Attend the Oncology Leaders’ Forum 2006
to learn from the individuals – and the
companies – leading the development of
nov...
Morning plenary session
Government, industry and analyst perspectives on market
potential and what it will take to commerc...
Main afternoon session
Early stage oncology development: Selecting the most
promising targets and designing predictive pre...
Morning plenary session
Comparing current US, European and Japanese
regulatory requirements for proving the safety and
eff...
OR | Breakout session
Optimizing the application of imaging in the development
of oncology therapeutics and diagnostics
Ch...
Morning plenary session
Emerging business models for the co-development and
reimbursement of diagnostics and drugs in onco...
OR | Breakout session
Pricing novel and combination therapies for oncology
Chair’s introduction
Michael Pollock, Vice Pres...
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www.phacilitate.co.uk/oncology

  1. 1. Attend the Oncology Leaders’ Forum 2006 to learn from the individuals – and the companies – leading the development of novel cancer therapeutics. Speakers include: Duke Collier, Executive Vice President, Cardiovascular & Oncology, Genzyme Corporation Briggs W. Morrison, MD, Vice President, Clinical Oncology, Merck & Co, Inc Roy D. Baynes, MD, PhD, Vice President, Clinical Development, Therapeutic Area Head. Oncology Supportive Care, Amgen Inc Dr Gary Gordon, Divisional Vice President, Global Oncology Development, Abbott Laboratories Dr Rachel W. Humphrey, Vice President, Global Development Champion, Immunology/Oncology, Bristol-Myers Squibb Dr Charles Morris, Vice President of Clinical Development Projects (Oncology), AstraZeneca R&D Lee F. Allen, MD, PhD, Cambridge Site Head, Vice President, Medical Research Oncology Therapeutic Area, Wyeth Research Dr Debasish Roychowdhury, Vice President, Clinical Drug Development, GlaxoSmithKline Pierre Démolis, PhD, Head of Clinical Evaluation of Anticancer Products, AFSSAPS Mark J. Enyedy, Senior Vice President, General Manager, Oncology, Genzyme Corporation Mark Moyer, MS, Vice President, US Regulatory Development - Oncology/Anti-infectives/Bone Domain, Sanofi-Aventis Dr Giulio Draetta, Head, Worldwide Basic Oncology Research, Merck Dr Thomas Metcalfe, Global Head of Biomarker Program, F. Hoffmann-La Roche AG Dr Dirk Reitsma, Vice President, Clinical Development, Oncology, MedImmune Flavia Borellini, PhD, Director, Product Portfolio Management, Genentech Phillip L. C. Banks, MS, FRS, Senior Director, Biostatistics & IT, Prologue Research International Dr Liqun Wang, Global Head of Imaging, Novartis Pharma AG Dr Clet Niyikiza, Vice President, Oncology Strategic Portfolio Management, Medicine Development Center, GlaxoSmithKline Dr David Chang, Senior Director, TA Head, Oncology Therapeutics, Amgen Ann F. Hanham, PhD, Managing Director, Burrill & Company Michael Pollock, Vice President, Global Health Economics, Biogen Idec, Inc Dr Donald Rosen, Founder & Chief Strategy Officer, Radpharm Inc Dr Robert Abraham, Vice President - Oncology Research, Wyeth Research Dr Christopher Slapak, Distinguished Medical Fellow (Executive Director), Eli Lilly and Company Dr Charles Baum, MD, PhD, Oncology Clinical Leader, Pfizer Inc Dr Haren D. Rupani, Head, Imaging Division, Oncology, GlaxoSmithKline Kevin J. Carroll, Chief Statistical Expert, AstraZeneca R&D Dr Cheryl Marks, Associate Director, Division of Cancer Biology, & Director, Mouse Models of Human Cancers Consortium (MMHCC), National Cancer Institute Ronald Martell, Senior Vice President of Commercial Operations, ImClone Charles C. Duncan, PhD, Managing Director, Senior Biotechnology Analyst, JMP Securities Kim Popovits, President & Chief Operating Officer, Genomic Health 30 October - 1 November The Hilton La Jolla Torrey Pines, San Diego www.phacilitate.co.uk/oncology REGISTER BEFORE 28 JULY 2006 TO SAVE $200! Dr Howard Fingert, Senior Director, Clinical Lead, Signal Transduction Development Program, Pfizer Oncology, Pfizer Global R&D Thomas G. Roberts, MD, MSocSci, Senior Health Care Analyst & Portfolio Manager, Noonday Asset Management, LP (sub-adviser to Farallon Capital Management, LLC) Jeffrey L. Evelhoch, Director, Medical Sciences, Imaging, Amgen Lee D. Arnold, PhD, Vice President, Cancer Chemistry & Discovery Technologies, OSI Pharmaceutical, Inc Toshi Kobayashi, PhD, Technical Advisor, PhRMA (USA) - Japan Office Jerome B. Zeldis, MD, PhD, Chief Medical Officer, Celgene Corporation Thomas R. Barr, Executive Director, Oncology Metrics Dr David Urdal, Chief Scientific Officer, Dendreon Corporation Julie Fleshman, JD, MBA, President & CEO, Pancreatic Cancer Action Network (PanCAN) W. Neil Palmer, Principal Consultant, Palmer D'Angelo Consulting Inc Dr Carl K. Hoh, Associate Professor, Radiology, Division Chief, Nuclear Medicine, UCSD Medical Center SEE INSIDE FOR THE FULL PROGRAM! Co-sponsors
