Biologics, Cell, and Gene Therapy

Early-Clinical Research for Cell and Gene Therapy

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. The FDA has innovated approval pathways to meet these expectations, such as the Regenerative Medicine Advanced Therapy (RMAT) designation.

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

Strategies that move products to market faster:

  • A cost-effective Clinical Plan that saves time and resources
  • Medical Monitoring
  • Ad-interim Chief Medical Monitor
  • Indications Selection and Prioritization
  • Trial Design and Protocol
  • Study Remediation and Rescue
  • Clinical research consultation for regulatory submissions and meetings
  • Program Gap Analyses



Phase 1 & 2 objectives are to collect and analyze the product’s early safety profile, optimal dosage, and effectiveness trend. Combining phase I and II maximizes data collection opportunities.

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