Blood biomarkers for early detection of cancer · • Updates in predictive biomarkers for drug development ... New for 2020, we are pleased to introduce a pre-event focus ... •

For more information please contact [email protected]

Benefits to Attending

✓ Hear from and meet with the key industry and

academic innovators in biomarkers, translational

medicine, clinical development and diagnostics. 2020

attendees include: Director, Lundbeck; Director in Discovery

Research, Boehringer Ingelheim; and Fellow and Vice

President, UCB

✓ Discover the latest integration of biomarkers in

drug development through case studies by major

pharma on multiple therapeutic areas, including immuno-

oncology, neuroscience, cardiology, immunology respiratory

and rare diseases

✓ Gain novel insights into key biomarkers for

detection, monitoring and diagnosis, including innovative

applications of digital markers. Further talks look at early

detection of cancer

✓ Discuss the use of cellular, transcriptomic and

proteomic biomarkers in preclinical and clinical

development: trial design & data analysis, assay

development, patient stratification & selection and the role

of safety & efficacy markers

✓ Benefit from case studies on topical technology

innovation within imaging, multiplexing, mass spectrometry

and screening processes

✓ Unparalleled networking opportunities. The two-day

congress offers an interactive platform for high-level

scientific and business discussions. Participate in formal

or informal discussions during our networking breaks and

pre-organised 1-2-1 meetings

✓ A high quality and outstanding interactive

programme. Benefits include 2 pre-event webinars, over

80 expert presentations, and 6 roundtable discussions

2020 Speakers Include:

Miro Venturi Holly Soares Roy Baynes

Roche Pfizer MSD

Day 1 Stream 1 – Biomarkers in Drug Discovery & Development – Therapeutic

Areas: Oncology, Immuno-Oncology and Immunology

• Updates in predictive biomarkers for drug development

• Check point inhibitors and dual therapies in immuno-oncology

• Biomarker discovery in oncology and autoimmunity

• Translational biomarkers and patient stratification

Day 2 Stream 1 - Biomarkers in Drug Discovery & Development – Therapeutic

Areas: Neuroscience, Cardiovascular Disorders and Rare Disease

• Case studies in biomarker discovery and validation in neuroscience, rare

diseases and cardiovascular disorders

• Novel stem cell biomarkers for neurodegenerative disorders

Day 1 Stream 2 – Biomarkers for Detection, Monitoring & Diagnosis

• Early detection

• Blood biomarkers for early detection of cancer

• Diagnostic Development: Companion, Tissue & PoC

• Digital Biomarkers for disease detection and monitoring

Day 2 Stream 2 – New Biomarker Technologies & Data

• Immunoassays and screening processes

• Big data analytics and sampling techniques

• Imaging technologies, CNS imaging techniques and digital pathology

• Multiplexing technologies, Flow cytometry and Mass spectrometry

Pre-Event Focus Day

New for 2020, we are pleased to introduce a pre-event focus

day to the Series, featuring the following sessions:

