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Regulatory intelligence

Using this speciality asset assists the regulatory section of a company and leads to better strategic decisions across the wider business and portfolio

books_hammerRecently I came across a perfect and involuntary example of business blindness in a financial magazine, which led me to ponder on the real meaning of intelligence, from a professional perspective. The whole winter issue of the publication was dedicated to emerging markets, but one sentence caught my attention: 'Libya is not only a place where political and economical stability lie, but one of the major opportunities to invest your money…'

The word 'intelligence' is biased, since in most European languages it means 'the intellect, the understanding (of a person or an animal)'. However, the English language includes a further subtle definition, according to the Oxford English Dictionary: 'the collection of information, especially of military or political value.' Being a regulatory professional in the pharmaceutical field, I started thinking about 'regulatory intelligence' (RI), its definition, implications and value.

In recent years, RI has evolved rapidly and is now a speciality. Increasing numbers of companies are establishing dedicated intelligence groups. However, the scope of RI varies depending on geography, resources and company size.

Not only does RI lead to intelligent regulatory affairs, it also leads to intelligent strategic decisions for the wider business and portfolio. RI is something that transforms a 'box ticker' into a regulatory professional. It is a mixture of experience, knowledge, instinct and networking, combined with common sense and a learned ability to distinguish between news and important news.

RI can advance product lifecycle (value chain) in terms of procedural, technical, scientific and strategic input. Core roles include general information gathering and tracking legislation, followed by information dissemination and use. Procedural intelligence can include advising on marketing authorisation applications (MAA) format and procedures, content and copy requirements in Europe and subsequent rest-of-the-world dossier preparation, plus compilation of internal working practice documents, templates and policies.

Organisations use RI to advance development candidates by creating product regulatory strategies and development plans (based on knowledge of regulatory environment and changing guidelines) and in response to specific projects. It is crucial to understand that the regulatory world is a living and evolving body and regulatory science shapes and studies this evolutionary process.

A Google search of 'regulatory intelligence' calls up about 25,600 results in a moment. When so many results are achieved, this query is clearly pointless. The amount of information found is not significant; it is the impetus behind the process that counts. This can be divided into three parts:

1.    The goals
2.    Sources of information
3.    Benchmarking the outcome.

The goals may vary, but their importance remains the same, irrespective of whether a generic product or an innovative therapy is the subject. Consistency is of paramount importance; competitors, development streamline, marketing opportunities, regulatory guidelines and previous experiences are key considerations. Ask how another company succeeded (or failed) previously. How can colleagues in the nonclinical and clinical fields be directed towards a focused development stage? How will the product be placed in a competitive market (including price and reimbursement)? How and where can regulatory advice be sought? Finally, do not worry if plans have not been tried before. Ask colleagues, regulatory societies, social networks, personal contacts and competent authorities for advice because today there is a spirit of transparency and willingness to listen, understand and cooperate.

Sources of information
One of the major issues in gathering information is to balance quantity and quality. Usually, quality is scarce and quantity is overwhelming. When searching for something specific, there are plenty of databases to help, some of which are free of charge. The real problem lies in how a single piece of information is used and how much it can be relied upon. That is one of the most important reasons why a professional organisation is essential to discriminate between the few crucial items of information and the flow of useless (and probably unsafe) everyday news. There are no automated processes. Software cannot support the automation of MA procedures. It is a nice dream, but the reality is more complex and relies upon the value of knowing the key to open doors; right person, right place, right time.

A common misconception is that RI is an expensive burden that many small companies cannot afford, but in reality there is a plethora of information sources, many free. Furthermore, success is achieved through effective internal and external networking and drawing on previous roles or company experiences. Information gained should always be validated before use and assessed in relation to the current environment.

Benchmarking outcomes
Traditionally, a dedicated RI function has been considered a luxury, with regulatory focus on product approvals rather than influencing policy or anticipating regulatory change. However, companies are increasingly establishing dedicated intelligence groups and sharing non-confidential regulatory information. Despite this, little has been published, with experience emerging only via presentations and case studies.

A regulatory strategy coming from the exercise of RI would be good, but it would be unsuccessful. Mathematicians say that, for a theory to be valid, there are two elements to be taken into consideration: the inherent beauty, elegance and simplicity and the experimental challenge. If a theory is too complicated, it is more likely to be proved wrong. However, even a simple and elegant equation must pass experimental examination. To be creative must involve copying competitors, while considering the evolutionary essence of regulation. Simulations can be carried out when planning a regulatory strategy, including cost and time implications.

However, in the end, the result gives success to a strategic pathway, which has to be lived as an ever-changing process with a step-by-step approach. Someone could be brilliant in solving non-clinical problems, but once in the ward, not able to cope with a clinical setting. Simply, it is a matter of being a team, with different cultures having the same aim. Absorbing different cultures is one of the winning factors in RI.

Effectiveness is considered a key measureable. A continuum should be established which transforms personal knowledge (implicit/tactic) into organisational artefacts using external processes, such as team interactions, experts, training and face-to-face conversations. Tactic knowledge can be created from explicit knowledge by internal processes, like evaluating, observing and listening. This requires a combination of search engines, document management, data-mining tools and social networking, on top of established best practices, including adding contextual information to entries, standardising formats and templates, providing clear navigational aids and being user-orientated.

In conclusion, all companies perform RI to some extent and more and more are establishing dedicated intelligence groups. However, much RI scope varies. RI, in the form of active analysis and interpretation, does not equate to regulatory information (raw data). Regardless of company size, an RI strategy is required along with allocation of key tasks to ensure compliance, future awareness and adequate resourcing. This should serve as a living document as priorities and the environment change.

Having the correct regulatory information and using it to design and implement good regulatory strategy can lead to reduced time to market (both via accelerated development and smoother registration assessment), reduced costs, increased compliance and ultimately optimisation of return on investment. This not only requires a supportive and enthusiastic company culture, but also completes the cycle by creating a positive culture of inclusion and a desire to share knowledge and experience.

In the regulatory context, the immortal question 'to be or not to be?' could be translated into 'to know or not to know?'

The Author
Dr Paolo Biffignandi is an independent regulatory consultant based in Torino, Italy and past president of The Organisation for Professionals in Regulatory Affairs (TOPRA)

To comment on this article, email pme@pmlive.com

14th April 2011

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