By Rebecca Stauffer
Stephanie Gaulding, who moderated the keynote, Shrinking Time to Market Through the Targeted Integration of Technology, Modeling, and Patient Centricity, took a few minutes to answer some questions about quality mindsets within drug development and commercialization, at the AAPS Media Booth at PharmSci 360.
“Sustainable compliance,” or avoiding the mindset of complying with the minimum of GMP requirements, has become a focus within manufacturing. What can scientists involved in drug development take from a sustainable compliance approach?
From my perspective, one of the biggest things that scientists—especially those working in product development—can take from sustainable compliance is to focus on developing a good, solid, scientifically sound framework that helps bring products to market. And coupled with that is an opportunity to integrate in two of the fundamental tenets for sustainable compliance, which really center on risk management and continuous improvement.
When you look at developing products and you can integrate strong risk management principles early in the development lifecycle, I think you can end up with better patient outcomes and, as you get through the clinical stages, achieve better long-term results for product manufacturing as you get closer to commercialization.
What are the key metrics or indicators used to measure the quality outcomes of technology and modeling integration being used to accelerate drug development?
I think there are a lot of metrics you could use. I’ll focus on a couple of them that I think are worthwhile. One of those measures that we all look at is time to market. Certainly, if you are using advanced technologies or modeling, in theory, that should decrease your time to market. You should also be looking at the accuracy of your modeling against the actual patient outcomes, so it’s good to be developing some metrics around that.
I also think that looking at attrition rates for drug products is important because in theory a lot of these technologies are designed to find the best targets and their associated patient outcomes. If you are doing a good job of utilizing the technology and it's accurate, then you should also see a lower attrition rate in your drug development pipeline.
How can proper data management and analytics adapt to and/or enhance quality control?
One of the main things I think of when it comes to good data management that can enhance quality control is data consolidation, i.e., looking at and collecting all the data, putting in place some good hygiene habits, and providing the ability to look across multiple systems and sources of information.
That, ultimately, gives you the ability to look at larger spectrums of analytics and look for trends in product history, development history, and things like that. To me, it all centers on strong data collection and that good aggregation and data hygiene piece that is core and part of a robust data management foundation.
Can you share insights into how pharmaceutical scientists are balancing the need for speed to market with rigorous quality assurance processes, especially in the context of expedited regulatory pathways for critical medications?
The most important thing for me when looking at the development space in accelerated pathways is looking at and staying in tune with technology advancements. We’ve seen a recent shift by FDA and many health authorities where they’re looking for real-world data and they’re looking at integrating modeling to either replace or supplant the need for human testing. In some cases, the changes can shift the requirements and even the steps that need to happen in that development space.
I think the biggest factor with the accelerated pathways and what that brings to development is all of a sudden you can go from an early-stage development process all the way to commercialization very rapidly. I’ve seen companies come out of Phase I and they go into Phase II as their next trial and that’s their pivotal trial, and then they’re facing approval. So that accelerated pathway can literally lightspeed the product. Instead of taking years in the traditional development pathway, you can be there in months or maybe a year. That’s a significant shift in the overall development timelines. Being aware of that is important.
Stephanie Gaulding, CPGP, CQA is the Managing Director at Pharmatech Associates, Inc., a consultancy serving the regulated life science industry. Stephanie draws on over 25 years of experience in quality management systems and leadership roles in the regulated life science industry to develop and deliver efficient and sustainable quality management systems assuring compliance with global regulatory requirements and industry best practices. Over the past ten years, her consulting services have helped both start-up and industry-leading clients successfully pass inspections by global health authorities.