Showing the value of regulatory intelligence in pharma Measuring and communicating the ROI

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Contents

Regulatory intelligence raising awareness of its return on investment 2

Regulatory intelligence: multifaceted function helping to drive strategy and reduce revenue risks 3

Regulatory intelligence: the best ally of regulatory policy 5

Value of regulatory intelligence and functions: questioned, yet more critical than ever 7

Defining KPIs for regulatory intelligence: alignment with company objectives 8

Regulatory intelligence and policy functions: invest in strategic and impactful activities 10

Increasing awareness internally 10 Gaining recognition externally 10 Utilizing robust data management tools 10

Leverage the value of regulatory intelligence and policy teams 12

References 13

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Regulatory intelligence raising awareness of its return on investment

The regulatory intelligence (RI) function continues to develop and increase in importance as companies operate globally. While the scope of RI varies by geography, resources and company size, it has become an essential component of maintaining awareness of and remaining compliant with the ever-evolving regulatory landscape.

However, RI often operates in the background of a company, with limited awareness of its value and contribution to the company’s success. The ability to determine the return on investment (ROI) of RI remains elusive for many companies, leaving senior leadership unclear on its value.

This report describes the importance of RI, key performance indicators (KPIs) that can be used to measure its value and opportunities to increase awareness of its contribution both internal and external to the company.

Our data and expertise At Clarivate, our vision is to improve the way the world creates, protects and advances innovation. We can better understand the changing landscape by looking at intelligence from our integrated solutions.

We have combined our data and expertise to provide you with this analysis, including:

Cortellis Regulatory Intelligence™, a single source of comprehensive, global and expertly analyzed information that spans all regulatory functions across the R&D lifecycle.

Centre for Innovation in Regulatory Science (CIRS), an international forum for industry, regulators, health technology assessment (HTA) agencies and other healthcare stakeholders to meet, debate and develop regulatory and reimbursement policy and improve healthcare access through the innovative application of regulatory science.

Clarivate Consulting Services, which lie at the center of our unique combination of steadfast industry expertise, high-quality data and innovative technology applications. Through harnessing these capabilities, Clarivate consultants can get you the answers you need in ways that makes sense to your organization.

In addition to these solutions, Clarivate technology and experts harmonize billions of datapoints from thousands of sources, providing a unified view to drive decision-making for a variety of use cases, including regulatory intelligence, regulatory strategy and more. Specialized consultants and analytics experts help clients turn insights into action and stay ahead of competitors.

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Regulatory intelligence: multifaceted function helping to drive strategy and reduce revenue risks

Regulatory compliance, foresight and strategy apply to every stage in the product lifecycle, from pre-clinical to commercialization. As such, all company departments involved in research, pre-clinical and clinical development, submission readiness, submissions, manufacturing, marketing and post-approval are impacted by RI outputs.

RI activities help minimize the risk of non-compliance and associated financial, operational, regulatory and personal costs

The financial costs include:

• fines from regulators, • the potential end of a business line, • impact on share price, • competitive disadvantage, • lost opportunity and • ultimately, decreased capital and liquidity or solvency requirements.

Expensive and time-consuming remedial actions also contribute to these costs, and an indirect effect is increased difficulty recruiting and retaining highly skilled resources.

Regulatory agencies might also more closely scrutinize organizations with previous non-compliance on their records, which could increase the amount of regulation, cost and complexity for that asset category overall.

At the individual professional level, non-compliance can result in forced changes to senior management, the need for more expensive personnel with the required risk and compliance skills, a damaged reputation and increased personal liability.

“The cost of non-compliance is huge. If you don’t invest in regulatory intelligence, you won’t be compliant, you won’t have robust regulatory strategies, and this will have a huge cost to your organization.”

- Celine Rodier, Senior Health Policy Manager, Clarivate2

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The RI group plays an integral role in asset development and compliance by:1

• monitoring and turning information into intelligence, • helping ensure compliance, • informing and driving regulatory strategy early in an asset’s development, • continuing to evolve that strategy throughout the product lifecycle, • helping the company to be proactive and innovative, • assisting with timely, efficient new drug applications and lifecycle management activities, • preparing for regulatory agency meetings, • providing training for other departments and • impacting policy by identifying the latest changes to the framework and upcoming trends.

