Biomarkers for Personalised Health Care: Need, development and use.

, London
Friday, 09 September 2011


Biomarkers for Personalised Health Care: 

Need, development and use

An event from European Scientific Conferences - Euroscicon "Specialising in communicating cutting edge technology & methodology in the Life Sciences"  Linked In

Biomarkers for Personalised Health Care: Need, development and use.
Friday, 09 September 2011 09:00 - 17:00

The Penridge Suite
470 Bowes Road

London
N11 1NL
United Kingdom

Map and Directions

Biomarkers identify patients who are most likely to benefit from a drug leading to effective targeted treatment and a reduction of human and financial cost of the administration of inappropriate medication. This conference will bring together experts from Pharmaceutical, Biotechnology, Industrial and Academic sectors in a forum of academic presentations and discussion sessions to review what are the current issues surrounding the need, development and use of biomarkers for personalised health care.  

 We include a troubleshooting panel session in this event, so that delegates can discuss their work directly with a panel of experts.

 This event has CPD accreditation

Meeting Chair: Dr Tony Warford, Warford Technology Ltd, Newmarket, Suffolk, UK

9:00 – 9:40                 Registration

9:40 – 9:50                 Introduction by the Chair:  Dr Tony Warford, Warford Technology Ltd

9:50 – 10:20               Theranostic Development in Oncology – how is it different to current best drug development practice ?

Dr Darren Hodgson, Principal Scientist, AstraZeneca UK Ltd, R&D Drug Development, Oncology and Infection Therapy Area, Macclesfield, Cheshire 

The co-development of a drug and diagnostic products requires pharmaceutical companies to change practice across all internal functions.  In this presentation we will discuss the impact of co-development on six key functional areas and focus on the new requirements of pure and applied biomarker science and clinical trial design and execution.

10:20 – 10:50             Biomarker validation for clinical use - how to go from bench to bedside   

Dr Hayley Whitaker, Cancer Research UK Cambridge Research Institute, Cambridge

Using well defined questions academic laboratories have the means to identify large number of potential biomarkers for diagnosis, prognosis and disease monitoring. Validating these biomarkers to demonstrate that they are robust and fit for purpose is a major challenge in translational research. The pipeline from bench to bedside will be demonstrated with examples and key milestones. Overall the talk will aim to give a structured method for taking novel targets from the laboratory setting to pharma and the clinic by providing high quality, reproducable data.

 

10:50 – 11.20             Mid-morning break

11:20 – 11:50             Development and implementation of HercepTest for gastric cancer

Dr Hans Christian Pedersen, Dako, Glostrup, Denmark

HercepTest was originally developed and approved as a pharmacodiagnostic test to determine breast cancer patients HER2 status in order to assess eligibility for Herceptin (trastuzumab). This talk will go over the recent development and regulatory approval of HercepTest  for gastric cancer. HercepTest was approved for gastric cancer in 2010.

11:50 – 12:20             Begin with biomarkers

Dr Peter H Bach, Director: BioPharmaLogic LLC, Cambridge.

Biomarkers are key to drug development and personalised medicine. The identification of the “right” fit-for-purpose biomarker is complex and resource intensive. Small companies have modest potentials to implement a biomarker strategy, but can still ensure that they built their development programmes around potential biomarkers. A biomarkers strategy should be a core to the development of each molecule, and not a bolt on addition to clinical development. If undertaken as part of discovery-development transition there is a potential to help shape the assessment of possible biomarkers as part of nonclinical development so that they are credible when needed.  .

12:20–13:10               Lunch

13:10 – 14:00             Question and Answer Session

Delegates will be asked to submit questions to a panel of experts.  Questions can be submitted before the event or on the day

14:00 – 14:30             New Prognostic and Prognostic Markers in Breast Cancer.

Professor Anthony Rhodes, University of the West of England, Bristol.

Triple negative (TN) breast cancers are defined by their lack of expression of hormone receptors and human epidermal growth factor receptor – 2 (HER2) and account for 10-24% of all breast cancers. These tumours have a poor prognosis and unlike hormone receptor and HER2 positive breast carcinomas, there are no targeted therapeutic regimes that have been shown to significantly improve survival. Various studies show that between 56-84% of triple negative breast cancers express high molecular weight cytokeratins and have the basal-like phenotype similar to that defined by molecular expression profiling.  Approximately 11-percent of patients with triple negative breast cancers have a mutation in the BRCA1 gene. Conversely, most patients with BRCA1 mutations have breast tumours that are triple negative. Breast cancer research at the University of the West of England, in collaboration with the University of Malaya and the University of Bristol, is focused on identifying and validating new prognostic and predictive markers for these high grade and aggressive cancers.

