Cell and Gene therapy are often considered the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Clinical trial outcomes remain consistently encouraging, and the next generation of Cell and Gene therapies show significant potential for many patients and families. We can assist with strategies that move products to market faster, […]
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.
Every clinical study has its unique challenges that initially may not have been factored for, presenting the need for study remediation and rescue. Experienced management can help sponsors to address prolonged trial timeline and high quality data. Rare Diseases and Precision Medicine Require Unique Approaches In Clinical Trial Design. There could be any number of […]
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 […]
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.