Repurposing acts to lower the need for early stage clinical trials. 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.

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 to identify new uses for existing drugs.

About a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs. For example Gleevec, a drug that revolutionized the treatment of chronic myeloid leukemia, now has nine orphan approvals.

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 pathway
• FDA meeting and submission
• Pre-IND integrated development plan
• Clinical study design and protocol
• CRO and project management
• Project remediation and rescue

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. 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.

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