Moderators, Panelists & Speakers
Morning Session
Afternoon Session

Program Description
A two-part, national conference offering a high-level roundtable discussion in the morning and a seminar on legal, regulatory and policy issues on personalized medicine in the afternoon. You can attend either session or the entire conference. But space is limited, so register now.

Morning Session -- 9:00 am - 12 Noon
Anticipating Personalized Medicine: A Roundtable Discussion

Moderator
Susan Dentzer
Health policy journalist and on-air correspondent for the PBS NewsHour
Editor-in-Chief, Health Affairs (effective May, 1, 2008)

Panelists
Finley Austin, Ph.D., Head, US External Research & Innovation Environment, Hoffmann-La Roche, Inc.
Greg Downing, D.O., Ph.D., Program Director, Personalized Health Care, Immediate Office of the Secretary, Department of Health and Human Services
Carolina Hinestrosa, M.A., M.P.H., Executive Vice President of Programs and Planning, National Breast Cancer Coalition
Howard. P. Levy, M.D., Ph.D., Assistant Professor, Division of General Internal Medicine and McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University
Kavita Patel, M.D., M.S.H.S., Deputy Staff Director, Health Subcommittee
of Senator Edward M. Kennedy
Charles Rotimi, Ph.D., Director, NIH Intramural Center for Genomics and Health Disparities; Senior Investigator, Inherited Disease Research Branch, NHGRI
Joan A. Scott, M.S., C.G.C., Deputy Director, Genetics and Public Policy Center,
Johns Hopkins University
Grail Sipes, J.D., Partner, Covington & Burling
More panelists to be announced

Predictions about the future course of medical care generally include some form of personalized medicine.  The scientific basis and individual and societal implications of personalized medicine will be explored at this morning Roundtable, Anticipating Personalized Medicine.

Rather than one size fits all medicine, personalized medicine is tailored to account for individual differences. Although doctors have long incorporated personal information like family history into treatment plans, personalized medicine holds the promise of revolutionizing medical care by using knowledge of molecular biology and genetics that will allow more precise diagnoses, better diagnostic tests, greater predictability of disease course, more successful therapies by targeting the right treatments to the right patients, and improved patient safety by selecting drugs and their proper dosage to reduce adverse side effects. 

The prospect of offering patients more precise and effective treatments without inflicting mayhem on the rest of the body is tantalizing.  Scientific “progress,” however, like life, comes with no guarantees, and the medical and policy challenges are daunting.  Personalized medicine may lead to increased concerns regarding privacy and discrimination based on medical information and uncertainty about the costs of research and of medical care. 

The stakeholders participating in the morning Roundtable — including scientists, physicians, the pharmaceutical and insurance industries, government, patient groups, and others —will discuss a case study, which will be used as a springboard to confront issues from the highly technical to the economic, ethical and regulatory that will need to be addressed if personalized medicine is to be incorporated into mainstream health care.

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Afternoon Session -- 1:00 pm - 5:00 pm
Implementing Personalized Medicine: A Legal, Regulatory and Policy Seminar

Keynote Speaker
Mark B. McClellan, M.D., Ph.D., Senior Fellow and Director, Engelberg Center for Health Care Reform, The Brookings Institution and former FDA Commissioner & CMS Administrator

Moderators
Jeffery N. Gibbs, Principal, Hyman, Phelps & McNamara, P.C.
Gail H. Javitt, J.D., M.P.H., Law & Policy Director, The Genetics and Public Policy
Center, The Johns Hopkins University

Speakers
Kevin T. Conroy, President and CEO, Third Wave Technologies, Inc.
Maryellen de Mars, Ph.D., Director, Clinical Biomarkers, Critical Path Institute
Steven I. Gutman, Ph.D., Director, Office of In Vitro Diagnostic Device
Evaluation & Safety, CDRH, FDA
Shiew-Mei Huang, Ph.D., Deputy Director for Science, Office of Clinical
Pharmacology, CDER, FDA
Steve McPhail, President and Chief Executive Officer, Expression Analysis, Inc.
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP
Allen D. Roses, M.D., Jefferson-Pilot Professor of Neurobiology and Genetics,
Professor of Medicine, and Director, Deane Drug Discovery Institute, Duke University Medical Center; Senior Scholar, Fuqua School of Business; Member, Duke Institute of Genome Sciences and Policy
More speakers to be announced

This afternoon Seminar focuses on the legal, regulatory and policy implications of developing drugs, biologicals and diagnostics for the rapidly emerging field known as personalized medicine.

