Did you know that about a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs? Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. We invite you to learn more about how BBCR can […]
BBCR team experience in biologics for rare diseases included rare cancers and precision medicine can help develop a targeted strategy including studies with fewer patients that control for safety issues. 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 […]
The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process. Who We Serve: Small & Medium Sized Biotech Companies currently moving from pre-clinical studies toward clinical trials in need of interim Chief Medical Officer in need of regulartory strategy consultancy in need of preparing a pre-IND meeting […]