NIVIRON Team

A team designed to integrate scientific insight, computational power, and strategic management into a single engine — capable of advancing complex R&D programs and building transformative gene therapy technologies.

Shapovalov Nikita

CEO

An entrepreneur with over 11 years of experience in creating and managing technology projects in biotechnology, digital health, and artificial intelligence.

Specializes in:
• launching and developing projects at the preclinical stage,
• IP licensing,
• collaboration with universities and research institutions,
• building R&D infrastructure,
• securing funding,
• preparing for grant and venture rounds.

Possesses hands-on experience in:
• team formation,
• market entry strategy development and implementation,
• product packaging,
• regulatory engagement.

Additional expertise includes:
• AI and process automation in medicine,
• development of digital solutions (mobile applications, patient portals, chatbots, mini apps),
• strategic marketing and systematic sales in highly competitive niches.

Has access to a strong network of experts, investors, and contractors across the EU and US.

Capable of building projects from scratch to investment readiness, including comprehensive development of business models, scientific tracks, and market strategies.

Bolni Marius Nagalo

Principal Investigator

Associate Professor, Program in Oncology, Department of Pharmacology & Physiology;
Co-Leader, Translational Working Group,
at the University of Maryland School of Medicine

Dr. Nagalo was a principal investigator in the following studies:
cGAS-STING Pathway Targeting Replicative Adenoviruses with CD46 Tropism and AFP Promoter Conditional Replication Restriction for the treatment of hepatocellular carcinoma.
Virally Induced Aberrancy for Treatment of Hepatocellular Carcinoma. Development of a gene therapy approach for the treatment of hepatocellular carcinoma (HCC).
Hybrid oncolytic VSV for the treatment of pancreatic cancer.
Generation of a Synthetic Biology-enabled Vesiculovirus to treat soft tissue sarcoma (STS).
Hybrid Vesiculovirus Library to enhance oncolytic viral therapy in acute myeloid leukemia (AML).
Mayo Clinic Pancreatic Cancer SPORE (Co-Investigator): combination therapy with oncolytic virus and CAR-T in advanced pancreatic cancer.
Preclinical study of a novel oncolytic adenovirus to treat advanced HCC.

Alex Baker

Preclinical Development Consultant

Non-clinical Drug Development & Gene Therapy
A non-clinical drug development leader with extensive experience advancing gene therapy and advanced therapeutic programs from early concept through IND and First-in-Human studies.

Areas of focus:
• Preclinical development of biologics, ATMPs, and gene therapy assets.
• Design and execution of non-clinical development packages.
• IND / IMPD preparation and regulatory submissions.
• Targeted drug and viral vector development.
• Strategic IP development in collaboration with legal and business teams.
• Management of international CRO and CDMO workflows.

Hands-on experience:
• Building and leading multidisciplinary R&D teams.
• Advancing first-in-class therapeutic programs to clinical approval.
• Coordinating complex GxP studies across multiple geographies.
• Regulatory engagement in the UK, EU, and US.

Additional expertise:
• Toxicology, ADME, and early drug development strategy.
• Preclinical safety and efficacy evaluation of viral vector–based therapies.
• Scientific leadership within professional societies and policy-facing organizations.

Track record:
• Successful delivery of preclinical packages supporting approved clinical trial applications.
• Ongoing contribution to the advancement of gene and cell therapy technologies through scientific leadership, collaboration, and strategic execution.

Evgeny Ditkovsky

Head of AI Development Group

An expert with over 17 years of experience in project management and the implementation of IT and AI solutions.

He has led the creation and development of complex digital products aimed at optimizing processes, enhancing performance, and automating decision-making in high-tech industries.
As the Head of the AI Development Group, he oversees the design, training, and deployment of advanced machine learning models and their integration into research and development workflows. His expertise covers system architecture design, large-scale data processing, and AI-driven predictive analytics.
He is a specialist in operational and strategic management, coordinating interdisciplinary teams and ensuring alignment of technological solutions with business and scientific objectives. He also has extensive experience in building and scaling engineering teams, establishing development pipelines, and implementing best practices in software engineering and AI research.

Development Group (AI)

A team specializing in the creation of AI models has been formed. The main task of the team is the development of infrastructure for the automation of R&D.

Team Structure:
• ML/AI Engineers.
• 3 Data Scientists.
• 2 MLOps Specialists.
• 2 Systems Architects.

Scaling Potential In addition to the core team, the project is supported by 15 external experts, ready to join at any moment to address specialized tasks — from algorithm optimization to the integration of new research directions.
The team already possesses the necessary expertise and competencies to develop complex AI systems that integrate the work of different models and approaches. This provides a strong foundation for building a proprietary AI infrastructure, focused on accelerating and optimizing R&D processes.

Development Group (IT)

A team specializing in the development of IT solutions has been formed. The main task of the team is the creation of a digital platform that integrates AI models into a unified infrastructure, as well as the development of supporting tools and services to enable the full R&D cycle.

Team Structure:
• Head of IT Development Group.
• 4 Software Engineers (Backend/Frontend).
• 2 Data Engineers.
• 2 DevOps Specialists.
• 1 System Architect.

Scaling Potential In addition to the core team, the project is supported by 10 external developers and integrators who can be engaged for specialized tasks — from data processing to integration and platform scaling.
The team already possesses the necessary experience in designing and implementing large-scale digital systems, combining flexibility, reliability, and scalability. This provides a solid foundation for building a proprietary IT infrastructure, ensuring the effective operation and growth of the digital R&D ecosystem.

Operations Team

A specialized team has been formed to ensure the execution of key supporting tasks within the NIVIRON project. This working group covers functions essential for the effective evolution of the project:

Team Functions:
• Preparation and support of business documents — presentations, one-pagers, project summaries, reports, financial calculations.
• Systematization and structuring of project information — pipeline management, deadlines, progress tracking, task control.
• Analytics — market research, competitor analysis, collection of reference and benchmark information.
• Data and process management — maintaining working spreadsheets, CRM, tracking financial and organizational parameters.
• Fundraising support — materials, applications, letters, summaries.
• Business strategy support — contribution to positioning and basic product packaging.
• Coordination of interactions between the technical, scientific, legal, and investment aspects of the project.
• Other tasks arising in the course of project development.

NIVIRON Team

Shapovalov Nikita

CEO