Clinical & Pharmaceutical Solutions through Analysis
February 4-7, 2020
London, U.K.
Where Technology for the Patient and Solutions Meet
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CPSA Europe 2020Meeting ProgrammeUpdated 18 March, 2020 Tuesday | Wednesday | Thursday | Friday Tuesday February 4 8:00 am - 11:00 am Wimpole Hall 
Organizer: Neil Spooner, Spooner Bioanalytical Solutions Where Technology and Relationships Meet the Road! Join friends and colleagues in the 1st Annual CPSA Walk for Life at CPSA Europe. Have a great time, meet new friends. It's a walk in the park and all for a great cause! 12:00 pm Lobby Registration Front Lobby 1:00 pm - 4:30 pm Pre-Conference Workshops Queen's Room WORKSHOP 1 Sponsored by New Objective Workshop Leader: Emily Ehrenfeld, New Objective This years workshop will build upon the previous two pre-conference workshops (see the notes from last years pre-conference workshop) and programmes at CPSA Europe and will explore how we generate and utilize quantitative data for human healthcare and wellbeing. Established workflows for the generation of quantitative analytical data used for decision making by clinicians, pharmaceutical companies, central clinical laboratories and academics have remained essentially unchanged for decades. This approach has suited the established means of one size fits all approach to delivering healthcare. However, this approach is no longer ideal, or indeed sustainable. Personalized medicines and treatments are increasingly becoming the norm. Further, technologies are enabling patient sampling and subsequent analysis to be performed in locations and with technologies that are more patient centric and importantly, many subjects are taking a more active interest in their own medical data and the decisions resulting from it. This paradigm shift calls for a change from the established workflows. This workshop will explore these changes, their implications and what a new normal might look like in 5-10 years time. We welcome you to join our discussion. Panel Discussion:
Magdalene Room WORKSHOP 2 Sponsored by Merck (MilliporeSigma in USA/Canada) Moderator: Jason Wrigley, Merck Bring all analytical and biological data into one common format. Aggregate all converted raw data, meta data and results in a highly scalable file store and comprehensive meta data repository. Archive your data with/without the original data set and use meta data information to navigate on your data, without compromise. Review data from different sources even combined in a single viewer, at any time, at any place and one any device. Clean-up, combine and interpret and even process all data completely decoupled from the vendor software. Interface your instruments bidirectionally with your LIMS, ELN or ERP (SAP) to establish full data integrity and compliance. Join us to gain an overview and insight into this new software. Discuss how we can make this into what you want for your requirements e.g. global sample tracking, raw data interrogation from multiple platforms. This is an opportunity to help shape and mould the software of the future. Join us to be part of the solution. 6:00 PM - 9:00 pm College Suite Welcome Reception & IMAGINE SUMMIT
Imagine Summit Sponsored by New Objective & Spooner Bioanalytical Solutions Welcome
Imagineer
Scribe: TBC Scribe: Deanne Rudd, MSD (Merck & Co. in USA/Canada) Scribe: Jason Wrigley, Merck (MilliporeSigma in USA/Canada) Scribe: Michelle Reid, ETH Zurich Wednesday February 5 7:00 AM - 8:30 AM Lobby Registration Front Lobby 8:30 AM - 8:45 AM University Suite Welcome & Opening Remarks 
Welcome 
Format, Objectives, Opening Remarks 
8:45 am - 9:30 am University Suite Plenary Lecture Duchenne Muscular Dystrophy – Why the Way We Sample Blood Matters 
Fleur Chandler Duchenne UK 9:45 am - 11:30 am University Suite
Session 1 Pushing the Boundaries of Sample Collection – Near and Small Discussion Leaders: Emily Ehrenfeld, New Objective; Matt Barfield, GlaxoSmithKline With such an impactful plenary speaker we didn’t want to jump straight into a series of presentation, so this session is a panel discussion bringing together leading experts with the vision and passion to challenge the status quo. The theme is based on delivering the promise of near patient sampling, overcoming the perceived and real obstacles but most importantly listening and learning from the patient. This session is designed to focus on the patient and sets the theme that will run throughout the meeting and aims to deliver the dream Panelists: 11:30 am - 1:00 pm Parallel Sessions University Suite Session 2 Discussion Leaders: Deanne Rudd, MSD (Merck & Co. USA/Canada); Ian Dawson, Covance Is there such a thing as fit-for-purpose bioanalytical methods when it comes to human samples? Should all samples be treated with the same level of rigor? How does this rigor apply to patient-centric sampling and micro sampling? How do current study requirements impact time to market and end user cost? This session will feature a round table that will discuss these topics with the hopes of sharing experiences and getting at why we do what we do, if change is needed, and how to effect a change in a complex organization. Corpus Christi Room Session 3 Discussion Leaders: Jenny Royle, digital Experimental Cancer Medicine Team; Scott Summerfield, GlaxoSmithKline Creativity and progress is frequently hampered by people not collaborating across boundaries. This session uses the World Café format to structure a fun and interactive discussion on how to break down these boundaries and speed up deployment of new innovations in trials. The aim