Reflections on life science’s regulatory environment  

Regulatory concept

In this article, Amplexor asks some of the company’s closest industry partners and BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and explore some of the most prominent themes and priorities seen throughout 2023.  

Those asked to share their thoughts included: 

  • Steve Gens, Managing Partner, Gens & Associates 
  • Remco Munnik, Associate Director, Iperion – a Deloitte business. 
  • Kelly Hnat, founder and Principal of K2 Consulting 
  • Tris Nockles, Labeling Networks Lead at Navitas Life Sciences 

 Here’s what they had to say. 

What, for you, is the single biggest issue of importance in relation to the regulatory function right now, and why? 

Steve Gens (SG): It has to be improving global ways of working. Decreasing the time for market approvals has been the biggest area of focus and progress, not least having witnessed biopharma companies with Covid-19 products being able develop and gain regulatory approval in record time.  

Never in our history has getting products to patients been so critical, and new approaches developed to accomplish this, something we’ve been tracking closely. We’re seeing new ways of working, increased application of modern technology and digitisation, and good old-fashioned process enhancement (change control, label management, regulatory intelligence) at an end-to-end level. 

Remco Munnik (RM): Up to now, regulatory has always been the spider in the web within a pharmaceutical company – collecting all of the relevant information for submission of the registration: Clinical, CMC, administrative data, etc – then compiling a valid eCTD by the submission deadline. Up to now this process has always been very document driven. That’s what has to change now, and is starting to change. In future, everything will be data driven, which requires a different approach to managing everything and ensuring its quality. 

Kelly Hnat (KH): Yes, we’re seeing a revolution in regulatory submissions at the moment and it’s changing everything about how we need to look at, manage, think about, and share data across pharma organisations. The current advance toward structured data and new submission paradigms will have benefits for regulatory, and across the enterprise, as we begin to tap the value of clear, accurate, and complete data representations of registered medicinal products. 

Tris Nockles (TN): Certainly, regulatory affairs is on the front line to deliver submissions in increasingly condensed timeframes. Finding people with the right skills to work in regulatory, which has been problematic historically, seems to have become a more difficult and lengthy pursuit in recent years. It can take 6-12 months to onboard mid-level and senior staff. On top of that, technology is under-delivering in many cases. It’s not uncommon for companies to augment their RIM capabilities with more friendly technologies to capture and feed data in, or look to flexible resourcing to enter data on behalf of their regulatory staff  

How do you see all of this playing out, and what should companies be doing now? 

SG: Companies that are modernising RIM now are focused on evolving the regulatory operation organisation – driven by the data sciences and advanced technology including robotic process automation, structured content generation, and connectivity to other critical functions such as quality, manufacturing, safety, and clinical. 

RM: With EMA’s direction now toward agile development, pharmaceutical companies too must become agile – in terms of adapting their own processes and systems. The biggest challenge ahead is for companies to become more data-driven organisations, and to adapt complex processes and transform the content from large volumes of legacy documents into more dynamic, reusable data. 

KH: The majority of organisations are already well into the planning and implementation of registration system enhancements now. That will continue, but organisations need to watch that they are not over-engineering their solutions. Structured regulatory data is only partly a technical problem; really the challenge ahead is a business process one. We need to change the way regulatory product teams work with technology. 

TN: With the twin challenge of speed of delivery in a highly competitive job market, companies should consider new and innovative ways of filling the staffing void.  Whilst companies continue to grow their internal talent bench they could look to flexible resourcing (outsourcing/offshoring) and technology and automation to enable routine operational work.  Alternative recruitment strategies may also include looking outside the traditional paradigm of only recruiting experienced staff and also seeing the value of the more technology savvy newcomers in the workforce. 

What do you see as being the main facilitators for change? What decisions/actions in particular will be important in determining how well companies do? 

SG: Companies need a clear digitisation strategy, in conjunction with other functions (e.g. R&D, manufacturing), as well as improved information exchange at a local affiliate or “last mile” level where further innovation is required. These two factors will greatly enhance both the efficiency and effectiveness of the regulatory organisation. 

RM: It’s really important that companies reset their strategy now, toward data-driven ways of working. And, has been said already, companies absolutely need to implement an agile way of working now, to cope with the huge task ahead – allowing them to move forward with small steps, while making real progress overall. 

KH: I also think regulatory needs to set its sights beyond its own borders – both in how data is collected and created, and also in how and where it is consumed. The main benefit of the structured regulatory data future is what this data can be used for. Regulatory affairs will not be the only consumer of this new, deep, accurate and complete set of data that is coming into being. It will have great value across the enterprise – for supply chain, commercial, and beyond. Thinking about the key potential consumers of data will help build its value beyond the regulatory compliance use case, and shift regulatory’s role within the enterprise as a data producer. 

As soon as we look beyond the immediacy of the regulatory function, the picture shifts for data management and its potential. What might that look like? 

SG: We are in the early stages of the “data connectivity” period, where critical data from various functions (regulatory, quality, manufacturing, safety, clinical, etc) are gradually being connected.  

This requires a clear focus and excellence around cross-functional data governance. It’s where the promise of cross-functional business analytics, real-time information visualisation, and advanced technology will play out. What we’re witnessing is the birth of the data science era. 

What frustrates you in terms of what companies still haven’t realised, or aren’t doing – and what should they do differently in 2023? 

SG: Pharma companies need to become better at central, regional, and local affiliate collaboration and information management. Lost opportunities persist when it comes to improving how real-time regulatory information is available globally, to support day-to-day operational tasks across different markets. On top of that there is substantial untapped scope to strategically improve the “time to patient” for new products – especially in the smaller markets around the globe. Improved regulatory intelligence sharing; global dossier management excellence; and the central organisation working more seamlessly with the local affiliate will be critical success factors. 

Finally, what’s next with digital labelling?  

TN: It’s a mixed picture globally but there are some real hotspots emerging. EMA is developing the technology to underpin the ePI common standard, and has a minimum viable product planned for a limited pilot in 2023, with a phased and flexible implementation to follow. This is in a shared workstream with DADI and SPOR, and the hope is that in future data will be interoperable across these platforms. 

Pilots continue to proliferate, and some countries have accelerated the conversion into formal regulations, notably in the Asia-Pacific region. Expansion is particularly prevalent with regard to hospital-only products, and this is where there are a number of expansions in the EU. Another potential opportunity could be to consider the model adopted by Norway with extended implementation timelines where digital labelling is available. 

Apps and blockchain continue to offer options for the technical delivery of patient information but this needs alignment on a single solution. Otherwise, patients and healthcare professionals will need a myriad of apps. Scanning codes on packaging appears to be a preferred option moving forward and, with an appropriate education program, this could be beneficial in ensuring patients are accessing the most up-to-date information. 

KH: Organisations shouldn’t rely on technology to solve their problems though – it’s only a tool. The key to success is always going to be manifested through business process and organisational culture. Top-performing organisations excel at the process and organisational work, along with strong implementation execution. These strengths can overcome the weaknesses with almost any software platform… but the opposite is never true. 

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