  2. 2. Morning plenary session Government, industry and analyst perspectives on market potential and what it will take to commercialize novel combination and mono therapies for oncology Chair’s introduction – VC perspective Ann F. Hanham, PhD, Managing Director, Burrill & Company Analyst Keynote Address 5 year forecast of market size and potential opportunities for oncology therapeutics in US and globally Comparative analysis of various market forecasts for anti-cancer agents Promise of different classes of cancer therapy Prospective combination therapies in oncology Thomas G. Roberts, MD, MSocSci, Senior Health Care Analyst & Portfolio Manager, Noonday Asset Management, LP (sub-adviser to Farallon Capital Management, LLC) Questions & discussion NCI Keynote Address Working with industry, academia, payers and patients to drive combination and standalone oncology therapies to market Phasing combination therapies into trial design How does the NCI’s recommendation process work? How is NCI working with industry and advocacy groups to overcome patient recruitment obstacles, particularly for trials involving genetic testing? Working with NCI on design of screening, testing and clinical trials How will NCI’s Cancer Genome project impact the way that pharma and biotech develop new cancer therapies? Leave space for speaker Questions & discussion Industry Address Addressing the economics of targeted and personalized medicine for oncology Portfolio management to prioritize oncology research and development – which areas show most scientific and commercial promise? - Using portfolio management to enable early stage decision-making - Prioritizing between different patient subpopulations - Subpopulation-based trials to enable earlier attrition Defining customer value of targeted and personalized therapies Briggs W. Morrison, MD, Vice President, Clinical Oncology, Merck & Co, Inc Questions & discussion Morning coffee in the exhibition area Industry Keynote Address Fully exploiting the knowledge of the human genome for the discovery and development of novel therapeutics for cancer Strategically applying new technologies – what have the ‘omics achieved so far for oncology? Expression analysis of tumor specimens and circulating cells to predict patient prognosis and responsiveness to therapy - To what extent have these approaches been validated in prospective trials? Target identification - What is the progress in RNAi screens of key pathways to prioritize targets for subsequent development of therapeutics? Proteomic-based analysis and diagnostics - how close are we to serum samples as indicators of cancer? Leave space for speaker Questions & discussion Panel discussion Debating the future direction of combination, targeted and complementary therapies for oncology What will it take to drive progress with many high incidence cancers? Why has so little progress been made to date? - Pancreatic - Lung - Prostate How will supportive care / complementary therapy develop as oncology becomes increasingly targeted to specific pathways? Developing smarter agents to counter resistance downstream Panellists: Duke Collier, Executive Vice President, Cardiovascular & Oncology, Genzyme Corporation Dr Gary Gordon, Divisional Vice President, Global Oncology Development, Abbott Laboratories Buffet lunch in the exhibition area Optional working lunch sessions 1 Debating the pros and cons of target selective vs spectrum selective kinase inhibitors for current and future oncology applications 2 Blood-derived cancers FOLLOWED BY YOUR CHOICE OF TWO PARALLEL SESSIONS OR 12.45 12.05 12.00 11.30 11.00 10.55 10.25 10.20 9.50 9.45 9.15 9.00 DAY 1 - Monday October 30th 2006 Quantifying and qualifying the opportunities and ri What are the costs and timelines for developing n 8.00 Registration & buffet breakfast in the exhibition area Informal discussion-based sessions for a maximum of 12 participants each Partners The Oncology Leaders’ Forum provides an annual high-level meeting place for senior level figures driving the development, approval and launch of novel cancer therapies of all classes. Featuring a stimulating blend of highly interactive workshops, expertly moderated panel sessions, and insightful keynote addresses, the program provides a great opportunity for benchmarking, and for learning from your peers’ experiences in such areas as: Development and validation of biomarkers Clinical trial design and interpretation Optimising benefit:risk ratios Conditional and priority review Application of imaging Co-development of drugs and diagnostics Pricing novel oncology therapies The full program at the time