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LIQUID BIOPSY SUMMIT · 2019-10-08 · MMD-PCR (Multiplex Mutation Detection PCR) 17:40 Panel discussion: Conclusions and future directions With speakers of both days Relevancy to

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20 - 21 February 2020 | Lisbon, Portugal

LIQUID BIOPSY SUMMIT

Latest findings on the clinical

applications of CTCs, ctDNA, miRNAs

and exosomes in real t ime monitoring

of systemic anticancer therapies will

be discussed only at the Liquid

Biopsy 2020.

Experts will present and consider

process and technology refinements

that can enable molecular l iquid

biopsies to become a fulcrum in the

future of precision medicine.

Group

B I O T E CHPHARMASUMM I TOn 20 and 21 February 2020, Lisbon

(Portugal) will host the BioTech

Pharma Summit: Liquid Biopsy 2019

conference.

This year’s event will bring together

the leaders in the field from pharma,

biotech, Dx companies and healthcare

and be the home of multi-stakeholder

and pan-industry collaboration for

l iquid biopsy, molecular pathology

and precision medicine experts to

explore the expanding and evolving

field whereby Circulating Biomarkers

of various classes are being evaluated

for their potential to be developed into

diagnostics for cancer as well as

application of l iquid biopsy testing,

across biofluids, biomarkers and

disease indications, as the needle

shifts on the gold standard of

personalized healthcare testing.

WHO SHOU LD A T T E ND

CEOs, VPs, Drug developers, Academics and Researchers,

CROs, Scientists and Medical Doctors of :

• L iquid biopsy

• Cl inical Pathology

• Molecular Assay

Development

• Medical Laboratory

• Scientific Affairs

• Sales and Marketing

• Quality Management

• Process Development

• Commercial & Outreach,

Oncology

• Molecular pathology

• Research Scientist

• Molecular Biology

• Sales & Business

Development

• Cl inical and Translational

Affairs

• Cl inical Research

• Companion Diagnostics

• Biomarkers

• Manufacturing

• Scientific Affairs

• Cl inical Trial

• Oncology Business

Development

• Precision medicine

• Cl inical Laboratory

• Immunochemistry

• Cell Culture

• Cl inical Genomics

• Liquid Biopsy: New Opportunities, Technologies, and Challenges in the Field

• Clinical integration of l iquid biopsy

• Circulating Tumor Cells : History and Future Perspectives

• Improving the Quality of Circulating Tumor DNA Measurements

• Circulating Tumor Cells in Monitoring Cancer

• Extracellular vesicles (Evs)

• New Tools for Liquid Biopsies: Microfluidic Platforms for the Isolation of CTCs, cfDNA and Exosomes

• CTC Isolation Platforms and Using CTCs for Monitoring Therapy Responses

• Dissecting Mechanisms of Breast Cancer Metastasis Using Patient-Derived Circulating Tumor Cells

• Liquid Biopsies in Cancer Immunotherapy Clinical Drug Development

• Heterogeneity of Cancer-Derived Extracellular Vesicles

• Liquid Biopsies in Oncology and the Current Regulatory Landscape

• Validating Liquid Biopsies in Cancer

• ctDNA Liquid Biopsy Assay

K E Y P R AC T I C A LL E A RN I NG PO I N T S

GE

DR. DAGMAR KASPER

at Agena Bioscience

Managing Director (EMEA)

