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Programme

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8.30		Registration & Coffee
9.00		Chairman's Opening Remarks Nicholas Buss, Toxicology Project Leader, MedImmune View Bio
9.10		Biomarkers: discovery strategies and technologies Peter Parker, Deputy Director of the Integrated Cancer Centre and Head of the Division of Cancer Studies , Kings College View Bio Strategies for providing truly personalised predictive biomarkers and drugs in use and in development Review of some emerging new technologies for generating sophisticated readouts directly informative on drug action Predictions of drug responsiveness
9.45		Pharmacogenomic biomarkers- an update Mark Caulfield, Director of Institute, The William Harvey Research Institute, Barts and The London School of Medicine & Dentistry View Bio Progress in identifying gene regions coding for drug targets Results from genome-wide association studies Meeting the technical challenges of stratified medicine and companion diagnostics
10.20		How to do it: pharmacogenetics and biomarkers - clinical study and statistical design Aiden Flynn, Managing Director, Exploristics View Bio Design considerations Association analysis Design options Case studies and applications
10.55		Morning Coffee
11.25		CASE STUDY: Translational value of the bleomycin rat model for the treatment of patients with idiopathic pulmonary fibrosis (IPF) Yasmina Bauer, Senior Lab Head, Translational Science Biology, Actelion Pharmaceuticals View Bio Whole-genome data collected from an IPF animal model time-course experiment Comparison of animal model data from IPF patient-derived lung biopsies New possibilities to evaluate efficacy of novel therapeutics in preclinical models and human clinical trials
12.00		Translational biomarkers in drug development Mark Fidock, Group Director, Biomarkers & Translational Sciences, Strategic Development, Huntingdon Life Sciences View Bio Challenges and risk management in the development of new medicines Strategic development and use of biomarkers in translational medicine Case study: the TLR7 drug development programme
12.35		Renal safety biomarkers Yi Yang, Research Investigator, Abbott Laboratories View Bio Overview challenges and opportunities Urinary biomarker qualification efforts Current regulatory status Validation and implementation of urinary biomarkers
13.10		Networking Lunch
14.10		On setting the first dose in man: quantitating biotherapeutic drug-target binding through pharmacokinetic and pharmacodynamic models Andrew Warren, Director, PK/PD/Immunogenicity Bioanalysis, Novartis Pharma View Bio Delivering safe starting and therapeutically relevant escalation doses for human studies Target-mediated drug disposition Assaying captured drug-target complexes
14.45		Safety biomarkers for risk assessment of investigative drugs entering first-in-human studies Nicholas Buss, Toxicology Project Leader, MedImmune View Bio The principles of biomarkers for both safety and efficacy in regulatory toxicology studies Classical and emerging biomarkers used in regulatory toxicology studies to support FIH studies. Future direction and initiatives for safety biomarkers
15.20		Afternoon Tea
15.50		Understanding the mechanisms involved in immune responses to therapeutic proteins Matthew Baker, Chief Scientific Officer, Antitope View Bio Development of immune responses directed against protein therapeutics Antigen presentation and T-dependent responses Models for predicting immunogenicity Reducing immunogenicity by design
16.25		Panel discussion: Personalised medicine via biomarkers- where are we and what are the prospects for the future? Aiden Flynn, Managing Director, Exploristics View Bio Yasmina Bauer, Senior Lab Head, Translational Science Biology, Actelion Pharmaceuticals View Bio Yi Yang, Research Investigator, Abbott Laboratories View Bio Balazs Sarkadi, Head, Membrane Biology Research Group, Hungarian Academy of Sciences View Bio Topics discussed will include recent advances in multiple omics technologies with the help of bioinformatics and biostatistics to improve the discovery and development of robust biomarkers for complex chronic diseases. Developing a consistent framework for the validation, acceptance and qualification of biomarkers for regulatory use and clinical phases of drug development will also be discussed.  The panel will comprise a selection of the day’s speakers. Topics discussed will include recent advances in multiple omics technologies with the help of bioinformatics and biostatistics to improve the discovery and development of robust biomarkers for complex chronic diseases. Developing a consistent framework for the validation, acceptance and qualification of biomarkers for regulatory use and clinical phases of drug development will also be discussed.  The panel will comprise a selection of the day’s speakers. Topics discussed will include recent advances in multiple omics technologies with the help of bioinformatics and biostatistics to improve the discovery and development of robust biomarkers for complex chronic diseases. Developing a consistent framework for the validation, acceptance and qualification of biomarkers for regulatory use and clinical phases of drug development will also be discussed.  The panel will comprise a selection of the day’s speakers. Topics discussed will include recent advances in multiple omics technologies with the help of bioinformatics and biostatistics to improve the discovery and development of robust biomarkers for complex chronic diseases. Developing a consistent framework for the validation, acceptance and qualification of biomarkers for regulatory use and clinical phases of drug development will also be discussed.  The panel will comprise a selection of the day’s speakers.
17.00		Chairman’s Closing Remarks and Close of Day One Andrew Warren, Director, PK/PD/Immunogenicity Bioanalysis, Novartis Pharma View Bio