is to focus on problems you have. So, to win the chance of getting the whole conference helping to solve your issue, send your topic now to Jenny Royle for it to be added into the hat. Hang your coats at the door, roll up your sleeves, and let’s begin… 1:15 pm - 2:45 pm College Suite Sponsored Lunch & Roundtable The Future of Personalised Healthcare: Sponsored by New Objective Discussion Leaders: Matt Barfield, GlaxoSmithKline; Neil Spooner, Spooner Bioanalytical Solutions; Mike Lee, Milestone Development; Emily Ehrenfeld, New Objective 2:45 pm - 4:15 pm University Suite Workshop To Be Announced Discussion Leaders: Ute Gerhard, University of Hertfordshire; Emre Isin, UCB; Darragh Murnane, University of Hertfordshire 4:30 pm - 6:00 pm Parallel Sessions University Suite SESSION 4 Discussion Leaders: Jason Wrigley, Merck (MilliporeSigma in USA/Canada); Chris Bailey, AstraZeneca; Sergio Raise, Humber Foundation NHS Trust During this session, the speakers will highlight the practical and operational challenges of delivering a clinical trial that involves patient sampling in a clinic and/or home setting and discuss what more a scientific function can do to assist colleagues in clinical operations in improving the patient sampling experience. The Operational Challenges of Obtaining High Quality Samples from a non-Clinic Setting AstraZeneca’s AMBER trial case study It’s assumed the analytical challenges of assaying samples/microsamples for low levels of therapeutics are the main considerations of implementing a 'trial@home' strategy. However, our experience has shown our ability to develop and validate assays pretty much takes these challenges off the table, primarily leaving us with the more practical and operational challenges of non-clinical site sample collection. What more can scientists do? – changing our mindset to giving the patient the choice
We develop our science to answer questions that expand our knowledge, in the case of clinical pharmacology one question is - how much drug is there? Typically, our assays require µL of matrix but we routinely ask patients to provide us with mL of sample. Additionally, we request multiple samples over a time course, often with little evidence provided by the scientist justifying the numbers requested. Therefore, can we, as scientists, do more to meet a patient’s needs? A GP’s point of view
The potential practicalities of using a GP surgery, nurse clinic or mobile phlebotomist will be discussed. The patient’s point of view from a GP will also be highlighted including his thoughts on how to increase adherence and reduce drop out rates. Corpus Christi Room SESSION 5 Discussion Leaders: David Browne, PRA Health Sciences; Michelle Reid, ETH Zurich During this session, the speakers will highlight imaging techniques for patient diagnosis and treatment improvements. Mass Spectrometry in Medicine
This talk will look at the potential of mass spectrometry (MS) for the support of tissue identification in real-time using direction ionization techniques. With greater acceptance of MS technology, other avenues have opened for the use of MS in routine medical science, including imaging and automated analysis. Morphological Detection of Cancer Cells by Deep Learning Improves Personalized Drug Testing
We trained multiple network architectures to classify cancer cells from label-free imaging channels, either per patient or across all patients, and benchmarked their performance against cancer cell detection by immunofluorescence (IF) against diagnostic markers. Remarkably, treatments recommended by a single convolutional neural network (CNN) trained across all patients clinically outperformed those recommended by IF and all other networks. Through single CNN and IF recommended treatments, image-based drug response can be improved in patient biopsies for personalized medicine. 6:00 pm University Suite CPSA EUROPE GROUP PHOTO 
3rd Annual CPSA Europe group photo—including organizers, speakers, attendees—everyone! 6:30 pm - 8:30 pm College Suite Sponsored Reception & Dinner Sponsored by Tasso, Inc. Thursday February 6 7:00 AM - 8:30 AM Lobby Registration Front Lobby 8:30 am - 10:00 am University Suite Session 1 Emerging Technologies to Enable a Paradigm Shift from "Sick Care" to "Health Care" Discussion Leaders: Pawanbir Singh, Trajan Scientific and Medical; Emre Isin, UCB The primary goal for pharmaceutical industry is to develop medicines with the right exposure, reach the right target and treat the right patient. However, in the present information rich world, the ultimate objective is not only to control symptoms and treat disease but provision of technologies that facilitate both disease prevention and disease management. The enormity of this objective requires a transformative change. On one hand, there is the need to develop and have access to novel technologies which accelerate the drug development process and on the other, novel tools that enable a prevention model by focusing on forestalling disease development before clinical manifestation. The objective of this session is to discuss emerging technologies and avenues to facilitate a paradigm shift from "sick care” to “health care" Patterns of health and disease: Molecular images in cellular context Applications of metabolic phenotyping in pre-clinical and clinical safety 10:15 am - 11:45 am University Suite Session 2 What can the bioanalytical community learn from other analytical based industries and workflows? Discussion Leaders: Elizabeth Thomas, Alderley Analytical; Nathan Hawkins, Anatune; Jason Wrigley, Merck (MilliporeSigma in USA/Canada); Neil Spooner, Spooner Bioanalytical Solutions In the middle of difficultly lies opportunity: The assessment of vitamin status in the clinical setting Automation in Environmental Analysis, the Journey so far 12:00 pm - 1:30 pm College Suite Sponsored Lunch & Roundtable Let's make something happen and eat more birthday cake! Sponsored by Merck (MilliporeSigma in USA/Canada) Sergio Raise, Humber Foundation NHS Trust 1:30 pm - 3:00 pm University Suite
