CONFERENCE DAY TWO - SEPTEMBER 26

8 AM Check-In, Coffee & Light Breakfast

9:05 am Chair’s Opening Remarks

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

REINVENTING THE REGULATORY LANDSCAPE & FUELING NEXT-GENERATION APPROVALS TO MEET THE GROWING UNMET NEED IN PSYCHIATRY

9:15 am Securing Alignment with Regulators Around the Endpoints Used in Trial Design

  • Matt Kuntz Vice President, Global Regulatory Strategy, Neuroscience, Abbvie

Synopsis

  • Translating learnings from approval success stories
  • Outlining general framework to apply and follow through developmental plan and into pivotal studies
  • Timing and considerations for which authorities to prioritize alignment with

9:45 am Panel Discussion | Moving the Gold Standard Beyond Subjective Mood Scales & Evaluating the Potential of Surrogate Endpoints

  • Berra Yazar-Klosinski Chief Scientific Officer, Lykos Therapeutics
  • Aaron Koenig Chief Medical Officer, Delix Therapeutics
  • Paul Imm Senior Director, Global Regulatory Affairs - Neuropsychiatry, Janssen
  • Ariana Mullin Director, Regulatory Affairs, Bristol Myers Squibb
  • Snezana Milanovic Senior Director, TMED & Early Development, Sumitomo Pharma America Holdings, Inc.

Synopsis

  • What are the right endpoints to use in indications, such as substance use disorder, where a defined mood scale is not clear?
  • Critically evaluating the value of Hamilton and MADRS scales: are there different, more objective ways of tracking the severity of various psychological illnesses?
  • Are we close to having a surrogate in psychiatry with any kind of biological or digital marker?

10:30 am Implementation of CNS Biomarkers in Clinical Trials

Synopsis

  • Current use of EEG biomarkers in clinical development projects
  • Adapted strategies for successful EEG biomarker implementation e.g. site interactions, choice of hardware
  • EEG data reporting and data visualization approaches

For an efficient patient trial management - Biotrial - Biotrial

11 AM Morning Break & Refreshments

Track 1: Discovery & Preclinical

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

Track 2: Translational & Clinical

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

EMPLOYING IN VITRO & IN VIVO TOOLS TO ASSESS PRECLINICAL DRUG ACTIVITY

NON-HALLUCINOGENIC PSYCHOPLASTOGENS: EXAMINING EARLY CLINICAL PROGRESS

11:30 am Sensorium Discovery Engine: Leveraging Human iPSC Cell Models to Drive Discovery of Novel Therapeutics for Neuropsychiatric & Neurological Disorders

Synopsis

  • Discovery Engine leverages human iPSC models, machine learning, and phenotypic screening to develop novel classifiers based on standard of care
  • Novel therapeutic compounds identified through Knowledge Graph screened in iPSC models to understand mechanisms and differentiation
  • Screening data used to nominate and develop novel therapeutics for the treatment of neuropsychiatric and neurological disease

12:00 pm Session Reserved: bit.bio

Synopsis

Sure, Bit Bio got some significant cash for its cell coding work. But it's  the insiders who are backing them that will garner the attention |  Cambridge Network

12:15 pm Examining the Preclinical Pharmacology of Novel Neuroplastogens

Synopsis

  • Presenting effects on in vivo structural and functional neuroplasticity
  • Activity in animal models of antidepressant activity
  • Opportunities across neuropsychiatric indications

11:30 am De-Risking the Translation & Early Development of Novel Neuroplastogens to the Clinic

Synopsis

  • Highlighting opportunity for compounds with novel neuroplasticity-promoting properties to rapidly treat MDD and other related disorders
  • Where do these neuroplastogens live within the new and emerging landscape of novel neuropsychiatric treatments?

