SHL recently had the opportunity to participate along with various other experts in the industry in a questionnaire held by PharmTech.com on the topic of ‘Pointed Debate: Expert Views on Injectables’. The article features each participant’s respective insights on the injectable industry, more specifically in the area of self-administration and related technologies.
This is a re-post of the article with the sections SHL provided answers to. See the original full article here.
Q: Why has patient self-administration of therapies become such an important driver in the healthcare and pharma sectors?
Kaufman: Self-administration 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 auto injectors 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 auto injector 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 for their given therapeutic area.
Q: Which technologies (autoinjector, prefilled syringes etc.) are most suited for self-administration and why?
Kaufman: As patients are not medically trained, empowering them to feel comfortable enough to properly inject themselves requires a device that can make them feel safe both mentally and physically. To address this, devices with special features and technologies, such as the auto injector, are often designed so the patient never sees the needle and may finish administering the drug within a relatively short period of time.
While reactions to physical pain may vary for each patient, the mental pain connected to visually seeing a needle inject can largely be reduced, especially when the patient also has control over when to initiate the injection. As a result, auto injectors are becoming a commonly accepted drug delivery technology for self-administrated injectable therapies.
However, it is very important to note that each patient needs to be properly trained on how to use such devices and they must be provided with very clear instructions for use. The use of picture-oriented instructions and video has been a good step towards addressing this issue.
Another potential drawback related to self-administration technology is the cost associated with developing a drug delivery device and the actual cost of each device. At this time, it is much easier for larger biopharmaceutical companies, which have the necessary financial resources, to initiate these programmes. Additionally, the market value of the drug must be able to justify the cost of the device.
Q: What extra steps do companies need to take to have a drug approved for use in a self-administrative form?
Kaufman: Generally, a biological drug will need to be first approved as an independent drug, regardless of whether or not it is to be used in a self-administrative form. For the device constituent of a combination product, the medical device manufacturer will generally support biopharmaceutical companies by filing a master access file and/or 510K to help with the customer’s submission process.
Self-administered biological drugs can generally be placed inside a primary container such as a pre-filled syringe or cartridge, which will then reside in a device that possesses the mechanical system to perform the injection. The two together is a drug/device combination product that, although not yet official, has been identified by the FDA as an area that requires regulatory guidance. Companies that wish to introduce a drug in a self-administrative form will need to start regulatory planning at a very early stage to ensure that approval times do not become a potential bottleneck to a successful global launch.
Q: How are designers and manufacturers of self-administration devices approaching the challenges of ensuring sterility and accurate dosing outside of healthcare settings?
Kaufman: Accurate dosing is achieved through specially designed delivery mechanisms, rigorous testing and precise manufacturing. For example, in a mechanical device, highly accurate dosing can be achieved using the appropriate spring technologies. Thus, the design and testing of such devices is paramount.
Sterility is ensured again by designing a suitable device for the primary container selected by the biopharmaceutical partner; for example, a pre-filled syringe that is assembled into an auto injector under controlled procedures in line with related regulations and standards.
Q: The ability to offer adjustable doses, for example in diabetes, has great potential. What progress is being made in this area?
Kaufman: We see progress in the development of unique and robust mechanical designs that can accommodate the need to offer adjustable doses. This allows for the device to remain cost-effective, as some drugs do not have a market price that justifies complex drug delivery technology. However, we do see a renewed drive to incorporate electronics into some of the more expensive devices, which is perhaps inspired by the trend of cutting-edge designs related to smart phone and tablet innovations.
Q: What are the challenges of manufacturing devices suitable for self-administration?
Kaufman: Main challenges include anticipating numerous device usage scenarios against which to test the device, ensuring quality consistency and providing robust production lines to respond to mass production needs. To address these challenges, device manufacturers should work closely with biopharmaceutical companies to better understand end-user feedback and use it to more accurately reflect and construct usage scenarios for device testing. In addition, device manufacturers need to continually invest in the latest in-house capabilities and processes.
Q: Needle-free devices seem to have lost some traction in the market, why might this be the case?
Kaufman: At this time, innovations in drug delivery devices with needles continue to move forward in addressing the growing need to administer biologics. Auto injectors and pen injectors have been proven to be effective, safe and reliable devices. With this established track record, needle-based devices will continue to strengthen their position in the self-administration market.
Q: What recent groundbreaking innovations have you seen in the area of self-administration devices?
Kaufman: Groundbreaking is a powerful statement. I have seen a number of significant innovations in the area of auto injectors over the past seven years, particularly when it comes to the look and the size of devices. Auto injectors are more discreet and are now available in sizes that are not much bigger than a marker pen, which allows patients to travel and use the devices whenever and wherever they wish without feeling embarrassed.
Industrial designers have also worked closely with human factors engineering groups to make several devices (launching soon) that are completely customised to suit the needs of a specific patient group. For example, if rheumatoid arthritis patients have difficulty removing a cap, industrial designers can overcome this by engineering a new solution for cap removal. These may not be groundbreaking, but to me they represent a significant shift in the way devices are being made – working more with patients at the earliest stages and making drug delivery devices that are simple and intuitive.
Q: What is your overall assessment of the future of injectable drug delivery? What emerging trends, drivers and changes do you expect to see in the coming years?
Kaufman: With the wave of biologics coming to market, several new devices, such as auto injectors, will see increased competition. One clear way that companies will differentiate themselves will be in the choice of drug delivery device. Designing, developing, producing and launching a biologic in an innovative device will not only enhance patient compliance, but could result in more revenue.
For biopharmaceutical companies, the trend is clear: find the right partner, and develop devices for your biologics and future biologics now. It takes time and money, but it will be well worth it.
Steven Kaufman is marketing director at SHL Group.