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Meeting with approval

Integrating regulatory affairs into development plans helps products reach patients sooner

Several arms gesturing 'thumbs up'The regulatory affairs (RA) professional's main business objective is to obtain and maintain the authorisations for companies to market medicinal products, through navigating the complex and rapidly changing legislative environment. To help achieve this, the RA department provides strategic input on drug development plans and routes to approval, making it a key player in helping to get new medicines to patients sooner, and thereby supporting commercial success.

An important role; yet, a European survey undertaken through members of The Organisation of Professionals in Regulatory Affairs (TOPRA) shows that, of the 234 respondents, 61.5 per cent feel that the RA profession does not have a high enough profile in the industry. Over half believe regulatory input into the drug development process is not valued greatly enough.

A contributing factor may be that RA is a relatively new career, formed at the birth of modern pharmaceutical regulations following the thalidomide cases in the 1950s and 1960s.

Until recently, there has been neither accredited training nor professional designations, but now TOPRA offers a training programme that provides everything from a basic foundation in RA through to the modern business and management skills needed by those at the top level. For brand managers and marketers, a course on the basics of regulatory affairs aims to provide a clear and concise understanding of the role played by RA in obtaining and maintaining marketing authorisations for pharmaceutical products.

Critical speed
In today's competitive environment, reaching the market faster is critical to the success of a product and, therefore, the success of the company. The integration of RA strategy into development and life cycle management activities is of considerable economic importance.What is needed is for RA and marketing to work more closely together.

Professionals in RA are frequently associated with constraining regulations, but they can offer great strategic value in negotiating what can be a confusing and complex place – particularly if you have no formal RA background. Their role is key to a successful product launch and life cycle development.

Common objectives
Most successful companies are those in which RA and marketing understand each other, appreciate the purpose of the other function and work together towards the common objective of making new medicines available to patients. Your RA colleagues can guide you, and the company, through the journey from development, to approval and then post-marketing.

At Lundbeck, we work with the product team from early on in drug development, offering strategic input and technical guidance on regulatory requirements. Our RA team undertakes a regulatory risk assessment, which includes critical appraisal and hypothesis testing. This provides a framework for evaluating the impact of change and new information on development plans, including resources, timelines and market potential. We are then able to assess and mitigate early stage risk, enhancing our control over the project and helping to avoid late stage regulatory issues that can lead to delays in approval. This was demonstrated in practice when one product – to be administered by intramuscular injection – had a pharmacopoeial standard for its major excipient, but for a different route of administration and for lower amounts. It would have been possible to conduct the clinical development programme without knowing if this novel formulation would be considered approvable by health authorities. The RA team, however, dealt with this significant risk before Phase II trial.

Liaising with authorities
Another key role of RA is to interact with regulatory authorities, to know the trends in the global regulatory environment and to translate this information for the company. When working on a new treatment for a recognised chronic medical condition, using a novel treatment regimen and new primary efficacy endpoint, we explored the regulatory acceptability through the EMEA scientific advice procedure. It was through this process that we learned about a draft guideline in preparation that would impact our development plan.

RA also brings to the table:
• An understanding of the interdependencies of the activities across all functions in product development
• Guidance on suitable endpoints to support approval
• Knowledge of the regulations and timelines for required activities
• Knowledge of the external environment, which includes continuous assessment of the impact of changing regulations, competitors and treatment standards.

When RA is integrated into product development it can have a major business impact.

The Author
Heather Cook, PhD is head of department, regulatory development projects, at H Lundbeck  and a member of TOPRA
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Future trends in regulatory affairs

• Continued globalisation of R&D – with focus on emerging markets
• Exploration of fundamental changes in the R&D process
• Call for new business models
• Bundling of healthcare management – drugs, devices, information, patient services
• More specialist therapies – complex products requiring scientifically educated staff
• Regulators becoming more risk aware
• New skills needed for the new market – such as researchers capable of considering commercial imperatives

TOPRA's Annual Symposium

The three-day regulatory affairs event will bring together high-level speakers – including government ministers, heads of agencies, key officials from the European Commission, heads of unit from EMEA, leading pioneers and practitioners from within industry, pan-European policy makers, patients' groups and consultants – who will examine topical issues in European and global regulatory affairs.
The event provides a forum to find the most up-to-date RA information, collect new ideas to help meet the challenges and maximise the opportunities offered by the current regulatory environment.


8th September 2009


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