Early drug development Conference
The two day conference (28 – 29 October 2014), initiated by Auxiliis, will feature presentations from academia, regulatory authorities, pharmaceutical industry, and contract research organisations.
The awareness of the value of new medicines for children and clinical research with children has increased over the past decades, partially as a result of US and EU legislation. However, Paediatric clinical practice has changed less than had been hoped for as a result of this legislation. The initial enthusiasm for the effects of legislative attempts to increase paediatric drug development has been replaced by a more realistic assessment. Breakthrough therapeutic innovations have been introduced in both adult and paediatric medicine. New successful therapies have been developed for example for cystic fibrosis, for rare metabolic diseases, and others. However, they were not triggered by paediatric legislation.
In addition, while academic medical research is essential and its value recognized, it seldom results in transition from bench to bedside without commercial involvement. The value of commercialization in the drug development process has often been underestimated. The organizers of this meeting consider it desirable for public perception and discussion in the media as well as in academia to become more open-minded about the need for and value of commercial translational research.
Pediatric Drug Development
The enthusiasm associated with paediatric drug development legislation was driven by the generally recognized need for more and better pediatric drugs and devices. What then is the way forward?
- This conference will provide an update on both state-of-the-art methodology as well as the many operational challenges in paediatric clinical research.
- The faculty will represent different groups that all have a stake in paediatric drug development and paediatric research including academic and commercial researchers, patient advocates, regulatory representatives, and companies devoted to improving pediatric therapy.
- The conference will be highly interactive in order to allow a hands-on exchange of ideas and experiences.
- The conference aims to re-evaluate what is needed for more effective and efficient progresses in the development of drugs for both paediatric and rare diseases.
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