Regulatory Affairs

Drug repurposing offers your product shorter journeys to the clinics. It is especially crucial to rare and neglected diseases, cancers, and neurodegenerative diseases. Learn how we can help at

March 23rd, 2023 | Regulatory Affairs

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 […]

BBCR provides expert guidance for Orphan drug development. Our consultants have the experience to guide you through the Orphan clinical research process with a clinical plan and regulatory strategy for an accelerated approval.

March 20th, 2023 | Regulatory Affairs

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.

Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials.

January 10th, 2023 | Regulatory Affairs

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 […]

Orphan drug designation provides key incentives of the ODA, including significant tax credits for qualified clinical testing. The BBCR team will empower sponsors with medical insight, ODA application experience, strategic clinical plan, and streamlined trials design.

October 12th, 2022 | Regulatory Affairs

Developing drugs with substantial benefits in smaller, molecularly defined, pharmacologically relevant subpopulations of patients with the same clinically recognized disease is increasingly being viewed as a viable pathway for bringing drugs to market.    

BBCR supports innovative and repurposing treatments for orphan diseases.

October 4th, 2022 | Regulatory Affairs

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 customize strategies, simplify clinical research, design cost-effective trials, streamline protocols, and create a regulatory roadmap. Learn more about our services by visiting

September 20th, 2022 | Regulatory Affairs

How we can help The BBCR team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment We offer clinical strategy for orphan diseases and precision medicine RWE can be used to build orphan diseases evidence to support regulatory decisions BBCR serves small and medium sized Biotech Companies, […]

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