DK

DR. RASMUSBRØNDUM

at Leymus Genomics

CEO, Founder

DR. CECILIA SCHOTT

at Novartis

Head Precision Medicine Strategy

US

DR. DANIEL GRÖLZ

at QIAGEN

Scientific Associate Director R&D

DE

DR. CARLO BOTTARI

at NGS- HTGMolecular Diagnostics

Biomarker Signatures

UK

ES

DR. CLOTILDE COSTA NOGUEIRA

at Chus Joint Unit

Head of the Liquid Biopsy Line of the Roche

DR. GUOLIANG FU

Founder and CEO

at Genefirst ltd

UK

IT

DAVIDE ZOCCO

at Exosomics

Chief Technology Officer

DR. CATHERINE ALIX-PANABIÈRES

Director of LCCRH

at IURC

FR

DR. FRANÇOISE FARACE

FR

Head of RareCirculating Cell Translational Platform

at INSERM

DR. ANDERSSTÅHLBERG

Associate Professor

at the University of Gothenburg and Sahlgrenska University Hospital in Sweden

SE DE

PROF. DR. JENS K.HABERMANN

at Iqvia

President of ESBB

DR. ARJAN TIBBE

CEO

at VyCAP

NL

DR. CHRISTIAN WERNO

Group Leader, Preclinical Therapy Models

at Fraunhofer-Institut

DEUK

DR. LARASTEVANATO

at ANGLE plc

R&D Manager

PT

DR. LORENA DIÉGUEZ

at INL

Group LeaderMedical Devices

S P E AK E R S

SE

PROF. MIKAEL KUBISTA

at TATAA Biocenter

Chairman of the board and founder

SC I E N T I F I CAG ENDA

DAY 1

14:30 Metastasis is responsible for 90% of cancer related deathsBy Clotilde Costa Nogueira - Head of the Liquid Biopsy Line of the Roche at Chus Joint Unit

CTCs are responsible for distal metastasis are of great interest for biomarkers discovery to predict and monitor tumor progression and therapy failure. In this study we performed a monitoring of metastatic breast cancer patients before and after treatment througout CTC molecular characterization to identify biomarkers with interest for clinical oncology translation

14:30 Single cell isolationBy Arjan Tibbe - CEO at VyCAP

Single cell secretion

16:20 CTC Isolation Platforms and UsingBy Lorena Diéguez - Group Leader, Department of Life Sciences, Nano4Health Unit, Medical Devices Research Group, International Iberian Nanotechnology Laboratory

CTCs for Monitoring Therapy Responses

Circulating Tumor Cell isolation and analysis

15:50 Coffee & Networking Break

18:00 Chairman’s Closing Remarks

19:00 Gala Dinner

17:00 Circulating Tumor Cells: Finding Rare Events for a Huge Knowledge of Cancer DisseminationBy Catherine Alix - Panabières is the Director of this unique platform LCCRH- Université de Montpellier, Institut Universitaire de Recherche Clinique (IURC)

Technologies for detection of viable Circulating Tumor cells (CTCs)

Understanding the biology of CTCs

What about culturing CTCs in vitro to know more about metastasis-competent CTCs ?

17:40 Panel discussion: New Tools for Liquid BiopsiesWith speakers of both days

Advancements in microfluidic technologies

Microfluidic Platforms for the Isolation of CTCs, cfDNA and Exosomes

Progress in Circulating Tumor Cell Research Using Microfluidic Devices on clinical research parameters, such as survival statistics

Registration and Welcome Coffee08:00

08:50 Opening of the BioTech Pharma Summit

09:40 Speed Networking

10:20 Morning Coffee & Networking Break

12:50 Business Lunch

Thursday, February 20, 2020

09:00 Liquid Biopsy: Market TrendsBy Rasmus Brøndum - CEO, Founder at Leymus Genomics

Liquid biopsies 2019

Requirements for ctDNA analysis - What does extra analytes add to standard ctDNA assays e.g. proteins, RNA

Market outlook

Liquid biopsy analyses of human cancer is the future

11:30 Precision Medicine Using Liquid BiopsiesBy Lara Stevanato - R&D manager at ANGLE plc

ParsortixTM system microfluidic technology

Antigen independent capture of CTCs

Broad range of downstream analysis (Cytology, immunofluorescence, FISH, and molecular analysis)

Clinical applications to harvest cancer cells from patient blood and sample to answer (ParsortixTM system plus HyCEAD technology)

12:10 Clinical integration of liquid biopsyBy Christian Werno - Group Leader, Preclinical Therapy Models- Fraunhofer-Institut

CTCs are already used to predict disease progression and survival in metastatic patients, however functional analysis of ex vivo expanded CTCs remain challenging. We have generated CTC-derived in vivo and in vitro models from metastatic cancer patients. We have molecularly characterized these models and performed drug screens to improve personalized treatment strategies for metastatic patients in future

13:50 Circulating Tumor Cells in Monitoring CancerBy Françoise Farace - Head of Rare Circulating Cell Translational Platform CNRS UMS3655 at INSERM

