CONTENTS PREFACE... 11

CONTENTS PREFACE .................................................................................................................. 11 INTRODUCTION TO...
Author: Geraldine Blake
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CONTENTS PREFACE .................................................................................................................. 11 INTRODUCTION TO NEW PRODUCT LAUNCH PLANNING .................................... 17 Launch Excellence Defined ......................................................................................... 18 Benefits of a Product Launch Process ......................................................................... 19 The Launch Process ................................................................................................... 20 New Product Launch Planning .................................................................................... 20 Product Launch Process Stages ................................................................................. 21 Product Launch Process Framework........................................................................... 21 Prepare, Prepare, Prepare .......................................................................................... 22 Who Should Take this Course ..................................................................................... 22 The Excitement Begins ............................................................................................... 23 Module 1 STRATEGIC DECISION POINT 1: DEVELOP THE ORGANIZATION ....................... 25 Module Overview & Objectives.................................................................................... 27 Task 1: Establish Product Launch Planning Team ..................................................... 32 Task 2: Assess Inventory of Global Launch Resources ............................................... 34 Task 3: New Drug Submission (NDS) Guidance ........................................................ 35 Task 4: Product Monograph Development .................................................................. 36 Task 5: Create Project Number & Expense Budgets ................................................... 37 Task 6: Intellectual Property: Confirm Compound, Formulation Patents & Distribution Rights ......................................................................................... 38 Task 7: Product Trademarks, Branding & Naming ...................................................... 40 Task 8: Establish Key Launch Milestones ................................................................... 41 Task 9: Common Drug Review Consultation .............................................................. 42 Task 10: Develop & Initiate Market Research Plan ..................................................... 43 Task 11: Detailed Initial Commercial Assessment ...................................................... 44 Task 12: Corporate-Wide Launch Awareness ............................................................. 45 Task 13: Pricing Strategy: Pricing, Market Access Plan, Confirm Global Price Strategy & Price Corridor ..................................................................... 46 Summary of Strategic Decision Point 1 ...................................................................... 47 Module Progress Check .............................................................................................. 49

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Module 2 STRATEGIC DECISION POINT 2: DEVELOP THE PRODUCT ................................. 53 Module Overview & Objectives.................................................................................... 55 Task 1: Develop Key Opinion Leader (KOL) Mapping & Strategy ............................... 59 Task 2: Consult with PMPRB Experts ........................................................................ 62 Task 3: Prepare Strategic Brand Plan ......................................................................... 63 Task 4: Prepare Pricing Strategy ................................................................................. 64 Task 5: Perform Market Research .............................................................................. 65 Task 6: Branding ......................................................................................................... 66 Task 7: Forecasting..................................................................................................... 67 Task 8: Key Assumptions ............................................................................................ 68 Task 9: Launch Planning ............................................................................................. 69 Task 10: Life Cycle Management (LCM) Planning ....................................................... 70 Task 11: Initiation of Pre-launch Activities with KOLs & Advocates ............................. 71 Task 12: Certificate of a Pharmaceutical Product (CPP) ............................................. 75 Task 13: Customer Segmentation & Customer Targeting ............................................ 75 Task 14: File New Drug Submission (NDS) ................................................................ 75 Task 15: Look Alike Sound Alike (LASA) Assessment ................................................ 76 Task 16: Selection of Agency of Record (AOR) ........................................................... 76 Task 17: Transfer Product to In-line Product Management ......................................... 77 Task 18: Launch Timing Confirmation ........................................................................ 78 Task 19: Production and Packaging Components ....................................................... 78 Task 20: Packaging Development .............................................................................. 79 Task 21: Sales Force Planning.................................................................................... 81 Task 22: Product Training ........................................................................................... 82 Task 23: Commence Tactical Plan Activities ............................................................... 83 Task 24: Deploy Medical Science Liaisons (MSL) ....................................................... 87 Task 25: Product P&L Update ..................................................................................... 89 Task 26: Special Access Program (SAP) ................................................................... 90 Summary of Strategic Decision Point 2 ...................................................................... 91 Module Progress Check .............................................................................................. 93

