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Cell & Gene Therapy

Cell & Gene Therapy

From Strategy and Development to Infusion and Safety Follow-up

For decades, UBC has served as a trusted partner in bringing first-in-class, new molecular entities to market. We understand the challenges that our biopharmaceutical partners are facing when considering their clinical development, post-approval, and commercial evidence generation strategies.

We are a multidisciplinary, epidemiology-backed team of peri- and post-approval research experts, safety and risk management experts, and patient access experts who harness strong experience across the development lifecycle for cellular and gene therapies. We are passionate caregivers and educators that support and guide our clients and their patients toward accessing these life-changing therapies.

Indications Supported:

CELL

Relapsed or refractory large B-cell lymphoma • Relapsed/refractory mantle cell lymphoma (r/r MCL) • B-cell precursor acute lymphoblastic leukemia (ALL)

GENE

Spinal Muscular Atrophy • Hemophilia A • Hemophilia B • BCG-unresponsive high-grade non-muscle invasive bladder cancer (NMIBC)

Services Provided:

  • Regulatory Strategy
  • Late Stage Research & Clinical Trial Management (Ph II – IV)
  • Pre-Clinical & Post-Marketing Pharmacovigilance
  • Safety & Epidemiology Consulting
  • Risk Evaluation & Mitigation Strategies (REMS)
  • Modern Approaches to Long-Term Follow-up Requirements Using Real World Data
  • Registries & Observational Studies
  • Expanded Access Programs
  • Patient Access & Reimbursement
  • Lab & Care Coordination
  • Case Management
  • Patient Education
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