The identification of predictive biomarkers of sensitivity and resistance to targeted therapies in non-small cell lung cancer, single CTC analyses and CTC-derived xenograft models for a better understanding of the mechanisms of therapeutic resistance and metastatic progression. I think my presentation could fit the session entitled

10:50 Clinical Practice is Shaping the Precision Medicine Ecosystem: focus on liquid biopsiesBy Cecilia Schott - Head Precision Medicine Strategy, Oncology Business Unit at Novartis

New diagnostic platforms are being developed, such as liquid biopsy, to identify the patient most likely to respond to a given treatment

There is an ever growing need to understand the precision medicine landscape thought the eyes of the practicing clinician

Geographical differences in the access to various testing modalities and reimbursement must be accounted for in clinical development programs and go-to-market strategies

An overview of the considerations for the global development and life cycle management of patient diagnostic and monitoring tools

DAY 2

14:10 Applications of CTCs and ctDNA as a Non-Invasive Tumor TrackerBy Dagmar Kasper - Managing Director (EMEA) at Agena Bioscience

14:50 Targeting tumor heterogeneity and applying liquid biopsiesBy Jens K Habermann - President of ESBB at Iqvia

13:10 Business Lunch

15:30 Coffee & Networking Break

17:00 Chairman’s Closing Remarks & End of Summit

12:30 Quantitative miRNA ProfilingBy Carlo Bottari - Biomarker Signatures, Molecular Diagnostics, CDx, Precision Medicine, Early Cancer Detection, Molecular Profiling, NGS at HTG Molecular Diagnostics

Methods and Challenges

16:00 Novel Technologies By Guoliang Fu - Founder and CEO- genefirst ltd

MMD-PCR (Multiplex Mutation Detection PCR)

17:40 Panel discussion: Conclusions and future directionsWith speakers of both days

Relevancy to utilize CTCs and ctDNA during systemic therapy rather than as early diagnosis markers

Tests for mutations in genes encoding therapeutic targets

A paradigm shift in liquid biopsy research with EVs or ctDNA being preferred markers over CTC

Technical challenges involved in removing Evs

Friday, February 21, 2020

Registration & Coffee08:00

08:30 Opening Address from the Chairperson

10:40 Morning Coffee and Networking Break

08:40 Circulating tumor DNA- preanalytical considerations, international specimen improvement requirements, standards, legislation, technologiesBy Daniel Grölz - Scientific Associate Director R&D, Sample Technologies Department at QIAGEN

Need of specimen quality improvement to reduce diagnostic errors

Pre-analytical factors that influence the outcome of ccfDNA analysis

International initiatives and requirements to standardize pre-analytical workflows

Liquid biopsy preservation and workflow solutions

10:00 Liquid Biopsies in Cancer Immunotherapy Clinical Drug DevelopmentBy TBA

Robustness, reproducibility and consistency across laboratories

The expected standards for analytical validation of a liquid biopsy assay

ctDNA and CTC strengths and weaknesses

11:10 Extracellular vesicles (EVs)By Davide Zocco - Chief Technology Officer- Exosomics

The performance of common exosome isolation methods

The integration of microfluidics and various sensing components or sensors

Microfluidic isolation of Evs

On-chip detection and analysis of Evs

11:50 Two-Tailed PCR for Precision DiagnosticBy Mikael Kubista - Chairman of the board and founder at TATAA Biocenter

Two-Tailed PCR

Ultra-sensitive microRNA profiling

Ultra-specific rare mutation analysis

Quality assessment of liquid biopsy testing

09:20 Technical and biological challenges when analyzing cell-free tumor DNABy Anders Ståhlberg - Associate Professor at the University of Gothenburg and Sahlgrenska University Hospital in Sweden

Analysis of circulating cell-free tumor DNA (ctDNA) in liquid biopsies offers new means for early cancer diagnostics, real-time monitoring of treatment efficiency and detection of relapse. Despite its potential use ctDNA remains challenging to detect and to quantify as it represents only a small fraction of all cell-free DNA

