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. BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan drug indications by developing and nurturing the product’s unique strengths. Our operational mission is to craft […]
While an early clinical strategy offers numerous advantages, it also comes with certain challenges that need to be considered: Limited Information: Limited information available about the investigational product can make it challenging. High Risk of Failure: Developing an early clinical strategy without a comprehensive understanding of potential challenges and risks could lead to significant financial […]
Developing an effective early clinical strategy requires collaboration between various experts. The strategy is a living document that can evolve as new data becomes available and as the project progresses through clinical development. Study Design: The design must be robust enough to answer the intended scientific questions. Safety Assessment: It details how safety will be […]
Early clinical strategy refers to the comprehensive plan and approach that pharmaceutical companies, biotech firms, and researchers develop for the initial phases of clinical development of a new drug. These early phases, typically known as Phase 1 and Phase 2 clinical trials, aim to assess the safety, tolerability, and preliminary efficacy of the investigational product […]
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 […]
BBCR=Simplifying Clinical Research Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials. 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 […]
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.
Biomarkers are considered a routine part of drug development. Learn more about how BBCR can help get your product to market more efficiently with proper plan development and strategy. Plan Development Insightful strategy is the most effective way to ensure quality when including biomarkers into your product development plan. Validation or Qualification Understanding where […]
Biomarkers are now a routine part of drug development The FDA recognizes biomarker development as a high priority area for future research. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. […]