Pharma IQ's 2nd Annual Innovation in Phase I Clinical Development


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Innovation in Phase I Clinical Development

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Pharma IQ's 2nd Annual Innovation in Phase I Clinical Development

  1. 1. Register and pay before 22nd July 2011 to save up to €350 presents the 2nd annual In association with Aptuit, bringing you exclusive access to their world class Verona research facilities Location: Verona, Italy | Conference: 13th - 14th September 2011 | Pre-Conference Workshop: 12th September 2011 Benchmark the latest strategies engage with to prevent late stage failure and ema regualtors: allow information rich decisions Walter Janssens, Coordinator Early Phase to Be made during early clinical Development, FAGG-AFMPS development JW McBlane, Preclinical Assessor, Clinical Trials Unit, MHRA come away with fresh ideas on: get exclusive insight from top 1) The latest regulatory changes and expectations, hear from industry experts including: Walter Janssens, Coordinator Early Phase Development, FAGG Constance Hoefer, Head of Non-Clinical AFMPS and JW McBlane, MHRA - ask your questions directly! Drug Development, Medigene 2) Maximising your phase I data and facilitating go/no-go Michel Goldman, Executive Director, decisions through implementing alternative trial designs. Innovative Medicines Initiative Learn what your peers are doing through exclusive case studies Vikash Sinha, Clinical Pharmacology Leader, from MediGene and NovImmune. CNS, Johnson and Johnson 3) Reducing attrition rates through developing an effective Mark Baker, Group Leader, Clinical Pharmacology, imaging strategy. Understand the challenges and opportunities NovImmune with insight from Jan Passchier, Director PET and Dana Ghiorghiu, Research Physician, Imaging Clinical Radiochemistry, GlaxoSmithKline. Biomarkers Group, AstraZeneca Corina Dana Dota, MD, ECG Centre Director, 4) How to establish PoC during preclinical development and CPD Co-chair Cardiac QT/Arrhythmia Safety prevent late stage failure through optimal use of preclinical data Knowledge Group, AstraZeneca to establish IVIVC. Hear what Johnson & Johnson and Paulo Fontura, Head of Translational Medicine CNS, Roche Nerviano Medical Sciences are doing to achieve this. Dr Chris Twelves, Professor of Clinical 5) Driving innovation and drug development through a Pharmacology and Oncology & Head Clinical Cancer collaborative approach. Prof Chris Twelves discusses the Research Groups, Leeds Institute of Molecular Medicine latest alliance between Cancer Research UK, GSK, University of Nabil Al-Tawil, Consultant Physician, Karolinska Trial Leeds, St Bartholemew’s Hospital and Cancer Research UK. Alliance Phase-I Unit/Karolinska University Hospital David Eckland, Director, Eckland Consulting Kristof Vercruysse, Director Clinical Operations, Ablynx unique to this year’s Jan Passchier, Director PET and Radiochemistry, event – aptuit site visit GlaxoSmithKline 14.00 - 16.00 I 12th September 2011 Faron Jordan, Head of Preclinical and Clinical Project An exclusive behind the scenes tour through one of Management, Critical Pharmaceuticals the world’s most famous R&D sites. Get first hand Jürgen Moll, Director, Dep. Cell Biology, Oncology, insight into the workings of this top class facility! Nerviano Medical Sciences Andreas Krause, PhD Director, Lead Scientist Modelling and Simulation Dept. of Clinical Pharmacology new for 2011! Actelion Pharmaceuticals • Hosted at Aptuit’s worldclass research facility in Verona Dr. Paolo Bettica, Head of Clinical Sciences, Aptuit • Streamed sessions to tailor your learning Dr Philippe Danjou, Forenap CSO • More interactive breakout and networking sessions - seize the opportunity to have your say! Associate Sponsor Sponsors • Access to e-networker; set up meetings and interact with your peers and Event Hosts prior to the event • A showcase of imaging techniques to help make go no/go decisions as early as possible +44 (0)20 7368 9300
  2. 2. pre-conference workshop MONDAY 12th SepteMber 2011 Hosted by AptUIt, VeRoNA, ItALy14.00 - 16.00Aptuit Site VisitAn exclusive behind the scenes tour through one of the world’s most famous R&D sites. Get first hand insight into the workings of this top class facility!This exceptional facility brings enhanced and expanded capacity to Aptuit’s existing capabilities, ensuring even greater flexibility. In addition to complementing and enhancing core service offerings, Aptuit now provides an even greater range of integrated drug support services from Early Discovery to Candidate Optimization and beyond.The Verona team’s success rate is also due, in part, to their focus on clinical proof of concept from the very beginning, takinginto account market need, patient requirements, clinical compliance and study designs, drug physical and safety characteristics,as well as understanding the candidate’s mechanism of action leading to its efficacious effects. The interaction from multiplefunctions in both early and late stage discovery / development result in significantly reduced attrition rates in the clinic.10.30 – 13.30Using Biomarkers in Early Clinical Development• Understanding the role of biomarkers in population screening and personalised medicine• Assessing the advantages and limitations?