of printing is published here, but it will continue to be updated right up to the meeting itself, to ensure its timeliness. Please visit www.phacilitate.co.uk/oncology for the very latest version. Advisory Board Dr Mike Owen, Senior Vice President & Head of the Biopharmaceuticals Center of Excellence for Drug Discovery, GlaxoSmithKline Dr Richard Gaynor, Vice President, Cancer Research & Clinical Investigation, Eli Lilly and Company Dr Roberto Solari, Chief Executive Officer, Medical Research Council Technology Dr David Urdal, Chief Scientific Officer, Dendreon Corporation Michael G. McCully, Director & Senior Analyst, Recombinant Capital H. Kim Lyerly, MD, Director, Duke Comprehensive Cancer Center Pat Stanfill Edens, Assistant Vice President, HCA, Hospital Corporation of America
  3. 3. Main afternoon session Early stage oncology development: Selecting the most promising targets and designing predictive preclinical and phase I/IIa trials Chair’s introduction Getting your drug into human trials quicker - how do you know when you have a hypothesis that’s worth testing in man? Dr Robert Abraham, Vice President - Oncology Research, Wyeth Research What progress is being made with improving animal models as predictors of efficacy in humans? What new animal models are being developed for oncology? - How well do newer animal models simulate human cancers? Are animals providing any novel biomarkers for early detection of cancer or for early indication of response/resistance to therapy? Is determination of potential efficacy in animal models confined to the testing of lead compounds? - How can animal models guide target selection? - Are animal models useful in stratifying patients? What role will biomarkers play in the replacement of animal models? Dr Cheryl Marks, Associate Director, Division of Cancer Biology, & Director, Mouse Models of Human Cancers Consortium (MMHCC), National Cancer Institute Questions & discussion Case studies of phase I-IIa clinical trial design for mono and combination oncology therapies Case study Lessons from Erlotinib, a successful small molecule inhibitor of EGFR Target selection and Tarceva discovery & development timeline Correlation of efficacy with drug exposure and target inhibition in preclinical models Lessons from clinical trial analyses with regard to target expression, performance score, response rate, survival, rash, biomarkers, & mutations Effects of smoking, metabolic induction, active metabolites, and drug efflux Impact of translational research in identifying markers of sensitive tumors and determinant signalling pathways Application of lessons to clinical trials of new molecular targeted therapies Lee D. Arnold, PhD, Vice President, Cancer Chemistry & Discovery Technologies, OSI Pharmaceutical, Inc Questions & discussion Afternoon tea in the exhibition area Case study Leave space for title Leave space for bullet Leave space for bullet Leave space for bullet Leave space for bullet Dr Giulio Draetta, Head, Worldwide Basic Oncology Research, Merck Questions & discussion Case study Leave space for title Leave space for bullet Leave space for bullet Leave space for bullet Leave space for bullet Dr Rachel W. Humphrey, Vice President, Global Development Champion Immunology/Oncology, Bristol-Myers Squibb Questions & discussion Panel discussion Debating varying approaches to patient recruitment for early stage oncology trials Discussing the impact of the CD28 trial in UK – should human volunteers be used in oncology therapy trials? Update on cooperative groups being formed to improve the capture of appropriate patient populations - How are research nurses as well as physicians being incentivized as a route to tackling the patient recruitment problem? Offshoring – what are the ethical issues of conducting early stage trials in developing countries? - How successful have early stage trials been in India and China? - Ensuring that the data will be acceptable to the regulatory authority End of session – all attendees to reconvene for the day’s final plenary session 5.00 4.35 4.30 4.10 4.05 3.45 3.15 3.10 2.50 2.45 2.20 2.15 OR | Breakout session Optimizing benefit:risk ratios in oncology Moderator’s introduction Dr Clet Niyikiza, Vice President, Oncology Strategic Portfolio Management, Medicine Development Center, GlaxoSmithKline Implementing risk management plans in the development of oncology therapies What risk management tools are being used? Evidence-based risk management How are novel approaches to oncology trial design affecting the benefit:risk equation? How are combination therapies impacting benefit:risk in oncology? Dr Howard Fingert, Senior Director, Clinical Lead, Signal Transduction Development Program, Pfizer Oncology, Pfizer Global R&D Questions & discussion