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1 drug developmentv1 1 drug developmentv1 Presentation Transcript

  • 1Seminar 6-11-2012 Agenda1. Drug Development – General Overview2. Biopharmaceutics Definitions Types of products Development Production Quality Assurance Market and future developments3. Biosimilars Definitions Products Regulatory aspects Challenges Market and Future Developments
  • 2Jacques Schipper- 1974 Master Chemistry and Molecular Pharmacology- 1979 PhD Neuropharmacology- 1983 Scientist University of Amsterdam- 1992 Discovery Project Manager AntidepressantsSolvay Pharma- 1999 International Development Manager Solvay Pharma- 2007 Senior Project Director Organon- 2009 Senior Project Director Schering Plough- 2012 Senior Project Director MSD- Senior expert PUM
  • Drug DevelopmentGeneral OverviewFrom Molecule to MarketJacques Schipper, PUMLima, 6 November 2012
  • 4From Molecule to Market (small molecules)Knowledge & Medical needIdea for New TherapyChemical Synthesis and Biological TestingSelection of Development CandidatePreclinical Safety EvaluationPhase I - Clinical trials (Safety & Tolerance)Phase II - Clinical Trials (Efficacy)Phase III - Large Scale Clinical TrialsFirst Registration SubmissionApproval and launched to marketDiscoveryDevelopmentProducttimeestimatein years>4>8> 1
  • 5Drug Discovery Phase 1Clinical TrialsPhase 2Clinical TrialsPhase 3Clinical TrialsPriority Substance50%40%60%70%Drug Candidate Survival RatesProduct RegistrationOverall only 8% SurviveProbability of success in each phaseFFFNOON. maleate
  • 6Global R&D expenditure has grown significantlyConfidential Slide No. 12CMR International 2006/2007 Pharmaceutical R&D FactbookPerspectiveInsightOpinionGlobal pharmaceutical R&D expenditure 1996–2009p010203040506070801996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006p 2007p 2008p 2009pGlobalR&Dexpenditure(US$bn).YearP - Projected figures have been calculated based on an average annual growth in R&D expenditure between 2000 and 2005.
  • 7Yet, the number of new approved drugs tend to decreaseConfidential Slide No. 54CMR International 2006/2007 Pharmaceutical R&D FactbookPerspectiveInsightOpinionNumber of new molecular entities and new active substances firstlaunched onto the world market 1996-2005051015202530354045501996 1997 1998 1999 2000 2001 2002 2003 2004 2005Year of first launchNumberofNMEs/NASsNumber of NMEs first launched onto the world marketNumber of NASs first launched onto the World Market
  • 8Development time is long and has not decreased (in spite ofefforts)Confidential Slide No. 55CMR International 2006/2007 Pharmaceutical R&D FactbookPerspectiveInsightOpinionDevelopment time for medicines first launched onto the world market1998-200546810121416181998 1999 2000 2001 2002 2003 2004 2005*Year of first launchDevelopmenttime(3yearmovingaverage/years).All Companies Major Companies* The development time data point for 2005 includes data from 2004 and 2005 onlyMajor companies are defined as those spending =US$ 1.8 billion in 2005 on ethical pharmaceutical R&D.
  • 9Research Strategy: How to select R&D projectsMedical needCommercialOpportunityScientificFeasibility Viable Projects
  • 10Lead-FindingTeamsLO Teams ED TeamsLife CycleTeamsProjectTeamsProject Teams to facilitate development processTarget-focusDisease-focusTarget selectionfor LFTarget Engagement POC Lite POCPushfrom Target toClinical DiseasePullto Clinical Diseasefrom TargetLO nomination Approval
  • 11If you leave it to the departments, this happens in projects
  • 12Preclinical Developmentsafety pharmacologyacute toxicologysubacute toxicology(2-4 weeks)genotoxicityClinicalCandidateStart clinicalpharmacologyKg -production (GMP)early dose formClinical Development PlanBiomarker strategyProof of Concept StrategyDevelopmentCandidate
  • 13Phase 1 : Bridging from animals into humans: translationalmedicine and question based drug development• Translational approach: alignment between animal andclinical pharmacology• Use of biomarkers• Use of human models for disease state• Proof of Concept definition and study design• Question based drug development– Presence / absence of the compound in the target organ– Presence or absence of pharmacodynamic activity at well tolerated doses– Appropriate or inappropriate pharmacodynamic characteristics according to thetherapeutic indicationGo/no-go decisioninto PoC / Phase 2Combined with safety and first clinical data
  • 14Early DevelopmentTeamResearch and Early DevelopmentPoCStudyresultsFull Developmentin-houseDevelop witha PartnerOut-licenceStopKey decision points after Proof of Concept study
  • 15Full Development Clinical Program• Pivotal studies for proof of efficacy• Pivotal studies for proof of safety• Long term safety data (>100 patients for 1 year, >300 for 6months)• Long term efficacy data (EU)• Special populations• Drug – drug interactions• EtcTypically takes more than 3 years at the expense of >200 M$ and>3000 patients are included in clinical studies
  • ConfidentialSummary