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 to 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 team of epidemiologists, clinical development experts, safety and risk management 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 to obtain access to these life changing therapies.

Indications Supported:

Services Provided:

• Regulatory Strategy
• Full Service Clinical Development (Ph II – IV)
• Pre-clinical & Post-marketing Pharmacovigilance
• Risk Management, REMS, Epidemiology
• Modern Approaches to Long Term Follow-up Requirements Using Real World Data
• Observational Studies Registries
• Expanded Access Programs
• Patient Access & Reimbursement
• Lab & Care Coordination
• Case Management
• Patient Education