Jan Trøst Jørgensen, MScPharm, PhD
Director of Medical Affairs, CMC Contrast AB and External Lecturer, Faculty of Pharmaceutical Sciences, Univ. of Copenhagen

"An introduction to Companion diagnostics and Personalised Medicine in Cancer"

Dr Jørgensen recently published "Molecular Diagnostics - The Key Driver in Personalized Cancer Medicine" together with Dr Henrik Winther, Director of ImmunoHistology at Dako Denmark A/S
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Loïc Kubitza, Director, Pharmaceuticals & Life Sciences, Price Waterhouse Coopers

"Moving towards personalised healthcare"
- Deal activity trends in the IVD sector
- Companion diagnostics alliances between the pharmaceutical and diagnostics industries
- Key drivers for future alliances

Loïc Kubitza is co-author of "Diagnostics 2009: Moving towards personalised medicine"

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Dr Stephen Little, VP Personalised Medicine, Qiagen Manchester Ltd. (DxS)

"Diagnostic Solutions for Personalised Medicine"
- Clinical Biomarkers and targeted cancer therapies
- Overcoming obstacles in delivering personalised medicine
- Companion diagnostic development
Case Studies:
- EGFR for non-small cell lung cancer
- K-RAS for metastatic colorectal cancer

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Cecilia Schott, PharmD MBA, Business Development Director, Personalised Healthcare, AstraZeneca Pharmaceuticals LP

Research Partnerships for Targeted Oncology Treatment

• Personalised Healthcare pipeline strengthening through partnerships
• Flexible models for the successful development of drug-diagnostic
• No two deals are the same: Deals are structured to be mutually beneficial

Professor Ian A Cree, Director, Translational Oncology Research Centre, Portsmouth Hospitals NHS Trust / University of Portsmouth

The molecular basis of chemosensitivity to cytotoxic agents
Abstract: Most cancers exhibit considerable heterogeneity in their sensitivity to chemotherapy. We have tested the hypothesis that the molecular basis of this difference lies within the known resistance mechanisms inherent to these patients’ tumours. The chemosensitivity of a series of 192 lung, breast, ovarian and colorectal tumors was assessed using the ATP-based tumor chemosensitivity assay (ATP-TCA) and correlated with quantitative expression of resistance and target genes measured by RT-PCR in a Taqman Low Density Array (TLDA) following extraction of mRNA from formalin-fixed paraffin-processed tissue. Predictive multiple linear regression models were derived for single agents and for combinations commonly used in NSCLC, colorectal, breast and ovarian cancers. The genes most commonly associated with chemosensitivity reflect the mechanisms involved, including cell proliferation, DNA repair and the expression of drug pump molecules. The models identified suggest that a limited number of genes are important in anti-cancer drug resistance.
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Henrik Winther, Director of Immunohistology and Companion Diagnostics, Dako A/S

How does drug-companion diagnostics co-development add value to the development of oncology pharmaceuticals?

Abstract: The routine pathological identification (diagnosing), classification and phenotyping (prognosing) of malignant tumours are typically performed through slide-based tissue analysis searching for relevant biomarkers by applying the techniques of immunohistochemistry and in situ hybridization. More recently the slide based biomarker analysis of malignant tumour tissue also includes predictive markers (companion diagnostics) that selects or stratify patients within a certain tumour entity for a specific drug treatment. The development of oncology companion diagnostics needs to take place in close collaboration with the specific drug development and the successful outcome of this collaboration will increase the efficacy of the drug and thereby the safety of the patients.

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Søren Morgenthaler Echwald, Vice President Business Development, Exiqon A/S

Locked Nucleic Acids: Enabling MicroRNA Cancer Diagnostics

Abstract: MicroRNAs (miRNAs) comprise a family of numerous highly conserved small non-coding RNAs (~22 nt).During regulation of post-transcriptional gene expression, miRNAs play an essential role in many parts of development, differentiation, and physiological processes. It is now established that altered miRNA expression profiles are associated with a number of different diseases including heart disease, neurological disorders and human cancers. This suggests the use of miRNAs as a novel class of biological important biomarkers for disease diagnosis and prognosis.
Exiqon has developed a range of highly specific reagents for in situ-based as well as PCR based detection of microRNAs. We believe this will enable the development of microRNA-based tests to improve diagnosis and treatment selection in cancer.

