ASU Law Center Sponsors Conference on Personalized Medicine

ASU Law Center Sponsors Conference on Personalized Medicine

January 22, 2007

January 21, 2007

Joe Caspermeyer, Media Relations Manager & Science Editor
(480) 727-0369 | joseph.caspermeyer@asu.edu

 

The legal landscape of personalized medicine, which uses an individual’s genetic and molecular data to more accurately predict, diagnose and treat health problems, will be navigated by top experts in law, science, ethics and business at an upcoming conference at Arizona State University.

The Center for the Study of Law, Science, & Technology at the Sandra Day O’Connor College of Law at ASU will present “Personalized Medicine & Molecular Diagnostics: Legal, Regulatory and Ethical Perspectives,” from 8:30 a.m.-5:30 p.m. on Friday, March 2, in the Great Hall on the College of Law campus in Tempe.

Researchers believe understanding an individual’s genetic makeup is the key to developing personalized drugs that are safer and more effective. But as science moves forward and new products are discovered, tested and marketed, the law community must be prepared for co-developing legal questions, said Gary Marchant, the center’s executive director.

“There’s a lot of hype about and excitement and interest in personalized medicine — it’s really the wave of the future in health care,” he said. “A lot of the focus is on the scientific aspects of testing, but the legal and ethical issues haven’t received the same attention and consideration.”

These issues include drug and product liability, Marchant said, referring to lawsuits against vaccine manufacturers that ignored or overlooked available data about the genetic predispositions to certain illnesses of those taking the vaccine.

“Doctors will be on the front line of the liability issues, and we have to be adequately prepared,” said Marchant, noting the conference is for attorneys, researchers, administrators, physicians and other interested parties.

“Our view is that’s going to happen really quickly, and once it starts, it’s going to snowball and have a huge impact,” he said.

Other key issues to be addressed include intellectual property, and regulatory, reimbursement and ethical issues. Marchant said the program has a “superstar lineup” of speakers and topics, including:

—Steven I. Gutman, director of the Office of In Vitro Diagnostics at the U.S. Food and Drug Administration, addressing proposed guidelines for government regulation of genetic testing. To date, the FDA’s oversight of personalized medicine has been limited, but it is necessary, Gutman said.

“These (genetic) tests, I would say, often have less of a pedigree in terms of their knowledge base,” he said. “They’re very promising, but in many cases, they pop up in research settings that are not used to regular routes to market.”

—Barbara Caulfield, executive vice president and general counsel for Affymetrix, a Santa Clara, Calif.,-based manufacture of equipment used in molecular biology research. Caulfield will discuss intellectual property and diagnostics.

—M.J. Finley Austin, director of US External Science Policy at Hoffmann-La Roche, a pharmaceuticals and diagnostic tools’ manufacturer based in Basel, Switzerland. Austin will talk about the policy and business implications of linked diagnostics and drugs.

In addition to the Center, conference sponsors are the LL.M. Program in Genomics & Biotechnology at the Sandra Day O’Connor College of Law and The Biodesign Institute at ASU, the ABA Section of Science & Technology Law, Snell & Wilmer L.L.P., Quarles & Brady L.L.P., Gallagher & Kennedy P.A., TGen, Arizona BioIndustry Association, St. Joseph’s Hospital and Medical Center, Scottsdale Healthcare, C-Path and Gibson Ferrin & Riggs PLC.

Attendees may obtain continuing legal education credits. Early registration, by Feb. 1, is $150 with CLE credits, $50 without; registration after Feb. 1 is $200 with CLE credits, $80 without. Student scholarships are available, and fees will be waived for representatives of sponsors.

To register, go to www.law.asu.edu/personalizedmedicine. For more information, call Sandy Askland, director of the Center for the Study of Law, Science, & Technology, at (480) 965-2465 or e-mail sandy.askland@asu.edu.

About the Center:

The Center for the Study of Law, Science, & Technology at the Sandra Day O’Connor College of Law at Arizona State University is the nation’s oldest and largest multidisciplinary research center focusing on the legal implications of new scientific discoveries and emerging technologies. Since its founding in 1984, the Center has sought to contribute to the legal system’s response to the pervasive and increasing challenges posed by new scientific discoveries and their technological applications. It seeks to improve the quality of law and public policy affecting science and technology and supports work in an important reciprocal vein: the scientific study and understanding of law, legal institutions and legal process.


For more information contact:
Janie Magruder, (480) 727-9052, jane.magruder@asu.edu
Judy Nichols, (480) 727-7895, judith.nichols@asu.edu

 

Written by: Joe Caspermeyer