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Julian Upton is Pharmaceutical Executive's Online and European Editor. He can be reached at firstname.lastname@example.org
Can the pharma industry truly achieve a patient-centric supply chain? How some clinical trial logistics companies are racing ahead in making the patient a key link in the chain.
There is a lot of talk about the patient-centric supply chain, but can the pharma industry hope to really achieve it? Pharm Exec looks at how some of the pharma services and clinical trial logistics companies are racing ahead in the field of patient centricity
Amid increasing regulations and restrictions in access to patients or healthcare providers, pharmaceutical companies need to improve the reliability of their supply chains while at the same time build flexibility and reduce costs in the supply chain, wrote the authors of a 2016 LogiPharma Benchmarking Report.1 “The watchword is ‘visibility,’” the report went on. As demand models shift from push to pull, “businesses must go further than shifting their demand strategies and illuminating all the components of their logistics routes.” Companies should get closer to their customers, using analytics to derive insight out of their brand interactions, the report recommended. To gain competitive advantage in the future, they must remodel their supply chain practices using all channels available to them to reach out to patients and prescribers, and invest further into maximizing visibility, improving the visibility of their shipments and the needs and preferences of their customers.
This is easier said than done. In a December 2011 article, Hedley Rees, supply chain expert and author of Find It, File It, Flog It: Pharma’s Crippling Addiction and How to Cure It (2015), asserted that “the supply chain patient is sick” and that the cause of the “sickness” could be summed up in two words: “parental neglect.”2 The industry’s “single-minded drive to meet clinical endpoints and gain regulatory approval has resulted in [it] paying scant attention to the good practices and processes required to build and manage robust, secure and high performing supply chains,” he wrote.
For Rees, the root of this supply chain sickness goes back more than 30 years, when “big pharma began to jettison what it considered ‘non-core’ activities (clinical/non-clinical research, development, manufacture, logistics) by outsourcing on a massive scale.” The move created “a rapidly spiraling contract services sector” but the result was “hands-length, cost-based relationships between the various players in the pharma supply chain, each operating within their own separate organizational structures, quality systems, and
information technology investments.” As a result, supply chain visibility all but vanished: “There remains very limited two-way interaction at this critical interface between those developing/supplying drugs and the patient experience of their product,” Rees concluded in 2011.
Speaking to Pharm Exec six years after his diagnosis of the industry’s “sickness,” Rees maintains that pharma still has no grip on its supply chain. “The industry has become so fragmented in the last 40 years,” he says. “The way the supply chain has developed, there are so many different players-product license holders, clinical trial sponsors, contract research and contract development and manufacturing organizations (CRO/CDMOs), third-party logistics providers (3PLs), wholesalers, pre-wholesalers, pharmacies-that the supply and distribution of finished goods is highly convoluted. It is very difficult to keep track of them. Today, the CDMOs are integrating upstream and downstream and taking more control over the supply chain. So too are the CROs, wholesalers, and 3PLs. These contractors are getting bigger, where the pharma companies are becoming smaller. That leaves pharma companies in a weak position.”
The irony for Rees is that although drug manufacturers are totally responsible for their products, they have “almost no control” over them. “Pharma doesn’t own the CDMOs or any of the other contractors in the chain of custody; they don’t see the product when it has left their ownership, when it leaves the plant after being packaged, so they have no access to sales and other information,” says Rees. “They have to buy that information back at great expense, and when they receive the sales information, it is about six weeks old. So, when you talk about pull demand, pharma is not going to be able to achieve it.”
As Rees indicates, “control” of the supply chain rests outside the hands of pharma itself, so it is worth looking at how certain pharmaceutical services and clinical trial logistics businesses are achieving a more authentic level of supply chain patient centricity. Big companies like Cardinal Health, on the medical and pharma services side, and UPS, on the logistics side, have been investing heavily in patient-centric solutions that show how the space is really evolving.
For Jennifer Fillman, vice president and general manager, specialty services, Cardinal Health Specialty Solutions, a patient-centric distribution strategy is one that is “built around the needs of the patients and all the factors that might impact their treatment experience: medical needs, financial needs, social needs. It needs to consider not only how does the pharma company get its therapy to the right patient at the right time, but also how the company can help remove the barriers to access, and help support the patient in adherence and compliance to really optimize the outcome.”
Cardinal Heath Specialty Solutions subsidiary, Sonexus, is a hub services company that, according to its marketing, goes “beyond traditional hub services” to help patients and providers access specialty products “with unprecedented speed, efficiency, and empathy.” Sonexus integrates non-commercial specialty pharmacy services with direct distribution services to hospitals, practices, specialty pharmacies, and patients, and allows for direct interaction with patients and healthcare professionals (HCPs); it helps patients find financial assistance, explores their transportation considerations, and connects them with support groups and nursing services.