• Real life examples and case studiesattendee profile 2010Attendee by Job Function Attendee by Country Clinical Pharmacologist Scientific/Medical Officer France Italy Preclinical/Translational Scientist Clinical Specialist Denmark Israel Operations Head/Director/Manager Quality Director Germany Belarus Clinical Supplies Statistician Canada Belgium Clinical Trials Manager Business Development/Sales/ Poland Switzerland CEO/MD/Director Marketing United Kingdom Imaging Specialist Project Engineer The Netherlands Project/Unit Director Pharmaceutical Specialistabout pharma iqBecome a member of Pharma IQ and receive complimentary access to resources that will keep youat the forefront of industry change.You will receive access to our growing library of multi-media presentations from industry leaders, anemail newsletter updating you on new content that has been added, free aggregated news feed fromover 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 +44 (0)20 7368 9300
  3. 3. conference day one tueSDAY 13th SepteMber 2011 Hosted by AptUIt, VeRoNA, ItALy08.15 Registration and Coffee 12.50 Improving Dosage Developing an Effective09.00 Pharma IQ’s Welcome and Opening Remarks from Predictions and Establishing Patient Safety Strategy Chairperson Safe Concentrations for • Assessing the most effective design First in Man Studies approach to ensure optimumAchieving Regulatory Clarification and Harmonisation: • Achieving a safe FIM dosage and patient safetyWhat are the Submission Criteria? evaluating in vitro/in vivo correlations • Factors that have launched patient • Understanding the pharmacology safety to the forefront of public09.10 Keynote Presentation and mechanisms to ensure scrutiny, including the effects of Requirements for Early Phase Clinical Trials: optimum dosage increased reporting requirements A Regulator’s Perspective • Using preclinical data to effectively • What to look for when evaluating CRO • Preclinical requirements for early phase studies predict doses excellence and commitment to • Reflections of these requirements in the protocol • Assessing animal data, toxicity and patient safety • GMP aspects in early phase. toxicokinetic data to ensure • Optimising the role of the Data Walter Janssens, Coordinator Early Phase Development, FAGG-AFMPS appropriate dosage in FIM study Monitoring Committee09.50 Preclinical Data for Phase I/II Trials in Patients with • Establishing the evidence of safety • The evolution and future of regulations Cancer & ICHS9 in relation to dose concentrations to Corina Dana Dota, MD, ECG Centre • An overview of the ICHS9 guidelines ensure meaningful data and Director, CPD Co-chair Cardiac QT/ • Objectives in preclinical testing reaching go/no go decisions Arrhythmia Safety Knowledge Group, • Compare and contrast preclinical datasets between trials in advanced cancer Vikash Sinha, Clinical Pharmacology AstraZeneca and those in other populations Leader, CNS, Johnson and Johnson • Approaches to justifying the first human dose 13.30 Networking Lunch • Examples based on MHRA experience JW McBlane, Clinical Assessor, MHRA 14.10 Increasing FTIH Success by Combining Integrated Enabling Studies with Tailored Clinical Sciences Approach10.30 SPEED NETWORKING and Morning Coffee Dr. Paolo Bettica, Head of Clinical Sciences, Aptuit, Inc. This interactive session allows you to meet more of your peers through a series of 2 minute introductory meetings - the perfect opportunity to exchange ideas, Strategies to Make an Information Rich Go/No-Go Decision and forge new contacts and get a fresh perspective. Achieve Proof of Concept11.30 This session will be split into two streams to allow you to tailor your learning 14.50 The Role of PET Imaging in Preclinical and Early Drug and focus on the issues that are most important to you. Development • Reducing attrition rates through appropriate use of imaging: target validation, Stream A: Maximising the Use of Stream B: Developing Effective Preclinical Data, Establishing IVIVE Operational Strategies to Ensure GCP, supporting candidate selection and optimising dose selection and Making informed Decisions Maintain Patient Safety and Minimise • Challenges of PET imaging: timelines, tool validation, protocol and image Before Entering into the Clinic Trial Overrun analysis optimisation and standardisation and image processing • Risks: regulatory environment and costs CHAIR: Vikash Sinha CHAIR: Nabil Al-Tawil Jan Passchier, Director PET and Radiochemistry, GlaxoSmithKline Strategies to Establish Ensuring Participant’s Safety PoC During Preclinical and Enhancing the Trial’s 15.30 Applying Clinical Imaging to Biomarker