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Synergy in Action

2022 Autumn Conference

08 – 09 September, 2022   //   Boston Park Plaza, Boston, MA

Distinguished Poster Award Recipient:

A general theory of construct enrichment: Inclusion criteria for symptom structure not severity (Hopkins; Abstract)  

View all Poster PDFs and Abstracts 

 

8 September 2022

   
 Welcome from the President Gary Sachs
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Session 1: New challenges in Alzheimer’s and Dementia – Adapting to the new environment Chairs:
Rhoda Au
Judith Jaeger
 
  New approaches to cognitive endpoints in confirmatory trials of early Alzheimer’s Disease

Judith Jaeger
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  How can we use digital technology to augment conventional cognitive assessments?

Kristin Hannesdottir*
Gul Erdemli
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  Scaling functional neurophysiology to clinical trials in Alzheimer’s and other neurodegenerative conditions  Brian Murphy
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  Developing barrier-breaking approaches in Alzheimer’s trials – global cohort characterization, clinical trials, and healthcare delivery Rhoda Au
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  Commentary: Concepts of interest and outcome measurement tools at different stages of development Lorenzo Guizzaro
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  Panel discussion Facilitator:
Judith Jaeger

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 Session 2: Suicidality: What have we learned after a decade of research? What challenges remain?

Chairs:
Larry Alphs
David Sheehan
 
  Introduction and agenda for session Larry Alphs
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  Real world assessments of suicide ideation and behavior. Challenges and next steps. Eric Chan
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  Veteran suicide surveillance and development and evaluation of the REACH VET clinical program John McCarthy
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  Research in suicide ideation and behavior: Problems faced. What we have learned. Directions for the future. Jill Harkavy-Friedman
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  Insights into study design and methodology for assessing suicide ideation and behavior in clinical trials for safety and efficacy: Hurdles and advances David Sheehan*
 
  Statistical challenges and potential solutions for assessing suicide ideation and behavior endpoints Kari Nations
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  Panel discussion Facilitator:
Larry Alphs
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Concurrent Working Group Sessions

   
  Algorithms/flags to identify clinical inconsistency in the use of rating scales in CNS RCTs Chairs:
Jonathan Rabinowitz
Nina Schooler
 
  Behavioral and psychiatric symptoms in dementia (BPSD) Apathy  Chairs:
Krista Lanctôt
David Miller
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  Digital biomarkers decision process Chairs:
Vikas Mohan Sharma
Diane Hoffman
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  Joint ISCTM/ECNP COVID-19 methodologies blueprint Chairs:
Dragana Bugarski-Kirola
Gerard Dawson
Kemi Olugemo

 
  Orphan diseases Chairs:
Joan Busner
Gahan Pandina
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 Poster Session

Poster PDFs and Abstracts  

 9 September 2022

 
Session 3: Hot Topic Breakfast Session: Methodological implications of world events that impede subject recruitment Chairs:
Atul Mahableshwarkar
Michael Ropacki

 
  Are critical world events confounding factors for clinical trials? Steven Targum
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  Recent impacts on CNS clinical trial recruitment: Qualitative assessment of the impacts and resultant methodological assessment

Michael Ropacki
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  Impact of patient recruitment before and during COVID shelter-in-place: What do unblinded data reveal

Kerensa Saljooqi
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  Impact of war in Ukraine on clinical trials: Lessons learned from a phase 3 program in schizophrenia Debra Phillips*
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  Commentary: Estimands, power and general considerations

Panel discussion

Discussant:
Lorenzo Guizzaro
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Facilitator: 
Michael Ropacki
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Session 4: Post-traumatic stress disorder as a prototype disorder for heterogeneity in neuropsychiatry Chairs: 
Lori Davis
Tom Neyla
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  Introduction Lori Davis
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  Translational biomarkers and novel compounds to address the unmet need in the civilian PTSD population Kerry Ressler
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  Drug development in heterogeneous disorders: When to target subgroups? Case example in PTSD Thomas Neylan
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  Rationale and aims of a Phase 2, multi-center, multi-arm, randomized, placebo-controlled, double-blind, adaptive platform study to evaluate the safety, tolerability, and efficacy of potential therapeutic interventions in active duty service members and veterans with posttraumatic stress disorder Elyse Katz
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  Operational complexities when managing PTSD trials Kerrin Young
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  Panel discussion Facilitator:
Lori Davis
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Session 5: Algorithms, clinical outcomes, and digital biomarkers – Next generation endpoints Chairs: 
Adam Butler
Jane Tiller
 
  Introduction  Jane Tiller
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  Verification, analytical validation, and clinical validation for biometric technologies  Ariel Dowling
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  Voice My Health: A multi-modal approach to digital phenotyping  John Reynders
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  Gaps in the evidentiary requirements framework: Traversing the last mile for regulatory qualification of sensor-derived digital endpoints  Ritu Kapur
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  US regulatory considerations Ian Marcus
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Anita Bajaj
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  Panel discussion Facilitator:
Adam Butler
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  Meeting adjourns Gary Sachs
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  *Slides and/or video not released