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Tagged: Regulatory Strategies

The BBCR mission is to deliver cost-effective clinical plans and regulatory strategies for cell and gene therapy programs. We invite you to learn more at bbcrconsulting.com.

July 10th, 2023 | Regulatory Strategies

BBCR’s boutique consulting team specializes in rare diseases and orphan indications and dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR team provides consultancy in cell, biologics, and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for orphan diseases and precision medicine RWE can be used to […]

Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Clinical trial results have been promising, and the next generation of Cell and Gene therapies holds tremendous promise for many patients and families.

January 17th, 2023 | Regulatory Strategies

Early-Clinical Research for Cell and Gene Therapy The development of Cell and Gene Therapies is challenging due to complex study designs, adequately monitoring of adverse reactions, long-term immune response and safety follow-up. BBCR has delivered clinical plans and regulatory strategies for Cell and Gene therapy programs in Oncology and Rare diseases.

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