Development to Development Efficiency Speed Go/No-Go Decisions • Which are the most essential • An overview of the ethical aspects • Prioritising active compounds preclinical POC criteria? • Understanding the Good Clinical • Establishing proof of mechanism • How predictive is preclinical POC Practice principles • Achieving more accurate dosage predictions through successful development for clinical development? • Some clinical aspects/FiM of biomarkers • What setup is needed to reach • Recruiting participants and ensuring Dana Ghiorghiu, Research Physician, Imaging Clinical Biomarkers Group, preclinical POC? trial completion is on time AstraZeneca Jürgen Moll, Director, Dep. Cell Nabil Al-Tawil, Consultant Physician, Biology, Oncology, Nerviano Karolinska Trial Alliance Phase-I Unit, 16.10 Networking Refreshment Break Medical Sciences Karolinska University Hospital 16.40 RIPA and RICO Predicting Efficacy of ALX-0081 in vWF Mediated Thrombosis: A Phase I/II Analysis. • An overview of ALX-008112.10 PANEL: Preventing Late Driving Clinical Development • Strategic development of biomarkers Stage Failure through through Successful • Using healthy volunteers in phase I OptimalUse of Preclinical Outsourcing: The Small • Phase Ib PCI patients Dataand Establishing IVIVC Biotech Perspective • Phase I SC admin healthy volunteers This session will allow you to openly • Our approach to CRO selection - Kristof Vercruysse, Director Clinical Operations, Ablynx discuss preclincial strategies and how the importance of location for a they can save you time and money, small biotech 17.10 PANEL such as; • Assessing the benefits of a full vs. Assessing the Value and Risk of Imaging and Biomarkers •Using humanised animal models functional outsourcing strategy in Phase I: What are the Alternatives? to enhance accuracy of • Developing best practice when You’ve heard the advantages and potential challenges, now it’s your turn to ask predictions in man managing relationships and Setting the experts. • Ensuring effective error realistic KPIs from the outset Kristof Vercruysse, Director Clinical Operations, Ablynx spotting at both preclinical and • Ensuring smooth contract development Dana Ghiorghiu, Research Physician, Imaging Clinical Biomarkers Group, early development and negotiation AstraZeneca • Using comprehensive PK/PD data • Getting your voice heard throughout Jan Passchier, Director PET and Radiochemistry, GlaxoSmithKline the partnership and ensuring access to high quality CRAs 17.10 Closing remarks from chair person and end of day 1 Faron Jordan, Critical Pharmaceuticals 17.50 Evening Drinks +44 (0)20 7368 9300
  4. 4. conference day two WeDNeSDAY 14th SepteMber 2011 Hosted by AptUIt, VeRoNA, ItALy08.15 Registration and Coffee B) Evaluating the Challenges and Pitfalls of Using Patients09.00 Pharma IQ’s Welcome and Opening Remarks from Chairperson in Phase I This session will uncover the opportunities and challenges when using patients inAdopting Innovative Trial Design Approaches to Help Decision phase I. It will also explore the considerations when recruiting patients.Making and Get the Most Out of Early Development Data Kristof Vercruysse, Director Clinical Operations, Ablynx09.10 Taking a Statistical Approach to Optimise Dose Finding C) CRO Selection and Management Strategies • Predicting expected dose profiles and the effects of different doses Share best practice approaches when choosing and working with your CRO • When do we need precise dose finding and when is a rough estimate to ensure you get the most out of your partnership. Use this opportunity to refine good enough? your outsourcing strategy and ask the crucial questions to a past CRO employee! • Examples of our design approaches - the challenges and successes Faron Jordan, Head of Preclinical and Clinical Project Management, Mark Baker, NovImmune Critical Pharmaceuticals09.50 Integration of Key Non-Clinical Data Packages into the Design 13.40 Networking Lunch of Innovative Phase I Studies A case-study of targeted transition to clinical development, including 14.40 INTERACTIVE CRISIS MANAGEMENT: up-to-date developments Turning a Crisis from a Challenge into an Opportunity Constance Hoefer, Head of Non-Clinical Drug Development, Medigene for a Change Unexpected challenges can arise anywhere, anytime, leaving you very little time10.30 Phase 1 Trial Design to Optimise Outcome to prepare and regroup. This dedicated, interactive session will see attendees • Phase 1 studies; are potentially hazardous – considerations to ensure safe designs divided into small groups to work through the “crisis scenario” set by the session • Phase 1 studies; are commonly relatively short – minimising time between leader, Jurgen Moll. Your task, as a team, is to devise a strategy to ensure clinical studies is important development suffers as little interruption as possible whilst maintaining high • how to get the best within and between patient comparisons quality levels. • require