Scientific and Regulatory Consulting and Due Diligence

Developing diagnostics and treatments for brain disorders

The Global Impact of Brain Disorders

Brain disorders are the leading cause of disability and death worldwide, second only to cardiovascular diseases View Article. Currently, over one billion people are affected globally, and the number of patients is growing rapidly with the aging and increasing global population View Article.

Acquired neurological disorders, traumatic brain injury, and concussion affect ~70 million people worldwide each year, adding to the millions who are already suffering from a wide variety of TBI-induced diseases. Current treatments are aimed to alleviate symptoms, not the underlying pathology, causing significant side effects.

Challenges in TBI/Concussion Treatment

Unmet needs

Effective disease-modifying treatments

Roadblocks

Lack of high-fidelity modeling mimicking clinical trial design for candidate drug screening

Lack of adaptive molecular diagnostic platforms that can identify the molecular pathologies of TBI-induced neurological conditions

Lack of algorithms that can integrate molecular level information with other modalities (e.g. neuroimaging) and with clinical symptoms to assess therapeutic efficacy

Opportunities

The rapid development of various Artificial Intelligence (AI) and Machine Learning (ML) technologies and applications open new opportunities to identify the best diagnostic toolsets and to connect various diagnostic modalities that will identify the molecular pathobiology underlying clinical symptoms that will enable to identify molecular targets for drug development and assess treatment efficacy.

What we offer

Our comprehensive suite of services to support your drug development and diagnostic needs.

Preclinical Drug Screening

Subject matter expertise in designing clinical trial-based preclinical platforms for candidate drug screening.

Diagnostic Toolsets

Subject matter expertise in developing and validating molecular level diagnostic toolsets to assess drug efficacy.

R&D Strategy Evaluation

Subject matter expertise in developing and validating molecular level diagnostic toolsets to assess drug efficacy.

Regulatory Affairs

Support services for healthcare investors, from opportunity mapping, due diligence, and other partnership and investment decisions.

Quality & Compliance

Subject matter expertise in developing and validating molecular level diagnostic toolsets to assess drug efficacy.

Who we are, the Principals

NEUROmetix, LLC was founded by a physician-neuroscientist, a regulatory compliance & strategy expert, and a marketing & business development executive, each with decades of experience and accomplishments in their respective fields.

Denes has over 30 years of experience in biomedical research and development working both in academia and industry providing consulting for preclinical and clinical studies, published over 100 peer reviewed research articles, book chapters, reviews, regularly speak at national and international scientific meetings. He has successfully completed multiple large national and international R&D projects, assisted companies in product development.

Denes V. Agoston, M.D., Ph.D.

Scientific

Alan has over 35 years of experience in the areas of vaccines, plasma products, and biologics product development and manufacturing and directed till his retirement the Public Health and Security Action Team Program within the Office of the Commissioner at the FDA. He has lectured globally on using effective quality and compliance programs to enhance product development and manufacturing and on effective engagement with FDA throughout the product development process

Alan Liss, Ph.D.

Regulatory

Beth is an international business executive with over 30 years of experience in Life Sciences spanning technical, operational and project management, marketing, and business development disciplines. She has led the development and implementation of strategic marketing plans, corporate public image, and has guided companies to achieve revenue growth, increase client base by putting together successful business plans and funding applications to create and develop successful global sales efforts.

Beth Carino, M.S.

Business Development