Expert panelists from government, private industry, science and medicine will provide invaluable information on the legal and regulatory challenges faced by professionals practicing in areas affected by personalized medicine, including labeling issues, laboratory developed tests, IVD approval and reimbursement and PGx-tailored drugs and companion diagnostics.

You’ll want to take advantage of this unprecedented opportunity to hear directly from government regulators about their plans for dealing with novel issues arising from personalized medicine. And you’ll want to participate in our final Q&A policy panel about how personalized medicine issues should be regulated by FDA and others.

Who Should Attend
Pharmaceutical, biological, medical device, healthcare or venture capitalist professionals working in the legal, regulatory, policy, scientific, research and development and economic arenas to include scientists, lawyers, bioethicists, patient disease groups, congressional staff, government officials, consumer organizations, students and educators.

Registration Fees
Morning Session Only
FREE! If you wish to attend the morning session only, please click here.

Afternoon Session Only
Early Bird Rate (Received before Friday, June 6, 2008)
$345 Member, Non-member and Gov't/Academic/Non-Profit

Regular Rate (Received after Friday, June 6, 2008)
$395 Member, Non-member and Gov't/Academic/Non-Profit

Both Sessions
Early Bird Rate (Received before Friday, June 6, 2008)
$345 Member, Non-member and Gov't/Academic/Non-Profit

Regular Rate (Received after Friday, June 6, 2008)
$395 Member, Non-member and Gov't/Academic/Non-Profit

Special CD Price!
$49 Purchased with Registration for Morning Session Only
$49 Purchased with Registration for Afternoon Session Only
$89 Purchased with Registration for Both Sessions

To receive the special prices, 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.

Morning Session Speakers
[View Afternoon Session Speaker Bios]

SUSAN DENTZER is the Editor-in-Chief of Health Affairs, the nation’s leading journal of health policy, and an on-air health analyst with The NewsHour with Jim Lehrer on the Public Broadcasting Service (PBS). Dentzer assumed the job of Editor-in-Chief on May 1, 2008, after a decade as the on-air health correspondent for The NewsHour with Jim Lehrer on PBS. She led a unit that provided in-depth coverage of health care, health policy, and Social Security.  At The NewsHour, Dentzer was the recipient of multiple awards, including the 2005 Award for Excellence in Health Care Journalism from the Association of Health Care Journalists.

Prior to joining The NewsHour in 1998, Dentzer was chief economics correspondent and economics columnist for U.S. News & World Report from 1987 to 1997. She reported extensively on the debate over reforming and partially "privatizing" Social Security and over such health policy issues as regulation of managed care.

Dentzer is a member of the Council on Foreign Relations and serves on the Board of Directors of the Friends of the National Institute for Nursing Research, the International Rescue Committee, and the Global Health Council. She serves on the Kaiser Commission on Medicaid and the Uninsured, the advisory board of the California Health Benefits Review Committee, and is a member of the National Advisory Committee for the Robert Wood Johnson Foundation's Investigator Awards in Health Policy Research.

A graduate of Dartmouth, she is a member of the Board of Overseers of Dartmouth Medical School. Previously, she served on the Dartmouth College Board of Trustees from 1993 to June 2004, and was the first woman ever to serve as Chair of Dartmouth's board (2001 to 2004). She is also a former trustee of the Dartmouth-Hitchcock Medical Center, having served in that capacity until 2004. In 2007, she received the Dartmouth Alumni Award, the highest honor given to Dartmouth alumni for service to the college.

