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GTCbio, San Diego, CA
Mar 17-18, 2008
Day 1 - Monday, March 17, 2008
7:15
Registration & Breakfast
8:00
Chairman`s Opening Remarks
[KEYNOTE PRESENTATION]
8:10
Roderic Pettigrew, Ph.D., M.D., Director, National Institute of Biomedical Imaging and Bioengineering, NIH [Invited]
Session I - Novel Imaging Methods & Technology
9:00
TBA
Michael Paulus, Vice President, Product Management, Preclinical Solutions, Siemens Preclinical Solutions
9:30
TBA
Paul Picot, Chief Scientist, Pre-Clinical Imaging, GE Healthcare
10:00
Networking and Refreshment Break
10:30
Novel Imaging Tools for Inflammation and Arthritis Drug Development
Jingsong Wang, M.D., FACR, Director, Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb
Disease-modifying osteoarthritis drugs (DMOADs) is the center of focus for drug development in osteoarthritis (OA) -the most common form of arthritis. Limitations in measuring disease progression and identifying patients with meaningful progression hamper efficacy assessment for drug candidates. Currently, X-ray is the only imaging outcome measurement approved by the regulatory agencies. Development of more sophisticated molecular imaging techniques such as magnetic resonance imaging (MRI) and gadolinium-enhanced magnetic resonance imaging of cartilage is the subject of intense investigation. The application of these novel imaging modalities will provide platforms that precisely reflect the mechanism of action for DMOADs, hence will greatly enhance the efficiency for the drug development program. In this presentation, the challenges and great potentials in applying these exciting tools in DMOADs development will be discussed. In addition, the utilities of novel imaging tools such as MRI and positron emission tomography (PET) in drug development for rheumatoid arthritis (RA) will also be discussed.
11:00
Dynamic Contrast MRI
TBA
11:30
Optical Imaging
TBA
12:00
Luncheon
1:00
Oral Presentations from Submitted Abstracts
Submit your abstract by February 17, 2008
Session II - Imaging in Drug Development and Therapy
1:30
Molecular Imaging Approaches to In Vivo Pharmacokinetic and Pharmacodynamic Studies: A Pharmaceutical Prospective
Susanta Sarkar, Director, Molecular Imaging Center of Excellence, Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline
A major challenge facing the pharmaceutical industry today is the high attrition of drugs. This is, in large part due, to efficacies that are lower than expected from pre-clinical and clinical studies, and from side effects that are higher than expected in these studies. It is critical, therefore, to measure PK/PD relationship of compounds from target and pathways specific measurements in vivo early in preclinical drug discovery and development to increase the predictive values of preclinical studies. Multi-modal molecular imaging technologies promises to be a powerful approach towards addressing these issues. Towards this end, this talk will emphasize on the development of multi-modal imaging methodologies to measure efficacy, safety, mechanism of action and distribution of compounds in live animals and in real time across many therapeutic areas. Potential translation of these methodologies to clinical studies will also be discussed.
2:00
PET for In-Vivo Distribution and Pharmacokinetics, Including Novel Dosage Forms
Marc Berridge, President, 3D Imaging, Drug Design and Development
PET imaging is most commonly used as a method to examine regional pharmacodynamics to probe drug effects and mechanisms when that is important to drug development. However, it can also be used to probe regional pharmacokinetics to observe drug distribution to target and non-target regions. Understanding such distribution can make the difference between killing an apparently ineffective drug and converting it into the next marketable product by simple adjustment of formulation or delivery. This is especially true for the more novel dosage forms, exemplified by the growing field of inhaled drugs. Various techniques and examples will be discussed for a variety of dosage forms. PET scanning methods will be shown that give quantitative determinations of the important distribution parameters of the drugs of interest. Novel drug design, drug chemistry, radiochemistry, and scanning techniques combine to provide powerful information that can be used to optimize a drug formulation in the early clinical phases, or to conclusively demonstrate a failure of action or delivery before embarking on a clinical trial.
2:30
Strategic Role of Imaging in Drug Development: Structure and Function
TBA
3:00
Networking and Refreshment Break
Session II - Imaging in Drug Development and Therapy
3:30
Translational Nuclear Molecular Imaging in Drug Development
Yumin Zhang, M.D., Ph.D., Research Investigator, Advanced Technology, Abbott Laboratories
With the desire to facilitate and speed up the lengthy and costly drug development, pharmaceutical industries are embracing the evolving molecular imaging technology and adding small animal imaging scanners to their arsenal. Under the molecular imaging umbrella, nuclear imaging with microPET and microSPECT, some coupled with a built-in CT, is the unique modality that can be directly translated into human subjects in clinical trials. By labeling drugs or lighting up the drug targets, nuclear imaging can tell us where the drug has gone, whether it hits the target and the duration. With radiolabeled molecular probes tackling the downstream and tertiary biological processes, microPET or microSPECT can measure whether the drug is working. These applications can be summarized as pharmacokinetic (PK) imaging, pharmacodynamic (PD) imaging and pharmacogenetics (PGx) imaging (to predict target expression) with a whole-body resolution. These data, obtained in a longitudinal manner, can increase our confidence for making critical decisions in pre-clinical stages, and provide translational guidance to use these noninvasive approaches in human studies when the candidates survive into clinical development. The author will provide detailed examples of using microPET and microSPECT in real world along with a personal perspective of broadening the border of small animal imaging in drug development to bridge the discovery and clinical development.
