Program Description

Nanotechnology was incorporated into more than $50 billion in manufactured goods last year, according to Lux Research. By 2014, the market will grow to $2.6 trillion. By 2011, over $15 billion in nano-enabled drugs and therapeutics will be sold—up from more than $3 billion in 2006. And industry experts project that nanotechnology will be incorporated into $20 billion worth of consumer food products by 2010.

Yet, despite this rapid commercialization, no nano-specific regulation exists anywhere in the world. Most regulatory agencies remain in an information-gathering mode—lacking the legal and scientific tools, information and resources they need to adequately oversee exponential nanotechnology market growth.

Now, for the first time, you’ll get to meet all the top officials from these government departments in one place and learn of their plans for regulating food and drug nanotech products. You’ll hear what’s really happening in Europe and Asia, on Wall Street, in the corridors of major corporations, in the more advanced laboratories, at forward-thinking universities and in the halls of Congress.

And you’ll also get the answers to those questions you’ve been talking to your colleagues about for the last several months:

• How is FDA going to implement its Nanotechnology Task Force Report?
• How is OSHA going to deal with nanotech issues in the workplace?
• Is Congress ready to act on nanotechnology if federal regulators don’t?
• What first and second generation nanotechnology products are already on the market, and what’s to come?
• Do Europe and Asia approach nanotechnology safety and oversight differently
  than the United States?
• When it comes to nanotechnology, should size make a regulatory difference?

Who Should Attend
Pharmaceutical firm representatives, nanotech development specialists, venture capitalists, in-house and outside legal counsel, nanotech policy officials.

Registration Fees

> Standard Rate (Received after Friday, January 25, 2008)
$795 FDLI Members
$1,195 Non-members
$595 Academics, 501(c)(3) Nonprofit, Government

Special CD Price!
Purchase the CD set for just $99 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, D.C. addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.

FEBRUARY 28 >

8:00 am
Registration & Continental Breakfast

9:00 am
FDLI Welcome & Introduction
Michael D. Levin-Epstein, Editor-in-Chief, Food and Drug Law Institute
James J. Kelly, CEO and President, Food and Drug Law Institute
Ralph F. Hall, J.D., Visiting Professor, University of Minnesota Law School

9:15 am
Keynote Address
Michael R. Taylor, J.D., Research Professor of Health Policy, School of Public Health and Health Services, George Washington University   

9:45 am
Making Deductions and Sense of the Science of Nanotechnology
Moderator:  David W. Rejeski, Director, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars

Jay M. Ansell, Ph.D., Senior Director of Cosmetic Programs,
Personal Care Products Council
Scott E. McNeil, Ph.D., Director, Nanotechnology Characterization Laboratory, National Cancer Institute, Frederick Inc.
Karen H. Hunter, Program Specialist, Cooperative State Research, Education and Extension Service, U.S. Department of Agriculture
Bernie Liebler, Director, Technology and Regulatory Affairs, Advanced Medical
Technology Association

10:45am
Refreshment Break

11:00 am
Making Dollars & Sense of the Business of Nanotechnology
Moderator:  James N. Czaban, J.D., Partner, Wilmer Cutler Pickering Hale & Dorr LLP

Scott Livingston, Managing Director, The Livingston Group, Axiom Capital Management
Robert A. Hoerr, M.D., Ph.D., President and CEO, Nanocopoeia, Inc. 
Sean Murdock, Executive Director, NanoBusiness Alliance
Leon Radomsky, J.D., Chair, Nanotechnology Industry Team, Foley & Lardner LLP

12:15 pm
Luncheon Address: Nanotechnology & Congress

Ron Wyden, J.D., Senator, U.S. Congress

introduced by Stephanie Scharf, Ph.D., J.D., Partner, Schoeman Updike & Kaufman LLP  

2:00 pm
Nanotech Regulation: Key Issues
Moderator:  George Burdock, Ph.D., President, The Burdock Group

Ralph F. Hall, J.D., Visiting Professor, University of Minnesota Law School
Susan D. Brienza, Ph.D., J.D., Of Counsel, Patton Boggs LLP 

2:30 pm
FDA Regulation of Nanotechnology: What Are the Rules of the Road?
Moderator:  Ricardo Carvajal, J.D., Of Counsel, Hyman, Phelps & McNamara, P.C.   

Norris E. Alderson, Ph.D., Associate Commissioner for Science, Food and Drug Administration 
Jeffrey M. Senger, J.D., Deputy Chief Counsel, Food and Drug Administration
Laura M. Tarantino, Ph.D., Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration

3:45pm
Refreshment Break  

4:00 pm
Best Practices for Managing the Business and Legal Risks of Nanotechnology 
Moderator:  Fern P. O’Brian, J.D., Partner, Arnold & Porter LLP

Stephanie Scharf, Ph.D., J.D., Partner, Schoeman Updike & Kaufman LLP
Laura Sciarrino, J.D., Vice President of Legal, Commercial Products,
CV Therapeutics, Inc.
Lee W. Farrow, J.D., Senior Vice President, ACE-USA

5:00 pm
Adjournment for the Day 

5:00 pm
Networking Reception

FEBRUARY 29 >

8:30 am
Nanotech Regulation Beyond FDA
Moderator:  Julia A. Moore, Deputy Director, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars

Terry L. Medley, J.D., Global Director, Corporate Regulatory Affairs, DuPont Environmental and Sustainable Growth Center
James Willis, Director, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency
Paul A. Schulte, Ph.D., Director, Education and Information Division & Nanotechnology Research Center, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention
Rachel G. Lattimore, J.D., Partner, Arent Fox LLP

9:45 am
Academic Projects
Moderator:  Ralph F. Hall, J.D., Visiting Professor, University of Minnesota Law School

Gary Marchant, Ph.D., J.D., Lincoln Professor, Emerging Technologies, Law and Ethics, Sandra Day O’Conner College of Law, Arizona State University
Robert W. Carpick, Ph.D., Director, Nanotechnology Institute, University of Pennsylvania

10:15pm
Refreshment Break

10:30 am
Nanotechnology: The Public Perspective
Moderator:  Gary Marchant, Ph.D., J.D., Lincoln Professor, Emerging Technologies, Law and Ethics, Sandra Day O’Conner College of Law, Arizona State University

Jane Macoubrie, Ph.D., President, Embry Research
Dietram A. Scheufele, Ph.D., Professor, Life Sciences Communication & Journalism and Mass Communication, University of Wisconsin

11:00 am
International Developments: Spanning the Globe
Moderator:  Ellen Maldonado, J.D., Attorney & Sole Practitioner            

Philippe Martin, Ph.D., Principal Administrator, Nanotechnologies Policy Development and Coordination, Health and Consumer Protection Directorate-General, European Commission
Jurron Bradley, Ph.D., Senior Analyst, Lux Research

11:45 am
Meeting Wrap-up
Stephanie Scharf, Ph.D., J.D., Partner, Schoeman Updike & Kaufman LLP
Ralph F. Hall, J.D., Visiting Professor, University of Minnesota Law School

12:00 pm
Adjournment