March / April 2023

Introducing CoP Leader Profiles: Rachel Owen

Marcy Sanford
Introducing CoP Leader Profiles: Rachel Owen

With this issue, Pharmaceutical Engineering® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders. These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.

The new series follows the CoP profiles series published in the magazine during 2022. Behind every CoP are the ISPE members who join CoP Steering Committees and participate in sharing knowledge with ISPE members. We will be highlighting two CoP leaders in each issue of the magazine, and look forward to sharing their stories with you.

Rachel Owen

Rachel Owen is the Chair of the Investigational Products–Europe Region Steering Committee Community of Practice (IPNA-EU CoP). Located in Macclesfield, England, she has more than 22 years of experience supporting clinical trials. With a degree in biological sciences from King’s College London, Rachel knew she wanted a career in the science industry, but she did not necessarily want to work in a lab. She found the perfect profession at her first job with Almedica, where she was a project manager for the clinical trial supply chain.

From the beginning, Rachel was successfully tackling challenging projects and sharing knowledge from her experiences with others, like the lessons learned from Shire Pharmaceuticals Project that were presented by the team at the 2008 ISPE Europe Annual Conference.

The project required us to pack and blind a controlled substance, export from the US, and then re-export to multiple European countries, blinding at the very last stage of processing. New import and export rules had just been issued and at first, we did not even know how to get started. It was a tremendous feeling of accomplishment when the project was complete to know that we’d done something that seemed impossible when we first started it.

After earning her master’s degree in pharmaceutical medicine from Hibernia College, Rachel began working at AstraZeneca and is currently Director, Global Clinical Supply Chain Capability and Technology, where she leads a global team that delivers input to clinical trial setup and the lean, business process management, and training frameworks for applicable AstraZeneca clinical trials to enable delivery of new medicines to patients.

“I love the output of our work, that we’re developing new medicines, that we’re helping people with their quality of life, and changing the course of what were previously incurable diseases. I love what I do, the people I work with, and that we get to experiment and innovate, not only with new products but with industry innovations and new regulations such as direct-to-patient shipping and the EU falsified medicines directive.

The IPNA-EU CoP Steering Committee really helps in these situations by creating cross-industry task teams that can tackle these emerging challenges or opportunities together to influence and shape the way that the industry develops for the future.”

Rachel is excited about hot topics and potential task teams being discussed within IPNA-EU CoP, including cell and gene therapy. “Cell and gene therapy is moving us toward more and more personalized medicine, which isn’t a new concept, but it is becoming more of a reality.

“The patient will become the precise starting point for the product, which is not something we’ve been used to before. It’s a very different supply chain. These are some of the things we discuss in our CoP, the logistical challenges this shift can bring, the patient data challenges that could arise, and also the chain of custody for the product that needs to be followed from patient back to patient.

Rachel’s participation in ISPE began in 2007, when she attended an annual conference, minuting the round table discussions. This sparked an interest in cross-company collaboration.

It’s really enjoyable to be working on cross-industry forums and realize that the problems or challenges you’re having are experienced by someone else or they may have managed to solve those issues. By working together, we can hopefully solve problems in a standard way and a shorter time in industry, all of which is to the benefit of the patient, which is why we are here.