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    Targeting success Targeting success Document Transcript

    • SEE INSIDE FOR THE FULL PROGRAM! Targeting success 14-16 November The Marriott Long Wharf Hotel , Boston Defining the oncology marketplace of 2017 - what are the key strategic decisions that your organization must make today to meet the future demands of regulator, payer, physician and patient? Driving efficiency in oncology clinical development through the application of innovative trial designs and biomarkers Dr Nicholas C. Dracopoli, Dr Neil W. Gibson, Delivering a blueprint for the successful oncology Vice President, Clinical Discovery Chief Scientific Officer, R&D portfolio of the future - what will be the next Technologies, Bristol-Myers Squibb OSI Pharmaceuticals, Inc Pharmaceutical Research Institute Dr Robert L. Ilaria Jr, major technology areas to establish themselves in Geert Kolvenbag, MD, PhD, Medical Advisor for Oncology, the marketplace? Eli Lilly and Company Executive Director of Development, Emerging Oncology Brands, Dr Mark Sliwkowski, Staff Learn from - and network with - a speaker panel of AstraZeneca Scientist & Director of Translational Dr David Chang, Vice President, Oncology, Genentech, Inc over forty of the most influential thought-leaders and Global Clinical Development, Dr Cheryl Marks, Associate decision-makers working in the oncology therapeutics Oncology Therapeutics, Amgen Director, Division of Cancer Biology, field today – the individuals who will define the Joe Monforte, PhD, Vice & Director, Mouse Models of Human successful R&D, regulatory and commercialization Cancers Consortium (MMHCC), President, Chief Scientific Officer, National Cancer Institute models of the future: Althea Technologies Thomas W. Griffin, MD, Jeffrey D. Bloss, MD, Vice Executive Director, Therapeutic Area Mara G. Aspinall, President, Lee F. Allen, MD, PhD, President, Clinical Development, Head, Oncology Therapeutics, North Genetics, Genzyme Corporation Cambridge Site Head, Vice Onyx Pharmaceuticals, Inc American Medical Affairs, Amgen, Inc President, Medical Research - Dr Peter T. C. Ho, Senior Vice Dr Francis Kalush, Molecular Dr Bernhard Sixt, CEO & Oncology Therapeutic Area, President of Oncology Center of Diagnostics, Office of In Vitro Founder, Agendia Wyeth Research Excellence for Drug Discovery, Diagnostics (OIVD/CDRH), GlaxoSmithKline Christopher Seaton, Senior US Food & Drug Administration Dr John Waterton, Chief Vice President, Global Business Scientist, Translational Sciences, Barry M. Straube, MD, CMS Development & Licensing, Howard J. Fingert, MD, AstraZeneca Chief Medical Officer & Director, Bayer Corporation FACP, Senior Director & Clinical Dr Jens Oliver Funk, Office of Clinical Standards & Lead, Signal Transduction Dr Naomi Aronson, Head, Oncology Therapeutic Area, Quality, Centers for Medicare & Development Program, Executive Director, Technology Merck Serono Medicaid Services Pfizer Oncology Evaluation Center (TEC), Carlo Montagner, President, Dr Lawrence Shulman, BlueCross & BlueShield Association Professor James Abraxis Oncology Chief Medical Officer, Senior Vice Carmichael, CMO, KuDOS President for Medical Affairs, Steven D. Harr, Managing Pharmaceuticals Dr C. Anthony Altar, Director, Dana-Farber Cancer Institute & Director & Analyst, Morgan Stanley The Biomarkers Consortium Anne E. Hagey, MD, Global Director, Network Development, Dr Roy Baynes, Vice President, Project Head, Oncology Cytotoxics, Dr Mark Chang, Director, Dana-Farber/Brigham & Women's Clinical Development, Therapeutic Biostatistics, Millennium Cancer Care Abbott Laboratories Area Head, Oncology Supportive Pharmaceuticals, Inc Dr Brent M. Vose, Vice Care, Amgen, Inc Thomas G. Roberts, MD, Dr Maryellen de Mars, President & Head of Oncology & MSocSci, Senior Health Care Director of Clinical Biomarkers, Donald P Rosen, MD, Founder . Analyst & Portfolio Manager, Infection, AstraZeneca & Chief Strategy Officer, RadPharm The Critical Path Institute (C-Path) Noonday Asset Management, LP Professor Sir Michael Dr Stephen Kelsey, Vice (sub-adviser to Farallon Capital Dr David Urdal, Chief Scientific Rawlins, Chairman, National President & Head of Exploratory Management, LLC) Officer, Dendreon Corporation Institute for Clinical Excellence Clinical Development, BioOncology, Thomas R. Barr, MBA, COO, Dr Jay Feingold, Assistant Vice Kapil Dhingra, MD, Head of the Genentech, Inc Oncology Metrics, LLC President & Multi-Therapeutic Area Oncology Global Drug Development Dr Doris Slate, Vice President, Head, Global Medical Affairs, Dr Ulrik B. Nielsen, Group, Hoffmann-La Roche, Inc Scientific Licensing, Wyeth Research Vice President of Research, Johnson & Johnson Merrimack Pharmaceuticals Event sponsor Event co-sponsor REGISTER BEFORE 17th AUGUST 2007 TO SAVE $200! www.phacilitate.co.uk/oncology
