The urgency to develop novel therapies for patients experiencing neurologic, metabolic, and rare diseases has led to the need for global pre-competitive collaborations. In this session, we will address approaches used to facilitate the sharing of expertise and data to generate innovative drug development solutions fit for regulatory purposes. We will describe challenges and opportunities that have led to the adoption of novel solutions in multiple disease areas and inform regulatory decision-making. Lastly, through the use of case examples, we will hear perspectives from patient groups, regulators, and industry representatives.