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19 February 2013

Presidential Welcome

2013 ISCTM Research to Policy Forum
Chairs: Ron Manderscheid, PhD; Reuven Ferziger, MD

Introductions, Session Plan

Part 1: The Post-election Outlook for Healthcare Policy

  • The Post-election Healthcare Landscape
    Susan Dentzer
  • Stakeholders
    Judy Feder, PhD
    Kathy Buto
    Charles Ingoglia, MSW
  • Audience Q/A

Break

Part 2: What Evidence Matters? Impact of PCORI

  • PCORI: History, Research Priorities, Impact Goals
    Joe Selby, MD, MPH
  • PCORI and Industry CNS Research
    Freda Lewis-Hall, MD

Audience Q&A

  • Keynote
    David Meltzer, MD, PhD
  • Discussants
    Freda Lewis-Hall, MD
    Robert Temple, MD
    Sean Tunis, MD

Audience Q/A

Session Adjourns

Lunch

Developing Medicines to Treat CNS Side Effects: The Who, The What, The How, and The Why
Chairs: John Messina, PharmD; Jane Tiller, MBChB, FRCPsych

  • Treatment of Adverse Events: Some Background
    John Messina, PharmD
  • Levodopa Induced Dyskinesia
    Christopher Kenney, MD
  • Cognitive Dysfunction Associated with Cancer and Cancer Therapy
    Jeffrey Wefel, PhD, ABPP

Break

  • Challenges to Developing Medicines to Treat CNS Side Effects
    Jane Tiller, MBChB, FRCPsych
  • Input from the FDA
    Russell Katz, MD
  • Input from European Regulator
    Karl Broich, MD

Panel Discussion

Session Adjourns

Reception

Working Group Dinners

  • Adaptive Design (Haynes)
  • Biomarkers (Riordan, Potkin)
  • Cognitive Assessment in AD (Posner, Harvey)
  • Stimulant Dependence (Palumbo, Kosten)
  • Suicidal Ideation and Behavior (Stewart, Butler)
  • Assessing Abuse Liability Potential (Sokolowska, Klein, Setnik)
  • Signal Detection (Kalali)

20 February 2013

Andrew C. Leon Award Presentation

Reconceptualizing the Search for Treatments of the Schizophrenias in a Post-Bleulerian Era

Chairs:
Larry Alphs, MD, PhD; Michael Davidson, MD

  • Expectations and Unmet Need for the Schizophrenias: A Clinician-Researcher's Viewpoint
    Michael Davidson, MD
  • A Drug Developer’s Viewpoint: The Changing Research Agenda- Making Strategic Decisions in 21st Century Development
    Larry Alphs, MD, PhD
    Discussion
  • The Schizophrenias as Diseases of Neurotransmitters: Implications for Design of Clinical Trials
    Donald Goff, MD
    Discussion

Break

  • The Schizophrenias as Genetic Diseases: Implications for Design of Clinical Trials
    Anil Malhotra, MD
    Discussion
  • The Schizophrenias as Circuit Diseases: Implications for Design of Clinical Trials
    Steven Potkin, MD
    Aristotle Voineskos, MD, PhD, FRCP
  • Discussion
  • A Case Study: Novel Schizophrenia Development Program
    George Garibaldi, MD
    Discussion
  • Regulatory Implications for These Novel Drug Development Approaches
    Thomas Laughren, MD
    Panel Discussion: Pulling It All Together

Session Adjourns

Annual Business Meeting Luncheon

Parallel Sessions

Session A: Methodological Issues in Assessing the Impact of CNS Drugs on Driving Performance
Chairs: Thomas Macek, PharmD, PhD; Thomas Roth, PhD

  • Introduction: The Relatedness of Sleepiness and Drug Effects on Driving Performance
    Thomas Roth, PhD
    Discussion
  • Current Methodological Approaches to the Assessment of Driving Performance
    Joris Verster, PhD
    Discussion
  • Innovative Methods to Assess the Risk of CNS Agents on Driving Performance: Statistical Approach
    Eugene Laska, PhD
    Discussion

Break

  • NHTSA Drugged Driving Expert Panel Report: a Consensus for Assessing the Potential of Drugs to Impair Driving
    Richard Compton, PhD
    Discussion
  • Regulatory Perspective
    Ronald Farkas, MD, PhD
    Discussion