    • DAY 1 - Wednesday November 14th 2007 7.30 Registration & buffet breakfast in the exhibition area Morning plenary session What will the oncology healthcare environment look like in 2017? What are the repercussions for companies engaged in developing the products of tomorrow? Defining short-term action points for the pharma and biotech industries 9.00 Chair's opening address 11.30 Market analyst's perspective Analyzing the key drivers evolving the US and global Analyzing ongoing trends in the oncology arena - what are the healthcare models at large finance sector's expectations for the oncology marketplace moving forward? US and European private and public sector perspectives What will be the basis for competition in an increasingly crowded marketplace and what will be the keys to achieving market leadership? 9.15 View from the Blue Cross Blue Shield Technology Evaluation Steven D. Harr, Managing Director & Analyst, Morgan Stanley Center (TEC) 11.55 Questions & discussion What is important to Blue Cross and Blue Shield Plan medical decision-makers? What are the critical outcome measures and how good is the evidence? 12.00 Keynote industry response How will value and affordability shape benefit design and the market for How is a major industry player preparing their pipeline and new technologies? adapting their R&D strategy to meet the changing demands of Dr Naomi Aronson, Executive Director, Technology Evaluation Center (TEC), the marketplace? BlueCross & BlueShield Association How are we positioning ourselves to counter the forthcoming period of unprecedented 9.35 CMS perspective competition in the oncology area? How are we making the conceptual change in both R&D and commercial from the 'one Barry M. Straube, MD, CMS Chief Medical Officer & Director, Office of size fits all' to a stratified approach? Addressing the key remaining challenges Clinical Standards & Quality, Centers for Medicare & Medicaid Services Dr Brent M. Vose, Vice President & Head of Oncology & Infection, 9.55 'Value for money' in oncology: A European perspective AstraZeneca How are reimbursement criteria for oncology therapeutics set to evolve over the 12.25 Questions & discussion coming decade? What data will the payer require in the era of performance-based reimbursement? 12.30 Stakeholders' roundtable discussion Defining 'value for money' in the oncology therapeutic arena How will a balance to suit all stakeholders regarding price/demand and supply be Professor Sir Michael Rawlins, Chairman, National Institute for Clinical reached over the coming years? Excellence - Discussing the role of co-payment strategies moving forwards 10.15 Questions & discussion What will be the key steps for each stakeholder towards strengthening the value provided to patients? 10.25 Morning coffee in the exhibition area Can the off-label use of oncology therapeutics continue in the marketplace of 11.05 the future? Physician’s perspective To what extent, and in what timeframe, will the advent of biogenerics impact the How is the physician community preparing for the expected economics of oncology healthcare and pharma and biotech R&D? changes to oncology care over the coming decade and - What actually constitutes 'bioequivalence'? beyond? - Why haven't biogenerics reached the marketplace yet? What specific challenges still What data is/will be required as evidence-based medicine increases? need to be addressed? How is the e-enablement of the healthcare sector driving greater transparency and 1.10 Buffet lunch in the exhibition area accountability? How will changes in oncology care and technology affect physician practice? Dr Lawrence Shulman, Chief Medical Officer, Senior Vice President for OR Working Lunch 1 Medical Affairs, Dana-Farber Cancer Institute & Director, Network How will performance measurement metrics evolve in the Development, Dana-Farber/Brigham & Women's Cancer Care oncology field moving forwards? 