The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind. 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 […]
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 […]
An early-phase strategy improves productivity and the path to market approval. SCIO SM Advantages Accelerate Patient Recruitment Reduce Patient Number Reduce Clinical Development Time Reduce Trial Monitoring Time Increase Patient Retention Facilitate Decision Making Increase Data Quality The FDA has been calling for a smarter, more innovative process for market approval, and SCIO SM is […]
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 adopting biomarkers to mitigate clinical trial risk, identify patient subpopulations, facilitate decision-making, and accelerate a drug’s market approval.
Our goal is to optimize every aspect of the research and development process We will: Improve protocol development, including current trends in clinical trial designs and endpoints Benchmark relevant historical trial enrolment with unmet needs and ongoing trial inclusion criteria Develop a clinical strategy including patient segmentation and biomarkers, streamlining operational costs through more efficient […]
Real-world evidence (RWE) is increasingly important in clinical trial design and drug approval. RWE is clinical evidence related to patient health status and treatment safety and efficacy that are generated in clinical practice. BBCR’s team understands the role RWE plays for Natural History in Rare Diseases. We invite you to be in touch to learn […]
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 […]
As one of the first consultancy teams to streamline clinical trials, BBCR’s boutique consulting team specializes in rare disease and orphan indications dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR Team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for […]
The Strategic Clinical Innovation Organization SCIO SM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIO SM allows for time and cost efficiencies and relief of risk management. The SCIO SM method aims to learn, predict and make better decisions for a successful drug opportunity. This […]
BBCR’s boutique consulting team specializes in rare diseases and orphan indications and dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR team provides consultancy in cell, biologics, and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for orphan diseases and precision medicine RWE can be used to […]