Pharmaceutical New Product Commercialization: Preparing for Market Success

Summary

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 tin-line groups
• Relationship of Global Marketing tpre-market commercialization
• Building cross-functional teams around the Early-Stage Commercialization function
• Leadership/stakeholders
• Global and regional marketing interactions
• Portfolimanagement
• Investment decisions
• Lifecycle management processes
• Value that Early-Stage Commercialization group contributes tthe business
• Leadership skills

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 ta commercial function.
• The commercialization and portfolimanagement functions are typically centralized and report through marketing or new product planning functions. Centralization helps establish and ensure common process, performance and evaluation standards for projects, programs and product development.
• Matrix organizational structure provides expertise across appropriate functional areas tproject teams and/or evaluation committees.

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.
• Cross-functional product development processes ensure that there are checks and balances in place sthat perspectives from across the company are heard. This practice ensures well-informed decision-making.

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.
• The sales forecasting and commercial strategy functions involve all the benchmarked companies during at least one development phase.

Investment Decision Teams

• R&D most often leads the early-stage investment (or portfolimanagement) 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 tlead.
• R&D is the function most often drives issues presented for development decisions related tmajor development investments. In the large pharmaceutical segment, R&D drives issues for decisions on major investment at 45 percent of companies.

Lifecycle Management

• Lifecycle management emerges as a critical new skill in the hands of early-stage marketers. Once the domain of brand teams seeking tmanage 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 tevaluate the full potential of new and existing molecular entities.

Contents

• Pharmaceutical New Product Commercialization: Preparing for Market Success
• Executive Summary
  • Introduction
  • Research Approach
  • Participating Companies
  • Figure S.1 - Benchmark Partner Companies
  • Figure S.2 - Benchmark Partner Demographics
  • Report Structure and Organization
  • Key Findings
  • Alignment of Global Marketing in Early-Stage Commercialization
  • Figure S.3 - Relationship with Global Marketing
  • Aiding Better, Faster Decision
  • Figure S.4 - Investment Decision Drivers (Large Pharma)
  • Figure S.5 - Tailored Therapeutics Encourage Earlier Involvement
• Structuring Early-Stage Commercialization
• for Optimal Impact
  • Introduction
  • Organizational Structure and Oversight
  • Figure 1.1 - Commercialization Function Oversight (Full Class)
  • Figure 1.2 - Organizational Structure (Full Class)
  • Figure 1.3 - Organizational Structure (Large Pharma)
  • Figure 1.4 - Job Title of Esc Leader (Full Class)
  • Figure 1.5 - Job Title of Esc Leader (Large Pharma)
  • Figure 1.6 - Esc Function Reporting Lines (Full Class)
  • Figure 1.7 - Esc Function Reporting Lines (Large Pharma)
  • Alignment of Global Marketing in Early-Stage Commercialization
  • Figure 1.8 - Relationship with Global Marketing
  • Figure 1.9 - Duration of Global Marketing Involvement (Large Pharma)
  • Early-Stage Commercialization Corporate Structural Models
  • Figure 1.10 - Esc Structure: Commercial Model
  • Figure 1.11 - Esc Structure: R&D Model
  • Figure 1.12 - Esc Structure: Corporate Model
• Functions of Early-Stage
• Commercialization Organizations
  • Introduction
  • Functional Involvement
  • Figure 2.1 - Functions Included in Early-Stage Commercialization
  • Figure 2.2 - Functions with Most Involvement per Phase
  • Figure 2.3 - Pre-Clinical Commercialization Functions
  • Figure 2.4 - Phase I Commercialization Functions
  • Figure 2.5 - Phase Iib Commercialization Functions
  • Figure 2.6 - Phase Iii Commercialization Functions
  • Figure 2.7 - Commercialization Functions at Launch
  • Transitioning of Commercialization Roles
  • Figure 2.8 - Percent Companies Transitioning Commercialization
  • Roles per Phase
  • Figure 2.9 - Transition Points (Full Class)
  • Figure 2.10 - Transition Points (Large Pharma)
  • Snapshots of Company Transitioning Practices
  • Best Practices for Transitioning Responsibilities
• Leveraging Cross-Functional Relationships to
• Drive New Product Development
  • Introduction
  • Global Marketing Relationship
  • Figure 3.1 - Relationship with Global Marketing
  • Figure 3.2 - Duration of Global Marketing Involvement
  • Regional Marketing Interaction
  • Cross-Functional Teams
  • Figure 3.3 - Transition of Team Leadership
  • Selected Cross-Functional Team Snapshots
  • Pros and Cons of Cross-Functional Collaboration
  • Figure 3.4 - Cross-Functional Collaboration Pros & Cons
  • Building Relationships between Commercial and Research Staff
  • Figure 3.5 - Seeding Market Insights into Science Teams
  • Figure 3.6 - Developing Broad-Reaching Market Perspectives
  • Desired Skills for Early Commercialization Staff
  • Figure 3.7 - Early-Stage Employee Skills
  • Stakeholder Communication through Meetings
  • Figure 3.8 - Key Stakeholder Meetings (Full Class)
  • Figure 3.9 - Key Stakeholder Meetings (Large Pharma)
• Portfolio Management
  • Introduction
  • Figure 4.1 - Pathways for Commercial Input to Portfolio Committee
  • Figure 4.2 - Peer Review Committees
  • Composition and Leadership of The Investment Decision Committee
  • Figure 4.3 - Decision Committee Composition (Full Class)
  • Figure 4.4 - Decision Committee Composition (Large Pharma)
  • Figure 4.5 - The Investment Decision Table
  • Functions That Drive Issues Presented for Development Decisions
  • Figure 4.6 - Issue Drivers: Major Investment Decisions
  • Figure 4.7 - Issue Drivers: Market Development Funds for Phase Iii Asset
  • Figure 4.8 - Issue Drivers: Line Extensions
  • Figure 4.9 - Issue Drivers: Launch Monitoring
  • Figure 4.10 - Issue Drivers: Post-Launch Product Issues
  • Figure 4.11 - Issue Drivers: in-Licensing
  • Figure 4.12 - Investment Decision Leaders: Individual Responses