Moderator
Jeffrey N. Gibbs, Shareholder, Hyman, Phelps & McNamara, P.C.

Speakers
Jeffrey Cossman, MD, Founder and President, The United States
Diagnostics Standards (USDS)
Elizabeth A. Mansfield, PhD, Director, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA
Patricia B. Shrader, Senior Vice President, Corporate Regulatory and External Affairs, BD
Daniel B. Vorhaus, Attorney, Robinson, Bradshaw & Hinson, P.A.

Program Description
Laboratory-developed tests (LDTs) are playing an increasingly large role in diagnostics. The U.S. Food and Drug Administration (FDA) announced that it will start to regulate LDTs.  FDA recently held a two-day public meeting to get stakeholder input on how the agency should regulate LDTs.

Over the last 15 years, the nature of LDTs has changed.  Today, these tests are more often used to assess high-risk, but common, diseases and conditions.  They are also playing a prominent role in personalized medicine. Direct-to-consumer tests are becoming increasingly available.

This webinar will discuss potential changes to the regulation of LDTs—the regulatory status of LDTs, challenges for commercial labs, test manufacturers, specialty labs and others, and follow up discussion from the FDA public meeting.  This webinar will focus on what FDA regulation of LDTs will mean for stakeholders and how LDTs will be regulated. 

Registration Fees

$ 305 Member
$ 505 Non-Member

$ 305 Government Member
$ 405 Government Non-Member

$ 305 Academic Member
$ 405 Academic Non-Member

$ 305 Sole Practitioner Member
$ 505 Sole Practitioner Non-Member

$ 125 Student Member
$ 125 Student Non-Member
(Please call FDLI's customer service at (202) 371-1420 to receive this rate)

Special CD Price!
Purchase the CD set for just $75 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, DC and Maryland addresses will be
charged 6% sales tax.

Please contact Customer Service at (800) 956-6293 or (202) 371-1420, or by e-mail
at service@fdli.org, if you have any questions about your conference registration
or CD order.

JEFFREY N. GIBBS is a Principal in the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC Prior to entering private practice, he was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA). While at FDA, Mr. Gibbs received the FDA Award of Merit. Since entering private practice, he has assisted medical device, diagnostic, and pharmaceutical companies with a variety of regulatory issues, including FDA product approval, product labeling, clinical studies, promotional and marketing programs, FDA enforcement actions and product liability counseling. He has written extensively on FDA regulatory topics, and was previously Chair of the Editorial Advisory Board of the Food and Drug Law Journal. He is currently General Counsel of the Food and Drug Law Institute (FDLI) and a member of FDLI’s Board of Directors. He is also on the editorial advisory board of IVD Technology and Guide to Good Clinical Practices, and is a member of the Human Subjects Research Board for George Mason University. Mr. Gibbs is a graduate of Princeton University and New York University School of Law.

JEFFREY COSSMAN, MD is the Founder and President of United States Diagnostics Standards, Inc. (USDS), an independent certification body for laboratory and pathology diagnostics. Before founding USDS, he served as Chairman of the Department of Pathology at Georgetown University and as the Oscar B. Hunter Professor of Pathology at Georgetown. He is Director and Secretary of the Board of Directors of the Personalized Medicine Coalition. Dr. Cossman founded one of the nation's first molecular diagnostics laboratories while at the National Cancer Institute, where he developed and implemented lymphoma molecular diagnostic tests now in use worldwide. Previously, he was the Vice President and Medical Director of Gene Logic and Chief Science Officer of the Critical Path Institute. Dr. Cossman is a co-founder of Halcyon Diagnostics, Inc., Avalon Pharmaceuticals (now Clinical Data, Inc.), and the Association for Molecular Pathology. He has authored 150 scientific publications including the book Molecular Genetics in Cancer Diagnosis and has several patents in molecular diagnostics. Dr. Cossman received his MD from the University of Michigan Medical School, is board-certified in pathology and trained in pathology at the University of Michigan, Stanford University and the National Institutes of Health.

ELIZABETH A. MANSFIELD, PhD is the Director, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA. In this role, she works to develop programs to address companion and novel diagnostic devices. Prior to this, she served as a Senior Policy Analyst in the Office of In Vitro Diagnostic Devices (OIVD) where she managed policy and scientific issues. Before this position, Dr. Mansfield served as the Director of Regulatory Affairs at Affymetrix, Inc. from 2004 to 2006. She has also held other positions at FDA including Scientific Reviewer, Genetics Expert. She received a BA in biology from the University of Pennsylvania and a PhD in biochemistry from Johns Hopkins University. Dr. Mansfield completed further postdoctoral training at the National Cancer Institute (NCI) and the National Institute for Arthritis, Musculoskeletal, and Skin Diseases (NIAMS).

PATRICIA B. SHRADER is Senior Vice President, Corporate Regulatory and External Affairs for BD, a medical technology company. In this position she is responsible for all regulatory activities within BD worldwide, as well as serving as the primary interface with agencies and trade associates. She also has responsibility for Government Relations/Public Policy, Communications/Public Relations, and Social Investing. Previously, Ms. Shrader was Counsel with the law firm of Hogan & Hartson. Her practice focused primarily on medical devices, with an emphasis on product submissions and GMP issues. Prior to joining Hogan & Hartson, she was the Director of Quality Assurance and Regulatory Affairs at Whittaker Bioproducts, Inc. Ms. Shrader serves on the Board of Directors for the Food and Drug Law Institute (FDLI). She is a frequent speaker at various professional meetings and is active in FDLI, AdvaMed, and RAPS. She has also contributed numerous articles to MDM Magazine and IVD Technology. Ms. Shrader received her JD from Georgetown University Law Center.

DANIEL B. VORHAUS is an Attorney at Robinson, Bradshaw in Hinson, PA where he practices in the areas of mergers and acquisitions, pharmaceuticals, biotechnology and genomics and general corporate and commercial transactions. His experience includes representing both public and private companies in mergers and acquisitions, private equity groups in complex acquisition and financing arrangements and researchers, entrepreneurs, companies and investors in the development and commercialization of biotechnology products and services. As Editor of the Genomics Law Report, he is also actively engaged in the practice, study and development of the emerging field of law surrounding genomics and personalized medicine. He received his AB from Duke University and his JD from Harvard Law School.

Minimum requirements to run Conference America's WebEcho, the service that delivers visual presentations over the web in combination with a standard conference:

Windows 98 / ME / NT / 2000 / XP

Other compatible Operating Systems:
• SPARC Solaris
• IRIX and HP-UX
• Red Hat Linux 7.3
• Netscape 4.7
• Mac OSX
• Internet Explorer 5.1
• Netscape 6.2.3

Intel x86 (Pentium 400MHZ +) or compatible processor
256 MB RAM
JavaScript and cookies enabled in the browser
Java 1.4 Plug-in (www.java.com)
56K or faster Internet connection (DSL+ Recommended)