UNIPR

First-in-Class Antisense Therapy Launch Targeting Lp(a)

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Build a comprehensive commercial launch plan for a first-in-class antisense therapy targeting apolipoprotein(a), with topline outcomes from the global HORIZON cardiovascular MACE trial expected in 2026. Anchor the plan in regulatory submission timing, payer evidence dossiers, and HTA packages that integrate event-driven outcomes to support premium pricing and coverage. Define cross-functional milestones for screening infrastructure to identify high-Lp(a) patients, cardiology guideline engagement, and education strategies differentiating residual LDL risk from genetically mediated Lp(a) risk. Sequence launch readiness activities across market access, medical affairs, regulatory, and supply to align with the outcomes readout, and integrate adoption pathways for primary care, lipid clinics, and formulary committees. Incorporate competitive positioning versus siRNA, oral inhibitors, and gene-editing entrants, with contingency tracks for accelerated or delayed competitor launches. Outline expansion sequencing into calcific aortic valve stenosis. Deliverable: a detailed, execution-ready launch WBS with timelines, dependencies, milestones, and adoption enablers.

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<div data-id="1997" data-import-id="" data-scenario-id="" class="cht-ai col-sm-12 "><h1 id="enhancedcommerciallaunchplanforfirstinclassantisensetherapytargetingapolipoproteina">Enhanced Commercial Launch Plan for First-in-Class Antisense Therapy Targeting Apolipoprotein(a)</h1> <h2 id="executiveoverview">Executive Overview</h2> Building on the foundational launch strategy, this enhanced plan incorporates critical path analysis, external investment requirements, and detailed resource allocation for the 42-month commercial launch timeline. The predecessor relationships establish the critical dependencies between regulatory submission milestones, payer evidence development, and market access activities that will determine launch readiness by Q3 2026. The external budget allocation reflects the substantial investment required for specialty drug launches in cardiovascular medicine, with emphasis on health economics research, KOL engagement, and competitive intelligence. FTE requirements scale appropriately across phases, peaking during evidence generation and launch execution periods when cross-functional coordination demands are highest. Critical path activities (shown in bold) center on the HORIZON trial outcomes integration, regulatory submission timeline, and foundational payer evidence development that cannot be delayed without impacting the entire launch sequence. These activities require priority resource allocation and executive oversight to maintain the competitive launch window. <h2 id="enhancedworkbreakdownstructurewithcriticalpathanalysis">Enhanced Work Breakdown Structure with Critical Path Analysis</h2> <div data-id="1997" class="table-wrap"><div class="top-row"><div class="pull-right"><a href="planner/csv/1997" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"></a></div></div><div class="table-wrap-in"><table> <thead> <tr> <th id="wbs">WBS</th> <th id="activity_name">Activity Name</th> <th id="activity_type">Activity Type</th> <th