R&D Leaders' Forum Autumn 2005
Presentations
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Day 1
Wednesday, October 5th, 2005
Morning plenary session
Building a successful pharma R&D business model in an environment of product withdrawals, mounting regulatory hurdles and increasingly complex portfolio decisions
Chair's introduction
Dr Timothy Wells
Analyst's perspective
How will product withdrawals, the evolving regulatory environment and imminent patent expiries impact R&D productivity, costs and shareholder returns long-term?
Jo Walton
Keynote Address
Addressing the key challenges in constructing an R&D portfolio for a changing world
Dr Jan Lundberg
Keynote Address
The missing piece of the regulatory picture
John Leonard, MD
Panel Discussion
Panellist:
Dr Anders Ullman
Focus Session 1
Assessing the pros and cons of investing in and maintaining a core competence in a novel technology area versus the various collaborative options available
• Example: Imaging technologies
Chair's introduction
Dr Ray Hill
Case study
Utilisation of PET and MRI technologies for CNS drug discovery and development
Professor Jackie Hunter
Case study
Validation of a clinical imaging endpoint: Atherosclerosis
Dr David S. Lester
Case study
Considerations on the dilemma between speed and regulatory acceptance of imaging and biomarkers in CNS development
Dr Anders Gersel Pedersen
Panel discussion
Outsource, partner to develop or license-in new enabling technologies? How do you decide which collaborative strategy, or blend of strategies, to invest in?
Focus Session 2
Overcoming the functional genomics bottleneck to drive more quality targets through discovery
Chair's introduction
Delivering on the promise of functional genomics by optimising the value of novel validation technologies
Professor Martin Schneider
Case study
Exploiting novel genomics techniques and technologies to identify new disease pathways and drug targets
Dr Mark A. Labow
Case study
Using computational biology to drive drug discovery
Dr Ulrik Nielsen
Case study
What is the latest progress in the application of RNAi to improve efficiency and productivity at the target validation stage?
Dr Oliver Steinbach
Panel discussion
Systems biology and functional genomics: Where do we go?
Biotech Breakout
How to plan for and build the necessary infrastructure to ensure the efficient progression of your lead compound from preclinical research to phase III
Moderator's introduction
Dr David J. Mazzo
Case study
A 10-year journey made, with lessons learned
Dr Peter Heinrich
Case study
Navigating the early clinical phases (no hope in stroke?)
Dr Wolfgang Söhngen
Case study
Risks and rewards in effective working relationships with CROs
Dr Richard Palmer
Case study
Building a team to manage a development portfolio
Dr John Hutchison
Afternoon plenary session
What is the future for pharma R&D in Europe?
Chair's Keynote Address
Europe needs a strong pharmaceutical science base
Dr Ronald Grobe-Einsler
Keynote Address
What incentives will the European Commission put in place to maintain pharma and biotech R&D innovation in Europe over the long term?
Dr Nils Behrndt
Panel discussion
Panellists:
Dr Jan Lundberg
Professor Børge Diderichsen
Dr Anders Ullman
Dr Colin Wyatt
Day 2
Thursday, October 6th, 2005
Optional Breakfast
Opportunities in Beijing
Moderator:
Ms Yuqin Cui
Hayley Zen
Introduction of Materia Medica
Jianbo Sun
WPU Peking University Biotech
Yyou Chen
Morning plenary session
How will the global regulatory environment and the drug development model adapt to an increasing focus on drug safety?
Chair's Keynote Address
US FDA perspective
What can be done about drug safety: A lot less talk and a lot more action
Lawrence J. Lesko, PhD, FCP
What initiatives are in development in Europe to encourage increased R&D innovation?
Professor Ole J. Bjerrum
Industry response
How must the industry adapt to drive down cost and late-stage attrition in an increasingly stringent regulatory environment?
Dr Melanie Lee
Panel discussion
Are the Critical Path Initiative, and other initiatives designed to increase R&D productivity and innovation, going to be enough?
