LAUNCH MANAGEMENT. Preparing for a Global Launch. Through Alignment, Communication, Collaboration and Transparency

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1 LAUNCH MANAGEMENT Preparing for a Global Launch Through Alignment, Communication, Collaboration and Transparency Presented by: Lori Peters, QPharma, SVP Commercial Operations Ted Hoffman, Centerline Consulting, Managing Partner

2 COMPLEX AND EVER-CHANGING LANDSCAPE Strong Communication and Collaboration Minimizes Complexity Competitors Direct & Indirect Company Employee, Shareholders Channels Wholesalers, Distributors, Pharmacies Manufacturing Policy and Guideline Makers CMS, NCQA, NIH, Professional Societies, Legislators Regulators FDA, DDMAC, EU, Other Countries Clinical Operations Regulatory Launch Readiness Market Access Marketing Contract Negotiators GPOs, PBMs, MCOs, Medicaid, VHA, Military Payers Insurers, Government, Employers Medical Affairs Sales Thought Leaders Recognized Physicians, Researchers, Specialists, Special Interest Associations Advocacy / Policy Prescribers Physicians, Physician Assistants, Nurses, Pharmacists, Hospital & Clinic Staff Consumers, Patients, Caretakers 2

3 WHICH FUNCTIONS NEED TO BE ALIGNED? And how should they be engaged? 3

4 LAUNCH FUNCTIONS/DEPARTMENT Collaboration of Key Functions Critical to Success Alliance Management Clinical Operations Congress / Meeting Events Forecasting / Finance Health Economics & Outcomes Research IT Legal Manufacturing / Supply Chain Market Access Market Research Marketing Medical Education Medical Affairs Package Engineering Patient Advocacy Policy Project Management Promotional Development Public Affairs / Relations Publications Regulatory Affairs 4

5 OPTIMIZE LAUNCH TEAM Structured Launch Management Alignment Product Collaboration Functions / Departments Franchise Communication Geography / Regions Transparency 5

6 UNDERSTAND LAUNCH TIMELINE Coordination based on first launching regions and countries 6

7 ESTABLISH LAUNCH STRUCTURE Using Launch Structure to Govern Strategy Global Launch Strategy Communicate strategy effectively, provide requested resources, remove obstacles Regional Launch Team Strategy to optimize Global deliverables for region and country Set Objectives Manage change, adapt launch to address changes, risks and issues Local Launch Team Align to Global and Regional workflows to meet regulatory and manufacturing timelines Task Owners, Workstream Leads, execute and provide valuable input Cross-Functional Workstream Group Identify working groups to collaborate on critical workstreams such as clinical studies, regulatory submission support, publication activities, public relations and marketing Global Launch Strategy Regional Launch Team Local Launch Team Cross-Functional Working Groups 7

8 STRUCTURED LAUNCH MANAGEMENT Optimizing Launch Resources 1. Establish Launch Governance 2. Work to optimize Global activities for Regions and Countries 3. Drive alignment through cross-functional workstream groups 4. Ensure collaboration, communication and transparency with shared platform 8

9 LAUNCH STRUCTURE Communication Barriers Need to be Minimized Global Project Management Brand Leader Functional Team Member (Workstream Leads) Senior Management Training IT / Technical Support Business Development Alliance Management Regional Marketing Leader Franchise Leader Functional Leads/Work-stream Coordinator Senior Management New Product Group IT / Technical Support Country Brand Director and Manager Franchise Lead Functional/Work-stream Leads Country Managing Director / Senior Management IT / Technical Support 9

10 LAUNCH STRUCTURE Which structure works for your launch? Global Team US Team EU Team Asia Team Latin America Team Global Team US Global Team EU Team Asia Team Latin America Team 10

11 CROSS-FUNCTIONAL WORKING GROUPS Focus on critical crossfunctional workstreams Work with cross-functional colleagues to align timelines and workstreams Identify timing gaps or areas of concern Work to resolve or escalate for Global and Regional Team review 11

12 CROSS-FUNCTIONAL WORKING GROUP Aligned team with clear strategy & plan Team resources focused on respective objectives and contribution to overall goal Enhanced proactive planning, process discipline and rigor Strategic Objectives highlighted and team focus on key milestones Most urgent issues identified and resolution tracked 12

13 ESTABLISH RULES FOR COLLABORATION Cross-functional collaboration achieves launch goal Performance Accountability Respect Teamwork & Transparency No Excuses Results 13

14 COMMUNICATION PLATFORMS Cross-Functional Work Groups Collaboration Centralize but use various methods for all team types (Visual, Auditory, Tactile, Personal, etc.): Launch Team Meetings Internal Communications Sub-Team Meetings Launch Room Launch Updates from Team Leader 14

15 TRANSPARENCY Transparency in team communications for optimum collaboration Integrated Cross- Functional Launch Plan Single Platform Big Picture Awareness Knowledge Sharing Shared Learning / Best Practice Recognition Issue Resolution Change Management 15

16 LAUNCH WORKFLOW 36 months 20 months months Market Research Trial Results Review Global launch road map Market and Brand Strategy Scientific Platform Manufacturing Strategy Market Access Strategy Publication Plan Commercialization Decision 24 months Establish Regional launch team Scenario Planning Forecast assessment Market Research Brand Plan Counter-Competitive Strategies Prepare for NDA HEOR Studies Manufacturing, Distribution & Packaging Plan Government Strategy & Plan Market Access Plan Payer Advisory Board 20 months Launch team build up KOL identification Value Proposition 16

17 LAUNCH PLAN INTEGRATION Alignment from Tier 1 to lowest Tier level 17

18 GLOBAL LAUNCH PREPARATIONS What Needs to Happen? Impact Aligned team with clear strategy & plan Enhanced launch readiness Improved team performance Transparency in team communications for optimum collaboration Benefits Team resources focused on respective objectives & contribution to overall goal Enhanced proactive planning, process discipline & rigor Identified areas for collaboration and optimization Critical path highlighted and team focus on key milestones Most urgent issues identified & resolution tracked Cross-functional collaboration toward achieving launch goal facilitated Understanding of launch structure and governance Early warning of status & delays provided allowing for decision-making & contingency planning Mechanism to share progress & information Launch experiences transferred from leaders to team & across organization for future launches 18

19 STRUCTURED LAUNCH MANAGEMENT Optimizing Launch Team for Global Launch Alignment Roles and Responsibilities Strategy Cross-Functional Collaboration Rules of Collaboration Critical Workstream Focus Optimization Communication Communication Platform Issues Identification & Resolution Best Practice Sharing Transparency Integrated Launch Plan Single Platform Accessible Awareness of Progress and Status 19

20 THANK YOU FOR YOUR TIME. Questions? Lori Peters VP, Launch Solutions QPharma, Inc. 22 South Street Morristown, N.J (tel) ext (cell)