Cambridge Healthtech Institute’s 6th Annual

Enabling Technologies for Circulating Biomarkers
( 血中バイオマーカーの実現技術 )

臨床現場での利用に向けたアッセイの改良

5月7日~8日



血中セルフリーDNA、血中循環腫瘍細胞などのバイオマーカーを検出し、分析する技術は着実に進歩していますが、臨床現場で日常的に利用できるようにするためには適切な検証を行う必要があります。血中バイオマーカーの実現技術をテーマにしたこのカンファレンスプログラムでは、これらの技術に関する最新の研究成果と臨床応用への道筋について考えるセッションが予定されています。また今度の学会では、試料の調製、検出、抽出、分離、特性評価といった解析前の作業にまつわる課題に焦点を絞り込んだセッションも行われます。

Final Agenda

Recommended Short Course* Monday 6 May | 13:30 - 17:00

SC2: Biomarkers in Liquid Biopsy: CTCs, ctDNA and Exosomes

Lorena Diéguez, PhD, Staff Researcher, Diagnostic Tools and Methods Research Group, Life Sciences, International Iberian Nanotechnology Laboratory, Portugal

Roberto Piñeiro Cid, PhD, Cancer Modeling Lab, Instituto de Investigación Sanitaria de Santiago de Compostela- Roche-Chus Joint Unit, Spain

Biomarkers for early disease detection, therapeutic efficacy monitoring and outcome prediction are the key to precision medicine. Liquid Biopsy studies disease biomarkers in body fluids and can be paramount for precision medicine in cancer. The analysis of biomarkers in peripheral blood improves cancer diagnosis and treatment success. This course will give you a comprehensive overview and update on the established biomarkers, available technologies and clinical applications of liquid biopsy.

*Separate registration required.

5月7日(火)

08:00 Registration and Morning Coffee

血中バイオマーカー技術の実用化

08:55 Organizer’s Opening Remarks

Kaitlin Kelleher, Conference Producer, Cambridge Healthtech Institute

09:00 Chairperson's Remarks

Jörg Tost, PhD, Director, Laboratory for Epigenetics & Environment, Centre National de Recherche en Génomique Humaine (CNRGH), CEA – Institut de Biologie Francois Jacob, France

09:05 Realising Value from Liquid Biopsy: Assuring Analytical Validity, Clinical Utility, and Cost-Effectiveness

Messenger_MichaelMichael Messenger, PhD, Head of Personalised Medicine and Health, Leeds Centre for Personalised Medicine and Health, University of Leeds, United Kingdom

Careful consideration of the evidence requirements of decision makers early on in the test evaluation pipeline can reduce the time and cost of research and improve the likelihood of a successful reimbursement outcome. This presentation will provide an overview of efficient approaches and protocols for evaluating liquid biopsies for rapid adoption and reimbursement, using examples from real case studies. Furthermore, it will highlight various frameworks used for quality appraising research evidence on analytical performance, clinical validity, clinical utility and cost-effectiveness, that are used by reviewers and Health Technology Assessment schemes to look at the risk of bias, inapplicability and irreproducibility.

09:35 Paving the Way to Use Liquid Biopsies in the Real World – IMI CANCER-IDs Learnings and Outlook

Thomas Schlange, PhD, Senior Biomarker Scientist, Global Biomarker Research, Bayer AG, Germany

The Innovative Medicines Initiative project CANCER-ID set out in 2015 to establish criteria for evaluating technologies in the liquid biopsy field. At the core of the 5-year program are harmonized protocols for clinical use of CTCs, ctDNAs and miRNAs, standards for benchmarking technologies and implementing these technologies in clinical studies. Learnings from CANCER-ID will be presented and an outlook of further joint stakeholder activities will be given.

VolitionRx 10:05 Presentation to be Announced

 

 

10:35 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

 

血中バイオマーカーの事前分析と分析の課題

11:15 Achieving Measurement Traceability for Molecular Diagnostics in Compliance with the IVDR

Devonshire_AlisonAlison Devonshire, PhD, Science Leader, Molecular and Cell Biology, LGC, United Kingdom

The new In Vitro Diagnostic Device Regulation (EU 2017/746) states that calibrators and control materials used in diagnostic tests “shall be assured through suitable reference measurement procedures and/or suitable reference materials of a higher metrological order;” however, there are a scarcity of reference materials and reference measurement procedures for the nucleic acid and cellular analytes commonly measured by liquid biopsy tests. This talk will discuss a framework for developing a reference system for circulating biomarkers and CTCs, and recent progress in developing digital PCR as a reference measurement procedure for gene quantification.