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As US Head External Research and Innovation Environment, FINLEY AUSTIN’s work at Roche has allowed her to develop a unique understanding of R&D and business needs in the pharmaceutical, biotech and diagnostic industries, and to assist the company in promoting synergy and value capture at their interface. She advises the company on policy, legislation, regulation and external science activities with an emphasis on issues affecting stratified medicines. Her analysis and expert input as a human geneticist aids Roche in incorporating genetics, genomics and biomarker approaches into the company’s research, product development and business strategy.  She leads a project on economic analysis of external incentives influencing production of linked drugs and diagnostics.  She also acts as liaison with a variety of outside organizations, trade associations and partners, and participates on a number of committees addressing biomedical research, regulation and clinical application policy.

Dr. Austin was awarded a Ph.D. in Human Genetics in 1989 from the Medical College of Virginia at VCU.  Her graduate education included both course work and laboratory experience in human cytogenetics, quantitative genetics, and molecular genetics, and she received practical training in clinical genetics.  Dr. Austin then conducted postdoctoral research for four years in molecular genetics and pharmacology.  Her post-graduate career path has combined technology development and policy. Prior to joining Roche, Dr. Austin competed for and was awarded an American Association for the Advancement of Science - Science, Engineering and Diplomacy Fellowship.  She then accepted a position as Program Officer with the Burroughs Wellcome Fund (BWF), a private foundation supporting biomedical research in the U.S. and Canada.  In 1997, Dr. Austin was appointed Administrative Director of the Merck Genome Research Institute, a not-for-profit corporation dedicated to supporting the development of new technologies to enhance functional genomics research.  She joined Roche in 1999.

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DR. GREG DOWNING was appointed in March 2006 as Program Director for the United States Department of Health and Human Services (HHS) Secretary Michael O. Leavitt’s priority initiative for Personalized Health Care.  In this role, he coordinates trans-HHS agency programs for the analysis, planning and implementation of policies and systems to facilitate adoption of Personalized Health Care practices.

Prior to his move to HHS, Dr. Downing served at the National Institutes of Health since 1993 in research, policy, and program management roles. Dr. Downing earned his medical degree from Michigan State University and his Ph.D. in pharmacology from the University of Kansas.  He completed his residency in pediatrics and fellowship in neonatology before joining the faculty of the University of Missouri-Kansas City in the Department of Neonatology at The Children’s Mercy Hospital.  Dr. Downing is certified by the American Board of Pediatrics in pediatrics and neonatology — perinatal medicine.

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CAROLINA HINESTROSA is the Executive Vice President for Programs and Planning at the National Breast Cancer Coalition, and co-founder of Nueva Vida, a support network for Latinas with cancer in the Washington metropolitan area. A two-time breast cancer survivor, Ms. Hinestrosa is a member and former Chair of the Integration Panel of the Department of Defense Breast Cancer Research Program. She has served on various national committees at the National Cancer Institute, the Institute of Medicine, National Quality Forum, the Ethical Force of the American Medical Association, among others. She is a sought-after speaker on breast cancer advocacy in research, access and quality care. Born in Bogotá, Colombia, Ms. Hinestrosa came to the United States in 1985 as a Fulbright scholar. She holds graduate degrees in economics and public health. She has broad experience in strategic planning and nonprofit management in Colombia, New Zealand and the United States.

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HOWARD P. LEVY, M.D., Ph.D., is Clinical Director of the Johns Hopkins University Internal Medicine practice at Green Spring Station.  He received his PhD in Human Genetics and his MD from University of Maryland.  He completed a fellowship in Medical Genetics at the National Human Genome Research Institute (NHGRI), NIH and is board certified in Internal Medicine and Clinical Genetics.  His clinical and research interests include Ehlers Danlos syndrome and related disorders of connective tissue, primary care of adults with genetic conditions, genetic risk assessment for common complex diseases, and integration of genetics into primary care medicine. He cares care for adults with a wide variety of genetic disorders as well as primary care patients, with whom he emphasizes genetic principles to improve routine care and preventive medicine. 