11.25 Questions & discussion OR Working Lunch 2 Debating pros and cons of target selective vs. spectrum selective kinase inhibitors for current and future oncology applications (Very informal, discussion-based optional sessions for a maximum of 12 participants) Followed by your choice of : Main afternoon session OR | workshop NETWORKING SERVICES Complimentary private meeting rooms These may be booked in advance, via the website, or onsite – ideal if In addition to providing you with as many opportunities as you wish to conduct confidential discussions at the event possible to participate actively in the conference sessions, Working Lunches Phacilitate is pleased to offer a range of networking opportunities Optional Working Lunch discussion sessions enable attendees to go and services designed to maximize the return on your investment into detail on specific subjects in an informal atmosphere. A limit on the in the event. number of participants is imposed to encourage interaction and debate. We welcome your suggestions for topics - These include: please contact David McCall, Project Director The pre-event Meeting Request Service Tel: +44 (0)20 7839 6151, Once your registration fee has been received, we will send you a e: david@phacilitate.co.uk with your ideas username and password which will allow you access to the Delegate Buffet breakfasts, extended refreshment and lunch breaks Zone on the website. The service will be launched two weeks before and exciting, themed evening receptions, all designed to allow the event, enabling you to submit meeting requests to your fellow plenty of time for informal mixing through each day of the event. attendees. A G E N D A U P D AT E S | S P E A K E R U P D AT E S | O N - L I N E R E G I S T R AT I O N | L AT E S T E V E N T N E W S www.phacilitate.co.uk/oncology
    • PHACILITATE ONCOLOGY LEADERS’ FORUM 2007 Highly interactive workshop for a maximum of 30 participants Main afternoon session OR | Workshop REGISTER NOW TO GUARANTEE YOUR PLACE IN THIS SESSION Devising patient stratification and enrichment strategies Delivering collaborative solutions to the industry's key to mitigate risk and efficiently demonstrate efficacy of challenges in meeting the evolving demands of the oncology therapies early in development oncology therapy marketplace 2.20 Moderator's introduction 2.20 Moderator's introduction Dr Stephen Kelsey, Vice President & Head of Exploratory Clinical Big pharma perspective Development, BioOncology, Genentech, Inc How much emphasis is being placed on collaborative R&D in the oncology area 2.30 relative to internal efforts? Case study What specific criteria must prospective partners and their product candidates meet? The role of discovery research in successful selection of - Which classes of therapy/technology areas are of particular focus moving forwards? patients for cancer therapy Christopher Seaton, Senior Vice President, Global Business Development & Why is translational oncology so difficult? Licensing, Bayer Corporation Herceptin as an example of the right drug for the right patients at the right time 2.45 Questions & discussion Will there ever be another target like gene amplified HER2? Why do other targets present a challenge for co-development of predictive diagnostic tests? 2.50 Overcoming strategic challenges in partnering with diagnostic The ups and downs of pertuzumab, a HER2-directed heterodimerization inhibitor. Are we on the right track in ovarian cancer, where HER2 is activated but not amplified? companies Evaluating ROI for biomarkers for pharmaceutical and diagnostic companies Resetting expectations: Do we need to change our approach translational oncology Developing companion diagnostics within drug development timelines and drug development? Risk sharing models for development of companion diagnostics Dr Mark Sliwkowski, Staff Scientist & Director of Translational Oncology, Dr Nicholas C. Dracopoli, Vice President, Clinical Discovery Technologies, Genentech, Inc Bristol-Myers Squibb Pharmaceutical Research Institute 2.50 Questions & discussion 3.10 Questions & discussion 2.55 Case study 3.15 Discussion of the role of cooperative groups in oncology drug Patient enrichment in early phase clinical trials to enhance development successful delivery of Proof of Concept Defining the ways in which cooperative groups potentially facilitate oncology The focus of oncology drug discovery pipelines has transitioned from cytotoxic agents drug development to molecularly targeted therapeutics Cooperative groups are not all created equal and heterogeneity encompasses a The transformation of clinical trial designs to exploit molecular targeting has generally spectrum from loose affiliations of investigators, site management organizations, lagged behind the maturation of the current pipeline products effectively contract research organizations through nationally funded or subsidized Strategies and current examples of utilizing molecular and genetic biomarkers to research networks enrich subject populations and optimize the opportunity for demonstrating Proof-of- Strengths and weaknesses of any given cooperative group engagement are a Concept for