Food for thought: Life Science’s Biggest Challenges over the Next 5 Years

Your input from Knowledge & Network Day 2017

Life Science companies must embrace the digital future to achieve business objectives: patient-centricity, value beyond the pill or device, faster time-to-market, and much more. At the same time, new technology – cloud, AI, machine learning, IoT, etc – challenge their ability to stay in control of processes and quality. There is a huge potential to improve patient and business outcomes, but to get there, compliance efforts must be more transparent, predictable and efficient than ever before.

At Knowledge & Network Day 2017, we dug deeper into this subject. We asked Life Science professionals – QA, RA, IT and Line-of-Business managers and specialists – the same question: What is the biggest challenge facing the industry in the next five years? Responses highlight the biggest obstacles ahead of us—but also provide valuable insight into their solutions.

Challenge 1: Finding the optimal compliance level

Responses show that a large segment of the industry simply doesn’t know the optimal level for their compliance efforts. Finding this optimal compliance level is crucial to reach business objectives, including digitalization. Without it, companies risk setting compliance objectives too high, overspending on time and resources, or too low, putting them at risk during regulatory inspection.  

Life Science companies are often conservative and risk averse, so they opt for a very high level of compliance. Uncertainty about regulatory requirements leads to excessive compliance efforts. Critical efforts are not separate from unnecessary or legacy efforts. This type of overspending on time and resources hampers efficiency and wastes money. 

Consider the example of a biotech company that is appropriately conservative on the production side, and then applies these same risk-averse, high quality standards to their IT systems. The IT systems could be validated with less risk-averse, more flexible quality standards. The company spends extra time and money on validating IT systems, some of which are even outdated. Beyond losing flexibility and efficiency, they have difficulty adopting new technology. Digitalization goals fall behind. 

This simplified scenario highlights the importance of finding the optimal compliance level, and why so many Life Science professionals identified this as the biggest challenge facing the industry in the next five years.

Challenge 2: Staying in control of data, systems, and processes

Data is the ‘new gold’, but many of our respondents identified staying in control of data, systems and processes as the biggest industry challenge for the next 5 years. They raised concerns about data retrieval, data aggregation, data privacy, and data integrity, along with questions about how to support big data. 

Increasingly, authorities are asking for cross-organizational regulatory data. Regulations like IDMP, Serialization, and UDI are forcing companies in this direction. GDPR and Right to be Forgotten regulations pressure companies to increase data security and data privacy. More than ever, it is paramount that data is accessible, controlled, and secure.

On the positive side, new technology makes data insights extremely valuable, improves patient engagement and speeds drug development. Artificial intelligence and machine learning can give decision making objectivity. The internet of things and other new digital services, channels, and practices bring new revenue streams. These things drive the industry forward - AND increase the challenge of staying in control.

Because data insights are so important, companies are shifting from system-centric to data-driven. For a long time, the industry focused on systems and processes (as opposed to data), because that is how traditional validation works. Now, we must consider the data first and ensure that systems and processes support it. This new paradigm makes effective processes paramount to fulfill both compliance goals and business objectives. 

Challenge 3: Keeping up with new technology

Another major trend in the responses: practitioners and regulators are uncertain about how regulations relate to new technology. Regulatory bodies are not always seen as ‘front-runners’ of innovation, and technology is developing so rapidly that they can’t always keep up. How can the industry understand and incorporate the rapidly advancing technology – while also staying in compliance with the current regulatory requirements? 

One impact of new technology is that medical device software development moves so quickly, the software is often already outdated by the time it is approved by regulators. This challenge goes across the board for all companies. It also creates an opportunity—you can differentiate your company by using risk-based validation procedures with the optimal compliance level in mind. And clever companies will also get an advantage post-release by creating processes to update the medical device software after regulatory approval.

At the moment, there is a gap in understanding and awareness between regulators and industry. The regulations currently in place are important, but the interpretation by companies and inspectors needs to be more aligned. Regulations are most often viewed in a traditional manner, but a new way of thinking must be applied to them, so they support challenges from technology, processes, data and more.

Challenge 4: Keeping up with new regulations

New regulations—Serialization, UDI, IDMP, GDPR, MDR/IVDR, and more—are a major challenge that impacts time-to-market and other business objectives. There is often a significant delay between regulation and guidance on how to comply. This means that companies must interpret the regulations themselves in their Quality Management System (QMS), and decide how to comply in a way that meets quality objectives and supports business goals. Companies can actually see this gap as an opportunity for a competitive advantage. With mature QMS systems and a company-wide quality mindset, companies can begin to influence regulatory bodies by defining the right way to stay in control. In doing this, they can lead the market as first-movers.

Adding to the challenge, often each inspector conducting a regulatory inspection has his or her own interpretation of exactly how to meet compliance standards. How does QA know what to focus on in an inspection? A mature QMS will support the company’s interpretation of each level of guidance with well-documented rationale for their interpretation, why it fits the regulations, and how they are implementing it. In an inspection, this documentation is essential to counter overly rigid, confining, or outdated outside interpretations. Less focus should be on specific GxP ‘how-to’ SOPs, and more focus on building dynamic processes and integrating a quality mindset into the entire organization. Interpreting each level of guidance to support your company goals ties back to the necessity of finding the optimal level of compliance.

Food for thought

The Life Science industry must come up with a new way of thinking about regulatory compliance that defines what ‘risk-based’ really means, and provide guidance to practitioners, ideally in collaboration with regulatory bodies. Closing this gap will require collaboration from regulators and industry.

We appreciate your input during Knowledge & Network Day 2017. This type of dialogue creates a higher level of insight and maturity in the industry and helps us move towards the digital future. We’ll continue to explore these challenges in our quest to continuously improve regulatory compliance.