R&D Leaders' Forum Autumn 2004
Presentations
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Day 1 | Monday 4th October, 2004
Delivering sustainable R&D performance in the evolving pharma and biotech industries
Morning Plenary
Analysing the fundamental strategic drivers that will define the industry R&D model of the future
Chair's introduction
Dr Peter Kurtzhals
OPENING KEYNOTE ADDRESS
How does one construct a product portfoslio in a more demanding world?
Dr John Patterson
Continuing the move away from blockbusters to products with high therapeutic value -
strategic and organisational considerations to meet the new reality
Dr Abbie Celniker
Investment analyst’s perspective on the future outlook for the industry
Jo Walton
Focus Session 1
Comparing and contrasting differing big pharma research business models - what blend of outsourcing and in-house innovation holds the key to increased lead quality?
Chair's introduction
Dr Gianni Gromo
Case study
How does big pharma leverage scale and size in R&D?
Dr Emiliangelo Ratti
How do merged big pharma companies integrate research organisations and processes?
Dr Daniel Schirlin
Learning lessons from other sectors - increasing efficiency in pharma development through the implementation of "Lean Manufacturing Principles", or "decoding the Toyota DNA"
Dr Francois Xavier Frapaise
Presentations & panel discussion
Exploring the changing relationship with biotech, and the argument for big pharma to outsource all discovery research
Panellists:
Peter Chambré
Focus Session 2
Optimising the role of biomarkers in reducing your R&D timelines and costs
Chair's introduction
Dr Brad Guild
Which biomarker strategy offers the best prospect of providing wide applicability, rapid
development and low cost?
Dr Marcus Jerling
Design of biomarker development programmes
Dr Thorir D. Bjornsson
Case study
How can biomarkers be utilised in early (clinical) drug development to improve
the decision-making process?
Professor Jochen Kuhlmann
Case study
Enhancing drug development with imaging
Dr Liqun Wang
Presentations and panel discussion
Moving forward, what are the major issues still to be resolved in biomarker validation and commercialisation?
Workshop
Goal setting and performance measurement in R&D
Moderator's introduction
Peter Joshua
Case study
What are valid and useful leading indicators of productivity early in the R&D process?
Dr Esther Schmid
Case study
Productivity parameters in a novel R&D structure
Jonathan Gardner
Case study
Evolution of an R&D organization: Using metrics to change behaviour and drive productivity
Dr Tom Privette
Afternoon plenary
Closing panel discussion
Should the pharma industry utilise consortia to address key scientific and technological shortfalls and what are the barriers to their formation?
Moderator:
Dr Richard A. Kramer
Panellist:
Dr Doug Dolginow
Day 2 | Tuesday 5th October 2004
Optimising the role of strategic collaborations in boosting efficiency and output in R&D
Morning Plenary
Which forms of collaboration will best enable you to meet your R&D productivity targets?
Chair's introduction
Dr Ronald C. Newbold
Focus Session 1
Building an organisational structure to optimise innovation within your company
Exploring the interface between preclinical and clinical development - what blend of technology applications and strategies will speed your candidate drug into human trials?
Chair's introduction
Dr Lewis B. Kinter
How do you manage the preclinical through phase I process?
Dr Rebecca A. Taub
Accelerating disease and toxicity biomarker discovery and development utilizing
population transcript knowledge
Dr Doug Dolginow
Lunch Briefing
Grid ROI: It's not just cost-cutting
William Saurin
Dominique Comte
Clinically validated biomarker assays – utilizing quantitative multi-gene expression measurement (StaRT-PCR™) throughout the drug development process while successfully meeting the new regulatory guidelines
Dr Terry Osborn
C
ase study
How is in silico safety science impacting decision-making quality in early development in practice?
Dr Lutz Müller
Case study
Systems toxicology - the application of genomics and metabonomics to identify biomarkers and elucidate mechanisms of toxicity
Dr Kerstin Kramer
Panel discussion
What novel tools and technology application strategies will deliver the necessary increases in efficiency and quality in early development?
Focus Session 2
How can the industry improve the efficiency and effectiveness of phase II/III clinical development?
External perspectives: How is the clinical development process set to evolve over the coming decade?
NICE perspective
Professor Jeremy Wyatt
Regulatory perspective
Professor Donald R. Stanski
Industry response
Implementing a strategy to promote collaboration in clinical development
Dr Roy Bullingham
Case study
Addressing the evolving challenges in coordinating clinical trials in the developing world
Dr Atif Salib
Panel discussion
How must the clinical development model evolve to satisfy the expectations of both internal and external stakeholders?
Dr Paul Covington
Licensing & Partnering Breakout
Moderator's introduction
Kate Watkins
Culture - minimising the impact of cultural differences between countries and
companies involved in the partnership
Sean O'Connell
Processes - effective management of the transfer of data, documents and knowledge
from one party to the other
Dr Judith Hills
Project teams - proactive management of potential issues
Nicholas Adams
Panel discussion
Recommendations for success
Kate Watkins
Afternoon plenary session
How can your organisation build an optimal relationship with the regulators?
Chair's introduction
Dr Ronald Salerno
European and US regulatory perspectives:
KEYNOTE ADDRESS
How will recent and imminent FDA reforms impact industry R&D?
Dr Lester Crawford
How are European regulations evolving?
Dr Ian Hudson
Day 3 | Wednesday 6th October 2004
Developing an integrated approach to R&D decision making to maximise the value of your portfolio
Morning Plenary
Optimising the R&D decision making process
Chair's introduction
Guy Lefever
Improving R&D decision-making through the integration of project, resource and
portfolio management
Dr Richard J. Heaslip
Focus Session 1
Extracting maximum value from data from the length and breadth of the R&D pipeline to improve quality in drug discovery
Chair's introduction
Dr Katherine M. Call
What are the strategic steps that may be taken to prepare for the implementation of a
systems biology' approach to drug discovery
Professor Siegfried Neumann
Connecting the silos - better science, or just more silage?
Martin Tanke
Improving the odds: maximizing the value of information at early discovery stages
Dr Mor Amitai
Focus Session 2
How do you fill your pipeline? Integrating R&D portfolio management and partnering strategies
Co-development versus in-house development: Issues in strategic management
Jeff Edelson
Building an alliance-based pipeline: A case study in the evolving nature of alliances in
biotechnology companies
Christine A. Carberry