Regulatory viewpoint: Balancing the efficiency drivers of Critical Path against ICH/QT requirements for risk management How does pharmacogenomics alter the benefit:risk ratio from a regulatory perspective? Leave space for speaker Questions & discussion Afternoon tea in the exhibition area Case study Statistical issues in assessing risk:benefit in clinical trials Assessment of efficacy benefit in trials is too often constrained by binary considerations of p<0.05 vs p>0.05 Other simple approaches exist that allow both the degree and probability of benefit to be better characterized Risk, in terms of the incidence of AEs, is frequently examined suboptimally The common failure to allow for the correlation between different AEs can lead to over- and under- statement of risk Examination of laboratory values over time commonly underestimates the true magnitude of likely risk Simple approaches exist that allow increase in the risk of AEs and lab data to be better quantified Kevin J. Carroll, Chief Statistician, AstraZeneca R&D Questions & discussion Panel discussion Strategically balancing safety with risk management concerns for industry, regulators and payers What approach should be taken to benefit:risk assessment for chronic therapies in oncology? What is considered a favourable benefit:risk ratio? - What side effects can be both predicted and tolerated? End of breakout session – all attendees to reconvene for the day’s final plenary session THEN | Afternoon plenary session How is industry moving forward with the development of combination therapies and the treatment of cancer as a chronic disease? Developing therapies for chronic diseases: Similarities and differences in clinical development strategies between HIV and cancer Overview of clinical development paths and related timelines for HIV and cancer treatments How does endpoint selection guide study design considerations for HIV versus cancer clinical trials? Suitability of surrogate markers for chronic diseases Application of novel statistical methods to reduce patient exposure for outcomes requiring long-term follow-up Adopting HIV pivotal trial design template to facilitate accelerated, regular FDA approval of cancer therapies Phillip L. C. Banks, MS, FRS, Senior Director, Biostatistics & IT, Prologue Research International Questions & discussion Panel discussion Making progress with combination therapies – targeted/targeted and targeted/cytotoxic What is the future of cytotoxic therapy? How should it be managed in the context of targeted therapies? Close of day one followed by themed cocktail reception in the exhibition area6.15 5.40 5.35 5.05 5.00 4.15 4.10 3.45 3.15 3.10 2.50 2.45 2.20 2.15 sks presented by the oncology sector: ovel therapies? PHACILITATE ONCOLOGY LEADERS’ FORUM 200 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 Comparing current US, European and Japanese regulatory requirements for proving the safety and efficacy of novel oncology therapies Chair’s introduction Michael Doherty, Global Head - Pharma Regulatory Affairs, Pharmaceutical Division, F. Hoffmann-La Roche Ltd Keynote Regulatory Roundtable US perspective Defining, measuring and achieving quality outcomes for cancer – how will the Critical Path Opportunities List help? On what basis are biomarkers being accepted as surrogates of safety and efficacy in oncology therapies? What is the stance on eliminating phase III trials? How are the conditional and priority review processes working in practice? How will enrichment design and adaptive trial designs benefit the market? How is the FDA approaching concerns regarding accessing patients earlier in the cancer progression cycle? Orphan Drug Status – what are the implications of advances in molecular biology for smaller, targeted populations of oncology patients? Leave space for speaker Questions & discussion European perspective Clarifying the regulatory review processes in Europe - What are the European equivalents of conditional and priority reviews and what have they achieved to date? On what basis are biomarkers being accepted as surrogates of safety and efficacy in oncology therapies? What is the progress on the establishment of a European policy on orphan drugs? How is EMEA approaching concerns regarding accessing patients earlier in the cancer progression cycle? Pierre Démolis, PhD, Head of Clinical Evaluation of Anticancer Products, AFSSAPS Questions & discussion Japanese perspective What has precipitated the recent shift towards acceptance of combination therapies, increasing use of validated biomarkers and accelerated trial design for oncology therapy in Japan? How are new trial designs working in practice? How will data from oncology / biomarker trials outside Japan be applied internally? How is MHW