R&D Leaders' Forum Autumn 2006
Presentations
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Day 1
Wednesday, October 4th, 2006
Morning plenary session
Delivering innovative models for future interactions between industry and regulator
Chair's introduction
Dr Anders Ullman – NO SLIDES PRESENTED
Keynote perspectives
Innovative models: Industry’s perspective and experience
Joseph M. Feczko, MD
FDA perspective
The Critical Path: Now that I have your attention, where do we go next?
Dr Joga Gobburu
European perspective
The Innovative Medicines Initiative - what are the next steps?
Irene Norstedt
Panel discussion
Dr Peter Bachmann – NO SLIDES PRESENTED
Dr John Warren - NO SLIDES PRESENTED
Early development session (Preclinical to Phase IIa)
Workshop: Applying Critical Path tools to improve predictability of success or failure early in the development process
- How can drug and disease models be used to drive improved
development and regulatory review?
Moderator's introduction
FDA perspective
Dr Joga Gobburu
Wanted: New biomarkers and disease models
Kevin Hrusovsky
Case study
Model-based drug development at Novartis
Professor Donald R. Stanski - SLIDES NOT AVAILABLE
Panel discussion - NO SLIDES PRESENTED
Late phase development session (Phase IIb to IV)
What will the clinical development model look like in 2010-2015?
- How can you change your organisational model and processes today to drive further evolution?
Moderator's introduction
Heather E. Fraser
Updates on two alternative clinical development paradigms: How are they being applied internally today to inform decision-making and create efficiencies in the clinical trial process?
Case study
Learn & Confirm: A new paradigm for drug development at Wyeth
Dr Charles T. Gombar
Case study
A new paradigm for drug development: What could the future look like?
John J. Orloff, MD
Marketing perspective
How does the clinical model need to change to meet the evolving needs of payers and patients?
Stewart Adkins
Presentation & panel discussion
The eClinical equation: Bridging connections for innovation
Heather E. Fraser
R&D organisational models
Are novel R&D organisational models really working?
- Overcoming the challenges in switching from function- to project-oriented R&D
Moderator's introduction
Peter Joshua – NO SLIDES PRESENTED
Case study
The Centres of Excellence for Drug Discovery in GlaxoSmithKline: Five years later
Dr Lucio Da Ros – SLIDES NOT AVAILABLE
Case study
Moving from functional silos to an integrated franchise strategy and execution paradigm in early and late development
Dr Paul Bunch
Case study
Extenuating the traditional model of pharmaceuticals:
"There are no rules here - we're trying to accomplish something". --Thomas A. Edison
Douglas W Axelrod, MD, PhD
Case study
Reaping the benefits from removing the hierarchical barriers to R&D innovation
Dr Michael Hanley
Aerospace industry perspective - lessons for pharma
Case study
Why and how Lockheed Martin’s R&D model had to change
Douglas E. Barton
Questions & panel discussion
NO SLIDES PRESENTED
Afternoon plenary session
Moderator's introduction
Peter Joshua - NO SLIDES PRESENTED
Debate
Motion: The pharma industry is facing a Phase II crisis
The argument for the motion:
Why we need to take a proactive approach to addressing phase II attrition rates
Dr Charles T. Gombar - NO SLIDES PRESENTED
The argument against the motion:
Phase II attrition rates are high, but this is evidence that better decision-making in early development is having the desired effect
Dr Eiry M. Roberts - NO SLIDES PRESENTED
Questions & discussion
NO SLIDES PRESENTED
Day 2
Thursday, October 5th, 2006
Morning plenary session
How must pharma and biotech R&D refocus to address evolving pressures and demands from the marketplace?
Chair's introduction
Guy Lefever
Pharma 2010: The Threshold of Innovation -what's next?
Guy Lefever
Industry Keynote perspective
How must the R&D model adapt to the evolving healthcare environment in Europe and North America?
Dr David Boyko
NICE methods for health technology appraisal - implications for pharmaceutical research and development
Dr Carole Longson
Analysts' perspectives:
Pharma analyst
Has pharma turned the corner in terms of R&D productivity and efficiency?
