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 […]
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 measure the effects of a specific treatment. While the current law and regulations permit the FDA to base the approval of a drug product […]
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 […]
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. The FDA developed a framework to use RWE, which may combine with orphan, fast track, breakthrough therapy designation, and accelerated approval to […]
People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. About a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs. BBCR’s team of industry experts can help match treatments to rare genetic conditions […]
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 […]
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. Click the button below to learn more about how we have helped companies with their clinical trial needs.
SCIO is critical for accelerating approval and significantly reducing the costs of drug and medical device development. One of the major challenges facing this industry is the rising cost of clinical trials. Thus, it is crucial to ensure that trials are significantly more efficient and cost-effective with the involvement of strategy at the time of […]
How can SCIO help? To enhance your position, it becomes crucial to demonstrate that your product/technology is the “safe” option for investment and a stand-out opportunity by including a clinical roadmap and development strategy of your product/technology. This roadmap illuminates clearly for the investment team what the target indications will be and the paths to […]
We aim to transform the transition stage between pre-clinical and clinical endpoints with smart strategy that, at a minimum, redirects the costs to benefit patients. The FDA has been calling for a smarter, more innovative approach, and we believe SCIO is the integrative, multidisciplinary approach to deliver it. Why SCIO? Investing in Strategy Accelerate Patient […]