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生物標誌是近代醫療的中心，特別指定有效果的治療或與治癒有關之體內物理性和生物化學性的變化。法規當局在開發藥劑時開始採用能利用生物標誌測定的新結構，故生物標誌的作用逐漸變化中。第一次召開的Translational Biomarkers會議，介紹可以展開的生物標誌（藥力學、預測、癒後、毒性學、診斷）之最新動向。醫藥品的研究連續數十年都使用動物模式，若直接用在人類身上，其預測有界限。專家們發表使用與相互關係、預測、臨床的展開相連之生物標誌的模式與策略。

RECOMMENDED SHORT COURSES*

(SC5) Biomarker Qualification and Validation

(SC7) Planning Biomarker Development: Aligning Strategy, Science, and Technology

 

*Separate registration required

THURSDAY, SEPTEMBER 8

12:30 pm Conference Registration

1:30 Chairperson's Opening Remarks

Suso Platero, Ph.D., Director, Oncology Biomarkers, Centocor, Ortho Biotech Oncology R&D, unit of J&J PRD LLC

KEYNOTE Presentation 1:40 Evolving Laboratory Technologies to Assess Predictive and Prognostic Biomarkers: Potential Utility vs. Challenges Abdel Halim, Pharm.D., Ph.D., DABCC-CC, DABCC-TOX, DABCC-MD, FACB, Director, Clinical Biomarkers, Daiichi Sankyo Pharma Development Biomarkers have been playing a critical role in patient management and pharmaceutical trials as diagnostic, prognostic, predictive, and drug efficacy indicators. Technologies like genotyping, gene expression, proteomics, immunohistochemistry, and in-situ hybridization become more and more important tools to evaluate biomarkers. Classical sample-substitute, e.g. CTC and cell-free plasma DNA is gaining attraction and fame in the field. However, without proper assessment and consideration of related challenges and pitfalls, biomarkers could be misleading rather than beneficial. This presentation will address potential benefits versus risk of biomarker applications especially in relation to evolving technologies.

BIOMARKERS: GETTING TO THE CLINIC

2:10 Applying Genomic Platforms to Generate Unbiased Responder and Treatment Hypotheses for Oncology Translational Research

Jing Li, Ph.D., Head, Genomic Screening, Exploratory & Translational Science, Merck & Co.

The talk will be focused on using RNAi synthetic lethal screens and drug response screens in large panel of cancer cell lines to generate responder/resistance and drug treatment hypotheses for oncology translational research

2:40 Implementing Flow Cytometry Biomarker Assays in Clinical Studies

Dianna Wu, Director, Clinical Biomarkers & Diagnostics, Merck & Co.

The implementation of flow cytometric biomarker assays in clinical trials, especially global clinical trials, remains a challenge due to the limited stability of clinical specimens, lack of QC materials and the technical variations between analytical laboratories. We will summarize practice in validating and implementing flow cytometric biomarker assays in drug development.

Sponsored by
3:10 Sponsored Presentations

 

3:40 Networking Refreshment Break in the Exhibit Hall with Poster Viewing

4:20 CASE STUDY: Altered Expression of Insulin Receptor Isoforms in Breast Cancer

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

In response to blocking IGF1 and IGF2, dramatic levels of antitumor activity were observed in tumors that express both IGF1R and IR-A or IR-A. Furthermore, our results have identified the IR-A:IR-B ratio as a critical biomarker associated with the luminal-B breast cancer subtype. The use of the IRA:IRB ratio to guide patient selection for IGF-targeted therapy in breast cancer has the potential to provide significant clinical benefit to numerous cancer patients.

4:50 Standardization of Blood Biomarkers: Innovations through Automation

Denise L. Faustman, M.D., Ph.D., Director, Immunobiology, Massachusetts General Hospital; Associate Professor, Medicine, Harvard Medical School

In this presentation we demonstrate and quantify Ficoll's inaccuracy in terms of viability, purity, and yield of PBLs. We then demonstrate the value of our newly improved method that automates and standardizes whole cell PBLs without the use of gradient technology. The new procedures uses paramagnetic particles attached to antibodies to detect cells of interest with a newly designed robotic platform. We demonstrate that this new method can reliably isolate an extremely rare subset of autoimmune PBLs (<1 x 10-6 of whole blood cells) largely responsible for select disease processes and allow standardzations of biomarkers for select immune diseases.

5:20 Molecular Biomarker Profiles of Ovarian Cancer Cells Obtained from Intraperitoneal Fluid, Lymph and Blood

Marek Malecki, M.D., Ph.D., Associate Professor of Genetics, Genomics, and Gene Therapy; Director, Biotechnology Program, Western University of Health Sciences

Ovarian cancer is the leading cause of deaths among all gynecological cancers. Identification of molecular biomarkers present on surfaces of cancer cells not only helps to diagnose cancer at the earliest stages, but also to proceed with development of personalized vaccine, immunotherapy, and/or targeted delivery of suicide gene therapy. We have recently developed a novel technology to determine ovarian cancer cell molecular profiles based upon superparamagnetic, genetically engineered single chain single chain variable fragments generated from the libraries of the patients' B cells, which is followed by single cell arrays, sequencing, and analyzing their own antibody response profiles. This technology allows us to screen patients with instant broadcasting diagnosis and prognosis, while preparing therapies eliminating only cancer cells and leaving healthy cells unharmed.

5:50 Close of Day

6:30-9:00 Dinner Short Courses*

*Separate registration required

 

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