
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| 2011 ISCTM National Mental Health Research-to-Policy Forum Impact of National Health Reform and Shifting National Priorities on Mental Health Research-to-Policy-to-Implementation |
R Ferziger R Manderscheid |
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| Welcome, Introductions, Goals Setting the Context for the Forum and for Policy |
R Ferziger slides R Manderscheid slidesFerziger/Manderscheid video |
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| From Research to Policy (and Back Again): The View from NIMH | T Insel slides video |
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| Research: A Matter of Mission (One Federal Agency’s Story) | C Curie slides video |
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| Panel (Panel discussion is located at the end of the Curie video) |
A Basu R Mahmoud E Sorel L Ostrow |
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| Audience Discussion | ||
| Aligning Information with Decision Making | A Basu slides video |
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| The Future of Privately Funded CNS Clinical Research | R Mahmoud slides video |
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| The Future of Privately Funded CNS Clinical Research | E Sorel no slides presented |
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| Peer-Run and Delivered Mental Health Services | L Ostrow slides video |
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| Panel/Audience Discussion | video |
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| SESSION 2: Class Labeling: Implications for Treatment and Challenges to Differentiation in Development | S Romano S Potkin |
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| Introductory Comments and Problem Statement | S Romano | |
| Industry Perspective on Class Labeling: Opportunities and Challenges (video contains Romano Introductory Comments / Problem Statement and Industry Perspective) |
S Romano slides video |
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| Class Labeling for Psychiatric Drugs: Academic Perspective | S Potkin slides video |
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| The Adequacy of Class Label Communication | B Fischhoff slides video |
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| Effect of Class Labeling on CT Safety Parameter Assessments, Inclusion/Exclusion Criteria, General Trial Conduct | Facilitated Panel | |
| Class Labeling for Psychiatric Drugs: FDA Perspective | T Laughren slides video |
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| Class Labeling Implications for Treatment and Challenges to Differentiation in Development: Regulatory Viewpoints | K Broich slides video |
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| Implications for Developing New Treatments and Post-Approval Data Requirements | Facilitated Panel video |
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| Poster Session | View All Poster Abstracts | |
Day 3 (23 February 2011) |
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| SESSION 3: Developing Products for Personalized Medicine: Facing the Challenges of Biomarkers | L Alphs K Broich |
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| Welcome and Introduction | K Broich video |
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| The Opportunities and Challenges of Biomarkers: A View from the FDA | J Woodcock no slides presented |
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| Short and Long-term Vision for Biomarkers | L Alphs slides video |
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| Challenges for Biomarker Discovery: Psychiatric Disorders – An NIMH Perspective | L Brady slides video not released |
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| Clinical Development of Biomarkers: Lessons Learned in CVD – An Industry Perspective | J Creeden slides video |
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| Biomarkers as Tools for Clinical Development Expectations, Opportunities and Challenges: A Payer Perspective | R Epstein slides video |
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| A Regulatory Perspective on Biomarkers in Psychiatric Drug Development: An FDA Perspective | T Laughren slides video |
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| Biomarkers as Tools for Clinical Development: Emphasis on Safety: An EU Perspective | K Broich slides video |
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| Biomarker Qualification: What it means, What it is for, What it is Not | M Walton slides video |
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| ADNI Case Study: EU Experience and Views | H Hampel slides video |
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| Workshop Report Back & Critique Panel | video R Epstein T Laughren K Broich R Anand E Petkova |
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| Breakout 1 Leaders: Bowden/Walton/Brady |
Presentation slides |
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| Breakout 2 Leaders: Garibaldi/Haynes/Lebowitz |
Presentation no slides presented |
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| Breakout 3 Leaders: Leon/Meltzer/Messina |
Presentation slides |
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| Breakout 4 Leaders: Cantillon/Marshall/Ereshefsky |
Presentation slides |
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| Final Discussion and Summary | ||
| Meeting Adjourns | ||
| * Materials have not been released. | ||
2011 Autumn Conference
Tuesday, May 20th, 2014
Poster Awardee: |
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| Detecting Antidepressant Efficacy: The Impact of Study Design and the Value of Academic Sites BW Dunlop, ME Thase, C Wun, R Fayyad, C Guico-Pabia, J.Musgnung, PT Ninan |
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| All poster abstracts are available for public viewing. Link found at end of Day 1 | ||
Day 1 (3 October 2011) |
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| President’s Welcome | L Alphs slides video |
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| Session 1: Meta Analysis: Methods and Applications to Policy | Chairs: A Leon V Haynes SESSION SUMMARY |
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| Frequentist Methods of Meta Analysis | M Borenstein slides video |
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| Bayesian Methods and Meta Analysis | J Seaman slides video |
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| “Proof” in Medicine: The Role of Research Synthesis | J Greenhouse slides video |
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| Impact of Meta Analysis for Policy Decisions About Reimbursement – Payer Perspective | R Robinson-Beale slides video |
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| Discussant | J Davis | |
| Comments and Panel Discussion | video |
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| Session 2: Concurrent Workshops | ||
| WS1: How Can Large Registries Contribute to the Development and Evaluation of CNS Therapeutics? |
J Severe A Stemhagen Plenary Report slides Plenary Report video |
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| WS2: Evaluating Biomarkers for Schizophrenia: Issues in Identification, Categorization and Evaluation |
N Chen
S De Santi
S Potkin
H Riordan
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| WS3: Assessing Assessment Methodologies: Weighing Choices Based on Indications, Study Design and Needs |
M Davidson
M Detke
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| WS4: Suicidal Ideation and Behavior Assessment: Implementation in Clinical Trials |
A Butler
M Stewart
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| WS5: Adaptive Design in CNS Trials |
V Dragalin
J Pinheiro
V Haynes
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| Plenary Workshop Reports | ||
| Poster Session | View All Poster Abstracts | |
Day 2 (4 October 2011) |
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| Session 3: Beyond Insomnia: Issues in Non-restorative Sleep | Chairs: T Macek T Roth |
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| An Overview of Non-restorative Sleep | T Roth slides video |
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| Measuring Non-restorative Sleep | R Morlock slides video |
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| Issues in Conducting Trials in Non-restorative Sleep | V Pitman slides video |
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| Regulatory Perspectives on Non-restorative Sleep | R Katz slides video K Broich slides video adjunct document |
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| Session 4: Clinical Trials for Alcohol Dependence: The Alcohol Clinical Trials Initiative (ACTIVE) and Beyond | Chairs: N Schooler R Anton |
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| Rationale and Development of the ACTIVE Workgroup | R Anton slides video |
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| Evolution of FDA Approach to Clinical Trials for Alcohol Treatment Drugs | C Winchell slides video |
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| Outcomes and Endpoints in European Clinical Trials for Alcohol Dependence – Focus on Harm Reduction | K Broich slides video adjunct document |
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| Challenges to Industry in the Development of Pharmacological Therapies for the Treatment of Alcohol Abuse and Dependence | J Palumbo slides video |
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| Novel Reanalyses of Alcohol Treatment Endpoints in US Clinical Trials to Inform Methodologies | R Litten slides video |
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| Comments and Panel Discussion | R Meyer slides video |
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| Panel and Audience Discussion | video |
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| Meeting Adjourns | ||