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SM 182A Pharmaceutical New Product Planning

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SM 182A Pharmaceutical New Product Planning

  1. 1. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct PlanningDriving Growth ThroughPlanning, Structure andActivities: Best Practicesin Pharmaceutical NewProduct PlanningPROJECT BACKGROUND Benchmarking Report at-a-Glance Pharmaceutical and biotech companies are increasingly under pressure to deliver effective Featured Study Participants new products in shorter time frames while • Abbott Laboratories minimizing development costs. The structure, • Actelion activities, and resources of New Product • Alcon Planning (NPP) groups are critical to focusing • Allergan • Almirall new product development and optimizing • Altus product portfolios. • Amgen • Astellas This research identifies the structure and roles of • Auxilium NPP groups as well as the full set of activities • Bayer Healthcare that NPP groups perform across the development • Biogenidec • Daiichi Sankyo cycle. • Eli Lilly and Company • EMD Serono Best Practices, LLC initiated this research to • Human Genome Sciences help new product development leaders better • Merck understand the strengths and weaknesses of • Novartis various NPP organizational structures and how • Ortho Biotech • Sanofi-Aventis the operational characteristics of the NPP • Stiefel Laboratories function evolves as a company matures. In • Takeda addition, the research examines dozens of NPP • Theravance development activities in terms of timing during • UCB • Victory • Wyeth Copyright Best Practices, LLC (919) 403-0251
  2. 2. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct Planning the development process, intended outcomes and value for the organization.STUDY METHODOLOGY Best Practices, LLC conducted this Industry Analysis study in two phases involving a field survey as well as in-depth interviews 25 benchmark companies in the pharmaceutical and biotechnology with selected survey respondents. industries across the globe The survey tool collected quantitative Information Types data on the structures, roles and • 40+ Information Graphics responsibilities of benchmarked • 60+ Data Graphics companies’ NPP groups. In addition, • 700+ Metrics • 50+ Narratives the survey gathered data on the timing • 35+ Best Practices of the activities NPP groups perform during the development process. Best Report Length Practices, LLC analysts used deep-dive 176 Slides interviews with selected participants from 13 of the participating companies to collect qualitative information such as activity details highlighting why organizations undertook activities at specific times, what information they were seeking and how they used the information to inform the commercial development process. Twenty-seven managers and executives at 25 leading bio-pharma companies participated in the survey. Thirteen New Product Planning leaders also participated in one-on-one interviews with Best Practices, LLC analysts. In interviews, leaders shared best practices and lessons learned surrounding the NPP function. This research is focused on several major topic areas: (1) New Product Planning Evolution, Structure and Effectiveness, (2) Interactions and Optimal Working Relationships between Regional and Global NPP groups, (3) The Full Set of Activities NPP Groups Perform, their Timing, Intended Outcomes and Value for the Organization, and (4) The Future of the NPP Function. Note: Data is presented in three segments: Global Function, Large Pharma, Global Function, Small Pharma and Regional Function, Large Pharma. Copyright Best Practices, LLC (919) 403-0251
  3. 3. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct Planning Specific areas of coverage include: • Structural Traits that Build an Effective NPP Group • Evolution of the NPP Function • Coordinating Regional and Global NPP Activity • NPP Activities and Outputs – Pre-clinical to hand-off • Timing, Outcomes and Values for two dozen-plus NPP Activities • Key NPP Deliverables • Transitioning Activities from NPP • NPP Activities Summary • Future of NPPSAMPLE FINDINGS Among the findings that emerged from this research are the following: 1. Involving NPP early in the development process speeds decision-making and allows low-value projects to be pruned. While the structure of the NPP function affects how it carries out its roles and responsibilities, it does not in itself determine the extent of its influence in the larger organization. 2. Some activities, such as creation of the Target Product Profile, become central to the work of NPP groups because they serve as repositories of critical information and outcomes that can be updated with further studies. NPP activities generally follow established patterns of drug development. Market planning and research must support meeting development milestones, although the focus of NPP activity must be geared to align development with market potential, not just getting past regulatory hurdles.DATA & INSIGHT EXCERPTS Copyright Best Practices, LLC (919) 403-0251
