R&D Leaders' Forum Autumn 2003

Presentations

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Day 1 - 6th October 2003
Morning Plenary Session
Analysing the consequences of recent trends in the financial markets and in M&A activity on your R&D operations. How will these trends evolve over the next 5-10 years?

Chair’s introduction
Dr Sam Barnett

OPENING ADDRESS
How will pharma and biotech improve shareholder returns in the face of growing demands for greater productivity?
Jo Walton

Exploring the key factors influencing R&D productivity
Professor Rolf Krebs

Focus Session 1
Research business models: Biotech versus big pharma – which of them holds the key to increasing R&D productivity?

Big pharma case study
Implementing a strategy to deliver on the potential of your R&D portfolio
Pawel Fludzinski, PhD

The future of genomic medicine
Dr Robert Booth

External perspective
World class manufacturing in the automotive industry – lessons from other sectors
Professor Andrew Graves

Focus Session 2
How can the clinical development process be revolutionised to maximise its contribution to overall cost and time savings?

How can innovative, integrative trial design methods facilitate a new, more efficient and effective model?
Simon Hughes

Biotech perspective
What can big pharma learn from biotech companies forced to innovate in the clinic by their smaller development budgets?
William D. Matthews, PhD (Presented by Dr Phillip K. Weck)

The evolving role of the Data Manager in clinical development
Hugh Donovan

The global comparative aspergillosis study
Dr Mike Hodges

Panel discussion
What are the key elements to consider in designing the successful trial of the future? How can the pharma organisation enable sufficient integration of input from all parties to ensure that everyone is singing from the same song sheet?
Dr Roger Newbery

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
Dr Susan Ward

Vignette #1 – Products with commercial concerns
Dr Wayne A. Rosenkrans, Jr

Vignette #2 – Product with regulatory concerns
Dr Claude Nicaise

Vignette #3 – Product with clinical concerns
Dr Fredrik Lönnqvist, Medical Director, Vice President, Clinical Science, Biovitrum AB

Vignette #4 – Products in discovery
Dr Jonathan Freeman, Director, R&D Portfolio Management & Licensing, Serono International SA

Vignette #5 – The portfolio view
Dr Sabine Bernotat-Danielowski, Head of Global Portfolio Planning, Merck KgaA

Day 2 - 7th October 2003
Implementing an integrated approach to reducing R&D timelines and late-stage attrition rates

Morning Plenary Session
Restructuring your R&D portfolio and decision-making processes to take full advantage of technological advances and to increase overall productivity

KEYNOTE ADDRESS
Delivering increased R&D productivity through the restructuring of your R&D portfolio
Dr Pius Renner

Integrating science, business and medicine for successful drug discovery
Dr Frank Walsh

Focus Session 1
Developing an effective, integrated decision-making process early in the pipeline to optimise productivity and lower late-stage attrition rates across the R&D portfolio

Chair’s introduction
Dr Phillip K. Weck

How is the industry reorganising and integrating knowledge to enable excellent decision-making at the discovery and preclinical stages?

Balancing the outsourcing of discovery research to biotech with in-house innovation
Professor Bjoern Wallmark

Managing risk in a small, specialised portfolio
Robert Mansfield

Optional Lunch Briefing
Sponsored by Platform Computing Corporation
Taking life sciences from the cluster to the grid
Presenters
Dr Alexander Renner
Merten Slominsky

Better discovery through integration - information and workflow
Jean Colombel

External perspective
Risk management in the oil industry - a comparison
John Pothecary

Focus Session 2
Genomics vs proteomics – which do you put your money on to improve efficiency and productivity in discovery research and target validation?

Chair’s introduction
Defining the major differences between genomics, proteomics and genetics and the key challenges for their effective utilisation in the pharmaceutical industry
Dr Mark Cockett

Case study
Better targets, better compounds, through genomics
Dr Stefan Kass

Why proteomics holds the key to reduction of attrition at the target
assessment and lead identification stages
Dr David Brown

Metabonomics: Multivariate metabolic modelling of disease processes in space and time
Professor Jeremy Nicholson

Genomics, Proteomics and Genetics in Pharmaceutical Research / Integrating Technologies for Effective Target Validation
Dr Mark Cockett

Biomarkers Breakout
Identifying the application areas of greatest opportunity and defining the key challenges to be faced in order to capitalise on their potential

Moderator’s introduction
Biomarkers: new essential elements of R&D?
Dr Clarissa Desjardins
Please contact laura@phacilitate.co.uk if you would like this presentation.

Applying biomarkers throughout the pipeline - what are pharma companies doing to maximise the impact of biomarkers on their early-stage decision-making and on time-to-trial?
Dr Damian O'Connell

Case study
Biomarker applications in clinical development
Dr Nicholas Dracopoli

Afternoon Plenary Session

Presentations and final panel discussion
How do the major European regulatory bodies view the landscape at the moment? What are the key areas of concern for industry and regulator alike?
What biotech companies expect from EMEA/EU Commission
Patricia Pellier

How can the regulators help to combat the current declining submission rate of NCEs?
Dr Eric Abadie

Issues and challenges for clinical trials
Dr Ian Hudson

Transparency in the EU - room for improvement?
Janet Dahlstrom

Day 3 - 8th October 2003
Integrating emerging technologies and evolving regulatory requirements into your R&D process to deliver a strategy for future success

Morning Plenary Session
Taking the first steps on the way to transforming the R&D model – what role for targeted medicines?

KEYNOTE ADDRESS
Will R&D transformation be enough to deliver targeted treatment solutions?
Dr Steve Arlington

Industry perspective
Driving towards an alternative R&D model
Dr Daniel Zabrowski

Focus Session 1
What effect is the increasing implementation of pharmacogenomics having on the clinical development and commercialisation models? What strategies should your organisation implement to receive the maximum benefit?

What is the financial sector’s view of the impact of pharmacogenomics?
Francois Thomas

Integrated cancer care at Roche: The interplay between pharma and
diagnostics
Dr Gerd Maass

What is the FDA doing to prepare for pharmacogenomics as the science starts to bear fruit?
Dr Lawrence Lesko

Focus Session 2
Improving the quality of validated targets to increase the productivity of drug development

Is the gap between exploitation of advances in chemistry and biology widening in drug discovery and creating challenges for improving R&D productivity?
Professor Mikael Dohlsten

Exploring the promise and reality of siRNA’s and their potential to alleviate the target validation bottleneck
Dr Klaus Giese



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Documentation

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Reports

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