rapid turn around of data to allow efficient dose escalation Points to consider; Points to consider; - Keeping talent and motivation during a crisis - Making Phase 1 a bridge rather than a barrier to Phase 2 - Turning crisis management into risk management - What do I need to show in my studies? Jürgen Moll, Director, Dep. Cell Biology, Oncology, Nerviano Medical Sciences David Eckland, Director, Eckland Consulting 15.40 Networking Refreshment Break11.10 Use of Adaptative Design to Adjust for an Unknown Response Rate by sample size readjustment : case of a CCK-induced Driving Innovation and Drug Development through anxiety model as a Proof Of Concept study. Collaborations with Academia • An overview of existing POC designs in anxiety disorders 16.10 Precompetitive Research in Drug Development: Lessons • Preclinical data on BNC210 and model alignment between species • Principles of model and historical data for response rate and magnitude from the Innovative Medicines Initiative • An overview of IMI as the largest PPP in life sciences R&D of drug response • Real life examples of our delivery of R&D projects • Simulations and hypotheses for sample size based on in-house data and literature • Addressing the challenges and lessons learned (Intellectual property • End of planned cohort estimation of response rate and analysis of causative management,boundaries of precompetitive research, etc). factors for deviation from theory • Future directions for IMI and R&D collaborations across the industry • Follow up of response rate by clusters of subjects and termination of study Michel Goldman, MD, PhD, Executive Director, Innovative Medicines Initiative • Post mortem analysis of design :monitoring methods for the ongoing study and improvements (semi-continuous assessment of response rate and 16.40 Understanding the Different Models and Challenges early triggering of actions). of Collaborations between Academia and Industry • Final analysis of the power obtained at the end (lack of dilution by non- responders) • What do academia/charities have to offer pharma • Statistical message to take home • How academia/charities perceive pharma • Clinical data on BNC210 tolerability and panic response to CCK. • Models for engagement with industry Dr Philippe Danjou, Forenap CSO • Can academia/charities broker these kinds of collaborations? Dr Chris Twelves, Professor of Clinical Pharmacology and Oncology & Head11.50 Networking Refreshment Break Clinical Cancer Research Groups, Leeds Institute of Molecular Medicine &Investigating Data Requirements and Assessing Clinical Risk St James’s Institute of Oncology12.10 Visualisation of Pharmacokinetic and Pharmacodynamic 17.10 PANEL: Driving Development through Successful Industry - Models for Decision Making Academia Collaborations • Applying interactive graphics to show the effects of a drug for different This interactive session will examine the advent of pharma - academic groups of patients partnerships and the future of early clinical development. Engage with experts • Establishing different doses and dosing regimens from both sides of the collaboration to get a full perspective of the benefits and • Quantifying variability and optimising doses challenges and best practice when setting up partnerships Andreas Krause, PhD Director, Lead Scientist Modelling and Simulation Dept. Facilitators; of Clinical Pharmacology Actelion Pharmaceuticals Dr Chris Twelves, Professor of Clinical Pharmacology and Oncology & Head Clinical Cancer Research Groups, Leeds Institute of Molecular Medicine &12.50 Breakout Roundtable Discussions St James’s Institute of Oncology Participants will be able to choose one of the roundtables outlined below and Nabil Al-Tawil, Consultant Physician, Karolinska Trial Alliance Phase-I Unit, spend 45 minutes discussing the points Karolinska University Hospital A) Developing Biomarkers During Early Development: Michel Goldman, MD, PhD, Executive Director, Innovative Medicines Initiative Risks vs Benefits Jan Passchier, Director PET and Radiochemistry, GlaxoSmithKline What are the pitfalls and challenges of biomarker development? Discuss the 17.40 Closing Remarks from Chairperson and End of Day Two solutions and preventative strategies in this open discussion format. Paulo Fontura, Head of Translational Medicine CNS, Roche +44 (0)20 7368 9300
