BBCR’s epigenetic expert, Dr. Claudio Carini, has been a pioneer in epigenetics leading the effort of major pharmaceutical companies. BBCR helps to bridge the gap between pre-clinical and early clinical development. Translational medicine is a bridge between pre-clinical and early clinical development (from bench to bedside), creating the foundation for precision medicine in late clinical […]
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 […]
Early-Clinical Research for Cell and Gene Therapy The development of Cell and Gene Therapies is challenging due to complex study designs, adequately monitoring of adverse reactions, long-term immune response and safety follow-up. BBCR has delivered clinical plans and regulatory strategies for Cell and Gene therapy programs in Oncology and Rare diseases.
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 […]
BBCR specializes in taking the complexity inherent to the regulatory phase of the approvals and simplifying it by strategizing our support to each client based on product-specific regulatory requirements and functional needs. Our expertise spans: Regulatory Strategy FDA Meeting & Submission Pre-IND Integrated Development Plan Regulatory Submissions
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.
Rare disease drug development requires knowledge and experience that is not always intuitive or deductible from large population drug development experience. Looking for a Rare Disease drug development expert, both in regulatory and medical affairs, is highly recommended. We’d love to hear from you.