NQuantify

Expertise in Image Analysis for Neurodegenerative Diseases & Brain Cancer

Lowering Your Costs and Risks in Clinical Trials

Value NQuantify can bring to your company

lower costLower cost through shorter and smaller trials
trial and drug approvalImproved likelihood of successful outcome of trial and drug approval for desired claims
 clinical adoption Improved clinical adoption due to clearer patient benefit vs. risk profile

clinical trial90% of clinical trials fail

For example, in Alzheimer’s disease, only 1 of 244 compounds tested against the disease in clinical trials from 2002 to 2012 received FDA approval. 1 Of 83 Phase III clinical trials, not one met its primary endpoints. 2 Neurological drugs have the longest NDA review process. 3

patient selectionPoor patient selection

A recent clinical trial showed that 40% of patients who applied to participate didn’t have the disease, despite showing signs of early dementia. In another relevant Phase III Alzheimer’s trial, up to 25% of patients did not have the target for which the drug was expected to act. 4

trialOversized trials

Differences in subjective endpoints are often small and require long time frames and large cohorts to achieve statistical and clinical significance. 5

Smart Recruitment for a Successful Trial

Accurate, objective, sensitive and specific criteria for patient inclusion in the clinical trial ensures subjects actually have the disease in the study, improving likelihood of a successful trial outcome. 6

Neuroimaging analysis provides solid quantitative criteria for patient inclusion which avoid the use of ambiguous and highly subjective estimators, such as psychologic evaluations.

Better Data, Less Failures

Objective, sensitive and specific measures for effectiveness (primary endpoint) provide robust evidence, increasing likelihood of a successful trial outcome.7

Neuroimaging provides reliable measures of the structure and activity of the brain. It allows for the monitoring of the effect of a drug through quantitative methods yielding precise and robust demonstration of effectiveness.

Reducing the Size, Reducing the Cost

Trials with clear and objective measures of effectiveness, such as imaging, may require smaller cohorts to show it. 8

Quantitative biomarkers provide improved accuracy with both patient selection criteria and measurement of effectiveness allowing for smaller and shorter trials by reducing outcome’s variability in agreement with FDA recommendations.

“The prospective use of any patient characteristic to select a study population in which detection of a drug effect is more likely than it would be in an unselected population”.

FDA guidance for Enrichment strategies.9

Clearer Data, Faster Approval

Drugs showing clear effectiveness have a smoother and likely shorter regulatory review due to an improved risk vs Benefit analysis. 10

Neuroimaging approaches produce the robust and conclusive outcomes required for a successful drug-approval review. Quantitative and objective nature of NQuantify is supportive of the FDA’s primary requirements: clear, conspicuous, and neutral evidence. 11

IMPROVING YOUR TRIALSNQuantify brings next-generation neuroimaging to pharma industry needs

acepted and validated published algorithms

No black box

We only apply widely accepted and validated published algorithms. Proprietary algorithms do not offer transparency and traceability for drug regulatory approval process.

the best biomarkers and assessment method

Customization

We work with you to select the best biomarkers and assessment method for your trial. Our fast processing and modular computational architectures allow us to offer tailored solutions in a scalable and multipurpose way.

expertise is focussed on neurodegenerative diseases

Focus on brain

Our expertise is focused on neurodegenerative diseases -such as Alzheimer diseases and Multiple sclerosis- brain cancer and other CNS diseases. Ask us about the CNS disease you are working on.

Customer focus

Customer focus

Our focus is your focus: Successful completion of the clinical trial as quickly and inexpensively as possible leading to drug regulatory approval and commercialization. We bring science and technology to the needs of the pharma industry.

Target diseases

ALZHEIMER

There has been no real success in drug development for a disease suffered by nearly 35.6 million people worldwide. Quantitative neuroimaging may make the difference.

The subjective nature of the commonly used clinical endpoints have been revealed as an Achilles heel for AD clinical trial’s design. It results in poor patient recruitments, weak statistics and non-conclusive results. The use of quantitative biomarkers coming from neuroimaging applied to a careful patient recruitment process seems to have made the difference in a long trajectory of failures in AD clinical trials. A case of success is beautifully explained here 12.

MULTIPLE SCLEROSIS

MS is a paradigmatic example of how neuroimaging has accelerated new therapy development. Diagnosis and clinical trials are inconceivable without brain imaging for MS.

Neuroimaging has contributed to position MS as one of the most successful targets for drug development, reaching success rates of 27%, almost the triple when compared to the rates for the whole industry (10%).13 Currently, MRI lesion activity is gaining more and more weight as a qualified biomarker, being accepted as a surrogate primary outcome measure in clinical trials 14. With a high rate of success, the real challenge for the pharma companies is the competition for suitable patients 15. Quantitative neuroimaging provides objective criteria for a finer patient selection, allowing for reducing the size and needs of the trials in such a competing scenario.

BRAIN CANCER

Although it is a heterogenous disease containing a variety of types of brain tumors, neuroimaging lies at the heart of the evaluation criteria.

The currently internationally-adopted RECIST 16 and RANO 17 criteria (the first for solid and brain tumors in general and the second more specific for gliomas) compile those neuroimaging standards applied in almost any clinical trials for theses diseases. The continuing improvements have provided for solid quantitative measures of effectiveness with good examples of success. 18, 19

OTHER CNS DISEASES

Neuroimaging biomarkers are applied to a number of neurological disease. Some notorious examples are epilepsia, schizophrenia and autism, among others.

Quantitative neuroimaging offers large spectrum of techniques that provides quality information about structural and functional variations occurring in patient’s brain. Functional neuroimaging biomarkers may provide objective indicators for patients with schizophrenia and autism. Epilepsia may be beneficed from both structural functional approaches. Again the major advantage comes from the use of subjective descriptors based on human evaluation that weaken statistics and contribute to provide inconclusive outcomes.

The team

  • Senior scientist

    Domingo López-Rodríguez,PhD

    Senior scientist

    Neuroimaging analysis

    Senior scientist

    Carlos Rodríguez-Caso,PhD

    Senior scientist

    Complex systems

    Biomedical engineer

    Sara Reyes

    Scientist Assistant

    Neuroimaging

    Chief Operating Officer

    Jose Manuel Bernal

    Chief Operating Officer

  • Data scientist

    David Ballester

    Data scientist

    Big data architect

    Computer engineer

    Jose Carlos Trillo

    Computer engineer

    Information and security

    Computer engineer

    Juan Francisco Chico

    Computer engineer

    High performance computing

    CXO

    Juanjo Valderrama

    CXO

    Product Manager

  • Neuroimaging consultant

    Ramiro Jiménez

    Neuroimaging consultant

    Design and marketing

    Beatriz Vega

    Design and marketing

    CFO

    Raquel Caba

    CFO & General Manager

Drop us a line

Address

Edif.Bioinnovación. Parque Tecnológico de Andalucía , Málaga. Spain.

Phone

+34 951 136 978 / +34 653 937 331