Developing innovative or repurposed drugs for orphan diseases can be rewarding, but navigating the challenges is not for the faint of heart. Our regulatory and clinical research consultants are experts in biologics, cell and gene therapies, and small molecule developments. Identifying areas of need or economic interest can help sponsors find homes for treatments for […]
The BBCR consultants, experienced in orphan, rare and ultra-rare diseases, have advised biotech and venture capitalists for new indications evaluation and prioritization. BBCR’s team of industry experts can help match treatments to rare genetic conditions and unsolved diseases, then work with a product developer on the best plan to market. Candidate assessment for 505(b)(2) approval […]
Real-world evidence (RWE) is increasingly important in clinical trial design and drug approval. RWE is clinical evidence related to patient health status and treatment safety and efficacy that are generated in clinical practice. BBCR’s team understands the role RWE plays for Natural History in Rare Diseases. We invite you to be in touch to learn […]
As one of the first consultancy teams to streamline clinical trials, BBCR’s boutique consulting team specializes in rare disease and orphan indications dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR Team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for […]
BBCR=Simplifying Clinical Research Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials. The primary difference between a biomarker and a surrogate marker is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to […]
The Strategic Clinical Innovation Organization SCIO SM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIO SM allows for time and cost efficiencies and relief of risk management. The SCIO SM method aims to learn, predict and make better decisions for a successful drug opportunity. This […]
BBCR’s boutique consulting team specializes in rare diseases and orphan indications and dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR team provides consultancy in cell, biologics, and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for orphan diseases and precision medicine RWE can be used to […]
The Trial Management That Addresses Risks Experienced management address risks such as: Delayed enrollment Multiple protocol amendments Poor patient retention Poor data quality Prolonged trial completion timeline Poor safety monitor Let BBCR Consulting assist in your clinical trial strategy. Reach out to us to learn more about how we can help.
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. […]
As one of the first consultancy teams to streamline clinical trials, BBCR’s boutique consulting team specializes in rare disease and orphan indications dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR Team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for […]