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The Workshop
| Pre-conference workshop | ||
Challenges in early phase oncology drug development |
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Date: |
Monday, 10, November, 2008 |
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Led by: |
Dr Edwin Klumper Chief Scientific Officer SMS-ONCOLOGY Eric van der Putten Chief Operating Officer SMS-ONCOLOGY |
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About the workshop: |
The workshop will give an introduction to current challenges in early phase oncology drug development. Choosing the correct design (endpoints, target patient population) for Phase I and II studies is critical to the successful development of a new oncology compound. In the past decade oncology drug development has seen a shift from traditional cytotoxic agents to molecular targeted therapies. The different mechanism of action of targeted agents requires different approaches in study designs. Competition in oncology drug development has greatly increased. Once a new biological target has been identified many new compounds are being developed to hit such a target. A special focus of this workshop will be the value creation of oncology compounds by selecting the optimal development route. |
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Workshop agenda |
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| 12:00 | Registration and coffee |
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| 12:30 | Introduction |
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| 12:30 | Session 1: The use of biomarkers in phase I studies |
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| 13:00 | Session 2: Designs for phase I studies with cytotoxic and targeted agents |
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| 13:30 | Refreshments |
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| 13:45 | Session 3: Design of phase II studies with targeted agents |
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| 14:15 | Session 4: Case study: “New endpoints in clinical studies; circulating tumor cells” |
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| 15:00 | Refreshments |
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| 15:15 | Session 5: Selecting the best strategic options for oncology drug development | |
| 16:00 | Session 6: Case study: “Developing an early phase development strategy for a new angiogenesis inhibitor” | |
| 17:00 | Close of workshop | |
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| About your workshop leaders: | ||
Dr Edwin Klumper |
Dr Edwin Klumper carries over 15 years of experience in the pharmaceutical industry. Trained as a medical doctor Edwin got his PhD degree after spending 5 years of research to drug resistance in leukemia. Starting as Medical Director for Yew Tree Pharma and serving as local Business Unit Director Oncology for Asta Medica, Edwin became European Brand Director for Amgen Europe in Switzerland. With a keen interest in the dynamics of biotechnological drug development he Joined NABI Biopharmaceuticals Europe in Ireland as COO. In 2007 Edwin joined SMS-oncology as co-founder. |
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| Eric van der Putten | Eric van der Putten has over 20 years of clinical research experience. He started in 1983 as head trial department Comprehensive Cancer Center Amsterdam. Between 1990 and 2000 he has held several positions at clinical research companies. In 2000 he joined NDDO Oncology where he acted as chief operating officer and chief executive officer. After acquisition of NDDO Oncology by INC Research in 2005 Eric became Vice President Oncology for Europe of INC Research. Currently, Eric is Chief Operating Officer at SMS-oncology. |
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| SMS-oncology | SMS-oncology is a CRO that contributes to the overall success of oncology product development by assisting sponsors (innovative pharmaceutical, biotech & diagnostics companies) and investigators with the design and execution of early-phase clinical development programs and post-registration trials. Website: www.sms-oncology.com |
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