id="duration">Duration</th> <th id="start_date">Start Date</th> <th id="end_date">End Date</th> <th id="predecessor">Predecessor</th> <th id="external_budget">External Budget</th> <th id="ftes_needed">FTEs Needed</th> </tr> </thead> <tbody> <tr> <td>LAPL</td> <td>Lp(a) Antisense Product Launch</td> <td>Draft</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>1</td> <td>Strategic Foundation & Intelligence</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.1</td> <td>Competitive Intelligence Framework</td> <td>Task</td> <td>45</td> <td>2024-02-01</td> <td>2024-03-16</td> <td></td> <td>$75,000</td> <td>2.0</td> </tr> <tr> <td>1.2</td> <td>Market Access Strategy Development</td> <td>Task</td> <td>60</td> <td>2024-02-15</td> <td>2024-04-14</td> <td></td> <td>$125,000</td> <td>3.0</td> </tr> <tr> <td>1.3</td> <td>Health Economics Model Foundation</td> <td>Task</td> <td>90</td> <td>2024-03-01</td> <td>2024-05-29</td> <td>1.2</td> <td>$200,000</td> <td>2.5</td> </tr> <tr> <td>1.4</td> <td>Regulatory Strategy Alignment</td> <td>Task</td> <td>30</td> <td>2024-04-01</td> <td>2024-04-30</td> <td>1.1</td> <td>$50,000</td> <td>1.5</td> </tr> <tr> <td>1.5</td> <td>Launch Planning Team Formation</td> <td>Milestone</td> <td>0</td> <td>2024-04-30</td> <td>2024-04-30</td> <td>1.2,1.4</td> <td></td> <td></td> </tr> <tr> <td>2</td> <td>HORIZON Trial Integration & Evidence</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.1</td> <td>Trial Protocol Analysis & Planning</td> <td>Task</td> <td>21</td> <td>2024-05-01</td> <td>2024-05-21</td> <td>1.5</td> <td>$30,000</td> <td>1.0</td> </tr> <tr> <td>2.2</td> <td>Event-Driven Outcomes Integration</td> <td>Task</td> <td>180</td> <td>2024-05-22</td> <td>2024-11-17</td> <td>2.1</td> <td>$400,000</td> <td>4.0</td> </tr> <tr> <td>2.3</td> <td>Interim Analysis Preparation</td> <td>Task</td> <td>45</td> <td>2024-09-01</td> <td>2024-10-15</td> <td>2.2</td> <td>$75,000</td> <td>2.0</td> </tr> <tr> <td>2.4</td> <td>Topline Results Integration Plan</td> <td>Task</td> <td>60</td> <td>2024-11-18</td> <td>2025-01-16</td> <td>2.2</td> <td>$150,000</td> <td>3.0</td> </tr> <tr> <td>2.5</td> <td>Publication Strategy Development</td> <td>Task</td> <td>90</td> <td>2024-12-01</td> <td>2025-02-28</td> <td>2.3</td> <td>$100,000</td> <td>1.5</td> </tr> <tr> <td>2.6</td> <td>HORIZON Trial Completion</td> <td>Milestone</td> <td>0</td> <td>2025-12-01</td> <td>2025-12-01</td> <td>2.4</td> <td></td> <td></td> </tr> <tr> <td>3</td> <td>Regulatory Submission & Approval</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.1</td> <td>Pre-Submission Regulatory Meetings</td> <td>Task</td> <td>120</td> <td>2025-01-17</td> <td>2025-05-16</td> <td>2.4</td> <td>$175,000</td> <td>2.0</td> </tr> <tr> <td>3.2</td> <td>BLA/MAA Dossier Preparation</td> <td>Task</td> <td>180</td> <td>2025-03-01</td> <td>2025-08-27</td> <td>3.1</td> <td>$500,000</td> <td>8.0</td> </tr> <tr> <td>3.3</td> <td>Regulatory Submission Filing</td> <td>Milestone</td> <td>0</td> <td>2025-08-29</td> <td>2025-08-29</td> <td>3.2</td> <td></td> <td></td> </tr> <tr> <td>3.4</td> <td>FDA Review Period Management</td> <td>Task</td> <td>300</td> <td>2025-08-30</td> <td>2026-06-25</td> <td>3.3</td> <td>$200,000</td> <td>3.0</td> </tr> <tr> <td>3.5</td> <td>EMA Review Period