Inotek Pharma Solutions Collaborates with GMPc Vietnam
Aptuit Consulting Inc
1. From Idea to IND: “The Emerging Role of Virtual Drug Development Teams" Bill Mackin PhD, RAC Principal Consultant Head Regulatory Affairs
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8. Aptuit Consulting Expertise Formulations Experienced Team of International Drug Developers ePublishing CMC Pharm/Tox Medical Writing Clinical Development Regulatory DS/DP Mfg Biologics Mfg Due Diligence
15. Aptuit INDiGO TM The process EXECUTION of PLAN Draft Plan & Budget Executable plan for signature Consulting + Operations APTUIT INDiGO Team (DDE, PM, Ops) Secondary Review CDA, Initial mtg to determine Issues, Deliverables, Timelines, Indication Primary Review “ Is this an APTUIT INDiGO Program?” Proposal Go/No-Go Lead Generation
16. Aptuit INDiGO TM The process Lead Received Primary Review “ Is this an APTUIT INDiGO Program?” Go/NoGo Secondary Review CDA, Determine Issues, Deliverables, Development Plan Draft Plan & Budget Executable plan for signature Consulting + Operations Establish Aptuit INDiGO Team (DDE, PM, Ops) Execute Plan
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20. Model Assumptions Small Office Both Building/Space (Lab/Office) No Yes Personnel (6 PhD, salaries and overhead) Yes Yes Sr Management (CEO, CFO, CSO) Out-Sourced In-Sourced Item
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22. In-Source vs. Out-Source ($000) Comparable Costs to Deliver Phase 1 Data Getting it Done Well the First Time is a Value Proposition 2509 - - - - NPV Differential 3689 - - - - Cash Differential 818 - - - - NPV@12% 1000 - 200 400 400 Out-sourced Cost 3327 - - - - NPV@12% 4689 1563 1898 1175 50 In-sourced Cost Total Year 4 Year 3 Year 2 Year 1
26. Success Breeds Success Aptuit Consulting Inc. and Taiwan Liposome Company (TLC) Collaborate to Complete all IND Enabling Work and IND Submission for Novel Anti-Cancer Treatment in 12 Months --First Anti-Cancer Drug from Taiwan, Lipotecan®, to Begin Phase 1 Trial under U.S. IND– Aptuit press release, June 25,20080
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