Planning Real-World Studies to Support Cell and Gene Therapy Evidence Generation Needs

Cell & Gene Therapies (CGTs) Offer a Personalized Approach to Medicine for Patients Who Have Previously Had Few or No Options.

As the CGT landscape continues to evolve, sponsors are adopting modern approaches in RWE study design and data analysis to help demonstrate long-term outcomes that enable therapeutic access to as many patients as possible.

Our latest white paper Planning Real-World Studies to Support Cell and Gene Therapy Evidence Generation Needs addresses how RWD and RWE can be used to solve challenges throughout the product lifecycle by:

• Optimizing patient recruitment through use of RWD and inclusion of decentralized tactic
• Enhancing study design through appropriate use of RWD to construct direct comparator arms
• Demonstrating long-term effectiveness and optimal benefit/risk with registries
• Reducing payer uncertainty by incorporating RWE with clinical data

Hear from UBC’s Executive Director, Real-World Evidence Study Solutions, Judy Lytle, PhD, MBEE, PMP, and Executive Director, Evidence Development Operations, Eileen Moran, on how planning an integrated evidence generation strategy during the pre-marketing phases of development is key in proving product value in the real world.