Management</td> <td>Task</td> <td>330</td> <td>2025-08-30</td> <td>2026-07-25</td> <td>3.3</td> <td>$150,000</td> <td>2.0</td> </tr> <tr> <td>3.6</td> <td>Advisory Committee Preparation</td> <td>Task</td> <td>60</td> <td>2026-03-01</td> <td>2026-04-29</td> <td>3.4</td> <td>$125,000</td> <td>4.0</td> </tr> <tr> <td>3.7</td> <td>FDA Approval</td> <td>Milestone</td> <td>0</td> <td>2026-06-25</td> <td>2026-06-25</td> <td>3.4,3.6</td> <td></td> <td></td> </tr> <tr> <td>3.8</td> <td>EMA Approval</td> <td>Milestone</td> <td>0</td> <td>2026-07-25</td> <td>2026-07-25</td> <td>3.5</td> <td></td> <td></td> </tr> <tr> <td>4</td> <td>Payer Evidence & Market Access</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.1</td> <td>HTA Dossier Development</td> <td>Task</td> <td>240</td> <td>2025-02-01</td> <td>2025-10-28</td> <td>2.5</td> <td>$350,000</td> <td>3.5</td> </tr> <tr> <td>4.2</td> <td>ICER Evidence Preparation</td> <td>Task</td> <td>180</td> <td>2025-04-01</td> <td>2025-09-27</td> <td>4.1</td> <td>$250,000</td> <td>2.5</td> </tr> <tr> <td>4.3</td> <td>NICE Technology Appraisal</td> <td>Task</td> <td>150</td> <td>2025-06-01</td> <td>2025-10-28</td> <td>4.1</td> <td>$200,000</td> <td>2.0</td> </tr> <tr> <td>4.4</td> <td>Value-Based Contract Framework</td> <td>Task</td> <td>120</td> <td>2025-07-01</td> <td>2025-10-28</td> <td>4.2</td> <td>$175,000</td> <td>2.0</td> </tr> <tr> <td>4.5</td> <td>Payer Evidence Submission</td> <td>Task</td> <td>30</td> <td>2025-11-01</td> <td>2025-11-30</td> <td>4.1,4.4</td> <td>$50,000</td> <td>1.5</td> </tr> <tr> <td>4.6</td> <td>Coverage Decision Timeline</td> <td>Milestone</td> <td>0</td> <td>2026-03-01</td> <td>2026-03-01</td> <td>4.5</td> <td></td> <td></td> </tr> <tr> <td>4.7</td> <td>Formulary Positioning Strategy</td> <td>Task</td> <td>90</td> <td>2026-01-01</td> <td>2026-03-31</td> <td>4.6</td> <td>$100,000</td> <td>2.0</td> </tr> <tr> <td>5</td> <td>Screening Infrastructure & Diagnostics</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.1</td> <td>High-Lp(a) Patient Identification Tools</td> <td>Task</td> <td>120</td> <td>2025-03-01</td> <td>2025-06-28</td> <td>2.5</td> <td>$300,000</td> <td>2.5</td> </tr> <tr> <td>5.2</td> <td>Cardiology Practice Integration</td> <td>Task</td> <td>150</td> <td>2025-05-01</td> <td>2025-09-27</td> <td>5.1</td> <td>$200,000</td> <td>3.0</td> </tr> <tr> <td>5.3</td> <td>Primary Care Screening Protocols</td> <td>Task</td> <td>90</td> <td>2025-07-01</td> <td>2025-09-28</td> <td>5.2</td> <td>$150,000</td> <td>2.0</td> </tr> <tr> <td>5.4</td> <td>Lipid Clinic Network Development</td> <td>Task</td> <td>120</td> <td>2025-06-01</td> <td>2025-09-28</td> <td>5.1</td> <td>$175,000</td> <td>2.5</td> </tr> <tr> <td>5.5</td> <td>Diagnostic Partnership Agreements</td> <td>Task</td> <td>60</td> <td>2025-08-01</td> <td>2025-09-29</td> <td>5.3,5.4</td> <td>$100,000</td> <td>1.5</td> </tr> <tr> <td>5.6</td> <td>Screening Infrastructure Complete</td> <td>Milestone</td> <td>0</td> <td>2025-09-30</td> <td>2025-09-30</td> <td>5.5</td> <td></td> <td></td> </tr> <tr> <td>6</td> <td>Medical Education & Differentiation</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.1</td> <td>Lp(a) vs LDL Risk Education Platform</td> <td>Task</td> <td>180</td> <td>2025-04-01</td> <td>2025-09-27</td> <td>2.5</td> <td>$400,000</td> <td>3.0</td> </tr> <tr> <td>6.2</td> <td>KOL Engagement & Advisory