Pharmaceutical products are evolving and patient needs are changing, reshaping healthcare. How will supply chains keep up? PMP News asked Kevin Lawler, vice president of sales for Pelican BioThermal, how logistics might change.
PMP: How will the drug supply chain evolve in the future to meet patient needs? What factors are driving change?
Lawler: The entire patient-centric movement along with the advent of gene- and cell-based therapies will have a significant impact on the supply chain of the future. Reaching patients directly—having treatments available at the point of need—would create a strong competitive advantage. Biologics (gene- and cell-based therapies) require a unique supply chain to support each and every patient. The number of potential shipment lanes becomes endless and the temperature-controlled requirements will also evolve to support both raw material as well as finished goods transport.
Kevin Lawler, vice president of sales for Pelican BioThermal
PMP: Will drug companies be shipping to patients directly? Or will there be other new models?
Lawler: Yes, in some cases a patient-centric approach means that drug companies will ship to patients directly. Many scenarios involve organizations looking at this to create competitive advantage. All intended to further develop brands and develop loyalty with the patient population. Patients will also be shipping DNA material or blood samples directly to the manufacturer. This means a patient is part of the supply chain at multiple points—sending samples that they collect back to the manufacturer to be injected or otherwise applied and receiving the completed drug. It’s a very personal, and very costly, treatment.
PMP: What steps will drug companies need to take to ensure product protection and to provide packaging and labeling that can promote safe and effective product use?
Lawler: Identifying a temperature-controlled packaging solution that both prevents temperature excursions and is cost-effective is not only key to the maintaining the bottom line, but also essential to ensuring product integrity. When it comes to cold chain for a patient-centric approach, stakeholders will need to first develop a detailed understanding of the requirements and then develop a plan and solution to support the cold-chain transport. The value of each therapy is typically quite high, so there is little tolerance for any error or excursion.
PMP: How will cost concerns as well as consumers’ sustainability concerns influence drug companies’ supply-chain decisions?
Lawler: Many of the cell derivatives and drugs for gene-based therapies require rigid temperature control, making successfully regulating and maintaining temperature a top concern for a patient-centric approach. To most effectively address these needs, many stakeholders are looking to balance their packaging by lane using a combination of reusable and single-use packaging. Rental programs that offer services such as pre-conditioning and end of rental drop-off, such as our Crēdo on Demand program, allow businesses to lower their cost-per-use, while still selecting the shipper with the highest payload volume efficiency. Our program is set to expand in 2018, with 12 new service centers set to open and over 50 new drop-off hubs planned for various locations spanning Europe, Asia, and the Americas.
PMP: What supply-chain pitfalls are there, and how can they be avoided?
Lawler: Russia, India, and China, once referred to as emerging markets, have “emerged” and reached a new level of economic development over the last couple of years. The growing level of buying power within these countries—combined with unique regulatory requirements and addressing infrastructure challenges—is likely to have logistics providers scrambling to more effectively serve them in 2018.
These countries have come into their own with innovative offerings and more flexible pharma regulatory requirements. Research, planning, and general awareness can help pharmaceutical manufacturers and other stakeholders can avoid missteps in these markets.
PMP: Are there any new regulations or standards changing, and how can they be addressed?
Lawler: Although GPS, the Internet of things (IoT), and many other data-tracking analytics for high-value payloads are increasingly popular topics, from a life sciences perspective nothing from the FDA or Europe’s Good Distribution Practices (GDP) suggests new regulations are on the short-term horizon. However, we are hearing more about a potential new mandate from China FDA (CFDA) requiring shipments to be monitored for temperature along with GPS and other data points. Being the world’s second largest pharmaceutical market, a mandate such as this could increase the demand for this new technology worldwide and across industries.
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