approaching concerns regarding accessing patients earlier in the disease progression cycle? Toshi Kobayashi PhD, Technical Advisor, PhRMA (USA) - Japan Office Questions & discussion Morning coffee in the exhibition area Industry Address Regulatory initiatives on approval routes for targeted oncology therapeutics Lee F. Allen, MD, PhD, Cambridge Site Head, Vice President, Medical Research Oncology Therapeutic Area, Wyeth Research Questions & discussion Sponsor session – Radpharm – leave space for title Leave space for bullet Leave space for bullet Leave space for bullet Dr Donald Rosen, Founder & Chief Strategy Officer, Radpharm Inc Panel discussion What needs to change to encourage the proactive development, validation and adoption of biomarkers and surrogate endpoints for oncology? Can novel biomarkers be discovered, developed and validated in the time-frame of the development of a novel medicine? Encouraging biomarker development throughout the preclinical and clinical process - When is the optimal time to invest in biomarker discovery and validation? What’s the current thinking on non-survival registration of primary and secondary clinical end-points? - Genomics, proteomics, metabolomic, epigenetics factors What is the progress of the FDA/NCI/CMS Oncology Biomarker Qualification Initiative and PhRMA biomarker consortium efforts? Panellist: Dr Thomas Metcalfe, Global Head of Biomarker Program, F. Hoffmann-La Roche AG Buffet lunch in the exhibition area Optional working lunch sessions* FOLLOWED BY YOUR CHOICE OF TWO PARALLEL SESSIONS OR 12.50 12.15 11.50 11.45 11.20 10.50 10.40 10.15 10.05 9.40 9.30 9.05 9.00 THEN | Main afternoon session Phase IIb and III trials for mono and combination oncology therapies Chair’s introduction Dr Charles Morris, Vice President of Clinical Development Projects (Oncology), AstraZeneca R&D A series of case studies drawn from different classes of oncology therapy Case study Leave space for title Leave space for bullet Leave space for bullet Leave space for bullet Leave space for bullet Dr Debasish Roychowdhury, Vice President, Clinical Drug Development, GlaxoSmithKline Questions & discussion Case study REVLIMID clinical development as monotherapy and as combination therapy In oncology, what level of single agent activity is needed before embarking on combination trials? Can single agent controlled trials be run? If so, under what circumstance? What combination trials make sense from a regulatory and/or clinical perspective"? Jerome B. Zeldis, MD, PhD, Chief Medical Officer, Celgene Corporation Questions & discussion Case study Leave space for title Leave space for bullet Leave space for bullet Leave space for bullet Leave space for bullet Dr David Chang, Senior Director, TA Head, Oncology Therapeutics, Amgen Questions & discussion Afternoon tea in the exhibition area Case study Leave space for title Leave space for bullet Leave space for bullet Leave space for bullet Leave space for bullet Dr Dirk Reitsma, Vice President, Clinical Development, Oncology, MedImmune Questions & discussion Case study Progress in the development of Provenge (sipuleucel-T) for the active immunotherapy of prostate cancer The prostate cancer continuum and the unmet need for new treatments Development history of Provenge in prostate cancer Endpoints suitable for evaluation of active immunotherapy in prostate cancer Regulatory and clinical development milestones - cell / gene therapy Dr David Urdal, Chief Scientific Officer, Dendreon Corporation Questions & discussion Panel discussion Optimizing the timing and value of biomarker development during late stage clinical trials End of session – all attendees to reconvene for the day’s final plenary session Optional working lunch sessions* 1 Pathotropic nanoparticles (Rexin-GTM) for cancer gene therapy: Its impact on clinical drug development. Erlinda M. Gordon, MD, Founder, Chairman of the Board, Vice President, Operations & Medical Affairs, Epeius Biotechnologies Corporation 2 Comparing results of novel monoclonal antibodies against small molecules for oncology therapy 3 What approach are regulators adopting to biosimilars in the oncology sector? 12.50 5.25 5.00 4.55 4.35 4.30 4.10 3.40 3.35 3.15 3.10 2.50 2.45 2.25 2.20 DAY 2 - Tuesday October 31st 2006 Designing development programs for unprecedented targets: Industry and regulatory approaches to clinical trial design, validation of biomarkers and alternative end points 8.00 Registration & buffet breakfast in the exhibition area Informal discussion-based sessions for a maximum of 12 participants each