• Neuroscience Biomarkers Deep Dive

• Cardiovascular Biomarkers Deep Dive

• Immuno-Oncology Biomarkers Deep Dive

• Protein Biomarker End User Workshop

• Diagnostic Development & Precision Medicine End User

Workshop

• Genomic Biomarkers End User Workshop

Day 1 Stream 3 – Biomarkers for Clinical Development

• Biomarker trial design and data analysis

• Implementing clinical biomarkers in oncology, cardiology, neuroscience and

inflammatory diseases

• Transforming clinical development through biomarker driven clinical trial

design

• Use of cellular, transcriptomic and proteomic biomarkers in clinical trials

Day 2 Stream 3 – Biomarkers for Preclinical Development

• Assay development & validation

• Translational biomarkers

• Patient stratification and selection

• The role of safety and efficacy biomarkers

• Workshop: Accelerating the Treatment and Response Rate of Cancer

Immunotherapies

Day 1 Stream 4 – Co-Located Genomic Markers Congress

Part 1: Genomic Biomarkers in Drug Discovery and Development

• Validating and verifying genomic markers in preclinical drug development

• Predictive and prognostic biomarkers for oncology and rare diseases

• Applying NGS, Single Cell Technologies and other Genomic Technologies

in drug discovery and development

Part 2: Genetic Biobanking, Data Analysis and Precision Health

• Genome and EHR-Derived Phenomes in Large Patient Populations

• Challenges of Big Data Integration in Genomics & Precision Medicine

• Genetic Biobanking and Whole Genome Sequencing Initiatives

Day 2 Stream 4 – Co-Located Genomic Markers Congress

Genomic Biomarkers for Precision Medicine and Clinical Practice

• The Role of Genomic Markers in Clinical Pharmacology

• Molecular Diagnostics Development: Translation to the Clinic

• Development of Novel Computational Tools for translating Genomic

Markers into Clinical Practice

• Genomic markers in clinical diagnostic development

• Liquid Biopsy and its role in Precision Medicine

• Biofluid-based molecular biomarkers: ctDNA and CTCs

• Development of novel diagnostics for early disease screening, patient

monitoring and minimal residual disease detection

• Application of liquid biopsy testing in personalized healthcare testing

mailto:[email protected]


Confirmed Speakers 2020 Include: • Miro Venturi, Senior Vice President, Biomarkers, Roche

• Roy Baynes, Senior Vice President, Head of Global Clinical Development, Chief Medical Officer, MSD

• Alastair Lawson, Fellow and Vice President, Structural Biology, UCB

• Holly Soares, Head of Precision Medicine, Vice President, Pfizer

• Mark Fidock, Vice President & Head of Precision Medicine Diagnostic Development, AstraZeneca

• Liz Harrington, Executive Director, Head of Translational Science UK, Oncology IMED Business Unit, AstraZeneca

• Katherine Call, Senior Director and Head, Proteogenomics, Sanofi

• Birgitte Sogaard, Senior Director Experimental Medicine, Lundbeck

• Thomas Misko, Lead Scientist & Senior Scientific Director, Translational Neuroscience, AbbVie

• Marianne Scheel-Fjording, Scientific Director, Translational Science, Novo Nordisk A/S

• Jiri Aubrecht, Scientific Director, Translational Biomarker Research, Takeda

• Cornelia Dorner-Ciossek, Director in Discovery Research, CNS, Boehringer Ingelheim

• Rachel Salisbury, Regional Clinical Director, European Clinical Development, MSD

• Richard Batrla-Utermann, Medical Director, Roche

• Deepti Aurora-Garg, Director, Companion Diagnostics, MSD

• Ken Chang, Director, Clinical Biomarkers, Daiichi Sankyo

• Jim Turk, Pathology Director; Lead, Translational Cardiovascular Pathology and Biomarkers, Amgen

• Ziad Taib, Statistics Science Director, AstraZeneca

• Conrad Cowan, Director Translational Medicine, Teva Pharm

• Achim Kless, Scientific Director GI-PN-TSI and Principal Translational Scientist, Grunenthal

• Jenny Zhang, Associate Director, Clinical Biomarker Assay Specialist, Pfizer

• Andrew Pierce, Associate Director – Translational Science Oncology, AstraZeneca

• Mario Richter, Associate Director DMPK-BA, Operations Large Molecules and Biomarkers, AbbVie

• Chanchal Kumar, Associate Director (Team Leader), CVMD Bioinformatics, Translational Sciences, AstraZeneca

• Gerard Sanderink, Global Head Biomarkers & Clinical Bioanalyses, Sanofi

• Igor Rudychev, Head of US Digital, Data and Innovations, AstraZeneca

• Phil Murphy, Head, Imaging, GlaxoSmithKline

• Pia Davidsson, Head of Biomarkers, Discovery and Development, Translational Science and Experimental Medicine,

AstraZeneca

• Tarek Leil, Head – Quantitative Clinical Pharmacology, Bristol-Myers Squibb

• Charles Cox, Head of Pharmacogenomics, GlaxoSmithKline

• Ginette Serrero, Chief Executive Officer, A&G Pharmaceuticals

• Michelle Morrow, Vice President, Preclinical Translational Pharmacology, F-Star Therapeutics

• Patrick Kleyn, Vice President, Translational R&D, Rhythm Pharmaceuticals

• Christie Fanton, Director, Translational Research, Nektar Therapeutics

• Yael Silberberg, Director of Data Science, BiomX

• Marc Yeste-Velasco, Director, Translational Research, Ability Pharma • Markus Zettl, Director, Translational Immuno-Oncology, Pieris Pharmaceuticals

• Arun Satelli, Associate Director Target Biomarkers, Immatics

• Sudhir Srivastava, Chief, Cancer Biomarkers, NIH

• Jane Wilkinson, Senior Director, Broad Genomics Alliance & Project Management, Broad Institute