14:30 – 15:00             Afternoon Tea/Coffee

15:00 – 15:30             Epileptic very fast oscillations: a novel form of biomarker?

Dr Mark Cunningham, University of Newcastle Upon Tyne¸UK

A critical question in understanding human epileptogenesis is the pattern of electrical activity associated with the seizure focus and the underlying neuronal circuits that generate these pathological patterns. This is particularly important in the case of patients suffering from intractable epilepsy who may be eligible for neurosurgery. The ability to localise the abnormal regions of cortical tissue using electrophysiological biomarkers may increase positive outcome and reduce post-surgical morbidity for the patient.

Normal cortical activity is associated with a complex, low amplitude EEG  signal consisting of power-law distributed activity within the frequency range c.1-70 Hz. Higher frequencies than this are only seen at very low amplitudes. In contrast, electrographic seizures manifest as very high amplitude EEG signals with prominent higher frequency events (> 70 Hz, very fast oscillations - VFOs) that are rarely seen in normal invasive EEG records. In focal epilepsies VFOs are prevalent immediately prior to seizure generation and are spatially constrained to the cortical seizure focus both in vivo and in human cortical slices.

This presentation will summarise the main findings of our current work using  human epileptic cortical brain slices concerning the mechanistic nature of epileptic VFOs.

15:30 – 16:00              Blood born nucleic acids biomarkers in oncology

Dr Ged Brady, Paterson Institute for Cancer Research,UK

Analysis of circulating tumour cells (CTCs) and circulating free DNA (cfDNA) obtained from patient blood provides a convenient means of generating valuable measurements associated with clinical behaviour.  The number of CTCs in peripheral blood is associated with decreased progression free survival and decreased overall survival in patients treated for a range of cancers.  In addition, epigenetic alterations in cfDNA have been shown to be tumour-related and relevant to cancer development, progression and resistance to therapy.  We will present examples of CTC and cfDNA analysis which illustrate the utility, practical challenges and the potential for future development of improved biomarker assays.

16:00 - 16:30              Biomarkers for personalised healthcare: human biosample considerations

                                      Professor  Christopher Womack, Principal Clinical Histopathologist at AstraZeneca, Cheshire

                                      The last decade has seen a massive increase in the molecular understanding of disease fuelled by the mapping of the human genome and major advances in biomedical technology. The advances have enabled the evolution of personalised healthcare (PHC) the purpose of which is to develop and deliver the right treatment to the right target in the right patient. Biomarkers are crucial to all matters relating to PHC and most molecular markers will be measured in samples taken from patients. Wherever possible samples will be taken as part of routine clinical practice but novel technologies are beginning to highlight issues around the samples themselves.

16:30 – 16:40             Chairman’s summing up

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KeyWords:  breast cancer, immunohistochemistry, biomarkers, personalised health care, oncology, drug development, Biorepositories, biomarkers,  drug discovery, Histochemistry, Metabolism, Biologicals, Safety, Efficacy, predictive HercepTest ,gastric, PharmDx, pharmacodiagnostics

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About the Chair

Anthony Warford DPhil, CSci, FIMLS

Warford Technology Ltd, Newmarket, Suffolk, UK

Anthony (Tony) Warford expertise is in molecular histopathology.  He has set up and managed laboratories in the UK health service, academic institutions, biotechnology and Pharmaceutical companies. Technology developments he has spearheaded include the introduction of diagnostic immunohistochemical methods, validation of antibodies for use as biomarkers, production of probes and methods for in situ hybridisation and supervision and interpretation of GLP tissue based safety studies of potential therapeutic antibodies.  Concurrently he has championed quality assurance programmes in histopathology and automation of immunohistochemistry coupled with image capture and analysis.  He has also run laboratory safety and human bio-banking programmes. He has published in these fields and shared experience with fellow scientists by organising wet workshops, chairing symposia and lecturing in many countries.

About the Speakers

Hayley Whitaker is currently a Research Associate at Cancer Research UK’s Cambridge Research Institute, University of Cambridge.  Previously, Dr Whitaker was a Research Assistant/PhD student at Imperial College London.  

Her research focus is on prostate cancer biomarkers for improving diagnosis and monitoring disease. She is currently beginning to work on other tissues, including pancreatic cancer.  She has developed a robust and efficient biomarker pipeline to allow rapid, accurate validation of tissue, serum and urinary biomarkers.