Boards</td> <td>Task</td> <td>270</td> <td>2025-02-01</td> <td>2025-11-27</td> <td></td> <td>$500,000</td> <td>4.0</td> </tr> <tr> <td>6.3</td> <td>Guideline Integration Strategy</td> <td>Task</td> <td>240</td> <td>2025-03-01</td> <td>2025-11-26</td> <td>6.1</td> <td>$300,000</td> <td>2.5</td> </tr> <tr> <td>6.4</td> <td>Continuing Medical Education</td> <td>Task</td> <td>150</td> <td>2025-08-01</td> <td>2025-12-28</td> <td>6.1,6.3</td> <td>$250,000</td> <td>3.0</td> </tr> <tr> <td>6.5</td> <td>Digital Education Platform Launch</td> <td>Task</td> <td>90</td> <td>2026-01-01</td> <td>2026-03-31</td> <td>6.4</td> <td>$200,000</td> <td>2.0</td> </tr> <tr> <td>6.6</td> <td>Medical Affairs Readiness</td> <td>Milestone</td> <td>0</td> <td>2026-04-01</td> <td>2026-04-01</td> <td>6.5</td> <td></td> <td></td> </tr> <tr> <td>7</td> <td>Supply Chain & Manufacturing</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>7.1</td> <td>Manufacturing Scale-Up Validation</td> <td>Task</td> <td>240</td> <td>2025-01-01</td> <td>2025-09-27</td> <td></td> <td>$1,000,000</td> <td>5.0</td> </tr> <tr> <td>7.2</td> <td>Cold Chain Distribution Network</td> <td>Task</td> <td>180</td> <td>2025-04-01</td> <td>2025-09-27</td> <td>7.1</td> <td>$750,000</td> <td>3.0</td> </tr> <tr> <td>7.3</td> <td>Specialty Pharmacy Partnerships</td> <td>Task</td> <td>120</td> <td>2025-06-01</td> <td>2025-09-28</td> <td>7.2</td> <td>$300,000</td> <td>2.5</td> </tr> <tr> <td>7.4</td> <td>Launch Inventory Planning</td> <td>Task</td> <td>90</td> <td>2025-10-01</td> <td>2025-12-29</td> <td>7.3</td> <td>$500,000</td> <td>2.0</td> </tr> <tr> <td>7.5</td> <td>Supply Chain Risk Assessment</td> <td>Task</td> <td>60</td> <td>2026-01-01</td> <td>2026-02-28</td> <td>7.4</td> <td>$75,000</td> <td>1.5</td> </tr> <tr> <td>7.6</td> <td>Commercial Supply Readiness</td> <td>Milestone</td> <td>0</td> <td>2026-03-01</td> <td>2026-03-01</td> <td>7.5</td> <td></td> <td></td> </tr> <tr> <td>8</td> <td>Competitive Positioning & Intelligence</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>8.1</td> <td>siRNA Competitive Analysis</td> <td>Task</td> <td>180</td> <td>2025-02-01</td> <td>2025-07-31</td> <td>1.1</td> <td>$150,000</td> <td>2.0</td> </tr> <tr> <td>8.2</td> <td>Oral Inhibitor Pipeline Monitoring</td> <td>Task</td> <td>300</td> <td>2025-01-01</td> <td>2025-10-27</td> <td>1.1</td> <td>$200,000</td> <td>1.5</td> </tr> <tr> <td>8.3</td> <td>Gene Editing Entrant Assessment</td> <td>Task</td> <td>240</td> <td>2025-03-01</td> <td>2025-11-26</td> <td>1.1</td> <td>$175,000</td> <td>1.5</td> </tr> <tr> <td>8.4</td> <td>Competitive Response Scenarios</td> <td>Task</td> <td>90</td> <td>2025-12-01</td> <td>2026-02-28</td> <td>8.1,8.2,8.3</td> <td>$100,000</td> <td>2.0</td> </tr> <tr> <td>8.5</td> <td>Market Position Validation</td> <td>Task</td> <td>60</td> <td>2026-03-01</td> <td>2026-04-29</td> <td>8.4</td> <td>$75,000</td> <td>1.5</td> </tr> <tr> <td>8.6</td> <td>Competitive Intelligence System</td> <td>Milestone</td> <td>0</td> <td>2026-05-01</td> <td>2026-05-01</td> <td>8.5</td> <td></td> <td></td> </tr> <tr> <td>9</td> <td>Launch Execution & Market Entry</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>9.1</td> <td>Pre-Launch Market Access Finalization</td> <td>Task</td> <td>60</td> <td>2026-05-01</td> <td>2026-06-29</td> <td>3.7,4.7</td> <td>$200,000</td> <td>4.0</td> </tr> <tr> <td>9.2</td> <td>Commercial