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May 30, 2007, 1:00 – 3:00pm EDT
Personalized Medicine: Realizing the Full Potential

SPEAKERS FOR THIS EVENT:
- Raymond Woosley, MD, PhD, President and CEO, The Critical Path Institute Learn More
- Mara G. Aspinall, President, Genzyme Genetics Learn More
- Wayne Rosenkrans, Business Strategy Director External Scientific Affairs, Co-Chair Personalized Medicine Coalition, AstraZeneca Pharmaceuticals Learn More
- Dr. Elaine Weidenhammer, Associate Director, Strategic Market Development, Nanogen Learn More
- Annette K. Taylor, M.S., Ph.D., President and CEO, Kimball Genetics Learn More

 

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Pharmaceutical and Diagnostic Co-Development

Personalized medicine may have arrived. The initiative was established in 1990s with progress in the Human Genome Project with the premise of customized healthcare medicine. Personalized medicine is based on the use of detailed information about an individual’s genotype and patient’s medical data in order to administer medication and select preventive measures. Nowadays the Critical Path Initiative is one of the FDA’s priorities that will stimulate a national effort to modernize the scientific process.

The pharmaceutical industry is dominated by the blockbuster business model that assumes that a single compound would be able to effectively treat all or most of patients with a particular disease. Pharmacogenomics which is a part personalized medicine helps to cure diseases rather than symptoms by identifying biomarkers associated with specific conditions.

To change the practice of medicine and make personalized medicine a reality rather than hype--companies have to incorporate genetics and genomics into their R&D practice. The benefits of this approach are its efficacy, speed, safety, and cost-effectiveness for patients.

Our speakers will explore the opportunities and perspectives of personalized medicine and discuss what is required on the pharmaceutical and diagnostics part to make this model successful and practical for the society.

Conference highlights:

  • Personalized Medicine: Driving Acceptance by Demonstrating value
  • Improving decision making in Infectious diseases and anticoagulation therapy
  • Co-Development of Drugs and Diagnostics: Case Studies

THIS PROGRAM IS INTENDED FOR:

Chief Scientific Officers VPs, Directors, Heads & Managers of:

  • Infectious Disease
  • Molecular Diagnostics
  • Anticoagulation Therapy
  • Product Directors
  • Clinical Practices and Therapeutics

Within Pharmaceutical, Biotechnology, Nanotechnology, Medical Devices companies, Hospitals and Anticoagulation Clinics.

SPONSORING PARTNERS:
Nanogen

Nanogen’s advanced technologies provide researchers, clinicians, and physicians worldwide with improved methods and tools to predict, diagnose, and ultimately help treat disease. Nanogen is facilitating the development and adoption of new pharmacogenomics-based diagnostics with technologies that enable analysis of nucleic acid and protein biomarkers. The company’s products include real-time PCR reagents, the NanoChip® electronic microarray platform and a line of rapid, point-of-care diagnostic tests. By incorporating Nanogen’s real-time PCR and electronic microarray technologies into the drug development and clinical trial process, pharmaceutical companies can rapidly develop custom assays to assess the utility of potential biomarkers. Once specific biomarkers have been validated, companion diagnostic products can be commercialized on the same platform that was used during clinical trials, enabling more rapid adoption by the laboratory community.

http://www.nanogen.com/


kimball

Kimball Genetics is a national DNA diagnostic laboratory specializing in testing for common genetic disorders that are preventable or can be treated. Founded in 1994 by Annette K. Taylor, M.S., Ph.D., Kimball Genetics is known for its unparalleled turnaround times and distinctive focus on genetic counseling and education. The company has a longstanding reputation for its expertise in integrating new genetic tests into mainstream medicine and is committed to advancing the field of pharmacogenetics and personalized medicine. Kimball Genetics’ other major areas of testing currently include hypercoagulability, celiac disease, hemochromatosis, cystic fibrosis, and fragile X syndrome.

In the pharmacogenetics arena, Kimball Genetics is now offering the Warfarin DoseAdvise™ Genetic Test to detect specific gene variants that are associated with a lower dose requirement. The test will help optimize warfarin dosing and has the potential to improve the safety and efficacy of warfarin therapy. Results are available in one day and testing can be performed on cheek cells as an alternative to blood. The Clinical Pharmacology Subcommittee, an FDA advisory committee, recommends pharmacogenetic testing for warfarin therapy and use of reduced doses when indicated.

http://www.kimballgenetics.com/

ABOUT OUR SPEAKERS:
- Raymond Woosley, MD, PhD, President and CEO, The Critical Path Institute

Raymond L. Woosley earned a Ph.D. in Pharmacology from the University of Louisville and an M.D. from the University of Miami. He began his career as the first scientist in the US operations for Glaxo, now known as GlaxoSmithKline. Dr. Woosley specialized in Internal Medicine and Clinical Pharmacology at Vanderbilt University where he rose to the rank of Professor of Medicine. At Georgetown University he served as Chairman of the Department of Pharmacology and in 2000 was appointed Associate Dean for Clinical Research. In 2001 he became Vice President for Health Sciences at the University of Arizona and Dean of the College of Medicine. In January of 2005 he assumed the position of President of The Critical Path Institute (C-Path), a non-profit corporation formed by the Food and Drug Administration, SRI, International and the University of Arizona to accelerate the development of safe innovative medicines. Since 1999, he has directed one of seven federally-funded (Agency for Healthcare Research and Quality) Centers for Education and Research on Therapeutics (CERT).

