A successful clinical program should identify the right patients and the right dose range as early as possible. We will help you to prepare for First in Human studies by use of a safe first dose guidance that entails advice on start dose setting, expected clinical efficacious dose range and an early risk management plan. Furthermore, a tailored biomarker strategy and a solid understanding of your patient population is needed to take you closer to your final clinical goals. The biomarker strategy can be captured in a Translational Science Plan that bridges the animal models and early clinical trials, facilitating integration of relevant biomarkers for patient stratification. This includes biomarkers for different purposes in drug development, such as those to show target engagement, proof of mechanism, -principle, or -concept and personalized medicine/patient stratification.