Clinical Trials in Oncology


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The Clinical Trial in Oncology event on 1-2 December 2009 in Munich will show you how to utilise target approaches to optimize your clinical research and enhance your patient enrolment, data quality and much more.

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Clinical Trials in Oncology

  1. 1. vIBpharma Supported by 15.25 credit points 2nd Annual Clinical Trials in Oncology Tuesday 1 and Wednesday 2 December 2009, Hilton Munich City, Munich, Germany Targeted approaches to optimising clinical research while enhancing patient enrolment, data quality and the value of your trial outcome JOIN OUR 19 CASE STUDy KEyNOTE SPEAKERS: PRESENTATIONS AND: Robert A. Morgan, Group Director Senior Vice President, Early Oncology, BRISTOL- • Understand the amended RECIST Regulatory Affairs, Quality, MyERS SQUIBB EUROPE 1.1 guidelines and Clinical Development, ZIOPHARM ONCOLOGy Jonathan Allis, • Explore IPH 2101, a novel anti-Natural Head Global Killer Immunoglobulin like Receptor Thomas Pepper, Imaging Network, (KIR) monoclonal antibody that enhances Clinical Research and GE HEALTHCARE Exploratory Development NK cells cytotoxicity (CRED), Operations Leader Murray yule, Vice President - Oncology (COL), Clinical Clinical Development, • Find out how your peers increase the ASTEX THERAPEUTICS Programme Management amount of high quality data they obtain - Study Management Clemens Stoffregen, • Benefit from presentations and Group (PDEC-S), ROCHE Internist, Regional Tumour PRODUCTS discussion sessions with your peers Team Leader, European from pharma and biotech manufacturers Prof. Dr. Stefan Endres, Platform, Oncology, Dean of Research, Medical Medical Advisor, LILLy as well as regulators Faculty, UNIvERSITy OF MUNICH COMPANIES REPRESENTED INCLUDE: Thomas Bogenrieder, Attend • F. HOFFMANN • GPC BIOTECH Clinical Director Oncology, excitin the confer gp Oncology Centre of ence w re- LA ROCHE • JOHNSON & Excellence, Europe, on Mo orks Asia-Pacific, Japan & nday 3 hop • ZIOPHARM JOHNSON Novem 0 Emerging Markets, ber ONCOLOGY • LILLY GLAXOSMITHKLINE 2009 • ASTRAZENECA • PROSTRAKAN Christiane Langer, Lead sponsor: Silver sponsors: REGISTER NOW: Sponsor: Email: Tel: +44 (0)207 7753 4268 Co-sponsor: Fax: +44 (0)20 7915 9773
  2. 2. Programme Day One Tuesday 1 December 2009 08:30 Registration and coffee 11:10 Morning refreshments 09:00 Opening remarks from the Chair Understanding new regulatory considerations Clare Wareing, CEO, NEXUS ONCOLOGy surrounding cancer clinical trials Optimising patient recruitment, data capture and 11:30 Explaining amendments to clinical trials guidelines trial design to ensure faster regulatory approval in terms of continuous safety monitoring and 09:10 Keynote address: From design to decision-making reporting requirements from a clinical development perspective: effective ● Clarifying Eudralex Volume 10: ● New additions: Q&A document on safety reporting project management techniques for ensuring your ● Detailed guidance on the collection, verification and study runs smoothly presentation of adverse reaction reports arising from clinical ● Ensuring overall project management of trials in order to contribute trials on medicinal products for human use to R&D excellence ● Guidance on Investigational Medicinal Products (IMPs) and other ● Managing the team: what makes a good compound leader and medicinal products used in clinical trials how to coordinate the internal teams and external stakeholders ● International Conference on Harmonisation of Technical Requirements ● Establishing effective approaches to solve strategic problems for Registration of Pharmaceuticals for Human Use (ICH): exploring the and address challenges effectively revision of the Development Safety Update Report guideline ● Implementing trial design into practice: making the right decisions Janet Schriever, Unit Clinical Trials, BFARM to boost strategic effectiveness of your trials within drug development Panteli Theocharous, Senior Clinical Project Scientist (Associate 12:00 Establishing innovative trial marketing approaches Director), J & J Global Clinical Development, JOHNSON & JOHNSON involving academic research networks and study sites 09:40 De-risking oncology clinical development: mitigating to maximise patient enrolment ● Realistically forecasting the number of patients to be recruited to risk from phase I to III enable efficient trial execution ● Phase I trial design: single agent or combination studies? Solid ● Assessing the means to proactively communicate with sites in order or haematological tumours? All tumour types or disease specific to accelerate the process of finding appropriate patients patient populations? ● Defining the role and