Blagoja Ristevski, CHE

Spearheading the design of a novel patentable new oral drug delivery nanotechnology, tested in humans, facilitating the instant penetration and absorption of lipophilic molecules encapsulated in protein nanoparticles through the oral mucosa. Driving intellectual property strategy and patent filings for lipophilic molecule absorption.

Executive Leadership: Directing a private venture focused on the incubation and development of emerging technologies in the human healthcare sector. Innovation Strategy: Identifying and de-risking high-potential biotech assets, overseeing the bridge between early-stage research and commercial viability.

Targeted Delivery Innovation: Pioneered the use of nanotechnology to target drug delivery to specific heart and pericardium tissues, improving the bioavailability, efficacy and significantly reducing systemic off-target toxicity. Bioavailability Optimization: Engineered novel solutions for the absorption of lipophilic drugs across oral, and subcutaneous route of administration Platform Development: Invented and optimized novel subcutaneous oil-sustained platform for delivery of oil solutions of lipophilic active molecules with water like viscosity, and platform for delivery of biological active nanoparticles and nanoparticles carrying lipophilic or hydrophilic active molecules targeting damaged heart tissues. Manufacturing: Overseeing the entire production process of Cardiol drug products pipeline ensuring that all operations comply with stringent FDA, EMA, and other regulatory guidelines while meeting production schedules, budgetary goals, and quality standards. Strategic Planning: Developed and implemented long-term manufacturing strategies, including capacity planning, resource allocation, and budget management. Facility Management: Ensure the manufacturing facility is properly maintained, validated, and operated in compliance with EHS (Environmental Health and Safety) and cGMP standards. Cross-Functional Collaboration: Partner with Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Supply Chain, and R&D to facilitate tech transfers and ensure product quality.

Regulatory Technical Advisory: Provided comprehensive CMC consultancy, ensuring formulation and manufacturing processes met rigorous international standards for stability and quality control.

Strategic Licensing: Successfully negotiated the licensing and technology transfer of HEK293 cells as a foundational platform for recombinant protein production. Facility Design & Execution: Directed the design and negotiation of new vaccine manufacturing facilities, managing complex stakeholders including architects, builders, and regulatory consultants.

Licensing & IP Acquisition: Negotiated the licensing of thiolated polymers (thiomers), pioneering their use for enhanced mucoadhesion and penetration in oral drug delivery systems.

IP Development: Spearheaded the development of patentable formulations for a novel anti-inflammatory drug product utilizing charged, nano-sized liposomal carriers. Production Oversight: Managed the transition of complex liposomal formulations from R&D to full-scale pharmaceutical manufacturing for Phase1 and Phase2 CT, ensuring batch consistency and GMP compliance.

Core Engineering: Served as the Principal Author of the foundational patent: ‘Stable Liposome Compositions Comprising Lipophilic Amine Containing Pharmaceutical Agents’ (Granted 2007). Technical Design: Developed the original chemical engineering frameworks for lipophilic agent encapsulation, which served as a precursor to future lipid-based delivery platforms.