  5. 5. OR | Breakout session Optimizing the application of imaging in the development of oncology therapeutics and diagnostics Chair’s introduction Leave space for name Progress with definitions and standardization of imaging for establishing response criteria Current imaging endpoints in oncology revisited New imaging endpoints in oncology Tumor morphology - Tumor function Standardization of imaging response measurements Jeffrey L. Evelhoch, Director, Medical Sciences, Imaging, Amgen Questions & discussion Moving beyond RECIST with molecular imaging Quantitative measurements with Positron Emission Tomography Example study comparing PET and CT for evaluating biologic effectiveness of an experimental compound. Dr Carl K. Hoh, Associate Professor Radiology, Division Chief Nuclear Medicine, UCSD Medical Center Questions & discussion Novel molecular imaging to improve early risk discharge in portfolio management Increased new experimental therapeutics have specific and novel targets Early confirmation that experimental drugs reach intended targets and relevant biological pathways becomes more critical to early risk discharge Ability to define optimal biological dose (OBD) early becomes increasingly critical Molecular Imaging technologies such as PET (positron emission tomography) are effective tools in addressing the above needs Dr Liqun Wang, Global Head of Imaging, Novartis Pharma AG Questions & discussion Afternoon tea in the exhibition area Case study Practical considerations for imaging in late stage clinical trials Imaging modalities used in late stage clinical trials Outline the modality of choice depending on the mechanism of action of the investigational drug Current state of the art for the imaging modality - what imaging can and cannot do Challenges of conducting imaging portion of a multinational, multicenter clinical trial - Co-developing imaging endpoints with oncology therapies Haren D. Rupani, Head, Imaging Division, Oncology, GlaxoSmithKline Pharmaceuticals Questions & discussion Practical guidelines for submitting imaging and biomarker data to regulatory authorities Should exploratory biomarkers be submitted through the oncology or imaging divisions? What evidence will they be looking for and how does this translate into provisional or accelerated approval based on exploratory biomarkers Leave name for speaker Questions & discussion Panel discussion Tackling the practicalities of integrating imaging information with other data collected throughout the clinical development cycle Panellist: Dr Donald Rosen, Founder & Chief Strategy Officer, Radpharm Inc End of breakout session – all attendees to reconvene for the day’s final plenary session THEN | Afternoon plenary session Panel discussion Addressing the practicalities of data sharing and IP issues for tissue and blood-derived samples in oncology: Enabling pre- competitive collaboration via industry consortia Ownership of pharmacogenomics data Tissue sampling across borders Standardized tissue collection to decrease variability How are consortia enabling data sharing in practice? Avoiding antitrust issues Close of day two followed by themed cocktail reception in the exhibition area6.00 5.30 5.25 5.00 4.55 4.35 4.30 4.10 3.40 3.35 3.15 3.10 2.50 2.45 2.25 2.20 Networking Phacilitate has established an unrivalled track record for attracting genuine R&D leaders to our events – often individuals who simply do not speak at, or attend, other meetings. And we recognize that it is absolutely critical to give you the best possible opportunity to meet them in the sort of exclusive, informal, yet business-focused environment that is proven to be ideal for high-level networking. “Open forum with high level individuals from industry that interact on many issues. Truly a great networking opportunity to discuss the future direction of our industry” Gerald J. Vardzel, Gene Express, Inc The Oncology Leaders’ Forum will feature numerous extended networking breaks, including evening receptions, ideal for discussions with senior level participants representing pharma and biotech companies, the regulators, and representatives of the investment community. Additional networking support is provided by the Pre-event Meeting Request Service – giving you the chance to review the full attendee list and contact your fellow participants before the event starts. You are also able to book complimentary private meeting rooms, perfect for confidential discussions with current, and potential future, partners and clients. 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 1 location in just 3 days. Associate your company with an event designed to drive the development of the oncology sector. All of the Oncology Leaders’ Forum’s networking activities will take place in the exhibit area, directly alongside the conference rooms. We are pleased to offer a wide range of sponsorship and booth options to companies providing products, services and technologies to companies developing cancer therapeutics. For more information, please contact Nicola McCall at Nicola@phacilitate.co.uk (Tel: +44 (0)20 7839 6137). Highly interactive workshop for a maximum of 30 participants REGISTER NOW TO GUARANTEE YOUR PLACE IN THIS SESSION