responsibilities of CRAs in the recruitment ● Cost effective phase I studies: maximising the information collected process: how they manage to motivate and effectively communicate to inform decisions about phase II design and working with the right with sites in order to get them actively involved phase I sites ● Working with CROs to optimise the recruitment process ● Phase II study designs: the pros and cons of randomised phase II ● Facilitating cooperation between academic research organisations and studies: indications and dilemmas the industry to inform the maximum number of experts and patients ● Enriching patient populations in phase II development using ● Outlining options to inform patients directly about a trial to encourage biomarkers and genetics them to contact a clinician ● Feasibility assessments: how to ensure that recruitment rates ● Ensuring compliance with ethics committee guidelines quoted during feasibility are accurate ● Leveraging eHealth affinity of cancer patients ● Mitigating the risk to patient recruitment in phase II studies ● Finding new ways of cancer clinical trial marketing ● The decision to move into phase III Jody Spooner, Business Development Associate, CMED ● Going for gold: moving straight to phase III from an expanded phase I programme 12.30 Case study: Addressing the challenge of historical Clare Wareing, CEO, NEXUS ONCOLOGy efficacy data in the design of a phase III study for 10:10 Panel discussion: Improving the communication and a placebo-controlled chemotherapy trial cooperation between trial sponsors, academic research ● Ensuring effective product development and understanding the resulting networks and study sites to maximise patient enrolment clinical efficacy data for adjuvant instillation therapy of gemcitabine in ● Complying with the study sites’ requirements from a sponsor’s patients with non-muscle-invasive bladder cancer (NMIBC): An analysis perspective to ensure a smooth enrolment process following the outcome of a phase III trial: single postoperative instillation ● Identifying key obstacles with sites and sponsors to cooperate with of gemcitabine in patients with NMIBC, reviewing the results of a each other in terms of patient recruitment and how to overcome them randomised, double-blind, placebo-controlled phase III multicentre study ● Specifying actions to be taken by sponsors to help the site recruit ● Creating an effective study design based on an in vitro cell line, animal ● Assessing how networks can work more closely with sponsors and data, phase II data of the experimental drug and understanding of the physicians on-site to enrol patients effectively phase III data for the control arm ● Handling competition between oncology trials at one site: how to build ● Presenting an overview of an unplanned interim analysis: follow-up a strong sponsor-site-relationship to tackle this issue successfully during the study was terminated after only approximately 50% of ● Identifying crucial action points to prevent delays with patient recurrences occurred at the initially planned follow-up-period enrolment in order to guarantee the study starts on time ● Understanding why final results showed not different but unexpected Chair: Clare Wareing, CEO, NEXUS ONCOLOGy high rates for (recurrence-free survival RFS) in both arms ● Clarifying contributing factors to results: exploring the “experimental” Panellist: Prof. Christian Ohmann, Member of the Board, setting of the placebo arm (instillation of saline) Network of Coordinating Centres for Clinical Trials, KKS NETWORK Clemens Stoffregen, Internist, Regional Tumour Team Leader, Elmar Stridde, Head of Clinical Study Centre, CLINICAL CENTRE OF European Platform, Oncology, Medical Advisor, LILLy THE LUDWIG MAXIMILLIANS UNIvERSITy MUNICH Denis Mir, Senior Manager, Clinical Operations - Oncology, EISA, Moving towards personalised cancer therapies GLOBAL CLINICAL DEvELOPMENT to increase the potential value of a medicine with 10:40 Assessing the feasibility of oncology clinical trials to respect to reimbursement ensure trials stay on track at any development stage 13:00 Case study: Overcoming the operational challenges ● Establishing the need for a feasibility assessment and the crucial points to consider to ensure an accurate measure of implementing a personalised healthcare strategy ● Evaluating the benefits of feasibility surveys and how to measure them in early phase oncology studies ● Outlining the sources of data that can be used to help plan oncology ● Developing medicines with improved and more predictable studies whilst ensuring the data quality is maintained outcomes, thereby allowing the clinician to optimise the therapy ● Providing access to the data needed: presenting a PPD case study ● Selecting biomarkers of interest in the context of novel molecules and Martin Lee, Executive Director, Feasibility Services, Board Certified, identifying appropriate analytical laboratories and assay validation Internal Medicine and Medical Oncology, PPD
