exploratory clinical trials

Tuesday 8 and Wednesday 9 December 2009, Sheraton Brussels Airport hotel, Brussels, Belgium

KEYNOTE SPEAKERS:Dr. Thomas Senderovitz, Vice President Global Exploratory Development, UcB NEW mEDiciNES BELGiUm

Dr. Stephan Formella, Section head of human clinical Pharmacology, BOEhRiNGER iNGELhEim GERmANY

Prof. Johan Luthman, Vice President, Neuroscience R&D, mERcK USA

JW mcBlane PhD, Senior Pre-Clinical Assessor, mhRA UK

Dr. håkan Wennbo, Global Project Director, Cardiovascular & Gastrointestinal, ASTRAZENEcA SWEDEN

Dr. James Dow PhD, Director of Clinical Pharmacology & DMPK, (OSi) PROSiDiON UK

Edis Travancic, Director, Pharmacokinietics & Bioanalysis, BiOViTRUm SWEDEN

Bruno Boulanger, Director Exploratory Studies, UcB PhARmA BELGiUm

Gaby Anthonijs, Associate Director Clinical Pharmacology, Exploratory Development Department, ASTELLAS PhARmA GLOBAL DEVELOPmENT EUROPE NEThERLANDS

Erik mannaert, Director Clinical Pharmacokinetics, J & J PhARmAcEUTicAL R&D (a Division of Janssen Pharmaceutica N.V.) BELGiUm

TOP cOmPANiES REPRESENTED iNcLUDE:UCB• HOFFMANN-LA • ROCHEBAYER• MHRA• ASTRAZENECA•

BOEHRINGER • INGELHEIMNOVARTIS• FAMHP• ASTELLAS• JOHNSON • & JOHNSON

mAiN hiGhLiGhTS iNcLUDE:

16 • leading manufacturers represented on the programme to deliver case study driven presentations Spot • on presentation from the MHRA about the new ICH M3 guidelines coming into action this December 2009Benefi t • from the co-location with the 3rd annual Adaptive Clinical Trials conference to double your networking opportunities

ViBpharmaco-located with the 3rd annual Adaptive clinical Trials conference

Ensuring faster go/no-go decisions though effi cient exploratory development and studies to maximise cost and time savings

Exploratory clinical Trials

Register online now at: www.clinicaltrialsevents.com/exploratory

(OSi) PROSiDiON UK(OSi) PROSiDiON UK


Ensuring faster go/no-go decisions though effi cient exploratory development and studies to maximise cost and time savings



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Programme Day One Tuesday 8 December 2009

Linking therapeutic concepts to diseases successfully ●

Uncovering a comprehensive evaluation of pharmacodynamic actions ●

to maximise study success Identifying the best organisational solutions for integrated R&D ●

Prof. Johan Luthman, Vice President, Neuroscience R&D, mERcK USA

12:10 case study: connecting the dots from the pre-clinical phase to the probability of success: making it a reality through the integration of Bayesian statisticsOutlining how to turn information generated in pre-clinical phases ●

into direct valueIndicating how modelling is used to improve efficiency of exploratory ●

trials through the use of adaptive designs, optimal designs or Bayesian modellingIntroducing prediction-based decision-making and demonstrating the ●

new added value for clinical trials: improving predictionsUsing assay performance knowledge to improve clinical trial performance ●

Giving a broad Bayesian modelling perspective on exploratory ●

developmentDr. Bruno Boulanger, Director Exploratory Statistics, UcB PhARmA BELGiUm

12:40 Effectively overcoming the challenges in Fih studies in order to maximise study successChoosing a safe starting dose to ensure compliance with ●

national regulationsOutlining tools and techniques to maximise the success rate through ●

the use of practical examplesFlexible, data driven protocol design to combine SAD and MAD in ●

FIH studiesDebating if patients in other therapeutic areas to oncology can be ●

included in FIH studiesPhase ● 0 microdosing studies – do we really need labelled compounds?Dr. James Dow PhD, Director of clinical Pharmacology and DmPK, (OSi) PROSiDiON UK