  4. 4. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct PlanningNew Product Planning Evolution, Structure andEffectivenessNew Product Planning has become the central conduit for early cross-functional compoundassessment and resulting development decisions, and plays a critical role from early on in shapingdevelopment activity. New Product Planning’s main role is to drive a program forward byidentifying its value to the marketplace. Some interviewed New Product Planning leaders notedthat their insight and ability to shape portfolio decisions can be substantial, amounting to vetopower, even if they exercise their influence only in informal ways.One interviewed New Product Planning leader explained how the group directly influencesportfolio decisions: “We have veto power. If we don’t think that there’s a compelling economicmodel or a strategic fit in a program or a potential investment fails to get our endorsement, it’sprobably over. It’s got to have a huge champion with a great argument to be able to get past thatveto power. Otherwise, if there is something that we endorse, we’re working collaboratively withclinical, with medical research, thinking about clinical trials, thinking about target product profilesin the economic modeling.”By turning its commercial lens on development work even at the preclinical stage, New ProductPlanning has become recognized as the critical bridge between R&D and commercial interests.Despite the broadness of this mandate, and acknowledging that it is a task handled differently, andat varying scales, across different organizations, the balance being maintained is an important one.The central challenge here is in ensuring that the right new products get developed efficiently—with minimum risk and maximum value— to allow senior management to make smart decisionsconfidently. Copyright Best Practices, LLC (919) 403-0251
  5. 5. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct Planning New Product Planning Bridging the Gap Between R&D and Commercial Interests The central challenge is to ensure that the right new products get developed efficiently— with minimum risk and maximum value—to allow senior management to make smart decisions confidently. R&D pipeline marketing clinical patent COMMERCIAL brands molecules market competition phase I me-too lifecycle commercial pre-clinical co-promotion FDA submission pharmaceutical New Product physicians medical affairs Planning disease state compounds phase II sales development research forecast biotech blockbuster therapeutic area phase III drug “…with pressure on all stakeholders in the pharma industry and the few new drugs that came to the market in recent years, NPP should take on more and more importance in driving what projects to dedicate resources to…” 12 Copyright © Best Practices®, LLC B E S T P R A C T IC E S , ® LLC Figure 2.1: Bridging the Gap Between R&D and Commercial InterestsDevelop a process to align all stakeholders across different functions and createfocus on the decision at hand to combine wisdom and experience for making thebest possible decisions.All organizations value and employ committee-based decision making. Since the stakeholdersmaking up these committees come from various functions – scientific, commercial, marketing,medical, legal – all of which have their own agenda, it is important to centralize their focus inorder for them to be able to make good, sound decisions.One interviewed executive director stated, “You’ve got a number of different players that youwant to have aligned. You want the new product planning and the team that’s driving thetherapeutic effort to be aligned with not only the research group, but also with what we call ourglobal product team, because they’re the ones who will be the recipients of our work, and the oneswho will be tasked with taking it through the submission.”Stakeholders obtain their position on the committee through their extensive experience andknowledge, which are important traits in terms of adding the value and credibility necessary in arole that ultimately has the responsibility of making important portfolio decisions. Since tools andmarket research can be unreliable, especially in the early stages of development, a large group ofselect experts encompassing the gamut of impacted areas offer a credible basis for judging newinformation as it is presented. Copyright Best Practices, LLC (919) 403-0251
