8th Annual Scientific Meeting
Tuesday, May 20th, 2014The 8th Annual Scientific Meeting was dedicated to our dear friend and colleague, Andrew C. Leon.
Poster Awardees: |
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| The Relationship Between Urine Cannabinoid Concentration and Choice Reaction Time in Chronic Marijuana Users Boyd AF, Morgan DW, Goddard SG, Gray KM |
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| Severity Rating in Restless Legs Syndrome: Validation of the RLS-6 Scales Kohnen R |
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| Feasibility of Assessing the Pragmatic vs. Explanatory Design of a Clinical Trial Bossie CA, Hulihan JF, Alphs L |
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| (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 |
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Day 1 (21 February 2012) |
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| 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 |
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| Introduction | Session Chairs slides video |
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| 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 video |
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| Schizophrenia Perspective | R Heinssen slides video |
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| Alzheimer’s Disease Perspective | R Anand slides video |
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| Methodological Challenges | H Kraemer slides video |
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| Part 2: Responses | ||
| Industry Perspective | A Breier slides video |
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| FDA Perspective on Early Treatments and Long-Term Outcomes for Schizophrenia | T Laughren slides video |
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| FDA Perspective on Early Treatments and Long-Term Outcomes for Alzheimer’s Disease | R Katz slides video |
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| Panel Discussion | video |
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| Part 3: Current and Future Research | ||
| Current and Future Trials: Schizophrenia | A Breier slides video |
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| Current and Future Trials: Alzheimer’s Disease | R Anand slidesvideo |
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| Methodology Discussant | H Kraemer slides video |
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| Panel Discussion | video |
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| Summary and Next Steps | R Ferziger R Manderscheid L Ereshefsky |
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| ISCTM 8th Annual Scientific Meeting | ||
| President’s Welcome and Tribute to Andrew C. Leon | L Alphs slides video |
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| Session 1: Augmentation Strategies-Focus on Depression, Methodology and Regulatory Perspective | Chairs: A Kalali J Rasmussen |
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| Introduction | J Rasmussen slides video |
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| Background, Concepts and Definitions | A Kalali slides video |
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| Antidepressant Augmentation: Acceleration and Enhancement Strategies | S Kennedy slides video |
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| Current Example 1: Case Study – Add-On Trials in Depression | G Dunbar slides video |
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| Current Example 2: Focus on Depression Methodology and Regulatory Perspective | J Youakim slides video |
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| Current Example 3: Early Onset of Response in Treating MDD | E Buntinx slides video |
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| Panel Discussion | video |
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| Regulatory Forum | ||
| FDA | T Laughren slides video |
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| EMA | K Broich slides video |
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| Regulatory Panel Discussion | video |
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| Focused Panel Discussion | video |
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| 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) |
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| Working Group 1 Report Back: Adaptive Design – Haynes (Presented by Ginger Haynes) | slides video |
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| Working Group 2 Report Back: Biomarkers – Riordan (Presented by Hank Riordan) | slides video SUMMARY |
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| Working Group 3 Report Back: Negative Symptoms – Marder/Daniel (Presented by Stephen Marder) | slides video SUMMARY |
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| Working Group 4 Report Back: Suicidal Ideation and Behavior Assessment -Butler/Stewart (Presented by Adam Butler) | slides video |
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| Working Group 5 Report Back: Signal Detection – Kalali/Ereshefsky (Presented by Amir Kalali) | slides video |
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| Working Group 6 Report Back: Assessing Abuse Liability Potential – Klein, Ammann, Martynowicz (Presented by Marta Sokoloska) | slides video |
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| Working Group 7 Report Back: Metric-Based Measurement to Assess Cognitive Outcome in AD Trials? Posner/Harvey (Presented by Holly Posner) |
slides video SUMMARY |
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| SESSION 3: Defining Clinically Meaningful Effect for the Design and Interpretation of RCTs | Chairs: R Keefe AC Leon |
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| Introduction and Objectives | R Keefe slides video |
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| Consumer Perspective | J McNulty (presented by R Keefe) slides video |
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| Payer Perspective | R Epstein slides video |
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| Health Care Economist Perspective | S Reed slides video |
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| Investor Perspective | J Sanchez slides video |
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| Regulatory Perspective and Discussion Panel | T Laughren slides video K Broich slides |
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| The Special Case of Clinically Meaningful Similarity | AC Leon (presented by G Haynes) slides video |
