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7:00 am Registration Open

7:30-8:30 Morning Coffee


Implementing Personalized Medicine

8:25-8:30 Chairperson’s Opening Remarks
Edward Abrahams, Ph.D., Executive Director, Personalized Medicine Coalition

8:30- 9:00 Personalized Medicine: Opportunities and Challenges

Edward Abrahams, Ph.D., Executive Director, Personalized Medicine Coalition

The talk will focus on public policy and strategies to overcome barriers that influence development, investment, and adoption of personalized medicine products.

9:00-9:30 Moving Towards Personalized Medicine

Gerry J. McDougall, Partner, Personalized Medicine and Health Sciences Practices, PricewaterhouseCoopers LLP

The move towards personalized medicine is creating further incentives for collaboration between the pharmaceutical and diagnostics industries. This presentation will explore the value proposition of companion diagnostics for the pharmaceutical industry and the benefits of early detection to the pharmaceutical business model. It will explore criteria for a successful test for early detection; purpose for pharmaceutical companies to market such tests; and examples of how companies are benefiting from early detection tests today. The importance of such tests is likely to prompt an increase in alliances between the pharma and diagnostics industries in the next two-to-five years, but this will be driven by factors including the pricing of diagnostics, the extent of reimbursement coverage, and the burden of any clinical validation work required for market access. This presentation is based on a major piece of thought leadership that examines the pace of alliances, ROI and best practices.

9:30-10:00 Creating Competitive Effectiveness with Personalized Medicine and Comparative Effectives

Asif Dhar, M.D., M.B.A., Chief Medical Informatics Officer, Deloitte Consulting, LLP; Senior Fellow, Deloitte Center for Health Solutions

10:00-10:30 Commercial Plan Sponsors View of Personalized Medicine: Budget Buster or Realistic Clinical Solution

F. Randy Vogenberg, Ph.D., Principal and Senior Scholar, Institute for Integrated Healthcare and Jefferson School of Population Health

Commercial private plan sponsors represent more than 50% of payers for medicines’ insurance. Their view impacts access and reimbursement for all medicines along with their development. This presentation will explore and provide insight into strategy and benefit design considerations important for accelerating the future of personalized medicine.

10:30-11:30 Networking Coffee Break with Poster and Exhibit Viewing


Technology Showcase

Sponsored by
11:30-11:45 Biomarkers for Drug Development

Austin Tanney, Ph.D., Scientific Liaison Manager, Almac

In the development of personalized medicine, the discovery and application of biomarkers in the drug development pipeline is critical. With applications including diagnosis/prognosis, drug pharmacodynamics and patient selection biomarkers can guide drug development and patient selection and treatment across the board. This presentation will outline Almac’s experience in biomarker discovery and development in a range of different tissues and disease indications.

11:45-12:15 pm A Multiplexed Electrochemiluminescent Technology for the Simultaneous Analysis of Multiple Biomarkers from Complex SamplesSponsored by
Meso logo

David Sloan, Ph.D., Meso Scale Discovery
Meso Scale Discovery’s plate based electrochemiluminescent platform allows for the rapid development of high sensitivity immunoassays that cover a large dynamic range allowing for the quant-ification of biomolecules that can vary hundred to thousand fold in concentration without the requirement for multiple sample dilutions. Assays generally have a high matrix tolerance enabling samples to be run in high concentrations of sample matrix. The platform is compatible with a wide variety of both simple and complex biological matrices such as serum and plasma, cell and tissue extracts, and other biological fluids. Other advantages of the platform for ligand binding assays include the ability to multiplex assays, minimal sample requirements, reduced wash steps and flexibility in assay design or format. While many of the traditional optimization and validation parameters of ligand binding assays apply, the increased complexity of multiplexed immunoassays requires that additional considerations be taken into account during the development and validation of these assays. Strategies and examples of the development and characterization of multiplexed immunoassays on MSD’s plate based electrochemiluminescent platform will be discussed.

12:15-12:30 Analysis of Human Kidney Toxicity/Damage Using Multiplex ImmunoassaysSponsored by
EMD Novagen(1)

Wei Zheng, Ph.D., R&D Immunoassay Group Leader, EMD Chemicals
The FDA and EMEA have issued guidelines for 7 new urinary biomarkers of drug-induced kidney damage in rats. A natural continuation of this is to build on such efforts in studies performed in human patient material to advance the “rolling qualification.” To this end, a screen for potential protein biomarkers in relation to kidney toxicity/damage was performed in a set of urine and plasma samples from patients with documented renal damage. Multiplexed immunoassays were used to quantify protein analytes and standard blood and urine chemistry were determined. Statistical analyses using both univariate and multivariate tools indicated discrepancies in protein levels when comparing case and control samples. Future analysis aiming to qualify these biomarkers will indicate the potential of these candidates as markers for renal toxicity in humans.

