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Biotech Journey through the Phases of     Commercializing a Product                 January 24, 2013  Breck Arnzen        ...
Who we areArnzenGroup LLC                          The NemetzGroup LLC• Firm started in 2001 by Breck Arnzen   • Boutique ...
Session flow• Introductions and agenda review• Industry trends overview• Influence of corporate structure & strategy on co...
Who was in the room?                                                                         Phase 3/ Discovery        Pre...
Biotech Journey through the Phases of     Commercializing a Product              Susan Nemetz
Overview of industry trends                    •   Increased payer influence (e.g., value-based purchasing)   Changing    ...
Industry trends for HR professionals in variousstage companies to watchTrend                  Implications for HR         ...
Company structure and strategy determinescommercialization priorities              •   Vision and opportunity to inform pa...
Charting the path to commercializationDirect implications                  Indirect implications• Timing of commercial cap...
Commercial activities should be integrated into   development plan and organization   Late Lead OP                        ...
Commercial capability build is tied to                          development                          Time/PhaseDevelopment...
Example resource decision:“profile” of commercial leadership role• Need to consider company strategy, stage and  priority ...
Commercial Leader Profile Considerations                 Small or Large    Marketing      Company        Managed Care     ...
SummaryImportant aspects of commercial journey•   Understand your market•   Understand the needs of that market•   Ensure ...
Biotech Journey through the Phases of     Commercializing a Product            Breck Arnzen
Human Resources’ roleANTICIPATE• Understand the needs of your market• Envision your expanded role and influence• Conduct a...
Leading the journeyUnderstanding              Ownership              Commitment             Leadership Build A Common     ...
Key HR people & organization levers/toolsSymptoms & Challenges                    Levers                             Tools...
Contact Information    Breck Arnzen               Susan Nemetz    978-623-7045                 617-965-9304Breck@ArnzenGro...
Sue NemetzSusan Nemetz brings nearly 25 years of corporate strategy, sales,marketing, business development and management ...
Breck ArnzenWith 30 years of experience as both an internal and external businessadvisor to CEOs, GMs and Functional Leade...
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BioTech Journey through the Phases of Commercializing a Product

This presentation was delivered by Breck Arnzen of the ArnzenGroup and Susan Nemetz of The NemetzGroup at the HR BioTech Connect Group meeting in January 2013.

They shared a variety of guidance to help companies navigate the process of commercializing a product in the BioTech industry.

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BioTech Journey through the Phases of Commercializing a Product

