Pediatric Rare diseases and Rare Pediatric Disease Designation FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified. Section 529 of the FD&C Act is intended to encourage development of new drug and biological products for the prevention and treatment of rare pediatric diseases. Section […]
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 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 […]
Read more about BBCR’s Streamlined Clinical Development Strategies in DigiTech Insight
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 […]
Streamlined Clinical Development Strategies Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. […]
