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23 – 24 May 2012The Business Design Centre, London, UK

sponsors

co-located with

Europe’s largest early development conference

Now in its 6th year, Exploratory Clinical Development World Europe has established itself as the premier & largest European event for early development clinical trial leaders. Engage in the most rewarding 3 days spent out of the office in 2012. Avoid the futility and expense of carrying ineffective novel agents into full scale clinical development by learning current methods to assess safety and efficacy.

If you are looking to alleviate the bottlenecks in early development, Exploratory Clinical Development World Europe, is the leading forum for the world’s top pharma & biotech representatives and will help you find the solutions you are looking for.

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Learn new approaches in de-risking early candidate selection

Improve success rates through the stimulation of open innovation and collaborations

Develop successful early phase clinical design strategies

Maximise opportunities of biomarker lead clinical development

Understand the role of translational medicine

Discover how to make accurate risk assessments in first in human trials

Understand the regulatory environment for developing combination therapies

Review cutting edge research in the scientific poster display

Attend sessions in the co-located Biomarkers World Conference

Return to your company with new ideas and relationships

View the congress website on your phoneScan this QR pattern with the camera on your smartphone to view the Exploratory Clinical Development World website. Don’t have a QR reader app? You can download one for free from the App Store. Don’t have a smartphone? You can also visit the website on www.healthnetworkcommunications.com/explor

ACCELERATING EARLY DEVELOPMENT BIOMARKERS IN EARLY DEVELOPMENTOR

Exploratory Clinical Development World Europe - Wednesday 23 MayDay One

08:30

09:00

10:00

New approaches in de-risking candidate selection

Dr Gvido CebersSenior Project Director, Lead ToxicologistAstraZeneca

The Yin and Yang of biomarkers

Dr Stefan SchererGlobal Biomarker HeadRoche

09:30 Stimulating open innovation and collaborations in Pharma

Dr Andreas WallnoeferSenior Vice President, Global Head of Clinical Development Metabolic and NeuroscienceRoche

Design strategies for success in early phase trials

Dr Nigel DallowDirector of Clinical StatisticsGlaxoSmithKline

11:10 Opening remarksDr Willem Jan Drijfhout, Senior Vice President, Early Development Services, PRA

11:10 Opening remarks from the chair

11:15 Appropriate use of animal models and human disease linkage in COPD for biologicsDr Donna Finch, Principal Scientist, Respiratory, Inflammation and Autoimmunity, MedImmune

11:45 Quantitative prediction of reliability of gene expression based biomarkers for translational medicineProf. Dr. Andreas Schuppert, Director, Applied Sciences, Bayer Technology Serviecs GmbH

12:15 Why invest in biomarkers in early development?Dr Vincenzo Teneggi, Head of Early Development and Clinical Pharmacology, Roche China

13:45 Integration of biomarkers in early drug developmentProf Dr Georg Wensing, Head Development Clinical Pharmacology, Bayer Healthcare

14:15 Biomarker driven novel designs for early clinical trialsDr Richard Buller, Vice President, Translational Oncology, Pfizer

14:45 The use of safety biomarkers for risk assessment of investigative drugs entering first in human studiesDr Nicholas Buss, Toxicology Project Leader, MedImmune

15:15 Application of emerging safety biomarkers in drug development: a path from preclinical safety assessment to clinical translationDr Jiri Aubrecht, Senior Director, Safety Biomarker Group, Pfizer

16:15 Technology integration in biomarking validation for early drug development Prof Anthony Gee, Director of PET and Tracer Development, GlaxoSmithKline

16:45 Biomarkers in early stage CNS clinical developmentDr Mary Savage, Senior Research Fellow, Merck

17:15 Biomarker efforts in the inflammation and remodelling researchDr Jaime Masferrer, Senior Research Fellow and Lead Strategist, Translational Immunology, Pfizer

11:15 Challenges in formulation development in first-in-human strategiesDr David Elder, Director of Product Development, GlaxoSmithKline

11:45 Evaluating the bioperformance Powder in Capsule formulations for use in Phase IDr Brian Henry, Executive Director, Pharmaceutical Research and Development, Pfizer

12:15 Exploratory Clinical TrialsDr Lewis Kinter, Senior Director – Regulatory Toxicology, AstraZeneca

13:45 Flexible Phase I clinical trialsDr Daren Austin, Head, Biopharma Clinical Pharmacology and Biometrics, GlaxoSmithKline

14:15 Pharmacodynamic model-based adaptive design in Phase I first-in-man study Dr Ines Paule, Modeling and Simulation Scientist, Clinical Pharmacology, Actelion

14:45 Strategies for accelerating proof of concept (Fast Track)Dr Willem Jan Drijfhout, Senior Vice President, Early Development Services, PRA

