Excellent drug development is critical today, as patients across the world are relying on innovative new treatments and therapies to live healthy lives. Meeting demand is always a challenge. The process of narrowing down tens-of-thousands of chemical or biological compounds to identify but a single potential drug can require sophisticated molecular pathway modeling, data processing, and screening assays. But successfully navigating all phases of clinical trials requires the complicated calculus of compliance with shifting FDA regulations and delivering the bottom-line for shareholders.

Undergoing pressure from so many sources, it’s no surprise that R&D departments can experience stagnating or decreasing production rates over time. While a certain dosage and efficacy strategy may work seamlessly for the drug discovery phase, the same process may not be as effective in later stages of clinical trials. Continuous success in R&D requires analysis of deficiencies and a positive internal culture focused on improvement. A proven method for maximizing efficiency and results is through operational excellence (OE).

The Truth About Operational Excellence

Like selecting a niche rare disease market or choosing to pursue a novel gene therapy, employing OE can provide an R&D department with a massive competitive advantage. This advantage is created by taking a holistic view of operations and the company’s desired outcome, to identify where exactly to speed up processes, save money, and improve outcomes.

While OE can help R&D capture positive outcomes, this type of analysis can also be challenging, as there are many reasons why an OE program can fail. For example, if an OE program is to be successful in an R&D department, everybody, from top to bottom, must be on board.  If one manager is incentivized to improve the quality of data while another is driven by shortened cycle time, their goals may misalign and, in some cases, interfere. Unless both streams are aligned to work together, they are destined to fail. Investing in a sound OE program early-on can eliminate these types of bottlenecks down the road.

3 Potential Bottlenecks in Pharma R&D

While every firm encounters different problems, there are areas across R&D that are prone to inefficiency. Here are just a few:

1. Data Management – a critical part of R&D, managing data generated from experiments affects everything from success with regulation to strategy formulation. From raw data acquisition, to collection, to parsing, processing, and ultimately to visualization, the integrity of the data must be maintained throughout. If even a single step of data management is not sound, error can propagate easily and quickly, especially given the increasingly large and complex nature of datasets in drug development. Companies can face enormous, and unexpected issues down-the-line if data mismanagement misinforms leadership.
2. Compliance – truly a constant in R&D, compliance to FDA regulation must be built into the DNA of the company. Just because a handful of studies succeed does not guarantee compliance in future studies. The associated costs and resources required for repeated trials can put a major burden on R&D. Additionally, FDA site visits and investigations are major hindrances to innovation. Investing in OE for compliance can not only help in the short-run, but it can also orient an R&D department to evolve successfully for compliance in the long-run.
3. Decision-Making – assessment as to invest in, maintain, or cut sectors of R&D is necessary to keep pace with cycle timelines. In short, if it’s not working for you, it’s probably working against you. Utilizing OE can help you develop stronger business cases to justify these types of decisions. For example, when deciding whether to move a compound forward in the pipeline or scratch the project in favor of a more promising discovery, tools like initiative economic justification, cost-benefit analysis, and risk analysis can allow R&D leaders to better visualize the tradeoffs of their options.

The Bottom Line

When it comes to operational excellence, sometimes solving a problem starts with identifying you have a problem in the first place. Before jumping to adopt a fully-integrated OE program, consider options like a baseline performance assessment, which uses proven practices like lean, Six Sigma and Theory of Constraints (TOC) to identify tangible improvements in cycle time, quality, costs, and throughput. According to industry leaders improvement does not have to be drastic or disruptive, launching a successful OE program can involve an incremental Kaizen approach aimed at tackling highly specific issues. Understanding these specific root problems affecting R&D will facilitate planning an ideal OE transformation road map down the line.

What efficiency problems does your R&D department face? Does an OE solution apply to your company? How would OE implementation align with established department infrastructure and strategy?

If you would like to chat or have any questions related to enhancing R&D processes, R&D data, or R&D operations, augmenting efficiency, or strategic transformation, feel free to contact our R&D Consulting team.

Co-author and contributions: Adam Kershner