  3. 3. Day One Tuesday 1 December 2009 Programme Day Two ● Burden on both the patient and investigational sites in the collection, 08:30 Registration and coffee processing and management of multiple samples which can be particularly challenging in the context of serial tumour biopsies 09:00 Opening remarks from the Chair ● Integrating laboratory based biomarker assessments with radiological Prof. Dr. Stefan Endres, Dean of Research, Medical Faculty, assessments such as CT/PET or DCE-MRI within the same protocol UNIvERSITy OF MUNICH ● Ensuring a high level of compliance consistency in sample collection both within and across clinical centres Identifying diagnostic testing methods to evaluate Obtaining the necessary ethical and regulatory approvals ● ● Receiving patient informed consent the results of your oncology trial effectively Thomas Pepper, Clinical Research and Exploratory Development through the use of the right endpoints (CRED), Operations Leader - Oncology (COL), Clinical Programme 09:10 Keynote address: Exploring the amended guidelines Management - Study Management Group (PDEC-S), ROCHE PRODUCTS of RECIST 1.1 (Response Evaluation Criteria in Solid 13:30 Lunch Tumours) and learning how to adapt them accurately ● Understanding its use and benefits in clinical trials with a primary 14:30 Roundtable afternoon sessions endpoint of objective response Delegates will be able to attend three one-hour roundtable ● Evaluating the tumour response: assessing tumour shrinkage discussion groups from a selection of key topics. Each session will and disease progression based on the sum of diameters without be chaired by an industry expert who will facilitate an exchange of anatomical-based imaging opinions, essential experiences and learning related to a current ● Outlining the relevant changes: Number of lesions to be assessed, aspect of clinical trials in oncology. measurement of pathological lymph nodes, confirmation of response, disease progression and imaging guidance Roundtable 1 Exploring what strategies could be put ● Exploring remaining issues to be defined in place to increase patient enrolment ● Identifying how to adapt RECIST 1.1 and leverage benefits Optimising your approaches to engage study sites, CRAs and other Robert A. Morgan, Senior vice President, Regulatory Affairs, stakeholders like academic research networks in helping you recruit the Quality, and Clinical Development, ZIOPHARM ONCOLOGy maximum amount of patients with the right indications for your trial Thore Nederman, Head of Clinical Development, ACTIvE BIOTECH 09:40 Uncovering independent central review (ICR) for oncology clinical trials: challenges and lesson learned Roundtable 2 Overcoming the operational challenges ● Assessing endpoints in oncology trials and ensuring verification of implementing a personalised healthcare strategy for regulatory approval Identifying the process of an ICR as well as resources involved in early phase oncology studies ● ● Why ICR: outlining potential purposes and how to produce greater Understanding techniques to move towards tailored cancer consistency in image interpretation therapies in order to ensure the best outcome for each patient ● Clarifying operational considerations Thomas Pepper, Clinical Research and Exploratory Development (CRED), ● Explaining discordance between local and central interpretations Operations Leader - Oncology (COL), Clinical Programme Management - and how to handle this Study Management Group (PDEC-S), ROCHE PRODUCTS ● Overcoming challenges regarding protocol requirements Roundtable 3 Ensuring effective collaboration and Karoline Meurer, Managing Director, RADPHARM partnership between clinical R&D and clinical 10:10 Case study: Moving beyond simple procedures like operations to ensure a successful trial computed tomography (CT) to positron emission Managing communication and cooperation challenges by adopting successful clinical project management strategies tomography (PET): highlighting advances of tumour Panteli Theocharous, Senior Clinical Project Scientist (Associate development analysis Director), J&J Global Clinical Development, JOHNSON & JOHNSON ● Molecular imaging: making it real ● Imaging the hallmark of cancer with PET Roundtable 4 Integrating radiotherapy into clinical trials ● Angiogenesis, apoptosis, proliferation in combination with molecular targeted agents ● Enhanced amino acid transport Overcoming complexity issues surrounding the combination of ● Quality control in imaging clinical trials targeted therapy and radiotherapy ● The importance of sophisticated analysis tools Ozlem Ataman, Radiotherapy Combinations (ROCKIT ) Clinical Lead, Jonathan Allis, Head Global Imaging Network, GE HEALTHCARE ASTRAZENECA 10:40 Explaining Primary Systemic Therapy (PST) or Roundtable 5 How to do cost effective oncology drug Neoadjuvant (Chemo) Therapy (NA(C)T) in invasive development breast cancer: state-of-the-art, current issues, Evaluating how to increase efficiency and cost containment and future perspectives for drug development throughout your drug development processes without jeopardizing Explaining Primary Systemic Therapy (PST) or Neoadjuvant (Chemo) your trial outcome Therapy (NA(C)T) in invasive breast cancer: state-of-the-art, current Clare Wareing, CEO, NEXUS ONCOLOGy issues, and future perspectives for drug development ● Broadening the indication for PST or NA(C)T from downsizing locally Roundtable 6 Exchanging experiences in handling advanced, inoperable breast cancers to smaller breast cancers in order to biological samples to deliver reliable lab results allow breast conserving therapy (BCT) and to yield better cosmetic results Understanding pre-analytical factors, handling and logistics aspects ● Outlining the results of the large, randomized, pivotal phase III to ensure that samples arrive in good condition at the laboratory. neoadjuvant trials NSABP B-18 and NSABP B-27 and explaining the Inter-active discussion to share experiences on biomarkers, advantages and disadvantages of neoadjuvant chemotherapy personalized medicine and laboratory results ● Using NA(C)T for in-vivo chemosensitivity testing and as innovative Dr. Hermann Schulz, CEO, INTERLAB central lab services platform for the in-vivo testing of new drugs, e.g. cytotoxic and Dieter Sedlmair, Director Business Development, molecularly targeted agents and their combinations INTERLAB CENTRAL LAB SERvICES ● Accomplishing a pathologic complete response (pCR), i.e. the absence of invasive tumour in the breast specimen and/or in the 18:00 Closing remarks from the Chair and drinks axillary lymph nodes, which shows PST to be a surrogate end point reception hosted by Nexus Oncology for recurrence and survival ● Testing in-vivo chemosensitivity of new drugs and drug combinations in the neoadjuvant setting using the pCR-rate as a
  4. 4. Day Two Wednesday 2 December 2009 surrogate end point (i.e. substituting recurrence-free (RFS) and ● Understanding regulatory issues: how to get the right information overall survival (OS) in the adjuvant setting) in order to speed up and guarantee compliance with data guidelines drug development in early breast cancer ● Exploring approaches to speed up clinical operations processes ● Presenting large, ongoing, neoadjuvant clinical trials applying to optimise the trial outcome this new paradigm in drug development in primary breast cancers Denis Mir, Senior Manager, Clinical Operations – Oncology, according to their molecularly defined subtypes EISAI GLOBAL CLINICAL DEvELOPMENT Wolfgang Hamm, MD, PhD, Senior Clinical Research Physician, HARRISON CLINICAL RESEARCH 14:30 Case study: Phase II trial designs in oncology: what really matters to ensure an optimum outcome 11:10 Morning refreshments using common and innovative methods and prevent 11:30 ADAPTIvE AND SEAMLESS DESIGNS FOR LATE STAGE failure of the trial at a later stage ONCOLOGy STUDIES: examining actual interim analysis ● Establishing the purpose of phase II trials ● Assessing the success rate of phase III trials trial case studies and their impact on our industry and ● Outlining factors to reduce the number of failures your own development efforts ● Benefitting from using innovative ways to assess tumour burden ● Assessing why adaptive approaches are increasingly common in early ● Setting up statistical trial designs for phase II clinical studies, but only beginning to be utilized at the all important ● Validating biomarkers effectively confirmatory stage Christiane Langer, Group Director Early Oncology, ● Designing and implementing seamless phase 2 / 3 trials - defining BRISTOL-MyERS SQUIBB EUROPE the opportunities and challenges ● Re-estimating sample size and events for survival endpoints 15:00 Supportive care in oncology: challenges and ● Determining efficacy and futility stopping rules in cancer trials opportunities in drug development to improve Clarifying what to expect from regulators: best practices from ● outcomes for patients recent experiences ● Emerging areas of toxicity with new therapies yannis Jemiai, Ph.D., Associate Director of Biostatistics, CyTEL INC. ● Meaningful endpoints in supportive care Specific challenges in running supportive care studies Learning from case studies on novel therapeutic ● ● Patient reported outcomes and the regulatory perspective