Dr. Levy is active in several educational programs developed by the National Coalition for Health Professional Education in Genetics.  He serves on the advisory boards of the Ehlers Danlos, Cornelia de Lange and Joubert syndrome foundations.  He is a member of the Executive committees of the Adult Genetics Special Interest Group of the American College of Medical Genetics and the Johns Hopkins/NHGRI Genetic Counseling Training Program, as well as the Information and Education committee of the American Society of Human Genetics.  Dr. Levy is co-founder and co-Editor-in-Chief of GeneFacts, an Internet-based resource under development to answer health care providers’ genetics questions at the point of care.

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KAVITA PATEL, M.D., M.S.H.S., is the Deputy Staff Director for the Health subcommittee of Senator Edward M. Kennedy.  She was previously an Associate Scientist at the RAND Corporation as well as a health services researcher at UCLA.  Prior to her research training, Dr. Patel was the National President of the American Medical Student Association which really started her career as an advocate for improved health care access for all Americans. She completed her training in internal medicine at Oregon Health and Sciences University where she also served as a Chief Resident of Medicine. After that she entered and completed the Robert Wood Johnson Clinical Scholars program and received a Masters in Health Services Research.

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DR. CHARLES ROTIMI is the Director of the NIH Intramural Center for Genomics and Health Disparities and Senior Investigator in the Inherited Disease Research Branch, NHGRI. He received his undergraduate education from the University of Benin in Nigeria before immigrating to the United States for further studies. Dr. Rotimi started his education in the US at the University of Mississippi where he obtained a masters degree in Health Care Administration. He obtained a second masters degree and a doctorate in epidemiology from the University of Alabama at Birmingham School of Public Health. Dr. Rotimi was the former Director of the National Human Genome Center at Howard University. Dr. Rotimi provided the leadership for the establishment of the African Society of Human Genetics and he is the current president (http://afshg.org). His long-term scientific interest is directed at understanding the patterns and determinants of common complex diseases including diabetes, hypertension and obesity in populations of the African Diaspora. Collectively, diabetes, hypertension, obesity and their complications explain over 80% of the well-documented health disparity that exists between African Americans and their White counterparts in the US. Contemporary populations of African descent now live in very different social settings, from traditional to fully westernized lifestyles, with varying degrees of genetic admixture. Dr. Rotimi believes that studying these diverse populations may help explain phenomenon like the monotonic increase in hypertension rates as one moves from rural west Africa (about 7%) through the black nations of the Caribbean (about 26%) and the US (about 34%). Taking advantage of the huge contrast in the distribution of risk factors in these contemporary African populations, Dr. Rotimi uses genetic epidemiology models to test whether high rate of diseases like diabetes, hypertension and obesity among African Americans is the result of exposure to higher levels of environmental risk factors, an increased genetic susceptibility, or an interaction between adverse environments and deleterious genes.

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JOAN A. SCOTT. M.S., C.G.C., is the Deputy Director of the Genetics and Public Policy Center at Johns Hopkins University. The Center works to help policy leaders, decision makers, and the public better understand the rapidly evolving field of human genetics and its application to healthcare. To inform genetic policy decisions, the Center surveys public attitudes about genetics issues, conducts analyses of the existing regulatory landscape, monitors the transition of genetic applications into clinical practice, and posits options and likely outcomes of key genetics policies. In addition to surveying public attitudes, the Center has conducted public engagement activities to better understand public opinion about advances in genetics and the values that shape those opinions.

Ms. Scott is a certified genetic counselor with 30 years of experience in clinical genetics, the biotechnology industry, and genetic policy. Prior to coming to the Center, Ms. Scott was a Director at Gene Logic Inc., a genomics company. She also served as General Manager and Director of Genetic Services at a clinical diagnostic lab. Ms. Scott practiced clinically in a variety of academic, outreach, and private practice settings including pediatric, adult, and reproductive genetic clinics. In addition, she ran the genetic counseling training program at the University of Colorado Health Science Center. Ms. Scott is past president of the National Society of Genetic Counselors and served on the founding board of the American Board of Genetic Counseling. Ms. Scott holds certification from the American Board of Medical Genetics, sub specializing in Genetic Counseling. She holds an M.S. in Human Genetics from Sarah Lawrence College and a B.A. in Anthropology and Zoology from Kent State University.

