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Biomarker Assay Development - Main Conference - Day 2

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

Day 1 | Day 2 | Day 3



Sponsored by
Rules Based Medicine
7:30-8:15 am Breakfast Presentation
Development of OncologyMAP™:  A Public-Private Partnership Dedicated to Providing a Powerful New Tool for Discovery of Biomarker Patterns in Cancer
Brian T. Welsh, Ph.D., Application Scientist, Rules Based Medicine, Inc.
OncologyMAP is the newest service offering in Rules-Based Medicine's portfolio of Multi-Analyte Profiles (MAPs).  Developed in partnership with the National Cancer Institute's Proteomics Initiative, OncologyMAP contains 101 quantitative, multiplexed immunoassays for measuring cancer-related proteins in serum, plasma or tissue extracts. This novel tool offers an unparalleled platform to aid in the discovery and development of novel therapies and diagnostics in oncology. The OncologyMAP is powered by RBM's data-driven approach to efficiently and cost-effectively discover useful biomarker patterns.


8:25 Chairperson’s Opening Remarks

Calvert Louden, M.D., Senior Director, Pathology, Johnson & Johnson Pharmaceuticals

8:30 Summary of Key Take-Aways from Breakout Discussions

9:30 Using Mass Spectrometry and Immunoassays to Discover and Validate Serum Protein Biomarkers for Islet Autoimmunity and Type 1 Diabetes

Jin-Xiong She, Ph.D., Georgia Research Alliance Eminent Scholar in Genomic Medicine; Director, Center for Biotechnology and Genomic Medicine, Medical College of Georgia

Pancreatic islet autoimmunity marked by several autoantibodies against specific islet antigens occurs years before the onset of Type 1 diabetes (T1D) in most patients. These autoantibodies have been widely used as biomarkers for T1D prediction. However, earlier biomarkers are urgently needed so that preventive therapies can be administered before islet autoimmunity. We have used multiple proteomic platforms including mass spectrometry and multiplex immunoassays to investigate the serum proteome in large cross sectional and prospective cohorts.


Sponsored by
Meso logo 
10:00 Development of Mutiplexed Immunoassays for Personalized Medicine

Laure Moller, Ph.D., Field Scientific Support Manager, Meso Scale Discovery
Meso Scale Discovery® offers a high throughput, sensitive platform allowing for the quantification of biomarkers that can vary over a wide range of concentrations in single or multiplexed format. In this presentation, case studies involving the development and qualification of multiplexed protein biomarker assays for different stages of personalized medicine biomarker applications using Meso Scale Discovery’s plate based electrochemiluminescent platform will be presented.

10:30 Networking Coffee Break with Exhibit and Poster Viewing

11:00 Development of Drug-Induced Vascular Injury (DIVI) Biomarkers

James Fikes, Ph.D., DVM, Director, Clinical & Investigative Pathology, Global Safety Assessment, AstraZeneca Pharmaceuticals

Drug-induced vascular injury (DIVI), typically induced by vasoactive compounds, is a concern pre-clinically and clinically. Traditionally, heart rate and blood pressure have been used as functional DIVI biomarkers, but were deemed not to be surrogate biomarkers based on findings during the development of endothelin receptor antagonists (ETRA) and thus the need to qualify new DIVI biomarkers. This presentation will review the current hypothesis underpinning the development of DIVI and the cell types potentially involved in lesion formation. In addition, various biomarkers under investigation will be discussed together with an update on their qualification.


11:30 Development of Biomarker Panels: Opportunities and Challenges

Samir Hanash, M.D., Ph.D., Program Head, Molecular Diagnostics, Fred Hutchinson Cancer Research Center

An integrated cooperative effort is currently under way for the identification of biomarkers of cancer risk, early detection of cancer and identification of altered signaling pathways based on serum and plasma analysis. This is illustrated in proteomic studies of epithelial cancer that encompass analysis of specimens collected before onset of symptoms for the identification of risk and early detection markers and elucidation of signatures in plasma for altered signaling pathways in tumors. Such an effort requires and benefits from the availability of in-depth quantitative proteomics methods, bioinformatics resources and integration with other broad-based molecular profiling technologies. 


12:30 Lunch Presentation (Sponsorship Opportunity Available) or Lunch on Your Own



1:55 Chairperson’s Opening Remarks

Philip Baker, FRCOG, FRCSC, FMedSci, Dean, Faculty of Medicine & Dentistry, Professor, Obstetrics & Gynecology, University of Alberta

2:00 Biomarkers in the Development of BTK and HDAC Inhibitors

Sriram Balasubramanian, Ph.D., Senior Director, Translational Medicine, Pharmacyclics, Inc.

