Exploratory Clinical trials Conference


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At the Exploratory Clinical Trials event on 8-9 December 2009 in Brussels, Belgium you’ll have the opportunity to question the MHRA in person on the updated ICH M3 guidelines and find out how you can maximise your chance of easily gaining approval for your trials.

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Exploratory Clinical trials Conference

  1. 1. co-loca the 3rd ted with ViBpharma a Adaptiv nnual e clinica Trials co l nferenc e Exploratory clinical Trials Tuesday 8 and Wednesday 9 December 2009, Sheraton Brussels Airport hotel, Brussels, Belgium Ensuring faster go/no-go decisions though efficient exploratory development and studies to maximise cost and time savings from ose on of Cho ecti l cs to a se ble topi est dta lat s roun uss the ur peer disc with yo es issu mAiN hiGhLiGhTS iNcLUDE: KEYNOTE SPEAKERS: Dr. Thomas Senderovitz, Dr. James Dow PhD, • 16 leading manufacturers Vice President Global Director of Clinical represented on the programme Exploratory Development, Pharmacology & DMPK, to deliver case study driven UcB NEW mEDiciNES (OSi) PROSiDiON UK BELGiUm presentations Edis Travancic, Director, Pharmacokinietics & • Spot on presentation from the Dr. Stephan Formella, Bioanalysis, MHRA about the new ICH M3 Section head of human BiOViTRUm SWEDEN guidelines coming into action clinical Pharmacology, Bruno Boulanger, BOEhRiNGER this December 2009 iNGELhEim GERmANY Director Exploratory Studies, UcB PhARmA BELGiUm • Benefit from the co-location with the 3rd annual Adaptive Clinical Prof. Johan Luthman, Gaby Anthonijs, Vice President, Associate Director Trials conference to double your Clinical Pharmacology, Neuroscience R&D, networking opportunities mERcK USA Exploratory Development Department, ASTELLAS JW mcBlane PhD, PhARmA GLOBAL Senior Pre-Clinical Assessor, DEVELOPmENT EUROPE TOP cOmPANiES REPRESENTED iNcLUDE: mhRA UK NEThERLANDS • UCB • BOEHRINGER INGELHEIM Erik mannaert, Director • HOFFMANN LA ROCHE • NOVARTIS Dr. håkan Wennbo, Clinical Pharmacokinetics, • BAYER • FAMHP Global Project Director, J & J PhARmAcEUTicAL • MHRA • ASTELLAS Cardiovascular & R&D (a Division of Janssen Gastrointestinal, Pharmaceutica N.V.) • ASTRAZENECA • JOHNSON & JOHNSON ASTRAZENEcA SWEDEN BELGiUm Sponsors: Register online now at: www.clinicaltrialsevents.com/exploratory
  2. 2. Programme Day One Tuesday 8 December 2009 08:30 Registration ● Linking therapeutic concepts to diseases successfully ● Uncovering a comprehensive evaluation of pharmacodynamic actions 09:00 Opening remarks from the chair to maximise study success Dr. Thomas Senderovitz, Vice President Global Exploratory ● Identifying the best organisational solutions for integrated R&D Development, UcB NEW mEDiciNES BELGiUm Prof. Johan Luthman, Vice President, Neuroscience R&D, mERcK USA Looking into the crystal ball: forecasting the future 12:10 case study: of the pharmaceutical industry connecting the dots from the pre-clinical phase to the probability of success: making it a reality through 09:10 Keynote: the integration of Bayesian statistics changing the game: a look into the future of Research ● Outlining how to turn information generated in pre-clinical phases and Development (R&D) in the pharmaceutical industry into direct value ● How can pharma R&D change and become more productive? ● Indicating how modelling is used to improve efficiency of exploratory ● What will the future pharma-healthcare landscape look like? trials through the use of adaptive designs, optimal designs or ● Why is this relevant for you – translational and exploratory Bayesian modelling medicine experts? ● Introducing prediction-based decision-making and demonstrating the Dr. Thomas Senderovitz, Vice President Global Exploratory new added value for clinical trials: improving predictions Development, UcB NEW mEDiciNES BELGiUm ● Using assay performance knowledge to improve clinical trial performance Giving a broad Bayesian modelling perspective on exploratory maximising the efficiency of ADmE and PK properties ● development to improve the translatability into the clinic Dr. Bruno Boulanger, Director Exploratory Statistics, UcB PhARmA BELGiUm 09:40 Best practice strategies for the prediction of ADmE properties in humans from preclinical data 12:40 Effectively overcoming the challenges in Fih studies in ● Using human in vitro data versus animal studies to ensure data accuracy order to maximise study success ● Outlining the role of transporters in human drug disposition to ● Choosing a safe starting dose to ensure compliance with maximise precision national regulations ● Accurately assessing drug metabolism and the potential