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| Determining How Effective a Treatment Will Be for an Individual Patient | H Kraemer slides video |
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| How to Determine Benefit in a Clinical Trial (Incorporating Risk and Benefit) | E Frank slides video References (referenced by Kraemer and Frank) |
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| Comments (Davis) followed by Focused Discussion Panel | K Davis S Romano H Kraemer E Frank R Keefe video |
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| Joint Poster Session / Reception with ASENT | View All Poster Abstracts | |
Day 3 (23 February 2012) |
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| ISCTM / ASENT Joint Scientific Session | ||
| Welcome from ISCTM and ASENT Presidents | R Keefe R Hamill |
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| 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 |
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| Session Objectives | A Mahableshwarkar slides |
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| New Treatments for Neurodevelopmental Disorders | T Insel (presented by J March) slides video |
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| Therapeutics and the Developing Nervous System: Epilepsy as a Model | G Holmes slides video |
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| Experimental Medicines Development in Children and Adolescents | J March slides video |
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| Panel Discussion | video |
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| 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 video |
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| Panel Discussion | video |
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| Regulatory Perspective | ||
| US FDA: Pharmaceutical | T Farchione slides video |
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| US FDA: Devices | K Bowsher slides video |
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| PMDA | Y Uyama slides video |
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| EMA | K Broich slides video |
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| Panel Discussion | video |
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| 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 video |
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| Animal Models For Diseases, Drugs and Devices (Presented by Doug Feltner) |
G Holmes Y Uyama M Walton D Feltner slides video |
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| Pediatric Outcomes and Scales (Presented by J Horrigan) |
J Horrigan Peter Como S Comfort A Mahableshwarkar slides video |
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| IRB and Ethics | J Conry B Karp S Romano B Lavenstein slides video |
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| Summary and Next Steps | S Romano | |
| Meeting Adjourns | ||
| * Materials have not been released. | ||
2012 Autumn Conference
Tuesday, May 20th, 2014
Poster Awardee: |
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| Circadian Rhythms and Cognition: Using Time of Day Effects To Enhance Signal Detection in Clinical Trials of Pro-Cognitive Therapies for Schizophrenia M Hufford, V Davis, N Dgetluck, M Gawryl, D Hilt, A Rappaport, R Keefe |
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| All Poster Abstracts are available at the end of the second day Sample Presentation: Lon Schneider – Link found on Day 3 |
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Day 1 (1 October 2012) |
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| Session 1: Concurrent Workshops | ||
| Adaptive Design | G Haynes T Parke slides audioJ Kando slides audio Report Back |
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| Integrated Imaging and Genetic Biomarkers in Schizophrenia | H Riordan slides S Potkin Report BackSession Summary |
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| Cognitive Assessment in AD | H Posner slides P Harvey slidesT Goldberg slidesV Logovinsky slidesN Raghavan slidesD Mungas slidesS Hendrix slides Report Back |
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| Medication Development for Stimulant Dependence | J Palumbo slides T Kosten slidesT Whitfield slides Report Back |
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| Negative Symptoms | S Marder D Daniel slides Report BackSession Summary |
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| Precision Medicine in CNS Clinical Trials | D Feltner A Power slides Report Back |
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| Psycho-social Treatment Platforms in Psychopharmacology | N Schooler D Velligan slides Report Back |
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| Signal Detection | A Kalali Report Back |
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Day 2 (2 October 2012) |
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| Presidential Welcome | R Keefe slides video |
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| Session 2: Statistical, Clinical, Payer and Regulatory Perspectives on Dimensions that Define the Spectrum of Efficacy/Explanatory and Effectiveness/Pragmatic Trials | Chairs: L Alphs N Schooler G Haynes |
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| Introduction | N Schooler slides video |
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| What are the Major Considerations for Explanatory (efficacy) and Pragmatic (effectiveness) Trials? | G Haynes slides video |
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| Assessing Effectiveness in Naturalistic Data | D Faries slides video |
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| Epidemiologic, Regulatory, and Methological Considerations in the Design of a Trial with Both Pragmatic and Explanatory Features: the InterSePT Experience | R Anand slides video |
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| Combining Medications to Enhance Depression Outcomes (CO-MED): A Clinical Trial that Combined Explanatory and Pragmatic Elements | J Severe slides video |
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| Addressing Explanatory and Pragmatic Endpoints in a Single Trial: PRIDE a Study in Schizophrenic Persons Who Have Been in the Criminal Justice System | L Alphs slide video |
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| Where Did Pragmatic Trials Come From? The Slow Train Coming . . . | C Adams slides video |
