The biopharmaceutical sector is synonymous with innovation. There is a general sense, however, that biomanufacturers often don’t “have their houses in order” when it comes to adopting efficient processes, communications, and reporting tools. Indeed, many companies still rely on outdated methods to support areas such as research and development (R&D), manufacturing, clinical trials, and sales and marketing.
That is especially true now that the biopharmaceutical sector is undergoing an acquisitory revolution of both rival companies and products. The industry has put forth a huge effort to document processes and procedures so that traceability is kept high on the agenda. Biopharmaceutical companies are now under more pressure than ever to ensure traceability for compliance with regulations such as those from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), the US Health Insurance Portability and Accountability Act (HIPAA), and the UK Data Protection Act.
Other considerations to take into account include the AllTrials campaign, which is gathering pace. This campaign calls for all clinical trials to be registered and their results reported. It was launched in the United Kingdom in January and in the United States at the end of April 2013. Some 48,000 people and more than 250 organizations — including more than 100 patient advocacy groups — have joined the campaign. In February 2013, GlaxoSmithKline became the first pharmaceutical company to sign up to the campaign.
The biopharmaceutcal industry faces its biggest challenges in compliance (both company compliance with regulations and patient compliance with dosing). This is where business process management (BPM) can be valuable. For marketed drugs in the United States alone, poor patient compliance with treatment regimens is thought to cost the healthcare system nearly $100 billion per year (1).
Ensuring compliance can also be expensive. It is estimated that 35% of the total cost of a clinical trial is spent on meeting strict regulations laid out by agencies such as the FDA and HIPAA. The pressure to meet those standards can drive the cost of a clinical trial to far exceed its set budget. So manufacturers must strive to look again at their processes to discover efficiencies that reduce costs and bring final drug products quicker to market.
In addition, meeting industry standards can lengthen clinical trial procedures, with some estimates states related costs amount to nearly 40% of R&D spending (2). Costs can be greater if clinical trials miss deadlines and overrun. The total cost per patient of running a clinical trial is nearly $186,000 (3). A 2012 Forbes article points out that nearly half of clinical trials are behind schedule (4), which means more money wasted every day.
Business Project Management (BPM)
Remarkably, a great deal of biopharmaceutical R&D still uses traditional paper-based document management. This presents huge difficulties for compliance in clinical trials because it is extremely problematic to fully update such documents and meet stringent, global regulatory documentation standards. A paradigm shift needs to be made to move to an information management process rather than document writing. BPM introduces an organization-wide central repository that helps identify root causes of noncompliance and uncovers value-generating opportunities. BPM also facilitates decision making and helps pharmaceutical companies to better benchmark against competitors.
Integrating a BPM solution can also introduce a “source of truth,” whereby all employees have a line of sight to compliance using a process map that shows traceability and identifies gaps in knowledge. BPM can significantly affect the industry through adoption of a flexible modeling solution (tailored to each company). BPM affords outreach by giving users the ability to publish information as well as a reporting function that allows stakeholders to understand changes that have been brought about.
Put simply, BPM should be one of the top priorities for procedures, policies, and compliance groups and process management professionals. Fines for noncompliance can make or break an organization, and the search for ways of minimizing risk has never been wider. BPM could cut noncompliance out of the equation and engender an environment where R&D is a company-wide process, rather than the domain of one small division.
BPM solutions are playing a critical role in the development and documentation of “as-is” and “to-be” processes, roles and responsibilities, and key process information. They are providing key communication vehicles that underpin business process management activities. Results include enforced harmonization of terminology and process repository; unambiguous definition of roles and responsibilities; one-stop shopping for process information; and global sharing of process information from a single source. Ultimately, BPM can play a huge role in improving health outcomes — surely the raison d’être of every healthcare professional.
About the Author
Jeff Fraleigh is US senior vice president, and Eileen Cairo is a senior consultant, both at Casewise, 83 Baker Street, London, W1U 6AG, UK; 44-207-034-7550; [email protected].
2.) Patlak, M, and S Nass. 2008. Improving the Quality of Cancer Clinical Trials, National Academies Press, Washington.
3.) 2005. Simplifying Clinical Trial Management Using the Microsoft Office System, Microsoft Corporation.
4.) Roy, A 2012.How the FDA Stifles New Cures, Part I: The Rising Cost of Clinical Trials Forbes.
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