 2nd
Annual Biomarkers Conference
Discovery, development, validation and
advancement in biomarkers
To be held at 16th - 18th March
2009, BSG Conference Centre, London, UK
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Background Info
The biomarker market was
worth $5.5bn in 2007 and is forecast to grow at a CAGR of 17.6%
to $12.4b in 2012 - Business Insights, 2008.
The development and application of biomarkers have become an
increasingly important topic for the pharma/biotech companies.
Biomarkers are not only used as the valuable tools in the early
development stages in the lifecycle of a new drug but they also
play a significant role after the drug is introduced in the
market.
Our 2nd Annual Biomarkers Conference will provide an ideal
platform for the attendees to get an overview of the biomarkers.
This conference will enable you to identify and overcome the
challenges in the specific therapeutic areas and understand the
new developments and recent advancements in the field of
biomarkers.
Reasons for attending the Conference:
- Share and discuss the growth
trends in the biomarkers
- Get timely answers to the key
questions about the role of biomarkers in drug development and
clinical use
- Identify the challenges in the
specific therapeutic areas
- Examine the biomarker data
management and analysis
- Understand the recent
advancement in imaging modalities as biomarkers
- Hear about the effective
biomarker out- and in-licensing
- Gain an insight into the
commercial aspects in biomarkers
- Discuss the latest biomarker
assay developments and methods of clinical validation
Who will be there?
VPs, Directors, Heads and Managers of:
- Biomarker Development
Programmes
- Clinical Pharmacology
- Clinical Research
- Drug Discovery and Development
- Alliance Management
- Safety Assessment
- Assay Development
- Proteomics/ Genomics
Programmes
- Regulatory Affairs
- Translational Medicine
- Oncology
- CNS
- Inflammation and Immunology
- Biological Sciences
- Marketing
- Product
- Diagnostics
- Bioanalysis
- Pharmacokinetics & Drug
Metabolism
- Genomics Business Development
- Strategic Alliances
- Cellular & Molecular Dev
- Clinical Discovery
Technologies
- Pharmacogenomics & Human
Genetics
- Discovery Research
- Bioengineering
Key Speakers
- Dr Harsukh Parmar, Global Head
of Early Clinical Development Respiratory & Inflammation
Therapy Area, AstraZeneca
- Dr Michael Binks, Head,
Immuno-Epigenetics DPU Immuno-Inflammation CEDD,
GlaxoSmithKline
- Dr Jochen Theis, Owner and
Principle Consultant, InHeCon - Jochen Theis & Associates
- Dr Richard Kennedy, Vice
President of Translational Research and Development, Almac
Diagnostics
- Dr Christian Czech, CNS
Research, Roche
- Dr Oliver Steinbach, Senior
Director, Department Bio-Molecular Engineering, Philips
Research
- Dr Eddie Blair, Director,
Integrated Medicines
- Dr Timothy Ebbels, Lecturer in
Computational Bioinformatics, Imperial College London
- Dr Manuel Mayr, Lecturer,
Cardiovascular Division, Kings College London
- Dr Elke Roschmann, Senior
Director Strategic Development & Licensing, Epidauros
Biotechnologie
- Prof K. K. Jain, CEO,
PharmaBiotech
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Workshop :
Pre-Conference Interactive
Workshop:
Fit for purpose biomarkers and pharmacodiagnostics in clinical
development
Monday 16th March 2009
Timings: 09:30 - 10:00 Registration & refreshments
10:00 - 16:00 Workshop (Timing includes lunch and refreshment
breaks)
Led by:
Dr. Jochen Theis
Principle Consultant, InHeCon - Jochen Theis & Associates
Former Global Head, Biomarkers and Experimental Medicine, F.
Hoffmann La Roche
About the Workshop:
Biomarkers are frequently driven
by laboratory or technology based experts pushing their
technologies into the clinical arena. This course is designed to
provide the attendants with a clinical viewpoint on the
effective discovery, characterisation and clinical utilisation
of fit for purpose biomarkers. The course recognises that
biomarkers and pharmacodiagnostics exist in a truly
multidisciplinary environment, which requires the integration of
many expertises in order to provide the full value of biomarkers
and pharmacodiagnostics to each development project.
Workshop agenda:
The course is aimed to be very
interactive and to address the following topics:
- Subclasses of Biomarkers - and
their lifecycles
- PD biomarkers
- Disease and surrogate biomarkers
- Predictive biomarkers and pharmacodiagnostics
- Biomarker technologies
overview – how can they provide clinical value?