  6. 6. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct PlanningABOUT BENCHMARKINGREPORTS.COM BenchmarkingReports.com is a service of Best Practices, LLC, world leader in benchmarking research and analysis. BenchmarkingReports.com provides vital insights and data from our primary research at a fraction of original project cost. Best Practices, LLC has conducted pioneering benchmarking research for top companies since 1991, providing clients with "Access and Intelligence for Achieving World-Class Excellence." To learn how we can help you find solutions to your current business issues, visit our site at www.best-in-class.com. Copyright Best Practices, LLC (919) 403-0251
  7. 7. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct PlanningTABLE OF CONTENTSExecutive Summary Error! Bookmark not defined.INTRODUCTION...................... ERROR! BOOKMARK NOT DEFINED.RESEARCH APPROACH ......... ERROR! BOOKMARK NOT DEFINED.PARTICIPANT DEMOGRAPHICSERROR! BOOKMARK NOT DEFINED.DEFINITIONS AND ABBREVIATIONSERROR! BOOKMARK NOT DEFINED.REPORT STRUCTURE AND ORGANIZATIONERROR! BOOKMARK NOT DEFINEDKEY FINDINGS ...................... ERROR! BOOKMARK NOT DEFINED. Structure.........................................................Error! Bookmark not defined. Function .........................................................Error! Bookmark not defined. Market Planning Activities ............................Error! Bookmark not defined.New Product Planning Evolution, Structure andEffectiveness 4 Develop a knowledgeable team of the best minds available to identify the technical success factors that help determine a molecule’s ability to meet the criteria established by the draft launch label. .......................................Error! Bookmark not defined. Utilize market topography maps to align all decisions to fit within the portfolio strategy to aid in making decisions based on facts and not emotional attachment to a molecule.Error! Bookmark not defined. Develop a process to align all stakeholders across different functions and create focus on the decision at hand to combine wisdom and experience for making the best possible decisions.............................................................................................. 5 Coordinate resources and activities, including training opportunities, science and the timeframe at hand, so as not to waste budget allocations, which are based on the probability of a molecule’s success......................Error! Bookmark not defined. Employ tactics that encourage collaboration to help support balance in the endemic tension between regional and global New Product Planning groups. ..........Error! Bookmark not defined. Coordinate New Product Planning activities at high levels within the organization to balance corporate imperatives and therapeutic interests, as well as ease the transition of activities from New Product Planning Groups to other groups.Error! Bookmark not defined. Copyright Best Practices, LLC (919) 403-0251
  8. 8. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct PlanningNew Product Planning Activities and OutcomesError! Bookmark not defined.NOTABLE MARKET RESEARCH AND MEDICAL MARKETINGACTIVITIES AND TOOLS ......... ERROR! BOOKMARK NOT DEFINED. Target Product Profile (TPP)..............................Error! Bookmark not defined. Competitive Assessment ....................................Error! Bookmark not defined. Commercial Positioning .....................................Error! Bookmark not defined. KOL Identification and Management.................Error! Bookmark not defined. Lifecycle Planning..............................................Error! Bookmark not defined. Publication Strategy............................................Error! Bookmark not defined.The Future of New Product Planning, Best Practices andLessons Learned Error! Bookmark not defined. Copyright Best Practices, LLC (919) 403-0251
  9. 9. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct Planning TABLES AND FIGURESFigure 1.1: Benchmark Class.............................................Error! Bookmark not defined.Figure 1.2: Benchmark Segmentation................................Error! Bookmark not defined.Figure 1.3: Participant Titles..............................................Error! Bookmark not defined.Figure 1.4: Industry and NPP Experience..........................Error! Bookmark not defined.Figure 1.5: Company Headquarters Location...................Error! Bookmark not defined.Figure 2.1: Bridging the Gap Between R&D and Commercial Interests ........................... 