Session A Adjourns

Session B: Pharmacotherapy for Facilitating Non-pharmacologic Treatments
Chairs: Richard Keefe, PhD; Stephen Marder, MD

  • Scientific Rationale for Drugs Enhancing Psychosocial Treatments
    Donald Goff, MD
    Discussion
  • D-Cycloserine to Augment Behavior Therapy in Anxiety Disorders
    Mark Pollack, MD
    Discussion

Break

  • Implementation Issues
    Nicholas DeMartinis, MD
    David Walling, PhD
    Discussion
  • Methodological and Statistical Issues
    Robert Hamer, PhD
    Discussion
  • Regulatory Issues
    Thomas Laughren, MD
    Discussion
    Steven Marder, MD
    Atul Pande, MD

Session B Adjourns

Poster Session/Reception

21 February 2013

Suicidal Ideation and Behavior: Methodological and Technical Challenges
Chairs: Adam Butler; Michelle Stewart, PhD; Roger Meyer, MD

  • Introduction
    Adam Butler
  • 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
    Michelle Stewart, PhD
    Discussion
  • Results of a Prospective Validation Study of the Columbia Suicidality Severity Rating Scale and the Sheehan Suicidality Scale
    Eric Youngstrom, MD
    Discussion
  • Results of a Prospective Validation for Mapping Three Suicidal Ideation and Behavior Assessment Instruments to the C-CASA
    Larry Alphs, MD, PhD
    Discussion
  • Use of the C-SSRS in Clinical Trials: Predicting Short-Term Risk and Detecting Clinical Change
    Gregory Brown, PhD
    Discussion

Break

  • Methodological Approach to the Use and Interpretation of Baseline History of Suicidal Ideation and Behavior
    Sarah Dubrava, MS
    Discussion
  • Implementing Prospective Suicidality Assessments in Challenging Populations: An Alzheimer's Disease Case Study
    Vladimir Coric, MD
    Discussion
  • Panel Discussion
    Moderator: Roger Meyer, MD

9th Annual Scientific Meeting Adjourns

Confirmed Presenters

Click here for biographical profiles

Larry Alphs, MD, PhD
Therapeutic Leader, Psychiatry, Janssen Pharmaceutical Companies

Karl Broich, MD
Deputy Head of Federal Institute of Drugs and Medical Devices (BfArM)

Gregory Brown, PhD
Research Associate Professor of Clinical Psychology in Psychiatry, Penn Medicine Neuroscience Center

Adam Butler
Vice President, Client Services, Bracket Global

Kathy Buto, MPA
Vice President for Health Policy, Government Affairs, Johnson and Johnson

Richard Compton
National Highway Traffic Safety Administration

Michael Davidson, MD
Professor of Psychiatry, Department of Psychiatry, Sheba Medical Center, Israel

Nicholas DeMartinis, MD
Director, Pfizer, Inc., Assistant Clinical Professor, University of Connecticut School of Medicine

Susan Dentzer
Editor-in-Chief, Health Affairs Journal

Sarah DuBrava, MS
Associate Director, Clinical Statistics, Pfizer, Inc.

Ronald Farkas, MD, PhD
Lead Medical Officer, Division of Neurology Products, CDER, FDA

Judy Feder, PhD
Professor of Public Policy, Georgetown Public Policy Institute

Reuven Ferziger, MD
CNS Medical Affairs, Janssen Pharmaceutical Companies

George Garibaldi, MD
Global Head Neuroscience, F. Hoffmann LaRoche

Donald Goff, MD
Director, Nathan S. Kline Institute for Psychiatric Research, Vice Chair for Research, Psychiatry Department, NYU Langone Medical Center

Robert Hamer, PhD
Professor of Psychiatry, Research Professor of Biostatistics, University of North Carolina School of Medicine

Ginger Haynes, PhD
Principal Research Scientist, Global Health Outcomes, LBM

Philip D. Harvey, PhD
Professor of Psychiatry, University of Miami Miller School of Medicine

Charles Ingoglia, MSW
Senior Vice President, Public Policy and Practice Improvement, National Council for Community Behavioral Healthcare

Rusty Katz, MD
Director, Division of Neurology Product, Center for Drug Evaluation and Research, US Food and Drug Administration

Richard Keefe, PhD
Professor, Departments of Psychiatry and Behavioral Sciences and Psychology, Duke University Medical Center, President, Neurocog Trials, Inc.