  1. 1. Biotech Journey through the Phases of Commercializing a Product January 24, 2013 Breck Arnzen Susan Nemetz
  2. 2. Who we areArnzenGroup LLC The NemetzGroup LLC• Firm started in 2001 by Breck Arnzen • Boutique consultancy founded in who has more than 30 years of 2003 exposure in multiple industries • Led by Susan Nemetz who has more• Specialize in Leadership and than 30 years of pharmaceutical Organization Development with leadership experience start-up and large companies • A seasoned team of• Deep experience in the biotech biopharmaceutical professionals and pharmaceutical industry each with 15+ years industry• Expertise in consulting and experience coaching leaders and leadership • Deep and broad strategy and teams through major transitions and commercialization and marketing change skills • Experience spanning many therapeutic categories
  3. 3. Session flow• Introductions and agenda review• Industry trends overview• Influence of corporate structure & strategy on commercialization focus• Charting the commercialization journey – Case vignettes• Building commercial capabilities – Challenges & decisions along the way• Role of HR• Leading the journey• HR’s levers & tools• Action steps
  4. 4. Who was in the room? Phase 3/ Discovery Pre-Clinical Phase 1 Phase 2 Regulatory Approval Launch Submission Company position Pressing aspects of the commercialization journey • Differentiating our products 2 drugs on market, + Phase 3 • Accessing physicians • Reorienting the company, getting comfortable with change • Infusing a commercial discipline Pre-commercial • Becoming more disciplined in line with regulatory overview Launching a new company with existing products • Building the business infrastructure Product, + moving into Phase 3 • Risk of cannibalizing our existing product • Surviving check-to-check; how can we invest in early Discovery commercial activities? Pre-launch • Balancing continuing creativity & regulatory discipline Moving into Phase 3 • How soon do we need to do … what? Late Phase 2, + Discovery • Incorporating market thinking early on Discovery, + Phase 2 • The push & pull around pace vis-à-vis competitors
  5. 5. Biotech Journey through the Phases of Commercializing a Product Susan Nemetz
  6. 6. Overview of industry trends • Increased payer influence (e.g., value-based purchasing) Changing • New decision-makers and stakeholders healthcare • Widespread use of health information technology (HIT) landscape • Consolidation of delivery providers Novel Biotech/ • VC funding trends Pharma • Financing pressures • Prevalent mergers & acquisitions relationshipsIncreasing use of • Strategic outsourcing partnerships development • New skill sets to define and manage critical deliverables • Changing internal competency models outsourcing • Need to address health information technology (HIT) metrics Evolving • Reduced number of sales reps and high access barriers • Increased account management orientation commercial • More customer centricity models • Focus on specialty products vs. primary care
  7. 7. Industry trends for HR professionals in variousstage companies to watchTrend Implications for HR Early Late stage Commercial biotechPayer influence • Strengthen health economics competenciesDownsizing • Manage morale • Create lateral career pathsLeaner field model • Evolve skill set & IC systems • Support shift from detail rep to account manager/ science liaisonShift to specialists • Upgrade therapeutic skills & science backgroundR&D outsourcing • Develop virtual team skills & technologyConsolidation/ • Develop account management orcustomer-centricity “system” orientation to customersHealth information • Develop IT skills beyond IT departmenttechnology High impact Moderate impact Low impact
  8. 8. Company structure and strategy determinescommercialization priorities • Vision and opportunity to inform partnering strategy Platform • Target selection Pre-IND • Indication prioritization • Business development insight • Market/customer/patient insight to inform development Clinical • Partnering strategy stage • Opportunity assessment commercial development • Fully integrated commercial effort Product • Ongoing cross-functional life cycle management Company • Adapting to changing healthcare landscape
  9. 9. Charting the path to commercializationDirect implications Indirect implications• Timing of commercial capability • Creating integrated team culture build • Facilitating understanding of• Balance of internal hires vs. diverse personality profiles consultants between R & D and commercial team• Profile and role description of • Educating the organization about commercial hires commercial role, functions and• Executive expectations regarding contributions strategy and plans • Clarifying external relationship development – KOLs, patient• Development of current policies advocacy groups, etc. and SOPs • Instilling trust among team members • Managing egos
  10. 10. Commercial activities should be integrated into development plan and organization Late Lead OP Phase 3/ Phase 2 Approval Post-Approval Phase 1 Regulatory Submission Market Commercial Market Pre- Launch Commercialization Analysis Planning Cultivation LaunchMarket Assessments Business Plan Development Competitive Differentiation Launch Plan ExecutionIndication Prioritization Commercial Activity Product Positioning Sales Trainingand TPP Development Mapping and Budget Development and Creation Communications Planning ImplementationQuantitative MarketResearch Advocacy Development Performance Analysis Agency Selection andCompetitive Intelligence Guidance Integration with Medical Life Cycle Management Affairs Tactical Marketing PlanForecast Modeling Development Publication and MedicalMessage Strategy Meetings Strategy Payer Assessment and Strategy Pricing and ReimbursementCommercial Due Insight Sales Force PlanningDiligence for BusinessDevelopment Launch Planning
