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Implementing Personalized Medicine
May 21, 2009
12:00 - 2:00 p.m. EST

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12:00-12:10 Chairperson's Opening Remarks 

12:10-12:40  Translational Strategies for Personalized Medicine
Bruce H. Littman, M.D., President, Translational Medicine Associates LLC
The same principles applied in early drug development that focus on the “molecularly correct” population to achieve early confirmation of proof of concept for new drugs can be applied to medical practice.  Molecular definition of disease is rapidly replacing traditional pathology-based disease descriptions in cancer in part because of its utility in identifying the optimal treatment regimen for patients.  It is clear that the same changes are coming for many common chronic diseases.  Utilizing molecular disease definitions these chronic disease phenotypes can be split into distinct subpopulations with important implications for safe and effective personalized treatment choices.  Using rheumatoid arthritis as an example, several such scenarios are described.

12:40-12:50  Sponsored Presentation 
Opportunity available. Contact Ilana Quigley, Business Development, 781-972-5457 or iquigley@healthtech.com 

12:50-1:20  Delivering on the Promise of Personalized Healthcare: Examples from AstraZeneca
Ruth E. March, Ph.D., Lead, Personalized Healthcare Team, AstraZeneca Pharmaceuticals
This talk will cover discovering biomarkers in preclinical trials, qualifying biomarkers in clinical trials and commercializing biomarkers for launch.

1:20-1:30  Sponsored Presentation 
Opportunity available. Contact Ilana Quigley, Business Development, 781-972-5457 or iquigley@healthtech.com 

1:30-2:00  Will We Get More and Better Therapies through Biomarker Qualification?
Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics, Office of Clinical Pharmacology/Office of Translational Sciences/ Center for Drug Evaluation and Research, U.S. Food and Drug Administration
An accurate application of new and old therapies is a key goal of personalized medicine. Metrics by which we measure the success of these therapies are driven by biomarkers with which we can assess the success of these therapies. The impact of biomarkers in personalized medicine has been often associated with drug efficacy. Novel safety biomarkers add a new dimension in drug development and personalized medicine. How can we successfully integrate these biomarkers in drug development and in clinical practice? We will look at biomarker qualification as a process which can contribute to the accelerated acceptance of these biomarkers.

About the Speakers:

Bruce H. Littman, M.D., President, Translational Medicine Associates, LLC
Following post-graduate training as an internist, rheumatologist and immunologist at Tufts New England Medical Center, Harvard’s Robert B. Brigham Hospital and the National Cancer Institute, N.I.H. in Bethesda, MD, Bruce joined the faculty at the Medical College of Virginia, Virginia Commonwealth University.  During 13 years at M.C.V. his laboratory research was on cytokine regulation of complement production and the mode of action of RA DMARDs.  His translational and clinical research interests were rheumatoid arthritis pathogenesis and treatment.

After joining Pfizer’s first Experimental Medicine group in 1989, Bruce’s main focus became translational pharmacology, biomarker driven development decisions and exploratory clinical development across multiple therapeutic areas.  He became the head of the Experimental Medicine group at legacy Pfizer and later was instrumental in starting Pfizer’s Clinical Pharmacogenomics group and Pfizer’s first biomarker laboratory.  He played a key role in implementing important organizational changes through two major acquisitions. 

As Vice President, Global Head of Translational Medicine, he established Pfizer’s Global Translational Medicine organization with groups in each of eleven therapeutic areas. Translational Medicine worked to improve Phase 2 survival through biomarker development for early validation of drug targets; demonstration of desired pharmacological activity in Phase 1; and development of clinical methods and biomarkers to advance the development of Pfizer products.  In addition Bruce had other global responsibilities as a member of the Clinical Quantitative and Innovative Medicine Leadership Team, Scientific Excellence Board and CAN Quality Guidelines Committee.  Bruce is also Co-Chair of the Inflammation and Immunity Steering Committee of The Biomarker Consortium (Foundation for the NIH) and Co-Chair of the Predictive Efficacy Models Working Group, a PISC PhRMA initiative.

After 19 years at Pfizer, in December 2007 Bruce retired and started an independent consulting company, Translational Medicine Associates, LLC (TMA).  Bruce also remains co-chair for the Inflammation and Immunity Steering Committee of The Biomarker Consortium (Foundation for the NIH).

Through TMA, Bruce serves customers in the areas of translational research, early clinical development planning and execution, risk assessment for early biotech and drug investment opportunities and biomarker development.  In addition TMA helps guide biotech and translational research companies through Bruce’s membership on boards of directors.  TMA is also able to network with many experts in these and related areas of translational research, biomarker development, pharmaceutical sciences and clinicians in multiple therapeutic areas.

Ruth E. March, Ph.D., Lead, Personalized Healthcare Team, AstraZeneca Pharmaceuticals
Ruth March has led AstraZeneca’s Personalized Healthcare Team since its formation in November 2007.  She received her Ph.D. in the immunology of rheumatoid arthritis, and then spent over nine years in research into human genetics at the Universities of London and Oxford, specializing in the genetics of autoimmune disease.  She was a University Lecturer in Genetics before joining AstraZeneca (formerly Zeneca) to work on pharmacogenetics in 1998.  Ruth was a co-founder of AstraZeneca’s Pharmacogenetics Partnership, and has authored or co-authored over 40 publications in the field of pharmacogenetics and personalized medicine. She has been a member of AstraZeneca’s Personalized Healthcare Steering Committee since 2006, working with clinical teams to implement Personalized Healthcare in their drug development strategies. Ruth is based at AstraZeneca’s Alderley Park site in the UK.

Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics at OCP/OTS/CDER/FDA

Dr. Goodsaid works on the regulatory application and development of genomics and biomarkers in the Office of Clinical Pharmacology / Office of Translational Sciences / Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.  Before joining the FDA, Dr. Goodsaid was a Senior Staff Scientist at Applied Biosystems and Lead for the Molecular Toxicology Group at Schering-Plough Research Institute. In this capacity he interacted with the FDA in a collaboration that led to one of the first genomic data submissions (“mock submissions”) to the FDA. Prior to that, he was Director of Assay Development at the Fluidigm Corporation, a microfluidics company based in South San Francisco, CA.  Dr. Goodsaid received his B.A. in Biochemistry and Biophysics from the University of California at Berkeley; and his Ph.D. from Yale University, New Haven, CT, in Molecular Biophysics and Biochemistry.  He was a Postdoctoral Fellow at Cornell University in Ithaca, New York and at Washington University in St. Louis.  Dr. Goodsaid is a frequent speaker at conferences covering genomics, biomarkers and the translational sciences, and has authored and co-authored numerous publications in peer-reviewed journals.


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