Advancing therapeutics with rigor and quality
Welcome to Masinova, a drug development company committed to rigor-led therapeutic R&D using Quality-by-Design principles. We focus on reproducibility, safety, and efficient translation from discovery to preclinical milestones. Explore our science and join us in advancing the future of medicine.
Our approach
Masinova is a rigor-led and Quality-by-Design driven therapeutic R&D. We build reproducible data packages, integrate safety early, and advance programs from discovery through preclinical and IND-enabling milestones toward Phase I.
Therapeutic areas
We are focused on developing innovative therapies in several key therapeutic areas. Our research aims to address unmet medical needs and improve patient outcomes through cutting-edge scientific advancements.
Oncology
Developing targeted therapies and innovative treatments to combat various forms of cancer.
Neurology
Advancing research in neurodegenerative diseases to improve patient care and outcomes.
Genetic disorders
Pioneering genetic research to address and treat various inherited genetic disorders.
Immunology
Developing therapies to modulate the immune system and treat infectious and autoimmune diseases.
About masinova
Masinova is a drug development company dedicated to rigor-led therapeutic R&D with Quality-by-Design principles. Our focus on reproducibility, safety, and efficient translation from discovery to preclinical milestones sets us apart. We are committed to advancing the future of medicine through innovation and quality.
Pioneering drug development
Masinova applies Quality-by-Design to de-risk drug development. By prioritizing reproducibility, early safety integration, and disciplined translation, we aim to deliver therapies that can move efficiently from concept to clinical evaluation.
"Masinova's commitment to quality and rigor in their therapeutic R&D is truly impressive. Their Quality-by-Design approach ensures the highest standards of reproducibility and safety."
"Their focus on efficient translation from discovery to preclinical milestones is remarkable. Masinova is set to make significant contributions to the field of drug development."
"Masinova's innovative approach to therapeutic R&D is exactly what the industry needs. Their Quality-by-Design principles are truly setting a new standard."
Our services
We offer a range of specialized services tailored to meet your individual needs. Our approach is focused on understanding and responding to what you require, providing effective and practical solutions.
| Service Area | What We Provide | Typical Deliverables |
|---|---|---|
| Therapeutic Program Strategy (HIV, Cancer, Autoimmune) | Indication selection, target/product strategy, differentiation analysis | Program brief, risk/mitigation plan, milestone roadmap |
| Target-to-Lead & Drug Design | Precise research-driven hypothesis, candidate design/optimization | Design rationale, candidate shortlist, selection criteria |
| Quality-by-Design (QbD) Development Planning | Define CQAs/CPPs, control strategy thinking early | QbD framework, decision gates, critical quality attributes map |
| Assay Strategy & Reproducibility Framework | SOP-driven assay selection, robustness, repeatability | SOPs, assay plans, acceptance criteria, reproducibility package |
| Preclinical Study Design | In vitro/in vivo study plans aligned to TPP and IND goals | Study protocols, endpoints, statistical plan, go/no-go criteria |
| Translational & Biomarker Strategy | Bridge preclinical signals to Phase I endpoints | Biomarker plan, sampling strategy, translational rationale |
| Safety-by-Design (Early Risk Reduction) | Early safety/developability screens integrated into selection | Safety assessment plan, preliminary tox risk log, mitigation steps |
| IND/Phase I Readiness Planning | Preclinical-to-clinic planning for efficient progression | IND-enabling roadmap, Phase I outline, data package checklist |
| Partnering Support (NDA-ready) | Professional materials for pharma/biotech & investors | Confidential deck, one-pager, data room index, Q&A prep |
| Documentation & Governance | SOPs, templates, controlled documentation systems | SOP library, document templates, version control structure |
| Scientific Writing & Publications Support | Clear scientific communication for stakeholders | Manuscripts, abstracts, slide decks, technical summaries |