Guest Column | October 15, 2019

Cell & Gene Therapies Require the Right Tracking Solution

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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Marker Therapeutics is a clinical-stage immuno-oncology company based in Houston, Texas. The Company specializes in the development and commercialization of novel cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s MultiTAA was developed through a collaboration with the Cell and Gene Therapy Center at Baylor College of Medicine. Gerald Garrett, VP of clinical operations for Marker, describes it as a cell technology based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens and kill tumor cells expressing those targets.  

“Our MultiTAA T cells are designed to recognize multiple tumor targets,” says Garrett. “These tumor-specific T cells are able to recognize virtually any epitope of up to five different tumor-associated antigens. The technology is currently being used in various clinical trials at Baylor College of Medicine consisting of hematological and solid tumor indications, including pancreatic cancer. Marker’s first company-sponsored clinical trial, slated to begin in 2020, will be for the treatment of post-transplant Acute Myeloid Leukemia (AML).”

Marker’s manufacturing process selectively expands a range of naturally occurring, often extremely rare tumor-specific T cells present in patients’ blood. The result is a remarkably robust culture of T cells that can target and kill heterogeneous tumor cell populations.

Challenges with Cell Therapies

Gerald Garrett
The personalized nature of the therapy poses additional challenges that must be taken into consideration with the study. The upcoming trial is for a cell therapy treatment, and Garrett notes each administration will bring its own issues and challenges.

“We are not creating a pill, tablet, or vial that you can store in a storage facility until needed,” says Garrett. “There are many challenges associated with the supply chain process for cell therapy products. With personalized therapies, there is no room for errors.”

Because of the risks involved, the ability to track the product was a major focal point for Marker. For a smaller clinical trial setting, tracking the product using an Excel spreadsheet might have been sufficient. However, Marker is preparing to enroll 160 patients and will require an automated system for tracking patient cells. It will also involve multiple shipments for each patient, which Garrett notes adds an additional layer of complexity.

“For the safety of our patient, accurate tracking is a must,” states Garrett. “We need to know exactly where the product is at any step of the way. We also need to know critical details such as the shipping company and the temperature and orientation of the product. Chain of custody must be tracked all the way through from pickup to infusion, and we also need to know exactly when it arrives at the site and where it is physically located.”

A Single Source Solution

Today there are new requirements a manufacturer must comply with. For companies applying for a biologic license application with the FDA, an automated system will be required to track the therapeutics. Sponsor companies can no longer use spreadsheets to track a shipment and must ensure the right therapy gets to the right patient at the right time. The tracking capabilities needed today require advanced technologies that were not available in the past.

“As a therapeutics manufacturer, patient safety is our number one priority,” notes Garrett. “It is critical that we are able to automate workflows and introduce standard processes to help control costs. Today, when we look across the supply chain, we see many different stakeholders who are more dependent on each other than ever before. These stakeholders procure patient or donor cells in a clinical setting, subjecting that clinical setting to GMP and GCP regulatory oversight, and have the therapeutic material moved from the clinic into a manufacturing setting and then back to the patient for infusion. That interdependency is very difficult to standardize or industrialize.”

An automated tracking technology would allow all stakeholders, including clinical personnel, manufacturing personnel, and the logistics suppliers to see exactly where a product is in the manufacturing process.

Select the Right Vendor

Finding the right solution did not come quickly for Marker. One CRO that bid on this study told Garrett they use a tracking sheet for shipments and contact sites once a week to check on patients. He felt that solution was dated, and that Marker would need a system that was more advanced.

“If it was a smaller trial, this may have been manageable,” he says. “However, our trial will enroll 160 patients and require between three and five shipments per patient, with the shipments often taking different routes. We knew we would require a better solution.”

Garrett interviewed multiple companies with a solution that could solve the shipping challenge he faced. While there were some similarities between the solutions, he felt one company offered a robust solution that provided greater expertise. After extensive discussions with two finalists, he selected the Personalized Therapy Management solution, a cell and gene therapy platform from Vineti. The platform aligns the manufacturing, quality, supply chain, IT, commercial, and regulatory teams on a solution that is transparent from end-to-end.

“Cell therapy companies are concerned with configurability,” says Garrett. “We require flexibility in our systems to accommodate whatever workflow requirements arise in production and delivery. Since this is a field that is advancing quite rapidly, we also know our workflow requirements will evolve and we will add more products and complexity. We knew the tool we selected would have to expand and scale as quickly as we do.

A Successful Partnership

Vineti’s expertise in managing personalized therapies was an important consideration when it came down to selecting the right solution. “We spent a significant amount of time meeting with the Vineti team,” says Garrett. “The meetings were intense but thorough. They asked the right questions and helped us identify potential areas for concern. In the end, we successfully mapped out the entire supply chain process and it was beneficial for both teams to talk through every scenario.”

“This is a very high-risk environment we're working in,” adds Garrett. “If the logistics system fails, the patient will not receive a potentially life-changing therapy. When you have one shot at getting something right, the stakes are very high. We must get it right, every time.”