De Smet

Introduction - The challenges to drug approval: Going from an idea, early data onto registration

Purpose: Gain a better appreciation of the steps involved in drug/device development and registration. Specific aim of this segment: The first challenge is to decide whether or not a drug or device is worth investigating further. Obtaining sufficient data and keep the process attractive to potential investors is a challenge as academics face a need to publish, thereby securing additional funding, while investors want to preserve intellectual property. One year after publication or presentation, data referring to a specific compound, process or device is considered to be part of public domain and cannot be patented. Prior to approval, a well defined package of efficacy, safety, and purification/production characteristics are required under good laboratory practice (GLP) guidelines. The clinical trial phase presents its own challenges. The desire to establish rapidly proof of concept, dose and frequency of administration often leading to premature costly choices, or overly complex study designs. The need to recruit within short timelines, increases the risk of inappropriate patient selection criteria. This lecture and others in this symposium, an insight into drug development and its intricacies will be presented.