CONFERENCE DAY ONE - SEPTEMBER 25

7:30 AM Check-In, Coffee & Light Breakfast

8:20 am Chair’s Opening Remarks

  • Matthew Harlin Senior Director, CNS Discovery Research, Early Phase & Translational Medicine, Otsuka

INNOVATING A NEW ERA OF PRECISION NEUROPSYCHIATRY

8:30 am Panel Discussion | Transforming ‘Precision Neuropsychiatry’ from Idea to Realization: Are we There Yet?

Synopsis

  • Are we prone to have a biological marker for a psychiatric indication, and how far are we from reality of identifying best responders to a given treatment?
  • From subtyping disorders, to combining treatments for personalization, to identifying best responders: What do we mean by ‘precision’?
  • From evident success stories so far, what kind of data was collected and how did it affect recruitment, dropout rate and trial cost

9:00 am Session Reserved: Sama Therapeutics

Synopsis

Home - 6th Neuropsychiatric Drug Development

9:30 am Leveraging Artificial Intelligence & Large Language Models (LLMs) to Help Bring Precision Medicine to the Field of Mental Healthcare

Synopsis

  • Showcasing the potential of an AI model to predict outcomes in TRD using recordings during psilocybin treatment
  • Highlighting how AI can increase predictive power and overcome biological variability
  • Implications for how this can support delivery of more personalized treatments

10:00 am Speed Networking

Synopsis

A prime chance to make the most of in-person networking and forge new connections as new companies enter, and existing ones

broaden their presence within the psychiatric drug development space. Designed to maximize your introduction to numerous new

individuals and serve as a catalyst for ongoing discussions during the summit.

10:30 AM Morning Break & Refreshments

Track 1: Discovery & Preclinical

Chair: Matthew Harlin, Senior Director, Discovery Research, Early Phase & Translational Medicine, Otsuka

Track 2: Translational & Clinical

Chair: Patricio O'Donnell, VP & Head of Translational Medicine, Sage Therapeutics

IDENTIFYING NEXT-GENERATION TARGETS: ENHANCING SPECIFICITY & REDUCING OFF-TARGET EFFECTS

EXPLORING INNOVATIVE METHODS FOR CLINICAL STRATIFICATION IN NEUROPSYCHIATRIC POPULATIONS

11:00 am Innovating Symptom-Based Discovery Approaches to Identify More Personalized Mood Disorder Drug Targets

  • Wayne Drevets Vice President, Disease Area Team Leader, Neuroscience, Janssen

Synopsis

  • Outlining promising new targets in mood disorders
  • Using precision psychiatry pioneering approaches to identify patients most likely to benefit

11:30 am Session Reserved: Eurofins

Synopsis

File:Eurofins Scientific Logo.svg - Wikipedia

11:40 am Profiling of a Novel Orally Bioavailable NMDA Receptor Antagonist in Rodents & Humans Demonstrates Value of Translational Biomarkers

  • Zoë Hughes Vice President, Head of Biology, Gilgamesh Pharmaceutical

Synopsis

  • In rodents GM-1020 achieves antidepressant-like activity at doses well below those causing motor impairment or disrupting sensory motor processing and has a better therapeutic window than ketamine
  • GM-1020 doses that were antidepressant in rats produced marked effects on EEG power spectrum.
  • In healthy volunteers doses of GM-1020 that produced similar robust effects on EEG were not associated with sedation, ataxia or dissociation paving the way for evaluating GM- 1020 in patients with MDD

11:00 am Employing a Biomarker-Driven Approach to Depression with Selection Based on Neuroendocrine Changes

Synopsis

  • Showcasing a precision medicine study of ANC-501 for MDD
  • Outlining the rationale for harnessing biomarker-driven stress hormone system disruptions
  • Next steps for advancing the precision medicine study into phase 3 and beyond

11:30 am Demonstrating Easily Accessible Parameters for Patient Selection in Major Depression Trials Utilizing Autonomic Markers for Treatment With the 11beta-HSD2 Inhibitors Glycyrrhizin & Enoxolone

  • Harald Murck Apl. Professor, Philipps-Universität Marburg

Synopsis

  • Demonstrate utility of patient selection based on biomarkers of autonomic regulation: blood pressure, heart rate, metabolism and endocrine markers
  • Demonstrating predictive value of autonomic markers for symptom improvement and treatment differentiation in major depression
  • Discussing an example based on the effect of the 11beta hydoxysteroid-dehydrogenase type 2 (11betaHSD2) inhibitors glycyrrhizin and enoxolone.