We have developed SiMSen-Seq, that allows allele frequencies < 0.1% to be detected. SiMSen-Seq is simple to perform, flexible in multiplexing and requires minimal DNA input. Here, we will present recent updates

Here, we discuss important considerations for ctDNA analysis in plasma, including all experimental steps from sampling to data interpretation. Furthermore, the use of quality control assays enables the development of robust and standardized workflows that facilitate the implementation of ctDNA analysis into clinical routine

We will show data from various ongoing studies, related to both clinical and basic research questions

B I OG RA PH I E S

Lara Stevanto possesses a PhD in Biotechnology. She joined ANGLE PLC in 2016 as R&D project manager for the analytical evaluation of ParsortixTM system as part of the FDA application. As part of Cancer-ID, she led the protocol development for the CTC isolation and enumeration technology comparison (CANCER-ID Ring Trial ). Prior to joining ANGLE, Lara served as Head of Molecular Biology at ReNeuron, specializing in the development of stem cell-based clinical products.

LARA STEVANATO , UKR&D Manager at ANGLE plc

Having gained a BSc in biochemistry, over the past 18 years, Carlo has been working in sales and marketingin the scientific technology industry. In his role at HTGhe is focused on Molecular Profiling, Biomarker Signature Development and Molecular Diagnostic Applications, including development of applications in Liquid Biopsy, Early Disease Detection, Companion Diagnostics and Precision Medicine.

CARLO BOTTARI, UKBiomarker Signaturesat NGS- HTGMolecular Diagnostics

Davide Zocco joined Exosomics in 2013 with the mandate to introduce and implement into the R&D pipeline the develop-ment of molecular assays for detection of EV shuttled mutations. In 2015 he took on the role of the Head of Molecular Diagnostics. Today he is responsible for development of EV-DNA and EV-RNA targeted solutions and for management of clinical testing of assay prototypes. Davide actively participates in scouting for new technologies, as well as internal IP strategy and pre-market launch of RUO and diagnostic kits.

DAVIDE ZOCCO, ITChief Technology Officerat Exosomics

Anders Ståhlberg is working as principal investigator at the Sahlgrenska Cancer Center, University of Gothenburg and Sahlgrenska University Hospital in Sweden. Anders primary research interest is to understand molecular mechanisms in tumor initiation and tumor development, focusing on breast cancer and sarcomas. He has developed several strategies for DNA and RNA, especially at the single-cell and single-molecule level.

ANDERS STÅHLBERG, SEAssociate Professor at the University of Gothenburgand Sahlgrenska University Hospital in Sweden

Professor Jens K. Habermann, m.d., Ph.D., is director of ICB-L (Interdisciplinary Center for Biobanking-Lübeck) and scientific director of UCCL (University Cancer Center Lübeck) at the University of Lübeck and University Clinic Schleswig-Holstein. As specialist in human genetics, he combines clinical routine, biobanking, and cancer research to optimize individualized medicine by targeting tumor heterogeneity and applying liquid biopsies.

JENS K. HABERMANN, DEPresident of ESBBat Iqvia

Clotilde is a Biologist. In 2011 I developed my phD in Molecular Oncology at CIEMAT (Madrid) focused on the study of cell cycle genes in squamous cell carcinomas. In 2013 she moved to Santiago de Compostela to the Translational Medical Oncology Group to work in the study of metastasis through Liquid Biopsy. Since 2015 she is the leader of the Liq-uid Biopsy Line at the Joint Unit Roche-Chus, University Clinical Hospital of Santiago, focused on the understanding of the biology of Circulating Tumor Cells of metastatic Breast and Prostate patients.

CLOTILDE COSTA NOGUEIRA, ESHead of the Liquid Biopsy Line of the Roche at Chus Joint Unit

Françoise Farace is currently in charge of the Translational Laboratory of Rare Circulating Cells at CNRS UMS3655 - INSERM US23 AMMICA, and of the Circulating Tumor Cells team at INSERM U981, Gustave Roussy. For the past fourteen years, FF focused her research on rare circulating cells such as circulating endothelial cells and circulating tumor cells with the goal of identifying both sensitivity and resistance biomarkers of anticancer therapies.

