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Driving Growth Through Planning, Structure and Activities: Best Practices in Pharmaceutical New Product Planning

ID: SM-182


13 Info Graphics

6 Data Graphics

49 Metrics

33 Narratives

7 Best Practices

Pages: 72

Published: Pre-2013

Delivery Format: Online


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New products are the lifeblood of any biopharma company and organizations are increasingly under pressure to deliver effective products in shorter time frames. As development pressures have grown, leading companies have turned to the New Product Planning function to seed the development process with actionable insights across all the phases of product commercialization.

Best Practices, LLC conducted this research to identify the structure and roles of NPP groups as well as the full set of activities that NPP groups perform across the development cycle. The study details the strengths and weaknesses of various NPP organizational structures and how the operational characteristics of the NPP function evolves as a company matures. In addition, the research examines key NPP development activities in terms of timing during the development process, intended outcomes and value for the organization.

NOTE: The data in this research are segmented into three parts: Global NPP Function for Large Pharma, Global NPP Function for Small Pharma and Regional NPP Function for Large Pharma.

Industries Profiled:
Pharmaceutical; Biotech; Consumer Products; Diagnostic; Health Care

Companies Profiled:
Abbott Laboratories; Sanofi-aventis; Actelion; Alcon; Astellas; Allergan; Auxilium; Almirall; Theravance; Altus Biologics; Victory; Amgen; Bayer Healthcare; Biogen Idec; Daiichi Pharmaceutical Co.; Ltd.; Eli Lilly; EMD Serono; Human Genome Sciences; Merck; Novartis; Ortho Biotech; Stiefel; Takeda Pharmaceuticals; UCB Pharma

Study Snapshot

This pharmaceutical-focused study sheds light on which organizational structures create the most effective New Product Planning groups. The study also determines which development activities NPP is involved with, what time in the development process the activities are undertaken and why.
With interviews from executives at 13 top companies, extensive survey data and insights drawn from 25 surveyed companies, this report provides executives, directors, and managers at pharmaceutical companies with actionable insights that will improve the operations of their NPP groups and strengthen the development process of their organization.

Topics covered in this study include:

  • NPP group structures, roles and responsibilities
  • Interactions and optimal working relationships between Regional and Global NPP groups
  • Examining key activities NPP groups perform, their timing, intended outcomes, and value for the organization
  • The future of the NPP function

Sample Key Findings

  • Involving NPP early in the development process speeds decision-making and allows low-value projects to be pruned
  • NPP needs to be part of core team (with R&D, Clinical, etc) that shapes product development

  • NPP groups should follow a fairly standard set of procedures to evaluate the commercial viability of drugs in development.
      1. Variations occur based on the particular characteristics of a drug or therapeutic program

Market Planning Activities
  • Begin development of Target Product Profile (TPP) as early as possible in Pre-Clinical in order to:
      1. Assess how mechanism of action may be different or better than existing options
      2. Establish a “threshold of success” that must be met in order to have a viable product (or to kill project)
      3. Adjust as other products appear or as data changes
      4. Focus in Phases 1 and 2 on the level of appropriate dosing and delivery method
      5. Provide a foundation for effective positioning, publications, messaging, etc. later (Phase 3)
Table of Contents

Executive Summary 4

Introduction 4

Research Approach 5

Participant Demographics 6

Definitions and Abbreviations 9

Report Structure and Organization 10

Key Findings 10
Structure 10
Function 10
Market Planning Activities 11

New Product Planning Evolution, Structure and Effectiveness 14
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. 19
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. 21
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. 23
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. 24
Employ tactics that encourage collaboration to help support balance in the endemic tension between regional and global New Product Planning groups. 29
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. 34

New Product Planning Activities and Outcomes 41

Notable Market Research and Medical Marketing Activities and Tools 46
Target Product Profile (TPP) 47
Competitive Assessment 49
Commercial Positioning 52
KOL Identification and Management 54
Lifecycle Planning 56
Publication Strategy 59

The Future of New Product Planning, Best Practices and Lessons Learned 64

List of Charts & Exhibits

Figure 1.1: Benchmark Class 6
Figure 1.2: Benchmark Segmentation 7
Figure 1.3: Participant Titles 7
Figure 1.4: Industry and NPP Experience 8
Figure 1.5: Company Headquarters Location 9
Figure 2.1: Bridging the Gap Between R&D and Commercial Interests 15
Figure 2.2: Commercial Insights Help Shape Development Activity 15
Figure 2.3: NPP Uses Three Principle Structures 16
Figure 2.4: Structural Traits that Build an Effective NPP Group 17
Figure 2.5: Independence Seems to Carry Greater Weight 18
Figure 2.6: Structure Alone Does Not Determine Influence 19
Figure 2.7: NPP is Evolving to Cope with Industry Challenges 29
Figure 2.8: Evolution of the NPP Function – Maturity Curve 30
Figure 2.9: Level 1, Tactical Focus 31
Figure 2.10: Level 2, Process Focus 32
Figure 2.11: Natural Tensions Develop Along Two Dimensions 33
Figure 2.12: Level 3, Strategic Focus 34
Figure 2.13: Transitioning Activities from NPP 35
Figure 2.14: NPP is Responsible for Providing a Launch Roadmap 36
Figure 2.15: Balancing Corporate Imperatives and Therapeutic Interests 36
Figure 2.16: Global Oversight with Regional Oversight 37
Figure 2.17: Coordinating Regional and Global Activity 38
Figure 2.18: Balancing Regional and Global Interests 39
Figure 2.19: One “High-Level” Decision-Making Framework 40
Figure 3.1: NPP Shapes Development Activity 41
Figure 3.2: NPP Activities and Outputs, Early Stages 42
Figure 3.3: Global NPP, Large Pharma Segment Activity Overview 43
Figure 3.4: Global NPP, Small Pharma Segment Activity Overview 44
Figure 3.5: NPP Activities and Outputs, Later Stage 45
Figure 3.6: Regional NPP, Large Pharma Segment Activity Overview 46
Figure 3.7: NPP Develops Broad-Reaching Market Perspectives 47
Figure 3.8: TPP Provides Early Framework to Assess Product Viability 48
Figure 3.9: TPP Creation Usually Begins Early with Global NPP 49
Figure 3.10: Competitive Assessment Informs Go/No-Go Decisions 50
Figure 3.11: Competitive Assessment 51
Figure 3.12: Spotlight, Market Topography Maps 52
Figure 3.13: Positioning Research Starts in Phase II 53
Figure 3.14: Spotlight, Early-Stage Scenario Planning 54
Figure 3.15: KOLs Define Unmet Need and Optimal Market Fit 55
Figure 3.16: Spotlight, Getting KOL and Payer Perspective Early 56
Figure 3.17: Lifecycle Planning Can be Both Strategic and Tactical 57
Figure 3.18: Lifecycle Planning Starts Early for Some 58
Figure 3.19: Spotlight, Extending Product Lifecycle 58
Figure 3.20: Publication Strategy Can Shape the Commercial Context 59
Figure 3.21: Core Message Development Requires Market Testing 60
Figure 3.22: Spotlight, Seeding New Ideas that Challenge Orthodoxy 61
Figure 3.23: Managed Care Research Can Optimize Formulary Access 63
Figure 4.1: NPP’s Role Will Expand to Meet Business Needs 64