Preclinical Development – Biomolecular
2019 PharmSci 360
The medicines of future will be different from those currently in the market. Recent scientific breakthroughs will transform the current approaches of drug development. Recent approaches include nanobodies, bispecifics, nucleic acid-based, cell and gene therapies. We will cover the groundwork for developing such a program specific risk-based assessments and their mitigation strategies, consider state of the art tools to assess the safety and long term risks for new modalities to ultimately design clinical studies to have minimal impact on safety of these modalities.