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Translational Biomarkers - ADAPT Congress 2011

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FRIDAY, SEPTEMBER 9

7:30 am Sponsored Breakfast Presentation (Opportunity Available)

8:30 Interactive Breakfast Breakout Discussion Groups

Table 1: Prognostic Biomarker Discovery and Qualification: Slowing Down Drug Discovery?

Moderator: Thierry Sornasse, Ph.D., Consultant, Integrated Biomarker Strategies

 

The conundrum of establishing biomarkers of disease modification for new indications: without estabished effective treatment and no ongoing clinical program, biomarkers of disease modification can only be qualified by the end of Phase III. For companies with established clinical programs, is it worth it to conduct additional clinical trials to qualify disease biomarkers (prognostic, diagnostic, and/or disease modification)?

Table 2: Strategic Partnership Development and Management for the Co-Development of Drugs and Diagnostics

Moderator: John Bloom, V.M.D., Ph.D., President, Bloom Consulting; Adjunct Professor, University of Pennsylvania

 

QUALIFICATION & VALIDATION OF BIOMARKERS

9:15 Chairperson’s Opening Remarks

Thierry Sornasse, Ph.D., Consultant, Integrated Biomarker Strategies

9:25 Biomarker Development: Integrating Biomarker Qualification and Method Validation

Thierry Sornasse, Ph.D., Consultant, Integrated Biomarker Strategies

The development of biomarkers as decision tools in support of drug development and as diagnostic tools in support of personalized medicine is fundamentally dependent on the successful integration of method validation and biomarker qualification. The parallel processes of developing a technically reliable biomarker measurement method and establishing the significance of a biomarker relationship with a specific biological process will be discussed.

9:55 Validation of a Biomarker for Autoimmune Disorder

Yihong Yao, Ph.D., Director, Head, Pharmacogenomics, Translational Science, MedImmune

10:25 CPE-Delta N as a Multi-Tumor Biomarker for Predicting Future Metastasis

Y. Peng Loh, Ph.D., Chief, Section on Cellular Neurobiology, Program on Developmental Neuroscience, Eunice Kennedy Shriver National Institute on Child health and Human Development, National Institutes of Health

In studies of hepatocellular carcinoma patients, high CPE-deltaN mRNA or protein levels in the resected primary tumor predicted future intra-hepatic metastasis, independent of cancer stage. Additionally, colorectal cancer patients with high tumor CPE-deltaN mRNA levels were accurately diagnosed with metastatic disease. Resected pheochromocytomas with large CPE-deltaN mRNA copy numbers predicted future metastasis or recurrence in patients diagnosed with benign tumors at time of surgery. Thus CPE-deltaN is a multi-tumor biomarker for diagnosing and predicting future metastasis, superior to histopathological diagnosis.

Sponsored by
almac
10:55 Translating Pre-Clinical Biomarkers and their Application in Clinical Trials
Austin Tanney, Ph.D., Scientific Liaison Manager, Almac

 

11:25 Networking Coffee Break in the Exhibit Hall with Poster Viewing

 

CO-DEVELOPMENT STRATEGIES FOR
BIOMARKERS & DRUGS

12:10 pm Opportunities and Strategies for Co-Developing Drugs and Diagnostics in Today’s R&D Environment

John Bloom, V.M.D., Ph.D., President, Bloom Consulting; Adjunct Professor, University of Pennsylvania

The sophisticated, highly-targeted candidate drugs under development in R&D organizations today require biomarkers that show target engagement, enable patient selection/stratification and manage safety concerns. Opportunities to employ enabling technologies and serviceable biomarkers/diagnostics are currently greatest in oncology, where there are well-defined signaling pathways, sophisticated molecular profiling tools, and well-established collaboration constructs among academe, industry and government. For these reasons, cancer molecular markers will continue to dominate diagnostics development in the intermediate future.

12:40 pm Identification of Predictive Biomarkers for the TRAIL Death Receptor Targeted Cancer Therapies

Baolin Zhang, Ph.D., Principal Investigator and Product Quality Reviewer, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

1:10 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

CLINICAL UTILITY OF BIOMARKERS

2:25 Chairperson’s Remarks

John Bloom, V.M.D., Ph.D., President, Bloom Consulting; Adjunct Professor, University of Pennsylvania

2:35 Novel Biomarkers to Identify Indolent vs. Virulent Prostate Cancer

Hirak Basu, Ph.D., CSO, Research & Development, Colby Pharmaceutical Company

Failure to differentiate between indolent vs. virulent prostate cancer leads to unnecessary intervention causing pain and suffering of many prostate cancer patients. Increased glucose metabolism (Warburg effect) is a hallmark of progressing cancer. Increased mitochondrial activity due to glucose metabolism and the resultant generation of ROS and DNA damage causes protein expressions that leads to the progression of virulent prostate cancer. Overexpression of proteins in the glucose metabolism and ROS generation pathway may be used as biomarkers to differentiate between indolent and virulent prostate cancer.

3:05 Unbiased Identification of Antibody Biomarkers for Alzheimer’s Disease

Muralidhar Reddy Moola, Ph.D., Associate Professor, Department of Chemistry, The Scripps Research Institute

We developed a general and unbiased approach to the identification of antibodies unique to a given immunological state, such as an autoimmune condition. This method simultaneously provides synthetic ligands that bind to these antibodies with sufficient affinity and selectivity to retain them from crude serum. The method is also shown to be applicable to the discovery of immunobiomarkers for human disease by the identification of three ligands for antibodies that are present at high levels in the blood of patients with Alzheimer’s Disease (AD). We identified 3 peptoids that capture antibodies whose levels are 3-10-fold higher in each AD patient compared to each Parkinson’s disease and each normal control subject.

COLLABORATIVE BIOMARKER DEVELOPMENT
IN TRANSLATIONAL RESEARCH

3:35 Biomarker Discovery in Population Based Cancer Models

Joerg Heyer, Ph.D., Director, Genetic Models, Translational Research, AVEO Pharmaceuticals

Here we present a novel population based pre-clinical model that enables biomarker identification in early stages of drug discovery and allows for biomarker validation in subsequent clinical trials.

4:05 Proposed Virtual BioRepository Platform for Distributed Research Networks: Case Study in ALS

Alex Sherman, M.Sc., ABD, Director, Systems, Neurology, Massachusetts General Hospital

A Web-based platform was designed and built for managing distributed biological samples with Ad Hoc searches from heterogeneous data sources capabilities. The ALSBank™ BioRepository platform solution for managing biological samples and associated data is currently deployed to support a network of multiple BioBanks, thus allowing researchers to take advantage of a larger specimen collection that they might have at an individual institution.

4:35 Close of Conference

 

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