Clinical Trials Strategy: The Clinical Development Plan

Clinical Trials StrategyClinical Trials StrategyFebruary 12th 2007MaRS Discovery District AgendaI.The Clinical Development Plan-Wendy Hill, gap strategiesII.Logistics and Practicalities ofPhase I Clinical Research-Sue Gilbert Evans, VentanaClinical ResearchIII.Beyond Traditional Designs inEarly Drug Development-Miklos Schultz, Scian ServicesIV.Estimating the Maximum SafeStarting Dose for First-in-Human Clinical Trials-Beatrice Setnik, Ventana ClinicalResearchV.Panel Discussion andQuestionsMANAGING THE DRUG DEVELOPMENT GAPThe Clinical Development PlanWendy Hill gap!!! strategiesFebruary 12th 2007Yearly Drug Development Costs50Mil ionsofdol ars5DiscoveryPhase I/IIPhase IIIWhy proceed into the clinic ?DEVELOPMENT RISKReferences: “The Drug Discovery, Development and Approval Process,” Pharma New Medicine, (October 2004), page 43. *p values from DiMasi (2001), Clinical Pharmacology & Therapeutics 69:5: 287-307Clinical Development Plan (CDP)!Part of your Strategic Development Plan!Detailed evaluation of target indication(s) including unmet needs!Description of product with evidence or speculation of effect intarget indication!Analysis of market including competition and potential sales!Regulatory Strategy!“Mock” package insert!Project plan including development from preclinical to Phase III(timelines and budgets)!Could contain /Formulation/Manufacturing PlanIndication(s) Selection “Multi-factorial Iterative Process”!Based on MOA – Why should Drug/Device/Diagnosticwork?!Unmet medical need?!Market Analysis – market potential, competition,products in development!Presence or absence of FDA guidelines!Co-morbidities in indicated patient population!Limitations of clinical trial outcomesRegulatory Strategy!Orphan Drug!Device/Diagnostic Class!When to go to the FDA– Timing of Pre-IND meeting– End of Phase II meeting!Prepare your questions careful y!Consult with the appropriate bureau of HealthProducts and Food Branch of Health CanadaDrug Development TimelineYears61231-2Discovery /Review /Phase IPhase IIPhase IIIPreclinical Approval< 1%30%70%70%80%% Success RateOverall success rate: <10% for products entering Phase 1