Guest Column | October 14, 2021

Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product's Labeling & Shipment

By Christopher Ohms, senior director, supply chain, Rigel Pharmaceuticals Inc.

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Imagine a scenario: It is Friday morning, and you are managing a handful of clinical trials around the world. These trials all use the same therapeutic investigational product (IP). The IP was sent to a clinical packaging organization (CPO) as britestock (unlabeled) IP. To support these trials, you need to have more IP labeled and distributed as swiftly as possible to support additional site initiation visits (SIVs) in three foreign countries; fortunately, you have approved label copy on file with the CPO. Before you have the CPO execute any work, you need an approved scope of work (SOW). Given that you have an ongoing relationship with the CPO, and you have reserves of britestock IP residing in their inventory, there should be little reason to be concerned about having more IP available by mid-next week. After all, that is their core competency.

Reality: There is likely no way the IP will be available within this timeframe. More likely, nobody you trust or have worked with can meet this aggressive schedule. And certainly not a CPO that is trustworthy, GMP compliant, and with capacity, which is likely what clinical supply people expect. But what is the barrier to meeting this conceivable request? The short answer is the lack of innovation and technology at the CPOs. It is not as if the innovation and technology do not exist; it is simply not in use by many CPOs.

Leading The Field Through Innovating

When you assess other industries and companies like Amazon, Tesla, IKEA, and Coca Cola, each has a commanding use of innovation and technology to ensure they have what they need, when they need it, and that how it gets from pick-to-pack is swift and error-free. Some may say, “but they are not required to follow the GMPs” or “we work in a highly regulated industry.” To those who present this argument to follow the old ways, I say this an excuse. The clinical supplies community is generally conservative, cautious to adopt new thinking, and slow to change.

There are others, too, who will argue the need is not there for this technology to be implemented. And to those I would say, the CEOs of Daimler AG, Ford, and Honda likely scoffed at Tesla’s drive (pun intended) to create an e-vehicle; now these other automakers are following Tesla’s lead. Tesla innovated the space and now the competitors are following. Tesla has not only innovated the mass-production of an e-vehicle, but it innovated material sourcing, fabrication, assembly, and the integration of robotics in much of its processes. Further, it created a solar farm at its Nevada plant — considered one of the largest in a company — so it could use less fossil fuel to run its operations.

Many more people today are familiar with on-demand customer service because of Amazon, a company that was founded nearly 30 years ago. It is not that Amazon created on-demand or order fulfillment services, but it innovated how do it better than most. Jeff Bezos, the founder of Amazon, embraced technology and innovation in the warehousing operations to keep up with demand of online orders, order shipments, etc. Customer service is at the forefront of the innovative approaches used by Amazon. More products, even fresh items in certain areas, are capable of being delivered the same day or the next day when ordered online. These range from a box of fresh eggs (delicate by nature) to a 200-lb generator.

How Existing Technologies Can Get Your IP Where It’s Needed

It’s now Friday afternoon and you still have not heard back from your business or project managers about what you need to support these SIVs; they have been at an all-day off-site meeting and likely checking emails/phone messages intermittently. You were not able to reach anyone at the CPO and you are going to have to remember to jump on this issue first thing Monday morning. In this stressful scenario, how could innovation really help?

To start, there could be an online portal much like an online menu. Just as you can place a Starbuck’s order online or by using the app, you would use the CPO’s app to request more IP to be labeled, stored, and shipped. The approved SOW establishes the baseline for you to transact the requested services. You create the order and it’s sent to the CPO. An acknowledgement of receipt is sent back to you and an auto-alert is sent to the project manager and business managers at the CPO as well as the other relevant departments involved. Within seconds, you are given the time when your order will be ready — much like a cup of coffee, customized to your specification. The CPO begins to make your order.

The britestock IP is pulled from the warehouse shelves using a robot crew, country-specific labels are created on-demand and mechanically applied using a smart system. Once labeled, the IP are placed inside a shipping box pending your release. Any surplus labeled IP, had you requested them, are stored in the warehouse for subsequent shipments. The electronic batch records (EBRs) are sent to your team as identified on the SOW; the EBRs are not sent in a couple of days but in just minutes from the execution of labeling. There are no handwritten entries; everything is in the secure cloud and you have access to it as an existing customer. The EBRs are compliant and so is the electronic system.

Once your team has released the IP, the bill of lading, packing slip, and any other documentation you requested are included in the shipping box. This is all centralized, electronic, time-stamped, and visually verified by a smart system at the CPO. The correct IP is labeled, released, inspected, and prepared for shipment. FedEx or an alternate carrier is contacted by the CPO to pick up the IP, and away it goes to the sites. The whole process, from SOW generation through IP label/release, takes place in hours, not days or weeks. Innovation and technology are at the center of this plausible compliant and robust cycle time.

It is often difficult to change existing practices. It is even more challenging to integrate new technologies and systems into existing systems. However, as more clinical trials are being initiated and cycle times become shorter, it is essential to innovate approaches to maximize the benefits to the patients and support those transforming these therapies.

About The Author:

Christopher Ohms is a San Francisco Bay Area native who serves as senior director of supply chain at Rigel Pharmaceuticals. Prior to joining Rigel, Ohms held positions at Gilead Sciences, Patheon, Stanford School of Medicine, Pain Therapeutics, and ALZA.