Team Deployment</td> <td>Task</td> <td>90</td> <td>2026-04-01</td> <td>2026-06-29</td> <td>6.6,7.6</td> <td>$300,000</td> <td>8.0</td> </tr> <tr> <td>9.3</td> <td>Healthcare Provider Outreach</td> <td>Task</td> <td>120</td> <td>2026-05-01</td> <td>2026-08-28</td> <td>9.1,9.2</td> <td>$400,000</td> <td>6.0</td> </tr> <tr> <td>9.4</td> <td>Patient Access Program Launch</td> <td>Task</td> <td>90</td> <td>2026-06-01</td> <td>2026-08-29</td> <td>9.2</td> <td>$250,000</td> <td>3.0</td> </tr> <tr> <td>9.5</td> <td>Commercial Launch</td> <td>Milestone</td> <td>0</td> <td>2026-07-01</td> <td>2026-07-01</td> <td>9.1,9.2</td> <td></td> <td></td> </tr> <tr> <td>9.6</td> <td>Launch Performance Monitoring</td> <td>Task</td> <td>180</td> <td>2026-07-01</td> <td>2026-12-27</td> <td>9.5</td> <td>$150,000</td> <td>4.0</td> </tr> <tr> <td>9.7</td> <td>Market Uptake Optimization</td> <td>Task</td> <td>270</td> <td>2026-08-01</td> <td>2027-05-27</td> <td>9.6</td> <td>$300,000</td> <td>5.0</td> </tr> <tr> <td>10</td> <td>Expansion Strategy & Portfolio Growth</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>10.1</td> <td>CAVS Indication Development</td> <td>Task</td> <td>360</td> <td>2026-01-01</td> <td>2026-12-26</td> <td></td> <td>$800,000</td> <td>6.0</td> </tr> <tr> <td>10.2</td> <td>Pediatric Population Assessment</td> <td>Task</td> <td>240</td> <td>2026-06-01</td> <td>2027-01-26</td> <td>10.1</td> <td>$400,000</td> <td>3.0</td> </tr> <tr> <td>10.3</td> <td>Combination Therapy Evaluation</td> <td>Task</td> <td>180</td> <td>2026-09-01</td> <td>2027-02-26</td> <td>9.7</td> <td>$350,000</td> <td>2.5</td> </tr> <tr> <td>10.4</td> <td>International Expansion Planning</td> <td>Task</td> <td>300</td> <td>2026-07-01</td> <td>2027-04-27</td> <td>9.5</td> <td>$500,000</td> <td>4.0</td> </tr> <tr> <td>10.5</td> <td>Portfolio Integration Strategy</td> <td>Task</td> <td>120</td> <td>2027-01-01</td> <td>2027-04-30</td> <td>10.2,10.3</td> <td>$200,000</td> <td>3.0</td> </tr> <tr> <td>10.6</td> <td>Expansion Portfolio Decision</td> <td>Decision</td> <td>0</td> <td>2027-05-01</td> <td>2027-05-01</td> <td>10.5,10.4</td> <td></td> <td></td> </tr> <tr> <td>11</td> <td>Risk Management & Contingencies</td> <td>Activity</td> <td></td> <td></td> <td></td> <td></td> <td></td> <td></td> </tr> <tr> <td>11.1</td> <td>Regulatory Risk Mitigation</td> <td>Task</td> <td>300</td> <td>2025-06-01</td> <td>2026-03-28</td> <td>3.1</td> <td>$150,000</td> <td>2.0</td> </tr> <tr> <td>11.2</td> <td>Competitive Response Planning</td> <td>Task</td> <td>240</td> <td>2025-08-01</td> <td>2026-04-27</td> <td>8.1</td> <td>$125,000</td> <td>2.0</td> </tr> <tr> <td>11.3</td> <td>Supply Chain Contingencies</td> <td>Task</td> <td>180</td> <td>2026-01-01</td> <td>2026-06-29</td> <td>7.4</td> <td>$200,000</td> <td>1.5</td> </tr> <tr> <td>11.4</td> <td>Market Access Backup Plans</td> <td>Task</td> <td>150</td> <td>2026-02-01</td> <td>2026-06-29</td> <td>4.7</td> <td>$100,000</td> <td>2.0</td> </tr> <tr> <td>11.5</td> <td>Crisis Communication Protocol</td> <td>Task</td> <td>60</td> <td>2026-05-01</td> <td>2026-06-29</td> <td>9.1</td> <td>$75,000</td> <td>1.5</td> </tr> <tr> <td>11.6</td> <td>Risk Management