12:30-12:45 Layered-Immunohistochemistry: A Novel Technology for "So many markers and so little tissue"Sponsored by
20 20 GeneSystems logo

Michael S. Lebowitz, Ph.D., Director of R&D, 20/20 GeneSystems, Inc.
Analysis of tissue biomarkers is key to understanding the activation status of particular pathways in specific cell types and can be indicative of disease diagnosis, prognosis, prediction of therapeutic efficacy and monitoring of treatment outcomes.  This information is of further importance in identifying and validating novel drug targets.  While in certain instances detection of single biomarkers is sufficient, it is rapidly becoming clear that both panels of multiple markers and variations in biomarker levels relative to each other is more informative and more diagnostic of cell and disease status.  The ideal biomarker tests conserve precious tissue by multiplexing marker measurements, retain information regarding tissue morphology and cell type localization, and normalize marker levels to objective standards.  20/20 GeneSystems, Inc. has introduced Layered-Immunohistochmistry (L-IHC) a tissue biomarker platform that meets all of these requirements.  In L-IHC the proteins of the tissue are channeled upward through the membrane stack with each layer capturing a certain percentage of total protein.  Thus each membrane represents a “carbon” copy of the tissue and can be probed for different biomarkers using standard immunostaining techniques.  Specific marker staining is detected using fluorescently labeled secondary antibodies and is always normalized to total protein to account for differences in protein transfer.  L-IHC has already been applied to a case of disease prognosis and 20/20 is actively involved in the development of L-IHC-based tests to predict therapeutic outcomes.  20/20 is now offering L-IHC-based testing to the research market on a contract basis.

12:45-2:00 Lunch on Your Own


Clinical Trial Design for Personalized Medicine

2:00-2:30 High-Throughput Biomarker Adaptive Design: A Shortcut to Personalized Medicine?

Yu Shyr, Ph.D., Professor and Chief, Division of Cancer Biostatistics, Department of Biostatistics; Director, Cancer Biostatistics Center, Vanderbilt-Ingram Cancer Center; Ingram Professor of Cancer Research, Vanderbilt University School of Medicine

In the last decade, researchers have seen a veritable explosion in high-throughput biomarker data. Today’s technology makes it possible for molecular biologists worldwide to collect increasingly vast quantities of biological information of unprecedented detail. The advancement of personalized medicine depends on clinical trials with high-throughput biomarker endpoints. This talk outlines recent developments in biomarker-adaptive trial design, including adaptive signature design (ASD), biomarker-adaptive threshold design (BATD), and mixed design (ASD + Bayesian). The advantages and limitations of these designs will be highlighted.

Sponsored by
2:30-3:00 Designing Clinical Trials for Personalized Medicine

Scott Berry, Ph.D., President and Senior Statistical Scientist, Berry Consultants

Developing personalized medicines runs the risk of higher development costs for smaller markets. Looking for subgroup effects after a trial completes is a sure-fire way to find false positives. How can we look for possible subgroups effects without requiring huge trial sizes to cope with the multiplicities? Using examples, it will be shown how adaptive trial designs and Bayesian modelling can help.

3:00-3:30 Adapting Randomization Based on Patient Characteristics

J. Kyle Wathen, Ph.D., Research Statistician, University of Texas, MD Anderson Cancer Center

Randomized clinical trials are the gold standard for obtaining scientifically valid treatment comparisons. However, if a physician favors one treatment over another, it may be more ethical for the physician to used the favored treatment rather than randomizing. As a compromise, many adaptively randomized procedures exist to unbalance the randomization in favor of the treatment that, on average, has superior results. Most of these methods assume that patients are homogeneous, and thus are likely to reach incorrect conclusions in the presence of patient heterogeneity. I propose a Bayesian adaptively randomized design that adapts randomization probabilities for each patient by including patient characteristics such as biomarkers, prognostic subgroups or disease subtype. A simulation study is presented and the method is illustrated in the context of two ongoing clinical trials.

3:30-4:30 Networking Refreshment Break with Poster and Exhibit Viewing


Overcoming Challenges in
Implementing Molecular Diagnostics

4:30-5:00 Health Economics Outcomes Research for Innovative Diagnostic Technologies

Franz Hessel, M.D., M.P.H., Director, International Health Economics Outcomes Research, Abbott Diagnostics

The objective of HEOR studies is to demonstrate the relation of the patient-relevant clinical, epidemiological and patient-reported outcomes to the economic consequences of a defined health technology. Hereby often modeling techniques are used to estimate the cost-effectiveness. Although for pharmaceuticals in many countries HEOR studies are compulsory for reimbursement at a premium price, there are only a small number of HEOR studies for diagnostic tests available. With the examples of uNGAL for the prediction of acute kidney injury in patients undergoing cardiac surgery, PLEX-ID as a new diagnostic approach in patients with severe sepsis, and HE4 as a new marker for ovarian cancer, we show that innovative diagnostic tests have a high potential to increase the medical benefit of the patients in a cost-effective or even cost-saving way.

5:00-5:30 Nanotechnologies for Molecular Diagnostics

Krassen Dimitrov, Ph.D., Group Leader, Australian Institute for Bioengineering and Nanotechnology, The University of Queensland, Australia

Direct digital counting (DDC) of biomolecules offers sizable advantages over traditional biodetection techniques in terms of accuracy, sensitivity, robustness and ease-of-use. Fluorescent nanobarcodes for single molecules rely on conventional microscopic technologies for their optical detection and identification. These fluorescent structures, or nanostrings, are already finding commercial applications and outperforming existing bioanalytical techniques. Electronic nanosensors with dimensions comparative to those of individual biomolecules are becoming feasible at the latest nodes of CMOS fabrication. Nanobarcodes for electronic detection with such electronic nanosensors would further advance miniaturization, cost-efficiency and throughput, however, they require fundamentally different technological approaches.

5:30 Close of Day