13:10 Lunch

14:10 Optimising the design of early Phase i studies to achieve Poc fasterSelecting appropriate populations to conduct successful early ●

Phase I studies Outlining different model based approaches to achieve PoC faster ●

Maximising efficiency of PoC and proof-of-mechanism (PoM) studies ●

to improve translatability Achieving better informed dose selections ●

michael Derks, metabolic Disease Area clinical Pharmacologist, hOFFmANN-LA ROchE SWiTZERLAND

highlighting the role of animal models in translational medicine and how exploratory studies benefit14:40 case study:

The role of translational medicine in exploratory development and its impact on exploratory studies Exploring the mechanisms of action and potential importance of new ●

discoveries though effective experimental medicine Utilising biomarkers to detect drug effects in man and to demonstrate ●

pharmacological activity and the mechanism of action of novel drugs Ensuring a better understanding of the disease mechanism by ●

increasing the investment in clinical target validation and by performing more exploratory studies Improving the targeting of new drugs to increase the overall success ●

rates and the benefits of new drugs for patients Dr. håkan Wennbo, Global Project Director, cardiovascular and Gastrointestinal, ASTRAZENEcA SWEDEN

15:10 Afternoon refreshments

08:30 Registration

09:00 Opening remarks from the chairDr. Thomas Senderovitz, Vice President Global Exploratory Development, UcB NEW mEDiciNES BELGiUm

Looking into the crystal ball: forecasting the future of the pharmaceutical industry09:10 Keynote:

changing the game: a look into the future of Research and Development (R&D) in the pharmaceutical industry How can pharma R&D change and become more productive? ●

What will the future pharma-healthcare landscape look like? ●

Why is this relevant for you – translational and exploratory ●

medicine experts?Dr. Thomas Senderovitz, Vice President Global Exploratory Development, UcB NEW mEDiciNES BELGiUm

maximising the efficiency of ADmE and PK properties to improve the translatability into the clinic09:40 Best practice strategies for the prediction of ADmE

properties in humans from preclinical dataUsing human in vitro data versus animal studies to ensure data accuracy ●

Outlining the role of transporters in human drug disposition to ●

maximise precisionAccurately assessing drug metabolism and the potential role of ●

metabolites in assessing efficacy and safetyIdentifying the differences between small molecules and biologics ●

Edis Travancic, Director, Pharmacokinietics and Bioanalysis, BiOViTRUm SWEDEN

10:10 Determining human ADmE/PK early in clinical drug development to forecast and ensure study successRunning human Phase ● 0 microdosing studies – debating the pro’s and con’sMeeting the US FDA ‘MIST’ guidance using innovative protocol ●

designs to ensure regulatory compliance Determining absolute bioavailability and IV PK without extensive ●

preclinical studiesIs there a new paradigm for determining human PK? ●

Prof. colin Garner, molecular Epidemiology, Department of Biology, UNiVERSiTY OF YORK UK

10:40 Morning refreshments

Overcoming the challenges of personal medicine and patient selection by utilising selection and diagnostic tools11:10 case study:

Using pre-clinical data to facilitate the development of patient selection toolsMaximising the identification of patient populations for personalised ●

healthcare by utilising molecular diagnostics Increasing the likelihood of robust identification of those patients ●

who would benefit from treatment by using pre-clinical data from in-vitro systems and samples from undosed volunteers Debating reproducibility, robustness, evaluability, translation and ●

interpretability as key properties amongst others The implications of these inputs for the design of the clinical ●

programme will be discussedchris harbron, Technical Lead Statistician, Discovery Statistics, ASTRAZENEcA UK

connecting the dots between pre-clinical and first in human (Fih) studies to maximise the success of exploratory studies11:40 Overcoming strategic and technical challenges in bridging

the gap between animal and human pharmacologyOutlining the need for high translational value of data to support ●

major transitions

Day Two Wednesday 9 December 2009

08:30 Registration

09:00 Opening remarks from the chairDr. James Dow PhD, Director of clinical Pharmacology & DmPK, (OSi) PROSiDiON UK

09:10 Roundtable morningDelegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of exploratory clinical trials.

