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Joint Conference of European Human Pharmacological Societies 11-12 April 2013 ~ Nice Sophia Antipolis FRANCE. Lessons learned from late phase failures and successes Introduction Dr Yves Donazzolo and Dr Maikel Raghoebar. Photo: Marcus Augustine.

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Joint Conference of European Human Pharmacological Societies11-12 April 2013 ~ Nice Sophia Antipolis FRANCE

Lessons learned from late phase failures and successes

Introduction

Dr Yves Donazzolo and Dr Maikel Raghoebar

Photo: Marcus Augustine


Diagnosing the decline in the pharmaceutical R&D efficiency

PERSPECTIVES

Jack W. Scannell - Alex Blanckley –Helen Boldon – Brian Warrington

Scanell et al, Nature Reviews Drug Discovery 11 (March 2012):191-200

Dr Maikel Raghoebar & Dr Yves Donazzolo - Session 1 - Lessons learned from late phase failures and successes


Can the pharmaceutical industry reduce attrition rates
Can the pharmaceutical industry reduce attrition rates?

SUCCESS RATES FROM FIRST-IN-MAN TO REGISTRATION

PERSPECTIVES

Ismail Kola - John Landis

NATURE REVIEWS | DRUG DISCOVERY

I.Kola and J. Landis, Nature Reviews Drug Discovery 3 (2004): 711-715

Dr. Maikel Raghoebar & Dr Yves Donazzolo - Session 1 - Lessons learned from late phase failures and successes


How to improve r d productivity the pharmaceutical industry s grand challenge
How to improve R&D productivity: the pharmaceutical industry’s grand challenge

Steven M. Paul - Daniel S. Mytelka - Christopher T. Dunwiddie -

Charles C. Persinger - Bernard H. Munos - Stacy R. Lindborg - Aaron L. Schacht

THE QUICK WIN, FAST FAIL DRUG DEVELOPMENT PARADIGM

ANALYSIS

NATURE REVIEWS | DRUG DISCOVERY

Dr. Maikel Raghoebar & Dr Yves Donazzolo - Session 1 - Lessons learned from late phase failures and successes


Complexity of innovative drug development
Complexity of Innovative Drug Development

ANALYSIS

Minimize bureaucracy

Invest in Technology & People

Identify tailor-made processes

“Business as usual” is not an option anymore

Dr. Maikel Raghoebar & Dr Yves Donazzolo - Session 1 - Lessons learned from late phase failures and successes


Published lessons learned to challenge our speakers
Published Lessons Learned to challenge our speakers

Improvements of clinical trial design, selection of drug

targets, efficient execution of clinical trial design, etc.

Prioritize resources, avoid risks

Improve technical attrition

(translational target to medicine)

Develop/Hire experienced drug hunters

(every medicine had/has objectives to halt development)

CONCLUSION

Dr. Maikel Raghoebar & Dr Yves Donazzolo - Session 1 - Lessons learned from late phase failures and successes


How can clinical pharmacology contribute to reduce attrition rates
How can Clinical Pharmacology contribute to reduce attrition rates?

Human patient data and identification of

best indication in early clinical development

Tailoring for specific patient (sub)populations

(pathology, genotype, etc.)

Introduce creativity in translational and clinical research

Speakers: what else?

CONCLUSION

Dr. Maikel Raghoebar & Dr Yves Donazzolo - Session 1 - Lessons learned from late phase failures and successes


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