Message from the Chair: What’s Trending in the Pharma Industry?
This is a very common phrase, one that’s become part of the lexicon. You’ve probably heard it or read it countless times during the past year. I know I have.
So, from my perspective, it’s natural to ask the question about regulatory trends in the pharmaceutical industry in 2020. There are two trends among many that have the potential to be a disruptive influence on healthcare and the life sciences: data integrity and Software as a Medical Device (SaMD). Their influence on each other is another relevant reason for me to share some thoughts and observations about them with you.
In recent years, global regulatory bodies, including the US FDA, have heightened their focus on the significance of ensuring drug safety and quality through accurate and reliable data. In fact, the demand for data, in both quality and quantity, shows no signs of stopping in the near future. And with the rapid data-capture capabilities of SaMD, there’s a broadening regulatory call to attention that we should expect to see trending this year.
ISPE’s Pharma 4.0™ maturity model points to an end goal of digitalization for “smart facilities”: drug production facilities where systems respond to changes in real-time and prompt the needed remedial behaviors. To enable these corrective performance behaviors, organizations can be expected to rely greatly on quantifiable data that are both accurate and verifiable. This extent of digital maturation is on the horizon and trending, with many manufacturers starting to explore predictive quality techniques. Achieving the objective of predictive quality requires competency with large data sets, as well as data that accurately and rigorously reflect production and demonstrate competency with both AI and machine learning.
Software as a Medical Device
On the radar as another 2020 trend is the rapid advancement of technology in all areas of healthcare and the regulations governing it. Software has become an integral part of virtually every product. It has found its way into digital platforms that affect both medical and nonmedical purposes. Of particular note, the FDA has commented on the steady increase of SaMD and its use throughout a wide range of technology platforms, including medical device platforms, commercial “off-the-shelf” platforms, and virtual networks.
Because Software as a Medical Device has the capacity to capture massive amounts of data quickly, it can also easily invite feedback from users—thanks to its availability on personal mobile devices, like smartphones and tablets—generating copious amounts of additional data. That’s why the Software as a Medical Device is inextricably entwined with data integrity. For companies using or developing Software as a Medical Device, this fast response loop and the resulting data analysis can enable product iterations at an accelerated pace, reduce time to market, and propel more rapid innovation. How regulatory bodies and regulations can effectively address Software as a Medical Device and related data integrity topics while serving all stakeholders presents an appreciable challenge.
Throughout 2020, I look forward to seeing you at the many scheduled ISPE conferences and events.
The International Medical Device Regulators Forum (IMDRF) has noted that “the current application of regulations and controls may not always translate or address the unique public health risks posed by Software as a Medical Device (SaMD) nor assure an appropriate balance between patient/consumer protection and promotion of public health by facilitating innovation.”1 In acknowledging these circumstances, the International Medical Device Regulators Forum is working diligently to formulate and refine regulations that both maintain pace with the rapidly changing Software as a Medical Device technology landscape and place the well-being of the patient as priority 1. How this trend of regulatory oversight unfolds in 2020 will be interesting to see. And it is one we shall all be watching closely.
These regulatory and innovation trends were front and center among the many topics at the 2019 ISPE Global Pharmaceutical Regulatory Summit in December 2019. Those in attendance also received valuable information regarding regulation of innovation in biotechnology, quality maturity frameworks, and innovation and quality during life-cycle management. The collegial and thought-provoking atmosphere proved to be a rewarding two-day experience for everyone. I hope you had the chance to be there.
Throughout 2020, I look forward to seeing you at the many scheduled ISPE conferences and events as we share our knowledge, opinions, and insights about the technologies, approaches, and solutions that drive innovation and quality for the medicines that serve patients. ISPE remains committed to providing our members with thought leadership and tools to understand and implement these technologies and approaches.
- 1. “Software as a Medical Device (SaMD): Key Definitions.” International Medical Device Regulators Forum. 9 December 2013. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.docx