 

Hans Christian has been working in life sciences for the past 12 years. Hans Christian has been in Dako for the last 7 years working with pharmacodiagnostic development. Hans Christian has also been part of EU TOK project on predictive biomarkers for endocrine therapy in breast cancer at John Bartletts laboratory in Edinburgh. Hans Christian is currently responsible for pharmacodiagnostic development in Dako Denmark including the HercepTest product portolio.

Ged Brady has recently joined the CEP group in Manchester where he is working to further develop and apply biomarkers which are aimed at benefiting clinical practise and patient outcome.  Previously, Ged has spent over 30 years developing advanced molecular biological and applying the to key biological areas including DNA replication control, cancer initiation and stem cell regulation.  In the course of his scientific career he has carried out academic research in the Max Planck Institute, the German Cancer Research Centre, EMBL, the Ontario Cancer Institute and the University of Manchester as well as directing research at the successful biotech company Epistem.

 

Mark Cunningham, currently holds a Senior Lectureship in Neuronal Dynamics at the Institute of Neuroscience, Newcastle University. He is the co-director of the Human In Vitro Electrophysiology (HIVE) laboratory and holds an honorary research fellow position in Clinical Neurophysiology (RVI, Newcastle NHS Trust). Dr Cunningham began his scientific career at Queen's University Belfast where he read Physiology as an undergraduate. He obtained his PhD in Physiology from University of Bristol. His group works on neuronal oscillations in cortical circuits using a trans-species approach. Dr Cunningham focuses on the pathophysiology of neuronal oscillations pertaining to neuropsychiatric disease and in particular epileptiform activities generated by cortical tissue from epileptic patients.

Darren Hodgson is currently works in the Clinical Biomarker Group, Oncology Therapy Area at AstraZeneca.  Darren’s  principal responsibilities lie in the strategy for, and deployment of, decision-making biomarker science.  In a journey from pure to applied science Darren has moved through positions in academia, the diagnostics and biotechnology sectors.  Before joining AstraZeneca Darren was Principal Scientist at Renovo where set up the Genomics facility and several “omics” led clinical studies.  Darren is author of numerous original papers and patents, predominantly in the areas of applied genomics and translational science.  He is also a journal editor, chairman of the Manchester Consumer Healthcare Ethics committee and particularly interested in the evidence driven co-development of drug/diagnostic products.

 

Anthony Rhodes,  is Professor of Biomedical Research in the Faculty of Health and Life Sciences at the University of the West of England where the research group he leads focuses on the development and validation of prognostic biomarkers for breast and prostate cancers, in addition to markers that predict response to therapy. He obtained his PhD at the University of Wales College of Medicine (now Cardiff University) working on the validation of oestrogen receptor and progesterone assays in breast cancer and has been a member of several national and international working parties and committees on breast cancer to include those of the; Institute of Biomedical Sciences (IBMS), Royal College of Pathologists, American Society of Clinical Oncology (ASCO), College of American Pathologists, National Cancer Institute (NCI), National Institute for Standards and Technology (NIST) and the European Organisation for Research and Treatment of Cancer (EORTC). He is currently a Deputy Chief Examiner for the IBMS, Chair of the IBMS and Royal College of Pathologists working party on Immunocytochemistry, Honorary Research Fellow with the Dept of Clinical Sciences at Bristol University and a Visiting Professor to the Department of Surgery at the University of Malaya.

Christopher Womack  has been a histopathologist in Oncology R&D at AstraZeneca since 2006 and Alderley Park Site Biobank Head. Main research activity is human tissue biomarkers in relation to disease-target linkage in oncology drug development. Also honorary pathologist to the Manchester Cancer Research Centre Biobank and Professor of Histopathology Manchester University since 2008. Previously diagnostic consultant pathologist at Peterborough UK and has been actively involved in tissue biobanking for 15 years. Past president of British Association for Tissue Banking.

Peter Bach has worked in Academia, for National and International Medicine Safety Agencies, and Biotech companies on a spectrum of novel small molecules to third generation biologicals. Peter has a specialist interest in mechanistic pathology and toxicology, which allows a deeper understanding of the processes associated with disease and intervention, and identifying biomarkers that help establish efficacy and safety. This helps better match individual patients to maximised treatment.  BioPharmLogic is a speciality consultancy company that works with academics, investors, start-ups, and small and large Biotech companies to help fast track novel molecules through nonclinical studies and into the clinic.

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This meeting was organised by Euroscicon (www.euroscicon.com), a team  of dedicated professionals working for the continuous improvement of technical knowledge transfer to all scientists. Euroscicon believe that they can make a positive difference to the quality of science by providing cutting edge information on new technological advancements to the scientific community.  This is provided via our exceptional services to individual scientists, research institutions and industry. 

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