  11. 11. Commercial capability build is tied to development Time/PhaseDevelopment Clinical Late lead op – Phase I Phase II Phase III/ Regulatory Submission Approval Post-approvalDevelopmentCommercial Market Commercial Market Commercial- Analysis Planning Cultivation Pre-launch Launch ization Time/Phase Capabilities Needed • New product planning • Market analytics • Brand management • Commercial operations • Sales • Marketing • Product PR • Medical communications • Reimbursement, trade • Market access • Medical affairs including field MSLs
  12. 12. Example resource decision:“profile” of commercial leadership role• Need to consider company strategy, stage and priority to determine type of senior commercial hire – Chief business officer – Commercial lead focused on business development – Head of marketing – Chief commercial officer
  13. 13. Commercial Leader Profile Considerations Small or Large Marketing Company Managed Care Experience Sales Business Launch and Leadership Development Org Build Executive Strategic Therapeutic Experience Planning Area
  14. 14. SummaryImportant aspects of commercial journey• Understand your market• Understand the needs of that market• Ensure an integrated program team• Align incentives• Bring management team along
  15. 15. Biotech Journey through the Phases of Commercializing a Product Breck Arnzen
  16. 16. Human Resources’ roleANTICIPATE• Understand the needs of your market• Envision your expanded role and influence• Conduct a simple audit/assessment of your HR practices• Define commercial vision with external/customer perspective central to planning• Balance external and internal insight, ensure time for interpretationEDUCATE• Bring management team along• Ensure program/project manager values commercial insight• Get knowledgeable resources to educate and prepare you & your leadership team• Create opportunities for cross-functional education on each others’ rolesORGANIZE• Establish an integrated program team early, and ensure frequent team self-assessment• Modify processes & change responsibilities• Align incentivesRESOURCE• Map the needs of your business from now to full commercialization
  17. 17. Leading the journeyUnderstanding Ownership Commitment Leadership Build A Common Develop Shared Translate Sustain Sense Of Urgency Goals and Priorities Collective Momentum And Need Commitment Into Encourage open & Help individuals Individual Action adaptEngage the key divergent thinkingstakeholders Focus on priorities Explore all options Consolidate &Calibrate leverage progress Build agreement toexpectations & needs Establish shared goals an action plan & priorities Align the environmentKeep the Establish personalconversation forward- accountabilitieslooking
  18. 18. Key HR people & organization levers/toolsSymptoms & Challenges Levers Tools• Unclear strategy, goals, governance • Strategy & goal alignment• Delays, bottlenecks • Responsibility charting (RACI)• Lack of communication & Aligning Teams and Organization • Organization assessment coordination • Team development• Indecision, decisions don’t stick• Loss of critical skilled employees • Surveys – assess & monitor• Disconnect between stated values Defining and Cultivating Culture • Employee involvement and actions • Mentoring• Splintered culture • Performance management• Uneven performance & results • Rewards & incentives• Lack of leadership for expansion Managing Performance and • Talent reviews• High failure rate on promotions Development • Succession planning• Significant management distraction • Coaching • Training ‘programs’• Extended searches, high % of offers • Competency profiles declined • Recruitment efforts• Poor integration of new hires Attracting, Selecting, Onboarding • Hiring practices• High turnover in first 18 months • Onboarding• Extended time-to-productivity
  19. 19. Contact Information Breck Arnzen Susan Nemetz 978-623-7045 617-965-9304Breck@ArnzenGroup.com Susan@NemetzGroup.comwww.ArnzenGroup.com www.NemetzGroup.com
  20. 20. Sue NemetzSusan Nemetz brings nearly 25 years of corporate strategy, sales,marketing, business development and management experience in thehealthcare sector. Ms. Nemetz’ significant professional accomplishmentsinclude: creating international business and operating strategies for thelaunch of an innovative cancer therapy, growing a small nuclearmedicine business into a world-class medical imaging operation, andsuccessfully integrating two distinct therapeutic and imagingorganizations into a single, cohesive cardiovascular product franchise.Prior to establishing her consulting company, Ms. Nemetz served incommercial leadership roles at Millennium Pharmaceuticals and DuPont Susan NemetzPharmaceuticals. 617-965-9304 Susan@NemetzGroup.comIn founding The NemetzGroup, Ms. Nemetz sought to fill an unmet need in www.NemetzGroup.comthe life sciences arena. From her extensive industry experience, Ms.Nemetz recognized that there is a critical need to help organizationsenvision and articulate longer-term strategy while also focusing anddelivering on the near-term priorities and details of execution.Ms. Nemetz received a BS in Business Management and Marketing fromthe University of Minnesota and has been actively involved in mentoringfellow businesswomen throughout her career.
  21. 21. Breck ArnzenWith 30 years of experience as both an internal and external businessadvisor to CEOs, GMs and Functional Leaders, Breck has assisted start-upsto large global corporations in the areas of organizational alignment,change management, leadership development and executivecoaching in a wide variety of industries.Breck has worked extensively in the biotech and pharmaceutical industryassisting with early stage organization development, project andprogram leadership, process improvement and post-acquisitionintegration as examples. Prior to his role as an external consultant andcoach, Breck held the position of Vice President of Leadership andOrganization Development at Avery Dennison Corporation. He has also Breck Arnzen 978-623-7045held senior management positions with SmithKline Beecham(now Breck@ArnzenGroup.comGlaxoSmithKline) and Digital Equipment Corporation (now HP). www.ArnzenGroup.comBreck has a BA in International Relations from Colby College and amaster’s degree in Human Resource Management from Boston University.

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