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.
Tagged: Precision Medicine Consultants
With Biomarkers now a routine part of drug development, BBCR works with companies in assisting with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.
June 28th, 2023 | Precision Medicine ConsultantsBBCR’s experienced CRO Management and Drug development team identify study remediation strategies and provide a resource for any Study Rescue
August 23rd, 2022 | Precision Medicine Consultants
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 […]
Biologics can provide opportunity for identifying a treatment or cure in cases of rare disease. 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.
March 23rd, 2022 | Precision Medicine Consultants
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 […]
Identification and adoption of biomarkers are especially valuable in rare disease and precision medicine product development. BBCR can assist in developing your biomarker plan and validation process.
July 8th, 2021 | Precision Medicine Consultants
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.