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A Agenda National Cancer Policy Forum Workshop Institute of Medicine July 12–13, 2010 The Liaison Capitol Hill Hotel “The Hill” Conference Room 415 New Jersey Avenue NW Washington, DC 20001 DAY 1, July 12 8:30 am Breakfast Available 9:00 am Welcome Edward Benz, planning committee chair, Dana Farber Cancer Institute Session 1 Introduction to Nanotechnology and Nanomedicine Moderator: Edward Benz, Dana Farber Cancer Institute 9:15 am Historical View of Nanotechnology and Nanomedicine Mauro Ferrari, University of Texas Health Science Center–Houston 9:45 am The NCI Nanotechnology Alliance for Cancer: Making Personalized Cancer Medicine a Reality Anna Barker, National Cancer Institute 10:15 am BREAK 10:30 am Cancer Nanotechnology Beyond the NCI Steven Curley, MD Anderson Cancer Center 83

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84 NANOTECHNOLOGY AND ONCOLOGY Session 2 Clinical Research and Translational Science— Accommodating and Enabling Nanotechnology Moderator: Steven Curley, MD Anderson Cancer Center Each speaker is asked to comment on the flow of translational research: – What does a clinical investigator planning trials incorporating nanotechnology need to know? – What will it take to get there? Clinical Research Perspective Speakers are asked to address the following questions: – What do clinical researchers need to know about nanotechnology? – What tests must nano-materials themselves undergo? – What are potential and known risks with use of nanotechnology and how are unknowns being addressed? – Are there real advantages to nanotechnology (as diagnostics, screening tools, therapeutics, etc.)? 11:00 am Nanoparticles as Therapeutic Platforms Steve Libutti, Albert Einstein School of Medicine 11:30 am Biologic Barriers to In Vivo Nanomedicine Delivery: Major Hurdles for Clinical Translation King Li, The Methodist Hospital Research Institute 12:00 pm LUNCH Industry Perspective Speakers are asked to address the following questions: – How are companies thinking about moving nanotechnology products through the pipeline from proof of concept to development for clinical trials? – What is the current state of preclinical studies in testing efficacy and toxicity? – What are the long-term effects of these incredibly stable products? – Is it known what happens in degradation processes? 1:00 pm The nab-Platform: From Bench to the Clinic and Beyond Neil Desai, Abraxis Biosciences Preventive Medicine Perspective Speakers are asked to address the following questions: – What issues, opportunities, and known efforts exist within this domain?

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85 APPENDIX A – What challenges and unique enhancements does nanotechnology provide in this area? – How can nanotechnology be used to improve health (i.e., through environmental remediation or to make safer foods, etc.)? 1:30 pm Nanotechnology and Cancer Prevention Ernie Hawk, MD Anderson Cancer Institute Diagnostics and Therapeutics Discovery and Development Perspective Speakers are asked to address the following questions: – What issues, opportunities, and known efforts exist within this domain? – What challenges and unique enhancements does nanotechnology provide in this area? 2:00 pm Opportunities for Reproducibility and Uniformity of Therapeutics and Vaccines Using Templated Nanomanufacturing Methods Joseph DeSimone, University of North Carolina 2:30 pm James Heath, California Institute of Technology 3:00 pm BREAK Radiology and Laboratory Medicine Perspective Speakers are asked to address the following questions: – What issues, opportunities, and known efforts exist within this domain? – What challenges and unique enhancements does nanotechnology provide in this area? 3:15 pm Microfluidic Approaches for Single Cell Analysis Scott Manalis, Massachusetts Institute of Technology 3:45 pm Magnetic Nanoparticles and Magnetic Resonance: From Contrast Agents to Assays to Sensors Lee Josephson, Harvard University 4:15 pm Panel Discussion—Ideas for making progress in the next 2, 10, and 20 years All session speakers 4:45 pm Adjourn until Tuesday

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86 NANOTECHNOLOGY AND ONCOLOGY DAY 2, July 13 8:00 am Breakfast Available 8:20 am Welcome Back Session 3 Government Research Initiatives, Regulation, and International Standards Moderator: Mauro Ferrari, University of Texas Health Science Center–Houston Government Research Initiatives Speaker is asked to address the following questions: – Describe the role of the Nanotechnology Characterization Laboratory and how it may evolve over the next 10 years. – Describe some challenges overcome and current challenges facing the laboratory. – How do these lessons extend to other government research initiatives? 8:30 am NCI’s Nanotechnology Characterization Lab: Lessons Learned and Future Directions Scott McNeil, Nanotechnology Characterization Laboratory 9:00 am Discussion with Scott McNeil, Piotr Grodzinski, Mauro Ferrari, and Anna Barker 9:30 am BREAK International Standards: Cooperative Research and Regulation: Lessons and Challenges Speakers are asked to address the following questions: – What lessons can US regulators learn from regulation of nanotechnology in other countries? – What policies support cooperative research internationally? – What policies support product development and regulation internationally? 9:45 am Crossroad of Nanomedicine: Nanosafety and Policy Yuliang Zhao, Chinese Academy of Sciences, and Research Center for Cancer Nanotechnology

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87 APPENDIX A 10:15 am Successful Transfer of Innovative Technologies from Lab-Patient-Routine Use: Lessons Learnt and Global Opportunities Ruth Duncan, Cardiff, UK 10:45 am Nanomedicines Challenges and Opportunities in a Global Development Environment Rogério Gaspar, Research Institute for Medicines and Pharmaceutical Sciences 11:15 am Discussion 11:30 am WORKING LUNCH (boxed lunches available) Regulatory Challenges and Safety Speakers are asked to address the following questions: – What are regulators looking for? – How is nanotechnology being handled? – What concerns do the public have and how are they best addressed? 11:45 am Kristen Kulinowski, Rice University 12:15 pm Jonathan Sackner-Bernstein, Food and Drug Administration 12:45 pm Discussion 1:00 pm Workshop Wrap-up Moderator: Mauro Ferrari, University of Texas Health Science Center–Houston 1:15 pm Adjourn

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