On June 12, PAREXEL Academy hosted a symposium for the Investigational Products Community of Practice (IP CoP) of the International Society for Pharmaceutical Engineering (ISPE) in Berlin.
Organized by the ISPE EU Steering Committee, the annual event brought together more than 60 clinical supply professionals from a number of pharmaceutical companies, Contract Manufacturing Organizations (CMOs), couriers and clinical supply information technology vendors to network and discuss a variety of current trends and topics impacting the industry.
The topic of the conference was, “Insights into Driving Trends and Technology in Clinical Supply Chain - How to Integrate: Technology, Quality and Productivity.” A variety of topics were presented and discussed, including clinical supply aspects for investigator-initiated clinical trials, direct-to-patient shipments in patient-centric studies, regulatory changes, the latest labelling technologies, return and destruction of IPs, as well as Key Performance Indicators (KPIs) and performance metrics for clinical supply management and how to deal with challenges such as overages.
Professor Lutz Uharek, a hematologist/oncologist and head of the Charité stem cell facility in Berlin, delivered a keynote presentation on the Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) challenges and solutions for Advanced Therapy Medicinal Product (ATMP) manufacturing, with a focus on CAR-T therapies. As CAR-T therapy continues to advance and become more prevalent, Professor Uharek discussed how these treatments will change pharmaceutical manufacturing. The presentation also explored the concept of having decentralized GMP manufacturing units close to patients, with payment of therapy based on efficacy. In addition, Professor Uharek discussed how applying quality standards of pharmaceutical manufacturing to the laboratory and treatment processes in specialized clinical trials can help these promising therapies safely become available for patients in need.
In addition, participants discussed how current industry trends are impacting clinical supply chain and presenting challenges in their work every day. These include new technologies and adapted processes in order to comply with increasingly strict regulations, such as the Clinical Trial Regulation EU No. 536/2014, and how many processes vary greatly from sponsor to sponsor, presenting challenges for clinical trial sites and supply managers. Harmonization and guidance is a frequent request amongst these professionals, and just one of the tasks the ISPE teams are tackling. Many also shared the common challenge to get better control of their manufacturing and distribution planning in order to minimize overage and waste, and discussed various strategies to provide solutions.
PAREXEL was honored to host this event and gain insights from attendees. Our clinical trial supply and logistics experts and PAREXEL Academy leaders were pleased to share their expertise and experience on both the innovative tools and expertise needed to efficiently manage clinical trial supply and logistics tasks in an increasingly complex ecosystem, and the training and education required of the evolving workforce – all important components in the drug development journey.
Global Development Planning
Global Drug Development
Supply Chain Management