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Innovation and the Future of Life Sciences

Regulations and increased complexity are pushing the industry to adopt innovation more quickly

Published: Thursday, January 4, 2024 - 12:03

Traditionally, quality management in the pharmaceutical industry has strayed away from artificial intelligence (AI) for fear of setting it loose with such sensitive information. They have been cautious of implementing an additional element of intelligence into their process. But will organizations turn a new leaf this coming year to keep up with innovations?

At IQVIA, we have thought a lot about the future of the industry and how innovative technology might be incorporated. Certainly, the industry has begun to leverage large language models (LLM) and other capabilities of AI, a trend that is expected to continue in 2024. Additionally, the use of recommendation engines will increase because they enable a combination of AI and personal experience, focusing on augmented intelligence as opposed to AI alone. Recommendation engines can greatly improve responsiveness, cycle times, accuracy, and efficiency, making a significant impact on productivity.

The use of public generative AI (GenAI) will take longer to enter the space due to the risk of leaked intellectual property, which is critical in life sciences. However, as private GenAI becomes possible its use will increase. With these trends, there will be an expansion of investment in predictive and preventive analytics.

Additionally, as organizations work to break down siloes of quality and other departments, AI can be used to connect and work across systems, which will greatly benefit everyone by improving productivity and efficiency. This connectivity will allow greater access to data across disciplines such as enterprise resource planning (ERP), supply chain management (SCM), and product life cycle management (PLM), reducing errors and duplication of effort.

While the excitement and innovation of AI—including LLMs, natural language processing (NLP), and GenAI—are groundbreaking and advance the capabilities of technology, organizations are beginning to realize that success is not solely predicted by the latest and greatest technology solutions. Not only will organizations realize the limitations of this technology, but there also will be some impediments, such as regulations, the availability of industry/product-specific data to train the AI tools, and the commercial viability of AI solutions that will tailor the use of these technologies in life sciences.

“Especially in the healthcare and life sciences industry, organizations are realizing that technology is not the answer to every problem,” says Michael King, IQVIA senior director of product and strategy within technology solutions. “Rather, it is the proper implementation and utilization of technology, driven and understood by people and supported by processes, that will produce the most effective outcomes for patients.” Organizations often neglect the people and process portions of technological advancement, and the improved interfaces between these parties will bring about greater outcomes for companies and patients alike.

“Increasing regulations and standards are advancing the complexity of quality management in the life sciences industry,” says King. “Organizations are being asked to provide improved results while working with constrained investment and resources, driving the need for efficient, compliant business operations with controlled investment in head count.”

The way organizations will counter these difficulties is by providing consulting services, outsourced services, and technology. The real value of quality management is in the ability to combine these services to address pain points at a given time and as the organization scales in its company evolution, not just through deploying out-of-the-box technology or software.

One issue that many organizations do encounter is, ironically, a surplus of data. If managed incorrectly, this can actually affect outcomes. Though concerns about a lack of data previously fueled motivation to identify new technologies, many organizations now fall victim to the opposite. When organizations acquire technology and are unaware of how to use or properly leverage it, they can end up with large amounts of data but not know how to appropriately apply it to improving solutions.

The other realization that many organizations will encounter is that technology and head count are not always mutually exclusive. “Organizations are often resistant to adopting certain technologies, as they are fearful of reducing head count,” says Philip Johnson, IQVIA’s senior principal for quality and compliance solutions. “Although this is the case sometimes, it shouldn’t deter an organization from adopting technology that will improve quality. And more successful organizations will look at technology not just for what it does in regard to profit and loss and head count, but how it directly affects the areas it is meant to be improving, such as quality, regulatory, or safety.

“Organizations need to remember that technology requires a workforce that supports integration and is onboard to learn and train to effectively use the technology,” says Johnson. Not enough attention is given to supplying people with the appropriate support and training to feel comfortable with technology. Especially if people are pushing back on the implementation of technology, that can be a huge deterrent to an organization’s success. Moving forward, organizations that can create a culture that embraces change across people, processes, and technology will benefit in the coming years. Those that can jump into and embrace new innovations while supporting their staff and internal processes to fully understand and integrate new technologies will take full advantage of any change.

According to Michael Hidock, director of quality and compliance services for pharmaceutical consulting services, one realization that life science organizations might have in the coming year is a new perspective on trends in quality (e.g., CAPAs, investigations, complaints). “Often, organizations view singular issues or urgent matters and work to resolve them one by one but lack the ability to view the problem as a reflection of the work as a whole due to the nature of their software,” says Hidock. “Organizations are too often missing the forest for the trees and falling victim to their own software by neglecting to examine complaints in a holistic manner, understanding the reasoning behind the issues.” In the coming year, organizations that can take these issues highlighted by the software and apply them to high-level trends will reap the benefits.

Another trend necessary to advance the industry is improvement in broad-based system connectivity. Organizations still struggle with a siloed approach to management and software systems. Successful quality management will require a combination of quality management software (QMS), PLM, and ERP to not only connect and harmonize systems but also to ensure that the correct system is used to perform certain tasks. Too often, organizations are struggling to perform certain services because they may be using the wrong platform in the first place. Organizations that can optimize and connect their QMS will succeed moving forward.

“Although there has been an increase in automation, streamlining the process of triage, evaluation, complaint determination, and reportability decisions will be the determining factor in organizational success,” says Anthony Hudson, IQVIA senior principal, technology. “The distinction between the success of organizations will not be their use of intelligence technology but rather in how they are collecting data and implementing intelligence to analyze the data. Their access to data and data quality will be much more indicative of how far technology can take us.”

As quality is better understood and valued, organizations that approach quality management as a tool to drive continual improvement, as opposed to one that looks at quality as a nuisance and cost burden, will be more successful at improving outcomes. A few organizations are already doing this by automating key quality management processes to drive efficiency and to provide a systemwide view of quality process performance, reviewing trends and intervening where necessary. Companies that can transform their culture to look at quality as an incredibly beneficial steering tool while embracing automation will be those who succeed.

Discuss

About The Author

Kari Miller’s picture

Kari Miller

As the senior director of product management for IQVIA’s SmartSolve, Kari Miller is responsible for driving the strategic product roadmap, and delivery of industry best practices and regulatory compliance solutions for quality management. Kari has more than 25 years of experience delivering software solutions for life sciences. She brings that knowledge to her current team as they focus specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated life sciences QMS market. Kari earned a Bachelor of Science in Business Administration and a Bachelor of Science in Psychology from Marian College of Fond-du-lac, Wisconsin.