Roundtable 1Overcoming the challenge of developing biomarkers for personalised exploratory clinical trials to improve study outcomesDiscussing critical issues in the development of biomarkers to ensure translatability in personalised clinical studies. chris harbron, Technical Lead Statistician, Discovery Statistics, ASTRAZENEcA UK

Roundtable 2Exploratory clinical studies as the link between pre-clinical and patient studies: how to design Fih, experimental medicine and exploratory studies to gain maximum knowledge Understanding the pros and cons of using patients versus healthy volunteers for Phase 0 studies – focusing on scientific, operational and ethical issues.Dr. heidemarie Kletzl, clinical Pharmacologist, PDEP clinical Pharmacology, hOFFmANN-LA ROchE SWiTZERLAND

Roundtable 3maximising the exploratory PK and PK/PD investigation in early clinical oncology trialsIdentifying efficient strategies to measure PK/PD in order to achieve a go/no-go decision faster using oncology trials as an example. Ludy can Beijsterveldt, Director, clinical Pharmacokinetics, clinical Pharmacology, J & J PhARmAcEUTicAL R&D (a Division of Janssen Pharmaceutica N.V.) BELGiUm

Roundtable 4Translational PK /PD for the design of dosing strategies with monoclonal antibodiesUnderstanding the role of monoclonal antibodies and how the improve the translatability and dosage formulations. Dr. Stephan Formella, Section head of human clinical Pharmacology, BOEhRiNGER iNGELhEim GERmANY

Roundtable 5Predicting human PK - a problem solved?Debating if animal studies can accurately predict human metabolism to obtain consensus on the way forward. Prof. colin Garner, molecular Epidemiology, Department of Biology, UNiVERSiTY OF YORK UK

Roundtable 6: Understanding the regulatory environment to overcome hurdles and challenges Learning how to overcome regulatory hurdles while setting up exploratory studies to ensure regulatory complianceWalter Janssens, PhD, Senior Preclinical Assessor, Preauthorisation, coordinator Early Phase Development, FEDERAL AGENcY FOR mEDiciNES AND hEALTh PRODUcTS (FAmhP) BELGiUm

12:30 Lunch

Enhancing the identification and validation of biomarkers as a means of reducing costs and maximising trial outcomes15:40 Accelerating early clinical development utilising

predictive biomarkersFinding the right mechanism of action and Proof-of-Mechanism ●

(PoM) of biomarkers to filter out compounds that fail to show efficacy in humans Speeding the development of biomarkers to the status of ●

true surrogates Identifying approved biomarkers as guidance for future approvals ●

Case study projects in metabolics ●

Dr. Arne Ring, Team Leader Phase i – iia Statistics, BOEhRiNGER iNGELhEim GERmANY

16:10 case study: Biomarker development, validation and implementation from early development to clinical studiesApplying PoM, Proof-of-Principle (PoP) and PcC biomarkers in early ●

development phases to define the correct dosage for healthy subjects, e.g. FIH and patientsDebating biomarkers in early development – values and pitfalls to ●

improve future development The incidence of adverse events in early Phase I – can this be predicted ●

through the use of biomarkers?Outlining the regulatory environment for identifying approval biomarkers ●

Dr. michael-Friedrich Boettcher, Global clinical Pharmacological Project Leader, BAYER SchERiNG PhARmA AG GERmANY

Evaluating the potential of exploratory studies for biologics16:40 Opportunities for biologics using exploratory

clinical trialsIdentifying optimal trial design for biological exploratory studies ●

to achieve go/no-go decisions faster Understanding the pros and cons of using patients versus ●

healthy volunteers for Phase 0 studies - scientific, operational and ethical issuesOptimising safety testing methodologies to assure legislative and ●

safety compliance Debating the potential of using adaptive trial design in early phase ●

studies to speed up clinical trialsDr. Jennifer Sims, Director head NBx Translational Sciences and Services, NOVARTiS PhARmA AG SWiTZERLAND