- DNA, RNA, Proteins, Metabolites
- Imaging
- Others
- Logistical and operational
challenges of biomarker utilisation
- Clinical studies
- Projects at various development stages
- Effective partnering
- Commercial aspects of
biomarkers
- Ensuring cost effective biomarker provision
- Translating biomarker approaches into commercial value
- Pharmacodiagnostics
Who should attend?
Effective provision and utilisation of biomarkers requires an
extremely interdisciplinary approach and understanding. This
one-day workshop is therefore designed to provide valuable
insight across disciplines for individuals from pharmaceutical,
biotech, diagnostics and other life science companies having
responsibilities in such diverse areas as research, medical
science, laboratory technology, clinical development, clinical
pharmacology, regulatory affairs, commercial, operations,
logistics, quality assurance and project management.
About your workshop leader:
Jochen Theis is a recognised expert in the area of
biomarkers, pharmacodiagnostics and translational medicine. He
has recently founded InHeCon, an integrated healthcare
consultancy serving clients in the pharma/biotech, diagnostics
and venture capital industries. InHeCon works with the clients’
management or project teams to enable modern, rational, and
decision focussed drug and accompanying diagnostics development
through integrated application of clinical biomarkers,
technologies and innovative study designs.
Jochen is a physician with clinical training in paediatrics and
board certification in clinical pharmacology. He held positions
of increasing responsibility in all phases of clinical
development in Boehringer Ingelheim, GlaxoSmithKline, and F.
Hoffmann La Roche. His last position in Roche prior to founding
his consultancy was Global Head of Biomarkers and Experimental
Medicine with responsibility for all clinical biomarker and
pharmacodiagnostic activities related to Roche’s early and late
stage pharma projects.
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Day 1 : Tuesday
17th March 2009
09:30 Registration and
refreshments
10:00 Opening address from the chair
Dr Edward D Blair
CEO, Integrated Medicines
Former Director of Applied Diagnostics and Surrogates,
GlaxoSmithKline
BIOMARKERS – AN OVERVIEW
10:10 Biomarkers in drug development and clinical use
- Challenges to the
pharmaceutical industry: Why do we need biomarkers in pharma
R&D?
- Effective investing into
biomarkers: What biomarkers do we need?
- Biomarkers activities within
the R&D value chain: When are biomarker activities necessary?
- Enabling successful biomarker
activities: How are biomarker activities best managed?
- Delivering biomarker
solutions: Who needs to contribute, who needs to lead?
- Delivering biomarkers in R&D
projects: Why? What? When? How? Who?
Dr Jochen Theis
Owner and Principle Consultant, InHeCon
Former Global Head, Biomarkers and Experimental Medicine, F.
Hoffmann La Roche
10:50 Utility & value of biomarkers in human target
validation to change the R & D operating model
Dr Harsukh Parmar
Global Head of Early Clinical Development Respiratory &
Inflammation Therapy Area
AstraZeneca
11:30 Morning refreshments
11:50 Presentation to be announced
12:30 Biomarker assay development and validation
- Identifying best practices in
assay development
- Assessing difficulties in
assay development
- Discussing recent developments
Peter Kelly
R&D Manager
Axis-Shield
13:10 Networking lunch
BIOMARKER CHALLENGES IN SPECIFIC THERAPEUTIC AREAS
14:30 Biomarkers in oncology
- Problems in developing
biomarkers for cancer management
- The development of prognostic
biomarkers for cancer
- The development of
pharmacokinetic and predictive biomarkers for cancer
therapeutics
Dr Richard Kennedy
Vice President of Translational Research and Development, Almac
Diagnostics
Honorary Consultant in Medical Oncology, Belfast City Hospital
15:10 Biomarkers in inflammation and immunology
Michael Binks
Head, Immuno-Epigenetics DPU
GlaxoSmithKline
15:50 Afternoon refreshments
16:10 Recent advances in biomarkers for Alzheimer’s disease
- New approaches for disease
modification in Alzheimer’s disease
- Strategies for biomarker
discovery
- Metabolic profiling of
Alzheimer’s disease cerebrospinal fluid
Dr Christian Czech
CNS Research
Roche
16:50 Cardiovascular biomarker opportunities & challenges
- Predisease biological markers:
early diagnosis and prevention of arterial hypertension
- C-reactive protein, cytokines
and inflammation in cardiovascular diseases
- Key issues in the developing
synergism between cardiovascular imaging and biomarkers
- New cardiovascular biomarkers:
clinical implications in patients with valvular heart disease
Dr Mauel Mayr
Lecturer, Cardiovascular Division
Kings College London
17:30 Closing remarks from the chair
17:35 Networking Drinks Reception
Take your discussions further and build new relationships in
a relaxed and informal setting.