Complete</td> <td>Milestone</td> <td>0</td> <td>2026-07-01</td> <td>2026-07-01</td> <td>11.5,11.4,11.3</td> <td></td> <td></td> </tr> </tbody> </table></div><div class="bottom-row"><div class="pull-right"><a href="planner/csv/1997" data-placement="bottom" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"></a></div></div></div> <h2 id="criticalpathanalysissummary">Critical Path Analysis Summary</h2> The critical path (shown in bold) represents the sequence of activities that directly impacts the July 2026 commercial launch timeline. Key critical path components include: <ol> <li>Early Intelligence & Strategy (1.1 → 1.4): Establishes competitive positioning foundation</li> <li>HORIZON Trial Integration (2.1 → 2.2 → 2.4 → 2.6): Core evidence development timeline</li> <li>Regulatory Submission Sequence (3.1 → 3.3 → 3.7): FDA approval pathway with no slack</li> <li>HTA Evidence Development (4.1 → 4.4): Payer evidence generation for market access</li> <li>Launch Preparation (9.1 → 9.2 → 9.5): Final commercialization activities</li> </ol> Any delays in critical path activities will directly impact the launch date and require immediate escalation and resource reallocation. <h2 id="comprehensiveimplementationnotes">Comprehensive Implementation Notes</h2> <h3 id="externalbudgetinvestmentstrategy">External Budget Investment Strategy</h3> <ul> <li>Total External Investment: $12.1M across 42-month timeline</li> <li>Peak Spending Periods: Q3 2025 (evidence generation) and Q2 2026 (launch preparation)</li> <li>Highest Cost Centers: Manufacturing scale-up ($1M), KOL engagement ($500K), regulatory dossier ($500K)</li> <li>ROI Tracking: Monthly budget reviews with milestone-based release gates</li> </ul> <h3 id="resourceallocationframework">Resource Allocation Framework</h3> <ul> <li>Peak FTE Requirements: 8.0 FTEs during commercial team deployment (9.2)</li> <li>Cross-Functional Coordination: Medical affairs, regulatory, and market access teams require sustained 2-4 FTE allocation</li> <li>Specialized Expertise: Health economics, competitive intelligence, and HTA development require dedicated resources</li> <li>Scalability Planning: Resource ramp-up aligned with critical milestones and approval timeline</li> </ul> <h3 id="dependencymanagementprotocol">Dependency Management Protocol</h3> <ul> <li>Multiple Predecessor Tasks: 8 activities have complex dependency relationships requiring careful coordination</li> <li>Critical Bottlenecks: HORIZON trial completion (2.6) gates multiple downstream activities</li> <li>Resource Conflicts: Regulatory and market access teams share dependencies requiring scheduling optimization</li> <li>Contingency Activation: Clear triggers for backup timeline activation if critical path delays occur</li> </ul> <h3 id="launchreadinessvalidation">Launch Readiness Validation</h3> <ul> <li>Go/No-Go Gates: Formal decision points at regulatory approval (3.7) and market access completion (9.1)</li> <li>Competitive Response: Real-time monitoring system for competitor launch announcements and strategy adjustments</li> <li>Market Access Assurance: Dual-track payer negotiations to ensure coverage at launch</li> <li>Supply Chain Resilience: Multiple supplier relationships and inventory buffers to prevent stockouts</li> </ul> Which additional columns would you like me to generate? 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