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 […]
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. […]
The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process. Small & Medium Sized Biotech Companies currently moving from pre-clinical studies toward clinical trials in need of interim Chief Medical Officer in need of regulatory strategy consultancy in need of preparing a pre-IND, orphan petition, IND, […]
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 […]
Did you know that about a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs? Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. We invite you to learn more about how BBCR can […]
If you’re interested in learning more about drug repurposing to treat rare disease, BBCR can help with your regulatory consulting needs. We offer expertise in the following areas: FDA meeting and submission Pre-IND integrated development plan Clinical consultant Clinical study design and protocol CRO and project management Study remediation and rescue
According to recently released data, 12 out of the 28 drugs approved in the first quarter of 2020 by the FDA were repurposed drugs. The drug repurposing approval process is an effective tool that accelerates the development of drugs for new indications or drug reformulation. In addition, the development of drug repurposing compared to a […]
Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. One attractive option of Drug Repurposing is to use a scientific approach […]
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 […]