New Product Planning in Pharma: Preparing for the Market

Leading companies are integrating commercial insights earlier and earlier into the new product process in an effort to identify and target promising compounds, reduce development cycle time, focus resources for greatest impact and increase their potential for launching a blockbuster drug.

Early-Stage Commercialization activities range from therapeutic opportunity and competitive landscape assessments to thought-leader focus groups, initial pricing studies, and pre-efficacy forecasts during pre-clinical and Phases I and II development. Global pharmaceutical companies must find ways to improve early-stage decision making and enhance product design using commercial insights to gain an overall competitive advantage in the marketplace.

Best Practices, LLC conducted research for this report to identify winning strategies, structures, and best practices in early-stage product commercialization and portfolio management. Best Practices also sought to clarify and codify Global Product Strategy’s placement in the corporate organizational chart to determine a best fit for the organization to provide optimal support.

Through this report, executives at leading biopharmaceutical companies shared reasons why the work done through early commercialization groups is invaluable. The participants cited the following areas where Early-Stage Commercialization efforts benefit overall corporate success:

• Optimizing the value of assets
• Driving alignment of product development with unmet patient needs
• Identifying commercial viability of drug candidates and helping to redirect funding from projects with lower potential to those with higher potential for success
• Focusing all parties on areas expected to have the greatest return on investment
• Enabling project prioritization
• Facilitating collaboration between commercial and clinical development staff
• Informing internal and external investment decisions
• Continuously monitoring and communicating changes in the market that affect product potential
• Paving the way for successful product launch

Study Snapshot

Best Practices, LLC examined how other biopharmaceutical companies’ Early-Stage Commercialization functions are structured, how leaders of these groups manage their functions, and for what activities and roles Early-Stage Commercialization leaders have responsibility. The study examines how top companies achieve long-term Early-Stage Commercialization success through thoughtful development of each major program element including:

• Organizational structure and alignment – Optimal fit and utilization within the corporation

• Early-Stage Commercialization activities by phase – Functional involvement at each product development phase and transition of functional responsibilities to in-line groups

o Relationship of Global Marketing to pre-market commercialization

o Leadership/stakeholders
o Global and regional marketing interactions

o Investment decisions
o Lifecycle management processes

Key Findings

The following key findings emerged from this research:

STRUCTURE
• Although Early-Stage Commercialization staffs work closely with R&D, the Early-Stage Commercialization organization most often reports to a commercial function.

CROSS-FUNCTIONAL TEAMS
• Successful pharmaceutical product development demands a cross-functional approach, beginning in the earliest, pre-clinical stages. Early-Stage Commercialization staff typically serves on teams with R&D, medical affairs, regulatory, legal, clinical, manufacturing and others.

FUNCTIONAL INVOLVEMENT
• Sixty-one percent of the benchmarked companies begin early commercialization activities in at least one functional area during the pre-clinical phase. By Phase I, more than 70 percent of companies are involved in commercialization activities, compared with 94 percent during Phase II B and 89 percent during Phase III.

INVESTMENT DECISION TEAMS
• R&D most often leads the early-stage investment (or portfolio management) committee. In all, R&D either leads or co-leads 67 percent of the time within the large pharmaceutical segment, with medical affairs the group that leads next most frequently. Among the full benchmark class, R&D leads or co-leads the investment committee at 56 percent of companies and commercial strategy is the group next most likely to lead.

LIFECYCLE MANAGEMENT
• Lifecycle management emerges as a critical new skill in the hands of early-stage marketers. Once the domain of brand teams seeking to manage patent expirations in late-stage products, life cycle management is taking on new meaning in the early commercialization process. More than ever, early-stage marketers seek to evaluate the full potential of new and existing molecular entities.

Benchmark Class 5
Job Titles of Participants 6

KEY FINDINGS 7
Structure 8
Cross-Functional Teams 9
Functional Involvement 10

EARLY-STAGE COMMERCIALIZATION STRUCTURE 12
Commercialization Function Oversight 13
Organizational Structure 15
Relationship with Global Marketing 17
Duration of Global Marketing Involvement 18
Job Title of Early-Stage Commercialization Leader 19
Early-Stage Commercialization Function Reporting Lines 21
FTE’s in Early Commercialization 23
Early-Stage Commercialization Structure 25

FUNCTIONAL INVOLVEMENT IN EARLY COMMERCIALIZATION 28
Functions Included in Early-Stage Commercialization 29
Functions with Most Involvement per Phase 30
Pre-Clinical Commercialization Functions 31
Phase I Commercialization Functions 32
Phase IIB Commercialization Functions 33
Phase III Commercialization Functions 34
Commercialization Functions at Launch 35
Transition Points 36
Transition of Responsibilities to In-Line Marketing 38

CROSS-FUNCTIONAL & REGIONAL COLLABORATION 39
Cross-Functional Collaboration 40
Sample Teams Structure/Roles 41
Team Structure and Alignment 42
Transition of Team Leadership 43
Pros & Cons of Cross-Functional Collaboration 44
Developing Broad-Reaching Market Perspectives 45
Building Cross-Functional Relationships 46
Regional Interaction 47
Teaming with Scientists 48
Best Practices for Collaborating with Scientists 49
Seed Market Insights into Science Teams 50
Build Relationships Based on Common Goal 51
Stakeholder Communications 52
Stakeholder Communications Practices 53
Key Stakeholder Meetings 54

ESSENTIAL EMPLOYEE SKILLS & EXPERIENCE 56
Early-Stage Employee Skills & Experience 57
Importance of Seasoned Early-Stage Commercialization Staff 58

INVESTMENT DECISION LEADERS 59
Pathways for Commercialization Input to Investment Committee 60
Functions at the Investment Decision Table 61
Decision Committee Composition 62
Issue Drivers 64
Major Investment Decisions 64
Market Development Funds for Phase III Asset 65
Line Extensions 66
Launch Monitoring 67
Post-Launch Product Issues 68
In-Licensing 69
In-Licensing Responsibilities Pre-Filing 70
Investment Decision Leaders: Individual Responses 71

VALUE OF EARLY COMMERCIALIZATION 72
Value of Early Stage Commercialization 73
Specific Early Stage Commercialization & Areas of Impact 74
Tailored Therapeutics Encourage Earlier Involvement 75

SUCCESS FACTORS 76
Key Early Commercialization Success Factors 77
Additional Success Factors 78

LESSONS LEARNED 79

ABOUT BEST PRACTICES, LLC 81