R&D Leaders' Forum Spring 2004

Presentations

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Day 1 | Monday 1st March
Delivering the optimal R&D strategy to tackle rising attrition rates

Morning Plenary
Analysing the most significant factors behind the rising cost of drug development and increasing compound attrition rates

Chair's introduction
R&D costs and pipeline attrition in the global pharmaceutical industry: a brief appraisal
Dr John R. Gibson

KEYNOTE ADDRESS
How can the pharma industry counter the growing costs of drug development amid increasingly stringent regulatory requirements?
Dr Robert Ruffolo

What is the FDA's perspective on key areas of concern for the industry?
Dr Lester Crawford

Analyst's perspective
Will the pharma industry meet shareholder expectations over the coming decade?
Barbara Ryan

Focus Session 1
Which research business model offers the greatest opportunities for increased productivity and lead quality?

Chair's introduction
Professor Mikael Dolsten

Exploring the pros and cons for big pharma in maintaining discovery research operations in-house
Dr Jay McGill

Optional Lunch Session
Streamlining clinical development through better design & process
improvements - how to save weeks/months, significantly reduce cost and
maximize trial performance

Case study
Integrative strategy for drug discovery
Dr Joseph B. Bolen

Case study
Balancing resources between discovery research and product development in the evolving biotech organisation
Dr Peter Mueller

Panel discussion
What is the ideal balance between internal and external research that will enable big pharma to produce enough drugs to sustain itself?
Panellist:
Dr Michael H. Tarbit

Focus Session 2
Implementing strategies to improve the quality of your validated targets Quantifying and demonstrating the return on investment achieved through the integration of novel enabling technologies

Chair's introduction
Douglas W. Axelrod, MD PhD

Assessing the impact of high-throughput biology on target validation
Professor Dalia Cohen

Increasing the probability of success in discovering validated targets, therapeutic proteins and diagnostic markers
Dr Mor Amitai

How far has the technology advanced to date and what are the realistic expectations for the future impact of RNAi?
Dr Barry Polisky

The importance of integrative pharmacology in the target validation practice
Dr Louis A.Tartaglia

Biomarkers Breakout
Optimising the role of biomarkers in your R&D strategy

Data presentation
Quantifying the current and future impact of biomarkers on pharma R&D and the market place
Dr Clarissa Desjardins

Case study
Exploring the clinical application of biomarker and proteomic technology to advance the regulatory process
Dr Emanuel Petricoin

Case study
Imaging in cancer drug development - can it be cost effective?
Dr Susan Galbraith

Promises and challenges of diagnostic molecular technologies
Dr Sudhir Srivastava

Afternoon plenary

Closing panel discussion
Following the example of the SNP Consortium, what data shortfalls and areas of insufficient technological advancement could be addressed by pharma industry consortia in a bid to potentially impact rising attrition rates?

Moderator:
Arthur L. Holden

Day 2 | Tuesday 2nd March
What is the optimal blend of culture, organisational structure and process to promote and harness R&D innovation?

Morning Plenary
Managing the unmanageable - how can you optimise innovation within your R&D organisation whilst creating a structure to control it?

KEYNOTE ADDRESS
Managing innovation in R&D: Getting from vision to value
Dr Samuel T. Barnett

JOINT KEYNOTE ADDRESS
Designing a strategy to promote R&D innovation within the modern big pharma organisation...
Frank L. Douglas, MD PhD

...and building a process to implement it
Dr Nahed Ahmed

Focus Session 1
Building an organisational structure to optimise innovation within your company
Case studies analysing differing strategies for harnessing innovation within R&D organisations of varying scale

Case study
Creating a culture to optimise in-house innovation: the CEDD concept
Dr Jackie Hunter

Case study
How can smaller pharma organisations create competitive advantage in the race for innovation through their differing R&D cultures and capacity to integrate information across the organisation?
Dr Sudhir Sahasrabudhe

Case study
What were the key cultural paradigms and informatics tools required to create a highly innovative R&D organization?
Dr Michael Foley

Data presentation
Exploring the impact of varying pharma business models on productivity levels and ROI
Dr Terri Cooper

Panel discussion
In the light of the latest data on R&D productivity levels and attrition rates, what factors will be key to maintaining high levels of innovation in pharma R&D over the next decade?

Focus Session 2
Comparing and contrasting technologies applied during the early stages of drug development to reduce late-stage attrition rates

Chair's introduction
Strategic role of predictive ADME and toxicology in drug discovery
Dr Alan G. E. Wilson

Demonstrating the practical application of predictive in silico modeling technology
Dr Hui C. Kimko

Exploring the boundary between preclinical development and first-in-man trials - how do you overcome the challenges presented by poor animal models of human disease?
Dr Christine J. Cioffe

How can integrated in silico and experimental DMPK impact the drug discovery process?
Dr Anders Tunek

Case study
How can toxicogenomics be harnessed and integrated into the decision-making process to facilitate early-stage development?
Dr William D. Pennie

Workshop
Kill it or keep it?
Exploring the varying criteria by which diverse personnel within the pharma organisation reach key decisions regarding the R&D portfolio. Where do the major differences in opinion occur and how can these be resolved?

Moderator’s introduction
Professor Stuart Walker

Dr Jarl Andersen
Dr Rick Sax
Dr Charles T. Gombar
Monica Welling
Dr James Callaway
Dr Sue Steven

Day 3 | Wednesday 3rd March
Delivering a strategy to boost data and knowledge integration across the pipeline whilst evolving your R&D business model

Morning Plenary
Boosting R&D innovation and productivity through increased integration and collaboration

KEYNOTE ADDRESS
What strategies may be implemented to integrate cultures, portfolios and processes across the modern pharma organisation?
Dr Catherine Bonuccelli

Meeting the challenge of integrating knowledge from internal and external sources
Dr Sheryl Torr-Brown

Focus Session 1
Taking the first steps to targeted medicine - building a model for future success in the pharma and biotech industries?

Chair's introduction
Dr Robert Booth

Challenges in the introduction of pharmacogenomics into clinical R&D
Dr John Ryan

Regulatory perspective
How is the FDA preparing for the increasing application of pharmacogenomics in drug development?
Dr Lawrence Lesko

The targeted medicine opportunity: A view from within the diagnostic industry
Dr Thomas A. Metcalfe

Case study
Potential impact of patient stratification on clinical development costs
Dr Wayne H. Anderson

Panel discussion
Will biotech beat big pharma to personalised medicine?
Panellist:
Dr Robert Booth

Focus Session 2
Deriving knowledge from data - creating value from your investment through better integration across the pipeline

Chair's introduction
Dr Kurt A. Stoeckli

Is the ROI from technologies built to harness genomic and proteomic data on track to meet expectations?
Lee E. Babiss, PhD

Discovery informatics and information technology in pharmaceutical research: Strategic or not?
Lars Barfod

The National Health Information Infrastructure: Accelerating clinical development through data integration
Charles Jaffe, MD, PhD



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Documentation

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