Session Details

SFC Session 5: Providing effective cellular therapies in the face of commercialization – meeting patients’ needs and expectations
Saturday, May 30, 2020 08:00 AM - 09:00 AM
Strategies for Commercialization
Commercialization of cellular and gene therapies is irrelevant if the patients do not receive the therapy they require. We need to understand the patient’s needs and expectations when they consider cell and gene therapy options. It is also important to discriminate between legitimate, safe and effective therapies versus alternative treatments that are offered to patients who are desperate.

Speakers

Connecting the dots between preclinical efficacy studies and the ethical conduct of Phase 1 trials for cellular and gene therapies
Mark Yarborough, PhD, University of California Davis (US)

This presentation will examine the links between the quality and relevance of preclinical studies and the completion of two tasks critical to the ethics of Phase 1 trials:
1. Determining when there is a reasonable ratio between risks and benefits (and the role of the FDA and EMA in this determination)
2. Making adequate disclosures to research candidates about the possible risks and benefits of participating in a Phase 1 trial

Mohammed Abou El-Enein, MD, PhD, Charité - Universitätsmedizin Berlin (DE)

Advanced Therapies at the Point of Care – A nurse perspective
Kathie Rodden, BSc, QEHB NHS Foundation Trust (UK)

This presentation comprises a summary of advanced therapy trials undertaken at University Hospital Birmingham.  My activities within my role within the MW ATTC will be discussed (PPI, Education, TAP)  including some challenges faced and plans to overcome them.