Gene Therapy and Personalized Medicine

Medicine is evolving. The time may soon arrive when we no longer head to our local pharmacist to collect a pot of generic drugs over the counter, as a new generation of treatments is now finding its way into the pharma space.

What we're talking about is gene therapy and personalized medicines and the way they are being used to advance treatments and improve clinical outcomes. They are, however, creating new challenges for the pharmaceutical logistics industry.

These kinds of medicines require quite different logistical solutions when compared to generic drugs - and that first requires an understanding of what these treatments involve.

Gene Therapy and Personalized Medicine?

The University of Oxford and St Anne's College Centre for Personalized Medicine describes personalized medicine as, "Delivering the right treatment for the right patient at the right time."

Personalized medicine requires an understanding of the typical response to a specific treatment and the factors which can introduce variance within that response. By tuning a medicine to a particular patient's own biology, the effectiveness of that medicine can be significantly improved while simultaneously reducing the potential for any unwanted side effects.

While the integration of personalized medicine into current practice carries significant clinical, ethical, financial, societal, legal, and logistical (more on those later) challenges, it has the potential to benefit every level of healthcare, from health promotion and screening to diagnosis and treatment.

Gene therapy is a type of personalized treatment which involves editing a patient's own cells to help them better fight a disease. Their main application is in cancer treatment where a sufferer's immune system can be "reprogrammed" to recognize cancer cells as a foreign body and begin fighting them as they would any other infection.

"Cancer cells have changes in their genes (DNA) that make them different from normal cells. Genes are coded messages that tell cells how to behave," says Cancer Research UK. "These gene changes mean that cancer cells behave differently from normal cells. Different cancers have also different gene changes. Researchers call this the genetic makeup of the cancer. Every person's cancer has its own genetic makeup. Personalized medicine is looking at developing treatments that target those differences."

Personalized Medicine and Logistics

The keener minded amongst you will have already realized one of the main challenges when it comes to adapting existing pharmaceutical logistics operations to accommodate personalized medicines.

Whereas generic medicines can be shipped in large quantities and take advantage of the cost savings these kinds of shipments allow for. However, as each personalized treatment is made for a specific patient, this kind of mass shipping simply cannot apply. This will likely mean drug manufacturers have to rely on smaller courier services instead of large trucks, flights, and/or ships.

"It is about having the appropriate supply chain that's not necessarily a copy and paste," said Vice President of Clinical Distribution for Cell/Gene Supply Chain at Marken, Nina Vas. "In particular, we take the time to conduct risk analysis, feasibility and assessment and provide a bespoke service. When we talk about cell and gene, it's exactly like you said in the title - a personalized approach in terms of how we work together, collaborate and execute through setups."

The cold chain is also a challenge for logistics. Most cell/gene therapies need to be stored and transported at very cold temperatures and this requires a different setup to regular ambient medicine shipments. Thankfully, due to the COVID-19 vaccine rollout, many pharmaceutical logistics providers have already had to embrace this kind of logistics operation - the Pfizer vaccine needs to be kept at extremely cold temperatures.

Blockchain technology has the potential to help with cold chain logistics. With a combination of IoT enabled temperature sensors within the packages and blockchain's immutable ledger chain function, providers can easily and securely monitor the temperature of shipments at every stage of the journey and instantly identify any weaknesses in the supply chain.

Time is another issue. Many personalized medicines are incredibly time sensitive and need to be passed through the supply chain incredibly rapidly.

"We can have collection windows as short as 15 or 30 minutes for handoffs within the supply chain, we can have specified timeframes" continued Vas. "From a manufacturing perspective, working with the customer to understand manufacturing schedules is key. Upfront preparation - the execution mock shipments in advance - allows you to navigate that complex landscape in terms of understanding the demands of those shipments and lanes."

Final Thoughts

Personalized medicines are here, and logistics providers must adapt in order to offer the kind of services customers are going to be demanding. Those providers which are willing to adapt - even when that involves significant investment in new methods and technology - are the ones which are likely to secure the best contracts for shipping this exciting new generation of treatments.

You can hear an esteemed panel of experts in pharmaceutical logistics talk on this topic and more at LogiPharma 2021, taking place in October at the Hilton Philadelphia at Penn's Landing.

Download the agenda today for more information and insights.