11:45 Obtaining Every Droplet of Information out of Each Liquid Biopsy Sample

Dieguez_LorenaLorena Diéguez, PhD, Group Leader, Department of Life Sciences, Nano4Health Unit, Medical Devices Research Group, International Iberian Nanotechnology Laboratory, Portugal

Why choose between CTCs, ctDNA or exosomes when you can have it all? What if the information provided by the different biomarkers is not redundant, but complementary? We use microfluidics and nanotechnology to extract the most of each sample. Phenotypic analysis of single CTCs and mutation analysis is done using microdroplets and Surface Enhanced Raman Spectroscopy.

12:15 Fundamentals for the Automatic Classification of Quantitative PCR Amplification Curves: A Biostatistical Approach

Roediger_StefanStefan Rödiger, PhD, Group Leader, Institute of Biotechnology, Brandenburg University of Technology Cottbus – Senftenberg, Germany

Quantitative polymerase chain reaction (qPCR) is a widely used bioanalytical method in human diagnostics. Until now, classifications (e.g., positive or negative reaction) are performed manually or by fixed threshold values. This classification is error-prone and based on the operator’s experience. We developed a scientific software, PCRedux, which calculates predictors (features) of amplification curves automatically. The predictors can be used for the automatic analysis of large data sets for machine learning applications.

Biorad12:45 Luncheon Presentation to be Announced

13:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

13:45 Session Break

血中バイオマーカーの事前分析と分析の課題 (続き)

14:15 Chairperson's Remarks

Michael Messenger, PhD, Head of Personalised Medicine and Health, Leeds Centre for Personalised Medicine and Health, University of Leeds, United Kingdom

14:20 Analytical and Biological Variation of Analyses of Circulating Tumor DNA

Fredslund_Andersen_RikkeRikke Fredslund Andersen, PhD, Molecular Biologist, Department of Clinical Biochemistry, Vejle Hospital, Denmark

Serial analyses of circulating tumor DNA in cancer patients are being investigated for assessing treatment response or failure. It is important to determine if values have significantly increased or decreased compared to previous values. We have performed extensive validation of mutation and methylation analyses in cfDNA from colorectal cancer patients to determine analytical and biological variation. From these values the significant minimum change can be calculated.

14:50 Optimizing Liquid Biopsies for Clinical Use

Niels Pallisgaard, PhD, Molecular Biologist, Pathology, Roskilde University, Denmark

Sample tubes, sample size and handling, when to use pre-amplification, assay sensitivity and assay optimization as well as proper controls for sample and assay quality for liquid biopsies in a clinical setting will be discussed in this presentation.

セルフリーDNAに対応する技術

15:20 KEYNOTE PRESENTATION: Novel Digital PCR and Mutation Enrichment Technologies for the Analysis of Clinically Relevant DNA Alterations in Liquid Biopsies

G. Mike Makrigiorgos, PhD, Professor, Dana Farber Cancer Institute and Harvard Medical School, United States

With the increasing interest in treatment assessment using liquid biopsy and circulating DNA, sensitive and multiplexed detection of tumor-derived alterations in blood are desirable. We provide novel forms of digital PCR, as well as mutation enrichment-based real time PCR methods that (a) enable several orders of magnitude improvement of detecting mutations or microsatellite instability than currently possible; (b) are highly multiplex-able; (c) reduce cost of analysis. Application in circulating DNA from clinical cancer samples will be presented.

15:50 Analysis of Mutations and Methylated Molecules in Cell-Free DNA Using Enhanced-ice-COLD-PCR Enrichment Combined with Next-Generation Sequencing

Tost_JorgJörg Tost, PhD, Director, Laboratory for Epigenetics & Environment, Centre National de Recherche en Génomique Humaine (CNRGH), CEA – Institut de Biologie Francois Jacob, France

Circulating cell-free DNA has great potential for non-invasive diagnostics, prediction and monitoring of treatment response. We have previously developed Enhanced-ice-COLD-PCR for the detection and sequence-based identification of mutations in mutation hotspots as well as methylated molecules. While the initial developed workflow used Pyrosequencing for a short time-to-results, we have now moved the assays to an NGS platform improving further signal/noise ratio, correlation with ddPCR results and providing detailed information on enriched molecules.

