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TUESDAY, OCTOBER 16

BIOIMAGING FOR MONITORING RESPONSE TO THERAPY, DOSE SELECTION, ASSESSING MOLECULAR ACTIVITY AND RECEPTOR OCCUPANCY

8:00am Chairperson’s Remarks
David S. Lester, Ph.D., New York Site Head, Pfizer Human Health Technologies, Global Clinical Technology, PGRD 
8:05 Studying Fracture Healing - The Use of Bioimaging for Recombinant Human Bone Morphogenetic Protein-2 (Rhbmp-2) Studies
Alex Valentin, M.D., Senior Director, Clinical Research, Wyeth 
Bone morphogenetic protein two (BMP-2) is a growth and differentiation factor expressed notably during the development of the human skeleton and during fracture repair. The therapeutic use of the recombinant human protein was established in skeletally mature patients with open tibia fractures. There are no surrogate end points such as systemic biomarkers indicative of rhBMP-2 activity. The clinical trials supporting this indication were designed to demonstrate avoidance of surgical re-intervention for delayed fracture union and accelerated fracture healing. Fracture healing is established on radiographic and clinical evaluations. Radiographically, the fracture must be “united”: a solid fracture line bridging indicating that the primary repair process is complete. Clinically, the patient’s lower limb should be returning to its normal function: full weight bearing at rest or during ambulation. Standardizing the assessment of subjective radiographic and clinical end points are some of the challenges faced in these orthopaedic trials. Assessing secondary fracture displacement and using patient reported outcome instruments is likely to improve clinical trial quality in this field of research. 
8:30 The Use of Magnetic Resonance Imaging Measures of Disease Activity as a Surrogate/BioMarker for Multiple Sclerosis Treatment Trials
Joseph E. Frank, Ph.D., Chief, Experimental Neuroimaging, National Institutes of Health 
A discussion of the imaging correlation between MRI and Multiple Sclerosis and how it impacts our understanding of pathology will be discussed. It will also be demonstrated how MR imaging measures of disease activity has played an important role assessing the value of these new therapies for MS. Lastly, examples will be provided of how MRI could be used in designing early phase treatment trials in MS and the future challenges in imaging MS patients.
8:55 Use of Imaging in Support of Tailored Therapeutics 
Loretta McQuaid, Ph.D., Manager, Biomarkers, Diagnostics and Experimental Medicine, Eli Lilly and Company
The goal of Tailored Therapeutics is to provide meaningful improved health outcomes for individual patients by delivering the right drug at the right dose at the right time. The use of imaging to support the Tailored Therapeutics model in early drug development will be discussed. In addition, the use of imaging to drive key drug development decisions will also be highlighted. 
9:20 PET Receptor Occupancy - Accelerating Drug Development by Non-Invasive Measurement of Drug Action Early in the Development Pipeline
Robert A. Comley, Imaging Scientist, Clinical Molecular Imaging, GlaxoSmithKline and Visiting Research Scientist, Centre for Addiction and Mental Health 
The development of drugs targeted at the CNS poses several interesting challenges: how do we know a putative drug reaches its intended site of action, is the in vivo pharmacological profile consistent with the proposed mechanism of action, and what is the relationship between dose [or plasma exposure] and target occupancy. An inability to gain access to the target tissue in humans, difficulties in interpreting non-human behavioural data, and an absence of viable surrogate markers, all contribute to making these questions non-trivial. This talk will focus on the use of in vivo molecular imaging with positron emission tomography to bridge the gap between basic research and clinical development by measuring biomarkers of drug action in healthy individuals, and the impact such studies can have on the progression of molecules along the development pipeline.
9:45 Technology Workshop (Sponsorship Available)
10:00 Poster Session, Exhibit Viewing, and Coffee Break
10:35 The Use of Cardiovascular Imaging in Drug Development: From Preclinical to Diagnostic Applications
David S. Lester, Ph.D. 
Cardiovascular imaging has a long history in contributing to both drug development and diagnostics. Applications of CV imaging will be discussed in relation to preclinical imaging, clinical trials and clinical care, i.e. diagnostics. Experiences from Pfizer's clinical trials in CV imaging in relation to both Lipitor and the failed CETP inhibitor, torcetrapib, will be discussed. The future of CV imaging as a potential surrogate in atherosclerosis drugs will also be discussed.
11:00 The Opportunities and Challenges of Developing Imaging Biomarkers to Study Lung Function and Disease 
Daniel Schuster, M.D., Professor of Medicine and Radiology, Washington University School of Medicine, Washington University 
Recent advances in imaging offer exciting opportunities to develop and validate lung-specific biomarkers as valuable adjuncts to diagnosis, tests of treatment efficacy, and/or treatment monitoring. State-of-the art structural, functional, and molecular imaging methods allow the lungs to be visualized non-invasively in vivo at sub-millimeter and sub-second spatial and temporal scales. However, the development and validation of imaging biomarkers presents some special challenges. Establishing performance characteristics, especially for single investigators at single academic institutions, can be daunting if not impossible for costly biomarkers such as imaging. Therefore, to take full advantage of the opportunities presented by state-of-the-art imaging methods, new approaches to analytic and clinical validation must be developed in collaboration with industry, foundation, and federal funding agencies. The use of FDG-PET imaging as a biomarker of lung inflammation will serve as a useful case study for discussion of these issues.
11:25 Circulating Oncoproteins as Cancer Biomarkers for Targeted Therapies
Walter P. Carney, Ph.D., Head, Oncogene Science, Bayer Healthcare, Siemens Medical Solutions Diagnostics 
Pharmaceutical companies have developed targeted therapies such as Trastuzumab and Lapatinib for HER-2/neu positive tumors, Tarceva and Erbitux for EGFR positive tumors and Rencarex for CAIX positive tumors. The major challenge is to select the appropriate therapy or combinations of therapies for each patient. Since current clinical trials are combining these different targeted therapies in cancer patients, new blood tests are needed for patient stratification, selection, and monitoring. This presentation describes clinical studies with ELISAs specific for the HER-2/neu, EGFR and MN oncoproteins that have the potential to be linked with the specific targeted therapy for patient management. Linking diagnostic biomarkers with specific targeted therapies supports the new paradigm for delivering personalized medicine to cancer patients

11:50 The 21-Gene Oncotype DX Breast Cancer Assay: Clinical Validation and Application
Audrey Goddard, Ph.D., Director, Laboratory Development, Genomic Health, Inc.
The summary is: A major challenge in management of early breast cancer patients is the selection of patients for adjuvant chemotherapy. The Oncotype DX™ assay is validated for use with patients with node-negative, estrogen receptor-positive disease who will go on to receive hormonal therapy. The assay is prognostic and quantifies the likelihood of breast cancer recurrence and survival. In addition to being prognostic, the assay is predictive of tamoxifen benefit and chemotherapy benefit. Oncotype DX™ provides a roadmap for the successful development, validation and real-life application of a novel multi-analyte RNA-based test in the oncology field. 

12:15 Luncheon Workshop (Sponsorship Available) or Lunch on Your Own

1:45 Close of Innovations in Clinical Trials: Implementation of Biomarkers Conference

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