Session Speaker

The Role of Modern Experimental Biomedical Research in the Development of New Products with Clinical Applications. The example of the Experimental - Research Center ELPEN Pharma
Apostolos E. Papalois
Greece

Drug development in the medical arena is dependent on a variety of support structures. The introduction of a new molecule or drug ideally begins with innovation responding to clinical need, progresses through engineering and development, is fostered by financing from a variety of sources, and reaches the markets through disparate commercial structures. Along the way, the drug is subject to scientific, clinical, engineering, and regulatory scrutiny and may be lost to the target community by recognition of a lack of validity, safety, or effectiveness, or by mismanagement of its development. It is critical to understand the method by which new drugs with clinical applications are funded in the period between concept and product launch. Data available reflect the stage of development and therefore reflect the stage of the investment as well as the terms of the development. Nonetheless, diligence must demonstrate at least the following parameters, as organized by stage of development:

1 - Seed stage : a logical mechanical, physiologic and engineering approach to well - defined clinical problem and need for which current solutions remain imperfect.

2 - Early stage : proof of concept as represented by computer modeling, prototype development with in vitro testing or early animal validation.

3 - Pre-clinical stage : demonstrated safety and efficacy in animal models with progression to phase I testing demonstrating safety in humans.

4 - Pre- launch stage : phase 2 and phase 3 trials demonstrating efficacy and ultimately effectiveness under tightly controlled circumstances.

The Experimental -Research Center of Elpen Pharmaceuticals was established in 1996. It has developed a great progress and activities since 1996 with lab facilities and equipment for biomedical and pharmaceutical research as well as for training projects with other Institutions. Activities :

1 - Scientific co-operations with Clinics of Hellenic Universities and National Health System. 2 -Training for skilled and trainee doctors. 3 -Experimental performances of programs concerning Elpen S.A. projects' with the General Secretariat of Research and Technology and the European Union. 4 - Pre-clinical experimental research on new molecules where Elpen also keeps exclusive rights. 5 - Scientific information about Clinics, doctors and other scientists concerning the proper industrial operations of Elpen S.A. From May 1996 to May 2009, there has been accomplished more than 15.000 experiments. The results constitute a significant part of more than 300 protocols which has to do with research projects, scientific programs and elaboration of PhD Thesis. Also we have training workshops (A.P.L.S., D.S.T.C., Laparoscopic Surgery and other). Since 1996, more that 170 PhD Thesis and Master Degrees have been carried out or are still to be proceeded.

Furthermore, the Lab of Elpen S.A. has been awarded with 60 prizes in Hellenic and International Scientific Congresses and Organizations as well as from the Athens Chamber of Commerce and Industry for Research and Technology. Our new facilities and labs (1.000 s.m. - 8 surgical stations, 2 units for imaging, 5 labs for experimental physiology, amphitheater and other) are available after January 2007. The Experimental - Research Center of the Elpen S.A. is a successful model of private industry with high participation in scientific projects. This eligible job model is based on the ICLAS and European Union's Principles and Regulations for scientific research and training