16:20 Refreshment Break in the Exhibit Hall with Poster Viewing

17:00 Breakout Discussions View Details

18:00 Welcome Reception in the Exhibit Hall with Poster Viewing

19:00 Close of Day

5月8日(水)

08:00 Registration and Morning Coffee

単一細胞解析とセルベース診断

09:00 Chairperson's Remarks

An Hendrix, PhD, Assistant Professor, Laboratory of Experimental Cancer Research, Ghent University, The Netherlands

09:05 Biological and Technical Aspects of Single-Molecule Analysis in Liquid Biopsies

Stahlberg_AndersAnders Ståhlberg, Associate Professor, Sahlgrenska Cancer Center, Clinical Pathology and Genetics, University of Gothenburg, Sahlgrenska University Hospital, Sweden

Early detection of individual tumor cells and molecules is essential in cancer diagnostics. We have developed several approaches to analyze individual cells and molecules and applied them to various applications within cancer and beyond. Here, we present our experience of using ultrasensitive analysis from both a clinical and technical point of view. Data from different tumor entities will be shown.

09:35 Inertial Microfluidics for High-Throughput Isolation of Circulating Trophoblastic Fetal Cells from Maternal Blood

Thierry_BenjaminBenjamin Thierry, PhD, Professor, Bioengineering, Future Industries Institute, University of South Australia, Australia

Inertial microfluidics has been successfully applied for the enrichment of circulating tumour cells, but its application to the isolation of circulating trophoblastic fetal cells presents additional challenges. We have developed an integrated combining inertial microfluidic and single cell manipulation towards the development of a semi-automated cell-based NIPT compatible with downstream genomic testing.

10:05 Standardized Analysis of Extracellular Vesicles in Liquid Biopsies: From Research to Clinical Applications

Hendrix_AnAn Hendrix, PhD, Assistant Professor, Laboratory of Experimental Cancer Research, Ghent University, The Netherlands

The identification of extracellular vesicle (EV)-associated biomarkers is challenging owing to the complexity of liquid biopsies. We 1) performed quality control studies to identify the impact of (pre-) analytical variables on biomarker identification, 2) developed reference materials to ensure standardized EV measurements, and 3) created EV-TRACK to stimulate researchers to put experimental guidelines into practice. This combined expertise boosted the identification of bacterial EV in the systemic circulation of patients with intestinal barrier dysfunction.

10:35 Presentation to be Announced

10:50 Sponsored Presentation (Opportunity Available)

11:05 Coffee Break in the Exhibit Hall with Poster Viewing


全体セッション

11:35 議長の発言

Charlotte Ryckman, Associate, Covington & Burling LLP, Belgium

11:45 腫瘍治療の分野における精密診断:拡大するリキッドバイオプシーの役割

Nitzan Rosenfeld, PhD, Senior Group Leader, Cancer Research UK Cambridge Institute, University of Cambridge; CSO, Inivata Ltd., United Kingdom

Effective clinical management relies on accurate diagnostic information, which requires effective techniques and the right samples. Next generation sequencing can provide a wealth of information, but implementing innovative technologies into clinical routine can be a challenge. We’ll examine how analysis of cell-free DNA can provide an opportunity to re-examine many of the current clinical decision points, and a test case for adoption of new diagnostic tools.

12:15 精密医療と診断機器の分野における法規制の動向

Erik Vollebregt, Partner, Axon Lawyers, The Netherlands

  • What changes will be brought about by the IVDR?
  • What is the impact of the GDPR in the field of precision medicine and diagnostic devices?
  • What are the practical implications of implementation of new European regulations?
  • What are the consequences of the interplay of the IVDR and the GDPR?

12:45 パネルディスカッション:欧州での診断分野への投資にまつわる課題と可能性

Moderator:

Philippe Peltier, Partner, Kurma Partners, France






Panelists:

Florian Kainzinger, PhD, Managing Partner, Founder, Think.Health Ventures, Germany





Makinen_SeppoSeppo Mäkinen, Partner, Pathena Investments


  • What is different in Europe versus other markets (e.g., US and Israel). How do different European markets compare?
  • What has changed in the landscape of European investments over the past few years? What can be improved?
  • The role of regulators and governments
  • How can start-ups stand out and get attention in the current landscape?

13:30 Close of Enabling Technologies for Circulating Biomarkers

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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更新履歴
2019/04/11
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2019/03/27
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2019/03/08
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2019/01/21
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