Learn from - and network with - a speaker panel of
over forty of the most influential thought-leaders and
decision-makers ...
Morning plenary session
What will the oncology healthcare environment look like in 2017?
What are the repercussions for co...
Main afternoon session
Devising patient stratification and enrichment strategies
to mitigate risk and efficiently demonstr...
Morning plenary session
Rethinking oncology drug development: Defining the
successful clinical trial model of the future
C...
THEN | Afternoon plenary session
Examining the evolving agendas of industry, payer, regulator and academia regarding bioma...
Plenary session
Looking to the future:
What will be the next breakthrough in the targeted
oncology therapeutics arena?
How...
Sponsorship and exhibition opportunities
Raise your company’s profile with top-level oncology R&D
and business development...
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Targeting success

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Targeting success

  1. 1. Learn from - and network with - a speaker panel of over forty of the most influential thought-leaders and decision-makers working in the oncology therapeutics field today – the individuals who will define the successful R&D, regulatory and commercialization models of the future: Mara G. Aspinall, President, Genetics, Genzyme Corporation Dr Peter T. C. Ho, Senior Vice President of Oncology Center of Excellence for Drug Discovery, GlaxoSmithKline Barry M. Straube, MD, CMS Chief Medical Officer & Director, Office of Clinical Standards & Quality, Centers for Medicare & Medicaid Services Dr Lawrence Shulman, Chief Medical Officer, Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute & Director, Network Development, Dana-Farber/Brigham & Women's Cancer Care Dr Brent M. Vose, Vice President & Head of Oncology & Infection, AstraZeneca Professor Sir Michael Rawlins, Chairman, National Institute for Clinical Excellence Kapil Dhingra, MD, Head of the Oncology Global Drug Development Group, Hoffmann-La Roche, Inc Lee F. Allen, MD, PhD, Cambridge Site Head, Vice President, Medical Research - Oncology Therapeutic Area, Wyeth Research Christopher Seaton, Senior Vice President, Global Business Development & Licensing, Bayer Corporation Dr Naomi Aronson, Executive Director, Technology Evaluation Center (TEC), BlueCross & BlueShield Association Steven D. Harr, Managing Director & Analyst, Morgan Stanley Dr Roy Baynes, Vice President, Clinical Development, Therapeutic Area Head, Oncology Supportive Care, Amgen, Inc Donald P. Rosen, MD, Founder & Chief Strategy Officer, RadPharm Dr Stephen Kelsey, Vice President & Head of Exploratory Clinical Development, BioOncology, Genentech, Inc Dr Doris Slate, Vice President, Scientific Licensing, Johnson & Johnson Dr Nicholas C. Dracopoli, Vice President, Clinical Discovery Technologies, Bristol-Myers Squibb Pharmaceutical Research Institute Geert Kolvenbag, MD, PhD, Executive Director of Development, Emerging Oncology Brands, AstraZeneca Dr David Chang, Vice President, Global Clinical Development, Oncology Therapeutics, Amgen Joe Monforte, PhD, Vice President, Chief Scientific Officer, Althea Technologies Jeffrey D. Bloss, MD, Vice President, Clinical Development, Onyx Pharmaceuticals, Inc Dr Francis Kalush, Molecular Diagnostics, Office of In Vitro Diagnostics (OIVD/CDRH), US Food & Drug Administration Howard J. Fingert, MD, FACP, Senior Director & Clinical Lead, Signal Transduction Development Program, Pfizer Oncology Professor James Carmichael, CMO, KuDOS Pharmaceuticals Anne E. Hagey, MD, Global Project Head, Oncology Cytotoxics, Abbott Laboratories Thomas G. Roberts, MD, MSocSci, Senior Health Care Analyst & Portfolio Manager, Noonday Asset Management, LP (sub-adviser to Farallon Capital Management, LLC) Dr Jay Feingold, Assistant Vice President & Multi-Therapeutic Area Head, Global Medical Affairs, Wyeth Research Targeting success 14-16 November The Marriott Long Wharf Hotel , Boston www.phacilitate.co.uk/oncology REGISTER BEFORE 17th AUGUST 2007 TO SAVE $200! Dr Neil W. Gibson, Chief Scientific Officer, OSI Pharmaceuticals, Inc Dr Robert L. Ilaria Jr, Medical Advisor for Oncology, Eli Lilly and Company Dr Mark Sliwkowski, Staff Scientist & Director of Translational Oncology, Genentech, Inc Dr Cheryl Marks, Associate Director, Division of Cancer Biology, & Director, Mouse Models of Human Cancers Consortium (MMHCC), National Cancer Institute Thomas W. Griffin, MD, Executive Director, Therapeutic Area Head, Oncology Therapeutics, North American Medical Affairs, Amgen, Inc Dr Bernhard Sixt, CEO & Founder, Agendia Dr John Waterton, Chief Scientist, Translational Sciences, AstraZeneca Dr Jens Oliver Funk, Head, Oncology Therapeutic Area, Merck Serono Carlo Montagner, President, Abraxis Oncology Dr C. Anthony Altar, Director, The Biomarkers Consortium Dr Mark Chang, Director, Biostatistics, Millennium Pharmaceuticals, Inc Dr Maryellen de Mars, Director of Clinical Biomarkers, The Critical Path Institute (C-Path) Dr David Urdal, Chief Scientific Officer, Dendreon Corporation Thomas R. Barr, MBA, COO, Oncology Metrics, LLC Dr Ulrik B. Nielsen, Vice President of Research, Merrimack Pharmaceuticals SEE INSIDE FOR THE FULL PROGRAM! Event co-sponsorEvent sponsor 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 Delivering a blueprint for the successful oncology R&D portfolio of the future - what will be the next major technology areas to establish themselves in the marketplace?
