Niviron AI

We help scientists turn their ideas into viable biotechnology companies.
NIVIRON is a team that takes on all the operational tasks required to transform a scientific hypothesis into a real venture.

We join projects at the earliest stages — when the idea is still being tested and the data is barely structured. We handle strategy, team formation, legal architecture, intellectual property protection, and engagement with investors, grant bodies, and regulatory authorities.

Our goal is to build companies capable of progressing from lab to clinic and solving real-world challenges in modern medicine. We focus on breakthrough developments in the following areas:

  • gene and vector delivery systems
  • gene therapy
  • immunotherapy (including oncolytic viruses)
  • cell therapy (e.g., CAR-T)
  • bioinformatics
  • artificial intelligence at the intersection with life sciences

We believe that deep science, supported by the right ecosystem, can shape the future of healthcare.

Cumulative career achievements of the team

> 50

Number of preclinical trials

1

Number of approved products marketed

> 150 M

Private funding received

5

Number of clinical trials

191

Number of patents

1

Number of companies went to IPO

45

IND Approvals

4

Created oncolytic viruses

4

Number of sold technologies

9

NDA Approvals

41

Number of grants received

4

Created sales departments

2

BLA Approvals

> 100 M

Government funding received

> 200

Number of signed service contracts

Team

Shapovalov Nikita
СЕО NIVIRON

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, and preparing for grant and venture rounds.

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

Darrick Carter

Consultant NIVIRON

PhD, Scientist, Serial Founder

An internationally recognized expert in immuno-oncology and structural biology, founder of five biotechnology companies, one of which went public via IPO. Serves on the boards of two biotech companies in Seattle and acts as a scientific advisor to the Gates Foundation and PATH.

Combines deep academic expertise with entrepreneurial experience:

  • Over \$150 million in raised investments
  • 100+ patents and publications
  • 50+ completed preclinical studies
  • 8 IND submissions and one registered market product

Adjunct Professor at the University of Washington (School of Medicine and Global Health). Holds an extensive network within the US scientific and investment communities. Skilled in building world-class teams and advancing biotechnologies from the lab to the market.

Consultants and Project Managers

Consultants and Project Leaders

A specialized group of consultants bringing together experts from biotech, law, science, and management. They actively engage in key project stages, ensuring decision-making, investment readiness, and risk mitigation.

Areas of consulting and support include:

  • Preclinical and clinical trials — assistance with design, contractor selection, and results analysis
  • Regulatory support — strategies for interacting with FDA, EMA, and local regulators
  • Corporate law — jurisdiction selection, capital structuring, IP frameworks
  • Non-dilutive funding — grant strategies, joint applications with universities and research institutes
  • Intellectual property protection — patenting, licensing, legal safeguarding of technologies
  • Management and development — mentoring from current and former CEOs, biotech executives, and venture partners

This group functions as an integrated advisory board, scalable to the specific needs of each project. All members have practical experience in bringing biotechnologies to market, and their involvement enhances decision quality and builds trust with investors and grant providers.

Working Group

A specialized team responsible for executing key support tasks in early-stage startups. The working group handles critical functions necessary for advancing the project toward investment rounds or grant funding, including:

  • Preparation and support of business documents: presentations, one-pagers, project summaries, briefs, and financial models
  • Systematization and structuring of project information: pipeline, deadlines, progress tracking, task management
  • Analytics: market research, competitor analysis, reference data, and benchmarking
  • Management of spreadsheets, CRM, and tracking of financial and organizational parameters
  • Preparation of investment and grant materials, applications, letters, and summaries
  • Contribution to business strategy development, positioning, and basic product packaging
  • Coordination between technical, scientific, legal, and investment components of the project

This team does not perform assistant or secretarial functions, but operates as an operational-analytical unit capable of handling all routine company tasks.

Contractors

A network of external partners and contractors engaged by the venture studio as needed, when a project reaches a stage requiring specialized technical or operational expertise.

Key areas covered by the contractor network include:

  • CROs
  • CDMOs
  • Laboratories, including GMP-accredited facilities
  • Grant writers
  • Medical writers — preparation of regulatory and scientific documentation (IND, CTA, reports, publications)
  • Patent attorneys — IP filing and protection in target jurisdictions
  • Automation and AI engineers — implementation of AI and digitalization of business processes

All contractors are selected based on their experience in biotech and medical projects, their understanding of startup dynamics, and their commitment to results. They act as an extension of the studio’s operational capacity, ensuring flexibility and rapid project scaling at any stage.

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