Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Related 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
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 […]
BBCR provides expert market guidance and embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Developing drugs for rare diseases and precision medicine indications can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where the patients are few, lack of […]
Focus must go to cost containment and value-based developments that allow sponsors to move more treatments to market faster. BBCR’s team expertise in rare diseases and precision medicine combined with SCIO approach helps streamline trials for swift regulatory approvals. Real-World Data can be collected and approved by regulators for Evidence Generation Regarding Safety and Effectiveness. […]
The BBCR team of experts has worked in pre-clinical and clinical product development and regulatory affairs. We believe that understanding the perspective, challenges, and needs of our clients allows us to serve as a trusted adviser throughout the clinical development process. BBCR clients are domestic and international drug and device biotechnology firms as well as […]
BBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
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.
Our Strategic Clinical Innovation Organization (“SCIO”) method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. The Strategic Clinical Innovation Organization (SCIO) concept developed by BBCR was designed specifically to help pharmaceutical innovators address the concerns and maneuver around evolving challenges. SCIO allows […]