targeted therapeutics will be presented function of the particular drug development need and the particular cooperative Dr Peter T. C. Ho, Senior Vice President of Oncology Center of Excellence for group construct Drug Discovery,GlaxoSmithKline Factors to be considered when engaging cooperative groups 3.15 Questions & discussion Dr Roy Baynes, Vice President, Clinical Development, Therapeutic Area Head, Oncology Supportive Care, Amgen, Inc 3.20 Case study 3.35 Questions & discussion Identifying and overcoming the chief obstacles in 3.40 Panel discussion implementing an international clinical development operation for a stratified patient population How can the industry capitalize on collaboration Global advanced renal cell carcinoma trial opportunities with the patient advocacy community to drive - Advantages the development and commercialization of novel therapies? • Diverse patient population • Local experience with the molecule 4.05 End of session followed by afternoon tea in the exhibition area • Potentially more rapid patient enrolment • Allows for development of local expertise and potentially interaction with local Followed by Afternoon plenary session regulatory agencies • Stratification by region may allow for regional medical practices to not affect outcomes - Challenges • Satisfy multiple constituencies THEN | Afternoon plenary session • Differences in clinical practice • Differences in regulatory rules for trial conduct as well as registration 4.45 • Language, cultural, time differences, multiple vendors Short presentations & panel discussion • Stratification is frequently by large geographic region(s) and may not account for How are pre-competitive collaborations and consortia driving heterogeneity within such region(s). innovation and efficiency in oncology therapeutic R&D? Dr Jay Feingold, Assistant Vice President & Multi-Therapeutic Area Head, Case study: Utilizing a collaboration model to bridge the disconnect between Global Medical Affairs, Wyeth Research academia and the industry Update on the specific goals and timelines of the NCI's Mouse Models of Human 3.40 Questions & discussion Cancers Consortium (MMHCC) and the Biomarker Consortium (incorporating the 3.45 Panel discussion FDG- PET evaluation initiative) - The Biomarkers Consortium: Promoting innovation and efficiency in cancer How can you introduce and achieve consistency of data from drug discovery discovery, through clinical development in a stratified • Bridging the disconnect within industry population, to the marketplace? • Strengthening ties between industry, academia and government Panellist: • Shared goals of the stakeholders Joe Monforte, PhD, Vice President, Chief Scientific Officer, • Coordinating the activities of these diverse groups • Update on the specific goals and timelines of the FDG-PET Lung and Lymphoma Althea Technologies imaging projects 4.05 End of session followed by afternoon tea in the exhibition area Moderator: Dr Nicholas C. Dracopoli, Vice President, Clinical Discovery Technologies, Followed by Afternoon plenary session Bristol-Myers Squibb Pharmaceutical Research Institute Speakers: Dr C. Anthony Altar, Director, The Biomarkers Consortium Dr Maryellen de Mars, Director of Clinical Biomarkers, The Critical Path Institute (C-Path) Dr Cheryl Marks, Associate Director, Division of Cancer Biology, & Director, Mouse Models of Human Cancers Consortium (MMHCC), National Cancer Institute 6.00 End of day 1 followed by a themed cocktail reception in the exhibition area www.phacilitate.co.uk/oncology
    • DAY 2 - Thursday November 15th 2007 8.00 Registration & buffet breakfast in the exhibition area Morning plenary session THEN | Main session Rethinking oncology drug development: Defining the Implementing innovative clinical trial designs to successful clinical trial model of the future deliver lower development costs/timelines while more 9.00 Chair's introduction effectively demonstrating the efficacy of oncology Lee F. Allen, MD, PhD, Cambridge Site Head, Vice President, Medical therapeutic candidates Research - Oncology Therapeutic Area, Wyeth Research 11.45 Moderator's introduction Keynote regulatory perspectives Dr Robert L. Ilaria Jr, Medical Advisor for Oncology, Eli Lilly and Company Exploring the latest regulatory initiatives from the US FDA 11.55 and European authorities Utilizing 'Phase Zero' to improve the decision-making process in early development 9.10 US FDA perspective Speaker to be announced How is the Critical Path Initiative continuing to drive 12.25 Questions & discussion innovation in clinical trial design? Speaker to be announced Exploring the potential of adaptive