  2. 2. 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 Chair's opening address Analyzing the key drivers evolving the US and global healthcare models at large US and European private and public sector perspectives View from the Blue Cross Blue Shield Technology Evaluation Center (TEC) 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? How will value and affordability shape benefit design and the market for new technologies? Dr Naomi Aronson, Executive Director, Technology Evaluation Center (TEC), BlueCross & BlueShield Association CMS perspective Barry M. Straube, MD, CMS Chief Medical Officer & Director, Office of Clinical Standards & Quality, Centers for Medicare & Medicaid Services 'Value for money' in oncology: A European perspective How are reimbursement criteria for oncology therapeutics set to evolve over the coming decade? What data will the payer require in the era of performance-based reimbursement? Defining 'value for money' in the oncology therapeutic arena Professor Sir Michael Rawlins, Chairman, National Institute for Clinical Excellence Questions & discussion Morning coffee in the exhibition area Physician’s perspective How is the physician community preparing for the expected changes to oncology care over the coming decade and beyond? What data is/will be required as evidence-based medicine increases? How is the e-enablement of the healthcare sector driving greater transparency and accountability? How will changes in oncology care and technology affect physician practice? Dr Lawrence Shulman, Chief Medical Officer, Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute & Director, Network Development, Dana-Farber/Brigham & Women's Cancer Care Questions & discussion11.25 11.05 10.25 10.15 9.55 9.35 9.15 9.00 NETWORKING SERVICES In addition to providing you with as many opportunities as possible to participate actively in the conference sessions, Phacilitate is pleased to offer a range of networking opportunities and services designed to maximize the return on your investment in the event. These include: The pre-event Meeting Request Service Once your registration fee has been received, we will send you a username and password which will allow you access to the Delegate Zone on the website. The service will be launched two weeks before the event, enabling you to submit meeting requests to your fellow attendees. Complimentary private meeting rooms These may be booked in advance, via the website, or onsite – ideal if you wish to conduct confidential discussions at the event Working Lunches Optional Working Lunch discussion sessions enable attendees to go into detail on specific subjects in an informal atmosphere. A limit on the number of participants is imposed to encourage interaction and debate. We welcome your suggestions for topics - please contact David McCall, Project Director Tel: +44 (0)20 7839 6151, e: david@phacilitate.co.uk with your ideas Buffet breakfasts, extended refreshment and lunch breaks and exciting, themed evening receptions, all designed to allow plenty of time for informal mixing through each day of the event. Market analyst's perspective Analyzing ongoing trends in the oncology arena - what are the finance sector's expectations for the oncology marketplace moving forward? What will be the basis for competition in an increasingly crowded marketplace and what will be the keys to achieving market leadership? Steven D. Harr, Managing Director & Analyst, Morgan Stanley Questions & discussion Keynote industry response How is a major industry player preparing their pipeline and adapting their R&D strategy to meet the changing demands of the marketplace? How are we positioning ourselves to counter the forthcoming period of unprecedented competition in the oncology area? How are we making the conceptual change in both R&D and commercial from the 'one size fits all' to a stratified approach? Addressing the key remaining challenges Dr Brent M. Vose, Vice President & Head of Oncology & Infection, AstraZeneca Questions & discussion Stakeholders' roundtable discussion How will a balance to suit all stakeholders regarding price/demand and supply be reached over the coming years? - Discussing the role of co-payment strategies moving forwards What will be the key steps for each stakeholder towards strengthening the value provided to patients? Can the off-label use of oncology therapeutics continue in the marketplace of the future? To what extent, and in what timeframe, will the advent of biogenerics impact the economics of oncology healthcare and pharma and biotech R&D? - What actually constitutes 'bioequivalence'? - Why haven't biogenerics reached the marketplace yet? What specific challenges still need to be addressed? Buffet lunch in the exhibition area OR Working Lunch 1 How will performance measurement metrics evolve in the oncology field moving forwards? 