4:00
Translational Imaging
David Shalinksy, Ph.D., Associate Director, Translational Medicine, Pfizer
4:30
Using MRI to Monitor Cellular Therapy
Joseph A. Frank M.D., Chief, Experimental Neuroimaging Section, Laboratory of Diagnostic Radiology Research, National Institutes of Health
5:00
Poster Session & Networking Reception
Top of the page
Day 2 - Tuesday, March 18, 2008
7:30
Continental Breakfast
7:55
Chairman`s Review of Day One
Session III - Imaging Applications in CNS
8:00
Imaging in CNS Drug Development
Richard Margolin, M.D., Vice President & Global Head, CNS, i3 Research
8:30
TBA
Raymond Nunnally, Vice President, InvivoMetrics
9:00
Application of Novel Imaging in Rheumatology
TBA
9:30
Novel Imaging Applications in CNS Drug Development
TBA
10:00
Networking and Refreshment Break
Session IV - Imaging Applications in Oncology
10:30
TBA
Simon Robinson, Ph.D., Director, Discovery Biology, Bristol-Myers Squibb Medical Imaging
11:00
PET Imaging for Efficacy of Anticancer Drugs
TBA
11:30
Novel Imaging Applications in Oncology Drug Development
TBA
12:00
TBA
TBA
12:30
Luncheon
Session V - Imaging Applications in the Cardiovascular System
1:30
Non-invasive Imaging of Atherosclerosis: MRI versus CT
Stefan Ruehm, M.D., Ph.D., Associate Professor of Radiological Sciences, Director, Cardiovascular Imaging, CT, UCLA
The emergence of fast high-resolution imaging methods has enabled CT and MRI to non-invasively image the atherosclerotic arterial wall. This capability has captured the interest of clinicians who consider MRI and CT as a tool to assess the severity of atherosclerotic disease based on the characteristics of atherosclerotic lesions themselves rather than only their effects on the vessel lumen. Both MRI and CT have the potential to be used to determine atherosclerotic plaque burden, detect plaque composition, and ultimately vulnerable plaque before it leads to a clinical event such as stroke or myocardial infarction. In addition, the determination of plaque regression by both MRI and CT has been proposed for the monitoring of therapeutic strategies to treat atherosclerotic disease. This presentation will review the current state of the art of plaque imaging both by MRI and CT. Advanced techniques such as whole body MR angiography and coronary CT angiography will be discussed.
2:00
Atheroma: Developments in Imaging Surrogates of Risk with MRI
Jonathan Gillard, BSc, M.D., FRCR, Department of Radiology, University of Cambridge
Despite tremendous advances in the recognition and management of risk factors for atheromatous disease as well as the treatment of acute events, it remains responsible for substantial morbidity and mortality in the Western world. Until recently the risk of carotid disease in symptomatic patients was determined by simple luminal measurements based conventional angiography, all on more subjective changes in Doppler ultrasound measurements which would establish whether a patient should undergo carotid endarterectomy or optimal medical therapy. Developments in MR and CT over the past decade have given us alternative tools to measure luminal stenosis which have reduced risks when compared with conventional X ray angiography. The relentless progression of faster, more robust sequences and contrast materials have only recently allowed us to assess plaque itself, rather than its effect on the degree of stenosis. We are now able to image individual plaque components including the fibrous cap, lipid core and hemorrhage. The current goal is to be better able to characterise plaque risk, whether it is in the carotid, coronary or peripheral vasculature. MR imaging of the carotid is feasible due to its size and superficial position, equivalent reproducible imaging of the coronary arteries being considerably more challenging. Although the carotid artery may be viewed as a surrogate for disease in the coronaries, this is probably an oversimplification. Nevertheless it remains an important and practical tool. Our understanding of the natural history of atheroma development continues to grow. Whilst the assessment of risk is aided by the quantification of individual morphological components in plaque viewed with MR, it has been difficult to image true plaque function. Enticing studies of plaque activity demonstrated by Weissberg using FDG PET showed that it is possible to image inflammatory activity in man. We now have USPIOs which are MR contrast agents that are taken up by macrophages and are visible with high-resolution MR. We are also able to image not only individual plaque structure, but also function allowing an improved understanding of why two patients will identical degrees of luminal stenosis may have completely different degrees of vulnerability; why one patient should be symptomatic and the other asymptomatic. The tide continues to slowly change as people accept that simple luminal stenosis may not be the best method of assessing plaque risk. As we develop tools, such as USPIOs, we may be able to better target patients with increased inflammatory activity and other risk factors. In addition, USPIOs may allow us to produce surrogate markers for atheromatous disease which could be used to monitor novel therapeutic compounds, reducing the need for someone to undergo a clinical event or not as a clear clinical end point. There have been tremendous advances in our ability to access plaque instability using MR over the last few years. The challenge is to validate these techniques in the carotid and to take them into the coronary as the relentless progress of technology continues.
2:30
Using Dynamic Imaging to Visualize Vascular Immunotargeting and Transport In Vivo
Jan Schnitzer, M.D., Scientific Director, Professor, Cellular and Molecular Biology Program, Sidney Kimmel Cancer Center
3:00
Novel Imaging Applications in Cardiovascular Drug Development
TBA
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Organized by:
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Tiffany Chin |
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Invited Speakers:
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Visit our web to see invited speakers!
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Deadline for Abstracts:
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February 17, 2008
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Registration:
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Register for 2, the 3rd goes FREE - Register Now!
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E-mail:
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tiffany.chin@gtcbio.com
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