12:00 pm Unlocking the Potential of Digital Biomarkers to Overcome Biological Variability of Mood & Behaviour & Drive More Reliable Patient Selection

  • Snezana Milanovic Senior Director, TMED & Early Development, Sumitomo Pharma America Holdings, Inc.

Synopsis

  • Emphasizing the clinical value of objective and continuous measurements with wearable sensors
  • Challenges and pitfalls in developing minimal burden portable biomarker assessment tools
  • Selecting the right digital measures to identify and enrich patient population and generate Phase 1 through Phase 3 data
  • Capturing trait and/or state digital markers: the value of longitudinal assessments from Phase 1 to Phase 3 in drug development

12:30 PM Lunch & Networking

1:30 pm Applying Circuit-Based Approaches in Neuropsychiatric Drug Discovery

  • Nina Dedic Senior Director, Head of CNS Pharmacology, Discovery Sciences, Sumitomo Pharma Oncology

Synopsis

  • Understanding neurocircuit dysfunction in psychiatric and neurological disorders
  • Translating knowledge of disease and treatment mechanisms into new drug discovery projects
  • Identifying translational measures for agents with single versus multi-target pharmacology  
  • Exploring the cross-therapeutic potential of novel drug mechanisms

2:00 pm Roundtable Discussion | Identifying New Windows of Opportunity for Next-Generation Targets in Depression, Bipolar, PTSD & More

  • Zoë Hughes Vice President, Head of Biology, Gilgamesh Pharmaceutical
  • Nina Dedic Senior Director, Head of CNS Pharmacology, Discovery Sciences, Sumitomo Pharma Oncology

Synopsis

More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas.

In each indication:

Schizophrenia & Bipolar | Anxiety & PTSD | Depression

Are there any specific targets showing success in early studies?

What are the most promising tools available to aid discovery of new targets?

How can we progress to a more mechanism-based approach?

Moderator Feedback & Audience Debate

Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open wider audience debate.

1:30 pm Emerging Dosing Concepts for Plasticity-Enhancing Drugs: Insights Supporting a Phase 2 Study of Once-Weekly Oral Zelquistinel in MDD

Synopsis

  • Event-driven pharmacology is a new and important concept in emerging psychiatry treatments
  • Understanding metaplasticity and optimizing repeat dose strategies
  • Leveraging symptom clusters and objective biomarkers to stratify patients

2:00 pm Roundtable Discussion | Generating Additional Data Beyond Questionnaire & Mood Scale Ratings to Objectively Identify Patient Subtypes

  • Patricio O’Donnell Vice President & Head of Translational Medicine, SAGE Therapeutics
  • Snezana Milanovic Senior Director, TMED & Early Development, Sumitomo Pharma America Holdings, Inc.

Synopsis

More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas.

Selection based on:

Genetic Profiling | EEGs | Digital Biomarkers

What are the hesitancies to additional data collection and

what will it take to implement in large scale clinical practice?

Moderator Feedback & Audience Debate

Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open wider audience debate

3 PM Afternoon Break & Refreshments

REVIEWING PIPELINE PROGRESS & RECOGNIZING FUTURE INNNOVATION IN THE NEUROPSYCHIATRY TREATMENT LANDSCAPE

3:30 pm The Potential of the Muscarinic System: Highlighting the Journey of KarXT Through Phase 1-3

Synopsis

  • Evaluating the landscape of muscarinics in development for schizophrenia
  • Explaining how the combination KarXT minimizes off-target muscarinic side effects in the clinic
  • Outlining the factors that contributed to the strong results of the late phase trials

4:00 pm How Patient-Centric Prescription Digital Therapeutics Can Improve Clinical Outcomes

Synopsis

  • Showcasing the impact of digital treatments on neuropsychiatric disorders
  • Highlighting the potential for prescription digital therapeutics to work alongside pharmaceuticals to broaden accessibility and transform treatment options for patients
  • Future implications for drug-software combination products in the neuropsychiatry space

4:30 pm Investigating & Developing an Evidence-Based Prescription Digital Therapeutic (PDT) to Target Negative Symptoms of Schizophrenia

Synopsis

  • Approach employed to develop digital health products
  • Outlining efficacy signals seen in early studies
  • How evidence may support adoption of PDT

5:00 pm Chair’s Closing Remarks

  • Matthew Harlin Senior Director, CNS Discovery Research, Early Phase & Translational Medicine, Otsuka

5:10 pm Scientific Poster Session

Synopsis

This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of preclinical, translational, and clinical scientists eager to hear the latest advancements in neuropsychiatric therapeutic development, you will have the opportunity to display a poster presenting your own work and innovations. Don’t miss out on the chance to connect, learn, and present.