8.30		Registration & Coffee
9.00		Chairman's Opening Remarks Jill Walker, Diagnostics Director, AstraZeneca View Bio
9.10		The challenges of translating biomarkers into clinical diagnostics Jill Walker, Diagnostics Director, AstraZeneca View Bio Identifying patient subpopulations with improved response Adapting development strategies to deliver companion diagnostics Ensuring access to diagnostics
9.50		Membrane proteins as personalised biomarkers Balazs Sarkadi, Head, Membrane Biology Research Group, Hungarian Academy of Sciences View Bio
10.30		Morning Coffee
11.00		Novel clinical trial design in the era of high-density biomarker data Yu Shyr, Director of the Vanderbilt Center for Quantitative Sciences, Vanderbilt University Medical Center View Bio Understanding high-density biomarker data Repeatability and reproducibility of the pre-clinical high-density biomarker data Intra & inter-tumor/subject variability Pathway of drug development based on high-density biomarker data
11.40		Opportunities for the development of stratified medicine in the UK Graham Bell, Lead Technologist, Stratified Medicine, Technology Strategy Board View Bio Description of the Technology Strategy Board’s Stratified Medicine Innovation Platform Joining up academia, diagnostic and therapeutic development and driving product uptake Encouraging wide collaboration from biomarker discovery to product launch Current and future focus for public funding
12.20		Networking Lunch
13.40		Evaluating the cost-effectiveness of diagnostics: the NICE diagnostics assessment programme Nick Crabb , Associate Director - Diagnostics Assessment Programme, National Institute for Health and Clinical Excellence View Bio Explaining the structure and purpose of the diagnostics assessment programme Evaluating the cost-effectiveness of a diagnostic test Explaining how the diagnostics industry can engage with the programme
14.20		CASE STUDY: Molecular characterisation of solid tumours to aid stratified medicine Lisa Thompson, Laboratory Manager and Clinical Scientist, The Royal Marsden NHS Foundation Trust View Bio Improving diagnostic strategies to facilitate personalised therapeutic interventions BRAF V600 mutation testing for malignant melanoma KRAS mutation testing for patients with colorectal cancer
15.00		Afternoon Tea
15.30		Multi-centre imaging in the context of clinical trials Veronique Bragulat, Clinical Imaging Manager, GSK View Bio Managing multi-centre clinical trials and their associated challenges in oncology Examples of best practice in imaging models Notable trends gleaned from such studies
16.10		Imaging biomarkers of cancer progression Simon Walker-Samuel, Senior Research Associate, Centre for Advanced Biomedical Imaging, UCL View Bio Noninvasive Measurement of tumor blood flow and interstitial fluid pressure Tumor adaptations to ensure nutrient delivery Assessing metatstatic potential
16.50		Chairman’s Closing Remarks and Close of Day Two

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