• Ana Alfirevic, Professor, Molecular and Clinical Pharmacology, University of Liverpool

• Yong-Jie Lu, Professor in Molecular Oncology, Queen Mary University of London

• Anka Ehrhardt, Science Director, CHDI Foundation

• Georges Dagher, Research Director, INSERM

• Graham Pockley, Director & Professor of Immunobiology, Nottingham Trent University

• Thomas Joos, Deputy Managing Director, NMI Natural and Medical Science Institute

• John-Michael Sauer, Program Officer, Biomarker Programs and Executive Director, Predictive Safety Testing Consortium, C-

Path Institute

• Annette Amon-Hassenzahl, Clinical Trial Biosample Manager, Merck KGaA • Brad Evans, Associate Principal Scientist, MSD

• Tim Erkens, Senior Scientist, Biomarkers & Clinical Pathology, Nonclinical Safety, Janssen

• Marco Ranzani, Senior Scientist, Artios Pharma

• Erik Vollebregt, Partner, Axon Lawyers

• Anguraj Sadanandam, Team Leader, Systems and Precision Cancer Medicine, Institute of Cancer Research

• Maggie Cheang, Team Leader, Institute of Cancer Research



Platinum Sponsor

Gold Sponsor

Silver Sponsors

Meet Senior Decision Makers - 450 VPs, Directors & Senior Managers

from leading pharmaceutical organisations, biotech companies and

academic institutions. Delegate job titles include:

Next Generation Diagnostics

Computational Biology

Clinical & Genomic Biomarkers

Clinical Cytometry

Personalised Medicine

Preclinical Safety

Translational Medicine Biomarker Validation

Discover New Solutions - Formal and informal meeting opportunities

offer delegates the chance to discuss key solutions with leading service

providers. Services to be discussed include:

Assay Validation

Biomarker Verification

Nanotechnology

Companion Diagnostics

Patient Selection Markers

Flow Cytometry

Genomic Biomarkers

Digital Pathology



Bronze Sponsors

Networking & Programme Sponsors



Biomarkers Series UK

Pre-Event Focus Day – 18th February 2020

15th Annual Biomarkers Congress

09.30 – 10.00 Registration

Neuroscience Biomarkers Deep-Dive Session

Cardiovascular Biomarkers Deep-Dive Session Oncology Biomarkers Deep-Dive Session

