Global Regulatory Considerations in the Development of Oncology Biologics Products for the Treatment of Cancer
October 29, 2008
Westin Gaslamp Quarter Hotel
San Diego, CA
Presentation Slides & Schedule
Slides for select presentations below have been provided by the corresponding speaker for your convenience.
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| Wednesday, October 29, 2008 |
| 11:00 am – 7:00 pm |
Registration Open |
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| 1:00 pm – 1:20 pm |
Welcome and Introductions |
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Ulrich Kalinke, PhD – Paul-Ehrlich-Institut, Germany
Raj K. Puri, MD, PhD – U.S. Food and Drug Administration, CBER
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| United States: Regulatory Considerations in Oncology Biologics Product Development |
| 1:20 pm – 1:50 pm |
FDA: Chemistry, Manufacturing and Controls (CMC) Issues for Investigational New Drugs (IND)
Keith Wonnacott, PhD – Food and Drug Administration
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| 1:50 pm – 2:20 pm |
FDA: Perspective on the Preclinical Evaluation of Biological Therapies for Cancer
Yongjie Zhou, MD, PhD – Food and Drug Administration, CBER
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| 2:20 pm – 2:50 pm |
Introduction to FDA Drugs and Biological Review Process
Ke Liu, MD, PhD – Food and Drug Administration, CBER
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| 2:50 pm – 3:15 pm |
Break |
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| Europe: Regulatory Considerations in Oncology Biologics Product Development |
| 3:15 pm – 3:50 pm |
European Medicines Agency: New Regulations for Advanced Therapies
including Oncology Biological Products
Patrick Celis, PhD – European Medicines Agency
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| 3:50 pm – 4:25 pm |
Paul-Ehrlich-Institut: Considerations in Product Development
with Advanced Therapies and Cancer Vaccines
Thomas Hinz, PhD – Paul-Ehrlich-Institut, Germany
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Japan: Regulatory Considerations in Oncology Biologics Product Development
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4:25 pm – 5:00 pm |
Cancer Vaccines and Immunotherapy Regulation
Masatoshi Narita - Pharmaceuticals and Medical Devices Agency, Japan |
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Global Regulatory Considerations in Oncology Biologics Product Development
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5:00 pm – 5:30 pm |
Gina Coleman, MD – Health Canada
Bindu Dey, PhD – Department of Biotechnology, Government of India
Jianhui Luo, MD – Center for Drug Evaluation, SFDA, P.R.China
Andreas Marti, PD, PhD – Swissmedic, Swiss Agency for Therapeutic Products
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Roundtable Discussion
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5:30 pm – 6:30 pm |
Moderators:
Ulrich Kalinke, PhD – Paul-Ehrlich-Institut, Germany
Raj K. Puri, MD, PhD – U.S. Food and Drug Administration, CBER
Panelists:
Ashok M. Batra, MD – U.S. Food and Drug Administration, CBER
Patrick Celis, PhD – European Medicines Agency
Gina Coleman, MD – Health Canada
Bindu Dey, PhD – Department of Biotechnology, Government of India
Thomas Hinz, PhD – Paul-Ehrlich-Institut, Germany
Jianhu Luo, MD – Center for Drug Evaluation, SFDA, P.R. China
Koji Kawakami, MD, PhD – Japan Science and Technology Agency
Ke Liu, MD, PhD – U.S. Food and Drug Administration, CBER
Andreas Marti, PD, PhD – Swissmedic, Swiss Agency for Therapeutic Products
Masatoshi Narita - Pharmaceuticals and Medical Devices Agency, Japan
Keith Wonnacott, PhD – U.S. Food and Drug Administration, CBER
Yongjie Zhou, MD, PhD – U.S. Food and Drug Administration, CBER
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Reception
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6:30 pm – 8:00 pm |
Open to registered attendees for the Global Regulatory Summit |
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