ERP Biomarker Qualification Consortium

ERP Biomarker Qualification ConsortiumERP Biomarker Qualification ConsortiumERP Biomarker Qualification Consortium

ERP Biomarker Qualification Consortium

ERP Biomarker Qualification ConsortiumERP Biomarker Qualification ConsortiumERP Biomarker Qualification Consortium
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Mission

MissionMissionMission

Operationalize and qualify

ERP Biomarkers for use in

large-scale therapeutic CNS trials.

Contact Us

Phone: (502) 561-9040 x7001

Charter

Introduction

Introduction

Introduction

The pursuit of effective pharmacotherapies to treat the broad range of symptoms in Alzheimer's disease, schizophrenia, Parkinson's dementia and other cognitive disorders has been complex and difficult.  An important reason for this has been the lack of qualified biomarkers of the underlying synaptopathologic processes associated with thes

The pursuit of effective pharmacotherapies to treat the broad range of symptoms in Alzheimer's disease, schizophrenia, Parkinson's dementia and other cognitive disorders has been complex and difficult.  An important reason for this has been the lack of qualified biomarkers of the underlying synaptopathologic processes associated with these diseases. For more than 30 years researchers in both academy and pharma have employed advanced event-related potential (ERP) techniques to make reliable measurements of cortical function.  When properly implemented these ERP biomarkers can be sensitive measures of the synaptopathology in schizophrenia, dementia, and similar disorders.  They could also prove to be the enabling technology to precisely measure the brain’s response to pharmacotherapies in complex CNS clinical trials. Unfortunately equipment complexity and methodological variability in ERP testing has led to inconsistent results, thus limiting the technique to research labs and a few small pharma-sponsored trials. Now, with the availability of low-cost, easy-to-use, automated equipment like the COGNISION® System these ERP techniques could be operationalized to scale in many pharmaceutical trials of neurotransmission-targeting compounds.

Purpose

Introduction

Introduction

This Consortium will bring together industry, academic, and regulatory stakeholders in a spirit of pre-competitive cooperation to ensure that robust and reliable ERP biomarkers can be collected in target clinical populations, such as schizophrenic patients, in real-world settings.  The Consortium will communicate, collaborate, support, an

This Consortium will bring together industry, academic, and regulatory stakeholders in a spirit of pre-competitive cooperation to ensure that robust and reliable ERP biomarkers can be collected in target clinical populations, such as schizophrenic patients, in real-world settings.  The Consortium will communicate, collaborate, support, and execute this effort to standardize and qualify the equipment and methods necessary to meet the objectives.  Furthermore, the Consortium will provide the structure, governance, funding, and management to perform all necessary activities.

Goals

Introduction

Goals

  1. Develop and document standardized methods and detailed SOPs for performing scientifically validated ERP tests in clinical populations and for performing automated, pipelined analyses.
  2. Establish normative ERP biomarker metrics in healthy subjects reflective of the population used in Phase 1 safety trials, and to characterize the biomarker r

  1. Develop and document standardized methods and detailed SOPs for performing scientifically validated ERP tests in clinical populations and for performing automated, pipelined analyses.
  2. Establish normative ERP biomarker metrics in healthy subjects reflective of the population used in Phase 1 safety trials, and to characterize the biomarker range and variability in those populations.
  3. Establish normative ERP biomarker metrics in a wide range of schizophrenic patients and to characterize the biomarker range and variability in this patient population.
  4. Calibrate PD effects on ERP biomarkers using well-replicated clinical pharmacological paradigms which mimic the impairment observed in schizophrenic patients.
  5. Formally qualify ERP biomarkers for use in drug trials under the FDA Drug Development Tools Qualification Program.

Members

Pharmaceutical Companies

Pharmaceutical Companies

Pharmaceutical Companies

AbbVie Inc. (ABBV)

Alkermes, Inc. (ALKS)

Anavex Life Sciences Corp. (AVXL)

Astellas Pharma US (ALMPY)

Lundbeck (LUN.CO, LUN DC, HLUYY)

Merck & Co (MRK)

Neurocrine Biosciences (NBIX)

Novartis (NVS)

Sage Therapeutics, Inc. (SAGE)

Takeda Pharmaceutical (TAK)

Biomarker Companies

Pharmaceutical Companies

Pharmaceutical Companies

Cognision

Scientific Advisors

Pharmaceutical Companies

Scientific Advisors

Daniel Javitt, MD, Columbia University

Daniel Mathalon, MD, UCSF

Richard Keefe, PhD, CEO, VeraSci

William Potter, MD, PhD

David P. Walling, PhD, Apex Early Phase

Larry Ereshefsky, PharmD, Follow the Molecule

Stakeholder Benefits

Stakeholders

Benefits to Stakeholders

Benefits to Stakeholders

  • Pharmaceutical companies developing compounds to treat schizophrenia and other cognitive disorders
  • ERP biomarker companies
  • Clinical study sites and site service providers
  • Contract research organizations (CRO)
  • Key opinion leaders (KOL) in relevant academic, scientific, and clinical areas
  • FDA Center for Drug Evaluation and Research (CDER)
  • FDA Drug Development Tools (DDT) Qualification Programs

 

Benefits to Stakeholders

Benefits to Stakeholders

Benefits to Stakeholders

  • Reduced operational risks and costs in employing EEG/ERP biomarkers in therapeutic trials
  • Increased statistical power of EEG/ERP biomarkers to help minimize trial size and cost • Streamlined regulatory process for trials leveraging the EEG/ERP biomarkers
  • Demonstrated expertise and validated methods in implementing ERP biomarkers for pharma 

  • Reduced operational risks and costs in employing EEG/ERP biomarkers in therapeutic trials
  • Increased statistical power of EEG/ERP biomarkers to help minimize trial size and cost • Streamlined regulatory process for trials leveraging the EEG/ERP biomarkers
  • Demonstrated expertise and validated methods in implementing ERP biomarkers for pharma trials by member CROs and study sites
  • Correlations to standard psychometric testing instruments

Clinical Studies

Benefits to Stakeholders

Clinical Studies

  • EBS-A:
    Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
  • EBS-B:
    Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers

PRESENTATIONS, PUBLICATIONS, & STUDY DATA

Presentations

Shared Publication Data

Presentations

Scalable Implementation and FDA Qualification of Event-Related Potential Biomarkers for Drug Development in Schizophrenia


Validation of ERP biomarkers in a pre-competitive, industry-led study in schizophrenia and healthy subjects

Publications

Shared Publication Data

Presentations

Validation of a Suite of ERP and QEEG Biomarkers in a Pre-Competitive, Industry-Led Study in Subjects with Schizophrenia and Healthy Volunteers

Shared Publication Data

Shared Publication Data

Shared Publication Data

Validation of a Suite of ERP and QEEG Biomarkers in a Pre-Competitive, Industry-Led Study in Subjects with Schizophrenia and Healthy Volunteers

NEWS

Pharma Consortium Publishes Results of Large EEG/ERP Biomarker Study in Subjects with Schizophrenia and Healthy Volunteers


Pharma Industry Consortium Completes Brain Wave Study of Ketamine Effects on Healthy Volunteers


Industry Consortium Launched to Qualify Biomarkers for Schizophrenia Drug Development


The Hunt for Schizophrenia Biomarkers 

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ERP Biomarker Qualification Consortium

1044 E Chestnut St, Louisville, KY 40204, US

(502) 561-9040



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