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Day 2 :
Wednesday
18th March 2009
09:30 Registration and
refreshments
10:00 Opening address from the chair
Dr Jochen Theis
Owner and Principle Consultant, InHeCon
Former Global Head, Biomarkers and Experimental Medicine
F. Hoffmann La Roche
TECHNOLOGY SECTION
10:10 See, treat, cure: Biomarkers and imaging for diagnosis
and treatment of diseases
-
Molecular imaging as a fast developing field to analyse
pathological processes at the cellular and molecular level
rather than anatomical level as in ‘classical’ diagnostic
imaging
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Use of in-vivo imaging for early detection and staging of
diseases, more accurate therapy planning and monitoring, and
improved follow-up care
-
Development of targeted (contrast) PET, MRI, ultrasound and
others to detect imaging biomarkers
-
Imaging techniques to visualise and follow drug –target
interaction and biological processes in-vivo on a molecular
level for development of new drugs and therapies for mental
disorders, cardiovascular diseases and cancer
-
Need of precompetitive collaborations and networks to advance
the development of biomarkers and biosignatures
Dr Oliver Steinbach
Senior Director, Department Bio-Molecular Engineering
Philips Research
10:50 Genetics and epigenetics – where are we heading?
-
General morphological and biological features of neoplasms:
integration of molecular findings
-
Dissection of signal transduction pathways as a tool for the
development of targeted therapies
-
New pathways in epigenomics
David Latto
European Business Development Manager
Oxford Gene Technology*
11:30 Morning refreshments
11:50 Bioinformatic approaches for predicting toxicity and
biomarker data mining in metabolic profiling
-
How metabolic profiling can be used to investigate toxicity in
pre-clinical toxicology trials
-
Bioinformatic methods for modelling metabolic profiles and
deriving predictive models
-
Identifying and ranking putative metabolic biomarkers and
other characteristics from statistical models
Dr Timothy Ebbels
Lecturer in Computational Bioinformatics
Imperial College London
12:30 Making sense of the data: Biomarker data management and
analysis
-
New technologies around biomarkers and their interplay with
drug development
-
Emerging technologies and their implications
-
Promises of biomarkers in drug development--a reality check
Hermann-Josef Huss
Head-Data Acquisition and Management, Europe and Overseas
Bayer Healthcare*
13:10 Networking lunch
BIOMARKERS – COMMERCIAL ASPECTS
14:30 Commercialisation of biomarkers
-
Biomarkers markets linked with molecular diagnostics,
proteomics, drug discovery, clinical trials, pharmacogenomics/
pharmacogenetics, and bioinformatics
-
Biomarker markets according to technologies/applications
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Biomarker markets according to therapeutic areas
-
Geographical distribution of biomarker markets
-
Drivers for the growth of markets for biomarkers
-
Strategies for developing biomarker markets
Prof. Kewal K Jain
CEO
PharmaBiotech
15:10 Effective biomarker out- and in-licensing
-
Key factors in effective and collaborative partnerships
-
IP issues
-
Building up your pipeline
Dr Joanna Segieth
Director, BioSynetix*
Former Manager, Clinical Development, GlaxoSmithKline
15:50 Afternoon refreshments
PHARMACODIAGNOSTICS
16:10 Selecting the right drug for the right patient – a view
from the diagnostics industry
-
Challenges and opportunities for the development of predictive Dx- tests for clinical use
-
Tests to reduce side effects versus tests to improve efficacy
-
Co-development of Dx- and Rx versus development of Dx-
post-approval of Rx
-
Demonstration of clinical utility
-
Demonstration of cost-effectiveness
-
Adoption of tests in clinical practise
-
Regulatory and reimbursemenent issues
Dr Elke Roschmann
Senior Director Strategic Development & Licensing
Epidauros Biotechnologie
16:50 Expectation management: Providing value to the
patients, the society the pharma- and the diagnostics-industry
-
Patients lie at centre of value net supported by industry,
government and primary healthcare providers and have personal
expectations that must be managed by these other stakeholders
-
Articulation of economic value begins with assessment of the
added value that biomarkers, in form of on-market companion
diagnostic tests, bring to innovative treatment approaches
-
Additional value drivers come from how and when these
innovative treatment approaches are delivered, in addition to
the basic assumptions that they will be safe and effective
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The impact of patient demographics and thus changes in disease
modalities (e.g., acute to chronic illness) must be considered
in delivering innovative treatments in times to come
Dr Edward D Blair
CEO, Integrated Medicines
Former Director of Applied Diagnostics and Surrogates,
GlaxoSmithKline
17:30 Chair’s closing remarks and end of conference
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information, kindly contact us
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Phone : +91 22 2757 8668 /
2757 9438
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