role of ● Outlining tools and techniques to maximise the success rate through metabolites in assessing efficacy and safety the use of practical examples ● Identifying the differences between small molecules and biologics ● Flexible, data driven protocol design to combine SAD and MAD in Edis Travancic, Director, Pharmacokinietics and Bioanalysis, FIH studies BiOViTRUm SWEDEN ● Debating if patients in other therapeutic areas to oncology can be included in FIH studies 10:10 Determining human ADmE/PK early in clinical drug ● Phase 0 microdosing studies – do we really need labelled compounds? development to forecast and ensure study success Dr. James Dow PhD, Director of clinical Pharmacology and DmPK, ● Running human Phase 0 microdosing studies – debating the (OSi) PROSiDiON UK pro’s and con’s ● Meeting the US FDA ‘MIST’ guidance using innovative protocol 13:10 Lunch designs to ensure regulatory compliance ● Determining absolute bioavailability and IV PK without extensive 14:10 Optimising the design of early Phase i studies to preclinical studies achieve Poc faster ● Is there a new paradigm for determining human PK? ● Selecting appropriate populations to conduct successful early Prof. colin Garner, molecular Epidemiology, Department of Biology, Phase I studies UNiVERSiTY OF YORK UK ● Outlining different model based approaches to achieve PoC faster ● Maximising efficiency of PoC and proof-of-mechanism (PoM) studies 10:40 Morning refreshments to improve translatability Achieving better informed dose selections Overcoming the challenges of personal medicine ● michael Derks, metabolic Disease Area clinical Pharmacologist, and patient selection by utilising selection and hOFFmANN-LA ROchE SWiTZERLAND diagnostic tools highlighting the role of animal models in 11:10 case study: translational medicine and how exploratory Using pre-clinical data to facilitate the development of patient selection tools studies benefit ● Maximising the identification of patient populations for personalised 14:40 case study: healthcare by utilising molecular diagnostics The role of translational medicine in exploratory ● Increasing the likelihood of robust identification of those patients development and its impact on exploratory studies who would benefit from treatment by using pre-clinical data from ● Exploring the mechanisms of action and potential importance of new in-vitro systems and samples from undosed volunteers discoveries though effective experimental medicine ● Debating reproducibility, robustness, evaluability, translation and ● Utilising biomarkers to detect drug effects in man and to demonstrate interpretability as key properties amongst others pharmacological activity and the mechanism of action of novel drugs ● The implications of these inputs for the design of the clinical ● Ensuring a better understanding of the disease mechanism by programme will be discussed increasing the investment in clinical target validation and by chris harbron, Technical Lead Statistician, Discovery Statistics, performing more exploratory studies ASTRAZENEcA UK ● Improving the targeting of new drugs to increase the overall success rates and the benefits of new drugs for patients connecting the dots between pre-clinical and first Dr. håkan Wennbo, Global Project Director, cardiovascular and in human (Fih) studies to maximise the success of Gastrointestinal, ASTRAZENEcA SWEDEN exploratory studies 15:10 Afternoon refreshments 11:40 Overcoming strategic and technical challenges in bridging the gap between animal and human pharmacology ● Outlining the need for high translational value of data to support major transitions
  3. 3. Day One Tuesday 8 December 2009 Day Two Wednesday 9 December 2009 Enhancing the identification and validation of 08:30 Registration biomarkers as a means of reducing costs and 09:00 Opening remarks from the chair maximising trial outcomes Dr. James Dow PhD, Director of clinical Pharmacology & DmPK, (OSi) PROSiDiON UK 15:40 Accelerating early clinical development utilising predictive biomarkers 09:10 Roundtable morning ● Finding the right mechanism of action and Proof-of-Mechanism Delegates will be able to attend three one-hour roundtable discussion (PoM) of biomarkers to filter out compounds that fail to show groups from a selection of key topics. Each session will be chaired efficacy in humans by an industry expert who will facilitate an exchange of opinions, ● Speeding the development of biomarkers to the status of essential experiences and learning related to a current aspect of true surrogates exploratory clinical trials. ● Identifying approved biomarkers as guidance for future approvals ● Case study projects in metabolics Roundtable 1 Dr. Arne Ring, Team Leader