Pursuing Perfection: Gaps and Opportunities to Standardise and Streamline the Supply Chain Workflow
7 February 2022
Automation & Digitisation
Regulatory & Standards
In this Event Report, we explore the data and system gaps in the supply chain workflow for clinical and commercial therapies, considering the regulations and standards for simplifying digitised systems.
With today’s meeting continuing discussion on pursuing automation and best practice in the space, the working group shifted its focus to analyse gaps and opportunities in vein-to-vein tracking and the supply chain workflow.
To focus the discussion, four key questions were presented and answered in turn. These each guided the group towards an output that could help answer a wider query: What does perfect look like, and how do we get closer to it through standards development and consensus-building?
1. We currently have multiple systems and information from varying sources. What could simplify or streamline this?
“Global issues like the pandemic exacerbate logistical problems. With governing processes often being poor, we can turn to standardisation to address this instability.”
Processes that come before the administration of apheresis present a gap. Logistics in cell therapy is complicated and is a regular pain point, with communication between the many involved parties comprising regular risk and difficulty. Vendors and partners would benefit from enhancing their teams to include logistics specialists, but budget is a serious limitation for smaller organisations.
Shipments can be delivered incorrectly and teams are micromanaging autologous patients and the progress of shipments. The severity of this issue is compounded by how ill these patients tend to be; a single day lost can affect a prognosis. Some groups are trying to mitigate this risk, but efforts are not standardised.
Companies in the cell & gene therapy space are aiming to reduce logistics costs, approaching this result through activities such as shipping at temperatures below cryogenic storage. This is questionable, with improvements to standardisation expected to result in comprehensive savings in logistics. It was also noted by the group that Global issues, like the pandemic, exacerbate logistical problems. With governing processes often being poor, we can turn to standardisation to address this instability.
Tracking from the hospital or patient’s perspective is often also lacking and may be similarly improved. Tracking samples through labs and hospital systems is challenging and has led to varying middleware platforms to address the gap. Competition and price points in this space also limit progress, leading the group to a consensus of standardising over continually creating new offerings. In the case of hospitals, it was also noted that there are stakeholders such as IT professionals and clinicians who benefit from improved visibility – if they don’t feel part of new standards, compliance may be limited.
The advantage of a universal cell therapy ID that all hospitals and manufacturers could use was discussed. This could be something that sits in the system and can be moved through the whole manufacturing flow. A centralised subject ID framework would be hugely beneficial to the space, particularly to avoid mishandling and overlapping of labels from stakeholders during movement and use.
Screening activities at sites is also difficult and is trial-specific; while this is an opportunity to address, it’s very complex. Stakeholder lists for packages are diverse, with each needing different points of information at specific times, resulting in high variability.
2. What potential standards are practical to develop to help simplify these processes?
“Collaboration from early clinical stages through to commercial is key. If we can extend this mindset across the industry, we’d see results.”
Having robust internal standards for best practices in logistics is where many organisations start. Leading to the ability to have consistent and reliable shipping, the definition of these standards is incredibly important.
Cryoport, which are producing a plug-n-play approach that can integrate with other platforms, are working towards this end. Drawing on their own experience to define a robust logistics process that is defined by internal SOPs. This approach serves as a guiding example that can stimulate discussion on what best practice is for defining those standards.
Collaboration from early clinical stages through to commercial is key. If we can extend this mindset across the industry, we’d see results.
3. Is it practical to develop a common IT platform? If so, what are the hurdles to creating it?
“Right now, companies are capturing the same data differently. We need to standardise.”
The IT perspective is also critical. Is it practical to have a common IT platform to pursue standardisation through? In the opinion of the group, differing scales and budgets of businesses make this otherwise feasible concept difficult. Operations are at different points in their own product development and maturity, compounding the complexity of the issue further.
Different perspectives also have different needs. Therapy manufacturers want the same systems, while other specialists may want different systems for isolation, modification, and expansion. In the molecule space, many companies have adopted the approach of finding common platforms or communication utilities to send data to DeltaV or Rockwell.
Would an approach similar to this, such as via common APIs, be more practical in the space? If so, the group noted the importance of defining common and critical data to be collected; if this can be done, the API can be easily constructed. Right now, companies are capturing the same data differently. We need to standardise.
The possibility of requiring the sharing of data at certain stages of clinical trials was discussed. The group concluded this was an advanced concept that would prove difficult from a regulatory perspective and for smaller businesses that are limited in budget and partnership options.
4. What issues would require regulatory guidance that standards cannot address?
“Narrowing our focus to the automation of the connectivity of data is pragmatic.”
The manufacturing process is likely too much to take on at this stage. Effort is ongoing into the space to automate and standardise, but progress is limited by the unique nature of each therapy. Narrowing our focus to the automation of the connectivity of data is pragmatic. Progress such as from DeltaV and Rockwell is making strides in this area.
The amount of data in this regard is a further challenge. With patient records entering hundreds of pages, streaming data for enhanced connectivity could overload the capabilities of companies in the space – particularly if they are smaller in scale and budget. The presentation of data, not just the amount, is also key to solving this issue.
The contract and research organization (CRO) AmplifyBio has announced the acquisition of select assets from privately held biopharmaceutical company PACT Pharma Inc to advance its cell and gene therapy service offerings.
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