September 22 - 25, 2020 | Sheraton Boston, MA

Tackling the Personalized Medicine Supply Chain

By: Elizabeth Mixson
06/14/2019

What is personalized medicine?

The Mayo clinic defines personalized medicine as “individualized, precision or personalized medicine provides a genomic blueprint to determine each person's unique disease susceptibility, define preventive measures and enable targeted therapies to promote wellness. (1)”. In short, the tailoring of medical treatment to the individual characteristics of each patient. As a result, the rise of personalized medicine is expected to (2):

  • Increase the use of direct targeted therapies vs. trial-and-error prescribing
  • Underscore prevention vs. reactive treatment
  • Reduce the overall cost of health care
  • Reduce the need for high-risk, invasive procedures 
  • Reduce the frequency of adverse drug reactions in patients 
  • Increase patient adherence to treatment
  • Enable the discovery of additional targeted uses for medicines and drug candidates

Though still in its infancy, the global precision medicine market already accounted for roughly $43.59 billion in 2016 and is estimated to reach $141.70 billion by 2026, according to a 2017 market intelligence report by BIS Research, titled "Global Precision Medicine Market- Analysis and Forecast, 2017-2026" (3). Furthermore, in 2017, the FDA broke a record for the most new drug approvals, the majority of which were for personalized medicines.

Considering the specialty and personalized pharma market is only expected to grow, we asked 4 of our 2019 Cold Chain Global Forum Speakers, "What are the biggest challenges you face when it comes to the personalized medicine supply chain and how are you confronting them?". The following is a summary of what we learned.


The impact of personalized medicine on the pharma supply chain?

There’s no doubt about it: personalized medicine is poised to change how clinicians diagnose and treat patients for the better. However, depending on the technology used, the rise of personalized and specialty medicines could make supply chains much more challenging and expensive. As Cold Chain Global Forum Spring speaker Mark Karhoff, the Supply Chain Project Manager, DSCSA Workgroup Member HDA, GS1, MediLedger, told us, personalized medicine “has the potential to be as disruptive to the supply chain as the age of the configure to order PC was to the PC industry for certain segments of medicine. “ 

Pharmaceutical manufacturing hasn’t changed much in the past 50 years. Even in 2019, most pharmaceutical manufacturers still rely on traditional large batch production with large volume production using 1000 L vessels. While reliable and more or less straightforward from a supply chain perspective, this process can be slow, inefficient and doesn’t really allow for much flexibility or customization. 

However, personalized medicines are highly complex and can’t be made to the same scale or delivered using the same siloed supply chain processes used for traditional medicines. For starters, the personalized medicine supply chain often starts and ends with the patient. As Mark explains, specialty medicine “has an entirely different product planning, packaging, distribution and shipping profile. It will likely move product towards smaller parcel shipping volumes.” Kevin Hickman, the Senior Manager, Supply Chain Distribution of Gilead Sciences adds, “it will challenge pharma supply chains simply through the huge increase in ‘high visibility, high touch’ service levels that customers will demand. It's already putting a strain on courier and white-glove service providers because they don't have the number of employees with specific skill sets available. There will certainly be a growing pain period.” Furthermore, 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.


Confronting the Challenges of Personalized Medicine

Speaker Tip #1
Continue to be open to new technology and "outside the box" solutions to manage these shipments and supply chain networks more efficiently and effectively.

The supply chain leaders we surveyed heavily emphasized technology as the key enabler for flexible, multi-product, small batch production. End-to-end supply chain digitization will enable companies to integrate their supply chain (internally as well as externally with partners/vendors), reduce the need for manual intervention and enhance their operational processes, which will lead to planning precision, manufacturing efficiency, better control over inventory levels, and improved patient experience. Integration of Cell orchestration Platforms, the patient management system, MES, LIMS, or the courier system to track the position and condition (temperature, humidity etc.) of the patient`s cells could also harness the power of data for real-time reporting.


Speaker Tip #2
Establish a complete chain of custody capabilities and a chain of identity

Across the pharmaceutical supply chain industry, there is growing emphasis on leveraging technologies that provide real-time or near real-time visibility and transparency into the location of a shipment, temperature, barometric pressure, and any potential risks while in transit for a myriad of reasons such as regulatory compliance, cost-effectiveness and to support anti-counterfeiting efforts. However, having these systems in place is especially critical for personalized medicine given the high manufacturing costs and temperature sensitivity requirements associated with these products. Adopting strong standards for product identification, using digital technologies such as Internet of Things (IoT) tracking sensors and having end-to-end sterilization systems in place will help ensure the shipping integrity of personalized medicines by making it easier to monitor products in transit and in storage.


Speaker Tip #3
Work closely with vendors to develop the required skills and infrastructure to support personalized medicine.

One of the biggest challenges of the modern pharmaceutical supply chain is the growing number of suppliers, vendors and other third-party vendors involved. As the personalized medicine supply chain will be more complex and high risk, having fully integrated systems that provide visibility into every step of the supply chain will be essential to ensuring manufacturers know where, when, and how materials are sourced, manufactured and delivered.

To further support these systems, manufacturers will also need to ensure that third-party providers are fully equipped from a training standpoint. Though some service providers are already recruiting pharmacists and other specialty medicine experts to close their knowledge gaps, others, especially those who rely on high-volume, low-profit-margin business models, and tend to be lean from a resource and capital perspective, may find the transition to personalized medicine especially disruptive. Working with your external partners to ensure they’re able to adapt their processes to personalized medicine production, have the right systems in place to ensure visibility and fully bought into this new way of production will be essential to continued success.


Any additional pearls of wisdom?

  • Expect storage volumes and batch sizes to be smaller. Plan accordingly
  • Learn from similar transformative changes in other industries: automotive, PC, grocery
  • Ensure formulations are stable, particularly of cell products
  • Clarify payer responsibilities



Want to learn more?

Did you know that managing the personalized/individualized supply chain will be one of our top focuses at the upcoming Cold Chain Global Forum? See below for a summary of sessions to attend if this is a topic of interest. 



Thursday, October 17, 2019


1:00pm

GROUP DISCUSSION: How to Scale for Growth Within Individualized Medicine


4:00pm 

KITE PHARMA CASE STUDY: Enabling Personalized Medicine through a Flawless Supply Chain


4:30pm

Packaging Implications of the Increased Focus on Personalized Care



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Sources:

Precision medicine and pharmacogenomics; The Mayo Clinic. https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/personalized-medicine/art-20044300

Challenges in the Personalized Medicine Supply Chain; Chris Striffler. https://clarkstonconsulting.com/insights/personalized-medicine-supply-chain/

SHOWCASE: Supply Chain: Rethinking the Supply Chain in the Personalized Medicine Age; PharmaVOICE. https://www.pharmavoice.com/article/2018-10-personalized-medicine-supply-chain/