“Regulatory intelligence professionals support the drug development process with strategic information, serve as liaisons with regulatory agencies and channel information to appropriate stakeholders.” Source: Brown-Tuttle, M. Regulatory Intelligence and Policy: Shaping the Global Landscape. (November 2019) Regulatory Focus.3

Directed research and monitoring typically involve a wide range of sources, and the use of each is specific to the organization. These sources can include:

• National and global regulatory agency websites • RI databases • Blogs • Guidance documents, laws, consultations • Panel meetings • Previous submissions and approvals • Interactions with reviewers and other regulatory professionals • Warning letters • Regulatory agency presentations • White papers • Trade association presentations and position papers • Email alerts or RSS feeds from health authorities • Competitor information • Local chapter meetings of various organizations • Business intelligence websites • Advisory Committee meeting minutes • Clinical trial registries • Consortia participation • Professional and scientific publications

Because it impacts so many different aspects of asset development, the RI function needs to work with multiple external stakeholders, including the pharma and medtech industry, regulators, patient groups, trade associations and non-profit organizations — at local, regional and international levels. Incorporating feedback from these stakeholders to develop regulatory strategies early in a program saves development and approval time and expense.

RI professionals also, and foremost, need to network with internal stakeholders in order to best understand their goals, challenges and needs so that the RI function can provide optimal support.

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Regulatory intelligence: the best ally of regulatory policy

RI is a key input for shaping policy recommendations, which is why, in many companies, RI and regulatory policy are often conducted by the same team.4 By understanding the current context and upcoming trends of the regulatory landscape, companies can anticipate and influence future regulations and the regulatory framework.

“The real value comes from regulatory intelligence driving strategy —thinking about the current and future framework so teams can be proactive and innovative.”

- Carolyn Hynes, Regulatory Affairs Intelligence Director- Oncology, AstraZeneca

In this collaborative relationship, the RI function provides the intelligence, and the policy function aligns that intelligence with company goals to work with regulators, working groups, trade associations and other stakeholders to inform policy changes. Persuasive, well-founded comments for draft documents are more likely to be incorporated and meet industry stakeholder expectations. This partnership presents opportunities to innovate how products are developed, evaluated and marketed.

Collaboration is important across the regulatory environment When queried as part of a CIRS survey,5 multinational pharma companies stated they would like to see the regulatory environment become more collaborative, consistent and transparent by 2025:

• Continued collaboration with the International Council on Harmonisation (ICH), U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA)

• Harmonization of regulations and marketing application requirements (one global submission)

• Transparency and consistency in requirements and the review and approval process

• Knowledge sharing with Brazil, Russia, India, (Mainland) China and South Africa (BRICS) to accept joint assessments for faster, more transparent and consistent reviews

Regulators and health agencies are also increasingly using intelligence and collaborative relationships to ensure they optimize resources and address unmet medical needs. They gather intelligence from other regulators, participate in CIRS workshops and professional conferences (The Organisation for Professionals in Regulatory Affairs [TOPRA],6 Drug Information Association [DIA]7

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and Regulatory Affairs Professionals Society [RAPS],8 to name a few), industry publications and more. Discussions with sponsors and consortia are also instrumental, as seen with the COVID-19 crisis and the development of emergency approval pathways.

Sharing knowledge from well-established agencies to those in emerging markets supports harmonization activities. The CASSS Chemistry Manufacturing and Controls (CMC) Strategy Forums,9 held in the United States, Europe, Japan, Latin America and Mainland China, are an example of collaborative knowledge sharing about CMC challenges and solutions. Regulators also benefit from international capacity building initiatives that aim to strengthen regulatory systems.10

The regulatory framework can be shaped and more resilient in the midst of a crisis by sharing and using knowledge from previous outbreaks as well as timely intelligence. For example, analyses of existing Emergency Use Pathways (EUPs) can provide information about where they can be used, which are suitable for the current situation (e.g., COVID-19) and the appropriate processes to follow.11 Additional evidence of the outcomes from the use of EUPs can be used by regulatory policy teams to communicate their value and advocate for a new development and regulation paradigm or by introducing these regulatory agilities into the standard normative processes in order to speed up approvals and patient access to medicines. Participating in the national and international debate will allow companies to gather intelligence and make their voice heard.12

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Value of regulatory intelligence and functions: questioned, yet more critical than ever

With the growing number of global regulatory-related publications, staying on top of and analyzing the latest intelligence has become increasingly challenging, yet even more important (Figure 1). Despite the reach and impact of the RI and policy functions, they have too often been perceived as cost centers rather than as an investment. This could potentially be because they are primarily support functions with intangible outputs. Furthermore, the functions are not providing a revenue-generating service. This view of RI and policy is compounded by the fact that most companies lack a formal set of indicators to demonstrate the value of the RI and policy functions to the organization.