5Figure 2.2: Commercial Insights Help Shape Development ActivityError! Bookmark not defined.Figure 2.3: NPP Uses Three Principle Structures..............Error! Bookmark not defined.Figure 2.4: Structural Traits that Build an Effective NPP GroupError! Bookmark not defined.Figure 2.5: Independence Seems to Carry Greater WeightError! Bookmark not defined.Figure 2.6: Structure Alone Does Not Determine InfluenceError! Bookmark not defined.Figure 2.7: NPP is Evolving to Cope with Industry ChallengesError! Bookmark not defined.Figure 2.8: Evolution of the NPP Function – Maturity CurveError! Bookmark not defined.Figure 2.9: Level 1, Tactical Focus ...................................Error! Bookmark not defined.Figure 2.10: Level 2, Process Focus ..................................Error! Bookmark not defined.Figure 2.11: Natural Tensions Develop Along Two DimensionsError! Bookmark not defined.Figure 2.12: Level 3, Strategic Focus ................................Error! Bookmark not defined.Figure 2.13: Transitioning Activities from NPP................Error! Bookmark not defined.Figure 2.14: NPP is Responsible for Providing a Launch RoadmapError! Bookmark not defined.Figure 2.15: Balancing Corporate Imperatives and Therapeutic InterestsError! Bookmark not defined.Figure 2.16: Global Oversight with Regional Oversight ...Error! Bookmark not defined.Figure 2.17: Coordinating Regional and Global Activity..Error! Bookmark not defined.Figure 2.18: Balancing Regional and Global Interests ......Error! Bookmark not defined.Figure 2.19: One “High-Level” Decision-Making FrameworkError! Bookmark not defined.Figure 3.1: NPP Shapes Development Activity.................Error! Bookmark not defined.Figure 3.2: NPP Activities and Outputs, Early Stages.......Error! Bookmark not defined.Figure 3.3: Global NPP, Large Pharma Segment Activity OverviewError! Bookmark not defined.Figure 3.4: Global NPP, Small Pharma Segment Activity OverviewError! Bookmark not defined.Figure 3.5: NPP Activities and Outputs, Later Stage ........Error! Bookmark not defined.Figure 3.6: Regional NPP, Large Pharma Segment Activity OverviewError! Bookmark not defined.Figure 3.7: NPP Develops Broad-Reaching Market PerspectivesError! Bookmark not defined.Figure 3.8: TPP Provides Early Framework to Assess Product ViabilityError! Bookmark not defined.Figure 3.9: TPP Creation Usually Begins Early with Global NPPError! Bookmark not defined.Figure 3.10: Competitive Assessment Informs Go/No-Go DecisionsError! Bookmark not defined.Figure 3.11: Competitive Assessment ...............................Error! Bookmark not defined.Figure 3.12: Spotlight, Market Topography Maps ............Error! Bookmark not defined.Figure 3.13: Positioning Research Starts in Phase II.........Error! Bookmark not defined.Figure 3.14: Spotlight, Early-Stage Scenario Planning .....Error! Bookmark not defined.Figure 3.15: KOLs Define Unmet Need and Optimal Market FitError! Bookmark not defined.Figure 3.16: Spotlight, Getting KOL and Payer Perspective EarlyError! Bookmark not defined.Figure 3.17: Lifecycle Planning Can be Both Strategic and TacticalError! Bookmark not defined.Figure 3.18: Lifecycle Planning Starts Early for Some .....Error! Bookmark not defined.Figure 3.19: Spotlight, Extending Product Lifecycle ........Error! Bookmark not defined.Figure 3.20: Publication Strategy Can Shape the Commercial ContextError! Bookmark not defined.Figure 3.21: Core Message Development Requires Market TestingError! Bookmark not defined.Figure 3.22: Spotlight, Seeding New Ideas that Challenge OrthodoxyError! Bookmark not defined. Copyright Best Practices, LLC (919) 403-0251
  10. 10. Report Summary: Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical NewProduct PlanningFigure 3.23: Managed Care Research Can Optimize Formulary AccessError! Bookmark not defined.Figure 4.1: NPP’s Role Will Expand to Meet Business NeedsError! Bookmark not defined. Copyright Best Practices, LLC (919) 403-0251
  11. 11. Report Summary: The High Performing District Sales Manager: Current Trends & Future DirectionsORDER FORM I’d like to order the following Best Practice Benchmarking Report.® ID Publication Title QUANTITY PRICE Ordering SUBTOTAL Driving Growth Through Planning, Options Structure and Activities: Best PracticesSM-178 in Pharmaceutical New Product Planning 3 or more reports Deduct 10% ONLINE Shipping and Handling: Add $26 ($48 international) per report Hbenchmarkingreports.com TOTAL PHONE (919) 403-0251 SHIP TO: Name FAX (919) 403-0144 Title Company EMAIL Hbestpractices@best-in- Street Address class.com City/State/Country Zip MAIL Best Practices, LLC Phone Fax 6350 Quadrangle Drive Suite 200 Chapel Hill, NC 27517 Email PAYMENT OPTIONS: Check enclosed payable to “Best Practices, LLC” Visa MasterCard American Express Card Number Exp. Date Authorized SignatureBest Practices, LLC © (919) 403-0251 11

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