AGADA Biosciences specializes in expediting drug development programs, particularly in the field of neuromuscular diseases. The company is recognized for its leadership in pre-clinical drug trials that utilize human disease models and offers comprehensive support for human clinical trials. This includes training and management of clinical site muscle biopsies, conducting biomarker assays, and providing guidance on regulatory pathways and trial design. AGADA's expertise extends to managing frozen tissue collections on a global scale, ensuring a high success rate in sample integrity and biomarker data generation, which has earned the trust of numerous pharmaceutical, biotech, and academic clients.

The technical focus of AGADA lies in the meticulous management of frozen samples, especially muscle biopsies. The company oversees the entire biopsy process, from patient tissue extraction to the management of shipping and sample integrity. AGADA's trained staff are proficient in performing frozen sections for histology and immunohistochemistry, and they can conduct assays on-site or coordinate with preferred vendors. Additionally, AGADA excels in generating high-quality biomarker data, including RNA, protein, and DNA analyses, which are crucial for clinical trial outcomes. They have developed pre-validated bioassays for dystrophin, which are essential for FDA accelerated approvals, and have also created a LIPS assay for post-marketing safety surveillance of treatment-emergent anti-dystrophin antibodies.

Canada

AGADA Biosciences is a biotechnology company that specializes in providing expert assistance with drug development programs in neuromuscular disease, offering pre-clinical trials in mouse models and human clinical trial support.

AGADA Biosciences

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