approaches: highlighting targeted, antibody ● Old drugs for new problems and supportive care therapies Julian D. Howell, Head of Clinical Development, PROSTRAKAN 12:00 Case study: A phase I-directed, non-clinical development 15:30 Afternoon refreshments strategy for a CDK-/kinase inhibitor: establishing non- clinical data to give guidance on phase I trial design in 16:00 Case study: Outlining skin toxicity of targeted terms of the determination of safety/efficacy relevant therapies: epidemiology and management endpoints and early warning signs for adverse effects ● Understanding cancer epidemiology and clinical presentation ● A non-clinical testing strategy: an overview (PD, PK and toxicology) ● Managing skin toxicity from a scientific perspective ● Specific aspects of individual non-clinical safety studies ● Clarifying international guidelines ● Dealing with drug-specific, non-clinical study findings ● Skin toxicities in clinical trials: presenter’s experience ● Non-clinical study results and their impact on phase I ● Establishing a guide for patients clinical trial designs ● Investigator education ● Regulatory feedback and overcoming related issues Thomas Bogenrieder, Clinical Director Oncology, Oncology Thorsten Meyer, Associate Director, GPC BIOTECH Centre of Excellence, Europe, Asia-Pacific, Japan & Emerging Markets, GLAXOSMITHKLINE 12:30 Case study: IPH 2101, a novel anti-Natural Killer Immunoglobulin like Receptor (KIR) monoclonal 16:30 Combining targeted cancer therapies successfully: antibody that enhances NK cells cytotoxicity: what are the possibilities, crucial factors to be preclinical and phase I studies results in various considered and solutions to benefit from? hematological malignancies ● Deciding whether to combine targeted therapies or run sequential ● NK cell activation as a novel immunotherapy approach for the therapies: outlining the benefits of combination treament of hematological cancers ● Explaining how to handle toxicity issues when complying with ● Pre-clinical development: pharmacodynamic and pharmacokinetic safety guidelines aspects and relevance of preclinical models ● Leveraging synergetic effects of combined targeted therapies: ● Modelisation for dose ranging to be tested in phase I how to make your targeted therapies more effective ● Designing the first in man study: selecting safe starting dose and ● Exploring how to maximise the effectiveness of a targeted therapy escalation scheme choosing the right complementary therapy ● Selection of indications to be tested in phase II and impact of ● Outlining the combination opportunities between targeted therapy potential surrogate endpoints and radiotherapy: decisive parameters for an optimal combination Patrick Squiban, Chief Medical Officer, EvP Medical and ● Combining targeted therapy and chemotherapy: how to merge Regulatory Affairs, INNATE PHARMA schedules effectively ● Creating strategies for reaching a balance between efficacy 13:00 Lunch and safety to optimise the overall outcome of the combined targeted therapy 14:00 Overcoming operational challenges in large phase III Murray yule, vice President Clinical Development, oncology studies ASTEX THERAPEUTICS ● Choosing and managing CROs by proactively building a strong relationship with them 17:00 Closing remarks from the Chair and ● Gaining access to laboratory and imaging data in a timely manner champagne prize draw ● Considering the use of pharmacogenomics when running global clinical trials in order to evaluate scientific differences accurately ● Describing new testing systems and trial strategies based on the genetic differences of patients ● Monitoring the trial processes and increasing investigator site performance and productivity
  5. 5. Pre-conference workshop Who should attend: Drug targeting in cancer clinical Directors, Senior Managers and Managers from the trials: establishing potential following areas within pharmaceutical manufacturers developmental pathways and biotech companies: ● Oncology clinical trials MOnDay 30 nOveMber 2009 ● Clinical research & development, clinical trials, Steen Knudsen, PhD, CSO and Founder, Medical Prognosis Institute clinical operations ● Medical affairs, medical department About the workshop: Drug targeting is traditionally based on a single DNA ● Drug development or protein marker that separates responders from non- responders. However, gene expression is emerging as a ● Biochemical engineering universal approach that works where single markers fail. ● Biostatistics, statistics This workshop will explain how gene expression can be used for drug targeting in cancer. ● Pre-clinical research, development About the workshop leader: ● Pharmacokinetics and dynamics Steen Knudsen, PhD, is CSO and founder of Medical Prognosis Institute