PRODUCT LIFE CYCLE MANAGEMENT IN PHARMACEUTICALS: A REVIEW
Second, with a common development model outlined for the enterprise and key challenges identified, a business case can be developed to prioritize on which initiatives are most critical to address. A business case also helps justify the investment and provides metrics to measure realized business improvements such as ROI and operational performance for each specific initiative.
Third, for the initiatives that have been prioritized by the development challenges and justified with a business case, specific transformation requirements need to be defined. To define requirements, a review of the current IT landscape supporting these activities and the content managed in various systems must be compiled. This activity will establish base line processes to improve and help define requirements, plus define historical content that needs to be migrated/integrated to support the transformation.
The final step is to define a deployment plan to manage the transformation of these key objectives. It is critical that functional constituents who own these business processes are members of the deployment team in addition to executive sponsorship across the organization. With a well-represented cross-functional team supporting the transformation, concrete objectives will be defined and expectations clearly outlined for success. This approach also provides the foundation for “think big - start small – scale fast” for ongoing enterprise transformation.
SELECTION OF LCM TACTICS IN PHARMACEUTICALS
1. New formulation
2. Pediatric market exclusivity
3. Disease management programs
4. Strategic price change.
5. Authorize generics.
6. Combination products.
7. Next-generation product
8. New dosing regimen
9. Patent litigation
10. Rx to OTC switches
STRATEGIC BUSINESS PROCESSES REQUIRED TO SUPPORT TRANSFORMATION
Several companies are actively pursuing transformation initiates to address these challenges. Benchmarking of these initiatives helps identify common business processes required to enable this transformation. Based on input from 15 leading pharmaceutical companies who are members of the Oracle Pharmaceutical Strategic Council, seven common enabling elements have been identified to support this transformation. These 7 elements are as follows.
1. DRUG DEVELOPMENT PORTFOLIO MANAGEMENT.
The complexity of individual drug development programs is further complicated as there are typically multiple programs occurring simultaneously in the R&D pipeline at any given time. Traditional drug development program management has focused on general program metrics such as schedule, and cost performance. To improve drug development execution, program management that synchronizes cross-functional collaboration and archiving of critical program deliverables is required. Integration of the decisions and approvals of these deliverables provide the regulatory evidence needed to confidently advance the drug development process through each phase. Management of each program and required deliverable evident in one system can also enable standardization of best practices to improve pipeline performance.
2. STRUCTURED ELECTRONIC DRUG DEVELOPMENT RECORD (eDDR).
With the volume of program deliverables and regulatory evidence required in the development process ever increasing, a structured drug development archive is needed to effectively manage all of the associated content. This highly iterative development record must be automated to capture historical developmental information to support product claims and regulatory audits. Creating a structured archive for each individual design dossier in one unified system can also facilitate re-use of the Common Technical Documents (CTD).
3. INTIGRATED CLINICAL SUPPLY CHAIN MANAGEMENT.
Clinical trial management is a pivotal phase in the drug development process that has become more complicated with global and adaptive trials. As companies look for ways to reduce costs while significantly increasing profitability, externalization of clinical trials to CROs for example has become increasingly common and impacts everything from pre-clinical to post marketing research. The supply chain for clinical trials has also become increasing complex with multiple manufacturing sites and CMOs engaged in supporting the scale up for the required clinical inventory. For all supplies dispensed to each clinical site, a complete lot history of the campaigns producing the product must be archived. Synchronizing the approved manufacturing evidence of the clinical supplies with trial activity is required for clinical trial integrity to be maintained.
Figure-8 integrated supply chain
4. TECHNOLOGY TRANSFER AND COLABARATION.
The production of drug product is highly iterative and controls must be established for each lot from scale-up through commercialization of the final approved product. Effective scale-up of drug production requires collaboration across many interrelated activities and dependences. An enterprise solution that enables the analysis of the drug product value chain including suppliers, materials, equipment, and processes will not only provide individual lot control but also facilitate the scale-up to commercial drug production volumes.
5. INTEGRATED QUALITY AND RISK MANAGEMENT.
Quality and risk management continues to be a challenge creating significant business impact when deficiencies are indentified during regulatory audits. Furthermore, with the industries transformation to QbD practices for product development, the need for an Enterprise Quality Management (EQM) solution is further justified. An effective EQM solution requires the integration and management of quality beginning at product development through commercialization. Early awareness of quality events and immediately assessing the impact across the enterprise will provide the foundation to leverage quality management resulting in improved business performance.
6. COMPHRENSHIVE PACKAGING AND CO-LATERAL MANAGEMENT
The integration of packaging, labeling and associated marketing collateral into the drug development process provides a significant business opportunity in the pharmaceutical industry. Often the creation of these assets is deferred until late in the drug development cycle creating delays in market launch and increased cost. This disconnect from the drug development evidence also creates the potential for misleading off-label claims that can be devastating for a product. Creation of a global repository for all packaging components, digital assets such as logos and artwork, and marketing collateral that references development evidence will improve the regulatory integrity of all the associated commercial content. Re-use of this commercial product content, and common translation services are just a few of the business benefits companies like GSK and Bayer have realized by the enterprise management of this critical asset.
7. GLOBAL PRODUCT REGISTRATION.
The ultimate successful outcome of any drug development program is regulatory submission and approval for commercial distribution of the product. Global product registration is complex and constantly evolving, making registration management increasingly difficult. As a result, this creates delays in market launch and significantly impacts the anticipated product revenue. Leveraging the evidence captured in the previously described use cases provides the content to support regulatory submittal requirements. This content also can be used for on-going global product proliferation through re-use of this registration process significantly improving ROI for each new product developed.
Increasingly, pharmaceutical companies seek to have a unified view of their entire product development lifecycle with the ability to view and trace every product detail throughout the entire process. Agile Product Lifecycle Management provides the capability to both manage and centralize product information, helping pharmaceutical companies realize their IT investments by addressing some of the most essential needs including speeding time to market, lowering overall operating and production costs and realizing quality standards such as QbD. Finally, by providing a unified view of the product(s) across the organization, companies can finally realize the benefits of cross-functional collaboration where product knowledge is transparent thus facilitating in product governance both internally and externally (i.e., compliance with regulatory agencies).In this white paper we have outlined 7 of the most essential steps in which pharmaceutical companies can approach PLM and lead the way towards a transformation of the entire business. Deployed properly, Oracle’s Agile PLM Software solutions for the Pharmaceutical industry can deliver rapid ROI by realizing productivity gains while reducing time to market and associated product development costs. These not only illustrate how transformational elements can improve the “lab to launch” process but also create a company culture for continuous improvement based on the mantra of “think big - start small - scale fast”
It is not the strongest of the species that survive
Nor the most intelligent,
But the one most responsive towards change.
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