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Julian Upton is the European Editor of Pharmaceutical Executive and Editor of Pharm Exec Global Digest. He can be reached at firstname.lastname@example.org.
Q&A explores the evolution of the patient-centric supply chain and how it's poised to impact the clinical trials landscape.
Research Triangle Park, N.C.-based Marken is a clinical trial logistics company involved in direct-to-patient services and biological sample shipments. Offering a GMP compliant depot network and logistic hubs in 45 locations worldwide, Marken is described as “the only patient-centric supply chain organization 100% dedicated to the pharma and life sciences industries.”
Ahead, Marken CEO Wes Wheeler discusses the evolution of the patient-centric supply chain and how it is set to impact the clinical trials landscape.
Q:What defines the patient-centric supply chain?
Wheeler: I think the best way of describing a patient-centric supply chain is that it is one that respects the life-saving nature of what we do, and respects the fact that we’re not just moving boxes, we’re moving a biologic sample, an organ, a life-saving drug, or a life-saving vaccine, and that we realize that there is a patient behind every single one of those shipments.
Every protocol is different and every protocol requires a patient’s informed consent. When the patient consents
to a study, they’re basically putting their personal data at risk, and they’re trusting that the sponsor company or the CRO will protect the privacy of the patient and all of their health data. They’re consenting to giving that data to a group of people they don’t know. So there is the concern, with direct-to-patient studies especially, that patient data that can cross country borders could end up in the wrong hands.
We’ve taken this really seriously. In the last three to four years, we’ve developed a direct-to-patient to program, which is now extending into the cell and gene area, where we respect the fact that every protocol has an informed consent signed by a patient and that we’re entrusted to protect their data.
Q:What are the key challenges associated with a patient-centric supply chain?
Wheeler: Data security and data privacy are the biggest challenges, when, for example, patients agree to a home-based trial or a personalized immunotherapy trial where their personal information is exposed. It’s not like the old days when you had thousands of patients in a diabetes study and the potential for an individual patient’s data to end up in the wrong place was minimized. We’re now talking about highly personal transactions.
We go to a patient’s home and deliver a drug, meet with a nurse, and the nurse administers the drug and maybe takes a blood sample and puts that back into the supply chain. That exposes the patient’s name, potentially, and so we’ve developed processes and procedures to ensure that all patient data is blinded in our systems, that whatever data that crosses country boundaries is encrypted, and that it’s not possible for the investigator to know what drug he or she is giving to the patient. Otherwise, you are compromising the integrity of the trial.
Q:How are digital and AI technologies impacting the patient-centric supply chain?
Wheeler: I’m not sure that we are being inundated by AI technologies yet on the clinical side, but on the digital side our biggest challenge will be dealing with wearable devices, point-of-care devices. I think ultimately the use of blood as the currency for clinical trials will diminish. It will be easier to transfer a patient’s health and vital signs through a wearable device like a Fitbit, one that might be enhanced for the clinical trial to extract the patient’s pulse, blood pressure, and perhaps blood content, temperature information, maybe even biomarker data.
When wearable devices replace the use of blood for testing, all that data will transfer to the Internet, and so can be compromised. That’s where we have to be very careful. In the future, we will potentially be delivering wearable devices, making sure they’re calibrated properly, making sure that they are transmitted under the appropriate conditions, etc., in addition to whatever blood we draw.
Q:How does social media/digital engagement feature as part of the patient-centric supply chain?
Wheeler: We are working with many companies now and have around 100 trials ongoing with a direct-to-patient feature. These are very personal transactions. A patient could be critically ill with cancer and not able to make it to the doctor’s office for treatment. We work on a training module for the drivers and we assign a project manager, who is responsible for setting up the trial, ensuring that the drivers are certified, and that the protocols are reviewed in detail. We get to know the patient by name, we can call the driver on his or her way over to the patient’s home, and we make sure the nurse is there at the same time. The nurse does his or her work, drawing and centrifuging the blood, puts it into tubes, into the box, and the driver takes it to the central lab.
What we’re working now, however, to make that process even better is an Uber-like technology. We hope to have this in pilot trials soon. It will offer the patient an Uber experience: they can go to their app, call up for a delivery, they can see which driver has been assigned and where the driver currently is. They can communicate with the driver, whether by phone or text message, and create that personalized experience.
Q:How do you see this approach evolving in the next two or three years?
Wheeler: I think right now every pharma company has got the message. There are some that are far ahead of others. I think in two years’ time, every single significant clinical trial will offer patients the opportunity to take part from their home. This will grow, for example, in studies with Alzheimer’s patients, Parkinson’s patients, epilepsy patients, and terminal cancer patients, who perhaps cannot drive, cannot get to the doctor’s office in time. The direct-to-patient approach will greatly increase retention and compliance among these patients, and enhance the experience for them. I think eventually that 10-20% of all patients will be treated at home.
Q:What emerging trends are you seeing?
Wheeler: The clear trend we see, which fits into our strategy, is that almost 50% of all trials in development right now are cancer-related, most cancer drugs are sterile, and about half of those drugs are biologically derived, requiring very sensitive handling. But the more exciting thing is the advent of cell and gene therapies, or immunotherapies. In autologous drug trials, where each patient’s tissue is used to create a drug, each treatment is personalized. There are many of these trials being developed now and we’re working with three major pharma companies as an exclusive supplier of cell and gene therapy supply chain work.
This is going to completely change the industry because every treatment is personalized, and requires an individual patient’s tissue to be transformed into a drug within a certain timeframe and under certain temperature conditions. It means the traditional model of making bulk product in a factory for distribution to warehouses and wholesalers will go away. We will have banks of small pharmaceutical storage areas in retail pharmacies to store a patient’s individual therapy, so when they’re ready for the next treatment, they can go to the pharmacy and they get their own personalized medicine. The system we see with the Walgreens, the McKessons and the Cardinal Healths of this world currently storing hundreds of millions of drugs in tablets and bottles will go away, and we will move toward small vials of sterile product that are personalized with the patient’s name on it.
Q: Is pharma prepared for this transformation?
Wheeler: Yes and no. I see a few companies that are very bullish and working hard at this, but the majority of this work is coming through small biotechs. They’re not able to manufacture the stuff outside, they can’t outsource to a [contract manufacturing organization], for example, so they’re developing their own laboratories.
There’s a whole cottage industry being formed, with small companies now advertising that they can do contract manufacture of cell and gene therapies. You are going to see a whole industry created around this.
Julian Upton is European and Online Editor for Pharmaceutical Executive