September / October 2023

CoP Leader Profiles: Catherine Hall

Marcy Sanford
CoP Leader Profiles: Catherine Hall

Catherine Hall is Chair of the Investigational Products, North America (IPNA) Community of Practice (CoP) Steering Committee and is one of the authors of the ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices. She has been a member of ISPE for 18 years.

She is currently Vice President of Data and Quality at endpoint Clinical, an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry and provides software that helps randomize patients, maintain confidentiality, and distribute clinical supplies for clinical trials. Catherine started her career as an academic scientist in molecular and cellular biology before finishing her MBA and transitioning into working with the pharmaceutical supply chain.

“I’m a biochemist by training and I’ve always had an interest in medicinal products and how they work. Before coming to endpoint, I worked for pharmaceutical companies for 20 years, mostly in clinical supply chain management. I enjoy learning about what is new on the horizon of medical research and what could bring help to patients and their families. Now, I get to be involved with hundreds of companies and have a part in bringing new medicines to market,” Hall said.

She feels that IRT, though decades old, is an essential part of the clinical trial in phases two and three. “But we still need to bring technological solutions to other phases of development. The size of data is continually growing and it’s getting to a point within a clinical trial that you need machines to evaluate the data to get some semblance of the results. I think naturally we need to be thinking about the role of artificial intelligence and machine learning and how it could help to support clinical trials and how they’re conducted and analyzed in the future.

“We still do one clinical trial at a time, and we collect data every time on control patients taking placebos. If you look through the history of clinical research, do we really need more data on patients without treatment? Or can we use and reuse data from previous trials to help ensure that volunteers that come into clinical trials are getting the option of care that they’re looking for and we are collecting data on the new drugs and not just on a condition that we already know a lot about? I really think as we move forward and think about technology, there will be a focus on standardizing the data and sharing it around the world.”

Sharing is the focus of the podcast the IPNA CoP Steering Committee is currently working on. “One of the things that we’ve noticed within the committee over the last several years is that the big pharma companies have good communication amongst each other. But when you get to the mid and smaller companies, they don’t really have that interaction. We want to give a face and a voice to all the leaders across our industry. What challenges are they facing? What innovations and solutions are they bringing to the table? We also want to explore what’s going on at clinical sites, with patients and the suppliers supporting the trials.”

In addition to her volunteer activities with ISPE, Catherine volunteers with Knitters for Knockers and is an advocate and educator for Tourette syndrome.