

CNS Biomarkers + Digital Health Consulting for Healthcare & Life Sciences
About Us
Brainformatika™ is a CNS biomarkers and digital health consulting firm, with a focus on providing strategy, research, innovation, and medical affairs services. We work with a variety of healthcare and life sciences organizations to advance data-driven, science-based, human-centered solutions:
- Startups (early & late-stage)
- Healthtech & Medtech
- Pharma & Biotech
- Medical Devices
- Health Systems
- Nonprofits
- VC Firms
- Payers
Founded and led by Igor Korolev, DO, PhD – a physician-neuroscientist with 20+ years of experience in healthcare and life sciences along with digital health, data science, and clinical research expertise – the firm leverages a broad network of experts in healthcare, life sciences, business, and technology in our advisory and consulting work.
Services

Strategy
- CNS Biomarkers & Diagnostics
- Digital Health & AI Use Cases
- Real-World Data & Evidence
- Research & Development
- Business Models / GTM
- Business Development
- Growth & Partnerships
- Regulatory Pathways

Research
- Scientific Due Diligence
- Evidence Synthesis
- Literature Reviews
- Market Research
- Study Design
- Data Analysis

Innovation
- Healthcare Domain Expertise
- Product / Service Feedback
- Innovation Hackathons
- Product Development
- Ideation Workshops
- Product-Market Fit
- Fundraising

Medical Affairs
- Scientific Content Development
- Medical & Scientific Writing
- Medical Communications
- KOL Engagement
- Education
Case Studies
(Coming Soon!)

Predicting Alzheimer's disease using biomarkers & machine learning

Digital health strategy for Alzheimer's disease-modifying therapeutics

Evidence synthesis on biomarkers of depression for drug development

Digital health technologies for monitoring CNS & mental health

Digital cognitive assessment solutions for pharmaceutical R&D

Integrated digital health technology platforms in pharmaceutical R&D

Evidence synthesis & assessment for digital health technologies

Digital health technologies for monitoring kidney health & disease

Strategy for direct-to-consumer digital, imaging, & blood biomarkers

Synthetic data for real-world evidence & health outcomes research

Healthcare innovation crowdsourcing via virtual hackathons & datathons
CNS Biomarkers
CNS biomarkers can be obtained using several technologies and modalities (digital, imaging, fluid, neurophysiological) to assess various aspects of brain structure, function, and biochemistry along with behavior and cognition. CNS biomarkers have multiple use cases in healthcare and clinical research: clinical assessment, diagnosis, and prognosis; patient phenotyping, enrichment, and stratification; use as pharmacodynamic measures and for treatment response monitoring and prediction. CNS biomarkers can provide valuable insights across a variety of brain / mental health conditions (e.g. Alzheimer's disease, Parkinson's disease, epilepsy, schizophrenia, depression, PTSD, ADHD, autism, concussion / traumatic brain injury) as well as drug mechanisms and other therapeutic interventions.

What is Digital Health?
Digital health refers to data-driven tools and technologies that support health, wellness, and patient care across a variety of applications (e.g. clinical, research, operational, informational). The following chart compares and provides examples of digital health, digital medicine, and digital therapeutics.#


An alternative approach to classifying Digital Health Technologies (DHTs) is by type and intended use. DHTs can be classified into eight categories on a spectrum based on their proximity to and impact on the patient, from industry and administrative-facing to healthcare provider-facing to patient-facing DHTs. Patient-facing DHTs can be further differentiated based on the level of risk, nature of clinical claims, as well as evidence and regulatory requirements. Health and wellness DHTs generally make no claims and have minimal evidence and regulatory requirements. Diagnostic and therapeutic DHTs have the most stringent requirements.^

REFERENCES
# https://www.dimesociety.org/digital-health-digital-medicine-digital-therapeutics-dtx-whats-the-difference
^ https://www.dtxalliance.org/wp-content/uploads/2023/06/Guidance-to-Industry-Classification-of-Digital-Health-Technologies-2023Jun05.pdf
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