Process excellence can lead to gains in drug discovery.
November 16, 2010 | Guest Commentary | The business model of developing and marketing innovative drugs is under siege. Despite increasing investments into R&D, pharma companies seem to fail to invent sufficient numbers of new products that would a) address currently unmet medical needs or provide significant advantages over the current standard of care and b) generate the profits—lost due to generics competition and pricing pressure from payers—required to finance further innovation. Perhaps it is time to consider the business implications of how science is performed and similarly apply scientific reasoning to improve business processes in R&D.
Approaches to reduce the investment needed for bringing a new drug to market can be characterized by the degree to which they address the success rate and the efficiency of drug development. Progress toward increasing overall success rates, e.g. by reducing late stage attrition due to safety or efficacy, is a worthwhile occupation. Public-private partnerships like the Critical Path Institute (C-Path, www.c-path.org) and the Innovative Medicines Initiative (IMI, http://imi.europa.eu) underscore this notion. However, among R&D staff it seems little individual benefits are earned by working to increase the efficiency by optimizing the drug development process. To some degree, this is because scientists in the biomedical and chemistry field traditionally value (or are valued by) the hours they put in rather than efficiency.
Process-oriented, continuous improvement techniques like business process management (BPM), lean or Six Sigma are often seen as a threat to innovation rather than an enabler. Indeed, according to a recent model (Paul et al. Nat Rev Drug Discov. 2010 Mar) delineating the influences on drug development cost, a mere 5% increase in efficiency (immediate cost and cycle times) would translate to savings of more than $150 million per newly approved drug. This amount corresponds to the out-of-pocket cost of funding eight projects from target through preclinical testing.
Naturally, certain processes are more amenable to standardization and optimization than others, including reducing administrative efforts, increasing transparency and quality of agreed services, and sharing best practices. In contrast, bad processes can be a major drain on work motivation and are likely to spur evasion strategies, cannibalizing the intended gains.
Process Fine Tuning
One example of improving research administration involves an E-procurement solution IDS Scheer realized at the German Cancer Centre (DKFZ) in Heidelberg. The project analyzed the procurement process for consumables, standard services and capital equipment needed by research groups or individual scientists. Following analysis, the process was simplified and largely automated as a software system. Instead of manually transferring data from multiple catalogues into paper order forms, researchers now can browse and search the offers of regular suppliers within a single web-based application. Comparing offers—including potential special conditions for delivery or discounts—is now straightforward and the error rates of orders and booking the cost against the correct budget have been reduced.
As a result research groups now have the flexibility to purchase goods according to their need and budget and at the same time benefit from the negotiation power and administrative backbone of the DKFZ. Finally, researchers spend significantly less time on the procurement process—time they can spend on research. Additional processes in R&D with potential to benefit from standardization involve technology and logistics services or the clinical supply chain.
Continuous improvement (CI) methodologies fundamentally provide guidelines and tools for applying the scientific method—collecting and analyzing information on a system to facilitate predictions about its future state and response to changes—to the way recurring tasks are performed. These recurring tasks can be as diverse as running certain assays or entering data into some computer system. Because nearly all aspects of drug R&D interact with or are dependent on IT systems, the proximity of BPM to IT is a definite plus. The plethora of systems in R&D environments often leads to highly fragmented or inaccessible information and thus creates a roadblock to efficient decision-making that could be avoided if process-centric strategies like service-oriented architecture (SOA) were followed.
BPM provides a systematic approach to collecting and describing processes, their time line and associated responsibilities, IT systems, input and output, and interfaces. This ensures that the process description is comprehensive and consistent, for example with respect to nomenclature for roles and systems, and thus is meaningful in a context beyond the isolated project. SOPs, regulatory documentation, and training materials can be generated automatically based on such process descriptions.
Detailed process understanding is a prerequisite for any improvement. Well-run CI projects will avoid secret society jargon and instead directly involve process owners and process participants in describing and modelling the business process in question, as well as in evaluating the process and defining improvements. This transparent and collaborative approach values and leverages the team’s experience and domain knowledge and lays the foundation for sustainable increases in efficiency and quality.
New drugs will not be invented on process excellence alone. However, process excellence is a strategy to free up resources to support the best science and sharpen the profile of R&D organizations compared to outsourcing competition. •
Jochen Koenig is business development manager, Pharmaceuticals at IDS Scheer. Email: email@example.com