Innovation in Phase 1 Clinical Development


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Practical app roaches to
phase I trial develop ment
to enable faster go / no -go
decision s, reduce co st and
speed time to market

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Innovation in Phase 1 Clinical Development

  1. 1. Register and pay before 11th June and save up to €450 is proud to present Two Day Conference: 21st – 22nd September Conference Focus Day: 20th September Marriott Hotel, Berliner Strasse 93, Munich, Germany PraCtiCal aPPrOaChes tO eNgage With mOre thaN WWW.Phase1CliNiCalDevelOPmeNt.COm Phase i trial DevelOPmeNt tWeNty Pharma & BiOteCh tO eNaBle Faster gO / NO-gO exPerts iNCluDiNg: DeCisiONs, reDuCe COst aND Dr Paul Passier, Global Clinical Pharmacology Lead, Pain, sPeeD time tO market Astellas JW McBlane, Preclinical Assessor, Clinical Trials Unit, MHRA key reasONs tO atteND: Dr Christen Steffen, Head of Preclinical Unit, BfArM 1) Get up to date on the latest regulations for submission criteria, Dr Walter Janssens, Senior Preclinical Assessor, Pre- authorisation, Coordinator Early Phase Development, Federal application processes and exploratory trials with case studies and a workshop Agency for Medicines and Health Products from the MHRA, BfArM and FAGGS Birgitte Søgaard, Divisional Director – Clinical Pharmacology & 2) Discuss the most effective trial design methodologies to ensure rapid Translational Medicine, H. Lundbeck A/S submission and approval timelines, with innovative methodologies from Michael- Friedrich Boettcher, Global Clinical Pharmacology NicOx and Novartis Project Leader, Bayer Schering Pharma AG Ludy van Beijsterveldt, Director Clinical Pharmacokinetics, and 3) Utilise preclinical data analysis: including PK/PD modelling, Pharmacology, Johnson and Johnson metabolomics and translational methods to improve FIM predictions and avoid errors. Share best practice with discussions and case studies from UCB, Jurgen Moll, R&D Oncology, Cell Biology, Nerviano Medical Lundbeck, Servier and Johnson & Johnson Sciences John Beaver, Senior Imaging Specialist, GlaxoSmithKline 4) Increase productivity and minimise costs through implementing Constance Hoefer, Independent Consultant patient-based phase I trials: enhancing the selection and recruitment processes and overcoming operational constraints Alessandra Vitaliti, Head of Cellular Biomarkers Group, Novartis 5) Streamline the outsourcing process and establishing an effective working Paola Tocchetti, Director Drug Metabolism and relationships with CROs; case study and discussion from Mubera Krijezi, Pharmacokinetics, NicOx Research Institute Outsourcing Project Manager, Actelion Dr James Dow, Director of Clinical Pharmacology and DMPK, (OSI) Prosidion Dr Miroslav Ravic, Managing Director and CMO, Pharma Integra and Affimed Plus aN iNteraCtive Pre- Dr Ruth Oliver, Director and Head of Modelling and Simulation, CONFereNCe DisCussiON Day: Global Exploratory Development, UCB A) Regulatory workshop – gain access to 3 top European regulatory experts! Arun Mishra, Director Global Regulatory Affairs (Asia-Pacific, Japan and Emerging Markets), GlaxoSmithKline Jimmy Dr Walter Dr Christian McBlane Janssens Steffen Reto Ossola, Group Leader for Biomarker Research, Biognosys MHRA FAGGS BfArM Dr Ansar Jawaid, Global Group Leader, R&D Genetics and Personalised Medicine, AstraZeneca Dr Richard Weaver, Scientific Director, Drug Safety B) Don’t miss an exclusive biomarker focus day addressing all the key Assessment, Servier questions surrounding early identification, development and validation of biomarkers. Hear case studies from Novartis, GlaxoSmithKline, Jennifer Larsen, Translational Medicine Scientist, Lundbeck Lundbeck and more Tony Gee, Director, PET & Radiotracer Development, GlaxoSmithKline Karin Meiser, Statistician, Novartis meDia PartNers Mubera Kreijzi, Senior Project Manager, Clinical Pharmacology, Actelion +44 (0)20 7368 9300 +44 (0)20 7368 9301
