R&D Leaders' Forum Spring 2005
Presentations
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Day 1 - April 11th, 2005
Strategies to maximize ROI from your R&D dollar and to reduce the overall cost of drug development
Morning plenary session
How will the ongoing major trends in pharma and biotech impact your R&D business model?
Chair's introduction
What are the latest data on R&D costs and productivity?
Professor Stuart Walker – Slides available soon
Keynote Address
Realizing the promise of the biomedical endeavor
Dr Peter B. Corr
Focus Session 1
Organizational models - how do you integrate technology functions with individual project teams and therapeutic areas to boost efficiency in R&D?
Chair's introduction
Professor Mikael Dolsten
Case study
How Lilly Oncology integrates biomarkers and pharmacogenomics into its drug development process
Dr Richard Gaynor
Case study
Integration or centralization: Lessons learned for maximizing the impact of technology
Dr James B. Summers
Discovery research perspective
How do you reconcile the pioneering aspect of genomics with the comparatively rigid drug development process?
Dr Frederick Monsma
Focus Session 2
Why haven't pharma companies seen more return on their investments in novel discovery technologies in the wake of the sequencing of the human genome?
Chair's introduction
Dr Roy Bullingham
Voting system Results - Questions 1-6
The necessity for an integrated approach to drug discovery and development
Dr Robert Booth
Wall Street's infatuation with genomics
Dr Stelios Papadopoulos – No slides presented
Where is the hard evidence that bioinformatics technologies have increased overall R&D productivity?
Dr Anastasia Christianson
What is the impact of new chemical and screening technologies on improving the quality of drug candidates and reducing cycle time?
Dr John Ellingboe
Voting system Results - Questions 7-9
Breakout Session
What is the value proposition and what are the pros and cons of increasing pharma R&D activities in China and India?
Chair's introduction
James Li, MD – No Slides Presented
China's R&D resources and opportunities
Mr Cheng Zhou
Case study
Planning and building a new research facility in China
Dr Laurent Perret
Case study
Using Global Delivery Centers to achieve high quality clinical data management
Dr Robert Maguire
Using clinical operations to lower the cost of drug development
Dr Adrian Otte
Afternoon Plenary Session
Drawing parallels between predictive R&D strategies implemented in other sectors and those utilized by the pharma industry
Chair's introduction
Dr Jean-Michel Gries
Portfolio approach to strategic planning and business management in oil & gasdrawing examples from the petroleum industry and discussing the strong parallels in pharmaceuticals
John I. Howell III
Turning rocket scientists into life scientists: The application of aerospace modeling and simulation to drug discovery and development
Mikhail Gishizky, PhD – Slides available soon
Day 2 - April 12th, 2005
How must pharma and biotech adapt their business models and R&D strategies to ensure long-term prosperity?
Morning Plenary Session
Sustainability through collaboration? What will be the successful strategy to deliver short-term consolidation and long-term increases in R&D productivity?
Chair's introduction
Larry M. Games, PhD – No slides presented
Keynote Address
Partner to prosper - Succeeding in a new paradigm as biotechs come of age
Dr Terri Cooper
Industry Keynote perspectives
Merge to prosper - why M&A still represents a viable option for the sector
Dr Burt Adelman
Collaborate to prosper - why innovative partnering and outsourcing models hold the key to increasing efficiency and productivity in R&D
Dr Anthony Ford-Hutchinson
Examining the convergence of diagnostics and therapeutics. What role for collaboration in molecular imaging R&D?
Dr Mike Klimas
Focus Session 1
Driving to proof of concept - strategies to increase the quality of clinical candidates by improving the predictability of success or failure in preclinical research
Chair's introduction
Dr Michael Gilman
How do pharma companies of different scale define 'proof of concept'?