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Pekka Simula, CEO, Oncos Therapeutics

From treatments to trials: Personalisation from day one

Abstract: Oncolytic viruses are emerging as promising tools for treating cancer refractory to current therapies. However it has been suggested that e.g. patients with antibodies specific to a virus are immune to that specific therapy, or that repeated dosing is not efficient because of induced immunity. In its unique Advanced Therapy Access Program, treating 200 patients already before clinical trials, Oncos Therapeutics helps patients with refractory cancers while at the same time cumulating knowledge about efficacy, immunity, and other aspects in each individual patient: True personalisation from day one.

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Finnbogi Thormodssen, Associate Research Professor, University of Iceland-Faculty of Medicine

Nationwide approach to chemo-sensitivity testing

Abstract: Generally the choice of drugs for chemotherapy follows set guidelines that do not allowed for adjustments based on assay results. In an attempt to prove the usefulness of the ATP-TCA chemosensitivity tests we are collaborating with the Icelandic healthcare system to test all appropriate samples in Iceland for the next three years. The outcome of the test will be compared with the results of the standard drug therapy. This partnership will give us access to well defined tumour tissue that will enable us to incorporate the more advanced molecular assays being developed by Ian Cree and his team in Portsmouth.

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Eric Christensen, CEO

DiaGenic - Norway's most innovative company 2009

DiaGenic ASA is an innovative Norwegian in vitro diagnostic company founded in 1998 and listed on the Oslo Stock Exchange.
Abstract: DiaGenic develops patient-friendly diagnostic tests for the early detection of devastating diseases where early intervention is crucial for successful treatment. DiaGenic's patented method is based on identifying disease-specific gene expression signatures from easily available sample material such as blood. DiaGenic's first two products, ADtect® for early detection of Alzheimer's disease and BCtect® for early detection of breast cancer, have received regulatory approval for Europe, CE mark, and are now being launched in selected markets in Europe. DiaGenic has an existing pipeline of projects focusing on discovery and documentation of gene expression signatures for Parkinson's Disease and for identification of patients with Mild Cognitive Impairment that will convert to Alzheimer's disease. The company is a leader in discovery and development of diagnostic tests based on peripheral gene expression profiling. The diagnostic tests together with an R&D cooperation with a major pharmaceutical company forms the basis of the company's biomarker strategy enabling early disease detection for clinical trials.

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Stefan Nilsson, PhD, Associate Professor, Senior Project Manager, Karo Bio AB

Estrogen receptor B selective agonists: First in class therapy for treatment of intra-hepatic cholangiocarcinoma?

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Mats Gullberg, Chief Technology Officer, Olink Bioscience

Quantifying protein-protein interactions in native cells and tissue samples - a new opportunity for Companion Diagnostics

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Dr. Austin Tanney, Scientific Liason officer, Almac Diagnostics

The development of multigene prognostic and predictive tests for cancer management

• The need for biomarkers in oncology
• The significance of prognostic and predictive tests
• The challenge in getting suitable tissue for discovery, validation and delivery of genomic based prognostic and predictive tests
• The value of formalin fixed paraffin embedded (FFPE) tissue archives
• The Almac approach to FFPE tissue analysis
• The issues around developing a prognostic or predictive test that can undergo regulatory approval

Dr. Jonathan Beech, Business Development Manager, The Institute of Cancer Research

Development of Targeted Oncology Therapies at the Institute of Cancer Research, UK

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Berwyn Clarke, Chief Scientific and Development Officer, Lab 21 Ltd

Development and provision of companion diagnostic services to the pharmaceutical and healthcare industries

Abstract: Lab21 is a vertically integrated diagnostic company providing companion diagnostic services to the pharmaceutical industry as well as commercialising its own diagnostic products. Lab21 has partnered with several major pharmaceutical companies to provide companion diagnostic testing through its accredited service laboratories. In addition Lab21 is a global provider of diagnostic assays and is developing its own portfolio of immunodiagnostic and nucleic-acid based assays some of which may provide some of the next generation of companion diagnostic assays.

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