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Challenges in the Personalized Medicine Supply Chain

The cell and gene therapy medicine supply chain represents a dynamic shift in traditional drug manufacturing models.

The global life sciences industry is on the verge of a revolution that will change how products are developed, marketed, and priced for patients. The role of global biotechnology, pharmaceutical, and medical device companies doesn’t end once treatment has started; these companies are changing their relationship with the patient by engaging and integrating the patient perspective into their business strategy.  With the rate and pace of advances in personalized medicine, precision medicine will be a normal function of patient treatments in the future.  As these treatments become ubiquitous, there are a myriad of challenges that arise for manufacturers in the era of personalized medicine supply chains.

A transformation is underway in patient treatment where the science is moving away from a one-size-fits-all, trial-and-error approach toward a targeted approach that uses patients’ molecular information to inform health care decisions. Although many doctors still prescribe therapies based on population averages, it is clear that healthcare professionals are already seeing the potential for personalized medicine to have a measurable impact on their ability to deliver more effective treatment options.

The drug development industry is betting heavily on personalized medicine, as leading life sciences companies have nearly doubled their investment in personalized medicines in the last five years, and expect an additional 33% increase over the next five years.

A few of the anticipated benefits of personalized medicine for patients and the healthcare system are:

  • A shift in the emphasis in medicine from reaction to prevention
  • An increase of direct targeted therapy and the reduction of trial-and-error prescribing
  • A reduction in adverse drug reactions in patients
  • The discovery of additional targeted uses for medicines and drug candidates
  • Increases in patient adherence to treatment
  • A reduction of high-risk invasive testing procedures
  • Further control of the overall cost of healthcare

At a time of extraordinary scientific and medical breakthroughs, personalized medicine has the ability to more accurately diagnose disease states, detect the onset of diseases earlier, target treatments, and increase the overall efficiency and effectiveness of the healthcare system.  As innovative value-based care contracts become more commonplace, traditionally innovative pharmaceutical companies will face disruption and a case for change. Increasingly, they will be forced to demonstrate the pharmacoeconomic value of their products.  With personalized medicine, that cost-benefit case can improve significantly with a higher efficacy rate per patient of these treatments.

“Personalized medicine stands right at the center of [the health care] revolution, with the science enabling greater precision that not only can improve the lives of patients, but can also create efficiencies within the health care system by delivering the right treatment to the right patient at the right time.” — Stephen J. Ubl, President and CEO, PhRMA 

Impacts to Drug Manufacturing in the Personalized Medicine Supply Chain

Pharmaceutical manufacturing historically consists of large batch production with large volume production using 1000 L vessels, generally considered a fairly simple process. These new personalized therapies, often exponentially more complex than more traditional medicines, simply cannot be made on the scale and with the speed, reliability, and traceability required for the efficacy and safety of the treatment.

The solution to this new challenge is far from simple. Single-use technologies, for instance, are already enabling flexible, multi-product, small batch production, a crucial component for personalized medicine. Modular construction lowers plant capital costs dramatically while enabling the ultimate in manufacturing flexibility. With these innovations, costs can come in as low as one-fifth of building a permanent stainless steel vessel batch facility. For continuous manufacturing, the challenges involve sophisticated process controls. Decision makers must be able to review all production variables as an integrated, interdependent system so that a change in one is met with the right response – all while the system continues to operate. This will also revolutionize the quality assurance functions in your organization.

The time and temperature sensitivities inherent to personalized medicine will also require companies to ensure that every node of a product’s cold chain is virtually error-free. Imagine a CAR-T autologous therapy product that is classified as gene-modified cell therapy and is designed or “trained” to attack cancer cells. This therapy requires T cells that are extracted from a patient’s blood, re-engineered in a lab to recognize and kill cancer cells, and then re-infused back into the patient, a process that may require 5 different shipments of 3 different materials at 4 different sub-zero temperatures. Imagine the shipping process, the strict quality control and safety requirements, and the fact that this entire process is completed in less than 3 weeks – all for one batch for one patient. Also, consider the patient’s health and wellbeing during this process – have they recently undergone a surgical procedure? Are they well enough for the treatment? How will that impact the production schedule? The structure of this complex and intricate supply chain will present new challenges for both emerging biotech companies and for big pharma.

While the current state of the cold chain is likely adequate for the transport of personalized medication, the necessary error rates of nearly 0% will pose the biggest challenge as unique medications and treatments are added to the process. With 25% of pharmaceutical costs and 40% of medical device costs tied to the supply chain, there are opportunities for significant cost savings. Where many pharmaceutical companies’ core competencies revolve around research and development, it may not be feasible to build your own supply chain capabilities to support this new type of treatments. While it may not be a strong capability at most pharmaceutical companies, initiatives underway in the supply chain around serialization and theft reduction are a good prelude to preparing your supply chain for the era of personalized medicine.

Improving your cold chain capabilities for transportation and storage (usually 2–8°C) requires a huge network of time and temperature sensors in factories, warehouses, trucks, labs, and pharmacies that can monitor and send this information for both clinical trial supplies and approved products. IoT tracking sensors and networks help life sciences companies ensure the safety and efficacy of their products in transit and in storage. The need for complete chain of custody capabilities and chain of identity will also have an enormous impact on the current supply chain model. This involves individual tracking from manufacture to patient delivery and sometimes from patient to manufacturer. This exacerbates the need for individual packaging, increased temperature monitoring, aid in customs clearance, GPS-based alerts for potential delays, and other regulatory hurdles.

Personalized Medicine’s Impact on the Extended Supply Chain

The impacts of the personalized medicine supply chain will not only affect drug manufacturers. The supply chain functions of contract third-party providers will play an important role in the development of personalized drugs. Those who prepare now to offer services may see tremendous financial rewards. Most leading logistics service providers (LSPs) are now beginning to employ pharmacists and patient coordinators who deal with apheresis sites, hospitals, clinics, and patients. With personalized medication often based on a patient’s own cells, moves are frequently two-way, starting and ending with the patient. Often blood or T-cell samples are taken to the production facility and the resulting medication is delivered to the patient after a few days, in two moves with different ambient temperature requirements, but managed by the same provider under an integrated service. Currently, there are only a handful of LSPs that have this type of capability.

Contract manufacturing organizations (CMOs) will experience a significant impact in the era of personalized medicine. The CMO industry generally operates on a high-volume, low-profit margin business model, and are lean from a resource and capital perspective in a very competitive marketplace.  The impacts of advancements in personalized medicine have the potential to significantly disrupt this business model. CMOs will have to navigate this innovative new world of personalized medicine by improving their ability to clearly articulate the benefits of their treatments, their value to the patient, and feel comfortable with the cost of the treatment.

The transformation is underway in patient treatment where a targeted approach using the patients’ molecular information to inform health care decisions can change the healthcare landscape. There is significant potential for personalized medicine to have a measurable impact on life sciences company’s abilities to deliver more precise treatment options, but with that opportunity comes challenges, particularly throughout the extended supply chain. How your business navigates this new era will impact your market standing and your ability to effectively treat your patient populations.

Co-author and contributions by: Brian Guillett

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Tags: Personalized Medicine, Serialization & Traceability