AGADA Biosciences
AGADA Biosciences Inc. is dedicated to accelerating drug development through expert guidance in surrogate biomarkers and outcomes, supporting sponsors with robust experimental design, data generation, and interpretation in preclinical and clinical projects. Founded in 2013, the company specializes in neuromuscular disease research, preclinical efficacy testing, and clinical trial support, with a focus on biomarkers, tissue banking, and regulatory compliance. Their mission is to de-risk drug development and support orphan drug designation, leveraging extensive experience and a global network to deliver high-quality, reliable data for regulatory approval and post-marketing surveillance.
Industries
Nr. of Employees
small (1-50)
AGADA Biosciences
Services
Operational support for clinical muscle biopsies including site assessment, supply kits, SOPs, training (video, quiz, live or remote), monitoring of procedures, sample processing, aliquoting, and coordination of shipments.
Execution of protein, RNA, and DNA bioassays (immunoblot, immunostaining, mass spec, ELISA, RT-PCR, RNAseq) and development of sponsor-specific validation plans to establish fit-for-purpose assays for trial endpoints.
Centralized frozen tissue storage with inventory management, freezer monitoring, backup power, repeat accessioning, aliquoting, and coordinated outbound shipments.
Protocol development, ethical review support, conduct of in-life studies in mouse models, functional outcome measures, muscle physiology, histology, and biomarker endpoints under QA/QC governance.
Advisory services on biomarker context-of-use, surrogate endpoint qualification, trial endpoint selection, and interactions with regulatory agencies including orphan designation and accelerated pathway considerations.
Implementation and operation of a Quality Management System covering document and equipment control, QA review of deliverables, QC verification of SOP adherence, quality event monitoring, and CAPA processes for clinical and preclinical operations.
Operational support for clinical muscle biopsies including site assessment, supply kits, SOPs, training (video, quiz, live or remote), monitoring of procedures, sample processing, aliquoting, and coordination of shipments.
Execution of protein, RNA, and DNA bioassays (immunoblot, immunostaining, mass spec, ELISA, RT-PCR, RNAseq) and development of sponsor-specific validation plans to establish fit-for-purpose assays for trial endpoints.
Centralized frozen tissue storage with inventory management, freezer monitoring, backup power, repeat accessioning, aliquoting, and coordinated outbound shipments.
Protocol development, ethical review support, conduct of in-life studies in mouse models, functional outcome measures, muscle physiology, histology, and biomarker endpoints under QA/QC governance.
Advisory services on biomarker context-of-use, surrogate endpoint qualification, trial endpoint selection, and interactions with regulatory agencies including orphan designation and accelerated pathway considerations.
Implementation and operation of a Quality Management System covering document and equipment control, QA review of deliverables, QC verification of SOP adherence, quality event monitoring, and CAPA processes for clinical and preclinical operations.
Expertise Areas
- Clinical trial biopsy management
- Biomarker assay development and validation
- Frozen tissue banking and cold-chain logistics
- Preclinical efficacy testing in murine models
Key Technologies
- Next-generation sequencing (RNAseq)
- Mass spectrometry
- ELISA and multiplex immunoassays
- Western blot (immunoblot)