Christopher Kenney, MD
Principal Medical Scientific Expert, Neuroscience, Novartis Pharmaceuticals Corporation

Michael Klein, PhD
Director, Controlled Substance Staff, US Food and Drug Administration

Thomas Kosten, MD
Professor of Psychiatry and Neuroscience, Baylor College of Medicine

Eugene Laska, PhD
Professor, Department of Psychiatry, New York University, Director, Statistical Sciences and Epidemiology Division, Nathan S. Kline Institute for Psychiatric Research, Director, WHO Collaborating Center for Research and Training in Mental Health Management

Thomas Laughren, MD
Division Director, Division of Psychiatric Products, Center for Drug Evaluation and Research, US Food and Drug Administration

Freda Lewis-Hall, MD, FAPA
Executive Vice President, Chief Medical Officer, Pfizer, Inc.

Thomas Macek, PharmD, PhD
Director of Clinical Services, CNS Products, Takeda Global Research and Development

Anil Malhotra, MD
Director of Psychiatry Research, Zucker Hillside Hospital
 
Ron Manderscheid, PhD
Executive Director, National Association of County Behavioral Health and Developmental Disability Directors

Stephen Marder, MD
Director, Department of Veterans Affairs, VISN 22 Mental Ilness Research, Education and Clinical Center, Professor, Psychiatry, David Geffen School of Medicine, UCLA

David Meltzer, MD, PhD
Chief, Section of Hospital Medicine; Director, Center for Health and Social Sciences; Associate Professor, Department of Medicine and Associate Faculty Member, Harris School and the Department of Economics, University of Chicago

John Messina, PharmD
Vice President of Clinical Development, Optinose

Roger Meyer, MD
Professor of Psychiatry, Pennsylvania State Hershey Medical Center

Joseph Palumbo, MD
Head, Clinical Research, Mitsubishi Tanabe Pharma Development America

Atul Pande, MD
Senior Vice President, GlaxoSmithKline

Mark Pollack, MD
Chairman, Department of Psychiatry, Rush University Medical Center

Holly Posner, MD
Senior Director, Research and Development, Primary Care Busines Unit, Pfizer, Inc.

Stephen G. Potkin, MD
Robert R. Sprague Director of the UCI Brain Imaging Center, Professor of Psychiatry and Human Behavior, and Director of Clinical Psychiatric Research, School of Medicine

Hank Riordan, PhD
Senior Vice President, Medical and Scientific Affairs, Worldwide Clinical Trials, Inc.
  
Tom Roth, PhD
Director of Research, Sleep Disorders and Research Center at Henry Ford Health System, Henry Ford Hospital Sleep Center

Joe Selby, MD, MPH
Executive Director, Patient-Centered Outcomes Research Institute (PCORI)

Beatrice Setnik
Senior Director, Medical Development, Pfizer

Marta Sokolowska, PhD
Director, Center of Excellence for Abuse Liability, Grunenthal-USA

Michelle Stewart, PhD
Director, Pfizer, Inc.

Robert Temple, MD
Deputy Center Director for Clinical Sciences, US Food and Drug Administration 

Jane Tiller, MBChB, FRCPsych
Vice President, Neuroscience, Bristol-Myers Squibb

Joris Verster, PhD
Assistant Professor, Utrecht University

Aristotle Voineskos, MD, PhD, FRCP
Head, Translational Imaging-Genetics Research, Centre for Addiction and Mental Health

David Walling, PhD
Chief Executive and Clinical Officer, Collaborative Neuroscience Network, Inc.

Jeffrey Wefel, PhD, ABPP
Chief ad interim, Section of Neuropsychology, Associate Professor, Department of Neuro-Oncology, M. D. Anderson Cancer Center

Eric Youngstrom, PhD
Professor of Psychology and Psychiatry, University of North Carolina at Chapel Hill, Associate Director, Center of Excellence for Research and Treatment of Bipolar Disorder

Click here for biographical profiles

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