15:15 Design of a proof of concept study in diabetic nephropathy using historical placebo dataDr Laurence Colin, Translational Science Scientific Support, Novartis

16:15 Exploring valuable tools to accelerate CNS product development: steps towards a mechanistic predictionDr Massimo Bani, Global Head Clinical Pharmacology, UCB

16:45 Faster, smarter clinical studiesPilar De la Rocha Mur, Global Monitoring Operations Head, Asia Pacific & South Africa, Novartis

17:15 Regulatory environment for early development in combination therapeuticsDr Walter Janssens, Senior Preclinical Assessor, Preauthorisation, Coordinator Early Phase, Federal Agency for Medicines and Health Products

12:45 Lunch

12:45 Lunch

15:45 Afternoon refreshments15:45 Afternoon refreshments

17:45 Closing remarks from the chair 17:45 Closing remarks from the chair

17:50 Networking drinks reception 17:50 Networking drinks reception

18:00 Evening Seminar: How can QT assessment in early studies be improved to provide same level of confidence as the ICH E14 ‘Thorough QT/QTc Study’?Borje Darpo, MD, PhD, Global Medical Director, iCardiac Technologies

18:00 Evening Seminar: How can QT assessment in early studies be improved to provide same level of confidence as the ICH E14 ‘Thorough QT/QTc Study’?Borje Darpo, MD, PhD, Global Medical Director, iCardiac Technologies

07:30 Registration

08:20

10:30

Opening remarks from the chair

Networking and morning refreshments

Exploratory Clinical Development World Europe - Thursday 24 MayDay Two

09:00

09:30

10:00

10:30

11:30

12:00

12:30

14:00

14:30

15:00

16:00

16:30

17:00

Proven predictive preclinical models for projections of anticipated human dose, PK/PD and food effect for optimized clinical outcome

Dr Tycho HeimbachFellow and LabheadNovartis

Leveraging toxicological study data to rationally design early clinical trials for unconventional biologics

Dr Balaji AgoramDirector, Clinical Pharmacology & DMPKMedImmune

Bridging systems biology and PKPD - towards novel drugs

Dr Piet van der GraafDirector of Discovery Biology and Head of Sexual HealthPfizer

PK/PD modelling in early clinical development

Dr Rolf BurghausHead of Modeling and Simulation, Clinical PharmacologyBayer Healthcare

Early predictions of pharmacokinetics in man

Dr Thierry LaveHead DMPK Modeling and SimulationRoche

Process enabling in early drug development

Dr Russell LindermanExecutive Director, Research Science & Technology PGRDPfizer

Novel exploratory approaches to define clinical PK and ADME – microdoses and microtracers

Graeme YoungManager of Accelerator Mass Spectrometry, Drug Metabolism and PharmacokineticsGlaxoSmithKline

Should a cardiac safety assessment strategy start with the first in human study?

Boaz MendzelevskiVice President CardiologyCoreLab Partners

Approaches and considerations in the cardiovascular safety assessment of compounds with QT effects and mixed ion channel activities

Dr Gary EichenbaumPreclinical Development LeaderJohnson & Johnson

Assessing safety in first in human clinical trials

Dr Malcolm MitchellMedical Director, Clinical PharmacologyEli Lilly

Making accurate risk assessment of first in human clinical studies

Dr Beate RohdeVice President, Head of Development Clinical Pharmacology WH/DI/STHBayer Healthcare

Detecting drug induced injury in early development

Dr Michael MerzPreclinical Safety, Translational SciencesNovartis

Dose selection for biologics first in human clinical trials

Dr Antoine DeslandesScientific Advisor – Biotherapeutic Drug DispositionSanofi Aventis

TRANSLATIONAL MEDICINE

FIRST IN HUMAN SAFETY

Go to www.healthnetworkcommunica-tions.com/explor for more details

08:00

11:00

15:30

17:30

13:00Registration

Morning refreshments

Afternoon refreshments

Closing remarks from the chair

Lunch

08:50 Opening remarks from the chair

Your workshop speakers

Dr Peter Clements, Director of Pathology, GSKDr David Salinger, Principal Scientist, AmgenDr Bernard Leblanc, Consultant, Non-Clinical Safety, NovosafeProf Colin Garner, Ex-Xceleron CEO; Principal, Garner Consulting Services; Honorary Professor, Hull York Medical SchoolDr Marten Heeringa, Associate Scientific Director, AstellasDr David Jones, Expert Pharmaco-Toxicologist, MHRADr Laurent Audoly, Chief Scientific Officer, Pieris Dr Gerhard Gross, Head Drug Metabolism, Lundbeck

Register today for a tailored sponsorship package to meet your business objectives.Contact Claire Conway on +44 (0) 207 608 7058 or email cconway@healthnetworkcommunications.com

www.healthnetworkcommunications.com/explor

“Interactive session, wide range of topics covered”

Country Study Manager | GlaxoSmithKline

Dr Jochen TheisPrincipal consultantInHeCon

Your workshop leader

Strategies to de-risk candidates in early drug development

Realising the full potential of biomarkers in early clinical development

Objective This workshop will assist participants in understanding de-risking strategies in non-clinical and early clinical development and their approach to current regulations.

