2024 Veeva R&D and Quality Summit: Q&A with Dee DeOliveira
DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) highlights her experience in regulatory operations and how to address increased oversight from regulators.
The evolving regulatory landscape in clinical research was an important topic covered at the 2024 Veeva R&D and Quality Summit. As the complexity of trials grow, regulatory agencies are enforcing greater oversight to ensure they remain compliant. At the Summit, Applied Clinical Trials caught up with Dee DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) to discuss the current regulatory landscape as well as her own experience with managing regulatory operations.
ACT: Could you tell us a little about Cerevel and your role?
DeOliveira: First of all, Cerevel was very recently acquired by AbbVie. I now work for AbbVie. Cerevel was a small pharmaceutical company established in 2019 seeking to transform lives of patients with neuroscience diseases.
At Cerevel, I was head of global regulatory operations. I was hired in early 2020 to establish the regulatory operations function. I built and provided oversight of the team that manages regulatory submission logistics, including publishing and we also administered all regulatory systems such as Veeva Vault RIM.
ACT: At Cerevel, you’ve built the regulatory operations function from the ground up. What was your vision for regulatory operations and the strategy to make it a reality?
DeOliveira: Given Cerevel was a small company, my vision was to create a full service global regulatory operations function that was fit for purpose. In a startup environment, you have individuals wearing many hats and things happening quickly. This required regulatory operations to be a nimble, focused function at Cerevel. Our key to on-time quality submissions was early engagement, frequent touchpoints, having a focus on quality by building QC steps along the way, and aiming to optimize logistics to allow submission teams to focus on the science.
The regulatory operations team consisted of internal individuals and an external publishing vendor. There is a lot of ways to do this, but at Cerevel the vendor was used strategically to optimize budget spend and allow us to get submissions out the door as quickly as possible. To do that we did submission/content plan management and document-level publishing in-house while utilizing the external vendor predominantly for the eCTD submission build.
ACT: Cerevel enabled site, product, and clinical study data to flow between the clinical and regulatory vaults. What are the benefits of establishing this connection between clinical and regulatory?
DeOliveira: Cerevel was early adopters of Veeva’s Regulatory to Clinical Connector, which allows both documents and data to be transferred between the regulatory and clinical vaults.
An industry pain point is the redundant work that is required due to the overlap of documents within the eTMF and RIM systems. You also have more than one person making duplicate uploads or entering identical information which could led to misalignment. The biggest benefit is we didn’t have people doing the same thing twice, this eliminated redundancy, ensured consistency, and maintained a single source of truth.
ACT: Our September issue is focused on regulatory, so this question will help our readers. As clinical trial complexity grows, regulatory agencies require more data and proof products are effective. We want to tap into your robust experience in regulatory operations. What advice would you give to companies looking to remain compliant while executing complex clinical trials?
DeOliveira: As clinical trials become more complex, a well-structured defined submission process is key. However, it’s crucial to strike the right balance, you still want to be able to do things efficiently and quickly. In my opinion, a centralized approach to managing CTAs can be extremely helpful. For example, having a dedicated regulatory operations resource who can guide the team through the process and ensure compliance can be a game changer. For example, for EU CTR, training was crucial to getting everyone on the same page cross functionally, and regulatory operations was involved to not only to provide CTIS portal administration but also the guardrails to ensure compliance with proper document handoffs and approvals.
ACT: Looking ahead, where do you see regulatory operations advancing over the next five years?
DeOliveira: As we move forward, I anticipate regulatory operations will continue to evolve towards a more technical and strategic role. Rather than administrative, the regulatory operations professionals should be seen as technical experts, data governors, and systems and process builders.
Technology will play a crucial role in this transformation. Automation can help streamline processes, reduce manual tasks, and improve efficiency. For example, I see the potential to delegate repetitive tasks to AI and focus on more strategic work that requires human expertise.
Additionally, data governance will become more important as we move away from document summaries towards data driven submissions.