Big pharma
A new operating model for R&D; driving the organisation to improve project success rates
Dr Kemal Malik
The use of integrated pharmacology in drug repositioning and selection
Dr Louis A. Tartaglia – Slide not available
Mid-size pharma
Integration of R&D activities to drive proof of concept in the clinic
Dr Andrew Nichols
Optional Lunch Session
In silico ADME/Tox profiling: Capitalizing on its increasing role in the race toward successful clinical candidates
Moderator:
Gregory M. Banik, PhD
Focus Session 2
Is the pharma industry doing 21st Century clinical development?
Moderator's introduction
Professor Stuart Walker – No slides presented
Voting system Results - Questions 1-5
The debate
Motion: The traditional clinical development model must and will change because drug development is becoming an unsustainable proposition for the industry
The argument for the motion
Dr Roy Bullingham
The argument against the motion
Glenn Gormley, MD, PhD
Voting system Results - Questions 6-8
Strategic issues and challenges in simultaneously developing therapeutics and
diagnostics
Dr Andrew Grupe
Healthcare provider's perspective
Integrating biotechnology into the provider setting: Clinical trials and payers
Pat Stanfill Edens
Voting system Results - Questions 9 -15
Breakout Session
Delivering innovative and effective partnering, outsourcing and collaboration strategies for pharma and biotech
Moderator's introduction
A strategic approach to determine when to partner, when to outsource or when to go it alone
Dan Shannon - Slides available soon
Case study
Overcoming the challenges in out-licensing both a compound and its project team
Neil Exter
Case study
Build or buy? A networked model that emerging pharma and biotech companies can utilize to mitigate risks, create successful development programs, and build value
Dr Bruce McCreedy
Panel discussion
For big pharma, will internal R&D continue to be a less efficient and productive alternative to in-licensing from biotech?
Panellist:
Tamar D. Howson – No slides presented
Afternoon Plenary Session
Addressing key issues in the global regulatory environment
Chair's introduction
Dr Claude Nicaise - No slides presented
Perspective on the evolving Japanese regulatory environment
What's changing in terms of both regulatory processes and the regulator's overall perspective on harmonization?
Dr Caroline Loew
Short presentations & panel discussion
Panellists:
Dr Claude Nicaise
Professor Donald R. Stanski
Day 3 - April 13th, 2005
Driving towards genuinely efficient R&D
Breakfast Roundtable
Faster innovation for future growth
Moderator:
Kevin Hrusovsky
Morning Plenary Session
Changing clinical drug development: An industry and regulatory agency partnership
Chair's introduction
Professor Donald R. Stanski
Keynote Address
Critical Path: One year later, what lies ahead?
Dr Janet Woodcock
Model-based drug development: Innovation for the future
Professor Donald R. Stanski
Industry case study
Pfizer experiences with model-based drug development
Dr Richard L. Lalonde
Organizational strategies to integrate newer approaches in quantitative methods: Case studies in drug development productivity
Dr Robert Powell – Slides available soon
Focus Session 1
Harnessing the power of biomarkers to optimize your decision-making process and reduce attrition rates and costs in drug development
Chair's introduction
Dr Eiry Roberts – No slides presented
Integration of biomarkers and diagnostics - how do you know what drugs need diagnostics, and when and how you make the decision whether or not to co-develop a diagnostic?
Dr Hal Barron – Slides available soon
Addressing the key strategic issues to maximizing the return on investment in novel imaging technologies
J. C. Waterton, PhD
Focus Session 2
Translational medicine - Strategies to improve the quality of preclinical decision-making through the application and integration of clinical data
Chair's introduction
Dr Brian Swanson
What does translational medicine mean to you? A series of case studies exploring how pharma companies are defining, focusing and implementing their translational medicine strategies
Case study
The integration of emerging technologies and their impact on the flow of knowledge between clinical and preclinical development
Dr Harsukh Parmar
Case study
How do you manage the disconnect between what you think you can do in preclinical and what you actually can do in clinical, once regulatory and ethical obstacles have taken their toll?
Orest Hurko, MD
Case study
Translational medicine: An iterative process between pre-clinical and clinical investigation
Claudio Carini, MD, PhD, CRL, CLL