Figure 1. The number of global regulatory-related publications has increased exponentially over the last two years, during the COVID-19 pandemic

Source: Clarivate Regulatory Intelligence

Determining the ROI of RI and policy can be challenging. Indeed, typical measures of ROI, such as short-term financial outcomes, cannot always capture the value of intangible assets, including knowledge, strategic input, advocacy and impact on broader regulatory initiatives.

However, it is worth taking the time to establish a set of relevant KPIs for RI and policy teams to demonstrate their value to upper management for continued investment. Insights such as whether RI and policy have an impact on a financial measure or contributed to overall business objectives can also improve future deliverables and help teams address unmet business needs.

“Demonstrating the ROI of the RI function is the best way to stop skepticism on its value and promote its development.”

- Celine Rodier, Senior Health Policy Manager, Clarivate

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Defining KPIs for regulatory intelligence: alignment with company objectives

Many pharma organizations are challenged with identifying and measuring the right KPIs for RI and policy functions. The following KPI categories and measurement methods can demonstrate both the short-term and long-term value of RI and policy.4,11

Source: Clarivate

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One way that the value, potential impact, relevance, efficiency and effectiveness of RI deliverables can be measured is with a survey of end users. Surveys conducted on a regular basis — such as quarterly or annually — help the RI and policy functions to continuously improve.

The aim of many of the deliverables is to help the organization stay on top, and even ahead, of the external environment, which is crucial for compliance, faster time to market and reduced cost of development. The RI and policy teams can leverage their ability to provide timely, accurate information and actionable insights to other departments and establish themselves as expert advisors, rather than just a source of information.

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Regulatory intelligence and policy functions: invest in strategic and impactful activities Increasing awareness internally KPIs represent just one method to increase awareness of the value of RI and policy teams. In many companies, when things are going well, these teams typically fly under the radar. It is only when a regulatory issue occurs that other departments become aware that the company has an RI group. Initiatives to improve recognition of the central role of RI include regular meetings with other teams to present:

• the RI/policy function’s aims, • what has been accomplished, • current projects and • how it can help those teams achieve their goals.

The same information can be shared via roadshows at manufacturing sites or affiliates.

Training is another opportunity to provide education about the how and why of regulatory compliance. It is typically not enough to understand the actions required — it is also important to comprehend the reasoning for regulations and the consequences of noncompliance. During educational activities, RI teams can highlight the intelligence needed to determine the how and why.

Gaining recognition externally Engagement and collaboration with other organizations are important. Not only will this provide additional information sources and strategies, it will also enhance the company’s reputation as a trusted partner in the drug development process.

Life science hubs can be a way to share knowledge without revealing business strategies or ideas. The risk of compromising competitive advantage by sharing too much can otherwise be a challenge for companies when trying to collaborate.

The TOPRA Regulatory Intelligence Hub6 is a partnership collaboration RI tool and a source for sharing regulatory knowledge. The E.U. Regulatory Intelligence Working Group (RING) has also provided a guide on how to engage RI partners.13 Other global organizations facilitating links with regulatory agencies and fostering knowledge sharing through their platforms are CIRS, RAPS, DIA and CASSS.

These resources can be particularly important for smaller companies that have not previously considered an internal RI function. The recent trends in funding from capital markets for smaller biotech companies and expansion of niche markets (e.g., rare diseases) mean that many of these companies are taking their assets to market themselves rather than selling them off.14 Gaining the knowledge required to navigate the regulatory landscape can be challenging without access to reliable resources.

Utilizing robust data management tools The vast amount of information, as well its accessibility, quality and accuracy, remains a challenge for the RI function of many companies.4 A centralized system for maintaining and accessing up-to-date regulatory intelligence is crucial to disseminating reliable information companywide, yet this is often unrealistic for regulatory teams to create and update. Robust databases and data sources of global regulatory information, such as Cortellis Regulatory Intelligence™, are invaluable resources, particularly when they ingest data in near real time.

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Furthermore, teams benefit from automated notifications of modified or new regulations. Taking advantage of automation frees up regulatory professionals’ time for the important work of analysis, insight and strategic planning. For example, automated, customized newsletters for specific job functions reduce information overload and provide the latest information. Functionality for country-to-country comparisons makes it easy to determine the commonalities, differences and minimum set of requirements to ensure compliance across all regions.

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Leverage the value of regulatory intelligence and policy teams

Establishing an RI and regulatory policy department doesn’t necessarily require a large investment. However, even a small investment is well worth it. Outcomes benefit departments throughout the company and all phases of asset development.

Providing relevant and meaningful metrics is an important first step in recognizing and demonstrating this value, as well as providing the RI and policy teams with the feedback they need to improve their processes and deliverables.

