Professor Graz University of Technology Graz, Austria
The speaker will present a number of foundational principles to assist the product and process development scientist/engineer in the leveraging prior experience in the development of challenging new modalities. Specifically, we will discuss (1) making simple things simple, (2) utilization of institutional knowledge when approaching new modalities (i.e. applying lessons from monoclonal antibodies in the development of gene therapy products and (3) the value of agility. These principles will be discussed and highlighted by a number of case studies.
learn and review several behavioral and systematic approaches to product and process development of biotechnology products.
discuss what approaches they may wish to consider as we, as an industry, wrestle with an increasing number of complex modalities and opportunities while balancing finite resources and reduced time.
explain a number of approaches, and case studies, that exemplify the approach to 'make simple things simple'.