Biologic treatments show promise in providing clinical solutions to a variety of diseases. Boston Biotech Clinical Research has experience in biologics for rare diseases and can help develop a targeted strategy for your needs.

Biologic treatments show promise in providing clinical solutions to a variety of diseases

Due to biological’s unique characteristics, study designers may find that results in pre-clinical trials do not predict acute, chronic and late onset immunogenicity and safety. In Addition, the biological orphan has a long PK half-life of months such as with any mAb, then a parallel design PK/PD study, and not crossover, would be appropriate. When the product case is appropriately presented and evidence provided to the FDA, it might result in approval with one adequate and well-controlled trial with supportive evidence.

BBCR’s team experience in biologics for rare diseases including rare cancers and precision medicine can help develop a targeted strategy including studies with fewer patients that control for safety issues.

• Indications analysis and prioritization
• Strategic drug assessment
• Clinical study design and protocol
• Biomarker strategy
• Early Clinical Development
• FDA meeting and submission
• Pre-ND integrated development plan
• CRO and project management
• Study remediation and rescue

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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