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) OR | workshopMain afternoon sessionFollowed by your choice of : 1.10 12.30 12.25 12.00 11.55 11.30 DAY 1 - Wednesday November 14th 2007 Registration & buffet breakfast in the exhibition area7.30 www.phacilitate.co.uk/oncology AGENDA UPDATES | SPEAKER UPDATES | ON-LINE REGISTRATION | LATEST EVENT NEWS
  3. 3. Main afternoon session Devising patient stratification and enrichment strategies to mitigate risk and efficiently demonstrate efficacy of oncology therapies early in development Moderator's introduction Dr Stephen Kelsey, Vice President & Head of Exploratory Clinical Development, BioOncology, Genentech, Inc Case study The role of discovery research in successful selection of patients for cancer therapy Why is translational oncology so difficult? Herceptin as an example of the right drug for the right patients at the right time Will there ever be another target like gene amplified HER2? Why do other targets present a challenge for co-development of predictive diagnostic tests? 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? Resetting expectations: Do we need to change our approach translational oncology and drug development? Dr Mark Sliwkowski, Staff Scientist & Director of Translational Oncology, Genentech, Inc Questions & discussion Case study Patient enrichment in early phase clinical trials to enhance successful delivery of Proof of Concept The focus of oncology drug discovery pipelines has transitioned from cytotoxic agents to molecularly targeted therapeutics The transformation of clinical trial designs to exploit molecular targeting has generally lagged behind the maturation of the current pipeline products Strategies and current examples of utilizing molecular and genetic biomarkers to enrich subject populations and optimize the opportunity for demonstrating Proof-of- Concept for targeted therapeutics will be presented Dr Peter T. C. Ho, Senior Vice President of Oncology Center of Excellence for Drug Discovery,GlaxoSmithKline Questions & discussion Case study Identifying and overcoming the chief obstacles in implementing an international clinical development operation for a stratified patient population Global advanced renal cell carcinoma trial - Advantages • Diverse patient population • Local experience with the molecule • Potentially more rapid patient enrolment • Allows for development of local expertise and potentially interaction with local regulatory agencies • Stratification by region may allow for regional medical practices to not affect outcomes - Challenges • Satisfy multiple constituencies • Differences in clinical practice • Differences in regulatory rules for trial conduct as well as registration • Language, cultural, time differences, multiple vendors • Stratification is frequently by large geographic region(s) and may not account for heterogeneity within such region(s). Dr Jay Feingold, Assistant Vice President & Multi-Therapeutic Area Head, Global Medical Affairs, Wyeth Research Questions & discussion Panel discussion How can you introduce and achieve consistency of data from discovery, through clinical development in a stratified population, to the marketplace? Panellist: Joe Monforte, PhD, Vice President, Chief Scientific Officer, Althea Technologies End of session followed by afternoon tea in the exhibition area Afternoon plenary sessionFollowed by 4.05 3.45 3.40 3.20 3.15 2.55 2.50 2.30 2.20 THEN | Afternoon plenary session Short presentations & panel discussion How are pre-competitive collaborations and consortia driving innovation and efficiency in oncology therapeutic R&D? Case study: Utilizing a collaboration model to bridge the disconnect between academia and the industry Update on the specific goals and timelines of the NCI's Mouse Models of Human Cancers Consortium (MMHCC) and the Biomarker Consortium (incorporating the FDG- PET evaluation initiative) - The Biomarkers Consortium: Promoting innovation and efficiency in cancer drug discovery • Bridging the disconnect within industry • Strengthening ties between industry, academia and government • Shared goals of the stakeholders • Coordinating the activities of these diverse groups • Update on the specific goals and timelines of the FDG-PET Lung and Lymphoma imaging projects Moderator: Dr Nicholas C. Dracopoli, Vice President, Clinical Discovery Technologies, 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 