Health Network Communications, Courtyard Philadelphia Downtown
24 - 26 June 2008
Day one Tuesday 25 June 2008 www.healthnetworkcommunications.com 08:30 Registration & coffee 08:50 Opening remarks from the chair BUSINESS STRATEGY; KEY DRIVERS AND DEVELOPMENTS 09:00 What are the financial sector's expectations for the oncology marketplace?
• market dynamics
• winners and losers
• critical success factors
Dr Sapna Srivastava, Vice President, Morgan Stanley 09:30 The value of the oncology drugs in development
• Review of recent deals by stages of development
• Is there space in the market for so many new products?
• Reimbursement issues
• Deal valuation
Brian Lovatt, Managing Director, CancerDeals 10:00 Pricing for outcome and risk sharing: what are the next steps?
Dr Mayur Amonkar, Director, Global Health Outcomes, GlaxoSmithKline 10:30 Morning tea 11:00 Value for money: a European perspective
• Who's values?
• Who's money?
• Who pays?
Professor Sir Michael Rawlings, Chairman, NICE (National Institute for Health and Clinical Excellence) 11:30 Are biotech companies prepared to recognise the needs of oncology patients and avoid the mistakes of large pharmaceutical companies?
• How are the issues that impacting today’s medical consumers
• Understanding accomplishments and strides
• How can biotech companies could win the respect of patients
• From the bench to the bedside – translating clinical progress
• Directions in public policy and positive outcomes through collaboration with patient advocates
Selma Schimmel, Founder & Chief Executive Officer, Vital Options International 12:00 Oncology vaccines: should pharmaceutical companies welcome or avoid them?
• Cancer vaccines, tumour types and technologies
• Primary role and synergy with other modalities
• The importance of inhibiting the T-reg and suppressor cell network
• The importance of sequential design and the right drugs in treatment
Professor Angus Dalgleish, Foundation Professor of Oncology, St George's University of London 12:30 Lunch TRANSLATIONAL MEDICINE AND BIOMARKERS 13:30 Targeting DNA damage detection and repair pathways to enhance the effectiveness of cancer therapeutics
• Targeted DNA damage detection and repair pathways have become increasingly attractive targets for cancer drug discovery efforts, with several agents now in clinical trials
• Rationale and promise of such agents to provide significant improvements in the treatment of cancer
Susan Ashwell, Director, Cancer Chemistry, Astrazeneca R&D 14:00 The utility & value of predictive response markers in oncology
Dr Hans Winkler, Senior Director, Translational Research, Johnson & Johnson 14:30 The development of imaging biomarkers for drug development: the potential of molecular imaging
• In-vivo molecular imaging as an emerging discipline to the development of cancer therapies
• New and emerging quantitative functional imaging technology to look at molecular pathways
• Imaging biomarkers in early clinical trials
• Molecular imaging biomarkers potential to streamline and accelerate rational drug development in oncology
Professor Patricia Price, Ralston Paterson Professor of Radiation Oncology, Christie Hospital NHS Foundation Trust and University of Manchester, UK 15:00 Afternoon tea 15:30 Breakthroughs in cancer biomarker discovery using innovative strategies
• Proteomics technologies; in-depth searches and identification of novel cancer markers
• Discovery research; individual lab effort to collective efforts
• Validation studies and the relevance of novel biomarkers for early cancer detection
Dr Samir Hanash, Molecular Diagnostics, Fred Hutchinson Cancer Research Center, Seattle 16:00 Biomarker Case study;
Dr Sridhar K Rabindran, Director GlaxoSmithKline Oncology Centre for Excellence in Drug Discovery 16:30 Closing Remarks from the chair 17:00 Networking drinks reception Day two Wednesday 26 June 2008 www.healthnetworkcommunications.com 08:30 Registration & coffee 08:50 Opening remarks from the chair EARLY CLINICAL
As exciting new products enter the clinic and are progressing through the development process, this session will examine the progress of specific products. Special attention will be placed on clinical and regulatory challenges and latest trial results. 09:00 Case studies on targeted therapeutics
Dr Gregory Berk, Chief Medical Officer, SuperGen, Inc 09:30 Achieving consistency of data from discovery to development to the
Marketplace
Joe Monforte PhD, Vice President and Chief Scientific Officer, Althea Technologies 10:00 Targeting the notch pathway
Dr Giulio Draetta, Head, Worldwide Basic Oncology Research,
Merck & Co 10:30 Utilising adaptive dose-ranging studies to improve decision making in clinical R&D
Dr Yusong Chen, Director of Statistical Science, AstraZeneca 11:00 Morning tea 11:30 Identification & early validation of cancer antibody targets
• target choices: inhibition of cell-surface receptors vs. immune effector targeting
• ligands and receptors: Screening the extracellular proteome for cancer-related functions
• rapid in vivo screening and validation for functionally relevant targets
Dr Steve Doberstein, Vice President, Research, Five Prime Therapeutics 12:00 Latest clinical results for Novartis' anti-angiogenesis treatment in early stage trials
Dr Christian Jacques, Executive Director, Oncology, Novartis 12:30 Amgen's pipeline of targeted therapeutics
• Vectibix; developed for use in patients with advanced stage CRC
• Pivotal trial vs. best supportive care
• Predicting responders which markedly enhanced the benefit: risk ratio
• Pre-specified retrospective analysis in biomarker development
• KRAS in the predictive biomarker field
• KRAS; establishing consistency of hypothesis
• Use of EGFR antagonists
Dr Roy Baynes, Vice President, Global Development, Oncology Supportive Care, Amgen 13:00 Lunch REGULATORY UPDATE AND REVIEW This session will look at specific regulatory challenges that are faced by developers of oncology products it will begin with a broad review of the international arena, followed by am FDA update on molecular diagnostics and ending with a case study focusing on the regulatory pathway to approval 14:00 An Industry Perspective
Michael Doherty, Global Head, Pharma Regulatory Affairs, Hoffman La Roche 14:30 The potential impact of recently approved & emerging molecular diagnostics
Dr Francis Kalush, Molecular Diagnostics, Office of In Vitro Diagnostics (OIVD/CDRH), US Food & Drug Administration 15:00 Undertaking head-to-head clinical trials in phase IIb: the commercial and
clinical implications of the 505 (b) (2) regulatory pathway to approval
Dr Carlo Montagner, President, Abraxis Oncology 15:30 Afternoon tea NOVEL APPROACHES FOR TARGETED THERAPIES Targeted therapies are now common place in standard treatment regimens. Many more products are forecast to reach the market over the next few years giving some organizations significant strategic advantages. This session will look at some novel approaches to targeted treatments ad future challenges.
16:00 Case study: development of a systems biology designed therapeutic for the treatment of cancer
Dr Ulrik B Nielsen, Vice President of Research, Merrimack Pharmaceuticals 16:30 The potential of molecular pathology for targeted therapies
Dr Sydney Finkelstein, Co-Founder & Chief Executive Officer, RedPath Integrated Pathology 17:00 Combination therapies for oncology: targeted challenges
Dr Geert Kolvenbag, Executive Director of Development, Emerging Oncology Brands,
AstraZeneca 17:30 Closing remarks and end of conference
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