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GRAIL WALSH SIPES practices in Covington’s food and drug and life sciences groups.  Her practice covers all aspects of drug and biologic regulation, including clinical trials and drug development; FDA approval and marketing exclusivity considerations; drug marketing and promotion; postmarketing surveillance; and privacy issues raised by the collection of data and biomaterials.  Ms. Sipes also has expertise in issues specific to the development of vaccines, including pandemic vaccine products.  She regularly counsels clients on a range of regulatory issues raised by corporate acquisitions and transactions in the pharmaceutical and biotechnology sectors.  Ms. Sipes is a magna cum laude graduate of Yale University (B.A., 1985) and the recipient of a Fulbright Teaching Fellowship.  She earned her law degree from Harvard Law School (J.D., 1994).

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Afternoon Session Speakers
[View Morning Session Speaker Bios]

MARK B. McCLELLAN, M.P.A., M.D., Ph.D., is a Senior Fellow and Director of the  Engelberg Center for Health Care Reform, and Leonard D. Schaeffer Director’s Chair in Health Policy at the Brookings Institution.  The Engelberg Center is studying ways to provide solutions for access, quality and financing challenges facing the U.S. healthcare system. A medical doctor and economist by training, he is developing and implementing ideas to drive improvements in high-quality, innovative and affordable healthcare. Previously, Dr. McClellan served as Administrator of the Centers for Medicare and Medicaid Services (CMS) and as Commissioner of the Food and Drug Administration (FDA). While at CMS and FDA, Dr. McClellan helped develop and implement major reforms in health policy, including the Medicare prescription drug benefit, the Critical Path Initiative, and public-private initiatives to develop better information on the quality and cost of care. His professional experience includes Associate Professor of Economics and of Medicine at Stanford University; Member of President George W. Bush’s Council of Economic Advisers and Senior Director for Health Care; Member of the Institute of Medicine; Research Associate with the National Bureau of Economic Research, National Fellow of the Hoover Institution, Stanford University; Director of the Program on Health Outcomes Research, Center for Health Policy and Center for Primary Economics, Stanford University; Associate Editor of the Journal of Health Economics; Deputy Assistant Secretary for Economic Policy, U.S. Department of Treasury. Dr. McClellan holds a B.A. from the University of Texas at Austin and an M.P.A. from Harvard University.  He earn an M.D. from the Harvard-Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology and his Ph.D. in Economics from MIT.

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JEFFREY N. GIBBS is a Principal in the law firm of Hyman, Phelps & McNamara, P.C. in Washington, D.C. Prior to entering private practice, he was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA). He also served as Special Assistant United States Attorney in the District of Columbia in the Civil Division. 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 a member of the George Mason University Human Subjects Review Board. Mr. Gibbs is a graduate of Princeton University and New York University School of Law.

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GAIL JAVITT, J.D., M.P.H., is the Law and Policy Director at the Genetics and Public Policy Center and is a Research Scientist in the Berman Institute of Bioethics at the Johns Hopkins University.  At the Center she has been responsible for developing policy options to guide the development and use of reproductive technologies and is currently leading an initiative to improve oversight of genetic testing quality.  Ms. Javitt is also an Adjunct Professor at the Georgetown University Law.  She served as an Adjunct Professor of Law at the University of Maryland School of Law, where she has taught Food and Drug Law and Genetics and Law, and at the Johns Hopkins School of Public Health, where she co-taught Health Law and Regulation. She was a Greenwall Fellow in Bioethics and Health Policy at the Johns Hopkins and Georgetown Universities. Previously, she was an Associate at Covington & Burling in Washington, D.C. specializing in Food and Drug Administration (FDA) regulatory issues. She served as law clerk to the Honorable Gary L. Taylor, U.S. District Court, Central District of California. Ms. Javitt has written on a variety of science regulatory and legal issues on topics including direct-to-consumer advertising of genetic testing and FDA regulation of biotechnology. She holds a B.A., magna cum laude, Phi Beta Kappa, from Columbia College, a J.D., cum laude, from Harvard Law School, and a M.P.H. from the Johns Hopkins University.

