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 […]
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 […]
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. BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan drug indications by developing and nurturing the product’s unique strengths. Our operational mission is to craft […]
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 development. A translational medicine program includes the adopting biomarkers to mitigate clinical trial risk, identify patient subpopulations, facilitate decision-making, and accelerate a drug’s market approval.
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 […]
Streamlining Clinical Development with Clinical and Regulatory Expertise Our team will empower you with medical insight, practical regulatory, translational medicine, and clinical research expertise, and streamlined clinical trials.
Our goal is to optimize every aspect of the research and development process We will: Improve protocol development, including current trends in clinical trial designs and endpoints Benchmark relevant historical trial enrolment with unmet needs and ongoing trial inclusion criteria Develop a clinical strategy including patient segmentation and biomarkers, streamlining operational costs through more efficient […]
Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks flexibility and efficiency to address today’s drug development demands. Challenges include managing product pipelines, targeting small and heterogeneous patient populations, meeting rising standards of evidence from payers moving towards value-based reimbursement models, and addressing the rising role of […]
Clinical trial results have been promising, and the next generation of Cell and Gene therapies holds tremendous promise for many patients and families. 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 successfully delivered cost-effective clinical plans […]
Due Diligence is typically performed by investors but can, and should, be conducted by sponsors to increase their chance of financing success, partnering, mergers, acquisitions (M&As), and product licensing. For companies developing multiple products, Due Diligence can also inform and assist in deciding which products to budget for as part of portfolio management. To learn […]