in 2004. He has ● Biomarker worked for more than 10 years with gene expression, bioinformatics, cancer and ● Imaging clinical trials and is the author of numer- ● Business unit oncology, therapeutic area oncology ous papers as well as three books on the subject. He previously held a position as ● Marketing Professor in academia. The Medical Prognosis Institute is a Danish pharmacodiagnostic company with proprietary ● Regulatory affairs pivotal technology (DNA microarray, qPCR based) which is universally applicable to any drug and any disease to ● External affairs determine drug response prediction. MPI offers this tech- nology as a service to pharma and biotech companies e.g. with a pipeline of cancer, diabetes or obesity drugs. TESTIMONIALS - previous attendees' thoughts: Workshop agenda: "Overall the experience was positive. It’s 09:00 Exploring a universal approach to drug good to hear the opinions of colleagues" targeting in oncology: gene expression ● Explaining the process of developing a predictor Associate Professional, Investigational ● What are the requirements? Supplies, Johnson & Johnson ● Identifying clinical validation results "Very good & informative" 09:45 Selecting the most promising cancer types for phase I/II trials Clinical Liaison, Amgen ● Demonstrating which cancer types will give high response rates by assessing a response predictor "The conference was very well organised Highlighting examples from the drug industry ● and the subjects were very diverse. . .I 10:15 Morning refreshments would recommend this to others" Senior Research Associate, Wyeth 10:45 Outlining trial designs for targeted drugs: large potential savings in trial size ● Selecting patients for inclusion "Very relevant to our situation." ● Testing the predictor after trial completion Corporate Director, Integrated Supply Chain, Laboratoires Serono 11:30 Explaining economic aspects of drug targeting ● Reducing patient population through drug targeting but not market size ● Clarifying why drug targeting is an insurance against failure in phase III Do you wish to exhibit your products 12:00 Presenting a brief overview of regulatory and services at this exclusive event? aspects of drug targeting If you want to be part of this leading industry event, ● Outlining how regulatory authorities have prepared for approval of more targeted drugs please contact Rizwan Qayum in our sponsorship team. Email: 12:15 End of workshop or call: +44 (0) 020 7753 4259
  6. 6. Supporting Associations PPD is a leading global contract research organisation providing discovery, development ASCO is the world’s leading professional and post-approval services as well as organization representing physicians who compound partnering programmes. Our clients and partners include treat people with cancer. ASCO's members pharmaceutical, biotechnology, medical device, academic and set the standard for patient care worldwide government organisations. With offices in 38 countries and more than and lead the way in carrrying out clinical research aimed at improving the 10,000 professionals worldwide, PPD applies innovative technologies, prevention, diagnosis, and treatment of cancer. therapeutic expertise and a commitment to quality to help its clients The European Society for Medical Oncology (ESMO) and partners maximise returns on their R&D investments and accelerate is the leading non-profit European professional the delivery of safe and effective therapeutics to patients For more organization focusing on advancing the specialty of information, visit our Web site at medical oncology and promoting a multidisciplinary INTERLAB central lab services for clinical trials - approach to cancer treatment and cure. ESMO is worldwide INTERLAB is an independent CENTRAL an international community of more than 6,000 oncology professionals, LABORATORY supporting regional, international spanning over 100 countries. We unite key stakeholders who share the and global clinical trials for pharmaceutical and common objective of eradicating cancer, fostering a favorable environment biotechnology companies. INTERLAB has developed into a worldwide for scientific research, and advocating for equal access to the best and network covering Europe, North and South America, Australia, Africa and most effective patient treatment and care available. Asia including India and China. Project teams assigned to coordinate OECI is a continuously growing and developing study logistics are in Germany and USA. network, presently regrouping 67 cancer centres across Europe, dynamically working in crosscut Sponsor expertise projects organised mainly within Working Groups. Established in Cytel Inc. is the leading provider of clinical trial design 1977 to promote greater cooperation among European cancer centres and services and specialized statistical software for the institutes in the field of cancer collaborative research, the «Organisation of biopharmaceutical, medical device, academic and European Cancer Institutes» held its first General Assembly in 1980. Please government research markets. 