Clinical trials are rising in both frequency and complexity. Increased global demand for U.S. manufacturing, along with the growth in specialty drug manufacturing nationally, have fast-tracked industry investment in drug development. Manufacturers are aware of the need to cut costs and increase production flow along the supply chain. Compliant labeling is an integral part of clinical trial administration. With the right kind of technology, clinical trial production label printing operations can be scaled to efficiently and cost effectively support the clinical trial supply chain across multiple channels.
Traditionally labeling technologies have been poor performers in this sector, unable to keep up with clinical industry standards. Current technologies are a different story. Shifting to color on-demand labeling can enable the kind of cost-cutting flexibility, accuracy and safety that clinical manufacturers are looking for.
CLINICAL TRIAL LABELING DEVELOPMENTS
Investment in global clinical trials is rising, which may explain why healthcare agencies and government services are cracking down on clinical trial transparency. Globalization – while benefiting the industry on one hand – complicates drug safety and track and trace implementations on the other, as drugs are increasingly imported or exported to and through global supply chains. Checkpoints for any vulnerabilities along global supply chains are thus necessary, to ensure end-user safety. Labeling complexity is a large topic of discussion for manufacturers and pharmaceutical distributors in 2015 – particularly when rigorous efforts are being made to combat drug counterfeiting and supply chain errors that compromise patient safety. The European Union has already responded to the threat of fraudulent drugs by releasing the EU Directive on Falsified Medicines + Delegated Act. The act has led to a global trend of turning to technologies that comply with regulations, build “agility and flexibility into packaging and labeling,” and are capable of both securing and streamlining the supply chain.
At a national and local level, FDA’s push for new and innovative medications parallels the rise of specialty drug development – marking the increased importance and dependency on clinical trials in the industry. The FDA has paved the way for increased clinical care for therapeutic drugs, while more sponsors are taking on the challenge of new product development in the niche market for specialty, therapeutic or orphan drugs for “rare diseases, breakthrough therapies, and novel new antibiotics.” A quarter of the more than 2,000 products currently in late-stage clinical development are specifically oncology therapies. By 2020, more than half of the industry’s sales will be from biologics, specialty drugs and therapeutic vaccines. Additionally, last year’s Ebola outbreak raised questions about the response time in testing and research, contributing to a larger discussion on global health concerns. The consequences of the outbreak–coupled with increased industry pressure for more organized and timely responses – only further demonstrated the critical need to fast-track clinical trials for rare diseases. Consequently, the specialty market is poised for increased competitiveness in an already fast-paced industry, pushing demand for technologies that can adapt to the rigorous manufacturing standards for new products.
In general, companies in 2015 will be on the lookout for partnerships with manufacturers that have established themselves as “high operational efficiency” performers and also, by necessity, expanding packaging and labeling services to include global clinical trial management. Operational efficiency has become an industry expectation, rather than simply a value-add. In order to keep up with the industry’s requirements, color labeling, printed on-demand, has the potential to improve clinical supply chain flow.
SUPPLY CHAIN CHECKPOINTS
For those not aware, drug development and clinical trial testing occur in two stages – a preclinical stage and a clinical stage that consists of four phases. The preclinical and clinical stages last approximately 9 years, consisting of research, development, testing and finalization. Regulators however, consider each clinical phase as if it were a separate, distinct trial, which means that the FDA must approve all data before the trial moves on to the next phase. This approval-by-trial phase process also impacts updates or changes to drug labels, which increase in frequency as the participants for drug testing grow larger with each incremental phase. A final labeling review takes place once a drug undergoes the New Drug Application process.
Within the trial itself, there are quite a few checkpoints during which a significant amount of time is devoted to crosschecking the accuracy of recorded updates or label changes. Clinical trials by nature often require smaller batch sizes that manufacturers maintain rigorous control over. Each batch comes along with specified preproduction and postproduction batch records that outline necessary guidelines to carefully track any label changes that occur. Maintaining supply chain precision for checkpoints such as these, that leave room for human error, requires durable labels that enhance quality control by withstanding wear and tear and ensuring readability of unique identifiers.