Biomarkers for Clinical Pharmacology
May 13, 2009
1:00 p.m. – 3:00 p.m. EST
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1:00-1:10 Chairperson’s Opening Remarks
1:10-1:40 Biomarkers in Early Development - Decision Support and Patient Selection Opportunities
Hans Winkler, Ph.D., Senior Director, Global Head Oncology Biomarkers, Ortho Biotech Oncology R&D, Johnson & Johnson
One of the major goals in early clinical development is to make firm decisions on progressing projects into advanced phases. Especially the Phase I to Phase II decision is often made difficult by the lack of clinical responses to targeted compounds. Pharmacodynamic markers that indicate the activity of the target (e.g. P-EGFR) can be used to assess the compounds ability to reach the site of action and modulate the intended target to the required extent. Robust changes in PD markers, especially if observed in serial tumor samples from several patients can add much value to decision making. Furthermore, Phase I and Phase II studies provide the ideal background to testing and evaluating predictive markers that are eventually intended to select patients with increased probability of clinical benefit. Examples for each of these approaches will be discussed.
1:40-1:50 Sponsored Presentation
Opportunity available. Contact Ilana Quigley, Business Development, 781-972-5457 or iquigley@healthtech.com.
1:50-2:20 Biomarkers in Oncology Development
Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen, Inc.
The application of biomarkers from FIH through to late-stage development and even post-marketing, enables better decisions to be made on the progression of candidate therapeutics. This can be achieved through analysis of direct effects of the candidates on biochemical pathways. Knowledge of the pathways that could influence response may also enable the development of patient stratification approaches. This presentation will discuss the application of these approaches and the range of different tools required to execute on this strategy from multiplexed protein arrays, flow cytometric analyses, to sensitive mutational analysis methods.
2:20-2:30 Sponsored Presentation
Opportunity available. Contact Ilana Quigley, Business Development, 781-972-5457 or iquigley@healthtech.com.
2:30-3:00 Speaker to be Announced
About the Speakers:
Hans Winkler, Ph.D., Senior Director, Global Head Oncology Biomarker Research, Ortho Biotech Oncology, Research & Development, Division of Janssen Pharmaceutica, Johnson & Johnson
Hans (Johann) Winkler is senior director at Ortho Biotech Oncology Research & Development leading Oncology Biomarker Discovery and Development globally. Hans originally joined the J&JPRD Drug Discovery team in Beerse, Belgium in 2003 as the head of Functional Genomics, a newly created department combining genomic technologies and bioinformatics. Before joining J&JPRD, he was Director and Global Program Manager for Target Validation Technologies at AstraZeneca, PLC in Manchester, UK, with responsibility for target validation technology assessment and acquisition across all disease areas globally. He held positions of increasing responsibility at AstraZeneca, including team leader in Target Discovery, working mainly in the cardiovascular area, and senior group leader and associate director responsible for TI/TV activities and technology assessment and acquisition across several disease areas. Prior to this, he was a scientist and instructor at Harvard Medical School's Deaconess Hospital (now Beth Israel Deaconess Hospital) in Boston, where he worked on endothelial cell biology and immunobiology in a xenotransplantation context, after working as a scientist and group leader at the Vienna International Research Cooperation Center in Vienna (Novartis Research Institute) on gene regulation in endothelial cells.
Hans was born in Austria, where he received his primary and secondary education. He studied Biochemistry at the University of Vienna after which he was awarded a Fulbright fellowship to attend graduate school in the U.S. where he obtained a Master’s degree in Molecular Biology (working on Caenorrhabditis elegans) from the University of Houston in 1986. Hans then returned to Vienna to work on his Ph.D. thesis. He completed his postdoctoral work at the Institute for Molecular Pathology. Hans is co-author of some forty original, peer-reviewed publications and book chapters and inventor on two patents.
Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen, Inc.
Dr. Patterson returned to Amgen Inc., California in 2003 and is an Executive Director in the Medical Sciences function leading the Molecular Sciences department (with the Computational Biology department also reporting to him). Medical Sciences is responsible for conducting first-in-human studies through to Phase 2a for all therapeutic areas in the company, and Molecular Sciences is part of this function to enable biochemical determination of whether the targeted pathway is being interdicted, whether exposure:response relationships can be generated (to inform dose ranging), and in which patient populations the therapeutic may be more efficacious (should that be necessary). He is well known in the field of protein chemistry, and a pioneer in the field of proteomics. He has published extensively and is a frequent guest lecturer. After leaving Amgen in 2000, he served as Vice President of Proteomics at the Celera Genomics Group and then as Chief Scientific Officer of Farmal Biomedicines, LLC. While at Celera, he established the company's initial foray into protein-based drug target discovery and validation in oncology, building a large group of cell biologists, protein chemists and mass spectrometrists whose efforts resulted in the identification of cell surface targets for therapeutic development and diagnostics, a number of which have been licensed to Pharma and Biotechnology companies. Dr. Patterson first worked at Amgen from 1993–2000 progressing from a Research Scientist to Department Head, ultimately leading the Department of Biochemistry and Genetics. He received his Ph.D. and B.Sc. from The University of Queensland, where he held positions of increasing responsibility over a period of 11 years, culminating in that of Senior Research Officer. In 1991 he joined the faculty of Cold Spring Harbor Laboratory, New York where he established a program in apoptosis and pursued his technical interests in analytical protein chemistry applications.
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