Our mission is to support domestic and international pharma, biotech, and device companies by nurturing their products’ strengths while improving efficiency and safety. We specialize in strategy and provide early clinical research services to enable informed, timely decision-making for our clients. Learn more about the services we provide within the areas of Early Clinical Research […]
Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Strategies that move products to market faster: A cost-effective Clinical Plan that saves time and resources Medical Monitoring Ad-interim Chief Medical Monitor Indications Selection and Prioritization Trial Design and Protocol Study Remediation and Rescue Clinical research […]
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 […]
Developing innovative or repurposing drugs for orphan diseases can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where patients are few; a lack of previous studies may hamper progress as you mount an orphan petition and negotiate a clinical plan with the FDA. […]
How we can help The BBCR team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment We offer clinical strategy for orphan diseases and precision medicine RWE can be used to build orphan diseases evidence to support regulatory decisions BBCR serves small and medium sized Biotech Companies, […]
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 […]
Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. 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 […]
We help to Identify areas of need or economic interest that can help companies find homes for treatments for rare diseases and precision medicine. 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 […]
BBCR’s team has experience in biologics for rare diseases including rare cancers and precision medicine and can help develop a targeted strategy including studies with fewer patients to control safety issues. 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 […]
Biologic treatments show promise in providing clinical solutions to a variety of diseases Due to biological’s unique characteristics, study designers may find that results in pre-clinical trials do not predict acute, chronic and late onset immunogenicity and safety. In Addition, the biological orphan has a long PK half-life of months such as with any mAb, […]