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| Pragmatic Studies: Why Do Payers Care? | R Epstein slides video |
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| Where are Pragmatic Trials Going? Keeping the Slow Train on the Tracks | C Adams slides video |
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| US Regulatory Perspective | NA Khin slides |
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| Australian Regulatory Perspective | G McColl slides video |
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| Panel and Audience Discussion | video |
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| Summary | L Alphs video |
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| Session 3: Neurocognition and Social Cognition as Endpoints for Clinical Trials | Chairs: M Green S Marder |
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| Neurocognition and Social Cognition: Overview and Relationships to Outcome | M Green slides video |
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| Evaluating Outcome Measures for Clinical Trials of Social Cognition in Schizophrenia | P Harvey slides video |
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| Experience from Multi-Site Clinical Trials on Neurocognition versus Global Cognition Endpoints | K Nuechterlein slides video |
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| Addressing Challenges in the International Assessment of Social Cognition | G Hellemann slides video |
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| Regulatory Impressions and Discussion | NA Khin | |
| Panel and Audience Discussion | video |
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| Poster Reception | Poster Abstracts | |
Day 3 (3 October 2012) |
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| Parallel Sessions | ||
| Session 4A: Clinical Trials in Autism Spectrum Disorders: Methods, Measurements, Designs, and Outcomes | Chairs: D Feltner J Horrigan |
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| Introduction | D Feltner slides video |
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| The Autism Spectrum: Clinical Features and Targets for Treatment | L Scahill slides video |
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| Practical Issues in the Design and Conduct of Autism Spectrum Disorder Clinical Trials | J Horrigan slides video |
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| Translational Methods for Demonstrating Clinical Efficacy | J Veenstra-VanderWeele slides video |
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| Review of Trial Designs in Past Randomized Controlled Trials in Autism Spectrum Disorders | C Erickson slides video |
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| Methodological Lessons Learned from an Autism Development Program and Approval | L Scahill slides video |
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| Two Industry-Sponsored Clinical Development Programs in Autism Spectrum Disorders | D Umbricht slides video S Graham |
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| Panel and Audience Discussion | ||
| Session 4B: Stratified Medicine and Targeted Clinical Trials for Alzheimer’s Disease Drug Development in Light of Recent Phase III Trial Results: Example ApoE Genotype | Chairs: L Schneider T Goldberg L Ereshefsky SESSION SUMMARY |
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| Introduction and Objectives of Session | Chairs slides |
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| Stratified Medicine for AD Drug Development | M Trusheim slides video |
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| The Impact of ApoE4 Carriage on Clinical Trials | T Goldberg slides |
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| Strategies for the Accelerated Evaluation of Preclinical AD Treatments in ApoE4 and Autosomal Dominant Mutation Carriers | E Reiman slides |
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| Simulating Stratified Medicine Trials in AD | L Schneider slides video |
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| Discussion: What Have We Learned About Stratified Trials and Development Programs? Next Steps and What Can Be Done Now | B Greenberg (Discussant) slides video |
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| Panel and Audience Discussion | video |
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| Meeting Adjourns | ||
11th Annual Scientific Meeting
Thursday, May 15th, 2014
Distinguished Poster Award Recipient: |
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| All Poster PDFs and Abstracts are available at the end of the second day. |
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Day 1 (17 February 2015) |
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| Presidential Welcome | S Romano slides video |
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| 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 |
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| Session Overview | J Severe slides video |
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| Database of Cognitive Training and Remediation Studies (DoCTRS): Goals, Value, Potential | ||
| Trials and Tribulations: Personalizing Cognitive Treatment in Schizophrenia | T Wykes slides video |
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| Hurdles and Solutions Encountered with DoCTRS | S Morris slides video |
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| 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 video |
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| Lessons from the Development and Regulatory Evaluation of a Clinical Trial Simulation Tool for Alzheimer’s Disease | K Romero slides video |
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| Impact of Varying Data Quality on Statistical Analysis of Integrated Datasets | E Andraca-Carrera slides video |
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| Panel Discussion | All Speakers video |
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Working Group Dinners |
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| Assessment of Abuse Liability in Drug Dependent Subjects | Chairs: M Sokolowska B Setnik M Klein Working Group Slides: SchoedelReport Back slides |
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| Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: R Keefe A Kalali Working Group Slides: slidesReport Back slides |
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| Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs | Chairs: J Rabinowitz N Schooler Report Back slides |