12:00 pm Streamlining Translation of a Next-Generation Psilocybin Derivative to Reduce Behavioural Symptoms Associated with FTD

  • Jackie von Salm Co-Founder and Chief Scientific Officer, Psilera Bioscience

Synopsis

  • Expanding our understanding of non-SSRI serotonergics for symptom management of Frontotemporal Dementias (FTD)
  • Presenting the effects of a non-hallucinogenic psilocybin derivative, PSIL-006, on translational biomarkers for neuroinflammation and neuroplasticity
  • In vivo mouse models for neurodegeneration and psychiatric symptomology including compulsive behaviors, circadian rhythm, and apathy

12:30 pm Grounding the Excitement of Psychedelics: Developing Non-Hallucinogenic Compounds That Are Commercially Viable

Synopsis

  • Developing therapeutics that will be embraced by mainstream payers and realistically adopted by pharmaceutical companies
  • Considerations for patient adoption: eliminating the psychotropic acute phase of their dosing

12:45 PM Lunch & Networking

BIOMARKER DISCOVERY IN NEUROPSYCHIARTY: EVALUATING THE PROMISE OF FLUID & IMAGING MARKERS

EVALUATING CLINICAL PROGRESS & MODERNIZING CLINICAL TRIAL DESIGN PROTOCOLS

2:00 pm Exploring the Potential of Synaptic Markers in Patients with Psychosis

  • Matthew Johnson Senior Group Leader, The Broad Institute of MIT & Harvard

Synopsis

  • Outlining the proposed role of synapse dysfunction, microglia, and synaptic pruning in schizophrenia
  • Exploring the possible links between neuroinflammation and synaptic pruning
  • Highlighting the potential of synaptic pruning biomarkers in schizophrenia, bipolar and other psychiatric indications

2:30 pm Innovating Translatable Image-Based Tools & Measurements to Accelerate Clinical Progress of Psychiatric Drug Targets

Synopsis

  • Performing in vivo studies to identify translatable biomarkers of target engagement and pharmacodynamics
  • Understanding the role of specific targets and processes in preclinical systems
  • Overcoming translational barriers associated with neuroimaging for psychiatric disorders

2:00 pm Succeeding in Phase 3: Enhancing Signal & Minimizing Noise

  • George Papakostas Associate Executive Director, MGH CTNI, Massachusetts General Hospital

Synopsis

  • Choosing the right population for your study
  • Key elements in study design
  • Minimizing placebo response

2:30 pm Exploring Novel Innovation to Meet Significant Unmet Needs in Post-Traumatic Stress Disorder

Synopsis

  • Reviewing the current developmental landscape for treatment of neuropsychiatric symptoms in PTSD
  • Outlining where we have seen evidence of progress and where the field must improve
  • Uncovering significant learnings from past failings and optimistic implications for the future

3 PM Afternoon Break & Refreshments

EXPLORING REAL-WORLD OUTCOMES & ANTICIPATING COMMERCIAL BOTTLENECKS TO STREAMLINE PATH TO MARKET

3:30 pm Spotlighting Future Implications from the Recent & Growing Commercial Success of Spravato: Are Psychedelics Commercially Viable for Mental Health?

Synopsis

  • Interpreting the predicted trajectory of sales for Spravato
  • Evaluating the commercial viability of additional emerging psychedelic treatments
  • Anticipating & mitigating concerns of reimbursement

4:00 pm Value of Medical Affairs in Supporting a Successful Drug Launch in Neuropsychiatry

  • Moeen Panni Head of Neuropsychiatry, Medical Affairs, Biogen

Synopsis

  • Providing medical expertise to support new drug launch
  • Gaining clinician insights to inform strategy and decision making
  • Engaging with clinicians to support medical education
  • Developing medical materials and providing training
  • Supporting publications, phase IV and real-world evidence generation

4:30 pm Panel Discussion | Navigating the Commercial Challenges of Reimbursement & Market Access to Streamline Route to Market for Psychiatric Therapeutics

Synopsis

  • What does the infrastructure look like for commercializing neuropsychiatric products and getting payers to pay?
  • How can we lower human resource costs as much as possible to increase profitability?
  • How do we determine which areas are worth the greatest commercial investment in psychiatry?

5:00 pm Chair’s Closing Remarks & End of Conference

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