After reporting on Deloitte’s acquisition of a risk-based platform to address good practice (GxP) requirements, Outsourcing-Pharma (OSP) spoke with a GxP requirement expert on the importance of digital innovation.
Andrew Anderson, VP of innovation and informatics strategy at ACD/Labs, told us everyone is a stakeholder looking for innovative ways to make processes easier, in order to get patients the treatments they need more quickly.
OSP: How does technology address some of these challenges and expedite the regulatory approval process?
Andrew Anderson: When you look at the regulatory approval process, it is tedious, cumbersome, and I’ll call it data-driven. If I look back at my time when I was working in regulatory affairs, it was very much document driven.
Looking at an NDA [new drug application] I was a part of, looking at it printed out, it stood taller than me … The pages were taller than me if you stacked it up together.
I see technology making this submission and approval process more efficient by implementing ways to submit data electronically to health authorities.
Two technology areas that I think are important are data standardization, and an extraction of that data in a format that can be consumed by a system, instead of a human.
OSP: How does adopting digital technology help ensure compliance?
Anderson: From my perspective, what digital innovation can do is simultaneously handle some of the security requirements and permissions, but also, at the same time, make proliferation of data more automated.
Digital innovation, like being able to stream data from the supplier to a system that can effectively consume that data, is really important.
OSP: What is the most often cited challenge for gaining regulatory approval?
Anderson: If you look back at clinical trial and drug product attrition rates through the different phases of pharmaceutical development, there is historical stats on why compounds fail.
What was once a six-foot stack of documents becomes 600 feet, because you’re not just reviewing the batch data, you’re looking at the process data with the process variations.
OSP: What has led to the recent increase in drug recalls?
Anderson: There are two possible factors, from my perspective, that might influence the recall frequency.
An increasing federated landscape when it comes to supply chains is one of the factors. The second factor is the increased requirement to implement what’s called quality by design in your development process.
We are in a state of transition between the quality by testing paradigm. The whole set of drug substances, generics, branded pharma compounds, all of those up to maybe five years ago were quality by test paradigms. Re-engineering your quality and testing processes will take time.
Andrew Anderson is the vice president of innovation and informatics strategy at ACD/Labs. Anderson holds a Bachelor of Science degree as well as a Master’s degree in business administration. He has worked within and in support of the pharmaceutical industry for more than 15 years.