Panellist:
Dr Charles T. Gombar
Lunch briefing
Implementing automated pathology solutions for preclinical safety
Moderator: Dr Neil Dey
Focus Session 1
Exploring novel models for partnerships with academia and the diagnostics sector to deliver innovation and reduce costs in drug development
Chair's introduction
Equality in the eyes of the portfolio; optimising the value of alliance and in-house products
Christine A. Carberry
Bridging the gap between academia and industry in Europe
Dr Colin Wyatt
Defining the potential of novel collaboration opportunities with academia to increase
R&D efficiency and productivity
Dr Ray Hill
Presentations & panel discussion
Examining the evolving relationship with the diagnostics sector
Moderator:
Guido Roumans
Panellists:
Dr Duncan McHale
Dr Gerd Maass
Dr Ray Hill
Dr Colin Wyatt
Focus Session 2
Utilising novel technologies to spot safety signals earlier in development and to reduce late-stage attrition
Chair's introduction
Dr Peter Høngaard Andersen
What are the early lessons learned from bringing tox and metabolism studies into discovery?
Gerald L. Fisher, PhD
Case study
Identifying toxicity and off-target liabilities using protein expression profiling and sequencing
Dr Gregory J Opiteck
Designing and implementing an integrated biomarker identification programme to improve decision-making in early development
Dr Peter Høngaard Andersen
Panel discussion
What are the strategic and technological keys to overcoming the poor predictive ability of preclinical pharmacology in order to spot potential safety issues in the early stages of development?
Workshop
Optimising risk assessment and management strategies for the modern pharma R&D portfolio
Chair's introduction
Dr David Slavin
Moving from risk analysis to risk management in the science-driven pharma
organization
Dr Gertrud Ahr
Product portfolio risk assessment and management in the biotech organization
Dr Philip Gotwals
Case study
Focusing development through a pragmatic approach to integrated risk management
Dr Garth McBride
Comparing and contrasting novel techniques and algorithms for assessing risk
Dr Christine Cioffe
Afternoon plenary session
Panel discussion
Pharmacovigilance is necessary, but is it sufficient?
Moderator:
Dr Peter Collins
Panellists:
Heinrich Klech, MD, PhD
Dr Garth McBride
Dr Wayne A. Rosenkrans Jr
Day 3
Friday, October 7th, 2005
Morning plenary session
Looking to the future of medicine - delivering R&D strategies to meet the shifting requirements of regulator, payer and patient
Chair's introduction
Dr Wayne A. Rosenkrans Jr
Plenary Keynote perspectives
Aligning R&D with regulator, payer, physician and patient
Dr Steve Arlington
Getting from genomics to drugs - how will the industry harness genetic variation and pharmacogenomics to deliver safe, efficacious drugs in the future?
Dr Jean-Jacques Garaud
Case study: How Rimonabant could challenge prescription habits for drugs in the obesity area
Dr Douglas Greene
Panel discussion
What are the key steps to be taken by all parties to reduce the potential for product withdrawals in the future?
Panellist:
Professor Alan Maynard
Focus Session 1
Adapting the R&D organisation to accommodate a translational medicine strategy
• What is the optimal model to quickly and efficiently drive targets to Proof of Concept in man?
Chair's introduction
Dr Chris Compton
Case study
Differentiation of a second in class molecule based on a biomarker strategy: transition from preclinical to clinical
Dr Sandra Kirkwood
Case study
Exploratory drug development model for a global company headquartered in Japan
Dr Alan Houston
Panel discussion
Focus Session 2
Delivering the latest results and key lessons learned from the successful application of novel biomarkers and pharmacogenomics in clinical development
Chair's introduction
Dr Nicholas Dracopoli
Case study
Identifying and applying a novel biomarker to reduce clinical development timescale and costs
Dr Ronald C. Hendrickson
Case studies reviewing and analysing the latest results from the application of pharmacogenomics in the clinical setting - what are the next steps?
Case study
Pharmacogenomic applications in clinical development
Dr Nicholas Dracopoli
Case study
Value of pharmacogenetics in phase I clinical studies
Dr Helen J. Ambrose
