Keeping up-to-date on the latest market developments is crucial for any team, particularly within regulatory affairs in the pharma industry, where horizon scanning for information includes therapeutic areas, trade associations, regulatory bodies, pharmacovigilance data, and the various global regions. And in an ever-changing market like pharmaceuticals, a missed insight could prevent an organization from remaining compliant.
So what’s the big deal? Surely there are plenty of resources out there that can help these teams stay on top of what they need to know?
Monitoring the entire regulatory landscape is no easy feat due to the sheer amount of data that is now available, whilst information being more widely available is regarded as a positive, it now means it is getting harder to discern the valuable insights from the noise. This, combined with the speed at which regulatory updates and changes are happening, is contributing to the increasing overload regulatory teams are facing.
Thankfully, advancements in technology, particularly within artificial intelligence (AI) mean that regulatory affairs teams can begin to harness the power of these new technologies, to surface more insights from their information than ever before. Here’s a breakdown of how new developments in AI are paving the way for the pharmaceutical industry to increase efficiency now, and into the future.
Driving forward drug discovery
The ongoing pandemic may be an over-used example as to why digital transformation is essential for any business to survive – but hear us out on this one. Within the pharmaceutical industry, digital transformation has shone a light on the drug discovery and development process – we’ve all seen how the vaccines were created, tested, and rolled out across the world at a speed never seen before. Technology had a big part to play; research has found that artificial intelligence (AI) has the potential to save firms over $70 billion in the drug discovery process by 2028.
Whilst these advances come with obvious positive outcomes, it also means that extra pressure is being placed on regulatory teams. They are having to be more vigilant than ever before to ensure they are staying on top of the regulatory landscape and any changes that come in that could impact their organization’s compliance. So whilst an increased rate in drug discovery is revolutionizing the pharma industry, regulatory teams must also ensure they are transforming – by taking advantage of the new technology available to them to increase efficiency, ease pressure and reduce the risk of missed information.
A case for compliance
The surge in new drug development also means a surge in information regarding legislations, guidelines and other critical updates. For regulatory affairs teams, this impacts how they would monitor those in the clinical testing phase and any updates from regulatory agencies such as the FDA and EMA. It is becoming increasingly difficult for regulatory teams to keep up, particularly as all the information needing to be monitored is spread across various sources, meaning there is a likelihood that critical information can get overlooked – which can result in legal (or sometimes financial) ramifications.
It is of great importance for pharmaceutical companies to ensure they are aligned to the latest changes in regulations, to avoid receiving huge fines and losing the trust of investors and consumers – particularly because the drug development process typically costs around $2.6 billion, so prevention of any extra costs or loss of funding is imperative.
Recent developments are helping to curb this risk through the application of sophisticated and tailored AI models to the datasets being used by regulatory teams to monitor the regulatory landscape. By pairing these models with the ability to integrate diverse regulatory sources in real-time, regulatory affairs teams can start to automate information discovery, which leads to huge productivity gains, but they can also be assured that the most relevant insights are being brought to their attention as a priority.
Having AI in place to pick up these changes gives organizations the opportunity to react quickly, or in some cases, predict changes before they happen by monitoring the media landscape.
Augmenting Human Expertise
Traditionally, pharma companies have relied on very manual processes when it comes to keeping up to date with regulations. It’s likely that at some point, we’ve all experienced laborious manual systems which often lead to delays and room for human errors. For regulatory affairs teams specifically, this combined with other factors including outdated technology and workflows are contributing to the millions of dollars incurred every year.
Technology can help reduce the risk of error by modernizing and improving the efficiency of current workflows, including the communication of regulatory changes and pharmacovigilance which is key to regulatory affairs teams. AI can also take the burden away from employees by using machine learning to carry out repetitive tasks and freeing up their time to focus on other areas such as analysis of information and assessing the impact any changes will have on the organization.
What solutions are available?
Thanks to the many advancements in technology, there are a number of solutions that are available to regulatory teams that enable them to monitor and gather critical insights, reduce the risk of missed information and help them stay compliant. More specifically, these solutions can help tackle a number of issues regulatory teams are often faced with, including:
- Reducing information overload
It is becoming increasingly difficult to keep up with critical information and insights, which is why leveraging the power of AI to help filter regulatory updates can help you and your team surface the information most important to you. When AI is coupled with human expertise, it also ensures that no ‘noise’ slips through the net – giving you confidence that the updates you receive are of the highest quality, and also means you can maximize the ROI on your information sources.
- Monitoring the landscape in real-time
Using advanced technology, information can be integrated and enriched from multiple regulatory bodies, news sources, and premium sources – all in real-time. By centralizing all of this key information into a single source, regulatory teams can save a huge amount of resources, including time and money.
- Communicating updates to key stakeholders
The ability to communicate key information and updates is key for regulatory teams, which is why it is important to find a solution that can be tailored to what works for you. Whether this looks like an internal information portal, weekly news briefings, alert notifications to your mobile, or programmable access to powerful services via an API – there is a range of delivery methods that you can choose from.
At InfoDesk, we’ve been working with regulatory teams for over 20 years, combining the latest in AI technology, with human expertise, to deliver critical intelligence that helps pharma organizations remain compliant. To discover more about what we can do to help your team, download our one-sheet below.
Ultimately, all regulatory teams have one thing in common – to ensure standards set by the regulatory bodies are being met, and that their organization is remaining compliant at all stages of drug development and distribution. Developments in technology, including the power of AI, are giving these teams the ability to do this more efficiently and also navigate the difficulties that come with the increasing availability of information in today’s digital age.
Investing in solutions that harness the power of advanced technologies not only improves ROI by reducing costs and driving efficiencies but also presents an opportunity to build a solution that can adapt to changing needs in the future. As investment into AI-based solutions starts to gain momentum, those who leverage the technology available to them will reap the benefits within an incredibly competitive market.