End of day 1 followed by a themed cocktail reception in the exhibition area6.00 4.45 OR | Workshop Delivering collaborative solutions to the industry's key challenges in meeting the evolving demands of the oncology therapy marketplace Moderator's introduction Big pharma perspective How much emphasis is being placed on collaborative R&D in the oncology area relative to internal efforts? What specific criteria must prospective partners and their product candidates meet? - Which classes of therapy/technology areas are of particular focus moving forwards? Christopher Seaton, Senior Vice President, Global Business Development & Licensing, Bayer Corporation Questions & discussion Overcoming strategic challenges in partnering with diagnostic companies Evaluating ROI for biomarkers for pharmaceutical and diagnostic companies Developing companion diagnostics within drug development timelines Risk sharing models for development of companion diagnostics Dr Nicholas C. Dracopoli, Vice President, Clinical Discovery Technologies, Bristol-Myers Squibb Pharmaceutical Research Institute Questions & discussion Discussion of the role of cooperative groups in oncology drug development Defining the ways in which cooperative groups potentially facilitate oncology drug development Cooperative groups are not all created equal and heterogeneity encompasses a spectrum from loose affiliations of investigators, site management organizations, effectively contract research organizations through nationally funded or subsidized research networks Strengths and weaknesses of any given cooperative group engagement are a function of the particular drug development need and the particular cooperative group construct Factors to be considered when engaging cooperative groups Dr Roy Baynes, Vice President, Clinical Development, Therapeutic Area Head, Oncology Supportive Care, Amgen, Inc Questions & discussion Panel discussion How can the industry capitalize on collaboration opportunities with the patient advocacy community to drive the development and commercialization of novel therapies? End of session followed by afternoon tea in the exhibition area Afternoon plenary sessionFollowed by 4.05 3.40 3.35 3.15 3.10 2.50 2.45 2.20 PHACILITATE ONCOLOGY LEADERS’ FORUM 2007 Highly interactive workshop for a maximum of 30 participants REGISTER NOW TO GUARANTEE YOUR PLACE IN THIS SESSION www.phacilitate.co.uk/oncology
  4. 4. Morning plenary session Rethinking oncology drug development: Defining the successful clinical trial model of the future Chair's introduction Lee F. Allen, MD, PhD, Cambridge Site Head, Vice President, Medical Research - Oncology Therapeutic Area, Wyeth Research Keynote regulatory perspectives Exploring the latest regulatory initiatives from the US FDA and European authorities US FDA perspective How is the Critical Path Initiative continuing to drive innovation in clinical trial design? Speaker to be announced Questions & discussion European perspective How will the emerging European Innovative Medicines Initiative position itself with regard to the implementation of biomarkers in oncology drug development and commercialization? Professor James Carmichael, CMO, KuDOS Pharmaceuticals Questions & discussion Keynote industry response Reconciling the need to reduce the costs and timelines of clinical trials in oncology with the Critical Path Increasing number of oncology drugs in development; increasing number of companies committing to oncology Rapidly increasing knowledge of molecular basis of cancer leading to increasing number of therapeutically relevant targets; increasing proportion of oncology pipelines are 'novel molecularly targeted agents' Increasing competition for patients, investigators, trial sites Increasing globalization of oncology trials All of the above translate into increased complexity and cost of oncology trials Additional complexity introduced due to the need to evaluate biomarkers in surrogate/tumor tissue Potential to reduce development timelines and costs through intelligent incorporation of novel trial designs and biomarkers in drug development based on a sound understanding of drug mechanism of action and the relevance of the target signaling pathway to tumor biology Specific examples will be discussed Kapil Dhingra, MD, Head of the Oncology Global Drug Development Group, Hoffmann-La Roche, Inc Questions & discussion Panel discussion How will the industry mitigate the growing risk in R&D from the perceived increase in the safety hurdles facing oncology therapeutics? Morning coffee in the exhibition area OR | workshopMain sessionFollowed by your choice of : 11.05 10.40 10.35 10.10 10.05 9.40 9.35 9.10 9.00 Working Lunch 1 How and where do we move beyond RECIST2? Moderator: Donald P. Rosen, MD, Founder & Chief Strategy Officer, RadPharm OR Working Lunch 2 Are we now in a position to challenge the conventional clinical wisdom that you can't plan a