Phase i – iia Statistics, BOEhRiNGER iNGELhEim GERmANY Overcoming the challenge of developing biomarkers for personalised exploratory clinical trials to improve 16:10 case study: study outcomes Biomarker development, validation and Discussing critical issues in the development of biomarkers to ensure implementation from early development to translatability in personalised clinical studies. clinical studies chris harbron, Technical Lead Statistician, Discovery Statistics, ● Applying PoM, Proof-of-Principle (PoP) and PcC biomarkers in early ASTRAZENEcA UK development phases to define the correct dosage for healthy subjects, e.g. FIH and patients Roundtable 2 ● Debating biomarkers in early development – values and pitfalls to Exploratory clinical studies as the link between improve future development pre-clinical and patient studies: how to design Fih, ● The incidence of adverse events in early Phase I – can this be predicted through the use of biomarkers? experimental medicine and exploratory studies to ● Outlining the regulatory environment for identifying approval biomarkers gain maximum knowledge Dr. michael-Friedrich Boettcher, Global clinical Pharmacological Understanding the pros and cons of using patients versus Project Leader, BAYER SchERiNG PhARmA AG GERmANY healthy volunteers for Phase 0 studies – focusing on scientific, operational and ethical issues. Evaluating the potential of exploratory studies Dr. heidemarie Kletzl, clinical Pharmacologist, PDEP clinical Pharmacology, hOFFmANN-LA ROchE SWiTZERLAND for biologics 16:40 Opportunities for biologics using exploratory Roundtable 3 clinical trials maximising the exploratory PK and PK/PD ● Identifying optimal trial design for biological exploratory studies investigation in early clinical oncology trials to achieve go/no-go decisions faster Identifying efficient strategies to measure PK/PD in order to achieve ● Understanding the pros and cons of using patients versus a go/no-go decision faster using oncology trials as an example. healthy volunteers for Phase 0 studies - scientific, operational Ludy can Beijsterveldt, Director, clinical Pharmacokinetics, and ethical issues clinical Pharmacology, J & J PhARmAcEUTicAL R&D (a Division ● Optimising safety testing methodologies to assure legislative and of Janssen Pharmaceutica N.V.) BELGiUm safety compliance ● Debating the potential of using adaptive trial design in early phase Roundtable 4 studies to speed up clinical trials Dr. Jennifer Sims, Director head NBx Translational Sciences and Translational PK /PD for the design of dosing Services, NOVARTiS PhARmA AG SWiTZERLAND strategies with monoclonal antibodies Understanding the role of monoclonal antibodies and how the 17:10 closing remarks from the chair improve the translatability and dosage formulations. Dr. Stephan Formella, Section head of human clinical Pharmacology, 17:15 close of Day One BOEhRiNGER iNGELhEim GERmANY Roundtable 5 Predicting 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 compliance Walter Janssens, PhD, Senior Preclinical Assessor, Preauthorisation, coordinator Early Phase Development, FEDERAL AGENcY FOR mEDiciNES AND hEALTh PRODUcTS (FAmhP) BELGiUm 12:30 Lunch REGISTER ONLINE NOW! www.clinicaltrialsevents.com/exploratory
  4. 4. Sponsors Day Two Wednesday 9 December 2009 cmed provides CRO services and unique clinical data technology. Services include: clinical project management and Reviewing the ich m3 guidelines and their impact monitoring, data management (eDC/paper) and statistical services. on exploratory studies Cmed is rapidly gaining a reputation for leadership in the adaptive 13:30 Keynote: The mhRA’s approach to exploratory trial design community through its unrivalled ability to conduct clinical trials and the ich m3 guidelines: complicated adaptive design studies using patented intelligent data ensuring faster approvals acquisition/management (iDAM) technology. As Cmed combines ● Defining an exploratory clinical trial and outlining the rising both CRO services and technology within a single organisation it importance of exploratory studies can execute these studies particularly efficiently without sponsors ● The MHRA’s approach to assessing applications for exploratory to coordinate multiple service providers. www.cmedresearch.com clinical trials ● ICH M3 and how to maximise your chance of receiving an approval Exhibitors: for an exploratory clinical trial ● Regulatory perspective of the impact of exploratory clinical trials on drug development ● Recent experience and future trends for exploratory clinical trials JW mcBlane PhD, Senior Pre-clinical Assessor, mhRA UK media partners The regulatory environment – different angles Pharmaceutical Technology is