Radyus Research
Radyus Research is a comprehensive drug development partner that accelerates drug development from lead optimization to clinical proof of concept. They offer scientific expertise, strategic counsel, and operational execution across pre-clinical, clinical, manufacturing, and regulatory stages. Their team integrates into clients' teams to streamline processes and manage programs efficiently, serving biotech companies, academic startups, and venture capital firms with a focus on immunology, oncology, infectious diseases, metabolic diseases, and neurosciences.
Industries
Nr. of Employees
small (1-50)
Radyus Research
Products
Preclinical development engagement — small molecule oncology (case study)
Multi‑year engagement covering indication prioritization, in vitro and in vivo efficacy studies, target product profile development, regulatory strategy, manufacturing strategy, dose‑range PK/PD and toxicology studies, and Pre‑IND planning.
Regulatory Pathway & Agency Engagement
Comprehensive IND strategy, FDA interactions, briefing packages, and regulatory positioning.
Nonclinical & Translational Planning
IND-enabling study design, translational strategy, and robust data packages that withstand scrutiny.
Development Strategy & Indication Selection
Portfolio-level strategy, target indication prioritization, and value inflection planning for biotech and pharmaceutical companies.
Program & Portfolio Management
End-to-end integration, timeline management, budgeting, risk management, and governance for drug R&D programs.
Commercial & Exit Strategy
Exit pathway design, pharma alignment, data positioning, and transaction readiness for licensing or acquisition.
Preclinical development engagement — small molecule oncology (case study)
Multi‑year engagement covering indication prioritization, in vitro and in vivo efficacy studies, target product profile development, regulatory strategy, manufacturing strategy, dose‑range PK/PD and toxicology studies, and Pre‑IND planning.
Regulatory Pathway & Agency Engagement
Comprehensive IND strategy, FDA interactions, briefing packages, and regulatory positioning.
Nonclinical & Translational Planning
IND-enabling study design, translational strategy, and robust data packages that withstand scrutiny.
Development Strategy & Indication Selection
Portfolio-level strategy, target indication prioritization, and value inflection planning for biotech and pharmaceutical companies.
Program & Portfolio Management
End-to-end integration, timeline management, budgeting, risk management, and governance for drug R&D programs.
Commercial & Exit Strategy
Exit pathway design, pharma alignment, data positioning, and transaction readiness for licensing or acquisition.
Services
End‑to‑end consulting and embedded program support across lead optimization, candidate selection, IND‑enabling studies and first‑in‑human planning.
Design and conduct of validation assays, in vitro and in vivo efficacy studies, dose‑range and PK/PD studies to support candidate selection.
Management of IND‑enabling toxicology and GLP animal studies and associated DMPK activities to prepare regulatory submissions.
Consulting on formulation, initial process development, scale‑up synthesis planning and GMP manufacturing vendor strategy.
Preparation of regulatory strategies, Pre‑IND materials and IND submissions, and coordination with regulatory authorities.
Protocol development, clinical operations planning, and oversight for early clinical trials including first‑in‑human studies.
End‑to‑end consulting and embedded program support across lead optimization, candidate selection, IND‑enabling studies and first‑in‑human planning.
Design and conduct of validation assays, in vitro and in vivo efficacy studies, dose‑range and PK/PD studies to support candidate selection.
Management of IND‑enabling toxicology and GLP animal studies and associated DMPK activities to prepare regulatory submissions.
Consulting on formulation, initial process development, scale‑up synthesis planning and GMP manufacturing vendor strategy.
Preparation of regulatory strategies, Pre‑IND materials and IND submissions, and coordination with regulatory authorities.
Protocol development, clinical operations planning, and oversight for early clinical trials including first‑in‑human studies.
Expertise Areas
- Preclinical development and IND‑enabling studies
- Toxicology and DMPK
- CMC, formulation development and GMP manufacturing strategy
- Clinical trial design and clinical operations
Key Technologies
- In vitro assay development
- In vivo animal efficacy models
- GLP‑compliant toxicology studies
- GMP manufacturing processes
News & Updates
A detailed case study of a preclinical platform company working on solid tumors using small molecules, highlighting their process from indication prioritization to pre-IND activities.
A detailed case study of a preclinical platform company working on solid tumors using small molecules, highlighting their process from indication prioritization to pre-IND activities.