Using the right tools and collaborative platforms will help ensure the success of regulatory professionals within your organization. Tools include robust databases with features that reduce administrative responsibilities and ensure all team members have current, relevant information for their job function. Collaboration within and without the organization provides new perspectives, opportunities to access the most recent information and recognition for the expertise of the organization.

Need help improving your ROI around your regulatory activities? Learn more about how Clarivate can help.

Contributor

Celine Rodier is Senior Health Policy Manager at Clarivate. She’s a PharmD with a post-graduate diploma specialized in Industrial and Biomedical Pharmacy and has over 16 years of experience in the regulatory spectrum (regulatory affairs, regulatory intelligence, regulatory science and policy), as well as over seven years in clinical and pharmacy settings where she regularly engaged with patients to understand their challenges with treatments. Céline joined Clarivate 11 years ago and brings her expertise to the Cortellis Regulatory Intelligence database, developed the Regulatory Consulting team and supported research work at the Centre for Innovation in Regulatory Science (CIRS), engaging with agencies and companies to benchmark regulatory practices in mature and emerging markets.

Céline has co-authored articles, reports and books and is conducting peer reviews for regulatory science articles. She is a TOPRA Fellow and has chaired the Regulatory Intelligence SPIN Steering Group since 2018. She received a Distinguished Services Award in 2020.

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References

1. MacFarlane, A. (2014) Information, knowledge & intelligence. Philosophy Now, 2014;98:18-20.

2. Brousseau, Z. (April 1, 2021). Regulatory Intelligence 101 authors stress importance of actionable info, communications, creativity. Regulatory Focus, [online], Available at: https://www.raps.org/news-and-articles/news-articles/2021/4/regulatory-intelligence-101-authors-stress-importa. (accessed September 16, 2021). (accessed: August 20, 2021).

3. Brown-Tuttle, M. Regulatory Intelligence and Policy: Shaping the Global Landscape. (November 2019) Regulatory Focus.

4. Executive Colloquium report – What is the value and return on investment for our company to maintain a regulatory policy function? (October 17, 2019). Centre for Innovation in Regulatory Science (CIRS), [online], Available at: https://www.cirsci.org/publications/executive-colloquium-report-what-is-the-value-and-return-on-investment-for-our-company-to-maintain-a-regulatory-policy-function/. (accessed August 1, 2021).

5. Patel, P. (June 2016). Strategies, enablers and barriers to medicines development in the Emerging Markets: The 2025 global regulatory landscape. DIA 2016 Global Annual Meeting, Philadelphia.

6. TOPRA Regulatory Intelligence Hub, [online], Available at: https://www.topra.org/. (accessed on August 1, 2021).

7. Drug Information Association (DIA), [online], Available at: https://www.diaglobal.org/. (accessed August 1, 2021).

8. Regulatory Affairs Professionals Society (RAPS), [online], Available at: https://membership.raps.org/. (accessed August 1, 2021).

9. CASS CMC Strategy Forums. CASSS, [online], Available at: https://www.casss.org/page/CMC. (accessed on August 1, 2021).

10. Heimann, E., Han, Z., Jamieson, J., Rodie, C. (September 2021). Achieving efficient regulatory intelligence in emerging markets. TOPRA Regulatory Rapporteur 18(9). https://www.topra.org/TOPRA/TOPRA_Member/REGRAP/Public/Regulatory_Rapporteur_Issue_Detail_Public.aspx?IssueID=599106&ID=57221.

11. Emergency Use Pathways (EUPs): applying regulatory flexibility in the age of COVID-19 (2020). Centre for Innovation in Regulatory Science (CIRS), [online], Available at: https://cirsci.org/wp-content/uploads/2020/05/CIRS-RD-Briefing-75-Emergency-Use-Pathways.pdf. (accessed August 1, 2021).

12. Rodier, C. (2020). Chapter 5: Contemporary Insights: Regulatory policy and the impact of COVID-19. CIRS 2020 Regulatory and Access Factbook, [online], Available at: https://clarivate.com/lp/2020-cirs-regulatory-and-access-factbook/. (accessed on August 1, 2021).

13. EU Regulatory Intelligence Network Group (EU RING). (March 18, 2021). A guide to engaging our partners in regulatory intelligence. Regulatory Rapporteur 18(3). Available at: https://www.topra.org/TOPRA/TOPRA_Member/REGRAP/Public/Regulatory_Rapporteur_Issue_Detail_Public.aspx?IssueID=565308&ID=57221.

14. Biopharma deals in review: A look back at an energetic H1 and what to expect next. (2021). Clarivate, [online], Available at: https://clarivate.com/lp/biopharma-deals-in-review/. (Accessed on September 16, 2021).

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