  2. 2. Pre-CONFereNCe FOCus Day mONDay 20th sePtemBer 2010 BiOmarkers – eNhaNCiNg iDeNtiFiCatiON aND DevelOPmeNt PrOCesses tO eNsure a returN ON iNvestmeNt 09.30 Registration and Coffee 12.10 Networking Lunch Break 10.00 Pharma IQ Welcome 13.30 Successfully Developing a Translatable Biomarker from Preclinical to Phase I Studies • How do in vitro studies relate to in vivo predictions and outcomes? 10.05 Opening Remarks from Chairperson; • Reaching the earliest possible go/no go decision Alessandra Vitaliti, Head of Cellular Biomarkers Group, Novartis Birgitte Søgaard, 10.10 Streamlining the Development and Validation Processes Divisional Director Clinical Pharmacology and • Assessing the challenges faced when choosing to adopt a biomarker Translational Medicine, Lundbeck • Usage of targeted mass spectrometry for early biomarker validation to reduce financial and time burdens • Outsourcing as a solution to biomarker development and validation • Merging data across several studies to improve discovery rate 14.10 Case Study: Biomarkers for Kinase Inhibitors Reto Ossola, Targeting the Cell Cycle Group Leader for Biomarker Research, • Pre-defining your patient population using primary endpoints, PK and Biognosys toxicology values • Stratifying patients into improved responder groups • Review of the field of different types of biomarkers used in the clinic for cell cycle inhibitors • Experiences and hurdles during transition from a preclinical towards a 10.50 Proof-of-Mechanism Biomarkers in Phase I Clinical Trials clinical biomarker • Ex vivo stimulation concept for Proof-of-Mechanism in healthy subjects • A case study on biomarkers for Aurora kinase inhibitors • Standardisation of customised flow cytometry-based biomarker assays in multiple centre clinical studies Jurgen Moll, • Current examples of use of biomarkers in clinical practice R&D Oncology, Cell Biology, Nerviano Medical Sciences Alessandra Vitaliti, Head of Cellular Biomarkers Group, Novartis 14.50 Design of PET Biomarkers for In Vivo Imaging • Overview of the PET technique • How PET biomarkers are produced 11.30 Developing and Launching Personalised Healthcare Therapies • Biomarker design criteria: impact on the in vivo signal - Lessons from AstraZeneca Tony Gee, • Challenges across value chain • Delivering personalized therapies globally Director, PET & Radiotracer Development, • Case studies from AstraZeneca GlaxoSmithKline Dr Ansar Jawaid, Global Group Leader, R&D Genetics and Personalised Medicine, AstraZeneca 15.10 Chairperson’s closing Remarks and End of Focus Day Pre-CONFereNCe WOrkshOP 15.45 - 18.45 Regulatory Updates: Speeding Up the Application Process This hands on workshop will allow attendees to interact directly with three top European regulators and discuss at length all of the latest regulations and their impact on Phase I, as well as gaining insight into the differences between how applications are processed in the respective countries. Jimmy Dr Walter Dr Christian McBlane Janssens Steffen MHRA FAGGS BfArM You will walk away from this workshop with a more thorough understanding of: • Protocol and quality considerations and what are the accepted submission criteria • The preclinical requirements for entering into Phase I • An assessor’s approach to assessing an application for the first clinical trial with a new agent +44 (0)20 7368 9300 +44 (0)20 7368 9301
  3. 3. CONFereNCe Day ONe tuesDay 21st sePtemBer 2010 08.15 Registration and Coffee INNOVATIVE TRIAL DESIGNS: EFFECTIVE 09.00 Pharma IQ Welcome APPROACHES TO IMPROVE EFFICIENCY AND TIME TO MARKET 09.05 Opening Remarks from Chairperson Paola Tocchetti, Director Drug Metabolism and Pharmacokinetics, 12.10 Maximising Efficiency and Reducing Trial Time Through NicOx Research Optimising Design; Combining Phases I and IIa • Effective trial design and planning procedures REGULATORY UPDATES: WHAT ARE THE CURRENT • Exploring new paradigms in trial design ExPECTATIONS FOR PHASE I CLINICAL TRIALS? • Assessing the different considerations for trial designs using patients and volunteers • Ensuring accurate and effective data via thorough design • Employing more efficient design methodologies to speed time to market 09.10 Understanding Submission Criteria to Speed Up Approval Times • Regulation updates: what impact is there on phase I? Paola Tocchetti, • Enhancing communication between regulators and those involved in phase I trials Director Drug Metabolism and Pharmacokinetics, • What data is expected for approval of different types of phase I trials? NicOx Research Institute • Understanding patient safety considerations for a more successful trial • Achieving effective compliance strategies to speed up approval times 12.40 Networking Lunch Dr Christian Steffen, Head of Preclinical Unit, BfArM 14.10 Combining Phase I and II Studies in a Single Trial Protocol • The advantage