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Measuring the value of a pharmaceutical company's regulatory intelligence function

This article was originally published in SRA

Executive Summary

The EU Regulatory Intelligence Network Group explains how the regulatory intelligence function can demonstrate what value its activities and deliverables add to a pharmaceutical company's business.

The growing complexity of the regulatory environment governing the pharmaceutical industry coupled with the movement towards greater transparency has resulted in an increase in information output from global regulatory authorities. There has also been an explosion of web-based regulatory information sources, including social media. Pharmaceutical companies have to keep pace with this information in order to remain competitive and compliant.

A pharmaceutical company's regulatory intelligence (RI) specialist is responsible for transforming regulatory information into regulatory intelligence and delivering it to internal customers and stakeholders. The aim is to facilitate the development of innovative regulatory strategies, enable timely responses to emerging regulatory risks and facilitate compliance with external regulatory requirements.

In an article published in 2007, the EU Regulatory Intelligence Network Group (EU RING)* – an industry forum created in 2006 – identified the core responsibilities of the RI function1. These include targeted dissemination of updates on the changing regulatory environment and managing the internal consultation of draft regulatory authority guidelines. These responsibilities are fulfilled through a variety of deliverables, eg email news bulletins, online systems or formal reports. RING members have also adopted knowledge management strategies to maximize the scope, relevance and availability of such deliverables.

The value of the RI function – its activities and deliverables – is difficult to measure. This article reviews common RI deliverables and explores conventional and alternative approaches to measuring their value. The aim is to provide a meaningful way of demonstrating how the activities of the RI function can contribute to the success of the organization.

Regulatory intelligence and common RI deliverables

The EU Regulatory Intelligence Networking Group (RING) defines Regulatory Intelligence as: "…the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – eg outlining risks and opportunities – to the regulatory strategy. The process is driven by business need and linked to decisions and actions..."2

Intelligence is information that has strategic potential - it enables an organization to compare the risks and opportunities of different options when the success of those options is uncertain. In the context of RI, the skill of the RI specialist is to know how to transform regulatory information into useful regulatory intelligence. This requires knowledge of the business, its priorities and pipeline, as well as the changing regulatory environment.

"…Information describes: it tells us how the world is now. Knowledge prescribes: it tells us what to do on the basis of accumulated past experience. Intelligence decides: it guides, predicts and advises, telling us what may be done in circumstances not previously encountered and what the outcome is likely to be…"3

The EU RING identified the core responsibilities of an RI function as follows4:

  • selection, analysis and targeted dissemination of updates on the external regulatory environment;
  • managing the internal consultation process on draft regulatory authority documents;
  • providing responses to regulatory queries from internal colleagues; and
  • developing and maintaining online systems for managing regulatory intelligence.

The RING also identified other responsibilities of the RI function but these are less common5:

  • tracking implementation of new legislation and co-ordinating the impact assessment of new/revised guidelines on internal working practices;
  • authoring trend reports on key regulatory topics; and
  • providing intelligence on competitor products.

Some of the common challenges for the RI function are:

  • achieving global scope – having the resource, systems and processes in place for gathering and storing reliable regulatory intelligence from markets outside the US/EU;
  • defining core customers versus wider stakeholders – managing expectations and understanding priorities;
  • identifying and engaging internal expertise and gathering tacit regulatory knowledge; and
  • keeping pace with the evolving company pipeline.

Table 1 lists the core RI responsibilities and provides a description of corresponding common deliverables.

Table 1. Core RI responsibilities and common deliverables

Core IR responsibility

Description of common deliverable(s)

Providing updates on the external regulatory environment

Articles delivered by email, automated alerts or online systems that provide a summary of the key changes together with potential implications for the organization and any internal actions.

Managing the internal consultation of draft regulatory authority documents

Co-ordinating the gathering of written comments from internal stakeholders through face-to-face and email interactions. Moderating comments to meet quality standards and submitting final drafts to trade associations and regulatory authorities by the required deadlines.

Providing responses to regulatory queries from internal colleagues

Gathering, analyzing and synthesizing data from multiple external sources, including commercial databases and providing a written response in a structured format. Query types can include: competitor product reviews; environmental "horizon" scans; due diligence support; procedural intelligence, ie practical experience on the interpretation or application of regulatory provisions; regulatory precedents, ie known instances of a novel regulatory approach or deviation from normal practice and approval metrics.