WORKSHOP 1 Are Current Clinical Chemistry Tests Still Fit for Purpose?
Discussion Leaders: Amanda Wilson, AstraZeneca; Research is showing that specific diseases are much more heterogeneric than we first thought. Thus our growing knowledgebase is allowing Medicine to become increasing personal. The knock on effect is that tests now need to become more specific for each subcategory of a disease in terms of diagnosis and monitoring. With clinical journals burgeoning full of fantastic new assays, which aim to fulfil these increasing needs, we seem to have a problem to overcome. Very few of these new assays are being adopted for routine clinical use. What is the reason for this and how can we find a path to bring forward new assays into the routine lab? During this session, Professor Brain Keevil (Head of Clinical Biochemistry at Wythenshawe Hospital) will give a short primer on the issues faced with adopting new assays in a busy hospital laboratory. During this he will highlight 3 questions / challenges which will then be discussed by the attendees. The group will split into 3 smaller groups who will tackle one challenge each. Towards the end of the session, each group will summarise their discussion and report to the wider group. Are Current Clinical Chemistry Tests Still Fit for Purpose? 3:15 pm - 4:45 pm Parallel Sessions University Suite SESSION 3 Discussion Leaders: Ian Wilson, Imperial College (London); John Smeraglia, UCB Bringing high quality analytical chemistry to the patient in the operating theatre, at their bedside, in the GP's surgery, or their own homes for therapeutic drug monitoring, biomarker analysis, diagnosis and therapy monitoring. If we have learned nothing from the Theranos scandal its that there is both a need, and an appetite, from individuals for good, accurate and reliable analytical information about health, disease the causes and time-course of disease, and the outcome of therapies. Cutting through to the patient with SABRE This talk will focus on showing how SABRE, a method to dramatically improve the detectability of materials by nuclear magnetic resonance spectroscopy, is expected to open up new opportunities for the rapid analysis of biofluids. Our aim is to create a hand-held detector capable of rapidly collecting a response that can be linked to health and disease Will the medical robot have a nose? The challenge of screening a large number of potential casualties for exposure to a chemical agent, or perhaps radiation injury, was addressed in the European funded research project TOXI-triage. The proposition was to use breath analysis and in 2018 and 2019 two large technical exercises demonstrated the feasibility of rapid on-site triage by breath screening. At the close of this project we know that delivering breath screening is practicable, and that we are waiting for the arrival of validated breath biomarkers. In parallel to the TOXI-triage project the pathology node EMBER was running clinical studies with acutely breathless patients. Ember was funded by the Medical Research Council who commented on the outcomes: "Breathomics to detect volatile organic compound biomarkers was now an accepted technology that had attracted considerable industry interest The EMBER investigators were congratulated for having the vision to take what at the beginning had been an innovative technology along the diagnostic path not only in a systematic way but in a comparatively short time The technology could be applied for screening or diagnosis across a wide range of major health concerns. EMBER had now embedded breathomics in interventional trials funded by Pharma in eg COPD, asthma, cardiovascular disease..." Perhaps it is still premature to claim that in the future breath analysis will be used routinely in clinical practice. However, the crux in realising this ambition is better defined than has previously been the case, and the research methodologies required for the creation of an appropriate library of breath biomarkers are nearly mature. The end-goal? Is probably volatile organic compound screening embedded into the patient's bed and integrated algorithmically into their care and management. Corpus Christi Room SESSION 4 Discussion Leaders: Laura Dormer, Future Science Group; Shane Needham, Alturas Analytics There are already many new ways to share information beyond the traditional printed white paper/research article. This session will include discussion between the panel members and audience on how they currently share their information and data, how this might evolve in the future utilizing electronic platforms and social media, and what risks/challenges/opportunities this might present. Discussion Panelists: 5:00 pm - 6:30 pm University Suite Vendor Session "Five Minutes of Fame" Discussion Leaders: Elizabeth Thomas, Alderley Analytical; Neil Spooner, Spooner Bioanalytical Solutions; Mike Lee, Milestone Development Services Participants are given the opportunity to present their idea, company, products and services to the participants of CPSA Europe 2020 using any format they'd like. The only rule is it is limited to just 5 minutes! Be bold, have fun, get noticed and make a statement.
