Drug Repurposing can 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.

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 de-novo drug development saves overall up to 11 years, 50-60% less cost and a significant number of subjects reduction in the clinical trials.

Repurposing drugs were developed for various diseases, including cancer, infection, inflammatory disorders, and neurodegenerative diseases. BBCR Consulting focus on the development of repurposing drugs for orphan indications and rare diseases. Due to the significant complexity of orphan drug development and lack of effective treatment for many of them, we aim to provide options to address the current unmet medical needs for a wide range of rare diseases worldwide.

Our team can provide experienced guidance in the areas of:

• 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

Contact BBCR to Learn More

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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