Dealing with High Complexity in Change Control- Life Sciences Sector

There is an ever-increasing rate of change in the macro environment which has a direct or in-direct impact on the life sciences sector. We are navigating a time of heightened?VUCA?(Volatility, Uncertainty, Complexity and Ambiguity) which has the potential to impact many areas across the value chain.

One key area in focus is Regulatory Affairs for companies of all sizes but most especially large organizations with global footprints.

Efficient and effective management of change is a critical success factor for Regulatory Affairs organizations and has become increasingly challenging over the years.

Some of the factors driving increased complexity and challenges around change management are outlined below as well as some of the approaches that can be employed to mitigate these. At the very highest level, when we look at change management, we need to consider?People,?Processes?and?Systems (PP&S). Below we will unpack to a lower level and map back to PP&S.

Increased Complexity (People and Process)

With the increasing downward pricing pressures, it is imperative to have a greater focus on the benefit/ risk ratio of new market entrants. This, in turn, has an influence on the design (and associated time/ cost) of clinical studies needed for registration. There are significant shifts in medical sciences (new medical frontiers) toward novel treatments such as gene and cell therapies (GCT), RNA interference, endogenous metabolic modulators amongst others and some big pharma companies are already actively changing their focus so as to deprioritize/ divest current assets (e.g. small molecules) to aggressively focus on new medical technologies and related opportunities.

For most, this will necessitate the building of new skill sets at scale and regulatory professionals will be focused increasingly on new development assets diluting their attention toward change management.

This means that less time is spent on change management activities and processes/ systems that are not well understood nor managed by the responsible professionals. This in turn can lead to inefficiencies and lack of oversight (increased compliance risks).

In order to mitigate this risk, many regulatory organizations are creating dedicated change management teams, often contracted or outsourced. This frees up time to focus on more value adding and higher complexity matters. By staffing these dedicated teams with appropriately qualified and trained regulatory professionals, there will be significant improvements in efficiencies and oversight even in the short term. This will also facilitate a laser like focus on more value adding activities creating a win-win situation for all involved.?

Increased focus on Efficiencies (People and Process)

The global healthcare spend is projected to exceed 10 trillion USD in 2022, which will further increase the downward price pressures and the drive toward more pricing transparency. As the economic instability increases globally the payors ability to pay will be increasingly stretched.

Given that these downward price pressures will impact top and bottom line, there is an ever increasing need to drive cost savings within operations, across the entire value chain, not least in regulatory affairs organizations.

As regulatory organizations focus more than ever on their core capabilities and assets and supporting the growth of the portfolio, change management may become under resourced. The lack of resourcing can lead to cumbersome processes that are not well understood and underinvestment in the area can also lead to regulatory professionals “battling” with legacy systems that are not fit for purpose.?This lack of focus and investment leads to inefficiencies and at worse compliance issues across the value chain.

To mitigate these challenges, once should consider process redesign to reduce “waste” and increase efficiencies end-to-end. Today there are also a raft of digital automation solutions available on the market that can support major disruption of how changes are identified, assessed, and managed. Robotic Process Automation (RPA) is increasingly used across operations.

These factors combined with dedicated change management resources (as mentioned above) can completely transform the way changes are managed end-to-end. Increasingly, organizations are looking to professional services firms to provide these dedicated, well trained change management professionals. Global (remote) access to talent has never been easier given the rapid improvement of digital solutions. This, in turn, means accessing resources through global outsourcing has just become way easier than it was in the past. Regulatory organizations have become increasingly networked and collaboration will be key to success going forward.

Increased rate of Change in Regulations (Process and Systems)

One of the greatest concerns of regulatory organizations in the life sciences sector is the rapid rate of regulatory change and their ability to stay abreast of the changes (stay in compliance) globally. Compliance has become a key component in regulatory affairs departments, not least CMC compliance/ conformance. The number of product recalls (many labelling and artwork related) over the years shone a light on the complex nature of organizations, including data and process silos.

At a time where the emphasis is on faster and more efficient innovation the other side of the equation is that companies need to make sure they continue to stay in compliance with ever changing regulations, globally.

