Transforming regulatory strategy to meet the evolving compliance landscape

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| 29 January 2021 | By William Buzzeo, MS, and Michelle Gyzen  | PDF Link PDF | ©

Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations today. These same pressures are extending to the medical device market. In this article, the authors explore how perception of regulatory compliance is evolving due to a variety of driving forces. They outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands while creating business value.
 
Introduction
Biopharmaceutical companies are under more pressure than ever to innovate, as they seek to stay competitive in a highly saturated space and advance global health. Meanwhile, global safety, regulatory, quality, and commercial compliance regulations are growing by the day, quantitatively and in terms of stringency. This is leads to more burdens, inefficiencies, and added costs for companies trying to navigate the complexities around safely and expeditiously bringing drugs to market.
 
A recent global survey of pharmaceutical CEOs shows an increase in regulatory scrutiny across many aspects of the business, including sales and marketing practices, government drug price reporting, data privacy management, and clinical operations.1 Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations.  Pharmaceutical leaders have cited these changes as a top threat to their companies’ potential future growth.
 
These same pressures are extending to the medical device market for the first time, with newly introduced protocols such as the EU Medical Device Regulation (EU MDR). In a 2020 outlook report, medical technology companies cited stringent regulations and operational inefficiencies as the key reasons they need to seek cost-reduction strategies.2
 
In this article, we will explore how perception of regulatory compliance is evolving – both from an industry perspective and in looking at recent moves from the US Food and Drug Administration (FDA). We will also outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands while creating business value.
 
Compliance and innvovation
Compliance has long been viewed as a necessary cost, but leading organizations are recognizing opportunities for innovation in this space. Increases in the amount and complexity of data have pushed the industry to explore ways to implement systems that eliminate silos and reduce the need for repeat data collection and reporting in individual platforms. In fact, the key drivers for technology adoption in the life sciences space have been cited as the need to keep pace with industry innovation and demanding regulatory shifts.3
 
Currently, data held in organizational silos prevents various departments from communicating and sharing data with one another as required. This is a missed opportunity for regulatory, safety/pharmacovigilance, quality, and commercial compliance departments to come together to deploy a more patient-centric strategy for delivering drugs and medical devices to market quickly and safely, as well as keeping them on the market.
 
Regulatory, quality, and safety teams are already beginning to align and integrate technologies to respond to regulatory changes more quickly and gain efficiencies through improved workflows and insights. This will become more prevalent in terms of how the information is being used and shared across entities and within life sciences organizations. This greater collaboration will yield further optimization of tools and resources, propelling the industry forward by enabling continued innovation.
 
Pharmaceutical companies have typically been faster to innovate than the governing regulatory bodies. The FDA is an example of a regulatory body that is moving toward adoption of a broader data strategy as it recognizes the potential benefits digital transformation can provide for its organization and the industries it supports.
 
It has become difficult for the FDA to detect when adverse events are the most relevant indicators of issues with a given drug. Data is now so voluminous, and is coming in at such a rapid pace, that the agency has called for a meeting to redefine its data strategy. The FDA initially announced plans for a public meeting on data strategy in January 2020.4 It was rescheduled to the end of June,5 but its intent remains the same – to create a forum for the FDA, the industry, and public at large to identify ways to improve the agency’s ability to mine data and process adverse event reports.
 
The FDA, like many regulatory bodies, has traditionally innovated at a much slower pace than the private sector. This lag time has made it difficult for the agency to develop a data strategy that remains relevant from inception to deployment.
 
As already noted, health care data are compounding faster than ever before. Available health care data that needs to be mined and codified has grown by 878% since 20166 and is expected to continue to grow exponentially. Further complicating the issue is that data types are both structured and unstructured. The pharmaceutical and medical device industries are strategizing around, and quickly investing in innovative technologies to grapple with this unprecedented level of complexity.
 
This expressed interest from the FDA in updating its data strategy will force companies that have been holding back on adopting new data processes to reconsider their reticence and start exploring ways to digitally transform their organizations. This drive toward improvements should be viewed as beneficial to organizations, as one considers how updating processes with automation will likely help pharmaceutical companies re-imagine compliance. Compliance will soon come to be seen, not as a cost center, but as a value-added business generator and driver of cost savings.
 
A new culture of proactivity comes with adopting a technologically advanced data strategy ‒ helping companies provide added assurances to the general public that they are operating as safely, efficiently, and ethically as possible as they look to bring new drugs to market. This translates to fewer risks, greater rewards (through greater opportunities for business growth), and a stronger brand image in the eyes of the public. Conversely, when companies treat compliance as a must-do, rather than a value-add, and fail to adequately invest in these proactive processes, they may be held liable for greater risks to patient safety, delays or denials of product approvals, license withdrawals, financial penalties, and potentially, criminal penalties. These adverse circumstances can be devastating to the individual life sciences company and generate negative public perception that affects the entire industry.
 