and disadvantage of combining phase I and II studies 09.40 Regulatory Perspectives on Phase I: What has Changed and • Combining single ascending dose (SAD) and multiple ascending dose (MAD) What are the Practical Implications? • Combining SAD, MAD and phase IIa • Data sets for the transition from preclinical to clinical testing • Interaction with the regulatory authorities and ethics committees • Recent changes in the regulatory environment and impact on processes • New trial designs with fixed and adaptive approaches (case study) • An overview of exploratory clinical trial regulations Dr. Miroslav Ravic, • Understanding the voluntary harmonisation procedure Managing Director, • The clinical trial assessment process – what do assessors actually do? Pharma Integra Jimmy McBlane, Preclinical Assessor, 14.40 Sponsorship Spotlight MHRA This is a unique opportunity to present on successful approaches and methodologies that you have used to accelerate and enhance the innovation in phase I clinical development. 10.10 Regulatory Perspectives on Phase I Trials Conducted in For more information on how to sponsor this session please contact Emerging Markets Nicola Ambler on:+44 (0)20 7368 9586 or • An overview of the regulatory frameworks in emerging markets • Key challenges and opportunities when conducting phase I and exploratory 15.10 Use of Historical Placebo Data for the Design and Analysis of a trials in emerging markets PoC Study in Osteoarthritis • Enhancing trial efficiency through complete understanding of regulations • Meta-analysis of historical data on pain VAS score and legislation • Use of the meta-analysis in the power calculation for the actual study • Use of the meta-analysis in the analysis of the actual study Arun Mishra, Director Global Regulatory Affairs (Asia-Pacific, Japan and Emerging Markets), Karin Meiser, GlaxoSmithKline Statistician, Novartis 10.40 Networking Refreshment Break 15.40 Networking Refreshment Break ASSESSING THE PRACTICAL AND BENEFICIAL ASPECTS OF ExPLORATORY TRIALS IN ORDER TO OBTAINING PROOF OF CONCEPT THROUGH EFFICIENT IMPLEMENT THEM SUCCESSFULLY AND MAKE FASTER IDENTIFICATION AND APPLICATION OF BIOMARKERS GO/NO GO DECISIONS 16.10 Practical Approaches to Identify Clinically Relevant Biomarkers 11.10 Regulatory Experience with Exploratory Clinical Trials and Effectively Target the Right Patient Population • Outlining critical issues in the trial application • An overview of animal disease models • An overview of quality issues • Ensuring effective collaboration between research and development • Evaluating the preclinical requirements • Applying companion diagnostics to assess patient response • Protocol related submission criteria • Enhancing the implementation of statistical and design aspects • Experience in Belgium with exploratory clinical trials: Birgitte Søgaard, how are they dealt with by regulators? Divisional Director Clinical Pharmacology Dr. Walter Janssens, Senior Preclinical Assessor, and Translational Medicine, Lundbeck Pre-authorisation, Coordinator Early Phase Development, Federal Agency for Medicines and Health Products 16.40 Employing Imaging in Phase I to Reduce Risk and Enable Informed Decision Making 11.40 Bridging Non-Clinical Drug Safety to Humans: Microdosing • Optimising dosage for proof-of-concept studies and Microtracer Studies • Use of imaging markers to differentiate candidate medications • Making the decision: Phase 0 or Phase I? • Improving the efficacy of phase I trials through successful use of biomarkers • Using microdosing to facilitate go/no go decisions John Beaver, • Saving time and cost through the implementation of microtracer studies? Senior Imaging Specialist, • Metabolites in Safety Testing (MIST) and microtracer studies GlaxoSmithKline Richard J Weaver, Scientific Director, Drug Safety Assessment, 17.10 Closing Remarks from Chairperson Servier 17.25 Close of Day One +44 (0)20 7368 9300 +44 (0)20 7368 9301
