1. European Technology Platform – Innovative Medicines for Europe 1 st Workshop on Education and Training, 24 & 25 February 2005 Educational gaps in the R&D process, a SME view

2. MediGene – A Brief Overview  Established in 1994 as a spin-off of the Munich Gene- Center by three professors and an enterpreneur  IPO issued in the year 2000  Approx. 120 employees in two locations (Munich & San Diego)  First German Biotech Company with a product on the market  Has the most advanced product pipeline in the German Biotech industry

3. Portfolio of Novel Cancer Therapeutics Product 1 2 3 Approval Clinical Phase IndicationPreclinicalMarketedPeak sales potential [MM €] Eligard ® √ Prostate Cancer √ > 100 Polyphenon ® EGenital Warts Actinic Keratosis > 100 > 200 Oncolytic HSV Glioblastoma Liver Metastases > 300 > 200 Prostate Cancer > 200 EndoTAG-1 Pancreatic Cancer > 200

4. Educational gaps in the R&D process, a SME view 1Do SMEs have specific educational requirements in R&D ? 2What is the current state of academic education and training for R&D ? 3What is desired ?

5. Educational gaps in the R&D process, a SME view 1Do SMEs have specific educational requirements in R&D ? 2What is the current state of academic education and training for R&D ? 3What is desired ?

6.  High Scientific Qualification  Interdisciplinary Approach  Expertise in non-scientific fields - management skills - economic expertise - regulatory requirements - project management Do SMEs have specific educational requirements in R&D ?

7.  Expertise in non-scientific fields In large organisations („big pharma“) internal training programs to acquire these additional skills are already in place. However, this is normally not possible for SMEs.

8. Do SMEs have specific educational requirements in R&D ?  Expertise in non-scientific fields Also, in large companies tasks requiring more experience are rather performed sequentially (i.e., an employee starts in the R&D department, then changes department, etc.), while in SMEs often it is required that several tasks are to be carried out at the same time.

9. Educational gaps in the R&D process, a SME view 1Do SMEs have specific educational requirements in R&D ? 2What is the current state of academic education and training for R&D ? 3What is desired ?

10. What is the current state of academic education and training for R&D? Substantial efforts to adopt academic education according to the changing challenges are being made. In Germany, the introduction of Bachelor, Master and Ph.D. Studies.  More orientation towards the practical needs in industry In Germany, initial steps have been taken to offer a specialized curriculum for the scientific needs in Biotechnology (Molecular Biotechnology /Univ. Heidelberg)

11. Educational gaps in the R&D process, a SME view 1Do SMEs have specific educational requirements in R&D ? 2What is the current state of academic education and training for R&D ? 3What is desired ?

12. What is desired ? Required are top-level scientists with additional skills. The reorganization of the curriculum in Germany and in Europe could provide the opportunity to incorporate non-scientific topics needed by SMEs in the Biotech field. e.g. patent lawyers are an example, where additional training after a scientific degree is already done.

13. What is desired ? Further examples:...... requirements of the regulatory authorities...... clinical development knowledge..... etc. More MBA-like studies for scientists (such as at the Universities in Maastrich/Liège) to obtain practical management or other skills.