Mission

Operationalize and qualify

ERP Biomarkers for use in

large-scale therapeutic CNS trials.

Charter

Introduction

The pursuit of effective pharmacotherapies to treat the broad range of symptoms in schizophrenia 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

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

  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

Alkermes, Inc. (ALKS)

Anavex Life Sciences Corp. (AVXL)

Cadent Therapeutics

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY)

Merck (known as MSD outside the United States and Canada) (MRK)

Sage Therapeutics, Inc.

Takeda Pharmaceutical Company Limited (TAK)

Biomarker Companies

Scientific Advisors

Daniel Javitt, MD, Glytech, Inc

Richard Keefe, PhD, CEO, VeraSci

David P. Walling, PhD, CEO, CNS Network, LLC

Larry Ereshefsky, PharmD, Follow the Molecule, LLC

Stakeholder Benefits

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

  • 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

Contact Us

Please tell us about your interest and we will followup shortly.

ERP Biomarker Qualification Consortium

1044 E Chestnut St, Louisville, KY 40204, US

(502) 561-9040