clinical trial designs to 9.35 Questions & discussion increase the efficiency of late-phase trials in the oncology area from industry R&D and regulatory perspectives 9.40 European perspective How will the emerging European Innovative Medicines 12.35 Case study Initiative position itself with regard to the implementation of R&D perspective Adaptive design: State of the art biomarkers in oncology drug development and Compared to a classic trial design with static features, an adaptive design allows for changing or modifying the characteristics of a trial based on cumulative information. commercialization? The utilization of adaptive designs will lead to increasing the probability of success, Professor James Carmichael, CMO, KuDOS Pharmaceuticals reducing the cost and time to market, and delivering the right drug to the right 10.05 Questions & discussion patient - Adaptive strategies for drug development 10.10 Keynote industry response - Adaptive design methods for oncology clinical trials Reconciling the need to reduce the costs and timelines of - Oncology adaptive trial case studies - Opportunities, challenges, and recommendations clinical trials in oncology with the Critical Path Increasing number of oncology drugs in development; increasing number of Dr Mark Chang, Director, Biostatistics, Millennium Pharmaceuticals, Inc companies committing to oncology 1.05 Questions & discussion Rapidly increasing knowledge of molecular basis of cancer leading to increasing number of therapeutically relevant targets; increasing proportion of oncology pipelines 1.15 Buffet lunch in the exhibition area are 'novel molecularly targeted agents' Increasing competition for patients, investigators, trial sites OR Working Lunch 1 Increasing globalization of oncology trials OR Working Lunch 2 All of the above translate into increased complexity and cost of oncology trials Additional complexity introduced due to the need to evaluate biomarkers in 2.25 Case study surrogate/tumor tissue Potential to reduce development timelines and costs through intelligent incorporation Novel collaborative trial designs to reduce cost and boost of novel trial designs and biomarkers in drug development based on a sound quality in oncology clinical development understanding of drug mechanism of action and the relevance of the target signaling Jeffrey D. Bloss, MD, Vice President, Clinical Development, Onyx pathway to tumor biology Pharmaceuticals, Inc Specific examples will be discussed Kapil Dhingra, MD, Head of the Oncology Global Drug Development Group, 2.50 Questions & discussion Hoffmann-La Roche, Inc 2.55 Presentation & panel discussion 10.35 Questions & discussion Examining the drivers behind, and the pros and cons of, 10.40 Panel discussion undertaking head-to-head clinical trials in phase IIb Case study How will the industry mitigate the growing risk in R&D from - Commercial/clinical implications of the 505 (b) (2) regulatory pathway to approval the perceived increase in the safety hurdles facing oncology - Is a randomized phase IIb outcome just as impactful as a phase III therapeutics? • versus the current standard of care? • when comparing multiple dosage regimens? 11.05 Morning coffee in the exhibition area Speaker: Carlo Montagner, President, Abraxis Oncology Followed by your choice of : Main session OR | workshop 3.55 Close of session followed by afternoon tea in the exhibition area Followed by Afternoon plenary session 1.15 Working Lunch 1 REGISTER NOW How and where do we move beyond RECIST2? AND TAKE THE Moderator: Donald P Rosen, MD, Founder & Chief Strategy Officer, . RadPharm OPPORTUNITY TO OR Working Lunch 2 PROPOSE A Are we now in a position to challenge the conventional TOPIC FOR A clinical wisdom that you can't plan a trial to avoid WORKING LUNCH metastases? SESSION (Very informal, discussion-based optional sessions for a maximum of 12 participants) A G E N D A U P D AT E S | S P E A K E R U P D AT E S | O N - L I N E R E G I S T R AT I O N | L AT E S T E V E N T N E W S www.phacilitate.co.uk/oncology