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| Behavioral and Psychiatric Symptoms in Dementia | Chairs: L Ereshefsky D Miller L Pani Report Back slides |
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| Biomarkers in Schizophrenia | Chairs: S Potkin D Goff Report Back slides |
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| Cognitive Assessment in AD and Its Precursors | Chairs: H Posner P Harvey Working Group Slides: Cosentino SchneiderReport Back slides |
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| Identifying/Reducing the Effects of Non-Adherence in Clinical Trials | Chairs: T Shiovitz E Bain Report Back slides |
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| Implementing Innovations in CNS Trials | Chairs: G Sachs M Detke Working Group Slides: slides |
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| Suicidal Ideation and Behavior Assessment | Chairs: M Stewart P Chappell L Alphs Working Group Slides: slidesReport Back slides |
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Day 2 (18 February 2015) |
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Parallel Sessions |
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| Session A: Adaptive Design in the Real World: Implications for Neuroscience Clinical Studies | Chairs: J Kando R Marcus |
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| Introduction | J Kando R Marcus slides |
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| Overview of Adaptive Design Methodology | V Dragalin slides video includes session introduction |
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| Review of Obstacles, Barriers, Problems and Logistical Issues with Adaptive Design Studies | J Quinlan slides video |
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| Bayesian Adaptive Trial Design: A New Approach for Phase 2 Clinical Trials in Alzheimer’s Disease | A Satlin slides video |
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| BMS-927711 for the Acute Treatment of Migraine: A Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial | R Marcus slides video |
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| Adaptive Design in Phase 2: Potential Treatment for Insomnia Disorder | M Moline slides video |
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| When is Adaptive Design Useful in Neuroscience | T Parke slides video |
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| Q & A and Panel Mediated Discussion | S J Wang* All Speakers video |
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| 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 |
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| An Overview of the Regulatory Requirements for Assessing the Abuse Potential of CNS Active Drugs in Different Populations | M Klein slides video |
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| Human Abuse Potential Study Design and Interpretation for CNS Active Drugs | M Sokolowska slides video |
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| Statistical Considerations for Human Abuse Potential Studies | L Chen slides video*** |
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| Q & A and Panel Mediated Discussion | S Calderon* P Geoffroy* video |
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| Methodological Approaches to Assess Dependence Potential in Clinical Trials | S Ratcliffe slides video |
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| Evaluation of Dependence and Withdrawal in Clinical Trials and Human Dependence Study – Design and Considerations | A Lerner slides video |
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| 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 video |
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| Q & A and Panel Mediated Discussion | S Butler* video |
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| Presentation of the Andrew C. Leon Distinguished Career Award | R Keefe slides S Romano slides video |
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| Challenges in Developing Therapeutics in Partially Responsive and Treatment Resistant Depression – Where Do We Go From Here? | Chair: H Martynowicz |
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| Introduction to the CHMP MDD Guidance and How the EFPIA Position Was Formulated | H Martynowicz slides video |
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| Clinical Perspective on Conducting Trials in Major Depressive Disorder | J Kent slides video |
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| Clinical Perspective on Conducting TRD Studies | H Eriksson slides video |
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| Regulatory Perspective—CHMP | K Broich slides video |
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| Advancing our Thinking About Partially Responsive MDD and TRD | T Laughren slides video |
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| Panel Discussion | J Kent H Eriksson K Broich T Laughren C Nelson M Mathis video |
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| Poster Session / Reception | Poster PDFs and Abstracts | |
Day 3 (19 February 2015) |
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| TBI Treatment Development | Chairs: G Ling A Faden R Ferziger |
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| Welcome from ISCTM and ASENT Presidents | S Romano H Federoff video |
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| Introduction | A Faden R Ferziger slides video |
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| State of Affairs | ||
| Traumatic Brain Injury State of the State | G Ling slides video*** |
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| State of the Science | ||
| Scientific Opportunities and Key Unknowns in TBI Research | S Hinds slides video*** |
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| TBI: Translational Issues and Opportunities 1 | A Faden slides video |
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| TBI: Translational Issues and Opportunities 2 | J Povlishock slides video |
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| Research at FDA on TBI Pathophysiology and Biomarker Development | C Welle slides video |
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| Discussant | D Hovda* video |
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| State of the Pipeline | ||
| TBI Clinical Trials: Past, Present and Future | D Hack slides video |
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| Reconceptualizing TBI Assessment and Clinical Trial Design | G Manley slides video |
