Program Area Leader
Beatriz Silva Lima
Nonclinical Safety Regulatory Scientist
Head of Department of Pharmacological Sciences of the Faculty of Pharmacy, Universidade de Lisboa
For a molecular candidate to successfully progress through development, strong knowledge on its target, target interactions, and role in health and disease are needed. Efficacy and safety require early prediction before human administration. Focus is on generating the pharmacological, pharmacokinetic and safety attributes needed to drive molecules into first-in-human studies. A coherent strategy integrates new drug delivery systems and non-biological complex drugs, including nanotechnology-based solutions. Supportive nonclinical studies aligned with International Conference of Harmonization nonclinical guidelines for different types of first-in-human exploratory studies are designed and conducted.