    • PHACILITATE ONCOLOGY LEADERS’ FORUM 2007 Highly interactive workshop for a maximum of 30 participants OR | Workshop REGISTER NOW TO GUARANTEE YOUR PLACE IN THIS SESSION Honing your combination therapy strategy: Defining the pros and cons of various drug classes when developed in combination 11.45 Moderator's introduction OR Working Lunch 1 Howard J. Fingert, MD, FACP, Senior Director & Clinical Lead, Signal OR Working Lunch 2 Transduction Development Program, Pfizer Oncology 2.25 Case study 11.50 Rationally combining targeted cancer drugs How do we best use ‘targeted’ cancer therapeutics in combinations? Monoclonal antibody in combination The number of targeted inhibitors currently in clinical development prohibits a strategy Recent introduction of multiple new molecularly targeted therapies is altering the of clinically testing all combinations! landscape of cancer drug development. To establish the value of these new therapies Animal models of cancer have historically not correlated well with patient efficacy in the first-line treatment of metastatic disease, it is necessary to add these new Physicochemical modeling of cell pathways can link prior knowledge about cell therapies to already aggressive drug combinations pathways, and experimental data of various types to create powerful tools for - Challenges: rationalizing combinations of targeted inhibitors for clinical development • How to maintain proper dose-intensity with multiple agents with different toxicities Examples of modeling combinations of existing targeted drugs will be presented • Are there sub-populations of patients not suitable for inclusion into such studies? Dr Ulrik B. Nielsen, Vice President of Research, Merrimack Pharmaceuticals • Will new and unexpected toxicities occur from the drug combinations? • What prior clinical data is necessary before starting pivotal studies? 12.10 Questions & discussion • What are proper efficacy endpoints for aggressive combined therapy? • How much added value will need to be demonstrated to justify the inclusion of 12.20 Combining targeted therapies: Science-based or several expensive drugs in combination? clinically driven? Thomas W. Griffin, MD, Executive Director, Therapeutic Area Head, Oncology Discussion on rationale to combine targeted therapies Therapeutics, North American Medical Affairs, Amgen, Inc Implications for clinical use Future considerations: Mixing cocktails or selecting a customized menu 2.45 Questions & discussion Geert Kolvenbag, MD, PhD, Executive Director of Development, Emerging 2.55 Case study Oncology Brands, AstraZeneca Exploring the combination product development strategy for a 12.40 Questions & discussion candidate cancer vaccine Introduction to sipuleucel-T (Provenge) an active cellular immunotherapy for Case studies: Exploring the development strategies for prostate cancer varying combination product candidates - what are the Other agents used in the treatment of prostate cancer and how they might specific implications for each complement active cellular immunotherapy (hormone therapy and chemotherapy) Novel approaches that might enhance active cellular immunotherapy through the In terms of potential toxicity issues? inhibition of immunosuppression (anti-CTLA-4; T-reg cell modulation) In terms of impact on efficacy? In terms of regulatory strategy Dr David Urdal, Chief Scientific Officer, Dendreon Corporation In terms of potential repercussions in the payer space with regard to pricing 3.15 Questions & discussion and reimbursement? 3.25 Panel discussion 12.50 Case study Debating the pros and cons of including your therapeutic in a Targeted small molecule drug in combination combination product development strategy Dr Neil W. Gibson, Chief Scientific Officer, OSI Pharmaceuticals, Inc Is it better to pursue a modular combination therapy product strategy, or to pile as many features as possible on a single molecule? 1.10 Questions & discussion How do you quantify the potential damage to an individual product's commercial 1.15 Buffet lunch in the exhibition area potential caused by negative results when trialled in combination with another product? 3.55 Close of session followed by afternoon tea in the exhibition area Followed by Afternoon plenary session THEN | Afternoon plenary session Examining the evolving agendas of industry, payer, regulator and academia regarding biomarker R&D/implementation 4.35 Short presentations & panel discussion What is the business value of imaging technologies applied for different purposes and at different stages of the clinical development pipeline, and Identifying the common goals and potential areas of what is the optimal ba lance of a company's resources between them? divergence - moving forwards, what are the keys to increasing - As internal portfolio decision-making tools in early development? the supply of innovative, effective oncology therapies to the - As indicators of efficacy in phase II? patient? - As providers of supporting data in phase III? Defining each stakeholder's primary goals for biomarker Moderator: development/implementation over the next decade Donald P Rosen, MD, Founder & Chief Strategy Officer, RadPharm . What is the ideal balance between the roles of industry and academic in Panellists: biomarker discovery? Dr John Waterton, Chief Scientist, Translational Sciences, - Should it actually be a task exclusive to one group or the other? AstraZeneca What should be the main use of biomarkers in clinical development? Thomas W. Griffin, MD, Executive Director, Therapeutic Area Head, - How do you strike a balance between developing biomarkers to be utilized as potential surrogate endpoints, and developing them as internal decision- Oncology Therapeutics, North American Medical Affairs, Amgen, Inc making tools to cut development costs and timelines? 