With the continuing growth of biologics, and the increased prevalence of patient self-administration, we will continue to see a need for more patient-centric drug delivery systems. This, when combined with increasing complexity of newer molecules (many require higher concentrations and therefore a higher dosing volume), means that pharma and biopharma companies need to consider an increasing number of parameters in order to optimize drug packaging and delivery systems, as well as considering how to ensure optimal patient outcomes. In order to provide delivery systems that patients can use, want to use, and are motivated to use on an ongoing basis, issues such as designs incorporating human factors, patient onboarding and training, and improving initial and ongoing adherence will be major factors.
 
Traditionally, drug development may have started with the packaging system, however, it is increasingly important that companies “start with the end in mind.” As an example, consideration of the final method of delivery and the patient population should drive container development. A drug designed for self-injection by an impaired patient that requires a dosage of 2mL per month to provide optimum outcomes, may require a wearable injector incorporating a drug container capable of containing 2mL of liquid and delivering in a comfortable way over an extended period of time. This drives the selection of a delivery technology, which in turn drives the selection of a drug container. Medications to be delivered in hospitals often require consideration of other factors. For example, if the drug will be delivered by injection, how would the pharmaceutical company address increasing requirements for needle safety systems? If reconstitution or transfer is necessary, how can this be done effectively and quickly, while protecting the healthcare worker?
 
Container systems have continued to evolve, and questions such as glass or plastic, coated or uncoated elastomer, syringe or cartridge will form the basis of decisions needed at an early stage of drug development. Increasing challenges with glass containers, due to delamination/particles and potential breakage during handling or use, is driving a general need for improved systems, including polymer-based drug containment. Ensuring effective functionality between the container and delivery device, in the case of combination products, is also critical. The U.S. FDA will continue to require increasing reassurance of the functionality of a combination product, including tolerance stack-up analyses, as well as the ability of the patient to use the system intuitively. Approval of new medicines will continue to focus on the safety and efficacy of the drug, but manufacturers will also need to ensure that there has been adequate consideration of patient needs, and that usability, functionality and safety have been considered.
 
It has often been stated that “drugs don’t work in patients that don’t take them,” and it’s clear that pharmaceutical and biotech companies are spending a huge amount of effort on ways to improve patient adherence. Such a venture can be enhanced by newer capabilities, in terms of connected health systems, as well as a more thorough understanding of patient psychology. In many cases, rewards are seen as a greater motivator than reminders. In addition, increasing emphasis is being placed on patient onboarding and training. Compliance rates for chronic medicines are low, and it has been shown that many patients do not use devices correctly. Connected health systems offer access to huge amounts of data that can help understand patient behavior. We have already seen increased awareness by patients, which is supported by access to information on specific medicines, social-media-based communication and increased advertising. The advent of connected health devices will further increase a patient’s ability to monitor and control their healthcare.
 
In the broader sense, there will be continuing growth in emerging markets driven by increasing access to healthcare. The advent of biosimilars may open opportunities for increased access to biologics. This is a significant area of opportunity for many companies planning to enter the market with biosimilars, versions of key drugs like Enbrel, Humira and Remicade, while innovators continue to explore new indications and options for lifecycle management.
 
In summary, there is a need for an increased focus on patient outcomes, while ensuring a continued focus on integrated drug delivery systems. Early collaboration between pharma and biopharma companies, and a range of key partners will be critical to ensure optimum speed to market, effective drug delivery, and enhanced outcomes for patients around the world.
 
Enbrel is a registered trademark of Amgen Inc.
Humira is a registered trademark of Abbvie, Inc.
Remicade is a registered trademark of Janssen Biotech, Inc.
 

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Graham Reynolds is Vice President, Marketing & Innovation, West Pharmaceutical Services, Inc., where he leads initiatives to market novel delivery systems and develop strategies for future growth, including the acquisition and development of new technologies to enhance West’s portfolio. Graham holds a degree in Polymer Technology from Trowbridge College, UK.