Pointed Debate

Industry experts discuss the benefits and challenges of self-administration of injectable therapies.
Apr 01, 2012
By BioPharm International Editors
Volume 25, Issue 4

(Maciej Frolow/Getty Images)
Increasing numbers of biological drugs are being developed, driving a strong demand for innovative injection technologies. This need extends far beyond the traditional syringe, and companies are now packaging their biological products into more advanced products, such as autoinjectors. Although these devices may be more expensive than basic syringes, they offer the potential for patients to self-administer a therapy outside of healthcare settings.

The biopharmaceutical industry is under increasing pressure to justify the cost of therapies, particularly if they want them to be included in national healthcare programs. Self-administration is one way of significantly reducing costs and offers further benefits, such as being more convenient for the patient. Here, industry experts discuss the importance of self-administration and what technologies are best suited to this cause.

BioPharm: Why has patient self-administration of therapies become such an important driver in the healthcare and biopharmaceutical sectors?

Kaufman (SHL Group): Self-administra-tion therapies have become an important driver in the healthcare and pharma sectors for a number of reasons. Empowering patients and giving them the freedom to take medications at home or while on the road is more than just a trend; it is vital to the economic viability of healthcare systems worldwide. Enabling patients to self-administer their medication means that healthcare practitioners can use their time more effectively. Most importantly, it has the potential to save money as fewer trips to the hospital can amount to millions in healthcare cost savings.

This trend has had a significant impact on the evolution of injectable drug delivery technologies. Many people are familiar with self-administered medications, such as inhalers for treating asthma, but few individuals, other than diabetics, have experience of injecting themselves using a syringe. As a result, drug delivery companies have had to develop devices that are both intuitive and safe. With the increasing number of approvals for new biologics in recent years, demand will also be quite strong for autoinjectors and pen injectors. However, developing and producing an injection device that is safe, ergonomic, easy to use, and accurate enough for a patient to self-administer involves meticulous designs, innovative technologies and consistent manufacturing. For example, the spring mechanism inside an autoinjector controls the force and timing of the injection and is designed to accommodate the desired injection specifications, while the outer shell of the device may be affected in size and design by the primary container inside and human factor constraints. Once a proven mechanism is designed, ensuring consistent manufacturing then becomes vital because quality needs to be built into every device produced. At this time, there are only a few companies in the world that can design, develop, manufacture, and assemble these pen-like devices, and these companies will need to work closely with biopharmaceutical partners to ensure that patients get the best drug-delivery devices possible.

Novara (BD): There is a growing prevalence of individuals living with chronic disease in the world. However, the good news is that pharmaceutical medicine is working in order to keep pace with this increase. Advancements in therapeutic agents and medicine have resulted in the availability of more sophisticated biologics for the treatment of many chronic diseases. In addition, there is a growing trend in self-administration medicines where patients can self-medicate. This trend has supported the need for further advancement in self-injection technology.

These biologics often have complex technical requirements for injection. For example, they have higher volume or are more viscous, so the technical specifications of these biologics are more challenging and require complex delivery technology. This trend explains why self-administration has become so important. In this respective, device manufacturers must be proficient in patient-centric design and should consider the ergonomic and human factors.

Integrating those biologics with the right delivery system has become critical, not only from a technical specification standpoint, but also from a competitive perspective. The competitive dynamics for new drugs in different fields will require different considerations in the selection of an injection device. Patient consideration is also a factor; for example, a patient with rheumatoid arthritis may have dexterity issues, requiring certain design specifications to make the device easy-to-use. In this respective, it's important for device manufacturers to be proficient in patient-centric design and to consider the ergonomic and human factors.

Integrating the primary container with the secondary device successfully is also critical. Companies offering self-administration technology need to have that expertise in order to improve performance of a drug-device solution, reduce risk of failure, and accelerate speed to market.

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