pharma

YOU MIGHT BE INTERESTED IN

Global Clinical Trial Business Report & Analysis 2008-2018
The global clinical trials business is worth an estimated $50bn in 2008, with a growth of rate of 10%. The market will show considerable growth in the future, as this visiongain report, Global Clinical Trial Business 2008-2018, explains in detail. In recent years, the nature of clinical trials has changed considerably.
...more details
In Vitro Diagnostics Market Report & Analysis 2008-2023
Technological solutions are playing an increasingly important role in both clinical practice and pharmaceutical R&D - increasing safety, speeding up clinical development and facilitating regulatory acceptance. Furthermore, current developments in diagnostics - especially molecular diagnostics - are paving the way towards the long-held goal of personalised medicine, to the benefit of patients, companies and healthcare providers.
...more details

CONFERENCE

...see all

2nd Annual Biomarkers Conference

Discovery, development, validation and advancement in biomarkers

16th - 18th March 2009, BSG Conference Centre, London, UK

Download brochure Products

Background Info
Workshop
Day 1
Day 2
Partners
Past Papers

Platinum Sponsor

Associate Sponsor

Media Partners

Background Info

"Market for biomarkers and related tests was worth approximately $11 billion in 2008 and this figure will expand to $19 billion by 2013" - Jain PharmaBiotech 2009

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

Key Speakers
• Dr Michael Binks, Head, Immuno-Epigenetics DPU Immuno-Inflammation CEDD, GlaxoSmithKline
• Eugenii A (Ilan) Rabiner, Director, Clinical Imaging Applications, GlaxoSmithKline
• Magnus Ivarsson, Team Leader in the Biomarker group, Pfizer
• Dr Jochen Theis, Owner and Principle Consultant, InHeCon Jochen Theis
• 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
• Gregory I. Berk, Chief Medical Officer, SuperGen
• Dr. Gerald Schnell, Partner, Simon Kucher & partners
• Dr Elke Roschmann, Senior Director Strategic Development & Licensing, Epidauros Biotechnologie
• Dr. Joanna Segieth, Director, BioSynetix Ltd
• Dr. Vincent Saulot, CEO, MicroBioChips Sas

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

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.

Day 1

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 Jochen Theis

10:50 Developing preclinical translatable biomarkers
• Biomarker definitions
• Preclinical biological markers in drug development
• Identification of translatable biomarkers

Magnus Ivarsson
Team Leader in the Biomarker group
Pfizer

11:30 Morning refreshments

11:50 Protein and antibody arrays for biomarker discovery and validation
• Serum antibody profiling
• Validation of proteomic data
• Validation of genomic data
• Custom antibody array
• New high-multiplicity nano-array technology

Dr. Vincent Saulot
CEO
MicroBioChips Sas

BIOMARKER CHALLENGES IN SPECIFIC THERAPEUTIC AREAS

12:20 Biomarkers in oncology
• Problems in developing biomarkers for cancer management
• The development of prognostic biomarkers for cancer
• The development of prognostic and predictive markers for cancer therapeutics

Dr. Richard Kennedy
Vice President of Translational Research and Development, Almac Diagnostics
Honorary Consultant in Medical Oncology, Belfast City Hospital

13:10 Networking lunch

14:10 Rational Incorporation of Biomarkers into Oncology Trials
• When do we develop a biomarker?
• How can we optimize the use of biomarkers in early drug development?
• How have biomarkers performed in oncology drug development?
• Incorporating biomarkers into the PK-PD model
• Using biomarkers for Go/No-Go decisions
• Establishing a surrogate marker though large late-stage trials

Gregory I. Berk, MD
Chief Medical Officer
SuperGen

14:40 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

15:20 Molecular imaging in CNS drug development - a biomarker aiding asset progression
• Molecular imaging in the CNS can provide information to facilitate the flow of assets through the drug-development pipeline
• Each stage of drug development raises specific questions which molecular imaging can aid in answering with appropriate experimental designs
• Mature methodologies, such as brain penetration studies and target occupancy studies can aid in go-no-go decision making
• Optimum utilisation of molecular imaging require a good understanding of the underlying methodology, and the assumptions inherent in its use

Eugenii A (Ilan) Rabiner
Director, Clinical Imaging Applications
GlaxoSmithKline

16:00 Afternoon refreshments

16:20 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

17:00 Biomarkers in inflammation and immunology

Michael Binks
Head, Immuno-Epigenetics DPU
GlaxoSmithKline

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.

Day 2

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 Jochen Theis

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
• 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 Commercialisation Excellence for Innovative Molecular Diagnostics
• Commercialisation Strategies for Molecular Diagnostics Molecular Diagnostics and its Place in Personalised Medicine
• Commercialisation Hurdles and Strategies for Molecular Diagnostic
- Physician Perspective ? Demonstrate Impact on Clinical Outcomes
- Payer Perspective ? Demonstrate Impact on Physicians? Clinical Practice or Choice
- Lab/Hospital Perspective ? Demonstrate Profitability to Test Providers Summary and Implications for Molecular Diagnostics

Dr. Gerald Schnell
Partner
Simon Kucher & PART

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
• Monitoring kidney safety in drug development: emerging technologies and their implications
• Promises of biomarkers in drug development--a reality check

Estelle Marrer
Biomarker Expert
Novartis*

13:10 Networking lunch

BIOMARKERS – COMMERCIAL ASPECTS

14:30 Presentation to be announced

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
• 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

17:30 Chair’s closing remarks and end of conference

Partners

Platinum Sponsor:

IMS Health
Operating in more than 100 countries, IMS Health is the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries. With $2.2 billion in 2007 revenue and more than 50 years of industry experience, IMS offers leading-edge market intelligence products and services that are integral to clients’ day-to-day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and consumer health offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide. For further information please visit: www.imshealth.com

Associate Sponsor:

Almac Group
Almac’s core expertise is in the provision of translational genomic based solutions. We have our own pipeline of IVD tests in development which have been developed from FFPE tissue.
With experience, expertise and unique Cancer DSA™ technology we offer translational genomic solutions including:
• companion diagnostics
• predictive biomarkers
• drug repositioning
• diagnostic and prognostics biomarkers
Our Cancer DSA™ technologies are the first high density microarrays which focus on the transcriptome of an individual disease. They contain the most comprehensive information available for the disease under investigation on a singe array and enable the obtaining of robust data from FFPE and FF samples.
We specialise in biomarker identification and validation, bioinformatics solutions and companion diagnostic development. For further information, please visit www.almacgroup.com

Media Partners:

PharmiWeb
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported
by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Nanomedicine: NBM
Nanomedicine: Nanotechnology, Biology, and Medicine (Nanomedicine: NBM) is an international, peer-reviewed journal focusing on basic, clinical, and engineering research in the field of nanomedicine. Article categories include basic, diagnostic, experimental, clinical, engineering, pharmacologic, and toxicologic nanomedicine. In addition, regular features address the commercialization of nanomedicine advances, ethics in Nanomedicine, funding opportunities, and other topics of interest to researchers and clinicians. We invite authors to submit original manuscripts and review articles. Visit the Journal online at www.nanomedjournal.com!

If you would like more information on the range of sponsorship or exhibition possibilities for this conference, please contact :
Ron Folgate, +44 (0)20 7549 9948
ron.folgate@visiongainglobal.com

Past Papers

Past papers are free to delegates. If you are unable to attend the event, Past Papers are published two weeks after the event and are available to purchase.

Buy Now