Short Courses  |  Day 1 | Day 2 | Day 3 |  Download Brochure

Pre-Conference Short Courses*

 

Tuesday, February 2

9:00 AM – 12:00 PM

(SC1) APPLYING NEXT GENERATION SEQUENCING TECHNOLOGIES TO RESEARCH

Introduction to New Technologies and Application in Research

Course Moderator:
Stanley Gloss, Founding Partner & Managing Director, BioTeam, Inc.

 

Technologies for next generation sequencing are accelerating at a rapid pace. This short course will help to keep you up-to-date on the newest options for DNA sequencing, and the tools to manage the data. The major new advantages will be showcased in the latest platforms, and strategies for managing the data to turn it into useful information will be demonstrated by leaders in the field.

• Technologies for newest platforms next generation sequencing
• Strategies and tools for managing data
• Demonstration of how tools can be applied to research

9:00 Introduction

Stanley Gloss, Founding Partner & Managing Director, BioTeam, Inc.

9:10 Next-Gen Sequence Assembly and Cloud Computing

Francisco M. De La Vega, D.Sc., Distinguished Scientific Fellow, Computational Genomics Research, Genetics Systems R&D, Life Technologies

10:00 Using Wikis for Managing Next-Gen Sequencing Data

Giles Day, Senior Director, BBC Informatics, Pfizer Biotherapeutics & Bioinnovation Center

10:50 Refreshment Break

11:00 Emerging 3rd Generation Sequencing Technologies 

Dr. Ronald W. Davis, Professor, Biochemistry & Genetics and Director, Stanford Genome Technology Center, Stanford University

11:50 Q&A and Wrap-up

Stanley Gloss, Founding Partner & Managing Director, BioTeam, Inc.

12:00pm End of Short Course

 

2:00-5:00 pm

(SC8) STRATEGIES FOR MOLECULAR DIAGNOSTIC COMPANIES: Achieving Success in Rapidly Changing Markets

Course Instructors: Peter S. Miller, Chief Operating Officer, and Keith F. Batchelder, Chief Executive Officer, Genomic Healthcare Strategies

The power of molecular diagnostics to direct the choice of therapies, reduce costs, and provide clinically valuable information is resulting in major market changes. The new science and new business strategies have led to strong investor interest in the field. This short course will review new and old models and describe several alternative strategies which diagnostic firms may pursue. Depending on the venture’s strengths and weaknesses, partnering or course changes may be appropriate, particularly in seeking future funding.

•  Why and how diagnostics markets have changed
•  Characteristics of successful ventures
•  Alternate strategies for success
•  What are your assets?
•  How to consider your strategy
•  Conventional or new markets: Which to pursue?
•  Potential partners
•  Your next round of funding: where and why?

(SC12) DESIGNING RIGOROUS OMICS STUDIES FOR BIOMARKER DISCOVERY AND DEVELOPMENT OF PROGNOSTIC AND PREDICTIVE MOLECULAR DIAGNOSTICS
Download Complimentary Course White Paper: Smarter Studies: Designing Rigorous Omics

Course Agenda

2:00 Experimental Design in Genomics, Proteomics and Metabolomics

Terry Speed, Professor, Department of Statistics, University of California, Berkeley; Head, Bioinformatics, WEHI, Australia

For most experiments in this area, we can recognize three main phases that are relevant to experimental design. I: choice and preparation of experimental material, choice of platform technology; II: assignment of experimental reagents to components of the technology; III: actual conduct of the experiment, including times, places and conditions of experiment, and protocols, reagents, operators and equipment used. In this talk we will mainly focus on examples where the experiments were poorly designed and led to unsatisfactory outcomes. This will show the need for good design

2:45 A Roadmap for Omics Study Design

Juergen von Frese, Ph.D., Managing Director, Data Analysis Solutions DA-Sol GmbH, Germany

Any biomarker or predictive or prognostic signature can only be as good as the data it was derived from. Study design critically determines the inherent signal (i.e. information) in the data. This talk will provide a systematic overview and roadmap for designing omics studies. This will range from defining study aims, determining sample size, randomization and reference measurements to an in-depth discussion of tackling confounding factors. Examples from cancer diagnostics will be given and crucial issues and pitfalls will be highlighted.

3:30 Refreshment Break

4:00 Beyond the Pilot Studies: FDA Perspectives on Biomarker Qualification

Donna Roscoe, Ph.D., Senior Reviewer, FDA/OIVD/DIHD

Major advances in research technology are allowing for the unprecedented identification of multiple genetic and protein biomarkers. The leap from characterizing these signatures to validating them for a specific use and applying them to patient diagnosis, screening, and therapeutic intervention is best accomplished with an understanding of the FDA regulatory process. This talk is intended to provide an overview of the current perspective of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in the FDA's Center for Devices and Radiological Health (CDRH) on the issues related to assessing analytical and clinical performance of biomarker-based in vitro diagnostic assays for use in clinical practice or medical product development.

4:45 Q&A

5:00 End of Course

 

*Separate Registration Required

 

Short Courses  |  Day 1 | Day 2 | Day 3 |  Download Brochure