Veeva R&D and Quality Summit 2023: Q&A With Scott Cleve, Vice President of Regulatory Operations, Information, & Compliance at Daiichi Sankyo


Cleve talks about the future of the industry and how data remains a key focus.

New technologies are changing the ways that life sciences and regulatory agencies approach the collection and analysis of data. Scott Cleve, vice president of regulatory operations, information, and compliance at Daiichi Sankyo sat down with ACT at the Veeva R&D and Quality Summit 2023 in Boston to discuss these topics.

Applied Clinical Trials: What are the current struggles with the regulatory environment right now?

Scott Cleve: For regulatory, we are so focused with understanding the regulations for delivering our products to market and working with FDA. For us, that’s dictated by FDA requirements and guidance, which are more scientific in nature. Those change from time to time, from health authority to health authority. Understanding what those changes are is part of our remit. We translate those to the organization and develop the processes and systems in order to make sure we’re compliant.

That’s where our focus is.

ACT: There are new regulations and new technologies to address those regulations. Where do you see the industry heading in the next few years?

Cleve: There’s a couple of factors. One is: what are the regulators asking of us? The trend in the industry has been data driven. Especially from FDA, and we assume that other health authorities are going down this path as well. Our data practices are certainly something we must consider going forward. We’re moving from a narrative-based submission to more of a data-based submission. Historically, we’ve created large summaries and clinical study reports.

Those contain narratives. How did we analyze our study data? What are our conclusions? We’re going to continue to shift towards presenting a data set, our analysis, and having agency analyze it and seeing if we come to the same results.

How do you ensure that discussion of the results, benefits, and risks continue to happen in those filings? That’s going to drive us a lot.

The second issue is the collaboration of multiple health authorities. From an efficiency standpoint, does that help us make our submission? Does that help us then move towards approvals in a quicker manner? Having more integration and discussion between health authorities is helpful.

ACT: How do you deal with data privacy concerns, especially during clinical trials?

Cleve: It’s the next step for the industry. If you think about decentralized clinical trials, that allows more patients to participate in trials. It doesn’t force them to come to a center to collect data or meet with the investigator. We’re able to meet with a wider population who may not be able to physically come there.

As we collect that data, however, that poses different challenges. How do we provide the technology to the patients? How do we have a secure way to collect it and ensure that there’s the right security and handling of the data? This applies to the data pertinent to the trial along with the protected data. There are privacy concerns.

We must have controls in place with technology to ensure the patient’s privacy is protected. The audit trail from the device to our systems is all there. There are companies that are doing that effectively, but it’s still early days.

ACT: You mentioned getting the technology into the hands of the patients. Is there concern about patients accurately collecting their own data?

Cleve: There’s such a wide range of patients. Depending on what disease or affliction that you are collecting data on, do the patients have the dexterity to enter in into a phone? Is there a voice capture? Whose validating on either the CRO or clinical side? There’s a lot of thought that goes into that. We’re trying to make that as easy as possible, but we’re only as good as the users are.

The onus is on the CROs or the people that are providing the technology to provide a level of training. That’s going to help the data collection be successful, but it’s an extra step, especially when they’re not in the clinic and instead in the care of a clinician or an investigator who’s used to filling in forms and other information to collect the data.

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