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| Regulatory Perspectives | C Pena* video |
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| Discussant and Moderator | G Ling* video*** |
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| State of Investment What Would it Take to Increase Public-Private Partnership in TBI Treatment Development? |
M Anderson slides M Stebbins S Romano G Ling R Ferziger video |
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| State of Selected Treatment Targets Reports from TBI Treatment Development Working Group Chairs: |
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| Neuroinflammation | D Loane slides video |
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| Biomarkers Development for TBI | G Small slides video D Smith slides video |
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| TBI & Sleep Disorders | M Yochelson** video E Wickwire** video |
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| TBI – Neuropsychiatric Sequelae | L Davis slides video |
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| Post-Traumatic Headache: Opportunities and Challenges for Clinical Trials | J Erickson** video*** |
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| Responses from Experts Panel and Open Discussion | Panel video*** |
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| Meeting Adjourned | ||
| * No slides presented ** Slides not released *** Video not released |
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2013 Autumn Conference
Friday, April 25th, 2014
Poster Awardees |
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| Retrospective Review of Safety and Tolerability of Continuous Cerebrospinal fluid (CSF) Collections During Phase 1 Studies in Healthy Volunteers and Patients (B English) | ||
| Prefrontal GABA Abnormalities Associated With Reduced Hippocampal Volume In Major Depressive Disorder (C Abdallah) | ||
| All Poster Abstracts are available at the end of the second day | ||
30 September 2013 |
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| Concurrent Workshops | ||
| Adaptive Design | G Haynes Report Back |
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| Addressing Methodological Challenges in International CNS Clinical Trials | R Keefe A Kalali Report Back |
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| Biomarkers – The Advantage and Challenges of Sharing Biomarkers Data | S Potkin L Alphs Report Back |
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| Options and Methods to Improve Cognitive Assessment in Clinical Trials of AD and Its Precursors | H Posner P Harvey Workshop Slides: Posner/Harvey Loewenstein Edland Bastings Report Back |
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| Initiating Innovation in CNS Clinical Trials | G Sachs Report Back |
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| Negative Symptoms | S Marder D Daniel Daniel Dunayevich Report Back |
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| Suicidal Ideation and Behavior | A Butler P Chappell Report Back |
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1 October 2013 |
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| Presidential Welcome | ||
| A Return to Rational CNS Drug Development: De-Risking Phase 3 Investments Through Rigorous Early Phase Drug Evaluations |
Session Chairs: S Romano R Keefe |
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| Session Introduction | S Romano Slides video |
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| Part 1: Translational and Early Development Strategies and Tools | Chairs: D Feltner W Potter |
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| Translational Pharmacology (‘Proof of Mechanism’): A Basic Model and Variations on a Theme | W Potter Slides videoD Feltner Slides video |
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| Examples of Go and No-Go Decisions after Rigorous Early Phase Drug Evaluation | G J Groeneveld Slides video |
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| Use of Exposure Response Modeling in Early Development | S Riley Slides video |
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| Conducting the “Right” POC Study | M Egan* | |
| Optimizing Phase II: Setting the Stage for Phase III Success | C Mallinckrodt Slides video |
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| Discussion Panel | Feltner/Potter Video of panel discussion found at end of Mallincrodt video |
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| Part 2: Designing the Right Series of Experiments Introduction |
Chairs: G Sachs A Mahableshwarkar Slides video |
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| What Would We Consider Doing Differently: Lessons from the mGluR2/3 Agonist Schizophrenia Program | B Kinon Slides video |
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| A Study to Delay the Onset of Mild Cognitive Impairment | S Brannan Slides video |
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| Targeting Ventral Striatal Activation and Anhedonia in Early Phase Clinical Trials of Mood and Anxiety Spectrum Disorders: The NIMH FAST-MAS Perspective | A Krystal Slides video |
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| The Pharmacological Characteristics of a Therapeutically Active Dose of Two First-in-class Drugs: Amorexant (ORX1/2-antagonist) and Rimonabant (CB1-antagonist) | J van Gerven Slides video |
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| Panel Discussion | Sachs / Mahableshwarkar video |
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| Poster Session/Reception | Poster Abstracts | |
2 October 2013 |
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| Part 3: Operational Challenges | Chairs: A Kalali C Canuso |
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| Introduction | A Kalali | |
| Operational Challenges: Novel Designs | V Dragalin Slides |
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| Novel Indications: Experiences from a Study in Mixed Depression | J Cucchiaro Slides video |
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| Novel Indications: Challenges of Identification and Assessment of the Target Population: Experiences from a Study in Anxious Depression | Daly Slides video |
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| Novel Outcome Measures: Standardization of Biomarker Endpoints – Examples from Studies of Schizophrenia and Alzheimer’s Disease | S Potkin Slides video |
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| Panel Discussion | Kalali / Canuso video inludes Keefe closing |
