Menu
Synergy in Action

2020 Autumn Conference

21 – 25 September, 2020   //   Virtual Conference

Distinguished Poster Award Recipients:

The Impact of Contextual Factors on Performance of a Smartphone-Based Word List Test (Parrish)
All Poster PDFs and Abstracts are available here.

Day 1 (21 September 2020)

 
Presidential Welcome Ramy Mahmoud
slides
slides
 video
Implications of pediatric initiatives on CNS drug development for all ages – 2020 and beyond Chairs:
Gahan Pandina
Joan Busner
  Welcome / Session objectives Gahan Pandina
 video
  Introduction to pediatric aspects of drug development Joseph Horrigan
slides
slides 
 video
  Drug development – the chicken or the egg? How the approach to research in pediatric populations affects the drug development process  or vice versa Gahan Pandina
slides slides 
 video
  Unique issues in outcome measurement when including pediatric populations Christine McSherry
slides slides
 video
  IRB / Ethics committee requirements for pediatrics and how these may affect drug research Alison Bateman-House
slides slides 
video
  Regulatory considerations when including pediatric populations

Tiffany Farchione
slides slides
 video
Luca Pani
slides slides 
video
  Expanded discussion on other needs to facilitate peds-first drug development approach

Facilitator/Discussant:
Judith Kando
slides
slides
video

Day 2 (22 September 2020)

 
Day 1 Highlights

Philip Harvey
 video
Hot Topic: Regulatory viewpoints from EMA and FDA on contemporary challenges and strategies for conducting and analyzing clinical trials in the COVID-19 era Chairs:
Richard Keefe
Mike Davis
Valentina Mantua
  Regulatory Panel / Audience Discussion Facilitators –
Richard Keefe
Mike Davis

Valentina Mantua
Panelists –
Florence Butlen-Ducuing

Sylva Collins

Bernard Fischer

Lorenzo Guizzaro

Elektra Pappadopoulos

Isaac Rodriguez-Chavez

Leonard Sacks

slides slides 
video
Special challenges in pediatric drug development
Chairs:
Philip Harvey

Gahan Pandina
Joan Busner
  Introduction Philip Harvey
 video
  Measurement of cognition and behavior: How do we measure a moving target? H. Gerry Taylor
slides slides 
 video
  Securing patients – value of pre-competitive consortia Meg Grabb
slides slides
 video
  Rater training for pediatric trials: pathology, parents, placebos, pandemics Joohi Jimenez-Shahed
slides
slides 
 video
  Speaker / Audience discussion including regulatory perspectives Facilitator –
Philip Harvey

Panelists –
Tiffany Farchione
Lucas Kempf
Speakers

 video

Day 3 (23 September 2020)

 
Day 2 Highlights

Gary Sachs
 video
Patient centricity: Design and conduct of clinical trials in orphan diseases Chairs:
Joan Busner
Gahan Pandina
  Introduction Joan Busner
video
  Session background – Patient-centric designs: Involving patients and families Simon Day
slides slides 
 video
  Case study: Lessons learned in an adolescent schizophrenia trial Eva Kohegyi
slides slides 
 video
  Case study: Lessons from a Tourette’s study Atul Mahableshwarkar
slides slides 
 video
  Regulatory perspective Lucas Kempf
slides
slides 
 video
Maria Sheean
slides
slides 
 video
  Incorporation of treatment preferences to endpoint selection Judith Dunn
slides
slides 
 video
  Including families in protocol design, protocol simulation, identification of meaningful clinical aspects, with patients

Traceann Rose
slides
slides 
 video
  Panel Discussion Facilitator –
Simon Day
Panelists –
Renie Moss
Speakers
 video

Day 4 (24 September 2020)

 
Day 3 Highlights

Ramy Mahmoud
 video
Borderline personality disorder: Clinical development challenges and opportunities in the current regulatory environment Chairs:
Michael Ropacki
Gary Sachs

  Introduction Gary Sachs
slides
slides 
video
  Methodological issues and barriers faced in Borderline Personality Disorder clinical development Michael Ropacki
slides slides 
 video
  Beginning with the endpoint in mind Gary Sachs
slides slides 
 video
  Adaptive clinical trials: A modern approach to drug development Ben Saville
slides slides 
 video
  Regulatory feedback and commentary on Borderline Personality Disorder clinical development Zimri Yaseen
slides
slides 
 video
Lorenzo Guizzaro
slides
slides 
 video
  Panel Discussion Facilitator –
Michael Ropacki
Panelists –
Speakers
 video
Poster Session Poster PDFs and Abstracts

Day 5 (24 September 2020)

 
Day 4 Highlights

Stephen Brannan
 video
Toward personalized medicine: Methodological challenges in implementing clinical trials Chairs:
Nina Schooler
Stephen Marder

  Introduction Nina Schooler
video
  Awaiting the biomarker fairy: Risk stratification in clinical trials Roy Perlis
slides slides 
 video
  Adaptive enrichment designs: Modifying pre-specified enrollment criteria Ronald Marcus
slides slides 
 video
  The application of machine learning to advance phenotyping, selection, and prediction of treatment response Isaac Galatzer-Levy
slides slides 
 video
  Assessment of clinical profiles and outcomes in personalized medicine Robert Gibbons
slides
slides 
video
  Regulatory perspective

Valentina Mantua
slides
slides 
video
Elena Martinez-Lapiscina
slides slides 
video
  Panel Discussion Facilitator –
Stephen Marder
Panelists –
Speakers
 video
  Meeting Adjourns

Ramy Mahmoud
slides
slides 
 video

Working Groups

 
Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs Working Group

Chairs:
Jonathan Rabinowitz
Nina Schooler
slides
summary
Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs



Chairs:
Elizabeth Ballard
Mark Opler
Christian Yavorsky
slides
summary
Behavioral and Psychiatric Symptoms in Dementia (BPSD) Working Group

Chairs:
Larry Ereshefsky
Krista Lanctot
David Miller
Cedric O’Gorman
Paul Rosenberg
slides summary
Orphan Diseases

Chairs:
Joan Busner
Gahan Pandina
slides summary
Utilizing Artificial Intelligence and Machine Learning for CNS Clinical Trials Chairs:
Larry Alphs
Adam Butler
slides
summary