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Issue 5 : September/October 2008


The Future of Medicine:
Up Close & Personalized
September/October 2008

Subscription Information

FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.
*Please contact FDLI at (800) 956-6293 or
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.


Featured Articles


Personalized Medicine: Panacea or Pipedream?

by Jeffrey N. Gibbs, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

Personalized Medicine: A Patient-Centered Perspective

by M. Carolina Hinestrosa, Executive Vice President for Programs and Planning, National Breast Cancer Coalition, Washington, DC

The Ever-Evolving Role of “Companion Diagnostics”

by Randy Prebula, Director of Regulatory Science at the law firm of Hogan & Hartson, LLP, Washington, DC

Personalized Medicine: The Role of Laboratories
by Victoria M. Pratt, Chief Director, Molecular Genetics at Quest Diagnostics, Nichols Institute, Chantilly, VA, and clinical Practice Committee Chair of the Association for Molecular Pathology

and

S. Terence Dunn, Associate Professor, Pathology Department and Director of the Molecular Pathology Laboratory, University of Oklahoma Health Sciences Center, Oklahoma City, OK and Secretary/Treasurer, Publications Committee Chair, Association for Molecular Pathology

and

Karen E. Weck, Associate Professor of Pathology and Laboratory Medicine and Director, Molecular Genetics, University of North Carolina, Chapel Hill, NC and past Program Committee Chair, Association for Molecular Pathology

Collecting and Testing Samples for Pharmacogenomic Research: Issues for Manufacturers of Drug and Biological Products
by Grail Sipes, Partner in the law firm of Covington & Burling LLP, Washington, DC

IP Considerations in Early Biomarker Development in the Personalized Medicine Age
by Peter Keeling, CEO, Diaceutics

and

Mollie Roth, Corporate Counsel, Vice President of Business Development, Diaceutics and Visiting Faculty Fellow, Center for the Study of Law, Science and Technology, Sandra Day O’Connor College of Law, Arizona State University

Research, Policy Advances Needed to Fulfill Promise of Genetic Medicine,
Experts Say at AAAs

by Earl Lane, Senior Communications Officer, AAAS Office of Public Programs, Washington, DC



Also In This Issue


Ensuring the Safety of Parenteral Pharmaceuticals: How Manufacturers Can Benefit from New Pyrogenicity Testing Methods
by Nancy Beck, Scientific and Policy Advisor, the Physicians Committee for Responsible Medicine, Washington, DC

Country of Origin Labeling: What You Need to Know
by Elizabeth B. Fawell, Associate in the law firm of Hogan & Hartson, LLP, Washington, DC

Pharmaceutical Safety Is Not Served By Federal Supremacy

by Thomas N. Tiedt, Director, Med-Tox Group, Sarasota, FL



Columns


Enforcement Corner
“Cosmetics Product Enforcement”―Not an Oxymoron
by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

Global Corner
Personalized Medicine
by Matthew R. Weinberg, Chief Executive Officer, The Weinberg Group, Washington, DC

and

Ross Davidson, Consultant, The Weinberg Group, United Kingdom, contributed to this article

Canadian Corner
Mercury in Fish: Canada’s Updated Risk Management Strategy
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
Planning and Preparation: Making FDA Inspection a Postitive Experience
by Ann Peper Havelka, Associate in the law firm of Shook, Hardy & Bacon LLP,
Kansas City, MO


(Note: All author affiliations are current as of the date of publication of the issue.)

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