and approaches to ensure regulatory compliance used daily as a means of creating 14:00 Reviewing the regulatory environment for exploratory partnerships and as a point of studies – FAmhP’s point of view reference by professionals within the pharmaceutical industry. ● Ensuring a balance between regulatory flexibility and stringent This comprehensive resource supplies the latest news releases, regulations to ensure patient safety detailed information on industry projects, white papers, event ● Maintaining collaborations with the different parties to achieve information and a thorough breakdown of products and services. global standardisation www.pharmaceutical-technology.com ● A statistical overview of exploratory study approvals in Belgium ● Forecasting future trends of regulatory approval numbers Drug Development Technology is a Walter Janssens, PhD, Senior Preclinical Assessor, Preauthorisation, coordinator Early Phase Development, FEDERAL AGENcY FOR procurement and reference resource mEDiciNES AND hEALTh PRODUcTS (FAmhP) BELGiUm providing a one-stop-shop for professionals and decision makers within the drug development Optimising exploratory studies with an adaptive and medicines industry. We provide a comprehensive breakdown trial design and operational excellence strategies of drug development contractors and suppliers, up-to-date news and press releases, white papers and detailed information on 14:30 Adaptive trials in early development current industry projects and trends. Our recruitment area provides ● Why early development is a good setting for adaptive clinical trials career information and the latest job vacancies in the field. ● Which early development trials are most suited for adaptive clinical trials ● Finding the balance between statistical rigor and practical feasibility www.drugdevelopment-technology.com ● What to worry about when considering a adaptive trial ● Simulation as a indispensable tool to assess performance and The Business Review websites are feasibility at the design stage your number one stop for all the Filip De Ridder, Director, Biostatistics & Programming, latest news, comment and industry information. Each Business JOhNSON & JOhNSON PhARmAcEUTicA R&D Review website offers content that is produced by a dedicated team of journalists and global industry experts. In addition to the 15:00 Afternoon refreshments free content made available on the sites an intelligence store will 15:30 Efficiency measures in the conduct of exploratory provide you with premium market analysis reports from the leading development studies to ensure operational global suppliers of market research and industry analysis. excellence in exploratory studies ● Focusing on operational excellence to maximise study efficiency Pharmaceutical Business Review is the ● Defining a clear roadmap to success through process world's leading pharma website, being improvement strategies used by over 100,000 visitors every ● Measuring performance by metric strategies to identify weaknesses month. For further information contact ● Establishing and implementing cross departmental agreements for jsharp@industryreview.com exploratory development studies Gaby Anthonijs, Associate Director clinical Pharmacology, Exploratory World Pharmaceutical Frontiers Development Department, ASTELLAS PhARmA GLOBAL DEVELOPmENT The pharmaceutical industry is World Pharmaceutical Frontiers www.worldpharmaceuticals.net EUROPE NEThERLANDS changing fast. There are more maximising exploraory study success by utilising regulations, technologies, faster product launches and shorter product life cycles than ever before. World Pharmaceuticals accurate simulation and forecasting tools frontiers is, and will continue to be, at the forefront of these 16:00 case examples of physiological-based PK-modeling changes, so visit us at www.worldpharmaceuticals.net and stay (PBPK) in early clinical development up to date with all latest developments ● Outlining the value of PBPK modeling to reduce uncertainty Identifying PBPK-based methods as alternative for empirical allometric ● scaling for the prediction of human PK. if you want to be a part of this ● ● Improving the prediction of DDI’s (Drug-Drug Interactions) Examining the prediction of dissolution-limited absorption in human successful event, we have a number of Erik mannaert, Director clinical Pharmacokinetics, J & J sponsorship opportunities available. PhARmAcEUTicAL R&D (a Division of Janssen Pharmaceutica N.V.) BELGiUm contact Nick mccudden to discuss your specific requirements nicholasmccudden@arena-international.com or call 16:30 closing remarks and close of conference +4420 7753 4259
  5. 5. 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