Discovering Novel Biomarkers For

Neurodegenerative Conditions

Novel Biomarkers For Cardiovascular And

Inflammatory Conditions

Multi-Modal Biomarkers For Cancer Detection And Treatment

10.00 – 10.10 Welcome Address

Facilitator: TBC

Welcome Address

Facilitator: Pia Davidsson, Head of Biomarkers,

Discovery and Development, Translational Science

and Experimental Medicine, AstraZeneca

Welcome Address

Facilitator: Anguraj Sadanandam, Team Leader Systems and

Precision Cancer Medicine, Institute of Cancer Research

10.10 – 10.30 Presentation 1: Sample Collection And

Datasets For Finding And Making Biomarkers

Available For Neurodegenerative Conditions

Anka Ehrhardt, Science Director, CHDI

Foundation

Presentation 1: Inhibition Of Sclerostin By

Sclerostin Antibody Does Not Affect Morphological

Or Transcriptional Endpoints Related To

Atheroprogression, Plaque Calcification, Or

Inflammation In Two Murine Models Of

Atherosclerosis

• Confirmation of Pharmacodynamic Effects of Scl-Ab

on Bone: Increased P1NP or Bone Mineral Density

• Total Plaque and Mineralized Plaque By μCT Was

Not Affected by Scl-Ab Treatment

• Genotype-Driven Gene Expression Changes Were

Not Affected by Scl-Ab Treatment

• Scl-Ab Did Not Affect Circulating Cytokines Reported

to be Regulated By Sclerostin

Jim Turk, Pathology Director; Lead, Translational

Cardiovascular Pathology and Biomarkers, Amgen

Presentation 1: Transcriptome-Based Biomarkers In Breast Cancer

Maggie Cheang, Team Leader, Institute of Cancer Research

10.30 – 10.50 Presentation 2: Imaging Technologies In

Neuroscience

Speaker To Be Announced

Presentation 2: Molecular Profiling Reveals A

Common Metabolic Signature Of Tissue Fibrosis

Reserved: Ji Zhang, Scientist, Cardiorenal Metabolic

& Ophthalmologic Drug Discovery, MSD

Presentation 2: Liquid Biopsy In Cancer

Reserved: Caroline Dive, Professor, Cancer Research UK Manchester

Institute

10.50 – 11.10 Presentation 3: Blood Biomarkers In



Presentation 3: Protein Biomarker Discovery In

Cardiovascular Research

Pia Davidsson, Head of Biomarkers, Discovery and

Development, Translational Science and

Experimental Medicine, AstraZeneca

Presentation 3: Measuring Evolutionary Dynamics Of Cancer

Formation

Reserved: Trevor Graham, Professor of Cancer Evolution, Barts

Cancer Institute

11.10 – 11.30 Presentation 4: Stem Cell Biomarkers For



Presentation 4: Metabolomic Biomarkers For

Inflammation And Cardiology


Presentation 4: Spatial Biomarkers Using Machine Learning

Approaches And Multiplex IHC

Anguraj Sadanandam, Team Leader, Systems and Precision Cancer

Medicine, Institute of Cancer Research




Pre-Event Focus Day – 18th February 2020

15th Annual Biomarkers Congress


Neuroscience Biomarkers Deep-Dive Session

Cardiovascular Biomarkers Deep-Dive Session Oncology Biomarkers Deep-Dive Session

Discovering Novel Biomarkers For


Novel Biomarkers For Cardiovascular And

Inflammatory Conditions

Multi-Modal Biomarkers For Cancer Detection And Treatment

11.30 – 12.20 Panel Discussion: Discovering Novel

Biomarkers For Neurodegenerative

Conditions

Panellists:

Anka Ehrhardt, Science Director, CHDI

Foundation

Further panellists to be announced soon

Panel Discussion: Novel Biomarkers For

Cardiovascular And Inflammatory Conditions

Panellists:

Jim Turk, Pathology Director; Lead, Translational

Cardiovascular Pathology and Biomarkers, Amgen

(TBC)

Ji Zhang, Scientist, Cardiorenal Metabolic &

Ophthalmologic Drug Discovery, MSD (Reserved)




Panel Discussion: Multi-Modal Biomarkers For Cancer Detection

And Treatment

Panellists:

Maggie Cheang, Team Leader, Institute of Cancer Research

Caroline Dive, Professor, Cancer Research UK Manchester Institute

(Reserved)

Trevor Graham, Professor of Cancer Evolution, Barts Cancer

Institute (Reserved)

Anguraj Sadanandam, Team Leader, Systems and Precision Cancer


12.20 – 12.30 Closing Remarks

TBC

Closing Remarks




Closing Remarks

Anguraj Sadanandam, Team Leader Systems and Precision Cancer


12.30 – 13.30 Lunch

End-User Workshop End-User Workshop End-User Workshop End-User Workshop

13.30 – 17.00

Hosted by Covance

For Sponsorship Opportunities please

contact

[email protected]


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contact

[email protected]

17.00 Close of Workshops







Day One – 19th February 2020



08.20 – 08.25 Oxford Global’s Welcome Address

08.25 – 08.30 Chairperson’s Opening Address

08.30 – 09.00 Keynote Address: Present And Future Of Precision Medicine

Miro Venturi, Senior Vice President, Biomarkers, Roche

15th Annual Biomarkers Congress Genomic Markers Congress

Biomarkers in Drug Discovery &

Development – Therapeutic Areas:

Oncology & Immunology

Biomarkers for Detection, Monitoring &

Diagnosis

Biomarkers for Clinical Development Genomic Biomarkers in Drug Discovery

and Development

09.00 – 09.30 Title To Be Confirmed

Senior Representative, Covance

Solution Provider Presentation


contact

[email protected]



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09.30 – 10.00 Tumour Localised Activation Of The

Immune System Using Bispecific

Proteins

Markus Zettl, Director Translational

Immuno-Oncology, Pieris

Pharmaceuticals

Data & Big Data Analytics In Oncology:

From PDL1, TBM, EGFR/ALK, BRCA To New

Biomarkers

• From Patient-Level Data & Big Data

Analytics to Patient Biomarkers Data:

from PDL1, TBM, EGFR/ALK, BRCA to new

biomarkers

• What is the Patient Biomarkers Data and

how to use it?