  4. 4. CONFereNCe Day tWO WeDNesDay 22ND sePtemBer 2010 08.15 Registration and Coffee 13.00 Networking Lunch 09.00 Pharma IQ Welcome 14.00 BREAKOUT ROUNDTABLE DISCUSSIONS: Participants will be 09.05 Opening Remarks from Chairperson able to choose between the different roundtables and spend 45 minutes Constance Hoefer, Independent Consultant discussing the points outlined below: Roundtable A: THE IMPORTANCE OF EFFECTIVE PRECLINICAL DATA Utilising more dynamic, flexible and collaborative trial designs to ANALYSIS TO IMPROVE PREDICTIONS, ESTABLISH streamline trials and enhance time to market PROOF OF CONCEPT AND ACHIEVE FASTER GO/NO Karin Meiser, Statistician, Novartis GO DECISIONS Roundtable B: Improving the efficiency of your selection process and effectively matching 09.10 Effective Approaches to PK/PD Modelling and Data Analysis your requirements and CRO capabilities Avoiding Errors and Making Predictive Assessments Mubera Kreijzi, Senior Project Manager, Clinical Pharmacology, Actelion • Current prediction methodologies from animal to man • The value of comprehensive data analysis during early development WHEN AND HOW TO USE PATIENTS IN PHASE I • Improving productivity through preclinical analysis TRIALS REDUCING COSTS AND IMPROVING GO/NO • Effective error spotting at both preclinical and phase I stages GO DECISIONS • Making accurate predictions using comprehensive PK/PD data and the associated cost saving benefits 14.30 Enhancing Patient Recruitment Solutions for Use in Ruth Oliver, Director and Head of Modeling and Simulation, Global Exploratory Development, UCB Phase I Trials • An overview of current use of patients in phase I 09.40 Metabolomic Studies to Confirm Clinical Candidate Selection • Identifying eligible patient subjects • Assessing the suitability of using patients in phase I per therapeutic area • Short overview of candidate optimisation and quality; what are the on/off target • Optimising patient recruitment strategies effects, PD/Tox and DMPK profile? • Overcoming geographical constraints during patient recruitment • Analysis of late stage failures, including imbalance of on/off target effects • Comparing dosage and PK/PD data in healthy volunteers and in patients: and contributing factors what is the relevance? • Using metabolomic studies to powerfully resolve species-specific pathways and products of metabolism (case studies) Michael-Friederich Boettcher, Global Clinical Pharmacology Leader, • Metabolomics in humanised animal models reveal on/off target effects (case studies) Bayer Schering Pharma • Analysing clinical trial populations through metabolomics - biomarkers of individual variability, disease, efficacy and toxicity 15.00 Challenges and Benefits of Patient-Based Phase I Trials Constance Hoefer, • Understanding the regulations surrounding patient-based phase I trials Independent Consultant • Operational constraints involved in conducting phase I in patients • Combining DDI studies in phase I to allow concomitant medication in patients 10.10 Improving Dosage Predictions for First in Man Studies • Expanding phase I trials in patients to a wider range of therapeutic indications Using A Physiologically Based Approach • Expediting trial development and reducing costs through use of patients in phase I • Evaluating in vitro in vivo correlations James Dow, Director of Clinical Pharmacology & DMPK, • Optimising the use of preclinical data to get mechanistic understanding of PK behaviour (OSI) Prosidion • Applying physiologically based PK (PBPK) modelling for prediction of human PK • Selecting FIM dosage using MABEL (minimum anticipated biological effect 15.30 Networking Refreshment Break level) approach Vikash Sinha, Clinical Pharmacology Leader, 16.00 Methods of Patient Selection to Improve the Responder Johnson&Johnson Rate in Early-Sign-of Efficacy Studies in Pain • An overview of the core challenges faced during patient selection 10.50 Networking Refreshment Break • How to increase the reliability of the response to enhance trial efficiency • Effective solutions to select potential responders 11.30 Successful Translation from Preclinical Studies to Phase I Trials Dr. Paul Passier, Global Clinical Pharmacology Lead, • Taking a multidisciplinary approach to reaching a proof of concept Pain, Astellas • Methodologies used to predict results from animal to human • Overcoming the complexities of translating from animal to human subjects PHASE I TRIALS IN ONCOLOGY: CASE STUDY ExAMPLES • Using modelling, simulation and PKPD investigations to facilitating go/no go decisions at an early stage 16.30 Resistance Mechanisms of Targeted Therapies • Assessing animal data, toxicity and toxicokinetic data to ensure appropriate • Similarities and differences in resistance mechanisms comparing targeted dose ranges in FIM studies compared to classical cytotoxic therapies • Making accurate predictions using comprehensive PK/PD