For rare disease patients, this is particularly important, Fillman told Pharm Exec, as “patients and their caregivers are typically managing a lot more complexity.” There is increased pressure on pharma companies to ensure they are meeting the needs of such patients, she adds. “There are the physical, psychological, and
emotional aspects of the disease, and there are very few resources for people to turn to for support,” says Fillman. “Patients and their caregivers are heavily dependent on the services that are provided through the supply chain.”
According to Fillman, as some of these niche disease states become more competitive, pharma companies will need to deepen their relationships with patients, caregivers, and HCPs “to help differentiate themselves as well as drive adoption of their products.” Although the focus here is on specialty products, Fillman underlines the broader issue of pharma’s limited visibility of its own products: “The majority of the clients we work with are launching their very first drug and may have limited supply chain experience. Their product goes from the manufacturer directly to our 3PL facility. We take care of it, we work on behalf of their brand, so we’re really an extension of the pharma company.”
For Wes Wheeler, CEO of Marken (now owned by UPS), which works in the clinical trial logistics space and offers direct-to-patient services and biological sample shipments, the patient-centric supply chain is “one that respects the life-saving nature of what we do, and respects the fact that we’re not just moving boxes, but moving a biologic sample, an organ, a life-saving drug, or a life-saving vaccine, and that there is a patient behind every single one of those shipments.”
Described as “the only patient-centric supply chain organization 100% dedicated to the pharma and life sciences industries,” Marken is involved with around 100 trials with a direct-to-patient feature. The company assigns a project manager to each of its trials and enlists its delivery drivers in training programs. As Wheeler told Pharm Exec, “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. The nurse draws and centrifuges the blood, puts it into tubes, back into the box, and the driver takes it to the central lab.”
Now Marken is delving further into the mobile space and developing an “Uber-like technology.” Wheeler says it “will offer the patient an Uber experience, where they can go to their app, call up for a delivery, see which driver has been assigned and where the driver is currently located. They can communicate with the driver, whether by phone or text message, and have that very personalized experience.”
Wheeler believes that within two years, every significant clinical trial will offer patients the opportunity to take part from their home. “This will greatly increase retention and compliance among these patients, particularly Alzheimer’s patients, Parkinson’s patients, epilepsy patients, and terminal cancer patients, who perhaps cannot drive, who cannot get to the doctor’s office in time,” he says.
Wheeler notes that almost 50% of all trials in development now are cancer-related, that 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,” he says. “In autologous drug trials, where each patient’s tissue is used to create a drug, each treatment is personalized.”
The move to personalized treatment is “going to completely change the industry” as far as the supply chain is concerned, Wheeler contends. “The traditional model of making bulk product in a factory for distribution to warehouses and wholesalers will disappear,” he says. “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 current system of 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.”
Where this leaves the pharma industry and its traditional, “20th Century” supply chain model is open to question. For Rees, the onus is on pharma to become truly patient-centric. But for all the marketing and communications talk about how important this is, he does not see this happening. “If you look beneath the talk,” he says, “the people who develop drugs are not talking to patients and HCPs.” What is required is a major shift at the heart of the industry-a complete overhaul of “an ingrained cultural mindset that drives behaviors counter to the needs of patients,” says Rees.
That will be no easy fix, of course. Rees believes it will take at least a generation, and probably longer, to achieve. As he wrote in 2014, “CEOs and their executive teams must step up to the plate and drive a new culture of patient engagement, not only talking to them, but building a deep understanding of their needs, across diagnosis, therapy, after-care, and prevention.” 3
Rees adds today that change must be kick-started by governments and politicians. “They should facilitate amendments to medical patent laws, so that companies are rewarded for building much stronger cases for the validity of a molecule before patent application,” he says. “The role of patents is to reward companies for bringing a workable product innovation to market. At the moment, given that it takes 10,000 patented molecules to get one to market, the proof of ‘workable’ is very much to the contrary.”
He concludes: “FDA’s CDER (Center for Drug Evaluation and Research) Director, Janet Woodcock, has been hanging out opportunities for pharma since 2002, in the form of the 21st Century Initiative and the Critical Path Initiative. Since they are merely advisory, lip service only has been paid to them. These FDA initiatives would make an excellent starting point for advancing a dialogue between the key stakeholders in the industry, but only politicians can get the ball rolling.”
Julian Upton is Pharm Exec’s European and Online Editor. He can be reached at email@example.com
1. Examining the Patient-Centric Supply Chain and Best Practices for Lean Health Car Fulfillment, LogiPharma Benchmarking Report, 2016.
2. Hedley Rees, “The ‘supply chain’ patient is sick: Is there a cure for the pharma supply chain?”, pharmaforum.com, Dec. 21, 2011.
3. Hedley Rees, “Patient-centric pharma: Brave new world or same old empty promises?”, pharmaforum.com, Feb. 25, 2014.