Smarter Studies: Designing Efficient and Rigorous Molecular Diagnostics and Biomarker Studies DVD

 About the DVD:
Omics measurements are inherently comparative—we compare healthy to diseased, responders to non-responders, good vs. poor prognosis, etc.  The focus of these evaluations is on the how of the comparison (the technology), but it matters just as much what we compare (samples, conditions).  It is generally difficult and costly to improve the measurement performance, but it is often rather simple to achieve a quantum leap in the quality and validity of your results with an improved study design.

This course is aimed at Omics practitioners responsible for setting up and running research studies in areas such as biomarker discovery, development of companion diagnostics and prognostic signatures or biomedical research in general.  No knowledge in biostatistics is required.

About the Conference:
The one scientific event for cutting-edge research, trends and analysis. The future holds great promise for molecular medicine, however the demand for results today is ever mounting, from both patients and businesses alike.  The Molecular Med Tri-Con is the place to find the tools to turn ‘someday’ into ‘now’. ATTEND. DISCOVER. APPLY. 

Molecular Med TRI-CON 2011 – a LIFE changing event

About the DVD:
3 Presentations
Over 148 Slides
155 Minutes
Individual Copy: $345
Site License: $1380

Agenda At A Glance:

Experimental Design in Genomics, Proteomics and Metabolomics
 Terry Speed, Professor & 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.

Biography: Professor Terry Speed is well known for his contributions to bioinformatics, and in particular to the analysis of microarrays data. He is the head of the bioinformatics division at the Walter and Eliza Hall Institute of Medical Research in Melbourne. He has also been a professor of statistics at the University of California, Berkeley. He was president of the Institute of Mathematical Statistics in 2004.

A Roadmap for Omics and Biomarker 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.

Biography: As responsible bioinformatician and biostatistician J. von Frese has been involved in industrial translational research for more than a decade. He has designed and analyzed several large scale studies for developing microarray cancer diagnostics.  "Invariably I find that my biggest contribution to the overall project success does not lie in the intricacies of bioinformatics analyses but by bringing about a quantum leap in data quality through rigorous study design."

Biomarker Studies: How Can They Tell Us More?
 Michael Palmer, President, Adaptive Pharmacogenomics, LLC
There are several levels of complexity and cost in the design of a biomarker study. In this session, we will discuss tools and models which can estimate the cost, complexity and efficiency of these studies. In particular, the Adaptive Pharmacogenomics Software Tool for modeling clinical development strategies was developed based on the experiences at the FDA with pharmacogenomic data submissions.  We will review these tools and models and show how they can help in the design of these studies.

Biography: U.S. Food and Drug Administration (FDA) since 2005 on software tools to help assess the cost and complexity of clinical trials. Michael graduated from the University of Michigan with an MS in biostatistics in 1979 and has worked in clinical research and development in the pharmaceutical industry since then. He and Cecilia A. Hale, Ph.D. founded Adaptive Pharmacogenomics in 2007.

Bonus Footage: This DVD includes two bonus presentations including:  “Deconstructing the Drug Development Process: The New Face of Innovation” delivered by Kenneth Kaitin, Ph.D., Director, Tufts Center for Study of Drug Development and “To the $1,000 Genome — and Beyond” delivered by Kevin Davies, Ph.D., Author, The $1,000 Genome; Editor-in-Chief, Bio-IT World. These two talks were presented as part of the Plenary Keynote at the Molecular Med Tri-Conference. Deconstructing the Drug Development Process: The New Face of Innovation  Kenneth Kaitin, Ph.D., Director, Tufts Center for Study of Drug Development For over 30 years, the Center for the Study of Drug Development at Tufts University has documented the increasing challenge of bringing new pharmaceutical products to market. To succeed in today’s competitive marketplace, research-based drug and biotech companies must not only maintain their focus on R&D efficiency and output, but they must also be able to adjust to a rapidly changing and highly volatile R&D environment. In this presentation, Dr. Kaitin will use Tufts CSDD data to document the current status of pharmaceutical R&D and explore new models of innovation. To the $1,000 Genome — and Beyond  Kevin Davies, Ph.D., Author, The $1,000 Genome; Editor-in-Chief, Bio-IT World The field of genome analysis has undergone a revolution in recent years. Next-generation sequencing technologies have dropped the cost of sequencing a human genome from about $1 million in 2007 to less than $10,000 in 2010, with new third- and fourth-generation technologies on the horizon. But will the arrival of the $1,000 genome have any meaningful impact on drug development and the practice of medicine? Kevin Davies, author of The $1,000 Genome will share his observations on the landmarks in next-generation sequencing. He will also highlight the challenges that remain in next-gen data generation, analysis and dissemination for the research and medical communities.