2013 Archived Content
Ninth Annual

Clinical and Translational Science

Strategies to Accelerate and De-Risk Clinical Development


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Thursday, February 14

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:00 - 9:40 Plenary Keynote Panel: Emerging Technologies & Industry PerspectivesThis session features a series of presentations on emerging and hot technologies in diagnostics, drug discovery & development, informatics, and oncology. Interactive Q&A discussion with the audience will be included. - Read more 

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9:40 Refreshment Break in the Exhibit Hall with Poster Viewing


Integrating Biomarkers and Genomics into Clinical Development 

10:40 Chairperson’s Remarks

Jaya Goyal, Ph.D., Principal Investigator, Translational Medicine, Biogen Idec

10:45 Clinical Trials in Genetically Defined Patient Populations

Jaya Goyal, Ph.D., Principal Investigator, Translational Medicine, Biogen Idec

There is an increasing realization that proof-of-concept for new therapies can be obtained by clinical trials in genetically well characterized patients. The prospect of using whole genome sequencing to stratify patients into different subsets for more efficient clinical trials is an enticing one.

11:15 From Biomarker to Companion Diagnostic: Different Bumps in Different Roads

Richard Buller, M.D., Ph.D., Vice President, Translational Oncology, Pfizer

There are usually multiple options for biomarker development and no two development plans are likely to be identical. Perspectives on the variables influencing diagnostic development for three different Pfizer compounds will be discussed including assay selection and post-marking activities.

11:45 Using Biomarkers in Clinical Trials – Perspectives from the FNIH Biomarkers Consortium

Maria Vassileva, Ph.D., Scientific Program Manager, Metabolic Disorders, The Biomarkers Consortium

The Biomarkers Consortium is involved in clinical trial execution and data compilation for biomarker qualification. This presentation will focus on two projects to demonstrate that data from multiple studies, once integrated, can answer questions that would otherwise be impossible to address.

Metabolon12:15 pm Luncheon Presentation I
Metabolomics for Improved Translation through New Targets and Biomarkers
Rob Mohney, Ph.D., Director, Projects (North American Pharma-Biotech), Metabolon, Inc.Technology advancements enable rapid, simultaneous assessment of >2800 metabolites to derive novel biomarkers and targets.  A GWAS study demonstrates metabolomics provides insight regarding gene function and biomarkers of disease or drug response to develop biomarkers for prostate cancer progression.

12:45 pm Luncheon Presentation II (Sponsorship Opportunity Available) or Lunch on Your Own 

1:15 Refreshment Break in the Exhibit Hall with Poster Viewing

1:40 Chairperson’s Remarks

1:45 Multifaceted Impact Potential of Biomarkers and Translational Research in Oncology Drug Development

Ronald Linnartz, Senior Director, External Collaborations, Oncology Correlative Sciences, Novartis

2:15 Multimodal Dynamic Profiling of Healthy and Diseased States for Personalized Healthcare

George I. Mias, Ph.D., Postdoctoral Scholar, Snyder Lab, Department of Genetics, Stanford University School of Medicine

2:45 Presentation to be Announced


genia3:15 Translating the Preclinical Pharmacology of the Select TLR8 Agonist VTX-2337, into Clinical Activityusing the Myriad/RBM MAP Inflammation PanelGregory N. Dietsch, Ph.D., Vice President, Research, VentiRx PharmaceuticalsVTX-2337 is a selective TLR8 agonist that activates myeloid dendritic cells, monocytes and NK cells to produce both chemokines and Th1 polarizing cytokines. Prior to the conduct of clinical studies in cancer patients,the Myriad/RBM inflammation panel was used to compare the potency of VTX-2337 on human and non-human primate leukocyte populations, and define pharmacokinetic/pharmacodynamic relationship in cynomolgus monkeys. This characterization definedpotential clinical biomarkers of VTX-2337 activity and established a Minimal Anticipated Biological Effect Level (MABEL) for the initial clinical trial. 

3:30 Sponsored Presentation (Opportunity Available)

3:45 Valentine’s Day Celebration and Poster Competition Winner Announced in the Exhibit Hall (Last Chance for Poster Viewing)


Quality of Pre-Clinical Evidence Matters 

4:30 Chairperson’s Remarks

4:35 Challenges in Translating Pre-Clinical Research into Benefit for Patients: Raising the Bar for Pre-Clinical Cancer Research

C. Glenn Begley, Ph.D., Senior Vice President, TetraLogic

There are multiple challenges translating research findings into drugs that ultimately benefit patients. Some are inherent in the disease and the models we employ, and are extremely difficult to address.Others are inherent to our processes, and may be more readily overcome.

5:05 Building More Predictive in vitro and in vivo Models to Identify Responder Populations Pre-Clinically

Emma Lees, Ph.D., Vice President, Oncology, NIBR Site Head Emeryville, Novartis Institutes for Biomedical Research

5:35 Challenges to Accurately Translating Results from Pre-Clinical Cancer Models to the Clinic

Peter Houghton, Ph.D., Director, Center for Childhood Cancer, Nationwide Children’s Hospital

Human tumor xenografts have been the predominant models for cancer drug development for about 30 years. However, there are concerns that results from such pre-clinical models do not translate into clinical reality.

6:05 PANEL: Improving Reproducibility and Predictability of Pre-Clinical Research

Moderator: Peter Houghton, Ph.D., Director, Center for Childhood Cancer, Nationwide Children's Hospital


C. Glenn Begley, Ph.D., Senior Vice President, TetraLogic

Emma Lees, Ph.D., Vice President, Oncology, NIBR Site Head Emeryville, Novartis Institute for Biomedical Research

Terry A. Van Dyke, Ph.D., Head, Mouse Cancer Genetics Program; Program Director, Cancer Pathways & Mechanisms, NCI

6:35 Close of Day


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