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Lessons learned from late phase failures and successes Introduction

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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Lessons learned from late phase failures and successes Introduction

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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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