A quick review from the Roth concert makes it clear that the FDACNS trials process is a mess lookin for some way to get cleaned up. ERP systems and AI offer a possible save the AXX move fore FDA CNS trials processing. The price of poker is about to go up substantially. BP is so screwed.
Event-related potentials (ERPs) are changes in the electroencephalogram (EEG) caused by sensory and cognitive processes. In schizophrenia, ERP deficits are associated with cortical synaptic pathophysiology, such as NMDAr (N-methyl-D-aspartate receptor) hypofunction, which is related to cognitive impairment experienced by these patients. For example, mismatch negativity (MMN) is an ERP associated with auditory novelty detection. MMN is impaired and correlates with cognitive and global function in patients with schizophrenia. The ability to measure a biomarker like MMN may play a predictive role in schizophrenia drug development.
About the ERP Biomarker Qualification Consortium, LLC
The ERP Biomarker Qualification Consortium, LLC, a subsidiary of Neuronetrix Solutions, LLC (dba Cognision), is a pharmaceutical industry collaboration that was established to formally qualify normative event-related potential (ERP) biomarkers with the goal of advancing and streamlining the clinical development of new investigational therapies for people with schizophrenia. Founding principal members include Alkermes, Inc., Anavex Life Sciences Corp., Cadent Therapeutics, H. Lundbeck A/S, Merck (known as MSD outside the United States and Canada), Neuronetrix Solutions, LLC (dba Cognision), Sage Therapeutics, Inc., and Takeda Pharmaceutical Company Limited
Launched two days ago - Ereshefsky's been working on it for almost a year:
Chief Scientific Officer - Early Phase Company NameCollaborative Neuroscience Network, LLC. Dates Employed May 2018 – Present Employment Duration 11 mos Location So. CAl Have conducted 200+ early phase trials in CNS, medical, Asian bridging, and HNV populations including FiH SAD/MAD, DDI, BA/BE, 505b2, and POCs. Have expertise in designing and conducting studies incorporating experimental medicine strategies, as well as translational drug development tools supporting neurocircuitry/biomarker based (RDoC) strategies, i.e., continuous CSF sampling, QEEG, ERP, PSG, sMRI, fMRI, PET, and cognitive and behavioral paradigms.