No market is immune to change, and life sciences continues to face its fair share of upheaval as the industry accommodates emerging innovation in healthcare and a raft of other challenges to the status quo. Below are five of the most prominent trends and what they mean in practice.
As a shortcut to attractive new product lines, when development and testing cycles can be frustratingly long, companies are increasingly sizing up strategic purchases. 2016 saw high levels of merger and acquisition (M&A) activity and more of the same had been forecast for 2017 (1,2). Though this has not quite materialised so far, it is expected to pick up in the second half of the year.
However, profiting from these deals means the acquiring company must be able to align its branding, content and labelling quickly, reliably and efficiently. This is essential in upholding brand image, stabilising compliance efforts and maximising process efficiency, as well as market opportunity.
Harnessing automated content checking using technology that can compare and accurately spot and highlight anomalies – at high-speed across huge batches of content assets – can reduce the time taken to verify output by as much as 85%. This can have a marked impact on speed to market for products under new ownership.
The growing global over-the-counter (OTC) drugs market and increasing emphasis on generic medications are also having an impact on the management of patient safety information. One research and advisory company suggests that the global OTC drug market, valued at $120 billion in 2015, will be worth $162 billion by 2020 – a compound annual growth rate of 6.37% (3). In the intervening period, large volumes of branded drugs will see their patents expire, leaving a gap that could be filled by generic products. If they are paying for their medication over the counter, patients are likely to be more cost-conscious, prompting them to choose store brands. Clinical prescribers also have a similar growing interest in these therapeutics.
The global generic drugs market is on course to grow at a compound annual rate of 10.53% between last year and 2020, according to a report from India – a popular source of outsourced generic manufacture (4). But what pharmaceutical manufacturers save in production and marketing costs must not be sacrificed in quality, safety and reputation. The more suppliers/product handlers present in the chain, the more critical it is that efficient and reliable quality checks are in place to align labelling and patient leaflets. As information is updated in light of emerging contra-indications or the discovery of new side effects, these should be reflected throughout. Strict deadlines are applied to such requirements, meaning companies need to move quickly or risk products being withdrawn from the market until they are compliant once more. Again, the advice is to harness reliable automation solutions.
Digital Patient Information
As patients are invited to have more involvement and control in their treatment, pharma companies are turning to digital channels to meet that need. Publishing information online is also more cost-effective and is easier to update quickly, so it makes sense to utilise online opportunities.
Across the Atlantic, digital channels have turned out to be a powerful and effective way of reaching out to and engaging with consumers for promotional purposes. In the US, brands having product-specific microsites – where they can drive traffic captured via social media, for instance – is increasingly commonplace. Surveys suggest that 73% of US adults now use online health information and tools, highlighting the need for firms to have a strong digital presence (5).
For safety’s sake, online formats must also include the relevant prescribing dose and safety information. Therefore, companies must be able to manage and coordinate these channels alongside the traditional physical patient leaflets, ensuring that messaging is consistent and accurate across the board. Practically, this means being able to check content in XML or HTML formats as well as PDFs and text or Word files.
Maintaining Standards Globally
Efforts to harmonise product information standards internationally are progressing and should make life much easier. However, for the time being, global life sciences players still need to put in a lot of work to ensure that they are meeting the quality and safety criteria in each individual market.
This can be a demanding requirement given the varying emphases, not to mention language, phrasing and symbol differences between countries. Checking content across different languages and cultures presents its own issues because of the subtle differences in the interpretation of particular phrasing. Unless the parties responsible for reviewing translations are completely fluent in multiple languages, the scope for error is significant. Thus, teams must have the backup of sophisticated software to smooth the process and highlight anomalies. One reliable way to do this is by comparing the code behind the characters to be printed – allowing two files to be compared in any language and any font (as long as these support Unicode).
Firms are advised to move away from after-the-fact checks and towards timely detection and resolution of compliance and quality events. This will reduce the risk of regulatory issues hampering innovation and slowing revenue generation (6).
In the current climate, prevention of problems is more cost- effective than cure, so tools that allow the industry to be ahead of the game have much in their favour.
Maintaining Relevant Talent
Finding and retaining the required skills for regulatory and quality purposes is increasingly problematic. A report published by a UK trade association two years ago pointed to challenges regarding the quality of experienced candidates applying for senior level regulatory roles, which was being cited as a critical concern (7). More experienced positions require a blend of regulatory and commercial knowledge; those with niche skillsets can encounter issues with absorbing other responsibilities.
Even in 2015, companies were reporting typical recruitment times of 6-12 months, and the situation is now worsening. There are further factors that make building and maintaining teams of regulatory professionals harder, including:
Brexit and the free movement of labour in Europe
Increasingly complex compliance requirements
The expanding presence of pharmacovigilance
The stress placed on those responsible to be absolutely meticulous in the accuracy of product information
Manual tasks are unrewarding, demotivating and a poor use of qualified experts’ time. In a recent study, almost three quarters (73%) of employees cited their greatest motivation at work was doing a job that had meaning and purpose(8). Despite this, rather than hiring proofreaders, pharma organisations use scientific writers with master’s degrees or PhDs to check over content, at great expense.
As they try to fill the gaps and keep hold of the qualified and experienced professionals they already have, life sciences companies need to be clever about how they support those people to make best use of their time, and how they manage the tasks that add the least value professionally but are vital to the organisation.
As predicted, 2017 is proving to be another challenging year in life sciences. Having said that, change can be healthy and bring about regrowth as long as companies do not put off inevitable adaptations until they are at a competitive disadvantage. Firms across the maturity spectrum are generally safe, providing they have the right mind-set and vision – even if some will take longer than others to deliver the necessities.
This article has been published in the European Biopharmaceutical Review, October 2017
1. Visit: www.pwc.com/us/en/health-industries/pharma-life-sciences/ publications/pharma-life-sciences-deals-insights.html
2. Visit: assets.kpmg.com/content/dam/kpmg/ch/pdf/clarity-mergers- and-acquisitions-2017-en.pdf
3. Visit: www.technavio.com/blog/top-20-vendors-global-over- counter-drug-market
4. Visit: www.reportsnreports.com/reports/586255-global-generic- drugs-market-2016-2020.html
5. Visit: www.ey.com/publication/vwluassets/ey-managing-regulatory- and-legal-risk-in-the-digital-world/$file/ey-managing-regulatory- and-legal-risk-in-the-digital-world.pdf
6. Visit: www2.deloitte.com/content/dam/Deloitte/us/Documents/ regulatory/us-life-sciences-regulatory-outlook-2017.pdf
7. Visit: www.abpi.org.uk/our-work/library/industry/documents/ skills_gap_industry.pdf
8. Visit: www.kornferry.com/press/korn-ferry-survey-lack-of-achallenge-