FRANÇOISE FARACE, FRHead of RareCirculating Cell Translational Platform at INSERM

In 1996 Kubista invented the light-up probes, which led to the foundation of LightUp Technologies AB as Europe´s first company focusing on qPCR based diagnostics. He co-founded MultiD Analyses AB, which develops the market leading software GenEx for molecular analysis, and in 2001 Kubista set up TATAA Biocenter as the first laboratory in Europe to obtain flexible ISO 17025 accreditation.

MIKAEL KUBISTA, SEChairman of the board and founder at TATAA Biocenter

ARJAN TIBBE , NL CEO at VyCAP

After completing his PhD in 2001, Arjan established and managed Im-municon Europe, Enschede, the Netherlands, a subsidiary of Immunicon Corporation, USA. Immunicon developed the FDA cleared CellSearch system for monitoring metastatic cancer by measuring the numberof CTC. Immunicon was ac-quired by Veridex, a Jonhson& Johnson company, in 2008 where he held the same position within the Enschede facility.

Dr. rer. med. Christian Werno is research group leader “Preclinical Therapy Models”, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Division of Personalized Tumor Therapy. He got his PhD at Goethe University Frankfurt am Main, then being a postdoctoral fellow at Fraunhofer ITEM Regensburg Division of Personalized Tumor Therapy.

CHRISTIAN WERNO, DEGroup Leader, PreclinicalTherapy Modelsat Fraunhofer-Institut

During this last decade, Dr Alix-Panabières has focused on optimizing new techniques of enrichment, detection and characterization of viable circulating tumor cells (CTCs) in patients with solid tumors. She is the expert for the EPISPOT technology that is used to detect viable CTCs in patients with breast, prostate, colon, head & neck cancer and melanoma. This technology has been recently improved to detect functional CTCs at the single cell level (EPIDROP).

CATHERINE ALIX-PANABIÈRES , FRDirector of LCCRH at IURC

RASMUS BRØNDUM, DKCEO, Founder at Leymus Genomics

Rasmus Brøndum, Molecular Biologist by training has worked for the leading companies in the genomic industry includ-ing companies such as Thermo Fisher Scientific, Illumina and Roche. At Roche as a director in Molecular Diagnostics he was part of a regional team launching worlds first liquid biopsy ( Cobas™ EGFR mutation test ). In 2016 he founded his own company Leymus Genomics which provides products for long read sequencing on Illumina sequencers and also big data on site storage for mainly clinical and national genome projects.

CECILIA SCHOTT, US Head Precision Medicine Strategyat Novartis

Cecilia is Head Precision Medicine Strategy Oncology Business Unit at Novartis. Prior to her current role Cecilia held positions VP, Precision Medicine for AstraZeneca Global Product & Portfolio Strategy, Global Marketing and US Medical Affairs. Cecilia background includes roles in the biotech and device industries. Before joining AstraZeneca she was part of Biogena Drug Safety and Medical Information function, and at Boston Scientific she was responsible for establishing the drug eluting stent franchise Medical Publications and Medical Information groups as part of Medical Affairs.

Dr. Grölz is the R&D project manager who led an international team within PreAnalytiX GmbH to develop the PAXgene Tissue and the PAXgene Blood ccfDNA Systems. He was the leader for the evaluation of the PAXgene Tissue System within the European collaborative grant project, SPIDIA, and manages work packages in two other grant projects to evaluate the PAXgene Tissue and PAXgene Blood ccfDNA Systems for use in routine pathology workflows. He is the main inventor of the PAXgene Tissue System and inventor/co-inventor of the PAXgene Blood ccfDNA stabilization chemistry.

DANIEL GRÖLZ, DEScientific Associate Director R&D at QIAGEN

Lorena Diéguez joined INL in 2014 as Staff Researcher and is, since May 2018, the leader of the Medical Devices research group. Her research is focused in the development of biomicrofluidic devices mainly devoted to Translational Medical Research in close collaboration with Hospitals. Her work is devoted to the development of integrated biosensing systems and nanobioengineered diagnostics microsystems for the isolation and characterization of Tumor Cells from body fluids of cancer patients, as well as the development of microfluidic organ-on-a-chip 3D models.

LORENA DIÉGUEZ, PTGroup Leader Medical Devices at INL

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