47 out of the top 50 visit biopharmaceutical companies and international regulatory agencies use Cytel software to design trials and analyze study data. For over Lead sponsor 20 years, Cytel has provided study sponsors with innovative tools Nexus Oncology is a specialist CRO offering oncology and consultative services to increase clinical efficiencies and reduce drug development services to the biopharmaceutical development costs. sector. Founded over 10 years ago, we maintain a commitment and focus to the conduct of oncology Exhibitors studies across Europe, the US and beyond. We work 100% in oncology. As such, our clients benefit from staff with a significant degree of specific experience in the highly specialised arena of clinical oncology research.Originally specialising in Phase I oncology studies we have successfully extended our area of expertise into phase II and phase III. In doing so we have expanded our UK base and have offices in France, Switzerland, Poland, Sweden and Hungary supplemented by an extensive network of field based staff throughout Europe. We also have operations in North America, headquartered in San Antonio, with satellites in San Diego and Atlanta, and again, field based staff covering the whole region. Nexus Co-sponsor primarily provide clinical and medical monitoring, project management, regulatory services, feasibility and development planning services. Through our network of excellent strategic partners we are able to offer clinical services in extended geographies as well as biometrics, central labs, drug supply and pharmacovigilance enabling Nexus to offer full service whenever a client requires. Nexus has an enviable reputation for high quality people and data, long standing relationships with oncologists Media partners the world over and real client focus. b3c newswire is the leading PR distribution service for biotech press releases. With more Silver sponsors than 1,500 media titles worldwide we have the largest reach in biotech/ pharma trades. Due to our “specialized channels” an excellent visibility of RadPharm partners with pharmaceutical, your news is assured. biotechnology and medical device companies to manage all facets of the imaging segment of ecancermedicalscience, the peer global clinical trials, Phase I-IV. We provide centralized, independent, reviewed, online open access blinded interpretation of medical imaging for clinical studies and a proven journal from the European Institute of Oncology, is targeted at oncology planning, tracking and implementation process, from protocol design professionals, publishing new, innovative research along with multimedia through regulatory submission. extras – video, news and blogs. ecancer aims to improve communications between sub-specialised cancer scientists and clinicians by working Cmed provides CRO services and unique clinical interactively and quickly. data technology. Services include: clinical project management and monitoring, data Breast Cancer Research is an international, peer- management (eDC/paper) and statistical services. Cmed is rapidly gaining reviewed online journal edited by Professor Lewis a reputation for leadership in the adaptive trial design community through Chodosh. Research articles are published in all areas its unrivalled ability to conduct complicated adaptive design studies using of biology and medicine relevant to breast cancer, with special emphasis patented intelligent data acquisition/management (iDAM) technology. on the genetic, biochemical, and cellular basis of breast cancer. Contact As Cmed combines both CRO services and technology within a single us at organisation it can execute these studies particularly efficiently without Every weekly issue of Cancer Drug News reports sponsors to coordinate multiple service providers. the important news on the companies, products, alliances and research that are shaping global Harrison Clinical Research, a globally working CRO (ISO 9001) with cancer markets with regular sections on cancers offices in Europe, Israel and USA and partners in Asia offers full affecting the brain, breast, GI tract, genito-urinary system, gynaecological service (including development strategy, project management and system, blood and lung as well as melanoma/sarcoma. For further performance, monitoring, data management, biostatistics, medical information please visit: writing, auditing, training, outsourcing) for clinical phase l (in own clinic) to phase IV trials.
