Hot Topic: Prior Knowledge Integration in Product Development

Use of prior knowledge in biotech industry is taking a steam and several companies are discussing the approaches in integrating prior knowledge strategy in the development to address projects accelerations. Although there are several discussions happening at the company/consortia level, this discussion has not happened at a conference stage. There is an opportunity to have a broader discussion on this at NBC.

We start with a problem statement and discussion points. In order to icnrease the engagement, I propose two discussion topics - one from Industry and one from regulators on prior knowledge.

Pharmaceutical product development scientists, academia (with an eye on developing scale down models to support prior knowledge)

Prior knowledge in product development is becoming more prevalent with acceptance from broader pharmaceutical product development community and regulatory acceptance. Individual companies have strategies in place to address prior knowledge and knowledge management around it although rarely this had been discussed on the larger forum where the pharmaceutical industry can learn from each other. A focused session on prior knowledge strategies and how it applies to process development, specification creation and developing overall control strategy would add a significant value. This proposed session will have speakers from industry and FDA to facilitate this discussion.