  6. 6. Morning plenary session Emerging business models for the co-development and reimbursement of diagnostics and drugs in oncology Chair’s introduction What are the real opportunities in oncology diagnostics: How big will the market be? Charles C. Duncan, PhD, Managing Director, Senior Biotechnology Analyst, JMP Securities What are the emerging business models and practicalities for the successful co-development of diagnostics and drugs for oncology? Partnership approach versus developing internal capabilities Launching the drug and diagnostic simultaneously, everywhere you launch How should diagnostics companies sell the cost:benefits to industry, payers and patients? Roy D. Baynes, MD, PhD, Vice President, Clinical Development, Therapeutic Area Head, Oncology Supportive Care, Amgen Inc Questions & discussion Panel debate How will the diagnostic element be valued and leveraged? How will this affect the licensing and partnering strategies that evolve to service drug/diagnostic co-development? Panellists: Kim Popovits, President & Chief Operating Officer, Genomic Health Mark J. Enyedy, Senior Vice President, General Manager, Oncology, Genzyme Corporation Morning coffee in the exhibition area What reimbursement models are emerging for premium priced and combination products in oncology? What is the role of reimbursement management in planning a product launch? What will be the impact of Medicare Part D – pay for performance and quality measurement? When will they hit oncology? How does the US situation now compare with Canada? What is NICE’s (National Institute for Clinical Excellence) streamlined approval process for single drugs and how does this compare to the FDA (Federal Drug Administration) streamlined process in the United States? Thomas R. Barr, Executive Drector, Oncology Metrics Questions & discussion Case study Integrating high cost chronic targeted therapies into oncology How to position a drug in managed care plans Leave space for bullet Leave space for bullet Leave space for bullet Ronald Martell, Senior Vice President of Commercial Operations, ImClone Questions & discussion Panel discussion What do patient advocacy groups need and how can industry work more effectively with them? Developing products in a patient and physician friendly way What are the pros and cons of IV versus oral delivery: Reimbursement issues, patient preference, compliance, combinations Improving the way patients gather information about trials - what do they consider to be reliable sources? Working in a highly fragmented industry How are diagnostics being applied for prognosis and treatment selection? Incentivizing research nurses as a route to tackling the patient recruitment problem Panellist: Julie Fleshman, JD, MBA, President & CEO, Pancreatic Cancer Action Network (PanCAN) Buffet lunch in the exhibition area Optional working lunch session Addressing the economic and regulatory issues facing cancer vaccines and their route to approval FOLLOWED BY YOUR CHOICE OF TWO PARALLEL SESSIONS OR 1.00 12.20 12.15 11.45 11.40 11.10 10.40 10.05 10.00 9.30 9.00 THEN | Main afternoon session Case studies illustrating the route to approval for recent oncology therapies: How is patient benefit being assessed pre- and post -marketing? Chair’s introduction Dr Christopher Slapak, Distinguished Medical Fellow (Executive Director), Eli Lilly and Company Case study Combining diagnostic capabilities with targeted therapeutics to expand post-approval markets - case study of Campath, a monoclonal antibody targeting the CD52 antigen Mark J. Enyedy, Senior Vice President, General Manager, Oncology, Genzyme Corporation Questions & discussion Case study Approval of SUTENT for the treatment of patients with advanced renal cell carcinoma or gastro intestinal stromal tumor Leave space for bullet Leave space for bullet Leave space for bullet Leave space for bullet Dr Charles Baum, MD, PhD, Oncology Clinical Leader, Pfizer Inc Questions & discussion Genentech case study Learning from the approval process for monoclonal antibody therapies in oncology Flavia Borellini, PhD, Director, Product Portfolio Management, Genentech Questions & discussion Afternoon tea Case study Taxotere (docetaxel): Bringing labelling in line with current medical practice through effective life-cycle management - the gastric cancer and head and neck cancer indication experience Mark Moyer, MS, Vice President, US Regulatory Development - Oncology/Anti- infectives/Bone Domain, Sanofi-Aventis Questions & discussion Panel discussion How are phase IV study expectations and post-marketing surveillance differing? End of session – all attendees to reconvene for the day’s final plenary session4.20 4.20 4.15 3.50 3.35 3.30 3.05 3.00 2.35 2.30 2.05 2.00 DAY 3 - Wednesday November 1st 2006 Co-development, registration, pricing and reimbursement of targeted and personalized medicine for oncology: Lessons learned from recent approvals 8.00 Registration & buffet breakfast in the exhibition area VISIT THE WEBSITE FOR THE LATEST EVENT INFORMATION: www.phacilitate.co.uk R&D Leaders’ Forums Recognised as the Leader by the Leaders DATES ANNOUNCEMENT 4-6 October, The Hotel Palace, Berlin incorporating the Early Development Forum 2006