ObjectiveThis interactive session will provide attendees with a clinical viewpoint on the effective discovery, characterisation and clinical utilisation of fit for purpose biomarkers. It will address these core questions in a highly interactive way.

Workshop 1 Workshop 2

Tuesday 22 May 2012Tuesday 22 May 2012

8:30 Registration and refreshments

10:20 Morning refreshments

15:10 Afternoon refreshments

12:50 Networking lunch

9:00 Pre clinical studies, modelling and simulation to inform early development

10:50 Revision of the ICH M3 guideline

12:10 Enhanced Phase 0 / I studies using microtracers

13:50 Regulatory review and safety assessment for first in human trials

15:40 Path to clinical development a novel therapeutic

16:20 End of workshop

8:30 Registration and refreshments

9:00 Sub classes of biomarkers and technology overview

10:30 Morning refreshments

11:15Utilisation of biomarkers in translational and exploratory medicine

12:45 Networking lunch

13:45 Effective clinical trial design with the inclusion of biomarkers

15:15 Afternoon refreshments

15:45 Logistical, operational and commercial aspects

16:30 End of workshop

REGISTER NOW

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Contact

Use our unique on-line contact system to boost your networking opportunities – look through the attendees to find your contacts and make your time at the conference work for you. Speak to your fellow attendees before and keep in touch after the conference.

Scientific Poster Display

The poster display will provide an interactive opportunity for researchers and practitioners to present their new and innovative work-in-progress. Don’t miss this opportunity to share your on-going research projects and obtain feedback from your peers and leading scientists.

Co-located Conference

Exploratory Clinical Development World Europe is co-located with Biomarkers World Europe. As an attendee of Exploratory Clinical Development World Europe you will be able to attend any of the biomarkers World Europe presentations allowing you more choice over your conference format. www.healthnetworkcommunications.com/explor

Bringing you dedicated 1:1 meetings

Identify the people you would like to meet with and we will arrange 1:1 meetings on your behalf. Make the most of your precious time by ensuring you have a pre-arranged and qualified meeting schedule, ensuring you spend your time meeting the right people not looking for them.

Keep in touch with the industry and get the latest information on the event. Go to www.healthnetworkcommunications.com/explor

“Excellent! Very interactive, communicative, responsive attendees!”

Senior Business Director | Ascent

Who should attend

PK/PD

Clinical Pharmacology

Translational Medicine

MedicalDirector

ClinicalDevelopment

Phase I Trials

Exploratory Development Clinical

Research

Co-located conference

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“High quality of speakers, all well prepared, covering a broad range of topics”

Clinical Project Manager | UCB

Scientific Poster DisplaySubmit a poster and review your research with peers and experts in the field, a rare opportunity to share your thoughts and refine your work.

Supported by

Exploratory Clinical Development is co-located with Biomarkers World Europe. As an attendee you will be able to attend any of the Biomarkers World Europe presentations allowing you more choice over your conference programme. www.healthnetworkcommunications.com/biomarkers

Consulting Services

Cardiac Safety Experts

Full-Service CRO’s

NicheCRO’s

Laboratory Services Technology

& Product Innovators

Electronic Data Capture

Vendors

Who should sponsor

Clinical Trial Design

Limited sponsorship opportunities Contact Claire Conway on +44 (0) 207 608 7058cconway@healthnetworkcommunications.com

To position your company as a leading solutions and service provider

Meet your market

Demonstrate your expertise

Generate brand awareness

Develop relationships

Why sponsor?

Featured sponsor

“Excellent content and great organisation”

Global Head | Roche

"Very useful to keep abreast of latest issues facing drug development and potential solutions being developed"

Director | Napp Pharmaceuticals

1:1 NetworkingSelect who you want to meet up with in advance and a Facilitated Networking Manager will arrange meetings for you!

PRA’s Early Development Service group conducts Phase I-IIa studies in our clinics in Europe and

the U.S. with bioanalytical laboratories in close proximity to each, facilitating analysis of time-critical patient samples. Additionally, we operate our Unit on Demand model in Central and Eastern Europe for early phase patient studies.

Pharmaceutical and biotech price

Service provider/vendor price

Register before

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02 March 2012

02 March 2012

Days

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13 April 2012

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04 May 2012

04 May 2012

22 May 2012

22 May 2012

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3 days

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