trial to avoid metastases? (Very informal, discussion-based optional sessions for a maximum of 12 participants) 1.15 THEN | Main session Implementing innovative clinical trial designs to deliver lower development costs/timelines while more effectively demonstrating the efficacy of oncology therapeutic candidates Moderator's introduction Dr Robert L. Ilaria Jr, Medical Advisor for Oncology, Eli Lilly and Company Utilizing 'Phase Zero' to improve the decision-making process in early development Speaker to be announced Questions & discussion Exploring the potential of adaptive clinical trial designs to increase the efficiency of late-phase trials in the oncology area from industry R&D and regulatory perspectives Case study R&D perspective Adaptive design: State of the art 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. The utilization of adaptive designs will lead to increasing the probability of success, reducing the cost and time to market, and delivering the right drug to the right patient - Adaptive strategies for drug development - Adaptive design methods for oncology clinical trials - Oncology adaptive trial case studies - Opportunities, challenges, and recommendations Dr Mark Chang, Director, Biostatistics, Millennium Pharmaceuticals, Inc Questions & discussion Buffet lunch in the exhibition area OR Working Lunch 1 OR Working Lunch 2 Case study Novel collaborative trial designs to reduce cost and boost quality in oncology clinical development Jeffrey D. Bloss, MD, Vice President, Clinical Development, Onyx Pharmaceuticals, Inc Questions & discussion Presentation & panel discussion Examining the drivers behind, and the pros and cons of, undertaking head-to-head clinical trials in phase IIb Case study - Commercial/clinical implications of the 505 (b) (2) regulatory pathway to approval - Is a randomized phase IIb outcome just as impactful as a phase III • versus the current standard of care? • when comparing multiple dosage regimens? Speaker: Carlo Montagner, President, Abraxis Oncology Close of session followed by afternoon tea in the exhibition area Afternoon plenary sessionFollowed by 3.55 2.55 2.50 2.25 1.15 1.05 12.35 12.25 11.55 11.45 DAY 2 - Thursday November 15th 2007 Registration & buffet breakfast in the exhibition area8.00 www.phacilitate.co.uk/oncology AGENDA UPDATES | SPEAKER UPDATES | ON-LINE REGISTRATION | LATEST EVENT NEWS REGISTER NOW AND TAKE THE OPPORTUNITY TO PROPOSE A TOPIC FOR A WORKING LUNCH SESSION
  5. 5. THEN | Afternoon plenary session Examining the evolving agendas of industry, payer, regulator and academia regarding biomarker R&D/implementation Short presentations & panel discussion Identifying the common goals and potential areas of divergence - moving forwards, what are the keys to increasing the supply of innovative, effective oncology therapies to the patient? Defining each stakeholder's primary goals for biomarker development/implementation over the next decade What is the ideal balance between the roles of industry and academic in biomarker discovery? - Should it actually be a task exclusive to one group or the other? What should be the main use of biomarkers in clinical development? - How do you strike a balance between developing biomarkers to be utilized as potential surrogate endpoints, and developing them as internal decision- making tools to cut development costs and timelines? - What is the real time saving of using biomarkers in phase I/IIa and to what extent have they influenced the quality of decision making to date? 4.35 What is the business value of imaging technologies applied for different purposes and at different stages of the clinical development pipeline, and what is the optimal ba lance of a company's resources between them? - As internal portfolio decision-making tools in early development? - As indicators of efficacy in phase II? - As providers of supporting data in phase III? Moderator: Donald P. Rosen, MD, Founder & Chief Strategy Officer, RadPharm Panellists: Dr John Waterton, Chief Scientist, Translational Sciences, AstraZeneca Thomas W. Griffin, MD, Executive Director, Therapeutic Area Head, Oncology Therapeutics, North American Medical Affairs, Amgen, Inc End of day 2 followed by a themed cocktail reception in the exhibition area 5.45 Moderator's introduction Howard J. Fingert, MD, FACP, Senior Director & Clinical Lead, Signal Transduction Development Program, Pfizer Oncology Rationally combining targeted cancer drugs How do we best use ‘targeted’ cancer therapeutics in combinations? The number of targeted inhibitors currently in clinical development prohibits a strategy of clinically testing all combinations! Animal models of cancer have historically not correlated well with patient efficacy Physicochemical modeling of cell pathways can link prior knowledge about cell pathways, and experimental data of various types to create powerful tools for rationalizing combinations of targeted