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Synergy in Action

15th Annual Scientific Meeting

19 – 21 February, 2019   //   The Fairmont, Washington DC

Distinguished Poster Award Recipient:

Trials, errors, and placebo prediction: Tradeoffs between effect size and sample size in machine learning models to mitigate the placebo response (Anderson)  

All Poster PDFs and Abstracts are available at the end of the second day. 

 

 19 February 2019

   
 Welcome from the President Carla Canuso
slides slides
 video
 
 Unresolved Problems in Neuroscience Drug Development: Point/Counterpoint Facilitator:
Amir Kalali
 video
 
  Are patients with any degree of suicidal ideation or behavior acceptable for inclusion in clinical trials? 

Chair: Carla Canuso
slides slides
 video
Discussants:
Jill Harkavy-Friedman
slides slides
 video
Tom Laughren
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 video
 
  Panel/Audience Discussion Panelists:
Jean Kim
slides 
slides
 video
Galia Siegel
 
video
 
  Are acute rapid onset anti-depressant results valid or just a consequence of functional unblinding? Chair: Steve Brannan
slides slides
Discussants:
Mark Opler
slides slides
 video
Torsten Madsen
slides slides
 video
 
  Panel/Audience Discussion Facilitator: Steve Brannan
 video
 

Tuesday Working Group Sessions 

   
  Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs Chairs: 
Mark Opler
Dawn Ionescu
summary
 
  Behavioral and Psychiatric Symptoms in Dementia—Apathy Subgroup Chairs: 
Krista Lanctôt
David Miller
slides slides
summary
 
  Cognitive Trajectories in Schizophrenia Chairs:
Philip Harvey
Kiri Granger
summary
 
  Estimands and Missing Data Chairs:
Pilar Lim
Elena Polverejan
slides
slides
 
  Orphan Diseases Chairs:
Joan Busner
Ravi Anand
slides Patient Centricity Subgroup summary
slides Case Histories Subgroup summary
 

20 February 2019

 
Strategies for Generating Meaningful Data for Payers: Methodological Challenges  Chairs:
Dawn Velligan
Rob Epstein
 
  Introduction Rob Epstein
 
  European perspective: Real world outcome needs of payers current and anticipated

Emma Medin
slides slides
 video
 
  US perspective: Real world outcome needs of payers current and anticipated

Jennifer Graff
slides slides
 video
 
  When novelty is not enough: Assuring adoption, access as well as approval within the clinical development process Michael Murphy 
slides slides
 video
 
  Models for increasing real world evidence in registration and post-approval clinical trials

Larry Alphs
slides slides
 video
 
  Health economics and outcomes research: What can be done differently in registration trials and in post-approval trials Steven Kymes
slides 
slides
 video
 
  Regulatory Perspective Peter Stein
slides slides
 video
 
  Panel Discussion Facilitator:
Dawn Velligan
 video
 
Methodological Issues Associated with the New Alzheimer’s Draft Guidance  Chairs: 
Judith Jaeger
Adam Butler
 
  Introduction Adam Butler
slides
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 video
 
  ADCOMS, new composite score, demonstrates improved sensitivity to disease progression and treatment effects in early AD   Veronika Logovinsky
slides slides
 video
 
  Bayesian adaptive design employing ADCOMS for dose selection Chad Swanson*

 
  Cognitive composites for preclinical and early AD derived from longitudinal registries: PACC-R and EMACC  Clint Hagen
slides slides
 video
 
  Is there a cognitive test that can detect cognitive impairment associated with AB+ in the absence of dementia? Jason Hassenstab
slides slides
 video
 
  Informant report to detect amyloid related cognitive decline in the absence of dementia Anna-Karin Berger
slides slides
 
  Panel / Audience Discussion  Discussant:
Judith Jaeger
slides 
slides
 video
 
Andrew C. Leon Distinguished Career Award Presentation Steve Marder
Carla Canuso
slides slides
Janet Williams
slides 
slides
 video
 
Finding the Signal: Strategies for Achieving Participant-Centric Trials in the Face of Participant-Introduced Validity Changes Chairs:
Sian Ratcliffe
Tim Mariano
Kari Nations

 
  Introduction and goals slides slides
Tim Mariano
 video
Sian Ratcliffe
 video
 
  Case studies on how stakeholders (sponsors, sites, patients) influence risks  Steve Brannan
slides slides
 video
 
  Evidence-based, data-driven design examples from various MDD programs Eva Kohegyi*

 
  Testing our assumptions: Moving from speculative to evidence-based trial design Fabrizio Benedetti
slides 
slides
 video
 
  Panel / Audience Discussion
Site and patient perspectives: Balancing risk mitigation with site/patient burden and acceptability
Panelists:
Lori Davis
, facilitator
slides slides
 video
Sarah Atkinson
slides 
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 video
Penney Cowan
slides 
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 video
David Walling
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Panel
 video
 
  Regulatory perspective on design and method solutions
Panel / Audience Discussion
Tom Laughren
slides slides
 video
Valentina Mantua*
Panel

 video
 
  Concluding Remarks Tim Mariano
Sian Ratcliffe
slides 
slides
 
 Poster Session/Reception Poster PDFs and Abstracts  

21 February 2019

 

Thursday Working Group Sessions (summaries to be posted)

   
  Algorithms/Flags Chairs: 
Jonathan Rabinowitz
Nina Schooler
 
  Autism Spectrum Disorder Chairs: 
Valentina Mantua
Tiffany Farchione
Celso Arango
slides summary
 
  Behavioral and Psychiatric Symptoms in Dementia—Agitation Subgroup Chairs:
Cedric O’Gorman
Paul Rosenberg

 
  Innovative Technologies for Clinical Trials  Chairs:
Richard Keefe
Michael Davis
 
  Late Onset Depression: A Distinct Indication? Chairs:
Patricia Capaccione
Peter de Boer
slides 
summary
 
  Prevention Trials in Alzheimer’s Disease Chairs:
Holly Posner
Philip Harvey
slides 
slides
 
Untangling the Regulatory and Statistical Challenges When Designing Trials for Disease Modification Chairs:
Larry Alphs
Luca Pani          
 
  Introduction and reprise of prior ISCTM work Luca Pani
slides slides
 video
 
  Prospects for a disease-modifying claim in neurodevelopmental disorders Tiffany Farchione
slides slides
 video
 
  Prospects for a disease-modifying claim in schizophrenia: Prevention, effects on cognitive function David Millis
slides slides
 video
 
  Clinical trials that demonstrate disease modification: The challenges and a possible solution for schizophrenia Larry Alphs
slides slides
 video
 
  Application of doubly-randomized delayed-start, matched control designs to demonstrate disease modification Ibrahim Turkoz
slides slides  
 video
 
  Statistical challenges of proposed modification approaches James Hung
slides slides
 video
 
  Regulatory reflections on disease modification: EU perspective Valentina Mantua*

 
  Panel / Audience Discussion    
  Meeting Adjourned

*Slides not released

Carla Canuso