day one | day two
| Biomarkers Focus DayOctober 22, 2008 |
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An in-depth focus day highlighting the continued importance of biomarker R&D and the realities and potential they hold for R&D productivity improvement: discussing business critical issues and scientific innovation
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09:00 |
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Applying new data and improved models to change the industry approach to biomarkers in depression
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- Verifying treatment effects – including safety markers during preclinical and early clinical development
- Finding an industry consensus – what, how and when we measure to help our understanding of the diseases, and eventually develop more specific treatments
- Guiding principles on Voluntary Genomic Data Submissions (VGDSs)
- Ramifications for R&D strategy in this field
Dr. Irina Antonijevic, Director, Translational Research, Lundbeck Research USA
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09:40 |
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Establishing a systemized process for biomarker diagnostic evaluations with the FDA
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- Overview of the initiatives taken by the Critical Path Institute working with the FDA to establish ways of validating diagnostics
- Explaining efforts to pioneer a national testing laboratory to develop new processes, through which diagnostic evaluation testing would occur
- Examples from the development of cancer diagnostics and warfarin genotyping cases
- Looking to the future of biomarker diagnostics - predictions for future methodologies
Dr Maryellen de Mars, Director, Clinical Biomarkers, Critical Path Institute
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10:20 |
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10:50 |
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The realities of stratified / personalized medicine: application of a biomarker strategy from Phase 1 to patient selection in a marketed product
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- 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
- 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 will be discussed
Dr. Scott D. Patterson, Executive Director, Medical Sciences, Amgen Inc.
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11:30 |
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Dynamic translation of biomarkers from discovery to clinic: Surmounting validation and safety obstacles
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From this case study learn how:
- Creation of a smooth transition from discovery through development and into early clinical trials was achieved
- Motivational leadership of the process stages was carried out
- Overcoming practical obstacles and regulatory challenges
Dr. Stephen M. Hewitt, Clinical Investigator and Chief, Tissue Array Research Program (TARP), Advanced Technology Center, NCI/NIH
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12:10 |
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13:30 |
Afternoon site visit: tour of The Genomics Institute of the Novartis Research Foundation (GNF). Main tour host:
Dr. Avi D. Spier, Director of Business Development, Novartis Research Foundation (GNF), San Diego, CA
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Afternoon site visit:
Tour of the Genomics Institute of the Novartis Research Foundation
October 22, 2008
The Genomics Institute of the Novartis Research Foundation (GNF) applies integrated state-of-the-art technologies in the pursuit of identifying novel biological processes and building an understanding of underlying mechanisms involved in human disease. The mission of the Institute is to exploit these technologies and biological discoveries to address complex biomedical problems in cancer biology, immunology, neuroscience, metabolic and infectious disease areas.
GNF was founded in 1999, and currently houses close to 550 employees in the heart of the Torrey Pines Mesa. The Institute is funded through the Novartis Research Foundation, which provides GNF the freedom to innovate large scale research technologies and conduct independent basic and applied research. This relationship has allowed GNF to develop a unique environment and technological infrastructure not found in any university or commercial pharmaceutical setting. This infrastructure includes state-of-the-art high throughput screening and profiling systems capable of evaluating millions of compounds per day in biochemical or cellular assays, automated protein production, purification and crystallography instrumentation that enables high throughput structural genomics studies, and functional genomics systems that facilitate genome-wide cellular assessments of gene function on a gene by gene basis.
Gain insights into cutting-edge R&D practices and network with leading researchers and industry experts from the GNF.
Please book early as places are restricted to a maximum of 40 persons only. Your place is secured on the tour only after email confirmation from the organizers
Agenda
| 13.30 |
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| 14:00 |
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Short introduction to the GNF and welcome presentation by Dr Avi Spier |
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| 14.10 |
Site tour, including a guide through GNF’s technology and the science behind this industry-leading facility
- An automated cellular profiling system (ACP) combining automated tissue culture capabilities with GNF’s established uHTS robotics to facilitate better informed, faster and more cost efficient drug discovery
- A large 1.6M data point scale profiling experiment which tested kinase inhibitors across a matrix of >35 cell based tyrosine kinase assays under full automation.
- A generic cellular STK assay platform
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| 14:40 |
Informal Networking Reception
Attendees can enjoy refreshments and meet other leading members of the GNF team to answer questions, share insights and swap business cards |
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| 15:45 |
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| 16:00 |
Arrive back at conference venue
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