Why Pharma R&D Processes Need a More Extensive Overhaul

Standard operating procedures, prevalent across pharma Regulatory Affairs, Quality, and Pharmacovigilance/Drug Safety functions, help ensure process rigor through detailed descriptions of agreed, standardized ways of doing things. However, these detailed definitions of processes have not been established with efficiency as the priority, nor with thought to how they might align with the needs and onward processes of neighboring functions. MAIN5’s Tobias Hitziger considers the cost of cumbersome or disjointed ways of working and the growing imperative to improve process efficiency on a wider scale.

The 2020s are both an intensely exciting time for pharma and a highly challenging and commercially precarious time to be in business. Operationally, there is now huge pressure for pharma R&D organizations to make their late-stage R&D processes as efficient as possible. Rising cost pressures, downward pressure on pricing and margins, intensifying global competition, and increased product sophistication/complexity are significant and increasingly daunting. Each time the clock is set with a new product patent, speed to registration and maximized sales potential are crucial.

Streamlining processes and applying technology appropriately play an integral role in enabling product opportunity optimization. As things stand, though, process rigor across Regulatory Affairs, Quality, and Pharmacovigilance/Drug Safety function is determined according to standard operating procedures (SOPs) – exhaustively documented step-by-step descriptions of how things are done to ensure a standardized way of working. Those SOPs are, in most cases, PDF versions of Word files managed in an electronic document management system to ensure compliance.

These snapshot definitions of processes do not, of themselves, foster efficiency or effectiveness, however. Even where processes are improved and optimized over time, as long as these improvements are taking place discretely - within a single function or sub-area - the benefits are often confined to that immediate context and do not look at the overall, end-to-end process. Problems can commonly arise at points of handover. That could be between teams working in the same department or as workloads pass between different functions (or potentially out to an external service provider and then back again). If the interfaces where processes join inhibit seamless continuity or clear visibility, momentum can be lost and initial efficiency gains undermined.

Taking an End-to-End View and Approach

Where companies take a more holistic view, which places the focus on the output of processes and the goals this is designed to serve, there are multiple gains on offer. These range from true improvements to overall efficiency, as well as new clarity about roles and requirements within each process. These developments, in turn, can inform new IT systems implementation, as well as outsourcing arrangements – ensuring that these deliver maximum value. It makes good business sense, then, to review and optimize processes on a broader scale.

Fuller process transformation requires a more extensive review of what is going on on an end-to-end basis. Without that, the potential benefits will always be compromised.

Tackling Constraints to Progress

So why hasn’t more progress been made, given the scope for holistic process improvement? What is holding back pharma R&D organizations from being bolder and more innovative in their process transformation?

Culturally, some reservations are linked to an instinctive fear of extended transparency, especially during inspections. Where processes are viewed, treated, and managed more holistically and continuously across the traditional boundaries or departmental divides in a process management suite, there may be a concern that inspectors might extend their curiosity and raise their gaze when reviewing current procedures. This concern is heightened when companies use business process management (BPM suites) to represent their entire process landscape within a single system (with the risk that inspectors can freely “jump” from one process to another). Yet, if processes have been well-defined and are running smoothly in a closely tracked way, the ability to see all of this at a glance is a positive development.

More practically, it is the lack of clear process definition (beyond the scope of individual SOPs) that is the greater sticking point. It is only when process owners and process ‘customers’ (those on the receiving end of the output) agree on what a good process looks like that this knowledge can be applied effectively to streamline it. This is because, in many cases, there has been a loss of sight of the deliverables of processes and who and what they are designed to serve - beyond inspectors’ satisfaction that no corners are being cut; that procedure repeatability is ensuring the highest standards of quality, safety and regulatory compliance of a created output. If the output is ultimately wrong, for instance, any gains in ‘throwing it over the wall’ more swiftly will be lost. If the output is a document (e.g., part of a regulatory dossier) that fails to meet the requirements, it will be sent back to the author - creating a costly and timely rework cycle.

Another common fear of investing in real process change is linked to concerns about the likely resources this will consume, both financially and in terms of people’s time – potentially detracting from business as usual. As long as process reviews and transformation plans are designed for and adapted to the particular needs of the organization, the justification for the improvements becomes clear, and these barriers to change are soon brought down.

How to Move Forward

True process improvement, especially end-to-end transformation across an extended environment, needs to start with clear, ideally in-person communication between the main parties involved – the process owner(s), process participants, and the process customer(s). The goal of this should be to identify the most efficient process to create the output as expected by the custom, er leveraging experiences where repeated issues emerged in the past (e,.g. repeated pushback, rework cycles).

Alongside, or to help provide a focus for, discussions about the scope for process improvements, process stakeholders can harness intelligent “process mining” tools to identify common bottlenecks and repeat loops.

The greater the scope of the process elaboration and the broader the range of stakeholders, the greater the timescale needed to evaluate, redesign and optimize the new agreed scenario.

Again, staying focused on the common goals will be important – such as improved and more effortless compliance; greater clarity for all parties about what is needed, when, and why; and the scope to alleviate resource pressures through the targeted automation of labor-intensive tasks using appropriate technology (e.g., modern Refualotry Information Management (RIM) capabilities).

Identifying and Delivering the Fuller Benefits

Once good, streamlined, and aligned processes are in place, teams can pull this content and create SOPs with a clear definition of process roles (“swim lanes”). Meanwhile, they can help identify the specific activities linked to them. This, in turn, could be used to inform role-based training for the individuals fulfilling the processes.

Ultimately, good process elaboration, oriented towards the process customer, enables greater operational efficiency. It also makes it much easier to introduce new technology systems and features since well-described processes inherently force robust descriptions of user requirements. Certainly, no business was poorly served by having a deeper insight into its end-to-end processes.

Author Details 

Tobias Hitziger- Management Consultant, MAIN5

Tobias Hitziger is a management consultant at MAIN5 with over 15 years of experience in the pharmaceutical industry and heads the firm’s process team. As an expert in business process management within pharma R&D, he specializes in organizational change, lean business transformations, and senior management coaching, with a focus on optimizing operations and driving efficiency in global regulatory affairs.

https://www.main5.com, tobias.hitziger@main5.de

Publication Details

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