PRODUCT LIFE CYCLE MANAGEMENT IN PHARMACEUTICALS: A REVIEW
PRODUCT LIFE CYCLE MANAGEMENT IN PHARACEUTICAL:
Management of the LAB to LAUNCH Process:
The Pharmaceuticals Industry faces three key challenges today:
1. Complex Drug Development Process.
2. Large Gaps between R&D Operational Performance and Strategic Importance.
3. Difficulty in managing Clinical Trial Inventories.
COMPLEX DRUG DEVELOPMENT PROCESS:
The drug development process is complex, consisting of many interrelated business activities and functional constituents participating in the “Lab to Launch” of any given product (Fig-1)
Figure 1 “Lab to Launch” Process
Real-time synchronization of these activities is critical for achieving improved performance and regulatory compliance in the R&D pipeline. Effective management, knowledge re-uses and accurate monitoring across these core activities requires automation. Automating will also enable standardization based on best practices and consolidation of content across the R&D pipeline, forming a compliant dataset for Quality by Design (QbD) based submissions.
LARGE GAP BETWEEN R&D OPERATIONAL PERFORMANCE AND STRATEGIC IMPORTANCE:
To address the development process, the pharmaceutical industry has identified key R&D functions that are considered important in optimizing R&D pipeline effectiveness (AMR). This research indicates significant gaps exist between R&D operational performance and strategic importance resulting in the industry operating at less than 50% effectiveness (Fig-2).And how a poor capital allocation lead to decline in pharmaceutical R& D Innovation (fig-3)
Figure 2 R&D Performance Gaps
Figure 3 R&D Decline
Finally, some of the key influencers that have commonly impacted profitability, risk and growth can be traced back to three fundamental issues within the industry itself
Increasing internal and external complexity in managing the entire product lifecycle from product inception to phase out due to the simple fact that many pharmaceutical organizations suffer from silos of information across the different functional areas. In the case of R&D organizations this is typically based on therapeutic areas whereby cross-functional information flow is either lacking or non-existent.
No single data source for products and related information due to a variety of different data sources and lack of collaboration across the organization. This often results in disparate, redundant and in worst cases inaccurate product information depending on functional area.
Gap Between R&D and Commercialization: Historically R&D processes have been largely viewed as independent of product launch and subsequent commercialization efforts within the industry thus resulting in a fundamental gap for coordinated and transparent collaboration.
HARD TO MANAGE CLINICAL TRIAL INVENTORIES:
A critical element of the drug development process is the production and management of the clinical trial inventory. Effective management of the “chain of custody” of this initial clinical inventory is difficult and becomes more complex as Contract Manufacturing Organizations (CMOs) and other external partners are utilized in this strategic process. Traditional inventory automation tools such as ERP or MES systems do not provide the flexibility needed at this stage of R&D production. Instead manual disjointed processes supported with desktop tools such as Excel® are often utilized resulting in unnecessary process and coordination complexity. Lack of precise coordination of the clinical trial inventory within the trial management plan is disruptive, adding considerable cost and time to this phase of product development (AMR). Consequently, key clinical supplies metrics routinely result in less than 25% of their targeted performance objectives (Figure 4).
Figure 4 Clinical Supplies “Chain of Custody”
This combination of poor execution of the R&D pipeline and compromised production efficiency of the initial clinical supply process results in inadequate R&D results (AMR). Industry metrics based on project timeline performance, project cost, expected financial margin, and market share capture, show that approximately only 1 in 3 programs achieve their expected performance targets (Figure 4).
Figure 5 Current R&D Pipeline Performances
TRANSFORMING THE PHARMACEUTICAL INDUSTRY: Accept the major changes that happening in the pharmaceutical market space and understanding what the change is.
AN OPPORTUNITY TO IMPROVE R&D: While there are significant challenges within the pharmaceutical industry, opportunities exist in this increasingly competitive landscape for innovative companies looking for ways to transform their business that lead to profitability and growth. Companies that successfully manage the transformation process to address these challenges will realize improved business performance and differentiation in the market place as a result. As companies look to speed up the process by which new products are brought through the development pipeline to commercialization while supporting new therapeutic areas, a business transformation focused on cross functional collaboration whereby product knowledge can be uniformly leveraged will result in both productivity and revenue gains. It is also important to appreciate that even small incremental improvements can produce significant results in both revenue growth and margin (Oracle customer business cases). For example, for every day a company can reduce from the overall development cycle, they can realize significant reductions in cost and provide significant returns in both profitability and margins (Figure 6)
Figure 6 R&D Pipeline Potential Improvements
ACHIEVING R&D IMPROVEMENT: To achieve this, companies should apply the mantra of “think big - start small - scale fast” for any initiative related to improving development and manufacturing of clinical supplies. This will allow the enterprise to prioritize on a few key initiatives, standardize on those processes, and expand through a process of continuous improvement across the development organization. Further, the initiative should have executive sponsorship across the entire organization, as this should be viewed as a business transformation and not a departmental project. Some common characteristics have been identified for successful transformation initiatives.
First, it is important to model the current R&D process and how it impacts clinical supplies. Understanding the functional requirements of each of the “swim lanes” and the inter-relationship across these constituents will define challenging areas to focus on for initiating this activity. A template of common drug development activities and constituents supporting this activity provides a starting point for many organizations beginning a business transformation process. (Figure 7).
Figure 7 R&D Pipeline Cross Function Participants
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