  7. 7. OR | Breakout session Pricing novel and combination therapies for oncology Chair’s introduction Michael Pollock, Vice President, Global Health Economics, Biogen Idec, Inc Comparing pricing policies and regulations for oncology products in US, Canada and Europe Price regulations in key markets Impact of internal and external price referencing Recent developments in price regulations Review of selected oncology product pricing in key markets Payers’ decision making criteria: – value or affordability (or both)? Review of payer’s decisions for selected oncology products in key markets Outlook and implications for pricing of oncology products W. Neil Palmer, Principal Consultant, Palmer D'Angelo Consulting Inc Questions & discussion What strategic approaches are being taken to pricing oncology therapies? Starting early when building the value story Projecting the pricing and reimbursement environment at the planned launch date Balancing the registration and pricing strategies – to niche or not? Pricing of combination therapy – is double the price double the hurdle? Michael Pollock, Vice President, Global Health Economics, Biogen Idec, Inc Questions & discussion Case study Value-based pricing in cancer diagnostics Personalized medicine, the need for new approaches in cancer OncotypeDx breast cancer assay - case study Economic rationale for applied genomic technologies across the continuum of care Kim Popovits, President & Chief Operating Officer, Genomic Health Questions & discussion Afternoon tea Panel discussion What pricing tools should be used and when? Setting the early price range assumptions – optimism vs. realism Building a pricing model – including NPV of off label indications Product launch sequencing to maximize price Pricing research – how early should you start? Panellists: Michael Pollock, Vice President, Global Health Economics, Biogen Idec, Inc W. Neil Palmer, Principal Consultant, Palmer D'Angelo Consulting Inc End of session – all attendees to reconvene for the day’s final plenary session THEN | Afternoon plenary session Panel discussion Transitioning novel therapies from oncology to other therapeutic areas to extend lifetime value What is the impact of the fast track and accelerated approval process on potential acceptance of these therapies for other indications? Close of the Oncology Leaders’ Forum 20065.15 4.45 4.40 3.50 3.35 3.30 3.05 3.00 2.35 2.30 2.05 2.00 Co-sponsors Prologue Research, Inc. is full service Oncology CRO specializing in the design, execution, data collection and translation of oncology clinical trials. Founded in 1998, Prologue has conducted over 80 trials in oncology, using 365 investigators at 1125 sites, involving over 22,000 patients. Trials span a wide range of both hematological and solid tumors. The company has managed all phases of clinical trials ranging from Phase I through Phase III registration trials. Prologue also has extensive experience in Phase IV programs as well as a number of Expanded Access Programs. The company offers a full range of services, including study and statistical design, protocol development, investigator/site sourcing and qualification, data collection, site and medical monitoring, safety reporting, data/statistical analysis, medical writing and regulatory submissions. www.procro.com 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 Highly interactive workshop for a maximum of 30 participants REGISTER NOW TO GUARANTEE YOUR PLACE IN THIS SESSION Two of North America’s leading life science meeting places will come together in 2007 22-24 January | The Baltimore Marriott Waterfront CELL & GENE THERAPY FORUM 2007 VACCINE FORUM BALTIMORE 2007 In 2007, the Cell & Gene Therapy Forum will run concurrently with Phacilitate’s 5th annual North American Vaccine Forum. Participants will be able to select the conference agenda of greatest current value to themselves and their organisation, with all networking opportunities shared between the two events. www.phacilitate.co.uk

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