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KEVIN T. CONROY is President and CEO, Third Wave Technologies, Inc. He joined Third Wave as Vice President of Legal Affairs in July 2004 and was appointed General Counsel and Secretary in October 2004. Prior to joining the company, Mr. Conroy worked for GE Healthcare, where he oversaw the development and management of its Information Technologies group intellectual property portfolio, and developed and executed litigation, licensing, and corporate and product acquisition legal strategies. Before joining GE, Mr. Conroy was an intellectual property litigator at two Chicago law firms, McDermott Will & Emery, and Pattishall, McAuliffe, Newbury, Hilliard and Geraldson, where he was a partner. He earned his bachelor's degree in electrical engineering at Michigan State University and his law degree from the University of Michigan.

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MARYELLEN de MARS, Ph.D. is Director, Clinical Biomarkers, at the Critical Path Institute.  Dr. de Mars has worked in biosciences for over 15 years. She was Executive Director of Genomics Services at Gene Logic, Inc., where she also served as Director of the Biorepository and Director of Program Management. Prior to Gene Logic, Dr. de Mars worked at Invitrogen (Life Technologies, Inc.) for 11 years, contributing in several positions, including Training Center Scientist, Business Development Manager and Marketing Manager.  Dr. de Mars holds a B.A. from Smith College and a Ph.D. in Virology from the University of Texas. She completed postdoctoral training in transcriptional regulation at The Johns Hopkins University.

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STEVEN I. GUTMAN, M.D. is the Director of the Office of In Vitro Diagnostic Device (OIVD) Safety and Evaluation, Center for Devices and Radiological Health (CDRH), FDA.  He completed residency training in pathology at Cornell – The New York Hospital (Anatomical Pathology) and the Mayo Clinic (Clinical Pathology). After 10 years of experience as clinical pathologist and chief of the laboratory service at the Buffalo Veterans Administration Medical Center, he joined CDRH’s Division of Clinical Laboratory Devices as a medical officer in 1992 and was promoted to division director in 1993.  Dr. Gutman is a board certified pathologist.  He received his B.A. from the Ohio State University, his M.D. from Cornell University Medical College, and his M.B.A. from the State University of New York at Buffalo.

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SHIEW-MEI HUANG, Ph.D. is Deputy Director, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).  Since joining OCP, Dr. Huang has assumed responsibility for a wide variety of scientific activities relating to review, policy development, research and scientific communications.  She chaired a working group that published a guidance document for industry on drug interactions, addressing issues in the study design, data analysis and impact on dosing and labeling.Dr. Huang has managed several extramural research projects in the areas of drug metabolism, drug-drug and drug-herb interactions, pharmacogenetics and clinical QT evaluations.  She has served on the FDA’s Gender Effects Science Council, Committee for Advanced Scientific Education; chaired an OCP Good Review Practice Working Group and was a member of the FDA Race and Ethnicity Working Group, CDER QT Working Group. She currently chairs a Renal Impairment Working Group, and is a member of the CDER Research Coordinating Committee and FDA’s Pharmacogenetics/ pharmacogenomics Working Group.  She has received more than two dozen awards from CDER and FDA since joining the Agency in 1996.  Prior to joing FDA, she was with the DuPont Pharmaceutical Company and was Director of the Pre-Clinical ADME Group of the Drug Metabolism and Pharmacokinetics Section at the DuPont Merck Pharmaceutical Company .  Before that, she was Senior Scientist at the Ortho Pharmaceutical Company.  She has published numerous peer-reviewed articles and book chapters focusing on the topics of clinical pharmacology, drug metabolism/transport and drug interactions, pharmacogenetics and biomarker areas. Dr. Huang was an Associate Editor for Clinical Pharmacology and Therapeutics and is on the editorial board of several journals.  She is an American Association of Pharmaceutical Scientists Fellow and a diplomate of the American Board of Clinical Pharmacology.  She is the 2008-2009 President-Elect of the American Society of Clinical Pharmacology and Therapeutics. Dr. Huang received her B.S. in Pharmacy from the National Taiwan University, Taipei, Taiwan and a Ph.D. in Pharmacokinetics and Biopharmaceutics ifrom the University of Illinois at the Medical Center, Chicago, IL.

