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12 Best Practices
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From the time a company’s R&D (Research and Development) group begins to develop a new prescription medicine until it receives FDA approval to market the drug in the United States, a drug company typically spends $1 billion over the course of 10 to 15 years.
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:
The following key findings emerged from this research:
• Although Early-Stage Commercialization staffs work closely with R&D, the Early-Stage Commercialization organization most often reports to a commercial function.
• The commercialization and portfolio management 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 to project teams and/or evaluation committees.
• 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 so that perspectives from across the company are heard. This practice ensures well-informed decision-making.
• 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 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.
• R&D is the function most often drives issues presented for development decisions related to major development investments. In the large pharmaceutical segment, R&D drives issues for decisions on major investment at 45 percent of companies.
• 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.