• Collaborating with the right partners on clinical trial design and execution can help manufacturers better understand the patient journey, and site and patient identification considerations
• Managing time-sensitive and temperature-critical cell and gene therapy logistics increases clinical supply chain complexity
• Software solutions can help orchestrate and simplify the clinical supply chains associated with advanced therapies

Designing cell and gene therapy clinical trials is a complex endeavor that requires a collaborative approach to align people and processes and ensure patients receive the best care.
The cell and gene therapy (CGT) market is expected to grow dramatically in the coming years, with hundreds of gene therapy, gene-modified and cell-based immuno-oncology, and cell therapy clinical trials now underway. The growth of the CGT market requires new workflows, processes, and tools to address the unique challenges of clinical trial design and execution. Collaborating with the right partners can help therapy owners navigate these complexities, which can include:

• Understanding the patient journey. A partner can define inclusion/exclusion criteria for the ideal patient and provide post-therapy monitoring and management.
• Site identification requirements. The appropriate infrastructure is essential to support trial complexities. That infrastructure includes the ability to deliver investigational therapy, perform investigator training, and offer care coordination.
• Patient identification. Patient identification may occur outside the clinical trial site. This factor requires a heightened focus on provider trial awareness so that they can identify ideal patients and refer them to the trial site promptly.

Strategic partnerships can provide full-service or integrated solutions to meet clinical trial requirements. A dependable partner can help remove clinical trial design complexities and ensure operational efficiency.

“Patient identification may occur outside of the clinical trial site, which requires an increased focus on provider trial awareness and their ability to identify the ideal patient in a timely manner. This leads to greater access for patients in need of these alternative therapies.”
Susan Weidner, IntrinsiQ Specialty Solutions

Shipping and handling requirements for cell and gene therapies increase logistics complexity.

With both autologous and allogeneic therapies, the initial biological material and therapy must be shipped under liquid nitrogen or refrigerated conditions in a compressed timeframe. The geographic location of the manufacturing site in relation to the clinic sites is also a consideration. Establishing a global supply chain for allogeneic therapies requires building up cryogenic storage infrastructure and a thorough understanding of import and export requirements for each country. Other considerations include labeling requirements and demonstrating compliant chain of identity and chain of custody management.

Errors at any point during the process can potentially be devastating for patients and costly for clinical trial sponsors. That’s why advanced software solutions are essential for assuring traceability and seamless orchestration of these complex supply chain logistics - ensuring the right therapy reaches the right patient within the correct timeframe.

“Clinical trials logistics become much more complicated for cell and gene therapies because we’re working with biological material that must be shipped under cryogenic conditions within extremely tight timelines while assuring traceability.”
Andrea Zobel, World Courier

 Orchestration and tracking technology can simplify and reduce risk from the clinical supply chain.
CGT supply chains involve many different stakeholders. Orchestration software coordinates activities across stakeholders to simplify and remove risk from the supply chain. Building the orchestration system requires a clear understanding of the cell or gene therapy product, process, and patient-related requirements and risks.

Keep these suggestions in mind during the planning, development, and introduction of the orchestration system:

Discovery phase: Map the process from end to end, identify key roles and stakeholders across the supply chain, and identify risk areas in the supply chain.
Development phase: Design and configure the system to reduce areas of risk, test the configuration and complete the IQ/OQ process.
Implementation phase: A software system is only as good as the people who use it. Create process specific and role-specific training, onboard clinical trial sites and service providers to ensure they understand their role in the supply chain, and complete user acceptance testing.

“When you’re introducing orchestration software into the advanced therapy supply chain, it’s important to recognize that a software system is only as good as the people who use it.”
Matthew Lakelin, TrakCel

• Just as the industry had to build up cold chain logistics capabilities for biopharmaceuticals more than 25 years ago, the rapidly expanding CGT market will require a comprehensive cryogenic infrastructure.
• Collaborative relationships with partner companies are essential to managing the complexities of the CGT clinical supply chain.
• Advanced therapies offer the potential not only to treat but potentially cure disease. Solving the clinical supply chain complexity is vital to commercializing these life-saving treatments.