Developing and maintaining online systems for managing regulatory intelligence

Platforms for storing and facilitating access to regulatory intelligence. These databases often use social media tools, eg RSS feeds, tag clouds and wikis to enable rapid retrieval of desired intelligence.

Measuring the value of common RI deliverables

The question of how to measure value in an organization is not new. The traditional measures tend to be short-term, quantitative and financial in nature, eg net profit or earnings per share. However, these measures do not fully capture the value of an organization's intangible assets such as its reputation or intellectual property – its good will, knowledge and know-how.

RI specialists are knowledge workers. They deal in information and frequently employ knowledge management (KM) practices in order to maximize the scope, strategic potential and availability of their deliverables. The approaches used to measure the value of KM will therefore be relevant to the RI function.

Knowledge management

RI specialists can be distinguished from other regulatory affairs professionals through their knowledge management activities.

Knowledge management is defined as, "a discipline that promotes an integrated approach to identifying, capturing, evaluating, retrieving, and sharing all of an enterprise's information assets. These assets may include databases, documents, policies, procedures, and previously un-captured expertise and experience in individual workers…"6

The skill set of an RI specialist may include database management, web development and experience with social media. To monitor the myriad of regulatory sources and avoid duplicative information gathering, the RI specialist will often employ sophisticated data gathering tools and search ontologies, often cultivating relationships with external solution providers in the process.

Conventional approaches - key performance indicators and their limitations

One way to measure value is to use key performance indicators (KPIs). KPIs equate value with performance, ie the performance of one's contractual duties in relation to a particular role. Value is determined by comparing actual performance against a set of pre-defined targets. These targets are usually quantitative in nature and are considered markers of organizational success. Achieving or exceeding the target is considered to bring or add value to the business.

KPIs are defined as: "a set of quantifiable measures that a company or industry uses to gauge or compare performance in terms of meeting their strategic and operational goals…7"

Table 2 provides a list of potential KPIs for the common RI deliverables.

Table 2. Potential KPIs for common RI deliverables

Core responsibility

Potential KPI(s) for common RI deliverable

Providing updates on the external regulatory environment

Number of subscribers to newsletters or alerts.

Speed at which RI group detects and communicates change on external environment compared with an external newswire.

Managing the internal consultation of draft regulatory authority documents

Number of draft guidelines circulated to stakeholders.

Number of comments received.

Providing responses to regulatory queries from internal colleagues

Number of query requests answered by RI function.

Time taken to respond to requestor.

Number of new queries from the same customer (ie repeat business).

Developing and maintaining online systems for managing regulatory intelligence

Number of page views.

Number of document downloads.

The KPI approach is limited when applied to information or knowledge. Similarly, it is limited when applied to (regulatory) intelligence. It is the impact that the information, knowledge or intelligence has on the recipient that is important. The KPI approach will merely reflect RI staff productivity rather than any benefit to the business. For example, the number of subscribers to a newsletter or email alerts does not indicate that the newsletter or alert has actually been read; equally, it does not indicate that the content has influenced a regulatory strategy or triggered an internal compliance review. Likewise, the number of comments received on a draft guideline says nothing about whether those comments have effected a helpful change in the wording of the final guideline. The KPI approach is also dependent on the rate of information output from external regulatory sources and this is largely beyond anyone's control. The true value of regulatory intelligence therefore depends on how (and when) it is used and whether its use leads to a positive outcome for the business.

When it comes to measuring the value of knowledge-based functions like RI, searches within the business literature appear to favor two approaches:

  • link a meaningful measure of value for a (knowledge-based) deliverable to a quantitative financial measure in one or two steps8, or;
  • demonstrate to senior management that quantitative measures of value are not appropriate for knowledge-based functions because the enabling quality of their deliverables is obvious9.

For common RI deliverables, the first approach involves translating a meaningful qualitative or quantitative measure into a recognized financial one. The second approach requires identifying the enabling quality of the deliverable as it relates to a particular business objective and then advocating this quality to senior stakeholders. The more compelling the link between the deliverable and the benefit to the business, the easier it will be to adopt the second approach.

Alternative measures of value for RI deliverables

With the limitations of KPIs and the two alternative approaches above in mind, a number of more meaningful measures for common RI deliverables are discussed below. Table 3 provides some examples together with some suggested links to financial measures (quantitative) and their potential enabling qualities (qualitative). A suggested method for obtaining the alternative measure is also provided.

