The ESRs had the opportunity to attend a two-day seminar on clinical development held by Novartis Hellas SACI, having an insight in how Novartis reimagine medicine in the global drug development in a patient-oriented way. The topics of the seminar included all the steps required to bring a new drug to the market, starting from the drug discovery, the innovation and technology behind it, the increasing role of Data Science and the potential role of Artificial intelligence to design clinical studies; the role of basic research and its translation in a meaningful target; the clinical trial (CT) phases (included the research methodology in CT and the different type of clinical research), with a focus on neurodegenerative diseases.
At the end of the first day, the President of the Hellenic Headache Alliance, shared her personal history and tough journey as a patient with migraine, giving her perspective on CTs. The seminar included also an introduction to the planning and execution of a CT, a practical example of it, the history of ethical clinical research and the ICH-GCP, the safety reporting in CT and risk management, the increasing investment of pharmaceutical company in the drug discovery process; the regulatory affair pathway involved in drug approval. The ESRs had also the opportunity to have an insight on the Medical Science Liaison activity and hear about real experiences from benchwork to pharma industry and how to make this transition successfully.
In conclusion, has been explained how to unlock access to patients through value-driven drug development and the market access challenge: to provide the right medicine for the right patient, at right time and right price.