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| Closing | R Keefe | |
| Meeting Adjourns | ||
| * Slide Presentations not released | ||
9th Annual Scientific Meeting
Friday, April 25th, 2014
Poster Awardee |
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| Methodological issues on the impact of central nervous disorders or psychotropic drugs on driving performance as encountered by an alcohol reference study in driving simulation (Kaussner, Y) | ||
Day 1 (19 February 2013) |
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| Presidential Welcome |
R Keefe slidesvideo |
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| 2013 ISCTM National Mental Health Research-to-Policy Forum | Chairs: R Ferziger videoR Manderscheid |
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| Session 1: Post-Election Health Policy Outlook | ||
| Introductions, Session Plan; Introduction of the Panelists | S Dentzer | |
| The Post-Election Outlook for Healthcare Policy | S Dentzer slidesvideo |
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| Panel | ||
| Comments by Democrat Healthcare Policy Expert | J Feder | |
| Comments by Republican Healthcare Policy Expert | T Troy | |
| Mental Health Policy Priorities and Realizable Goals | C Ingoglia | |
| Policy Outlook for Developing New Treatments and for Access to New Treatments |
K Buto | |
| What is Our Healthcare Policy Based On? | R Manderscheid | |
| video (full panel) |
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| Audience Q/A; Moderated by S Dentzer | ||
| Session 2: The Patient-Centered Outcomes Research Institute | ||
| Session Plan and Introductions | R Ferzigervideo |
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| PCORI: History, Goals, Challenges, Potential Impact on Treatment Development | J Selby slides |
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| Discussion | ||
| Key Questions that PCORI Raises About the Use of Data From Clinical Trials for Policy Decision Making | D Meltzer2 slidesvideo |
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| Discussion with Panelists | ||
| Industry R&D Perspective | F Lewis-Hallvideo |
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| Regulatory Perspective | R Temple | |
| CMS/Payer Perspective | S Tunis slides |
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| Discussion; Q/A with All Speakers | ||
| Forum Adjourns | ||
| Developing Medicines to Treat CNS Side Effects: The Who, The What, The How, and The Why | Chairs: J Messina J Tiller |
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| Treatment of Adverse Events: Some Background | J Messina slidesvideo |
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| Levodopa Induced Dyskinesia | C Kenney3 slides |
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| Cognitive Dysfunction Associated with Cancer and Cancer Therapy | J Wefel slidesvideo |
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| Challenges to Developing Medicines to Treat CNS Side Effects | R Marcus slidesvideo |
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| Input from the FDA | R Katz slidesvideo |
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| Input from European Regulator | K Broich slidesvideo |
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| Panel Discussion | video |
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| Reception | ||
| Working Group Dinners | ||
| Adaptive Design | Haynes Report Back slides |
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| Biomarkers | Riordan Potkin Report Back slides |
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| Cognitive Assessment in AD | Posner Harvey Report Back slides |
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| Stimulant Dependence | Palumbo Kosten Report Back slides |
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| Suicidal Ideation and Behavior | Stewart Butler workgroup slidesReport Back slides |
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| Assessing Abuse Liability Potential | Sokolowska Klein Setnik workgroup slidesReport Back slides |
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| Signal Detection | Kalali Report Back slides |
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Day 2 (20 February 2013) |
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| Andrew C. Leon Distinguished Career Award Presentation | video |
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| Reconceptualizing the Search for Treatments of the Schizophrenias in a Post-Bleulerian Era | L Alphs slidesvideo M Davidson |
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| The Unmet Needs of Schizophrenia Treatment: A Clinician-Researcher’s Viewpoint | M Davidson slidesvideo |
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| A Drug Developer’s Viewpoint: The Changing Research Agenda – Making Strategic Decisions in 21st Century Development | L Alphs slidesvideo |
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| Is Schizophrenia a Disorder of Neurotransmitters? (If so, Why is Drug Discovery so Difficult?) | D Goff slidesvideo |
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| The Schizophrenias as Genetic Diseases: Implications for Design of Clinical Trials | A Malhotra1,3 | |
| The Schizophrenias as Circuit Diseases: Implications for Design of Clinical Trials | A Voineskos slides S Potkin slidesVoineskos/Potkin video |
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| A Case Study: Novel Schizophrenia Development Program | G Garibaldivideo |
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| Regulatory Implications for Novel Approaches to Developing Treatments for the Schizophrenias | T Laughren slidesvideo |
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| Panel Discussion | slidesvideo |
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| Parallel Sessions | ||
| Session A: Methodological Issues in Assessing the Impact of CNS Drugs on Driving Performance | Chairs: T Macek T Roth |
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| Introduction: The Relatedness of Sleepiness and Drug Effects on Driving Performance | T Roth slidesvideo |
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| Current Methodological Approaches to the Assessment of Driving Performance | J Verster2 slidesvideo |
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| Innovative Methods to Assess the Risk of CNS Agents on Driving Performance: Statistical Approach | E Laska slidesvideo |
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| NHTSA Drugged Driving Expert Panel Report: a Consensus for Assessing the Potential of Drugs to Impair Driving | R Compton slidesvideo |