inhibitors for clinical development Examples of modeling combinations of existing targeted drugs will be presented Dr Ulrik B. Nielsen, Vice President of Research, Merrimack Pharmaceuticals Questions & discussion Combining targeted therapies: Science-based or clinically driven? Discussion on rationale to combine targeted therapies Implications for clinical use Future considerations: Mixing cocktails or selecting a customized menu Geert Kolvenbag, MD, PhD, Executive Director of Development, Emerging Oncology Brands, AstraZeneca Questions & discussion Case studies: Exploring the development strategies for varying combination product candidates - what are the specific implications for each In terms of potential toxicity issues? In terms of impact on efficacy? In terms of regulatory strategy In terms of potential repercussions in the payer space with regard to pricing and reimbursement? Case study Targeted small molecule drug in combination Dr Neil W. Gibson, Chief Scientific Officer, OSI Pharmaceuticals, Inc Questions & discussion Buffet lunch in the exhibition area1.15 1.10 12.50 12.40 12.20 12.10 11.50 11.45 OR | Workshop Honing your combination therapy strategy: Defining the pros and cons of various drug classes when developed in combination OR Working Lunch 1 OR Working Lunch 2 Case study Monoclonal antibody in combination Recent introduction of multiple new molecularly targeted therapies is altering the landscape of cancer drug development. To establish the value of these new therapies in the first-line treatment of metastatic disease, it is necessary to add these new therapies to already aggressive drug combinations - Challenges: • How to maintain proper dose-intensity with multiple agents with different toxicities • Are there sub-populations of patients not suitable for inclusion into such studies? • Will new and unexpected toxicities occur from the drug combinations? • What prior clinical data is necessary before starting pivotal studies? • What are proper efficacy endpoints for aggressive combined therapy? • How much added value will need to be demonstrated to justify the inclusion of several expensive drugs in combination? Thomas W. Griffin, MD, Executive Director, Therapeutic Area Head, Oncology Therapeutics, North American Medical Affairs, Amgen, Inc Questions & discussion Case study Exploring the combination product development strategy for a candidate cancer vaccine Introduction to sipuleucel-T (Provenge) an active cellular immunotherapy for prostate cancer Other agents used in the treatment of prostate cancer and how they might complement active cellular immunotherapy (hormone therapy and chemotherapy) Novel approaches that might enhance active cellular immunotherapy through the inhibition of immunosuppression (anti-CTLA-4; T-reg cell modulation) Dr David Urdal, Chief Scientific Officer, Dendreon Corporation Questions & discussion Panel discussion Debating the pros and cons of including your therapeutic in a combination product development strategy Is it better to pursue a modular combination therapy product strategy, or to pile as many features as possible on a single molecule? How do you quantify the potential damage to an individual product's commercial potential caused by negative results when trialled in combination with another product? Close of session followed by afternoon tea in the exhibition area Afternoon plenary sessionFollowed by 3.55 3.25 3.15 2.55 2.45 2.25 Highly interactive workshop for a maximum of 30 participants REGISTER NOW TO GUARANTEE YOUR PLACE IN THIS SESSION www.phacilitate.co.uk/oncology AGENDA UPDATES | SPEAKER UPDATES | ON-LINE REGISTRATION | LATEST EVENT NEWS PHACILITATE ONCOLOGY LEADERS’ FORUM 2007
  6. 6. Plenary session Looking to the future: What will be the next breakthrough in the targeted oncology therapeutics arena? How will the continuing convergence of therapeutic and diagnostic sectors drive the evolution of the R&D model? Chair's introduction Thomas R. Barr, MBA, COO, Oncology Metrics, LLC Keynote address Personalized medicine from ignorance to acceptance Why a changing business model is necessary for oncology research, development and drug commercialization The positive impact for both physician and patient The critical role of policy-makers if personalized medicine is to flourish Mara G. Aspinall, President, Genetics, Genzyme Corporation Questions & discussion Short presentations & roundtable discussion Analyzing the potential impact on the marketplace and on oncology R&D strategy of recently-approved and emerging molecular diagnostics Diagnostic company perspective - What are our ongoing plans for collaborating with pharma and biotech companies in the R&D space? - How is the trend towards value-based pricing mobilizing the diagnostics sector at large to get involved in the development of targeted oncology therapies? Payer's perspective - How might novel diagnostics change prescribing practices in