  5. 5. sponsorship and exhiBition Hosted by AptUIt, VeRoNA, ItALyassociate sponsor and event hosts maximise your involvement: sponsorship and exhibition opportunities Pharma IQ’s Innovation in Phase I Clinical Development is the only event in Europe that brings together regulatory and pharmaceutical professionals across the preclinical and clinical fields. The proportion of trials at phase I stage has grown from 25% to 40% in the pastAptuit Verona. Delivering Results. ten years and the industry is looking to ensure first time approval and that their drug reaches the market first.Aptuit’s newest facility in Verona is now fully integrated into the Aptuitglobal network, helping to deliver more science, more service and more The conference is attended by senior decision-makers, bringing together buyerspeople. The Verona team is a dynamic force within the company’s global and suppliers in one location. Focused and high-level, this is an excellent platformoperations, sharing world class expertise in target discovery and biology, to initiate new business relationships. With tailored networking, sponsors canlead characterisation and screening, medicinal chemistry and integrated achieve the face-to-face contact that overcrowded trade shows cannot deliver.lead optimization. The dedication, skills and enthusiasm of the entire Aptuit Packages can be tailor-made to suit your company’s needs. Packages includenetwork are at your disposal - helping you bring your drug concepts complimentary entry passes, targeted marketing to industry officials andsuccessfully to market. executives and bespoke networking opportunities. Other features of sponsorship include: • Access to e-networker • Inclusion on the Pharma IQ portal (+20,000 members) • Webinar production and promotion • Prominent exhibition space in the main conference networking • Tailored marketing strategies to suit your organisation’s size, capabilities and individual requirements For more information and to discuss the right opportunity, contact us on +44 (0)207 368 9300 or who will attend? Directors, senior managers and managers within pharmaceutical manufacturers, biotech and academic and healthcare institutes with responsibility for: • Clinical Pharmacology • Clinical Development • Clinical Operations • Clinical Research • PK/PD • Translational MedicineWebsite: www.forenap.comFORENAP is a full service CRO that has investigated the potential efficacy and safety of more • Biomarker Developmentthan 200 compounds. We are one of the world leaders in CNS and Pain drug development. • Clinical ImagingOur clinical pharmacology unit is a 6,000 m² clinic that houses a total of 72 beds. It includes • Regulatory Affairsclinical assessment space and dedicated pharmacodynamic equipments: EEG, polysomnographie, neurocognitive testing, driving simulation, pupillometry, body sway...In addition, we have developed novel models of human neuropsychiatric and Pain pathologiesin healthy volunteers. These models enable us to include proof of concept studies very early in media partners:development programs, with the following potential: dose finding, identification of therapeutic indication, and early signs of efficacy. Our final goal is to add value and accelerate your clinicalresearch for this yearThis online networking platform allows you to see who is attending beforethe event runs and make the most of your time at the conference itself. Get involved in the discussions!Other features include; Linked In at• Create your own profile and add links to Facebook, Twitter etc. Pharma IQ- Clinical Trial Development• Send networking requests to keep up to date with all the latest clinical news• Make appointments with other attendees and to network with fellow industry professionals.• Add important people to a key contacts list• Easily locate sponsors and exhibitors• Ask exhibitors and sponsors for information Take full advantage of our event-focused Twitter-based• View speakers’ biographies chat stream @ClinicTrialNews where you can inter-• Send questions to speakers act live with your peers while the event is taking place.• View and book Break-out sessions +44 (0)20 7368 9300
  6. 6. 5 Ways to Register FREEPhOnE: 0800 652 2363 or +44 (0)20 7368 9300 Conference: 13th June – 14th September 2011 Venue: Aptuit, Verona, Italy Pre-conference Workshop: 12th September 2011 FAx: +44 (0)20 7368 9301 To speed registration, please provide the priority code located on the mailing label or in the box below. My registration code POST: your booking form to PDFW IQPC, 129 Wilton Road, Please contact our database manager on +44(0) 207 368 9300 or quoting the Victoria, London, registration code above to inform us of any changes or to remove your details. 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Save €350 Save €250 Conference + Workshop* €2798 +VAT Save €300 €2898+VAT Save €200 €3098 +VAT VEnuE & ACCOMMODATIOn Conference + Site Visit* €2548+VAT €2648+VAT €2848 +VAT Save €300 Save €200 Venue: Aptuit (Verona) Srl., Via Alessandro Fleming 4, 37135 Verona (VR), Italy Conference Only* €2249+VAT €2349+VAT €2449 +VAT Accommodation: HOTEL ACCADEMIA, Via Scala, 12 - 37121 Verona Italy Save €200 Save €100 Tel: 39.045.596 222 Fax: 39.045.800 8440 Email: * To qualify for discounts, payments must be received by the early bird registration deadline. Web: Early booking discounts are not valid in conjunction with any other offer. Additional hotels can be found on: Tick this box if you wish to opt out of full conference recordings (reducing the price by €550) Italy VAT is charged at 20%. 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