Small molecule drug development in oncology can be accelerated greatly by utilizing pharmacodynamic and efficacy biomarkers, both in the pre-clinical and clinical stages. This talk will discuss two case studies: one is the development of a covalently-bound fluorescent probe for quantifying target occupancy by the Bruton’s tyrosine kinase (BTK) inhibitor PCI-32765, and its application in pre-clinical (mouse and dog) models as well as to optimize dosing in the Phase I clinical trial.  The other case focuses on the development and validation of ELISA as well as Taqman (mRNA) assays for the DNA repair enzyme RAD51, which can predict the efficacy of the HDAC inhibitor PCI-24781 when used in combination with DNA-damaging agents.

2:30 Towards Developing miRNA-Based Biomarker Assays in Cancer
Glen J. Weiss, M.D., Director, Thoracic Oncology at VGPCC at Scottsdale Healthcare and Co-Head, Lung Cancer Unit at The Translational Genomics Research Institute (TGen)
A single microRNA can impact hundreds of targets and can affect pathways controlling oncogenic processes. microRNAs show promise as biomarkers in part because these tiny RNAs are resilient and detectable in a variety of tissues and biofluids. Data will be presented illustrating how using microRNA can impact cancer treatment decision making. This talk will cover some miRNA biomarkers in development with the goal to improve oncology care.

Sponsored by
Millipore (updated)(1) 
3:00 Evaluation of Cytokine Signatures as Biomarkers of Immune Response to Aggregated Proteins using Milliplex Kits 
Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Medical Sciences, Amgen, Inc.
Aggregates in formulations are suspected of being associated with an increased risk of developing an immune response.  By examining multiple secreted cytokines from donor PBMCs challenged with various aggregated molecules, we found that aggregated monoclonal antibodies with higher rates of clinical immnogenicity induced a higher magnitude of inflammatory cytokine response compared to the non-immunogenic aggregated biotherapeutic antibodies.  This approach for multiplexed cytokine profiling could enable quality control of formulations during manufacturing and provide insight into the particle attributes that pose the most risk for inducing an inflammatory response and anti-drug antibodies before they are administered to patients.

3:30 Networking Refreshment Break with Exhibit and Poster Viewing

4:00 Exploiting an Unexpected Value of PCR Technology to Predict Efficiency of Anti-Cancer Drugs

France Carrier, Ph.D., Associate Professor, Radiation Oncology, Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Currently there is no prognostic tool that could predict a patient’s response to anti-cancer drugs targeting chromatin DNA or enzymes acting on DNA. Because most anti-cancer drug regimens include at least one drug targeting DNA or enzymes acting on the DNA, we have developed a simple quantitative assay to measure the efficiency of anti-cancer drugs and more specifically inhibitors of Topoisomerase 2. The technique measures DNA breaks, which are introduced in genomic DNA due to inhibition of topoisomerase function, and our data indicate that genomic DNA could be used as biomarker to evaluate drug efficiency in vivo.

4:30 Analyzing miR-122 as a Biomarker for Hepatotoxicity

Ameesha Batheja, Ph.D., Senior Scientist, Investigative Toxicology, Johnson & Johnson Pharmaceutical R&D

There continues to be an urgent need for more sensitive and/or specific biomarkers for hepatotoxicity, especially biomarkers that can improve mechanistic insight or predict the outcome of permanent or reversible liver damage both pre-clinically and clinically. MicroRNA (miRNA) such as miR-122 (endogenous, short non-coding RNA sequences that down-regulate gene expression) are rapidly emerging as potential biomarkers of organ toxicity that can be serially sampled in plasma. miR-122 is expressed with high specificity in the liver. A pre-clinical evaluation of miR-122 as a biomarker for hepatotoxicity is important to understand its advantages and limitations over existing hepatotoxicity biomarkers.

5:00 Metabolomic Screening for Pregnancy Complications

Philip Baker, FRCOG, FRCSC, FMedSci, Dean, Faculty of Medicine & Dentistry, Professor of Obstetrics & Gynecology, University of Alberta

Preeclampsia is a pregnancy-specific syndrome that causes substantial maternal and fetal morbidity and mortality.  We performed a two-phase discovery/validation study in pregnant women who subsequently developed preeclampsia and matched controls. A multivariate predictive model combining 14 metabolites gave a consistent discriminatory metabolite signature in early pregnancy plasma preceding the onset of preeclampsia offers insight into disease pathogenesis, and the tantalizing promise of a robust pre-symptomatic screening test.

5:30 PANEL DISCUSSION: Multiplexed Biomarker Assays and Technologies: Pros and Cons

6:15 End of Day Two


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