5.45 End of day 2 followed by a themed cocktail reception in the - What is the real time saving of using biomarkers in phase I/IIa and to what exhibition area extent have they influenced the quality of decision making to date? A G E N D A U P D AT E S | S P E A K E R U P D AT E S | O N - L I N E R E G I S T R AT I O N | L AT E S T E V E N T N E W S www.phacilitate.co.uk/oncology
    • DAY 3 - Friday November 16th 2007 8.00 Registration & buffet breakfast in the exhibition area Plenary session THEN | Plenary session Looking to the future: R&D and regulatory strategy updates on the some of What will be the next breakthrough in the targeted the leading stories from ASCO 2007 oncology therapeutics arena? Analyzing the clinical and regulatory strategies behind How will the continuing convergence of therapeutic and some of the biggest success stories to emerge from this diagnostic sectors drive the evolution of the R&D model? June's ASCO meeting 9.00 Chair's introduction What preparations are being made to get these products Thomas R. Barr, MBA, COO, Oncology Metrics, LLC reimbursed? 9.10 Keynote address 12.10 Moderator's introduction Personalized medicine from ignorance to acceptance Thomas G. Roberts, MD, MSocSci, Senior Health Care Analyst & Portfolio Why a changing business model is necessary for oncology research, development Manager, Noonday Asset Management, LP (sub-adviser to Farallon and drug commercialization Capital Management, LLC) The positive impact for both physician and patient The critical role of policy-makers if personalized medicine is to flourish 12.15 Case study Mara G. Aspinall, President, Genetics, Genzyme Corporation Amgen's pipeline of targeted therapeutics 9.35 Questions & discussion Dr David Chang, Vice President, Global Clinical Development, Oncology Therapeutics, Amgen 9.40 Short presentations & roundtable discussion 12.35 Questions & discussion Analyzing the potential impact on the marketplace and on oncology R&D strategy of recently-approved and emerging 12.40 Case study molecular diagnostics ABT-263 Diagnostic company perspective Anne E. Hagey, MD, Global Project Head, Oncology Cytotoxics, - What are our ongoing plans for collaborating with pharma and biotech Abbott Laboratories companies in the R&D space? 1.00 Questions & discussion - How is the trend towards value-based pricing mobilizing the diagnostics sector at large to get involved in the development of targeted oncology therapies? 1.05 Case study Payer's perspective First-in-class focal adhesion kinase inhibitor, PF-562271 - How might novel diagnostics change prescribing practices in oncology over the Balancing risk and benefit in development of signal transduction inhibitors long-term? Biomarkers for efficacy and safety – how to Learn and Confirm? Industry perspectives Howard J. Fingert, MD, FACP, Senior Director & Clinical Lead, Signal - How do we currently assess the pros and cons in incorporating a companion Transduction Development Program, Pfizer Oncology diagnostic development aspect in therapeutic R&D? • How can the industry reap the benefits of utilizing assays both to drive candidates 1.25 Questions & discussion to market and to defend products already on the market? 1.30 End of session followed by lunch & the close of the Phacilitate Oncology - Collaborative approach to multivariate biomarker development: Applications in clinical trial management and clinical diagnostic utilization Leaders' Forum 2007 Regulator's perspective - How are we driving the integration of diagnostics with R&D? Panellists: Dr Francis Kalush, Molecular Diagnostics, Office of In Vitro Diagnostics (OIVD/CDRH), US Food & Drug Administration Dr Bernhard Sixt, CEO & Founder, Agendia Joe Monforte, PhD, Vice President, Chief Scientific Officer, Althea Technologies Thomas G. Roberts, MD, MSocSci, Senior Health Care Analyst & Portfolio Manager, Noonday Asset Management, LP (sub-adviser to Farallon Capital Management, LLC) Mara G. Aspinall, President, Genetics, Genzyme Corporation 11.10 Panel discussion What will be the next major new class of biologic to follow antibodies