17:10 closing remarks from the chair

17:15 close of Day One

Day One Tuesday 8 December 2009

REGISTER ONLINE NOW! www.clinicaltrialsevents.com/exploratory

Day Two Wednesday 9 December 2009

Reviewing the ich m3 guidelines and their impact on exploratory studies13:30 Keynote: The mhRA’s approach to exploratory

clinical trials and the ich m3 guidelines: ensuring faster approvalsDefining an exploratory clinical trial and outlining the rising ●

importance of exploratory studiesThe MHRA’s approach to assessing applications for exploratory ●

clinical trials ICH M3 and how to maximise your chance of receiving an approval ●

for an exploratory clinical trialRegulatory perspective of the impact of exploratory clinical trials ●

on drug developmentRecent experience and future trends for exploratory clinical trials ●

JW mcBlane PhD, Senior Pre-clinical Assessor, mhRA UK

The regulatory environment – different angles and approaches to ensure regulatory compliance14:00 Reviewing the regulatory environment for exploratory

studies – FAmhP’s point of view Ensuring a balance between regulatory flexibility and stringent ●

regulations to ensure patient safety Maintaining collaborations with the different parties to achieve ●

global standardisation A statistical overview of exploratory study approvals in Belgium ●

Forecasting future trends of regulatory approval numbers ●

Walter Janssens, PhD, Senior Preclinical Assessor, Preauthorisation, coordinator Early Phase Development, FEDERAL AGENcY FOR mEDiciNES AND hEALTh PRODUcTS (FAmhP) BELGiUm

Optimising exploratory studies with an adaptive trial design and operational excellence strategies14:30 Adaptive trials in early development

Why early development is a good setting for adaptive clinical trials ●

Which early development trials are most suited for adaptive clinical trials ●

Finding the balance between statistical rigor and practical feasibility ●

What to worry about when considering a adaptive trial ●

Simulation as a indispensable tool to assess performance and ●

feasibility at the design stage Filip De Ridder, Director, Biostatistics & Programming, JOhNSON & JOhNSON PhARmAcEUTicA R&D

15:00 Afternoon refreshments

15:30 Efficiency measures in the conduct of exploratory development studies to ensure operational excellence in exploratory studies Focusing on operational excellence to maximise study efficiency ●

Defining a clear roadmap to success through process ●

improvement strategies Measuring performance by metric strategies to identify weaknesses ●

Establishing and implementing cross departmental agreements for ●

exploratory development studies Gaby Anthonijs, Associate Director clinical Pharmacology, Exploratory Development Department, ASTELLAS PhARmA GLOBAL DEVELOPmENT EUROPE NEThERLANDS

maximising exploraory study success by utilising accurate simulation and forecasting tools16:00 case examples of physiological-based PK-modeling

(PBPK) in early clinical developmentOutlining the value of PBPK modeling to reduce uncertainty ●

Identifying PBPK-based methods as alternative for empirical allometric ●

scaling for the prediction of human PK. Improving the prediction of DDI’s (Drug-Drug Interactions) ●

Examining the prediction of dissolution-limited absorption in human ●

Erik mannaert, Director clinical Pharmacokinetics, J & J PhARmAcEUTicAL R&D (a Division of Janssen Pharmaceutica N.V.) BELGiUm

16:30 closing remarks and close of conference

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Sponsors

cmed provides CRO services and unique clinical data technology. Services include: clinical project management and

monitoring, data management (eDC/paper) and statistical services. Cmed is rapidly gaining a reputation for leadership in the adaptive trial design community through its unrivalled ability to conduct complicated adaptive design studies using patented intelligent data acquisition/management (iDAM) technology. As Cmed combines both CRO services and technology within a single organisation it can execute these studies particularly efficiently without sponsors to coordinate multiple service providers. www.cmedresearch.com

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