Companies need to look for synergies in their regulatory compliance activities that can be used to build a business case for technology and talent investments to mitigate risks and add value through the compliance process. They should also seek opportunities to remove waste and any redundancies across the full product life cycle.
 
Identifying obstacles to effective compliance
Lack of innovative technology and harmonization
While the life sciences industry has invested billions in advancing technology for commercial purposes, those investments have been slow to trickle down to commercial compliance, regulatory, quality, and safety departments. Aging and disconnected platforms, as well as a lack of automation, can add time, cost, and poor visibility to the compliance process.
 
Difficulty staying abreast of shifting global and local regulations
Global pharmaceutical and medical device companies – and smaller biotechnology companies with global aspirations – need experts with a keen understanding of global regulations and how the latest sets of regulations, which change rapidly, will affect an organization’s processes from drug development to commercialization.
 
There have been more than 2,000 regulations introduced by the FDA alone since 19987 – compound that by the 150 regulatory bodies at the country level globally for a more general sense of what companies are up against when it comes to compliance regulation adherence. Separately for medical device companies, regulations are becoming more stringent than ever, particularly with the introduction of standards such as the EU MDR,8 and they do not yet have the infrastructure to manage.
 
Staying abreast of regulatory changes, which vary by country and region and shift frequently, is vital to achieving and maintaining compliance. With that said, when compliance is implemented manually without technological support, it can be a tremendous resource drain on companies.
 
Multiple silos, vendors, or manual processes
Many companies lack the horizontal integration needed for optimal efficiency around compliance tasks. Having numerous vendors, disparate platforms, and limitations around automation capabilities result in duplicative spending, a lack of internal company-wide transparency around the overarching cost of compliance, and inefficient operations.  As an example, simply harmonizing technology platforms within one discipline, such as quality, can improve the cost of quality by 10%-20%.
 
High volumes of unstructured data
The lack of conformity across data sets complicates downstream reporting and can delay the real-time insights required to maintain compliance. Particularly for adverse event reporting, consider that adverse events for postmarket drugs and devices originate from unstructured data that is available from various sources, including medical record notes, customer support interactions, telehealth calls, social media, wearable devices (more recently), and more. These wearable devices bring in massive amounts of unstructured data that could hold critical information about adverse events that must be reported to the FDA. Historically though, there has been no way to capture that data, and further, no way to determine the most important data points for reporting.
 
Technology will support safety and pharmacovigilance, as well as quality and regulatory compliance processes, in ways that were incomprehensible a decade ago. This will be critical for the future success of all life science companies. There are not enough people with sufficient skills and bandwidth to manage all the data and processes required to meet compliance needs. Technology will support the evolution of ways the life sciences industry structures its workforce and supports shifts in roles moving forward. The pharmaceutical industry once feared automation – now though, companies are looking to technology for solutions. These solutions will not eliminate jobs; rather, they will enable them.
 
Research largely supports that the adoption of technology will continue to stimulate value and opportunities in the regulatory compliance space, with 58 million net new jobs expected be created by 2022.9 A 2020 analysis of some of the drivers transformation in the life sciences suggested that software applications for compliance, risk management, and product life cycle management would likely have a key role in sciences and that the life sciences applications market could be expected to reach $8.9 billion by 2022, compared with US $7.7 billion in 2017.10
 
Large life sciences companies have a fair amount of disconnected legacy technologies that are not able to communicate with one another – on servers and with no cloud infrastructure. That means these companies have many different technologies for different functions and that the technologies cannot “talk” to one another. These data silos ultimately translate into department silos (as previously noted), which prevents companies from streamlining operations and acting as single entities.
 
This has been the main driver for large companies with many products and exponential amounts of data to adopt cloud-based automation with the underpinning of software-as-a-service platforms. This can be more challenging for small biotechnology companies struggling to find affordable compact and agile solutions. We are still in the early stages of companies’ ability to forecast their return-on-investment from automation and identify which new opportunities for innovation are available and most suitable. However, the industry-wide sentiment has been that integrated compliance is the most progressive approach, and, as such, it is likely the industry is headed in that direction. Here are a few of the technologies that exist today to help bring the vision of regulatory intelligence automation to fruition.
 
Technological path for compliance
Natural language processing
Natural language processing has gained traction in recent years for its value to pharmacovigilance and adverse event identification in addition to historically successful use cases in clinical development. This is the technological operation by which unstructured text-based documents are mined and converted into structured information that can be analyzed by a computer.
 
With patient-reported outcomes data growing exponentially and originating from more data sources than ever before, as mentioned previously, this technology is critical for automating the identification and reporting of adverse events to keep products safe, compliant, and on the market.
 
