Thursday, 6 June 2013

13:00

Summit Registration and Coffee.


Afternoon One of the Summit: Market Analysis and Round-Table Discussion

14:00

Biomarkers and Companion Diagnostics (CDx): Results from Market Tracking
Enal Razvi, Managing Director, Select Biosciences Inc, United States of America

This presentation presents the latest market analysis performed by SELECTBIO tracking the companion diagnostics (CDx) marketplace with emphasis on various classes of biomarkers.

This presentation will frame and discuss the following topics:

1. Classes of Cancer Biomarkers
2. Publications Analysis of Various Biomarker Classes to Reveal Research Trends and "Hotspots"
3. Epigenetics Research Trends and Deployment as Biomarkers
4. microRNA Research Trends and Utility as Biomarkers
5. Exosomes Research and Biomarker Utility

All Registered Delegates will Receive the SELECTBIO  MicroRNA and Epigenetics Research and Biomarkers 2013 Market Report underlying the Data/Analysis Presented Herein.

This 3-hour presentation will contain several blocks corresponding to the above topic areas and will be conducted in a round-table format with extensive discussions.


17:00

Martin LatterichKeynote Presentation

Biomarker-driven Translational Medicine
Martin Latterich, Chief Scientific Officer, Bioscale, United States of America

Biomarkers are molecules that provide information about a biological state in cells, tissues and entire organisms. A key goal of the translational medicine field is the identification and measurement of biomarkers that describe a disease or a response to a treatment. The biomarker field has rapidly evolved over the past decade, away from the use of descriptive or surrogate markers, to markers that are mechanistically linked to disease or that indicate treatment options and efficacy of treatment. There are numerous emerging examples of biomarker successes in translational research, such as pharmacodynamic markers and markers that provide actionable treatment options, often at an individual level.

The modern translational biomarker laboratory is characterized by having to develop a marker or panel of markers common to both patients, cellular and animal models of disease. These panels can now consist of mixed classes or markers, such a genomic, RNA protein and metabolite, making it harder to develop a universal analytical platforms as opposed to optimized assays to quantify these biomarkers on different platforms. In addition to technological challenges, such as matrix interference in immune assays and mRNA stability in blood and tissue, there are conceptual challenges that urge a rethinking of regulatory paradigms. For example, why do we have to structure clinical trials for an anti-cancer drug based on morphologically defined tumors using criteria that arose many years ago and reflect a rather poor understanding of tumor biology, or could we actually structure trials based on an actionable biomarker defining the tumor, irrespective of tumor morphology and location. The next decade should prove both interesting and conceptually challenging for the translational researcher and clinician.

18:00

Cocktail Reception Together with ELA2013 in the Exhibit Hall

19:00

Close of Day One of the Summit.

Friday, 7 June 2013

09:00

Coffee and Start of Day Two of Summit.


Session Topic: Epigenetic Biomarkers

09:00

Development and Validation of DNA Methylation Biomarkers
Andreas Weinhaeusel, Senior Scientist, Austrian Institute of Technology GmbH, Austria

Elucidation of DNA methylation changes is of utmost interest for the development of biomarkers. Along the biomarker developmental chain upon discovery of candidate markers, confirmation and validation are indispensable steps. We have successfully established genome wide screening using Illumina’s bisulfite deamination based 450k human methylation arrays in combination with high throughput-methylation sensitive restriction enzyme (MSRE) coupled qPCR for validation. Therefore we conduct high-throughput analyses of 96 samples x 96 qPCR assays in a single run using 10ng of patient’s DNA. Results from high throughput MSRE-qPCR using were successfully used for efficient confirmation of several panels of 100-200 top-candidate markers and further validation of DNA methylation changes in cancerous and non-cancerous disease. Our established platform combining bisulfite deamination based genome-wide screening and high throughput MSRE -qPCR enables reliable and very efficient validation of DNA methylation markers. 

10:00

Cellular Immune Monitoring in Clinical Trials using Epigenetic Markers
Ulrich Hoffmueller, Chief Business Officer/Founder, Epiontis GmbH, Germany

11:00

Translating Epigenetic Alterations in Leukemia into Biomarkers of the Disease and for Target Therapies with DNA Demethylating Drugs
Michael Schnekenburger, Team Leader, Laboratoire de Biologie Moléculaire et Cellulaire du Cancer, Luxembourg

Aberrant DNA methylation patterns are a common hallmark of tumor cells. We will discuss the translational potential of these epimutations as cancer biomarkers and possible therapeutic strategies related to DNA demethylation.

12:00

Lunch, Exhibitor, and Poster Viewing in the ELA2013 Exhibit Hall


Session Topic: microRNA Biomarkers

13:00

Exploring microRNA Biomarkers for Non-invasive Diagnosis of Diseases
Markus Beier, Vice President/European Patent Attorney, Comprehensive Biomarker Center GmbH, Germany

Teaming up with clinicians in the fields of cancer, autoimmune, cardiovascular and neuro-degenerative diseases a broad screening on microRNAs derived from blood was conducted. Case studies will be presented to demonstrate the potential of microRNA-biomarkers for use in non-invasive diagnosis of diseases.

14:00

MicroRNA Signature for the Prediction of Renal Cell Carcinoma Metastasis and Prognosis
Huiqing Wu, Assistant Professor, City of Hope National Medical Center and Beckman Research Institute, United States of America

This study is to develop and validate a microRNA expression signature for the early prediction of clear cell renal cell carcinoma metastasis and prognosis.

15:00

Deregulated Circulating microRNAs in the Blood of Cancer Patients
Heidi Schwarzenbach, Assistant Professor, University Medical Center Hamburg Eppendorf, Germany

In my talk I will introduce our recent data showing that deregulated levels of microRNAs are linked to a particular biology of breast and lung carcinomas favoring progression and metastatic spread. The identified microRNAs may expand our understanding of carcinogenesis and their pathogenic function in human tumors.


Session Topic: Therapeutics Applications--RNAi and microRNA Therapeutics

16:00

Lipid-based Nanoparticles and the Future of RNAi Therapeutics
Andrew Miller, Professor, Kings College London, United Kingdom

Lipid-based nanoparticles appear very promising as vectors for the functional delivery of RNAi effectors in vivo and in clinic. Therefore, how can we improve these vector systems further in order to maximize RNAi therapeutic effects using minimal RNAi effector doses?

17:00

Key Take-Aways and Closing Themes from the Summit.
Enal Razvi, Managing Director, Select Biosciences Inc, United States of America

17:30

Close of Day Two of the Summit.