Workshop A: Practical Biosafety Risk Management for the Handling of Emerging Modalities
Dive into the day-to-day realities of managing biosafety in evolving biopharma environments. Participants will tackle the practical side of working with live agents, hybrid hazards, and novel compounds, where toxicology data is scarce, contractors vary in competence, and operational demands can compromise safety. Take-away strategies for maintaining robust biosafety without slowing innovation.
Key Questions to Be Addressed
- How can site teams justify and protect biosafety controls, such as BSCs or isolators, when operational or space constraints challenge their necessity?
- What workable approaches exist for safely handling novel compounds and live materials when toxicological or exposure data are incomplete?
- How can teams verify validation quality, leak testing, and equipment integrity when local regulations or contractor experience are limited?
- What training methods, peer learning, or digital tools can quickly upskill teams transitioning to advanced modalities like ADCs, radiopharma, or gene therapy?
- How can site-level leaders foster a biosafety culture where biological risks are recognised early, discussed openly, and prioritised alongside productivity?