Artificial intelligence
Many will recognize AI as a buzzword but may not know to how assess or quantify its applicable value to the life sciences industry. Many companies want to say they have AI capabilities to gain a competitive advantage in their respective marketplaces, but few actually have a strategic roadmap and a clear understanding of what it entails. The true test for AI is whether you are able to quantify the way in which AI can reduce the complexities and time spend associated with regulatory compliance and ultimately lower costs and reduce false positives and human error. As an example, automation of data population and stewardship is a use case in which AI has shown to have true value for regulatory affairs.
 
Cloud computing
The value of cloud, which enables the instantaneous storage and delivery of information in a noncentralized way, extends far beyond regulatory compliance. This is because of the opportunity it presents for accessing information in a way that is interoperable and not siloed. Cloud computing can help ensure a company has a single source of truth throughout the life cycle of a product – from drug formulation to its eventual delivery to patients.
 
Cloud computing is not new and has been adopted in some form by virtually every industry. As of 2019, one report showed that 83% of life sciences companies are already using cloud environments.11 A global analysis projected cloud adoption will continue to grow in 2020 and beyond.12
 
This technology transformation has unique implications for medical device companies, particularly as they enter the relatively new world of regulatory reporting guidelines that pharmaceutical companies have become accustomed to over the years. To date, reporting requirements for medical device companies have not been as strict they have been for biopharmaceutical companies. In addition, medical device companies have not had as many electronic reporting requirements globally as their pharmaceutical industry counterparts. Nevertheless, the introduction of the EU MDR heralds a new era in which reporting expectations of the sector will expand rapidly.
 
On a positive note, the medical technology industry is effectively starting from square one in terms of getting the digital regulatory processes underway, which could protect it from experiencing the adoption challenges the pharmaceutical industry has had to grapple with in regard to phasing out old systems and introducing new ones. Still, systems cannot be considered one-size-fits-all and will continue to evolve. Thus, technology providers will have to consider the unique needs of the medical technology industry to provide it with purpose-driven, upgradeable automation solutions.
 
Conclusion
Having a company data strategy supported by automation is no longer a nice-to-have; it is a must-have to stay relevant, competitive, and compliant. Transforming your company’s approach to regulatory compliance is the only way to keep pace with the fluctuating regulatory landscape across the globe.
 
This new era should be welcomed. When companies start looking at automation around compliance more as a strategic investment and less as a necessary evil, they will start realizing cost savings and will find better ways to drive business value by leveraging data to find new ways to solve critical issues and improve overall global health.
 
Abbreviations
AI, artificial intelligence; EU MDR, European Union Medical Device Regulation; FDA, [US] Food and Drug Administration.
 
References
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  4. Brennan Z. FDA seeks help using algorithms to detect adverse event anomalies. www.raps.org/news-and-articles/news-articles/2020/1/fda-seeks-help-using-algorithms-to-detect-adverse?feed=Regulatory-Focus. Regulatory Affairs Professionals Society. Published online 23 January 2020. Accessed 28 January 2021.
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  6. Dell Technologies. New Dell EMC research: Most businesses worldwide now recognize value of data yet struggle with adequate data protection. PR Newswire. www.prnewswire.com/news-releases/new-dell-emc-research-most-businesses-worldwide-now-recognize-value-of-data-yet-struggle-with-adequate-data-protection-300815958.html. Published online 21 March 2019. Accessed 28 January 2021.
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About the authors
William Buzzeo, MS, is the vice president and general manager of the US Center of Compliance Excellence at IQVIA. He has more than 25 years of experience in life sciences, including 18 years with IQVIA and 7 years with Knoll Pharmaceuticals, in the areas of sales, operations, compliance, and executive leadership. Buzzeo currently leads IQVIA’s US compliance business unit, with a focus on expanding compliance services across the different verticals within the life sciences market. He has a master of science degree from Syracuse University, NY. He can be contacted at william.buzzeo@iqvia.com.
 
Michelle Gyzen, is US operations head, integrated technology and compliance solutions at IQVIA, where she is responsible for driving regulatory technology-enabled solutions and strategies to meet growing industry demands. Her expertise spans 14 years in the life sciences industry, with 7 years of consulting on drug product approvals across pharmaceutical, biotechnology, and medical devices. Gyzen has specific knowledge in regulatory business process services and systems, technology, and largescale outsourcing. She studied at North Carolina State University and the Southern New Hampshire University. Gyzen can be contacted at michelle.gyzen@iqvia.com.
 
Citation Buzzeo W, Gyzen M. Transforming regulatory strategy to meet the evolving compliance landscape. January 2021. Regulatory Focus. Regulatory Affairs Professionals Society.
 
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