NIVIRON Team

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.

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.

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.

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.