Providing key insights to success: how analytical science helps medicines reach patients
“Analytics is more than a service; it provides knowledge that helps shape strategies and innovation. We might get a request for hundreds of tests, but without these tests, we wouldn’t know if anything needs to change.”
As Director of Analytical Development, her team supports manufacturing, clinical operations, and regulatory submissions and is responsible for developing and validating the methods that define Ipsen’s Quality Control Strategy for its Biologic portfolio of medicines. Those methods determine how purity is measured, how stability is assigned, and how consistency is confirmed.
“That medicine is safe for you to take because my team has developed tests that measure and control quality to ensure a safe and consistent patient experience,” she explains. “We apply criteria to say that every batch is the same.”
Unique to working with one of Ipsen’s emerging medicines within the neuroscience space is the challenge of developing methods with high sensitivity; therefore, several novel and innovative methods have been developed to support the quality control for these products. “As a team, we’ve got that little taster now of what it’s like to be implementing novel and innovative methods as part of our control strategy, and it’s exciting,” she says.
Ipsen’s expanding portfolio in biologics brings new challenges. “We’re going to be at the forefront of developing methods,” she says. “We’re going to be trailblazing the way with new analytics to support new products.”
That work demands more than instruments. It requires collective intelligence. “Every week we all come together as a team,” she says. “If someone’s got a problem, they share it. As a collective, we try and solve it.”
Some team members have decades of experience. Others are just beginning their careers. “There’s no one individual that doesn’t contribute as a team member.”
While the methods her team develops may present raw data in many different forms, Elizabeth’s team takes this information and interprets it to deliver meaningful insights that drive the drug development process forwards. That knowledge her team generates doesn’t just sit in a report; it travels with the medicine, from development to approval, helping to secure safe and effective medicines for our patients.