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Oncology Drug Development USA

  February 22, 2008  
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


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


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

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 
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


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


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, 

17:30  Closing remarks and end of conference

Organized by: Health Network Communications
Invited Speakers: See programme for full speaker list
Deadline for Abstracts: No abstract submission

Book before 8 April and save up to $479.50!

50% off for Government, academia and non profit organisations

E-mail: jphillips@healthnetworkcommunications.com
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