AI-Driven Drug Development & Clinical Data Platform

AI-Driven Drug Development & Clinical Data Platform Alt

A unified platform that centralizes clinical, imaging, sensor, laboratory, and real-world data – enabling faster insights, automated workflows, and compliant decision-making across the entire drug development lifecycle.

Trusted by Industry Leaders:

Stage 1 – Pre-Clinical Research

Platform Overview Drug Development Lifecycle

Platform Capabilities

1 Multi-modal data ingestion (omics, imaging, toxicology, in vitro/in vivo studies)

2 Automated data harmonization & metadata mapping

3 Toxicity, safety & PK/PD analytics dashboards

4 Early-signal detection for adverse responses

5 IND-ready documentation generation

Customized Platform in Action

AI Cardiac Diagnostics Software

AI cardiac diagnostics software using real-time ECG, PCG, and PPG signal processing.

99%

Accuracy – exceeded legacy PoC performance

4 weeks

To validate the startup’s business hypothesis

Stage 2 – Clinical Research (Phase I–III)

Platform Overview Drug Development Lifecycle

Platform Capabilities

1 Multi-modal data ingestion (omics, imaging, toxicology, in vitro/in vivo studies)

2 Automated data harmonization & metadata mapping

3 Toxicity, safety & PK/PD analytics dashboards

4 Early-signal detection for adverse responses

5 IND-ready documentation generation

Customized Platform in Action

Computer Vision System for Real-Time Vital Signs Detection

AI cardiac diagnostics software using real-time ECG, PCG, and PPG signal processing.

90%

Accuracy in blood pressure measurement

<5 BPM

Heart rate measurement error

100%

Contactless vitals measurement

Stage 3 – Regulatory Review (NDA/BLA Submission)

Platform Overview Drug Development Lifecycle

Platform Capabilities

1 Automated preparation of submission-ready reports (FDA/EMA formats)

2 Evidence aggregation from all study phases

3 Full audit trails & traceability

4 Consistency checks, anomaly detection & compliance validation

5 Secure document management for NDA/BLA packages

Customized Platform in Action

Centralized Data Infrastructure and Automated Reporting System

Fully centralized enterprise data warehouse.

50%

Faster reporting cycles

1,000+

Employee hours saved annually

45%

Reduction in invoice/payment delays

Stage 4 – FDA/EMA Approval Support

Platform Overview Drug Development Lifecycle

Platform Capabilities

1 Rapid data retrieval for regulatory questions

2 Automated audit responses

3 Real-time evidence dashboards for approval teams

4 Version control for all regulatory materials

Customized Platform in Action

AI-Based Readmission Prediction Service

Integrated into ICS’s clinical platform.

$8M

Savings during 3-month observation period

32%

Drop in readmissions within 90 days of pilot rollout

84%

Of flagged high-risk patients

Stage 4 – Post-Market Safety Monitoring (Phase IV)

Platform Overview Drug Development Lifecycle

Platform Capabilities

1 Real-world evidence (RWE) ingestion (devices, apps, EMR, wearables)

2 Continuous AE/SAE signal detection using AI

3 Patient usage analytics & adherence insights

4 Automated safety reporting for regulators

5 On-device/app AI monitoring for post-launch populations

Customized Platform in Action

AI Dermatology Software Platform

For automated skin condition diagnosis and personalized skincare treatment.

$2.5M

Saved though 
improved workflow

$2M

Increased from
faster patient intake

20%

Wait time 
reduction

related testimonial

Transform your drug development workflows with an adaptive, end-to-end AI platform.

From preclinical data to post-market surveillance – accelerate every stage with automation, predictive analytics, and harmonized clinical data

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Our team

Meet Our
Leadership Team

Alex Gurbych, PhD

Chief Executive Officer (CEO)

Alex Gurbých, PhD in AI, has over 15 years of experience turning advanced research into practical systems for global companies including Google, Shell, and Bayer. He has published in Nature, presented at NeurIPS, and received multiple awards for AI research.

Alongside industry work, Alex spent 8+ years teaching AI and mentoring engineers, building a rare mix of scientific depth and hands-on execution that shaped the vision for Blackthorn AI.

Alex Gurbych, PhD

Chief Executive Officer (CEO)

Natalya Shakhovska, DrSci, Prof.

Chief Scientific Officer

Natalya Shakhovska is one of Ukraine’s leading scientists in artificial intelligence and data systems. With more than 350 scientific publications, 9 monographs, and 6 textbooks, she has shaped the direction of research in NLP, big data, and distributed systems for decades.

At Blackthorn AI, she brings deep scientific rigor to product development, ensuring that every solution stands on a solid foundation of validated methods and scalable data-driven architectures. Her work as CSO connects frontier research with practical business impact, making complex AI systems reliable for high-stakes industries.

Natalya Shakhovska, DrSci, Prof.

Chief Scientific Officer

Dmytro Krasnienkov, PhD

Principal Scientist, Bioinformatics

Dmytro Krasnienkov is a geneticist and bioinformatics researcher with over a decade of experience in epigenetics and aging science. As Head of the Laboratory of Epigenetics at the D.F. Chebotarev Institute of Gerontology, he has led studies on genetic regulation and its impact on longevity. At Blackthorn AI, Dmytro applies his expertise in genomics and computational biology to design AI-driven pipelines for multi-omics data analysis and biomarker discovery. His background bridges academic research and applied biotech, ensuring that scientific rigor translates into scalable AI solutions for healthcare and life sciences.

Dmytro Krasnienkov, PhD

Principal Scientist, Bioinformatics

Werner Baumgartner

Director DACH & MENA

With over two decades of international experience, Werner leads Blackthorn AI’s business development across the DACH and MENA regions. His background spans market access, strategic partnerships, and growth acceleration for tech and innovation-driven companies. Before joining Blackthorn AI, Werner built a strong track record guiding organizations through complex market landscapes in Europe and the Middle East – helping them translate strategic vision into measurable results.
At Blackthorn AI, he focuses on expanding enterprise collaboration, bridging global opportunities, and driving AI adoption within regulated and high-impact industries.

Werner Baumgartner

Director DACH & MENA

Serhiy Protsenko, DrSci, Prof.

Principal Data Scientist

Serhiy Protsenko is an accomplished researcher and engineer with over a decade of experience in AI, data science, and machine learning. Holding a Doctor of Sciences degree, he has led research teams and guided large-scale data-driven projects across academia and industry.

At Blackthorn AI, Serhiy drives the development of production-ready ML systems, bringing together deep technical expertise with a clear business vision. His work spans from advanced model design and scalable infrastructure to aligning AI initiatives with client goals in highly regulated industries.

Serhiy Protsenko, DrSci, Prof.

Principal Data Scientist

Ivan Izonin, PhD, DrSci, Assoc. Prof.

Scientific Advisor, Artificial Intelligence

Ivan Izonin is an accomplished researcher and educator in Artificial Intelligence with a strong track record in applied machine learning, data-driven modeling, and intelligent systems. As Associate Professor at Lviv Polytechnic National University, he has authored over 300 scientific works, led international research collaborations, and supervised multiple PhD students in AI and data science. His expertise spans neural networks, big data analytics, and biomedical applications of AI. At Blackthorn AI, Ivan provides strategic scientific guidance, ensuring that cutting-edge AI methods are rigorously applied to high-impact industry challenges.

Ivan Izonin, PhD, DrSci, Assoc. Prof.

Scientific Advisor, Artificial Intelligence

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Gary Martin

Head of Biotech AI Partnerships

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