Dr. Woosley’s research has investigated the basic and clinical pharmacology of drugs for the treatment of arrhythmias and the cardiac toxicity of drugs, and has been published in over 260 publications. His research discovered the mechanism of the toxicity of the antihistamine Seldane®. He is the recipient of the Rawls-Palmer Award from the American Society of Clinical Pharmacology and Therapeutics for his contributions to medicine and the FDA Commissioner’s Special Citation for his work to advise the agency on the toxicity of dietary supplements containing ephedra. Dr. Woosley is a Past-President of the Association for Medical School Pharmacology and the American Society for Clinical Pharmacology and Therapeutics. He has served on numerous boards including the US Pharmacopeia. He is a member of the Biodesign Institute at Arizona State University. As a member of the University of Arizona’s Sarver Heart Center and Bio5 Institute, he conducts research on the prevention of adverse drug interactions.


- Mara G. Aspinall, President, Genzyme Genetics

Prior to joining Genzyme, Mara was Director of Client Services at Hale and Dorr LLC, and was responsible for the firm’s worldwide practice and development, strategic planning and marketing. Mara started her business career at Bain & Company, an international strategic consulting firm. At Bain, she specialized in developing and implementing business strategies for health care product and service companies.

Harvard Business School was enriched with the John P. Stevens Prize for leadership. She has served on the board of the HBS Network for Women. A magna cum laude graduate of Tufts University, Mara majored in International Relations.


  - Wayne Rosenkrans, Business Strategy Director External Scientific Affairs, Co-Chair Personalized Medicine Coalition, AstraZeneca Pharmaceuticals

Wayne Rosenkrans is currently Business Strategy Director, External Scientific Affairs at AstraZeneca Pharmaceuticals. In this role he has responsibility for strategy development and business planning for AstraZeneca U.S.’s scientific influencing groups, including Regulatory Affairs and Medical Affairs.

Previous positions include Global Director/Intelligence Affairs, Director of Strategic Intelligence Systems for Windhover Information, Director of Drug Intelligence Systems Sales and Marketing for Adis International, and Associate Director and Head of Strategic Intelligence for SmithKline Beecham Pharmaceuticals R&D. He holds an SB in Biology from MIT, a PhD in Cell and Molecular Biology from Boston Univ., and received post-doctoral training in Cancer and Radiation Biology at the University of Rochester.


- Dr. Elaine Weidenhammer, Associate Director, Strategic Market Development, Nanogen

Dr. Elaine Weidenhammer is Associate Director of Strategic Market Development at Nanogen, a diagnostics company headquartered in San Diego. Elaine has been with Nanogen for nine years, and has held positions in Research & Development, Business Development, and Marketing. In her current role, Elaine evaluates business and product opportunities that will expand Nanogen’s offerings in molecular diagnostics, with particular focus on pharmacogenetics and personalized medicine.

Elaine received her Ph.D in molecular biology from Carnegie Mellon University and her MBA from the Rady School of Management at UCSD, where she was the recipient of the first DLA Piper Athena UCSD Rady FlexMBA scholarship. Elaine currently serves on the board of Athena, a San Diego professional organization for female executives in the technology, life sciences, and healthcare sector.


- Annette K. Taylor, M.S., Ph.D., President and CEO, Kimball Genetics

Dr. Taylor is the President and CEO of Kimball Genetics, a national DNA diagnostic laboratory she founded in 1994. She is board-certified in Clinical Molecular Genetics and in Genetic Counseling, a combination of experience that led to her conviction that genetic counseling is important as an integral part of genetic testing services. To this end, she built a unique genetic testing service at Kimball Genetics with genetic counseling and education for patients as well as clinicians, and her company has been a pioneer in offering cheek cell testing and a one-day turnaround time.

Translating the benefits of genetic knowledge into medical practice is a focus of Dr. Taylor’s participation in professional committees. She serves on the Department of Veteran’s Affairs Genomic Medicine Program Advisory Committee and is a reviewer for guidelines about warfarin pharmacogenetic testing currently being developed by the American College of Medical Genetics (ACMG). She is a co-author of policy statements by the ACMG on Factor V Leiden mutation testing and fragile X syndrome diagnostic and carrier screening and has served on the ACMG Laboratory Quality Assurance Committee and Intellectual Property Subcommittee. Dr. Taylor also participates in the Personalized Medicine Coalition, a non-profit group of organizations dedicated to advancing the adoption of personalized medicine for the benefit of patients.

Dr. Taylor leads a clinical molecular genetics research program and is recognized for her contributions to understanding clinical/molecular correlations in fragile X syndrome. Her investigations also helped define the molecular basis for high functioning status in a proportion of fragile X males. Other areas of her research include celiac disease and pharmacogenetics-based warfarin therapy.

Dr. Taylor earned her Ph.D. in Microbiology and Immunology from the University of California, Los Angeles and her M.S. in Genetic Counseling from the University of Colorado, Health Sciences Center. She was a magna cum laude graduate from Dartmouth College.



 
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