The emergence of new digital tools is opening the doors to greater efficiency, speed, and oversight (compliance). Regulatory intelligence tools employing AI and NLP/ NLU are being developed to automate the collection of regulatory data and intelligence from various external sites (including regulators) globally. Consolidation of global regulatory requirements in such a manner will facilitate the understanding of local/ regional and global requirements. Such tools can facilitate more “right first time” classification of changes (against the array of heterogenous regulations around the globe).?This will increase efficiencies in change management systems and ultimately improve compliance (less uncertainty related to requirements) and reduce the number and magnitude of surprises downstream.

Fragmented Systems (Systems and Process)

Many companies are working with highly fragmented systems. The root cause for these are various and include ineffective implementation of systems and the flurry of mergers and acquisitions over the past decades and less than optimal integration of legacy systems. It is also fair to say that the innovation budget (investment in new systems) are increasing squeezed and change management may not be top of mind for the key decisions makers. Whatever the root causes are, this has led to huge inefficiencies and lack of oversight (increased compliance risk) across the board.

To add fuel to the fire, there has been a flurry of initiatives over the last years in several areas including data privacy (e.g. GDPR in Europe and beyond), efforts to harmonize terminology and bolster transparency (e.g. XEVMPD, IMPD) leading to additional stretch and the (sometimes rushed) implementation of new systems.?At the same time everything to do with data management as whole is under more scrutiny from the regulators, including data integrity and anything to do with data breach (most particularly related to sensitive patient data). The investments have been channeled in those directions, disproportionately, over the past years.

The mitigation of system fragmentation goes well beyond the boundaries of the regulatory organizations. However, when focusing on change management there is much that can be done to improve efficiencies and oversight. These include making sure one has dedicated well-trained personnel, easy to follow/ simple processes and reliable systems end to end, from change initiation to proposal to approval and closure. Quick wins are easily identifiable and can be implemented with relative ease. The investments needed for large scale technology upgrades in the regulatory affairs change management space will clearly need to complete with many of the competing priorities across the entire organization. A focus on the overall potential for value created by these investments will undoubtedly lead to better outcomes compared to the traditional approach focusing on downside risk mitigation (and the creation of “burning platforms”). No easy fixes in the space for sure as most senior regulatory affairs leaders will have experienced first-hand.

Increasing focus on Compliance (People, Process and Systems)

There is an increasing focus on compliance amongst regulators leading to increased scrutiny of life sciences organizations across the entire value chain.

Regulatory organizations manage data from a multitude of sources across the entire value chain. It is imperative to have reliable systems in place so that regulatory departments know exactly what is registered where and what is in “trade” at all times. The only way to ensure this is by having a reliable change management systems and processes place, staffed by appropriately qualified and trained professionals.

There is massive investment, across the industry, in Regulatory Information Management Systems (RIMS). Additionally, companies are trying to optimize the data flow and stewardship (“one source of truth”) by improving the way master data is collected (MDM) as well as ensuring that EDMS (Electronic Data Management System) are linked to the RIMS systems. In doing so one can build efficiencies and reduce the chances for errors, hence improving compliance. There is a flurry of activity in this area. The quality of the legacy data is one of the limiting factors currently, but digital tools are also available to interrogate and extract unstructured data and transform to structured data. We will also see an explosion in the use of data analytics to take great advantage of the data at hand. If you are standing still in this space, you will be left behind rapidly.

?Conclusions

Companies will increasingly need to simplify and drive efficiencies in their change management processes and systems whilst ensuring the highest possible level of compliance. And to do so there are some core ingredients which include:

The right people:?well-trained people dedicated to the change management processes/ systems (leading to efficiency in operations)

Simple Processes:?easy to follow processes with the right governance to ensure the right changes are processed whilst non-value adding requests are filtered out early

State-of the art Systems:?user friendly, integrated systems ensuring “one source of truth” by using the same (Master) data across the value chain, thus reducing the possibility of?in market compliance breaches.

Just as all seasoned regulatory professionals will recognize, all of this is “easier said than done”. On the other hand, regulatory organizations do not have the luxury to standstill and must start somewhere. There is a flurry of innovation in the system space today, so the focus needs to be on well-informed decisions making as to what is the best fit for your company (process first, systems second). Given the rapid evolution of digital solutions, global (remote) access to talent has never been easier. This, in turn, means accessing resources through global outsourcing has just become way easier than it was in the past. Regulatory organizations have become increasingly networked and collaboration will be key to success going forward.