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Module 3 STRATEGIC DECISION POINT 3: DEVELOP THE MARKET.................................... 97 Module Overview & Objectives.................................................................................... 99 Task 1: Initiate Market Development Pre-Launch Activities ....................................... 102 Task 2: Provincial Formulary & PMPRB Consultations ............................................. 102 Task 3: New Drug Submission (NDS) Update ........................................................... 102 Task 4: Production and Packaging Components ....................................................... 103 Task 5: Launch Meeting ............................................................................................ 104 Task 6: Launch Plan Implementation ........................................................................ 105 Task 7: Financial Overview ....................................................................................... 106 Task 8: Distribution Plan ........................................................................................... 107 Task 9: Research: Preparing to Launch .................................................................... 108 Task 10: Pricing and Reimbursement Plan................................................................ 108 Task 11: Sales Force Deployment and Training ........................................................ 109 Summary of Strategic Decision Point 3 .................................................................... 111 Module Progress Check ............................................................................................ 113 Module 4 STRATEGIC CHECK-IN POINT 4: LAUNCH READINESS ...................................... 117 Module Overview & Objectives.................................................................................. 119 Launch Readiness Review ........................................................................................ 122 Objectives of Launch Readiness Review .................................................................. 122 Launch Readiness Review Guide ............................................................................. 123 Suggested Agenda for Review .................................................................................. 124 Summary of Strategic Check-in Point 4 .................................................................... 127 Module Progress Check ............................................................................................ 129

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Module 5 STRATEGIC CHECK-IN POINT 5: LAUNCH ........................................................... 133 Module Overview & Objectives.................................................................................. 135 Task 1: Pre-Launch Checklist Review ....................................................................... 139 Task 2: NOC Status .................................................................................................. 143 Task 3: Establish Launch Meeting Plan ..................................................................... 144 Task 4: Formulary Submission Packages ................................................................. 145 Task 5: Determine Final Selling Price........................................................................ 146 Task 6: Pharmacy Distribution Plan .......................................................................... 146 Task 7: Customer Target Lists by Territory................................................................ 148 Task 8: Update Profit & Loss Statement (P&L) for New Product................................ 148 Task 9: Supply Timing Confirmation .......................................................................... 148 Task 10: Pharmaceutical Advertising Advisory Board Submission ............................ 149 Task 11: Package Label Approvals ........................................................................... 149 Task 12: Drug Identification Numbers (DINs) Granted............................................... 150 Task 13: Electronic Medical Record Planning ........................................................... 150 Task 14: Notice of Compliance (NOC) Received ....................................................... 151 Task 15: Product Manufactured/Imported & QC Released ........................................ 151 Task 16: Announce Product Availability .................................................................... 151 Task 17: Finalize Launch Materials & Programs........................................................ 152 Task 18: Loading Product at Wholesalers ................................................................. 152 Task 19: Distribution of Sales Selling Tools ............................................................... 153 Task 20: Date of First Sale ....................................................................................... 153 Task 21: Sales Force Launch Event .......................................................................... 154 Task 22: Sales force Incentive Plan ......................................................................... 154 Task 23: KOL Launch Symposium ............................................................................ 155 Task 24: Phase IV Trials .......................................................................................... 155 Task 25: Initiate Launch Measurement ...................................................................... 156 Task 26: Report Pricing to PMPRB ........................................................................... 157 Task 27: Dating for New Product SKUs ..................................................................... 157 Summary of Strategic Check-in Point 5 .................................................................... 159 Module Progress Check ............................................................................................ 161

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Module 6 STRATEGIC CHECK-IN POINT 6: LAUNCH EFFECTIVENESS ............................. 165 Module Overview & Objectives.................................................................................. 167 Task 1: Establish Performance Metrics for Course Correction ................................... 171 Task 2: Promotion is Underway per Tactical Plan ..................................................... 172 Task 3: Ex-Factory Sales Registered ....................................................................... 173 Task 4: Message Testing .......................................................................................... 173 Task 5: Formulary Listings Achieved ......................................................................... 174 Task 6: Product added to EMR drug databases ........................................................ 174 Task 7: Medical Support ........................................................................................... 175 Task 8: External Launch Metrics are Available for Review ........................................ 175 Task 9: Launch Effectiveness Review ....................................................................... 176 Summary of Strategic Check-in Point 6 ..................................................................... 177 Module Progress Check ............................................................................................ 179 APPENDIX................................................................................................................ 183 Support Information .................................................................................................. 184 APPENDIX CONTENTS ............................................................................................184 Advertising & Public Relations Agency Briefs ............................................................ 185 Continuing Health Education (CHE) Overview .......................................................... 188 Data Services Organizations ..................................................................................... 189 Finance Overview ..................................................................................................... 194 Key Account Overview ............................................................................................. 196 Market Access Overview ........................................................................................... 197 Market Research Requirements Overview ................................................................ 205 Pharmaceutical Advertising Advisory Board (PAAB) ................................................. 211 Regulatory Affairs (RA) & Quality Assurance (QA) Overview. ....................................212 Strategy Development ............................................................................................... 214 Training Overview ..................................................................................................... 216 GLOSSARY .............................................................................................................. 223 ABOUT THE COURSE AUTHOR ............................................................................. 227 Pharma Launch Inc. .................................................................................................. 228 EMREACH Inc. ......................................................................................................... 228

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