Crunch Time: 2017’s Data Priorities Must Exceed Regulatory Requirements

Leaving aside intensified regulatory scrutiny, life sciences organisations still face a host of challenges as 2016 gives way to 2017. Globalisation, market consolidation, and calls for faster innovation and transformation are threatening existing business models and demanding that organisations begin to respond differently. Therefore, to survive and prosper, companies have to be breaking new ground by, for instance, exploring the impacts of looming trends towards preventive, collaborative health care, as well as wellness and nutrition, on their businesses. However mired in red tape it might be, the life sciences industry is not immune to disruption, so companies must have preemptive strategies in place for whatever could come next.

The right strategy for regulatory information management (RIM) holds the key, surprising as that might seem: control of critical operational data is essential to getting products to market promptly. And being able to distribute that kind of information securely is the key to innovative new collaborations, effective supply chain management, and increased transparency.

Focusing the mind: IDMP

The Identification of Medicinal Products (IDMP) remains an industry priority—as it must. IDMP standards encourage companies to be more systematic and comprehensive in their data-recording and data-handling processes, which actually presents not a challenge to be overcome but a range of new benefits that companies that approach it cleverly can enjoy.

A survey by the Implementation of Regulatory Information Submission Standards (IRISS) suggests that a sizable majority (79%) of organisations have IDMP projects under way and that senior management buy-in has grown, which is good news. And some companies are looking to achieve more than simply meet compliance requirements with IDMP. In the IRISS survey, 79% of responding companies claim to be using IDMP to improve internal processes. A study by Gens & Associates suggests companies’ growing desire to tackle information management on a panorganisation or global scale to boost decision making, better manage submissions to health authorities, and enhance output to stakeholders.

Turning safety into a differentiator

Safety is high on the life sciences agenda, with pharmacovigilance processes and the pharmacovigilance quality system under the microscope. But it isn’t only about meeting health authority requirements; safety (e.g., in the form of products with fewer side effects) is becoming increasingly seen as a market advantage.

Again, robust information management is crucial. RIM will also stand companies in good stead for new good pharmacovigilance practices around monitoring the Internet and social networks—assisted by big-data analytics—to track a drug’s real-world impact. And finding ways of navigating this complex requirement is likely to become a top priority in 2017.

Optimisation of resources: New options

The more centralised and holistic a company’s data management capabilities, the more extensive the options around who looks after associated processes, such as marketing submissions publishing. LEO Pharma and AbbVie are among companies that have talked openly about outsourcing’s potential for freeing affiliates in outlying markets to focus on commercial results.

Future product strategies

Now more than ever, life sciences companies must think outside the box in order to stay ahead in their markets. The growing trend towards the use of biosimilars is one example of where the field of product development may be going next. Although it’s still early days, the use of biosimilars represents another case in which a robust regulatory information management strategy could pay dividends—by coordinating all associated product data.

Preparing for the unforeseeable as well as for the known

If 2016 has been a challenge, 2017 is likely to be tougher still. Predicting the future is of course impossible, but with a solid starting point in the form of a robust, centralised data strategy, a company stands a better chance of getting to where it needs to be.

https://www.iriss-forum.org/news/iriss-publishes-the-results-readiness-surveys-for-idmp.

Pursuing World Class Regulatory Information Management (RIM); Strategy, Measures and Priorities, Gens & Associates, 2016.

About the author

A microbiologist by degree and a business development professional by career, Adam is a twenty seven-year veteran of the software and Life Sciences industry. In 2012 he was named to the PharmaVOICE 100, which recognises the 100 most influential people in the life sciences industry.

As CEO of ProductLife Group Adam is responsible for the overall direction and management of the company, partnerships and M&A strategy. Prior to ProductLife Group, Adam held roles as director of marketing & strategic business development at CSC Life Sciences and Vice President Global Sales & Marketing at ISI.

Adam holds a Bachelor of Science in Applied Biology from Liverpool University.