Tagged: Early Clinical Development
In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves treatment to market faster, and still meets the FDA’s expectations.
June 15th, 2023 | Early Clinical DevelopmentA translational medicine program includes the adoption of biomarkers to mitigate Phase I and II clinical risks, identify patient subpopulations, facilitate decision-making, and accelerate the release of a drug on the market.
February 16th, 2023 | Early Clinical Development
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 […]
Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials.
January 10th, 2023 | Early Clinical Development
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 […]
BBCR offers Translational Medicine and Biomarkers Program Consultation to bridge the gap between pre-clinical and early clinical development
September 21st, 2022 | Early Clinical DevelopmentTranslational 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 has extensive experience in early development Phase 1 and 2, from pre-clinical to pre-IND. BBCR’s early drug development experience includes the development of clinical strategy and plan, including target product profiles and clinical protocols.
June 30th, 2022 | Early Clinical Development
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 is highly experienced in developing innovative approaches to de-risk your product development during the early clinical development stage, including designing Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies.
January 25th, 2022 | Early Clinical Development
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 […]
Small molecule mediated targeting provides alternative strategies for polypharmacology, systems biology and personalized medicine.
September 7th, 2021 | Early Clinical Development
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 […]
BBCR has experience in biologics for rare diseases and can assist with the development of a targeted strategy to meet your study needs.
March 24th, 2021 | Early Clinical Development
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 […]