About Pre conference course D - Fit for the future: How to address and manage potential risks of new biotechnologies

Imagine you see yourself in a situation in which you have to decide on the biological risk classification of a new biologic and decide on the safety measures required to protect the people working in the lab and the environment and you have never come across any similar biologic, if it is biologic at all. This course is as much about risk assessment and risk management as it is about the process to find an answer and come to conclusions as well as dealing with uncertainty. Therefore, this course provides some background knowledge on biological risk assessment of new biologicsbut it is also about case work on how to proceedwith finding answers and coming to decisions as well as informing others onyour findings.  

We dive into quite well known concepts of attenuated viral vectors and virus for use as recombinant vaccines, mRNA vaccines and oncolytics, synthetic RNA andchemically synthesized modified oligonucleotides developed for new therapies, as well as RNA interference and gene drives in combinations with nanoparticles. 

This advanced course is directed to BSO in academia and industry settings where, despite all excitement about new biotechnologies,biological risk assessment and managementneeds to be defended against various interests. 

Main topics:

• Biological risk assessment of new biologics 
• Personnel and environmental protection from new biologics 
• Dealing with uncertainties of risk assessment and risk management 
• Development of a process how to gather and combine relevant information for risk assessment and risk management. 
• Building a case for defending protection in spite of preliminary data sets on characteristics and hazards of new biologics.