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| Regulatory Perspective | R Farkas slidesvideo |
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| Session B: Pharmacotherapy for Facilitating Non-pharmacologic Treatments | Chairs: R Keefe S Marder slidesvideo |
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| Scientific Rationale for Drugs Enhancing Psychosocial Treatments | D Goff slidesvideo |
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| D-Cycloserine to Augment Behavior Therapy in Anxiety Disorders | M Pollack2 slidesvideo |
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| Implementation Issues | N DeMartinis slides D Walling slidesDeMartinis/Walling video |
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| Methodological and Statistical Issues | R Hamer slidesvideo |
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| Regulatory Issues | T Laughren slidesvideo |
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| Discussion | S Marder S Romano |
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| Poster Session / Reception | Abstracts | |
Day 3 (21 February 2013) |
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| Suicidal Ideation and Behavior: Methodological and Technical Challenges | Chairs: A Butler M Stewart R Meyer |
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| Introduction | A Butler slidesvideo |
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| A Review of the Findings of the ISCTM SIB Working Group; Study Site Experiences & Attitudes Toward Prospective Assessments of Suicidal Ideation and Behavior in Clinical Trials | M Stewart slidesvideo |
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| A Cross-sectional, Randomized, Non-interventional Methods Study to Compare Three Methods of Assessing Suicidality in Psychiatric Inpatients | E Youngstrom slidesvideo |
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| Results of a Prospective Validation for Mapping Three Suicidal Ideation and Behavior Assessment Instruments to the C-CASA | L Alphs slidesvideo |
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| Use of the C-SSRS in Clinical Trials: Predicting Short-Term Risk and Detecting Clinical Change | G Brown slidesvideo |
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| Methodological Approach to the Use and Interpretation of Baseline History of Suicidal Ideation and Behavior | S DuBrava slidesvideo |
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| Implementing Prospective Suicidality Assessments in Challenging Populations: An Alzheimer’s Disease Case Study | V Coric slidesvideo |
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| Summary/Discussant | R Meyer slidesvideo |
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| Panel Discussion | Moderator: A Butler video |
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| Meeting Adjourns | ||
| (1) Slides not released. (2) Released for Member Access only (3) Video not released |
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10th Annual Scientific Meeting
Thursday, April 24th, 2014
Poster Awardee: |
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| The Utility of a Novel Cognitive Paradigm for Identifying and Tracking Subjects at High Risk for Early Alzheimer’s Dementia: Implications for Clinical Trials (Curiel R) | ||
| All Poster Abstracts are available at the end of the second day |
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Day 1 (18 February 2014) |
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| Presidential Welcome ISCTM 10th Anniversary Tribute |
R Keefe slides L Alphs slidesG Garibaldi slidesR Keefe slides video |
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| Developing Treatments for Schizophrenia in the 21st Century: Preventing Disease Progression ~ A Novel Paradigm for Research | Chairs: R Anand G Haig L Alphs |
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| Overview of Session | G Haig* video |
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| Disease Modification in Schizophrenia: Overview of the Issues | R Anand slides video |
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| Clinical Course of Schizophrenia: Implications for Therapeutic Intervention and Disease Modification/Discussion | J Lieberman slides video |
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| Defining, Measuring and Tracking Disease Modification in Schizophrenia/Discussion | S Kapur slides video |
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| Neurodevelopmental Course of Schizophrenia and Specific Therapeutic Strategies for Developing Treatments for Preventing Disease Progression in Schizophrenia/Discussion | H Meltzer slides video |
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| Identifying and Addressing Regulatory Challenges to Disease Modification in Schizophrenia/Discussion | B Levin slides T Laughren* video (Levin/Laughren) |
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| Panel and Audience Discussion | Facilitator: S Marder slides videoW Carpenter R Heinssen S Kapur J Lieberman H Meltzer L Pani |
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| Session Summary | R Anand* video |
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Working Group Dinners |
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| Adaptive Design | Chair: Haynes Working Group slidesReport Back slides |
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| Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: Keefe Kalali Report Back slides |
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| Assessing Abuse Liability Potential | Chairs: Sokolowska Klein Setnik Working Group Slides: Klein, Calderon, Schoedel, Sokolowska, Setnik Report Back slides |
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| Biomarkers – Minimum Standards Initiative | Chairs: Potkin Goff Report Back slides |
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| Cognitive Assessment in Alzheimer’s Disease and its Precursors | Chairs: Posner Harvey Report Back slides |
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| Implementing Innovations in CNS Clinical Trials | Chairs: Sachs Detke Report Back slides |
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Day 2 (19 February 2014) |
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| 2014 ISCTM National Mental Health Research-to-Policy Forum: Revitalizing Academia-Industry Collaboration in Psychiatry Treatment Research | Chairs: R Ferziger R Manderscheid |
