Ben earned a PhD in chemistry from the University of Pittsburgh, Pennsylvania, US, and a Master of Public Health from Johns Hopkins University, Baltimore, Maryland, US. He has co-authored over 30 publications and patents. He chairs the ISPE Artificial Intelligence Community of Practice (CoP), is a member of the ISPE Regulatory Quality Harmonization Committee (RQHC) Process Modeling Team where he co-chairs the Americas Regional Focus Group.
What Drew You to the Pharmaceutical Industry?
During my undergraduate research at the University of Rochester (New York, US), I worked in an organic chemistry lab, which sparked my interest in organic synthesis. Then, a course on molecular pharmacology piqued my interest in drug discovery and I ended up following that path through graduate school when I realized that I wanted to work in the pharmaceutical industry.
What Do You Do in Your Current Role?
Our broader regulatory CMC and nonclinical group is a mix of different functions, but the goal of the CMC policy team is to be informed and aware of the high-priority emerging regulatory CMC topics across the industry and to ensure that the company’s position is reflected in the growing consensus-building process. We do a lot of work behind the scenes internally to build consensus across departments and to help support our regulatory colleagues in their work toward generating filings for clinical trials and licensure.
For the past two and a half years, process modeling—including AI and machine learning models—has been a priority for us. GSK has been a strong advocate for the use of these technologies and the broader application of mathematical models and model-based control to pharmaceutical processes, such as drug substance and drug product development and manufacturing. We’re working to ensure regulators understand how we generate, use, and maintain these models from a technical standpoint, while also collaborating to build and adapt a regulatory framework that facilitates innovation.
What Do You Enjoy Most about Your Work?
It’s very rewarding to work together with teams on cutting edge regulatory issues where there aren’t a lot of black and white answers. Working in these teams allows me to continually learn and improve my ability to negotiate and build consensus. Given the challenge in getting consensus between so many groups or industry members, it’s particularly rewarding when you see the ultimate success of all the earlier and often long-term investment. I also get to work with a lot of folks from very different backgrounds who are incredibly knowledgeable subject matter experts. I enjoy helping these experts turn their deep knowledge, expertise, and passion into positions that are incredibly useful for guiding policy and regulation—and are often the foundation of many longer-term initiatives.
Tell Me about a Project You’re Proud Of.
I’m excited about the growing interest in and potential applications of process modeling and AI, and the emerging regulatory frameworks shaped on many of the discussions we’ve been part of over the years. It’s rewarding to have been engaged in this ongoing dialogue with regulators and to then see them recognize the importance of this space and work to adapt our input into practical and beneficial guidance. Previously, the industry had little guidance about process modeling and AI, but now the European Medicines Agency’s Quality Innovation Group has issued a concept paper informed by ISPE member companies. Likewise, the FDA’s recent AI guidance has been highly informative and reflects much of the industry perspective and input that has been provided over the last few years.
Tell Us about the AI COP.
The AI CoP pulls from all of the expertise across ISPE, including GAMP® and Pharma 4.0™, and then we take it to the next level. We’ve been working to establish sub-teams to work on important areas of AI, such as regulatory, preparedness and workforce, and applications and data. We welcome participation from across the industry. We’d love to hear from members who are interested in joining and are always open to new ideas.
Join a Communities of Practice
Are you an ISPE Member looking for a better way to connect with your colleagues from around the globe? Or are you a Member seeking information on new trends, issues or concerns affecting your profession and your day-to-day work life? Join an ISPE Community of Practice (CoP). CoPs are groups of ISPE Members with a common interest and similar job functions who collaborate on topic-specific discussions using the ISPE networking forum, ISPE Engage.