• From the data to the actuatable insights

• Understanding Biomarkers and Patient

Behaviour

Igor Rudychev, Head of US Digital Data

and Innovations, AstraZeneca

Clinical Development Within Immuno-

Oncology

Roy Baynes, Senior Vice President, Head

of Global Clinical Development, Chief

Medical Officer, MSD

Early Translational Studies For

Biomarker Identification And

Qualification In Drug Discovery

Katherine Call, Senior Director and

Head, Proteogenomics, Sanofi

10.00 – 11.20 Morning Coffee & Refreshments, One To One Meetings x4, Poster Presentation Session

11.20 – 11.50 Developing A Biomarker Strategy

Within Oncology

Liz Harrington, Executive Director,

Head of Translational Science UK,

Oncology IMED Business Unit,

AstraZeneca

Biomarker And Companion Diagnostic

Strategies

Annette Amon-Hassenzahl, Clinical Trial

Biosample Manager, Merck KGaA

Developing A Biomarker Precision

Medicine Strategy Within A Clinical

Development Portfolio

Holly Soares, Head of Precision

Medicine, Vice President, Pfizer

Utilising Genomic Technologies As

Predictive Biomarkers In Drug Targets

For Immunotherapy

Deepti Aurora-Garg, Director,

Companion Diagnostics, MSD












Diagnosis


and Development

11.50 – 12.20

Title To Be Confirmed

Senior Representative, Almac


Senior Representative, Nanostring


Senior Representative, Myriad RBM



contact

[email protected]

12.20 – 12.50 Early Biomarker Development For

Cancer Therapeutics

Gerard Sanderink, Global Head,

Biomarkers & Clinical Bioanalyses,

Sanofi

Determining Most Suitable Diagnostic

For The Application (TBC)

Mark Fidock, Vice President & Head of

Precision Medicine Diagnostic

Development, AstraZeneca

Selective Induction Of Functional

Regulatory T-Cells In Healthy Volunteers

By NKTR-358, A Novel IL-2 Conjugate

Treg Stimulator, Being Developed For

The Treatment Of Autoimmune Diseases

• Biomarker data from preclinical studies

• Clinical biomarker results from our Phase

1 healthy volunteer study

Christie Fanton, Director, Translational

Research, Nektar Therapeutics

Functional Omics Approach To Identify

Overlapping And Unique Pain Pathways

Achim Kless, Scientific Director GI-PN-

TSI, Principal Translational Scientist,

Grunenthal

12.50 – 13.40 Lunch, One To One Meetings x2, Poster Presentation Session


Senior Representative, Indica Labs


Senior Representative, Hematogenix


CONFIRMED: Senior Representative, LGC


Senior Representative, Biogazelle N.V.


Senior Representative, Fios Genomics


Senior Representative, Proteome

Sciences


Senior Representative, Fluidigm


Senior Representative, HTG Molecular

Diagnostics











Diagnosis


and Development

14.40 – 15.10 Quantitative Systems Pharmacology

(QSP), An Approach To Mechanistic

Modelling Of The Interaction Between

Biomarkers, Disease Pathophysiology

And Drug Pharmacology With Case

Studies In Autoimmune Disease Quantitative Systems Pharmacology (QSP) is an

approach to mechanistic mathematical

modeling of human disease pathophysiology

and drug pharmacology that integrates

biomarker data from both clinical and non-

clinical sources to build predictive models. QSP

models are used to generate novel hypotheses

about longitudinal patient outcomes and

biomarkers to inform decisions in

pharmaceutical research & development. QSP

requires a unique approach to data collection,

model building, model calibration and model

validation that will be summarized in this

lecture. Examples of the application of QSP

models to inform biomarker outcomes in clinical

development of treatments for autoimmune

diseases will be presented.

Tarek Leil, Head – Quantitative Clinical

Pharmacology, Bristol-Myers Squibb

An Overview Of Platforms For Biomarker

Detection: Flow Cytometry, AI And

Liquid Biopsy

Graham Pockley, Director, John van

Geest Cancer Research Centre, Professor

of Immunobiology, Nottingham Trent

University

Biomarker Platform For Multi-Target

Adoptive Cell Therapy Trials

Arun Satelli, Associate Director Target

Biomarkers, Immatics

Patient Selection Biomarkers In

Preclinical Drug Discovery: Application

To DNA Damage Response Agent In

Cancer Therapy • Introduction on the concept of patient

selection biomarkers

• Impact on drug discovery success

• Introduction to DNA damage response

targeting anti-cancer treatments

• Example of successful patient selection

biomarkers: HRD and PARPi

• Approaches to identify patient selection

biomarkers

o Screening approaches

▪ Cell line panels

▪ Mutagenesis

▪ siRNA

▪ CRISPR/Cas9

o Validation approaches

▪ KD

▪ Chemical perturbation

▪ Isogenic pairs

o Translation to preclinical studies

▪ Identification of the correct

animal models

o Summary and final remarks

Marco Ranzani, Senior Scientist, Artios

Pharma

15.10 – 15.40 Screening Of Therapeutic Monoclonal

Antibodies (TBC)