Jo Walton
Panel discussion
What changes can we expect to see within the marketplace over the coming decade and what should be the R&D strategist's response?
Dr Guido Lerzynski
Early development session (Preclinical to Phase IIa)
Pulling down the structural barriers to the implementation of novel translational medicine paradigms
Moderator's introduction
Organisational challenges in translational science and biomarker research
Dr Damian O’Connell – SLIDES NOT AVAILABLE
Imaging biomarkers in drug development: Optimal integration of imaging data into early stage decision making
Dr Johannes Tauscher
The scope of biological response markers in early clinical development
Dr Johannes Lampe
Panel discussion
Optimising the value of novel technologies to decision-making in early development - is it a case of changing the organisation, or is it a people game instead?
Professor Colin Garner
Late phase development session (Phase IIb to IV)
Delivering innovative late-phase trial designs to focus on demonstrating superiority
- What are the strategic keys for industry in putting Evidence-based Medicine into practice in an R&D context?
Moderator's introduction
The challenge of registration and reimbursement
Dr Douglas Greene
Case study
Using Patient Reported Outcomes (PROs) as tools for clinical development
Dr Robert DeMarinis
Adaptive trial methodologies and Bayesian approaches: Learn, adapt or fail
Dr Gervais Tougas
Debate
Motion: Monotherapy is dead
The argument for the motion:
Dr Michael Hanley
The argument against the motion:
John J. Orloff, MD
Questions & discussion
NO SLIDES PRESENTED
Workshop
Re-defining portfolio management best practices to mitigate risk in the new development paradigm
Industry case studies
A series of case studies from organisations ranging in scale - how are portfolio management best practices and risk:benefit analysis tools evolving to deal with the changing drug development environment?
Moderator's introduction
Portfolio management best practice in a big pharma company
Dr John E. Arrowsmith
Portfolio management in midsize companies - special requirements and challenges
Professor Dr Klaus Nickisch
Portfolio management in a small biotech company
Dr Peter Heinrich
Panel discussion
With today's evolving marketplace in mind, are there viable surrogates of financial benefit that can augment traditional financial methodologies to support R&D portfolio decision making? What are the alternatives?
NO SLIDES PRESENTED
Afternoon plenary session
Keynote address
Comparative Effectiveness Research in the US - a view from AHRQ's Effective Health Care Program
Jean R. Slutsky
Day 3
Friday, October 6th, 2006
Morning plenary session
What are the strategic keys to enabling the true globalisation of your R&D operations?
Chair's introduction
Dr Timothy Wells – NO SLIDES PRESENTED
Keynote Address
Pharma's path into specialty indications on a global scale
Dr Hanno Wild – SLIDES NOT AVAILABLE
What is the optimal strategy to capitalise on R&D opportunities in China and India?
The challenges in establishing China-based operations in drug discovery
Tom Marron, Ph.D. - SLIDES NOT AVAILABLE
Establishing a clinical trial "Super Center" in India
Dr John Gwynne
Why outsourcing in China is preferable to setting up and maintaining in-house facilities
Dr Theresa A. Branchek
Panel discussion
How do you define the cost-benefit ratio of offshoring versus developing long term in-house facilities in Asia?
NO SLIDES PRESENTED
Perspective on the evolving Japanese pharma industry
Satoshi Miki
Plenary session
Effectively utilising novel consortia models - the key to a productive future for pharma R&D?
Chair’s introduction
EU Framework Programme 6
Innovative Medicines Initiative - Integrated Project Predictive Toxicology
Professor Friedlieb Pfannkuch
PhRMA Biomarkers Working Group
Dr Chetan D. Lathia – SLIDES NOT AVAILABLE
Bridging the innovation gap: Developing a new approach to drug development by creating a translational medical capability in academia
Dr Colin Wyatt
TI Pharma, a public-private partnership in The Netherlands
Dr Ton Rijnders
Questions to the speakers & closing panel discussion
Consortia in pharma have traditionally been reactive - in which specific areas of R&D could we be more proactive?
NO SLIDES PRESENTED
