Clinical Development in Drug Repurposing

Preparing, executing and analyzing a clinical trial is a highly complex process that requires in depth knowledge of GCP, knowledge and experience in clinical science and – most of all – an entrepreneurial spirit and creativity in order to optimize the development of a new drug treatment. Especially in the case of trials for repurposed medicines, creativity and innovation can be a key denominator in the way the program is designed, what makes it such an exciting journey. For generic drugs and new chemical or biologic entities strict rules and guidelines are applicable and need to be followed and determine the amount of non-clinical and clinical evidence that needs to be delivered. For repurposed drugs, the body of evidence is different in every case, and it is up to the project team to come up with the best and most efficient development program. The author will take you on this journey, using real life examples, failures and successes with the aim to inspire the audience to make the most out of the journey that we are about to embark on in the REPO4EU program