in becoming established in the marketplace? Examining the prospects for and recent progress with key emerging technology areas - Cancer vaccines - RNAi therapeutics - Tumour stem cell R&D “An excellent mix of very Panellists: Christopher Seaton, Senior Vice President, Global Business Development & Licensing, Bayer Corporation informative discussions Dr Doris Slate, Vice President, Scientific Licensing, Johnson & Johnson Dr Jens Oliver Funk, Head, Oncology Therapeutic Area, Merck Serono Thomas G. Roberts, MD, MSocSci, Senior Health Care Analyst & Portfolio from various stakeholders Manager, Noonday Asset Management, LP (sub-adviser to Farallon Capital Management, LLC) 11.40 Morning coffee in the exhibition area in drug development” Dr Haren D. Rupani, Global Head, Followed by Plenary session Oncology Imaging, Novartis Pharmaceuticals Corporation commenting on the Oncology Leaders’ Forum 2006 A G E N D A U P D AT E S | S P E A K E R U P D AT E S | O N - L I N E R E G I S T R AT I O N | L AT E S T E V E N T N E W S www.phacilitate.co.uk/oncology
    • Sponsorship and exhibition opportunities Event sponsor: Raise your company’s profile with top-level oncology R&D and business development decision-makers. Make constructive contact with senior executives from your key prospects – individuals that are difficult to secure meetings with in the normal run of business. Meet with numerous current clients and partners, all at one location in just 3 days. Associate your company with an event designed to drive the RadPharm is a full service imaging core lab, managing all facets development of the oncology sector. of the imaging segment of global clinical trials, Phases I-IV. We are uniquely staffed to focus on "The Medicine Behind the Image." Don't miss this unparalleled opportunity to raise your company’s profile There are full-time board certified, subspecialty trained with numerous senior level executives from all the major players in the radiologists and oncologists on staff. As a result RadPharm has oncology therapeutics sector. Phacilitate offers a strictly limited range the distinct ability to provide centralized, independent, blinded of options for corporate involvement. interpretation of images for clinical trials with the responsiveness to exceed your expectations and meet your timelines. We provide Options available to your company include: a complete assessment of the oncology patient by having on-staff Gold, silver and bronze sponsorships, giving you the chance to place a high Radiologists, Radiation Oncologists, and Clinical Oncologists level executive in the conference agenda itself. These packages provide the very greatest levels of pre-event and onsite exposure, guaranteeing you significantly increase your organization’s profile within the oncology R&D community. Event co-sponsor: Sponsoring a breakfast or lunch briefing, providing you with the opportunity to discuss issues key to your company with a targeted group of participants. These packages are ideal for companies seeking to promote the strategic benefits of a particular technology or service. A wide variety of exhibit-based options, from space only through to our increasingly popular Meeting Areas. Meeting Areas remove the need for you to ship anything to the event, with even your signage being provided for you. Sponsoring event materials, including delegate briefcases and binders, key cards and stationery. And whichever package you choose, you will be able to use the Pre- Event Networking Service to make contact with individual speakers Althea Technologies, located in San Diego, California, is a leading and delegates prior to the forum itself – the perfect way to optimize your return on investment in the event by maximizing the number of meetings your provider of contract manufacturing and testing services. Althea’s team has in place. Plus - take the chance to book complimentary private meeting services include cGMP recombinant protein and plasmid DNA rooms, ideal for confidential discussions with current or potential clients and/or production, formulation and aseptic filling services, gene partners. quantification using real-time PCR, and gene expression analysis We are more than happy to tailor a package just for your company to ensure we using its proprietary eXpress Profiling™ technology. meet your exact objectives and budget. For more information please contact: Nicola McCall Tel: +44 (0)20 7839 6137 Email: nicola@phacilitate.co.uk Media Partners www.futuremedicine.com A G E N D A U P D AT E S | S P E A K E R U P D AT E S | O N - L I N E R E G I S T R AT I O N | L AT E S T E V E N T N E W S www.phacilitate.co.uk/oncology