Providing updates on the external regulatory environment

The emphasis should be on the usefulness of the regulatory intelligence, ie its ability to facilitate successful and timely decision-making. This involves digesting complex documents to expose the points of interest, outlining the magnitude and significance of any changes and the hidden opportunities or risks. If the RI function alone cannot evaluate the importance or implications of a change, its staff should liaise with internal experts to ensure this analysis is performed and communicated. Increased awareness of the change also drives an earlier response. The collective result is likely to be fewer unforeseen issues, better planning, and more effective deployment of resource. The regulatory department also becomes less inward looking and more attuned to the bigger picture.

Managing the internal consultation on draft regulatory authority guidelines

A draft guideline consultation often involves reaching out to multiple internal experts and stakeholders who may be located in different divisions of the company. The RI specialist can bring people together to create one set of clear, concise and scientifically-focused comments. Persuasive, well-written comments are more likely to lead to amendments to draft documents so that they better meet the expectations of industry stakeholders10 - for example, by removing any unnecessary barriers to a preferred product development strategy. This has the potential to reduce attrition and associated development costs.

Providing responses to regulatory queries from internal colleagues

The true value of this deliverable rests in enabling a successful outcome for the requesting colleague. For example, the regulatory evaluation of a competitor product may determine the likelihood of success of the company regulatory strategy. Due diligence support can enable the identification of potential risks with an in-licensing opportunity and may reduce the chance of acquiring a second-rate asset. Providing intelligence on the interpretation and application of regulatory provisions or highlighting deviations from normal practice helps shape dialogue with regulators if there is a need to justify a novel product development strategy. These activities have the potential to reduce review and approval times and enable delivery of earlier revenue streams.

Maintaining online systems

Online regulatory intelligence systems can expedite access to regulatory intelligence. They have in-built functionality that enables colleagues to find and retrieve intelligence documents on demand. Online systems can be used to promote a "pull" rather than "push" approach to intelligence dissemination. Users have the option to limit intelligence alerts to chosen topics of interest. Online systems can therefore reduce colleague search time and minimize the "noise" that characterizes information overload with the result that important updates are less likely to be missed11. Online systems can also facilitate compliance efforts and provide evidence to auditors and inspectors that company staff are being made aware of key changes to the regulatory environment. Data captured in an online system, eg regulator review and approval metrics can be re-used and re-analyzed in many different ways. This eliminates redundant data gathering. Finally, online systems enable a self-service approach to intelligence delivery that allows RI staff to focus on other activities. The overall value here is operational efficiency and reduced opportunity cost.

Table 3. Examples of alternative measures of value for common RI deliverables and links to financial measures and potential enabling qualities

Core responsibility

Alternative measure of value

Financial measure (quantitative)

Potential enabling quality

(qualitative)

Providing updates on the external regulatory environment

Reduction in staff time spent reacting to unforeseen regulatory issues or correcting submission errors.

Fewer critical or major findings in audits and inspections.

Better planning and deployment of regulatory resource.

No penalties for infringement of the regulations.

Greater awareness of the "bigger picture" – less inward looking regulatory department.

Enhanced reputation of the regulatory function amongst internal and external stakeholders. Regulatory seen as expert advisors rather than administrators .

Managing the internal consultation on draft regulatory authority documents

Number of comments that have been acknowledged or incorporated into the final guideline.

Fewer regulatory hurdles to derail a development program – potential to reduce attrition and development costs.

Will enhance industry's reputation as a trusted partner in the drug development process, potentially leading to better engagement with external stakeholders.

Providing responses to regulatory queries from internal colleagues

Reduction in time spent by non-RI staff gathering data.

Number of successful regulatory strategies.

Potentially faster review and approval times – enables earlier revenue streams.

Potentially earlier patient access to new medicines and enhanced reputation amongst patient advocacy groups and healthcare providers.

Maintaining online systems for managing regulatory intelligence

Fewer redundant conversations on the same regulatory issue.

Number of right-first-time regulatory submissions.

Less time spent looking for regulatory documents.

Reduction in redundant data gathering.

Reduced opportunity cost from re-work and duplication of effort.

Fewer expensive consultants or external platforms.