data and the • Preclinical and clinical case studies of kinase inhibitors associated cost saving benefits • Approaches to address resistances early in drug development Jennifer Larsen, Translational Medicine Scientist, Jurgen Moll, R&D Oncology, Cell Biology, Lundbeck Nerviano Medical Sciences 12:00 Sponsorship Spotlight 17.00 Effective Approaches to PK/PD in Early Oncology Development This is a unique opportunity to present on successful approaches and methodologies • PKPD model based FIH oncology drug development strategies that you have used to accelerate and enhance the innovation in phase I clinical development. • Evaluating PKPD and biomarkers For more information on how to sponsor this session please contact • Utilising preclinical PKPD in support of observations in patients Nicola Ambler on:+44 (0)20 7368 9586 or • Improving animal to man predictions • Implementing PKPD modelling and simulation to facilitate decision IMPROVING PHASE I TRIAL OPERATIONS – making during early development OUTSOURCING AND RELATIONSHIP MANAGEMENT Ludy van Beijsterveldt, Director Clinical Pharmacology, Oncology, 12.30 Enhancing CRO Selection & Management to Improve Trial Success Johnson & Johnson • Identifying a CRO to match the requirements of your trial • Optimising selection processes 17.30 Closing Remarks from Chairperson • Ensuring an effective working relationship with your CRO • Facilitating approval process and decreasing workload through effective CRO selection 17.45 Close of Day Two Mubera Krijezi, Senior Project Manager, Clinical Pharmacology, Actelion +44 (0)20 7368 9300 +44 (0)20 7368 9301
  5. 5. sPONsOrs aND exhiBitOrs Who should attend Directors, senior managers and managers from the following areas within pharmaceutical manufacturers and biotech companies with responsibility for: • Clinical Pharmocology • Exploratory Medicine • Clinical Research • Translational Medicine • PK/PD • Biomarker Development • Clinical Operations about Pharma iQ Become a member of Pharma IQ and receive complimentary access to resources that will keep you at the forefront of industry change. You will receive access to our growing library of multi-media presentations from industry leaders, an email newsletter updating you on new content that has been added, free aggregated news feed from over 1000 global news sources tracking your industry and special member only discounts on events. Become a member here: Web: Phone: +44(0)20 7368 9300 sponsorship Opportunities Why Now? Innovation in Phase I Clinical Development will be attended With the focus on cost control more important than ever, phase by senior officials and decision-makers from industry I clinical trials are becoming an increasingly crucial cog in the worldwide, bringing together buyers and suppliers in one drug development process as the bid to save time and money location. Focused and high-level, the event will be an excellent has spurred innovation in trial design and processes at all levels. platform to initiate new business relationships. With tailored Indeed, investment in phase I has the potential to reduce overall networking, sponsors can achieve the face-to-face contact costs by enabling faster go/no go decisions, which is why 40% that overcrowded trade shows cannot deliver. Exhibiting and of trials are now in phase I and the pressure is on to deliver sponsorship options are extensive, and packages can be results at an early stage. The Innovation in Phase I Clinical tailor-made to suit your individual company’s needs. Development conference offers the opportunity to discover new methodologies, cost saving strategies and clarify changes to For more information please contact sponsorship the regulatory landscape in a bid to reach proof of concept and on +44 (0)207 368 9300 or email make go/no go decisions as soon as possible. What Does Pharma iQ’s innovation in Phase i Clinical Development Offer? This conference provides a unique platform for drug developers to discuss practical, proven ideas to save time and money and ensure that companies have the knowledge they need to take their drugs to market fast. This case study driven agenda will help you uncover ways to make the incremental improvements to your clinical trials that can greatly reduce the time it takes to get your treatments to market. WWW.Phase1CliNiCalDevelOPmeNt.COm +44 (0)20 7368 9300 +44 (0)20 7368 9301
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