Assessing the paradigm shift from today's standard way of working towards a data-driven future
One of the most popular sessions of the week examined the regulatory industry's progress towards data-driven ways of working.
Here we explore the highlights of the panel discussion, which featured:
Kim Brownrigg, Senior Principal, Accenture
Rodrigo Palacios, PTR Global Head for Business Systems, Roche
Vada A. Perkins, Global Regulatory Policy & Intelligence, Bayer
Rebecca Brady, Conference Producer, Informa Connect Life Sciences (Moderator)
First, the shift to data-driven regulatory environment was addressed. Rodrigo Palacios emphasised that, with the fast pace of innovation in the pharmaceutical industry, there is a need to retool the whole regulatory process to meet the new opportunities and demands.
Vada Perkins believes that in the past the value of data was understood, but the level of innovation and technology did not allow its full utilisation. However, current technology advancements are changing this situation, and training, processes, and harmonisation should come together for optimal data analysis.
The experts were asked how the data-driven technology would have changed the current environment, including the COVID-19 pandemic, if it was already implemented. Vada Perkins stated that the possibility to access and summarise data in real time would have facilitated the decision-making process, including therapeutic decisions. In the case of the COVID-19 pandemic, this would have allowed fast access to data on promising medicines, which would have facilitated their further development. Rodrigo Palacios indicated that the implementation of data-driven technology would have permitted even better harmonisation of the knowledge regarding medicine availability in different countries of the EU and mitigation of any potential drug shortages.
Kim Brownrigg commented on the value of data-driven approaches for businesses. She indicated that a data-driven approach would allow businesses to do more with their data, avoid data duplication, and gain further insight from them. Vada Perkins agreed with this position and explained that the repurposing of data would increase the efficiency also from the regulator’s perspective. Rodrigo Palacios emphasised that avoiding data duplication would also streamline the process for patients, speed up the review process, and help face new challenges.
The possibilities and challenges in the implementation of the data-driven process were reviewed by Kim Brownrigg, who views the situation as an opportunity for business and IT to come together in the development of a holistic approach. The role of data governance analytics to drive innovation was also discussed. Kim Brownrigg emphasised the significance of a data management system to ensure high quality of the entered data and thus to drive the correct output. Vada Perkins discussed the governance of real-world data and the importance of infrastructure implementation to ensure appropriate analysis.
Next, a strategy for the attainment of more reliable data from original sources was discussed. Rodrigo Palacios views the workforce culture as one of the challenges, and a lot of effort is invested in raising the workforce awareness. Vada Perkins emphasised the fact that the number of stakeholders in the field is increasing and also includes technology and data companies. Thus, cohesion among stakeholders is necessary. FDA PQ/CMC and new submission formats were also addressed. For Vada Perkins, this is an example of structuring complex information for more efficient review and for the development of analytics for a variety of purposes. Kim Brownrigg noted that, with time, data may also be produced in a more structured way by laboratories.
Finally, the challenges faced by smaller companies in the implementation of a data-driven approach were discussed. The panelists agreed that partnerships with technology companies, formation of consortia, and collaborations with health authorities will help deal with these challenges.
The participants concluded the discussion their key messages concerning data-driven RIM. Kim Brownrigg emphasised that “data entry being accurate, consistent, of quality, structured, and standardised is vital for whatever possible readout … Just get the data itself correct.” For Vada Perkins, a holistic approach involving collaborative work between the business, regulatory authorities, and IT specialists is required to be successful. Rodrigo Palacios highlighted the importance of strong external partnerships to achieve data-driven RIM, which is a must-have for both pharma and regulatory authorities.