  7. 7. BOOKING FORM 2nd Annual Clinical Trials in Oncology, Tuesday 1 and Wednesday 2 December 2009, Hilton Munich City, Munich, Germany Prices & Payment Information (please tick option) Four Easy Ways To Book: yes, i would like to register for the event: beFOre beFOre beFOre aFTer ■ Register online at 8.9.2009 6.10.2009 3.11.2009 3.11.2009 Pharma and biotech manufacturers I would like the VIP Attendee Package to include €2,989 €3,129 €3,269 €3,479 ■ Email us at the 2 day conference + workshop + the interactive (VAT where (VAT where (VAT where (VAT where ■ Tel +44 (0)20 7753 4268 CD-ROM (saving €70) applicable) applicable) applicable) applicable) I would like to attend the two day conference only €1,820 €1,960 €2,099 €2,390 ■ Fax +44 (0)20 7915 9773 I would like to attend the two day conference + €2,359 €2,499 €2,639 €2,849 venue Details workshop The two day conference will take place on Tuesday 1 and I would like to attend the workshop only €599 €739 €879 €1,089 Wednesday 2 December 2009. 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The arising out of or in connection with this agreement. terms of any other electronic communications will not form part of this agreement. • Grant of Licence: If your booking includes the CD-ROM, you warrant that you will only use the CD-ROM for 2 Our commitment to you: Should the Event be cancelled or the location be changed for reasons or circumstances your business purposes and shall not, without our prior written consent, make available, copy, reproduce, transmit, beyond our control, we reserve the right to reschedule the Event, including changing the location, upon written disseminate, sell, licence, distribute, publish, broadcast or otherwise circulate the CD-ROM (or any part of it) to any notice to you. Should the event fail to be rescheduled for any reason your refund shall not exceed the total charge other person other than in accordance with these terms and conditions. received by us from you. • Arena International Events Group is subject to the UK Data Protection Act 1998 and is registered in the UK with the 3 Payment Terms: The Total Fees specified on the booking form are subject to an additional service charge of Information Commissioner to process your personal information. Our primary goal in collecting personal information 2.5% (“Service Charge”) applied to cover administration costs, and are exclusive of VAT and any other applicable from you is to give you an enjoyable customised experience whilst allowing us to provide services and features that sales tax which shall be payable in addition. most likely meet your needs. We collect certain personal information from you, which you give to us when using our • Following completion and return of the booking form, full payment including Service Charge is required within Sites and/or registering or subscribing for our products and services. We also collect certain personal data from other five days from the invoice date or prior to the event if this is sooner. All registrants must provide a credit card number group companies to whom you have given information through their websites. If you do not want us to continue using as a guarantee at the time of booking. We reserve the right to charge your card in full if payment is not received in this information please notify us at Any personal information supplied to SPG accordance with these payment terms. We reserve the right to refuse admission if full payment is not received in Media Ltd as part of this registration process and/or any other interaction with SPG Media Ltd will be collected, stored accordance with these terms. and used by SPG Media Ltd its subsidiaries, related companies or affiliates in accordance with the SPG Media Ltd 4 Cancellations: In the event of cancellation, 100% of the event fee is payable and non-refundable. All cancellation Privacy Policy. Please email for a copy of the SPG Media Ltd Privacy Policy. requests must be submitted to us in writing. If we agree to your cancellation then all cancellation fees are payable • The working language of the Event is English. Executives requiring an interpretation service must make their own immediately after the acceptance of your cancellation in writing by us. arrangements at their own expense. Arena International Events Group, a trading division of SPG Media Ltd. Registered Office: John Carpenter House, John Carpenter Street, London UK EC4Y 0AN. Registered in England No. 01155599. Delegate Details please photocopy form for multiple bookings Mr/Mrs/Ms/Dr: First Name: Surname: Email: Tel: Job Title: Fax: Department: Company Details Company: Address: Town: Postcode: Country: VAT Number: Nature of Business: Payment Details Purchase Order No. ■ I enclose a cheque drawn on a UK bank (please make cheque payable to VIBevents and write reference CTO1209 on the reverse) ■ I will transfer payment to your Lloyds TSB account City Branch, London, UK: 01492549, sort code 30-00-02 (using reference CTO1209) ■ I would like to pay with my credit card ■ Visa ■ Mastercard ■ AMEX ■ Maestro ■ Solo Card Number: Expiry Date: Issue Date: CSV*: Cardholder's Name: Cardholder's Address: *The CSV number is the last 3 digit number on the reverse of the card ■ Yes, I have read and understood the terms and cancellations conditions and am happy to proceed with my registration MKMF Signature Date