The primary difference between a biomarker and a surrogate endpoint 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. In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves […]
The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation.
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.
BBCR Consulting offers clinical, regulatory, translational, and biomarker consulting services that support our clients’ needs. Our process is designed to maximize time and cost efficiencies while mitigating risk. We partner with domestic and international companies. Our mission is to support pharma and biotech companies, and nurture their products’ strengths while improving efficiency and safety.
Our proprietary Strategic Clinical Innovation Organization (SCIO) concept was developed to address and maneuver around evolving challenges, allowing for time and cost efficiencies, and mitigating risk. BBCR works with clients in the areas of Biomarkers, Clinical Research consulting, Regulatory Affairs, and Early Clinical Development. To learn more about how BBCR can help with your research […]
Biomarkers are now a routine part of drug development In rare diseases and precision medicine, implementation of biomarkers during product translation into clinic and early clinical development, moves treatment to market faster.
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 […]
BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed to maximize time efficiencies, risk mitigation, and cost savings. We partner with domestic and international, small-to-medium drug and device companies that are entering early clinical development. BBCR is dedicated […]