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STEVE McPHAIL is President and Chief Executive Officer of Expression Analysis, Inc., a Durham, NC-based supplier of microarray services and solutions.  Expression Analysis has entered into a variety of alliances and collaborations with organizations such as Duke University to advance the use of genomic technology.  Additionally, in collaboration with the Food and Drug Administration (FDA) and a pharmaceutical company, Expression Analysis has developed a format for electronic submission of microarray-based gene expression data and associated results. The outcome of this work was the establishment of regulatory initiatives using genomic data to accelerate drugs and diagnostics through FDA’s approval processes. Mr. McPhail has spent his career serving companies in the diagnostic, biotechnology and medical device markets. He previously acted as Executive Vice President and COO of ArgoMed, Inc.  Earlier, he held senior level sales, marketing and business development positions for Xanthon, TriPath Imaging, Dynex Technologies and Abbott Laboratories. Mr. McPhail has extensive experience in executing mergers and acquisitions, developing strategic marketing plans, and establishing global distribution networks.  He serves on the board of the North Carolina Children's Hospital and the Pediatric Inflammatory Bowel Disease Network.  Mr. McPhail received a B.S. in Biology from San Diego State University.

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BRUCE QUINN, M.D., Ph.D., M.B.A. is a Senior Health Policy Specialist with Foley Hoag LLP in the Government Strategies practice where he focuses on Medicare coverage and payment matters. Dr. Quinn assists companies, providers and venture capital investors to develop strategies for Medicare payment for new technologies. A large part of this work is on local and national coverage decisions. He focuses, in particular, in the emerging field of molecular diagnostics and personalized medicine. He also advises clients on Medicare Administrative Contractor (MAC) reform and its effect on payment policy. Previously Dr. Quinn was the Contractor Medical Director for the California Medicare Part B program. Before serving in the Medicare Part B program, Dr, Quinn was a physician executive in the Health & Life Sciences division of Accenture and was a clinician-scientist at Northwestern University School of Medicine.  There he led pathology research for Northwestern’s NIH-funded Alzheimer Research Center. He also held academic positions at New York University School of Medicine and UCLA Center for Health Sciences.   Dr. Quinn received his M.D. and Ph.D. from Stanford University and his M.B.A. form Northwestern University, Kellogg Graduate School.  He carried out post-Ph.D. research in neurosciences at the Massachusetts Institute of Technology.

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ALLEN D. ROSES, M.D., FRCP (HON) is Director of the Deane Drug Discovery Institute, Duke University Medical Center.  The Drug Discovery Institute will bring together researchers with a wide range of skills pertinent to the drug discovery continuum.  Under Dr. Roses leadership, the Institute will employ an innovative new model designed to fill the void between academic drug discovery and translational medicine, resulting in bringing new, effective medications to market from overlooked molecular compounds. This first-of-its kind Institute will be a new approach to the development of drugs by spanning early molecular discovery to proof-of-concept clinical trials.  Additionally, the Institute will translate published research into therapeutic molecules by taking on a role that has traditionally been held by the pharmaceutical and biotech industriesHe spent the majority of his career at Duke during which he led research to uncover genetic links associated with the development of Alzheimer's disease. He is well known for his work surrounding the discovery of the ApoE4 gene that has been found to predispose those with the gene to develop Alzheimer's. Further, Dr. Roses was one of the first clinical neurologists to apply molecular genetic strategies to neurological diseases, and played a part in the identification of the chromosomal location of genes involved in more than 15 diseases, including several muscular dystrophies and Lou Gehrig's disease. In addition to his appointment as the director of the new Institute, Dr. Roses will reassume his chair as Jefferson-Pilot Corporation Professor of Neurobiology and Genetics and will be a member of the Duke Institute for Genome Sciences & Policy, with which the new Institute will also be administratively aligned. In addition, Dr. Roses is a Senior Scholar with the Health Sector Management program at Duke University's Fuqua School of Business. He earned a B.S. in chemistry at the University of Pittsburgh and his M.D. from the University of Pennsylvania.

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