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| Session Goals and Speaker Introductions | R Ferziger slides video R Manderscheid* |
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Current Status/Goals/Needs/Challenges
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J Lieberman* video F Lewis-Hall slides (not yet released)R Frank** video |
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| Panel and Audience Discussion: Response and Next Steps | E Szabo K Thompson J Lieberman F Lewis-Hall R Frank video |
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| Case Presentation Panel and Discussion |
Moderator: |
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| Closing Comments/Paths Forward | J Lieberman F Lewis-Hall R Frank H Goldman |
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Parallel Sessions |
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| Session A: Dementia Study Designs, Methodologies and Regulatory Perspectives – One Size Does Not Fit All! | Chairs: P Tariot J Rasmussen |
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| Defining the Problem and Session Overview | J Rasmussen slides video |
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| 20 Years of Clinical Trials in Alzheimer’s Disease: Some Lessons Learned | P Tariot slides video |
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| Pathobiological Targets in AD Trials: Where We Have Been and Where We’re Headed | M Jefson slides video |
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| Clinical Trial in Frontotemporal Lobar Degeneration: Focus on Tau/Discussion | A Boxer slides video |
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| Designs of Clinical Trials in DLB and PDD/Discussion | I McKeith slides video |
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Regulatory Challenges Across Dementia Subtypes
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M Haberkamp slides video N Kozauer slides |
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| Panel Discussion/Summary | video (Kozauer and panel) |
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| Session B: Taking Personalized Medicine Seriously – Biomarker Approaches in Phase llb/lll Studies in Major Depression and Schizophrenia | Chairs: H Murck T Laughren |
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| Introduction | H Murck slides video |
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| Regulatory Issues in the Use of Biomarkers in Phase llb/lll Studies in Depression and Schizophrenia | T Laughren slides video |
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| Biological Differentiation of Depression Subtypes: Cortisol, Inflammatory Markers, Proteomics and Course/Discussion | F Lamers*** slides |
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| Physiological Sensor Technology for Objective Clinical Data in Psychiatry/Discussion | R Picard slides video (video referenced in presentation not released) |
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| Target Based Biomarker Selection – Mineralocorticoid Receptor Related Biomarkers and Treatment Outcome in Depression/Discussion | H Murck slides video |
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| Actigraphic Monitoring of Physical Activity in Clinical Trials in Schizophrenia/Discussion | S Walther slides video |
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| The Use of Biomarkers in Clinical Trials in Schizophrenia | D Goff slides video |
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| Industry Perspective/Panel Discussion | J Wendland slides All Speakers video (includes Wendland and Laughren summary) |
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| Summary Comments | T Laughren* | |
| Poster Session / Reception | Poster Abstracts | |
Day 3 (20 February 2014) |
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| Presentation of the Andrew C. Leon Distinguished Career Award | S Romano L Alphs slides video |
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| Innovations in Clinical Trials: Opportunities for Research Using Practice-Based Networks | Chairs: J Severe R Heinssen |
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| Introduction | J Severe slides video |
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| New Research Platforms Are Needed to Speed Development and Deployment of CNS Interventions | R Heinssen slides video |
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| The Necessity for Practice-Based Research Networks: Making it Work at the National Heart Lung and Blood Institute/Discussion | M Lauer slides video |
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| The Mental Health Research Network: Practical Experience Using Health Care Plan Networks/Discussion | G Simon slides video |
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| Practice-Based Research Networks: How Can They Help Patients and Industry?/Discussion | R Dubois slides video |
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| Methodological and Statistical Issues in Designing RCTs on Practice-Based Networks/Discussion | H Kraemer slides video |
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| Discussion Panel | T Laughren* All Speakers video |
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| Domain-Based Approaches to Pathology in the Development of Novel Psychiatric Therapies: Enhancing Tractability in Discovery and Trial Methodology | Chairs: R Keefe G Garibaldi |
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| Introduction | R Keefe slides video |
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| Cross Diagnostic Disorders of Cognition/Motivation, the Why and the What | G Garibaldi slides video |
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| Neurocircuitry of Motivation and Cognition in Animal Models/Discussion | J Salamone slides video |
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| Neurocircuitry of Impulsivity and Motivation in Psychiatric Disorders/Discussion | S Potkin slides video |
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| Mapping Cognitive and Motivational Domains Across Levels of Analysis: Challenges for Target Specification/Discussion | R Bilder slides video |
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| Focused Panel Discussion | R Heinssen L Kempf T Laughren L Pani video |
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| Meeting Adjourns | S Romano video |
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| * No slides presented ** Slides not released *** Video not released |
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