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QSP Modeling Platforms for Neuroscience

Quantitative Systems Pharmacology (QSP) Modeling Platforms for Neuroscience

QSP models fitted for neuro indications

At Certara, we use Quantitative Systems Pharmacology (QSP) modeling platforms for neuroscience drug discovery to address the unique challenges in neuro indications. QSP modeling enhances the probability of successful drug development in neuro indications, by generating simulation tools incorporating critical biology relevant to brain function and cognition. Drug development for neurological diseases presents a unique set of challenges, including enormous heterogeneity and complex disease etiology, reliance on indirect biomarkers of brain pathology and surrogate endpoints, and difficulties with clinical trial recruitment. With QSP models, we can perform in silico studies to examine the effects of population dynamics via the generation of virtual patients to inform dosing, patient selection, co-medication effects, and competitor differentiation. Neuroscience QSP is optimally suited to investigate the effect of key and novel biomarkers specifically tailored to novel therapeutics on functional clinical outcomes, allowing you to best plan clinical trials with patient-centric outcomes. 

Certara’s Experience in Neuroscience QSP Projects

Our neuroscience QSP team has worked on projects involving various neurodegenerative diseases.

  • Alzheimer’s Disease
  • Amyotrophic lateral sclerosis (ALS)
  • Chronic pain
  • CNS disorders
  • CSF1R-related ALSP
  • Depression
  • Fibromyalgia
  • Frontotemporal Dementia
  • GBA-PD
  • Migraine
  • Mood and Psychotic Disorders
  • Multiple System Atrophy (MSA)
  • Multiple Sclerosis
  • Narcolepsy
  • Neuronal Hyperexcitability Disorders
  • Pain
  • Parkinson’s Disease (PD)

QSP Modeling for Alzheimer’s Disease 

Certara’s QSP model for Alzheimer’s Disease comprises of individual modules that can be mixed and matched to build a customized model to address specific hypotheses and be used to compare novel therapeutics with current competitors on the market. Incorporating quantitative strategies maximizes model-informed drug development decisions.   

Characteristics 

  • Aβ and tau pathology 
  • Disease progression 
  • BOLDfMRI 
  • Comedications and Standard-of-care (SoC) medication 
  • Tau propagation 
  • Adverse events (ARIA incidence
  • Genotype (ex. APOE, 5HT-R, DA-R) 
  • Brain electrophysiology: circuit, neuron, and receptor activity 

Biomarkers/Readouts 

  • CSF and plasma biomarkers  
  • Aβ42/40, p-tau, t-tau levels 
  • Imaging biomarkers (PET SUVR/centiloids) 
  • Volumetric Brain Changes (MRI) 
  • Microglial activation 
  • Cytokine release 
  • Brain Activity 
  • Cognition (e.g. CDR-SOB, ADAS-Cog) 
  • Agitation (CMAI-ABID) 

Drug Modalities  

  • Monoclonal antibody 
  • Bispecific antibody 
  • Small molecule 
  • Prodrug 
  • ASO 
  • Gene Therapy 
  • BBB shuttle 

Resources 

QSP Modeling for Parkinson’s Disease 

Certara’s QSP model for Parkinson’s Disease is state of the art and leading the advancement of QSP modeling in the field. Our detailed QSP model of the key brain systems involved in Parkinson’s Disease allow us to examine how our partner’s therapy can treat disease symptoms and ultimately affect cognitive outcomes (ex. UPDRS-Unified Parkinson’s Disease Rating Scale).  

Characteristics 

  • Anatomical connectivity 
  • Clinically relevant neuronal firing property (LFP in STN) 
  • Standard-of-care (SoC) medication 
  • Alpha-synuclein pathology 

Biomarkers/Readouts 

  • CSF a-synuclein dynamics
  • UPDRS Changes 
  • Time Off Changes​ 
  • Power spectrum of LPF in various basal ganglia regions 
  • BOLDfMRI  

Drug Modalities  

  • Optimized for augmentation therapy 
  • Effect of PK properties on Time-Off optimization 
  • Simulating PD-PD interactions of disease-modifying drug with SoC on functional outcomes

Resources 

Other QSP Models for Neurodegenerative Diseases 

  • Psychotic Disorders 
  • Pain 
  • Epilepsy 

For more information on our platform models or custom models, contact us

Leading Experts in QSP for Neuroscience 

Hugo Geerts

Head of Neuroscience Modelling, QSP R&D

With 20+ years in drug discovery and another 20 years pioneering QSP modeling in neurology, Hugo now leads Certara’s neurodegenerative QSP consortium, shaping the future of the field. 


Shaina Short

Sr Scientist, QSP R&D

With a Ph.D. in Neuroscience and over 15 years of experience in neuroscience QSP and computational neuroscience modeling, Shaina leads consultancy and the development of neurodegenerative and neurological QSP modeling platforms at Certara, advancing therapies from early discovery to market competition. 


Sarah DiBartolo

Sr Scientist, QSP Consultancy

With 10+ years experience, Sarah’s expertise in QSP modeling spans the entire drug development pipeline, from early feasibility assessment to clinical and post-market analyses, with a focus on Alzheimer’s Disease. 

Talk to a Certara Expert Today

For more information on our current platform models or custom models, contact us. 

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Resources