oncology over the long-term? Industry perspectives - How do we currently assess the pros and cons in incorporating a companion diagnostic development aspect in therapeutic R&D? • How can the industry reap the benefits of utilizing assays both to drive candidates to market and to defend products already on the market? - Collaborative approach to multivariate biomarker development: Applications in clinical trial management and clinical diagnostic utilization 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 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 Panellists: Christopher Seaton, Senior Vice President, Global Business Development & Licensing, Bayer Corporation 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 Manager, Noonday Asset Management, LP (sub-adviser to Farallon Capital Management, LLC) Morning coffee in the exhibition area Plenary sessionFollowed by 11.40 11.10 9.40 9.35 9.10 9.00 THEN | Plenary session R&D and regulatory strategy updates on the some of the leading stories from ASCO 2007 Analyzing the clinical and regulatory strategies behind some of the biggest success stories to emerge from this June's ASCO meeting What preparations are being made to get these products reimbursed? Moderator's introduction Thomas G. Roberts, MD, MSocSci, Senior Health Care Analyst & Portfolio Manager, Noonday Asset Management, LP (sub-adviser to Farallon Capital Management, LLC) Case study Amgen's pipeline of targeted therapeutics Dr David Chang, Vice President, Global Clinical Development, Oncology Therapeutics, Amgen Questions & discussion Case study ABT-263 Anne E. Hagey, MD, Global Project Head, Oncology Cytotoxics, Abbott Laboratories Questions & discussion Case study First-in-class focal adhesion kinase inhibitor, PF-562271 Balancing risk and benefit in development of signal transduction inhibitors Biomarkers for efficacy and safety – how to Learn and Confirm? Howard J. Fingert, MD, FACP, Senior Director & Clinical Lead, Signal Transduction Development Program, Pfizer Oncology Questions & discussion End of session followed by lunch & the close of the Phacilitate Oncology Leaders' Forum 2007 1.30 1.25 1.05 1.00 12.40 12.35 12.15 12.10 DAY 3 - Friday November 16th 2007 Registration & buffet breakfast in the exhibition area8.00 www.phacilitate.co.uk/oncology AGENDA UPDATES | SPEAKER UPDATES | ON-LINE REGISTRATION | LATEST EVENT NEWS “An excellent mix of very informative discussions from various stakeholders in drug development” Dr Haren D. Rupani, Global Head, Oncology Imaging, Novartis Pharmaceuticals Corporation commenting on the Oncology Leaders’ Forum 2006
  7. 7. Sponsorship and exhibition opportunities 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 development of the oncology sector. Don't miss this unparalleled opportunity to raise your company’s profile with numerous senior level executives from all the major players in the oncology therapeutics sector. Phacilitate offers a strictly limited range of options for corporate involvement. Options available to your company include: Gold, silver and bronze sponsorships, giving you the chance to place a high 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. 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 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 team has in place. Plus - take the chance to book complimentary private meeting rooms, ideal for confidential discussions with current or potential clients and/or partners. We are more than happy to tailor a package just for your company to ensure we meet your exact objectives and budget. For more information please contact: Nicola McCall Tel: +44 (0)20 7839 6137 Email: nicola@phacilitate.co.uk Event sponsor: RadPharm is a full service imaging core lab, managing all facets of the imaging segment of global clinical trials, Phases I-IV. We are uniquely staffed to focus on "The Medicine Behind the Image." There are full-time board certified, subspecialty trained radiologists and oncologists on staff. As a result RadPharm has the distinct ability to provide centralized, independent, blinded interpretation of images for clinical trials with the responsiveness to exceed your expectations and meet your timelines. We provide a complete assessment of the oncology patient by having on-staff Radiologists, Radiation Oncologists, and Clinical Oncologists Event co-sponsor: Althea Technologies, located in San Diego, California, is a leading provider of contract manufacturing and testing services. Althea’s services include cGMP recombinant protein and plasmid DNA production, formulation and aseptic filling services, gene quantification using real-time PCR, and gene expression analysis using its proprietary eXpress Profiling™ technology. Media Partners www.futuremedicine.com www.phacilitate.co.uk/oncology AGENDA UPDATES | SPEAKER UPDATES | ON-LINE REGISTRATION | LATEST EVENT NEWS

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