Neurocience Imaging | CNS Drug Development & Clinical Trials

Overview

Invicro has spent 20 years specializing in neuroscience imaging solutions for preclinical, early phase and late phase clinical studies. Our capabilities span from in vitro assays to in vivo imaging using PET, SPECT and MRI imaging biomarkers in CNS drug development and CNS clinical trials. We have expertise in coordinating worldwide multi-center imaging studies, and providing management and oversight of radiotracer supply for both commercial and non-commercially available agents. Solutions include:

CNS Expertise

Invicro has industry leading operational oversight and extensive experience with preclinical, early phase (single-site) and late phase (multi-center) trials. This enables us to provide sponsors with unparalleled support and guidance to ensure successful study execution.

- 370+ clinical imaging trials managed
  - >200 AD and PD Studies with >56,000 subjects imaged
- 90+ Phase I & II, multi-center trials conducted with PET and MRI
- 2100+ imaging centers qualified worldwide
- Two “in-house”clinical imaging centers
- Development and application of 90+ novel neuro imaging agents
- Redefining imaging analytic techniques
  - Amyloid, Tau and Dat IQ analytics
  - SUVR analysis
  - Centiloid analysis

Solutions

Preclinical

Invicro has many years of experience supporting preclinical CNS drug discovery and development programs. Our tissue biomarker services along with our functional and molecular imaging solutions are well-suited for non-invasive longitudinal studies to provide multiple readouts, such as biodistribution, target-occupancy relationships and therapeutic efficacy.

Tissue Biomarker Development
Biodistribution
Target Engagement & Occupancy Studies
Neuropharmacodynamics
Neurotransmitter Release
Biological Therapeutics Pharmacokinetics
Neuroinflammation
Neuromodulator Analysis
Neurogenetics

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Early Phase Clinical

We support a wide range of first-in-human, pre-proof of concept CNS clinical trial imaging studies spanning phases I-IIa.

MRI

Brain volumetric analysis
Changes in brain activity and cerebral blood flow
Tissue microstructure
Tissue susceptibility
Pharmacodynamic responses

PET

Radioligand dosimetry
Quantitative drug brain distribution
Target engagement
Drug concentration – Target occupancy relationship
Pharmacodynamic responses

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Late Phase Clinical

Invicro’s Late Phase (IIb-IV) CNS clinical trial imaging capabilities and tissue biomarker services enable the execution and delivery of large-scale clinical trials for diagnosis, progression, and disease monitoring through optimized study design, world-wide imaging site set up, iPACs driven data management and quantitative analytics. This end-to-end service is deployed in the necessary regulatory infrastructure to deliver clinical trial results ready for regulatory filing.

Tissue biomarker testing and development
Core lab capabilities with complete project support
Clinical imaging center evaluation, selection, set up, training and management
Rapid analysis for study eligibility
Quantitative analysis for monitoring drug effect
Image data management and regulatory compliance services

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Advanced Image Analytics

We develop advanced algorithms and pipelines to solve complex image science problems, including the use of machine learning and deep learning techniques. These methods are built on our deep scientific domain knowledge to deliver optimal analytical performance and relevant biological outcome measures for a variety of tasks, including:

IQ Analytics Suite – Tau, Amyloid and DaT Imaging
Batch Image Triage & QC
Tracer Kinetic Analysis
Tissue Biomarker Analysis
Biomathematical Modeling
Image Registration, Segmentation and Volumetric Analysis
Radiation Dosimetry

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Invicro's CNS Leaders

Roger Gunn, Ph.D. | Chief Scientific Officer, Neuroscience

Dr. Gunn is an international expert in biomedical imaging who has made significant contributions to the development of novel imaging biomarkers and quantitative algorithms for a wide range of imaging applications with a focus on the neurosciences.

Ilan Rabiner, M.D. | EVP, Head of Translational Applications

Dr. Rabiner is a psychiatrist and psycho-pharmacologist who was part of the team that set up the GlaxoSmithKline Clinical Imaging Centre, which transitioned to become Imanova and later acquired by Invicro.

Kenneth Marek, M.D. | Distinguished Scientist

Dr. Marek is an Internationally recognized expert in imaging of neurodegenerative disorders and has made significant contributions to early detection and diagnostic use of radiotracers for AD, PD, HD and other disorders.

John Seibyl, M.D. | Distinguished Scientist

Dr. Seibyl is an international expert on PET and SPECT neuroimaging and he has made significant contributions to the development of visual and quantitative analysis for imaging in neurodegenerative and neuropsychiatric disorders.

Modalities

Core histology
Multiplex Immunohistochemistry (IHC)
Multiplex Immunofluorescence (IF)
Quanticell™ high sensitivity immunohistochemistry (IHC)
RNAScope® ISH
BaseScope™ ISH
miRNAScope™ ISH
PET
SPECT
MRI
CT
Additional novel modalities include: Resting state fMRI, phMRI, MRS, DCE-MRI, ALS and Dynamic X-Ray