Mario Richter, Associate Director

DMPK-BA, Operations Large Molecules

and Biomarkers, AbbVie

Serum Progranulin/GP88 Assay To

Monitor Response To Therapy And

Progression Of Disease In Breast Cancer

Patients

Ginette Serrero, Chief Executive Officer,

A&G Pharmaceuticals

PDL1 And Tumour Mutation Burden

Biomarkers In Clinical Development

Rachel Salisbury, Regional Clinical

Director, European Clinical

Development, MSD

Utilising Genetic Biomarkers To Help

Predict Efficacy And Better Understand

Adverse Events

Charles Cox, Head of

Pharmacogenomics, GlaxoSmithKline

15.40 – 16.40 Afternoon Coffee & Refreshments, One To One Meetings x3, Poster Presentation Session










Diagnosis

Biomarkers for Clinical Development Part 2: Data Analysis Of Large Genomic

Samples


Senior Representative, Celerion


Senior Representative, Pelago

Bioscience


Senior Representative, PRA Health



contact

[email protected]

17.10 – 17.40 Workshop – Biomarker Qualification:

Technical Validation And Regulatory

Aspects

Moderator: Thomas Joos, Deputy

Managing Director, NMI Natural and

Medical Science Institute

Presentation 1: Regulatory Aspects Of

Biomarker Qualification

John-Michael Sauer, Program Officer,

Biomarker Programs and Executive

Director, Predictive Safety Testing

Consortium, C-Path Institute

Presentation 2: Case Study Of Novel

Biomarkers For Crohn’s Disease Drug

Development Program – GLDH Kidney

Biomarker

Jiri Aubrecht, Scientific Director,

Translational Biomarker Research,

Takeda

Presentation 3: Technical Validation

And Drug Induced Injury Biomarker

Qualification

Thomas Joos, Deputy Managing

Director, NMI Natural and Medical

Science Institute

Pre-Analytical Processes In Medical

Diagnostics: New Requirements And

Standards

• IVDR requirements for Biomarkers

development

• Pre-analytical ISO standards for

medical diagnostics

• Quality control of biological resources

• Biomarkers validation requirements

• Clinical evaluation requirements

Georges Dagher, Research Director,

INSERM

Best Practices For Incorporating

Potentially Predictive Biomarkers In

Early Clinical Development

Andrew Pierce, Associate Director –

Translational Science Oncology,

AstraZeneca

Harnessing Genomic Technologies To

Extract And Utilise Data From Biological

Samples

Jane Wilkinson, Senior Director, Broad

Genomics Alliance & Project

Management, Broad Institute

17.40 – 18.10 Molecular Screening And Early Detection

For Diagnosing Hereditary Non-

Polyposis Colorectal Cancer

Sudhir Srivastava, Chief of the Cancer

Biomarkers Research Group, NIH

Predictive Blood-Based Biomarkers For

Migraine Clinical Trials

Conrad Cowan, Director Translational

Medicine, Teva Pharm

Implementation Of Pharmacogenomic

Strategies Across Clinics (TBC)

Ana Alfirevic, Professor, Molecular and

Clinical Pharmacology, University of

Liverpool

18.10 – 19.00 Networking Drinks

19.00 Congress Dinner & End of Day One





Day Two – 20th February 2020


08.00 – 09.00 Think Tank Roundtable Discussions & Breakfast

09.00 – 09.30 Keynote Address: Novel Use Of Antibodies As Target Engagement Biomarkers

Alastair Lawson, Fellow and Vice President, Structural Biology, UCB


Development: Neuroscience &

Neurodegenerative Disorders

New Biomarker Technologies & Data Biomarkers for Preclinical Development Genomic Biomarkers For Precision

Medicine And Clinical Practice


Senior Representative, Charles River


Senior Representative, Merck


Senior Representative, Meso Scale

Discovery


For sponsorship opportunities please

contact

[email protected]

10.00 – 11.20 Morning Coffee & Refreshments, One To One Meetings x4, Poster Presentation Session