Better knowledge management leads to the appearance of hidden opportunities, eg emergence of novel filing strategies that lead to competitive advantage.

A method for obtaining alternative measures of value for RI deliverables

Establishing whether an RI deliverable has impacted on a financial measure or enabled some wider business objective is challenging. One approach is to use a "voice of the customer" survey to gather feedback from colleagues on whether and to what extent a deliverable has fulfilled its desired purpose. Such surveys can be carried out annually or quarterly using commercial survey tools or feedback gathered on an ad hoc basis. These tools employ numerical scales to rate value, as well as providing free text spaces to collect specific comments. The results from the survey will either capture the alternative measures of value above directly or will allow them to be determined indirectly. A proper analysis of the survey results will also help the RI specialist improve current deliverables and shape future offerings.

Conclusions

Conventional measures of value, like KPIs, have limited application to knowledge workers and, by analogy, to the RI function.

Demonstrating the value of common RI deliverables can be done in two ways:

  • converting meaningful alternative measures into conventional financial measures; or,
  • demonstrating to senior stakeholders that RI deliverables enable the achievement of business objectives and are thus inherently valuable.

The RING recommends the latter approach but appreciates the challenges involved. If, however, an organization is intent on maximizing its knowledge assets, it should accept so-called "softer" approaches to measuring value. Where there is acceptance, RI specialists should not waste their time developing complex, quantitative models.

The alternative measures of value for RI deliverables seen in Table 3 enable the adoption of either approach. Identifying the link between the alternative measures and a financial measure is relatively easy to perform. The suggestions put forward for enabling qualities provide a basis for advocating the inherent benefits that an RI function can bring to the organization. One method for obtaining the alternative measures is via a "voice of the customer survey". A proper analysis of the results will determine whether the RI function has truly added value to the business.

The common RI deliverables connect people in an organization. It is by working together and aligning objectives to business goals that functional groups can truly generate the value discussed above. Collaboration and enterprise thinking reduces the need for complicated and potentially divisive value measurement tools and fosters a more co-operative corporate culture that is mutually beneficial to all.

This article has explained the core responsibilities and common deliverables of the RI function and some conventional and alternative approaches for measuring its value. The approaches discussed here provide a starting point for the RI specialist to demonstrate in a meaningful way how the activities of the RI function enable a pharmaceutical company to keep pace with the ever-changing regulatory environment and how this can contribute to the success of the organization.

References

1. RING members, The company regulatory intelligence (RI) function, Scrip Regulatory Affairs 30, October 2007

2. See Reference 1

3. MacFarlane A, Information, Knowledge & Intelligence, Philosophy Now, May 2014; 98,18-20, http://philosophynow.org/issues/98/Information_Knowledge_and_Intelligence

4. See Reference 1

5. See Reference 1

6. Koenig, MED, What is KM? Knowledge management explained, KM World, 4 May2012. www.kmworld.com/Articles/Editorial/What-Is-.../What-is-KM-Knowledge-Management-Explained-82405.aspx

7. Investopedia accessed 12 February 2015, www.investopedia.com

8. Zimmerman KA, Can you measure return on knowledge, KM World, 1 April 2003, www.kmworld.com/Articles/Editorial/Features/Can-you-measure-return-on-knowledge-9454.aspx

9. Cohen D, What's your return on knowledge, Harvard Business Review, December 2006

10. RING members, Providing good quality comment on consultation documents, Scrip Regulatory Affairs, 13 June 2008

11. RING members, Sharing regulatory intelligence: Are newsletters here to stay or is social media the future?, Regulatory Rapporteur - TOPRA, 8(5), May 2011, 5-8

* The EU Regulatory Intelligence Network Group (EU RING) comprises the following individuals: Iain Todd, (GSK); Marianne Koehne, (Boehringer Ingelheim); Clare Lavery, (J&J); Carolyn Hynes, (GSK); Chloe Garay, (Eli Lilly); Hans Hoogland, (Leo Pharma); Claudia Hey, (Merck Serono); Lynne Scarlett, (Astra Zeneca); Kelly Munnery, (Gilead); Fiona Reekie, (Biogen Idec); Susanne Schertling, (Bayer)

This article reflects the views of the RING and not the individual member companies. The lead author is Iain Todd. Contributions have been provided by the other RING members. Iain Todd is a regulatory intelligence executive at GSK.

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