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Translational strategy consulting
Drug development consulting and regulatory guidance designed to align your rare disease study design with strict agency expectations.
Direct access to senior scientific leadership
We provide drug development consulting and direct advisory input early in your rare disease program to prevent costly downstream rework. Our founders and senior scientists help you define the exact context of use and select fit-for-purpose bioassays to ensure your data satisfies stringent FDA and EMA expectations.
Guidance across the development lifecycle
Precision handling for frozen muscle tissue
We use our specialized experience in standardizing collection and freezing procedures to protect longitudinal tissue integrity. Our workflows are fundamentally designed with frozen samples in mind. Clinical site personnel have the required expertise and training to handle your frozen samples in accordance with regulatory procedures. AGADA also works seamlessly with third-party vendors to transport frozen samples with care.
Pre-validated methods and custom development
We have a selection of off-the-shelf, pre-validated bioassays including dystrophin immunoblot (FDA-audited), anti-dystrophin antibody assays via LIPS and dystrophin immunofluorescence analysis in skeletal muscle tissues. AGADA is also able to help you select and deploy custom, fit-for-purpose bioassays to accurately measure critical biomarkers and satisfy rigorous FDA requirements for primary outcomes.
Rigorous efficacy studies
Our preclinical studies are built on deep, historical data and statistically powered designs that minimize risk long before human trials begin. We prioritize study rigor and regulatory alignment to ensure your data is robust, reproducible, and ready for scrutiny.
Our senior scientific leadership acts as an extension of your team, providing the advisory depth needed to refine your approach as programs evolve. Whether we are helping you optimize a study design or delivering precise bioanalytical outcomes, our focus remains on the continuity and integrity of your program.
Strategic input to de-risk your program
AGADA Biosciences acts as a strategic thought partner rather than a transactional vendor. We help you think through the critical decisions that shape clinical progress, providing the exact guidance required to keep your biomarker endpoints interpretable and your clinical data strictly fit for purpose.
Context of use focus:
We help define the exact regulatory context early so your bioassay endpoints remain strictly fit for purpose.
Direct scientist access:
Our lean model ensures you work directly with the senior experts, guiding your study design and interpreting your data.
Accelerated approval pathways:
We provide targeted guidance on primary and secondary biomarker outcomes to support efficient regulatory reviews.
Early risk identification:
We proactively address scientific and operational challenges during efficacy studies to ensure readiness for larger clinical evaluations.
Discuss your program strategy
Engage our senior scientists to establish a rigorous study design and clear regulatory strategy for your program.
Specialized expertise in rare disease research
Our scientific team applies decades of focused research to the disciplined execution of your program. We understand the unique challenges of rare disease development and deliver guidance that translates into data regulators trust.
Consistent audit success:
We successfully pass an average of five sponsor audits annually to support clinical trials across multiple phases.
Submission readiness:
We operate with deep familiarity across FDA and EMA regulations to ensure your data remains interpretable worldwide.
Historical benchmarking:
We leverage archival data from over 100 trials in mouse models of muscular dystrophy to accurately power your efficacy studies.
Harmonized workflows:
We align our preclinical standard operating procedures directly with our clinical protocols to drastically reduce downstream technology transfer time.
Quality and compliance
We operate in strict compliance with GCP, GLP and GDPR regulations to ensure your data remains interpretable and defensible. Every team member must hold a CITI certification before supporting any sponsor trial.