Patient Centric Sampling – Working across boundaries to get stuff done! BSSN – AnIML in Action Bioanalysis without boundaries How a specially designed laboratory increases sponsors' confidence and as a consequence generates growth Connections Smarter, Simpler, Patient-centric Sampling Instrument Top Automation will never work for sample preparation in routine bioanalysis Capitainer – next generation home sampling solutions Solutions for Life – Bringing practical analytical technologies to those who need them, how they need them, where they need them and when they need them 6:30 pm - 8:30 pm College Suite Sponsored Evening Event & Dinner The Future of Personalised Healthcare: Integrated Solutions – Mapping a Path Forward for Sample Preparation and Data Sponsored by New Objective Discussion Leaders: Matt Barfield, GlaxoSmithKline; Neil Spooner, Spooner Bioanalytical Solutions; Mike Lee, Milestone Development; Emily Ehrenfeld, New Objective Friday February 7 7:00 AM - 8:30 AM Lobby Registration Front Lobby 8:30 am - 10:15 am Peterhouse Room
Session 1 The Future of Digital Biomarkers Discussion Leaders: Kevin Bateman, MSD (Merck & Co. in USA/Canada; James Rudge, Neoteryx; Jenny Royle, digital Experimental Cancer Medicine Team The Potential of Digital Biomarkers to Transform Drug Development Can Remote Blood Testing and Digital Biomarkers Drive Behavioural Change? Digital Biomarkers – What’s the Point? 10:15 am - 12:00 pm Peterhouse Room Session 2 Little by Little: Discussion Leaders: Christophe Stove, Ghent University; Ute Gerhard, University of Hertfordshire; Darragh Murnane, University of Hertfordshire; Dan Baker, University of Hertfordshire Developments in silicon nanotechnology for healthcare applications In this talk, we will introduce how leveraging silicon technology can help to develop miniaturized biomedical devices as a route towards portable, decentralized diagnostics and healthcare. We will describe the potential of this approach in the transfer from innovative research concepts to mass-manufacturable prototypes while retaining advantages such as low reagent consumption, automation and controlled experimental parameters. Examples will be given for a fast and real-time detection of nucleic acids or protein biomarkers using minimal sample volumes. These examples are intended for the audience to get familiar with high-performance, integrated silicon chips and as an invitation for follow-up discussions towards other technological opportunities and application areas. Diagnostics where you need it 12:00 pm - 1:30 pm Peterhouse Room Lunch & Symposium Session How Does Software Impact Your Scientific Life? It’s Getting Personal! Discussion Leaders: Ismael Zamora, Molecular Discovery The capabilities of scientific software, such as those used for metabolite identification, are becoming increasingly sophisticated. This is now coming to the point where these solutions are able to fulfil many of the functions currently performed by skilled scientists, which brings us to an interesting junction….. This discussion based sessions will encourage attendees to reflect on where we might be goings with regards to these solutions. What might be the benefits and risks of their implementation and how should we be moving forwards to enable us to develop better solutions for human wellbeing and the patients that are waiting for better diagnoses and medicines. 1:30 pm Peterhouse Room Closing Remarks
Neil Spooner, Spooner Bioanalytical Solutions |