In the fields of orphan diseases and precision medicine, establishing a robust biomarker strategy during translational and early clinical development is key to expediting time-to-market. A well-defined biomarker plan not only streamlines regulatory approval but also aligns with FDA expectations for safety and efficacy. Discover how our expertise in biomarkers and surrogate endpoints can help […]
BBCR’s epigenetic expert, Dr. Claudio Carini, has been a pioneer in epigenetics leading the effort of major pharmaceutical companies. BBCR helps to bridge the gap between pre-clinical and early clinical development. Translational medicine is a bridge between pre-clinical and early clinical development (from bench to bedside), creating the foundation for precision medicine in late clinical […]
The primary difference between a biomarker and a surrogate marker is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to measure the effects of a specific treatment. While the current law and regulations permit the FDA to base the approval of a drug product […]
Translational medicine is a bridge between pre-clinical and early clinical development (from bench to bedside), creating the foundation for precision medicine in late clinical development. A translational medicine program includes the adoption of biomarkers to mitigate clinical trials risk, identify patient subpopulations, facilitate decision-making, and accelerate drugs’ market approval.
Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process and strategy. 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.
BBCR specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target site of action Investigate […]
Most ongoing research and clinical programs have precision medicine at the core. BBCR can assist in a number of areas in relation to precision medicine, including small molecule research, including: Strategic drug assessment Early Clinical Development Regulatory consultant FDA meeting and submission Pre-IND integrated development plan Clinical consultant Clinical study design and protocol CRO and […]
Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Services include: 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 […]