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Flexibility and agility in collaboration with CDMOs in view of product development and launch
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19 June: 16:40 - 17:00
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Dr Rudolf Hausmann, VP Technical Development & Operations, Santhera Pharmaceuticals
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ABSTRACT
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During development, launch and commercialization, there are a number of time-critical and cost-driving technical development & manufacturing steps which impact the progress and costs of the overall development program throughout all clinical phases and regulatory processes up to commercialization of a pharmaceutical product. This presentation is illustrating where critical technical development & manufacturing activities impact the overall timelines and ultimately "speed to market" and provides some examples with the focus on collaboration of small to medium size Pharma companies with contract development & manufacturing organisations (CDMO).
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BIOGRAPHY
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Rudolf Hausmann, originally from Kiel Germany, studied Pharmacy before his Ph.D. in Immunology. He has also a degree in Pharmaceutical Medicine from Basel University.
His career in the Pharmaceutical Industry started at Hoffmann La-Roche in Basel/Switzerland and he held different positions in Galenical Production, Formulation Development and Project Leadership. He worked on numerous development projects from pre-Phase-I up to launch. 2005 he started at Santhera Pharmaceuticals, a Biotech company near Basel, Switzerland, which is focussed on Development and Commercialization of new medicines against Neuromuscular Diseases. In his position as Head Technical Development & Operations he is responsible for Technical Development from Phase-I to Phase-III and commercial manufacturing & supply. He is also involved BD&L activities and has additional responsibilities as Project Leader. |
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COMPANY PROFILE
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Santhera Pharmaceuticals
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Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company with headquarter near Basel, Switzerland, focused on the development and commercialization of innovative medicines for rare and other diseases with high unmet medical needs. The portfolio comprises clinical stage and marketed treatments for neuro-ophthalmologic, neuromuscular and pulmonary diseases.
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