Meeting Agenda

Agenda: Policy Issues in Nanotechnology and Oncology

National Cancer Policy Forum Workshop
Institute of Medicine
July 12–13, 2010

The Liaison Capitol Hill Hotel
“The Hill” Conference Room

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, M.D. Anderson Cancer Center

Session 2 – Clinical Research and Translational Science – Accommodating and Enabling Nanotechnology
Moderator: Steven Curley, M.D. 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?
-    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, M.D. 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    Jim 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 & MR: 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


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 NCL 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

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?

9:30 am     Crossroad of Nanomedicine: Nanosafety and Policy                
                 Yuliang Zhao, Chinese Academy of Sciences, and Research Center for Cancer Nanotechnology

10:00 am    BREAK

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                   
                  Rogerio 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

Workshop Wrap-up

1:00 pm     Moderator: Mauro Ferrari, University of Texas Health Science Center - Houston

1:15 pm      Adjourn

Back to Meeting