How automation can help find efficiencies in regulatory reviews
The regulatory process is a patchwork of paper and digital procedures. Automation can streamline processes allowing for more meaningful collaboration among stakeholders.
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Regulator engagement is documentation-heavy and can be a patchwork of paper and digital procedures. To find efficiencies, the pharma industry should shift towards automation: pharma companies can streamline internal and external processes to rapidly summarize thousands of pages of documentation.
But automation uptake so far has been slow. As an example, there has been low adoption of electronic Common Technical Documents (eCTD) over the past two decades. eCTD is a digital format for pharma companies to submit information for regulatory review. Roche's Vijay Reddi added: “We deliver medicines in 120 countries, so we need eCTD in 120 countries – but we [the pharma industry] only have it in about 10. Even in those countries that have adopted it, there are different flavors, language issues and states of maturity.”
There are operational gains to automating regulatory interactions. There is potential for greater process harmonization, enabling quick filing and review procedures. Ipsen’s Stéphane André said this requires investing in data management systems that allow regulators to interrogate data at a faster pace at any stage of the drug development process.
Automation can lead to cost reduction of at least 20%. Rather than having to do it manually, forms can be completed via automation. For instance, conditional statements, also referred to as ‘if-then’ statements, can be completed through automation. Currently, routine tasks are outsourced to service firms which can be costly.
Automation can improve relationships between a company’s regulatory team and internal and external stakeholders. Communications will be more consultative and proactive, rather than prescriptive and reactive, which can increase the scope for deeper collaborations.
Further, automation can increase pharma companies’ work capacity, allowing them to have more time to dedicate to strategic and scientific planning. This can also translate to reduced operational costs. Receiving feedback from regulators quickly can accelerate development timelines, which can then lead to investigational assets reaching the market sooner.
For automation to be successful, harmonization is key. The European Union is executing its Clinical Trials Regulation (CTR) and its corresponding portal Clinical Trials Information System (CTIS). CTIS is a single-entry point for clinical trial sponsors and regulators for the submission and assessment of study data. Previously, pharma companies had to generate different clinical trial applications for the various member states. CTIS is indicative of the region having clear efforts to drive faster regulatory harmonization in clinical trials, and pharma companies should investigate ways on how to effectively adapt to new processes.
There are pharma companies already proactively looking into automation. Roche’s approach to near-term improvements is to conduct case studies with individual health authorities to drive automation in communications such as between sponsors and agencies.
Actionable Insights:
- Automation allows for harmonization of regulatory processes: Pharma companies should invest in data management systems that can allow regulators to review data more efficiently
- With shorter regulatory timelines, investigational drugs can reach the market sooner: There are also cost efficiencies with shorter timelines
- Europe is amid a shift towards harmonization of regulatory reviews, and pharma companies should investigate ways on how automation can adapt to new processes: Looking into case studies can provide insights on how to integrate automation
Industry Experts Who Contributed:
All contributors are senior leaders within the pharmaceutical industry
- Stéphane André, SVP, Head of Global Regulatory Affairs, Global Patient Safety, Research and Development Quality, Ipsen
- Stan Kachnowski, Director, Digital Health Program, Columbia Business School; Chair, Hitlab
- Lada Leyens, Senior Program Director Regulatory, Roche
- Vijay Reddi, Regulatory Transformation Lead, Roche
- Manjunath Shanabag, (formerly) Global Head, Life Sciences Solutions, DXC Technology