Workshop B – Regulatory Guidance for Clinical Stage Oncolytic Virotherapy
Time: 1:00 pm
day: Pre-Conference Workshop Day
As T-Vec exists as the only approved oncolytic virotherapy for patients, the regulatory environment and the clinical production of OV’s remain complex as ever. Led by biopharma leaders, this session will set out to deconvolute the regulatory landscape of OV clinical development, taking vital learnings from the Cell and Gene Therapy environment.
Topics to Cover:
- Reviewing where the OV community fits in with existing regulatory guidelines
- Considering the existing guidance for cell and gene therapy regulations and how can this be a valuable tool as OV’s navigate regulations
- Patient population considerations for OV clinical stage trials