11.20 – 11.50 Biomarkers In The Context Of

Schizophrenia

Cornelia Dorner-Ciossek, Director in

Discovery Research, CNS, Boehringer

Ingelheim

Enabling Patient Centricity In Clinical

Development Through At Home Sample

Collection For Biomarkers Traditional approaches for measurement of drug

exposure and biomarkers in clinical trials involves

having the patient travel to a clinical site for

collection of venous blood. This puts a burden on

the patient while also limiting the opportunities

for assessment of drug exposure or other

measurements to these clinical visits. The ability

to collect samples at home would provide a more

patient centric approach. At home collection

would provide benefit for more frequent

assessment of drug exposure and biomarkers of

efficacy and toxicity. This talk will share results

from recent pilot studies assessing at home

sampling technologies for biomarker analysis.

Brad Evans, Associate Principal Scientist,

MSD

Preclinical Biomarkers For Bispecific

Drug Discovery

Michelle Morrow, Vice President,

Preclinical Translational Pharmacology,

F-Star Therapeutics

Development Of A Novel Next-

Generation Sequencing (NGS)-Based

Assay For Measurable Residual Disease

(MRD) In FLT3-ITD AML And Its Potential

Clinical Applications • A custom-designed PCR-based fragment

analysis FLT3-ITD assay was developed to select

acute myeloid leukemia (AML) patients with

FLT3-ITD mutations for late-phase clinical trials

at Daiichi Sankyo

• The presence of MRD in patients with AML who

are in morphologic remission has been shown

to be a powerful predictor of eventual relapse

• Using isolated genomic DNA from bone

marrow aspirates or whole-blood samples, PCR

primers flanking exons 14 and 15 of the FLT3

gene were designed, highly diverse NGS

libraries were generated, and a sequencing

depth >100,000x was achieved for this FLT3-ITD

MRD assay

• Clinical utility validation results of this MRD

assay will be presented; this assay could be

used to define the depth of remission, identify

persistent disease, and help guide decision

making in the use of FLT3 inhibitors as

continuation therapy

Ken Chang, Director, Clinical

Biomarkers, Daiichi Sankyo









Neurodegenerative Disorders




Senior Representative, Bio-Techne


Senior Representative, Definiens

Silver Solution Provider Presentation


contact

[email protected]


Senior Representative, Volition


Senior Representative, Miltenyi


Senior Representative, Ultivue


Senior Representative, Intertek



contact

[email protected]

12.50 – 13.20 Solution Provider Presentation


contact

[email protected]


Senior Representative, Quanterix



contact

[email protected]



contact

[email protected]

13.20 – 14.10 Lunch, One To One Meetings x2, Poster Presentation Session

14.10 – 14.40 Biomarkers For Detection Of

Neurological Disorders

Richard Batrla-Utermann, Medical

Director, Roche

Workshop: Data Management &

Integration For Different Biomarker

Types

Moderator: Chanchal Kumar, Associate

Director, CVMD Bioinformatics,

Translational Sciences, AstraZeneca

Participants:


Sciences

Philip Murphy, Head, Clinical Imaging,

GlaxoSmithKline

Senior Representative, Almac (Reserved)


(Reserved)

Ron Kamienchick, Senior Director,

Digital Health, Head of Diagnostics and

Personalized Medicine, Teva

Panel Discussion: Learning And

Challenges In Integrating Data

Translating Exploratory Biomarkers Into

Clinical Trials

Marianne Scheel Fjording, Scientific

Director, Translational Science, Novo

Nordisk A/S

Workshop: Genomic Biobanking To

Facilitate Precision Medicine

• The scope of this field: past and future

perspective

• Novel target discovery through genomic

biobanking

• Role of biobanks in translational

medicine

• Clinical implementation of genomic data

for precision medicine

Moderator: Patrick Kleyn, Vice President,

Rhythm Pharmaceuticals

Invited Speakers:

Senior Representative, GlaxoSmithKline

Senior Representative, Regeneron

Pharmaceuticals

Senior Representative, BioMarin

Senior Representative, Vertex Pharma

Senior Representative, UK Biobank

14.40 – 15.10 Blood Biomarkers In Neurological

Disorders: Utility In Disease

Progression And Patient Response

Thomas Misko, Lead Scientist & Senior

Scientific Director, Translational

Neuroscience, AbbVie

Biomarker Assay Development And

Validation In Support Of A Clinical

Program

Jenny Zhang, Associate Director, Clinical

Biomarker Assay Specialist, Pfizer













Degenerative Disorders



15.10 – 15.40 The Important Developments Within

The Biomarker Field From A

Conceptual Perspective

• Interplay between developments and

guidelines

• Developments within the CNS Field

• Considerations for the future

Birgitte Sogaard, Senior Director

Experimental Medicine, Lundbeck

Workshop Continued: Data Management

& Integration For Different Biomarker

Types

Moderator: Chanchal Kumar, Associate

Director, CVMD Bioinformatics,

Translational Sciences, AstraZeneca

Participants:


Sciences

Philip Murphy, Head, Clinical Imaging,

GlaxoSmithKline

Senior Representative, Almac (Reserved)


(Reserved)

Ron Kamienchick, Senior Director,

Digital Health, Head of Diagnostics and

Personalized Medicine, Teva

Panel Discussion: Learning And

Challenges In Integrating Data

Developing PD Biomarkers For

Monitoring The Treatment Of A Phase II

Clinical Stage Drug

• Preclinical studies to investigate the

mechanism of action of ABTL0812

• Applying the studies in the clinics as PD

biomarkers

Marc Yeste-Velasco, Director,

Translational Research, Ability Pharma

Workshop Continued: Genomic

Biobanking To Facilitate Precision

Medicine

• The scope of this field: past and future

perspective

• Novel target discovery through genomic

biobanking

• Role of biobanks in translational

medicine

• Clinical implementation of genomic data

for precision medicine

Moderator: Patrick Kleyn, Vice President,

Rhythm Pharmaceuticals

Invited Speakers:

Senior Representative, GlaxoSmithKline

Senior Representative, Regeneron

Pharmaceuticals

Senior Representative, BioMarin

Senior Representative, Vertex Pharma

Senior Representative, UK Biobank

15.40 – 16.10 Afternoon Coffee & Refreshments, Poster Presentation Session








Degenerative Disorders



16.10 – 16.40 Understanding Early Markers And

Change In The Predementia AD

Spectrum

Reserved: Johannes Streffer, Vice

President, Head of Translational

Medicine Neuroscience, UCB

Statistical Issues In Biomarker

Validation • Review of some statistical methods relevant

for validation of different types of

biomarkers (prognostic, predictive and

surrogate) for use in e.g. clinical trials or

precision medicine.

• Presentation of some illustrative examples

from Asthma and Chronic Obstructive

Pulmonary Disease (COPD)

• Discussion of various sources of data that

can be used for validation of biomarkers

• Discussion of relevant guidance documents

relevant to validation of biomarkers

• Some simulation results addressing certain

statistical issues: (i) Low statistical power (ii)

Confusion of prognostic and predictive

biomarkers (iii) Use and misuse of

covariates (iv) Using cut points vs. using

continuous data. (v) The need for

pragmatism (vi) Absence of Consensus

• Discussion of additional caveats and

presenting some solutions: (a) data

involving repeated measures (b) multiplicity

issues when e.g. handling multiple

biomarkers. (c) selection bias in meta

analyses (d) Confounding in observational

data

Ziad Taib, Statistics Science Director,

AstraZeneca

Preclinical Experience Using Luminex-

Based Immunoassays • Assay performance plays a critical role when

applying safety biomarkers in drug

discovery

• Multiplex Luminex-based immunoassays

offer several advantages over single-analyte

assays, but also give rise to specific

analytical challenges

• Case examples will be presented

Tim Erkens, Senior Scientist, Non-Clinical

Safety, Janssen

Circulating Biomarkers For Cancer

Diagnosis, Prognosis And Prediction

Yong-Jie Lu, Professor in Molecular

Oncology, Queen Mary University of

London

16.40 – 17.10 LC-MS/MS Assays For Quantification Of

Targets For Muscle Degeneration

Related Diseases

Reserved: Lakshmi Amaravadi

Using The Microbiome As A Biomarker:

New Technologies And Approaches

Yael Silberberg, Director of Data Science,

BiomX

Enabling The Development And

Implementation Of Novel Safety

Biomarkers In Trials And Disease

Diagnosis

Reserved: Shashi Ramaiah, Executive

Director – Global Head of Biomarkers

Drug Safety R&D, Pfizer

Discovery And Implementation Of

Precision Health

Reserved: Rowena Sharpe, Head of

Precision Medicine, Cancer Research UK

17.10 End Of Congress


Documents

Blood biomarkers for early detection of cancer · • Updates in predictive biomarkers for drug development ... New for 2020, we are pleased to introduce a pre-event focus ... •