Citation: Love J, Lee M, Boyle A, “Enable Injections and Flex Set Ambitious Plans for Large Volume Drug Delivery”. ONdrugDelivery Magazine, Issue 86 (May 2018), pp 48-51.
The delivery of high volumes of biologics outside of the clinical setting remains a key challenge in the industry. Here, John Love, Mark Lee and Amy Boyle discuss how the enFuse™ on-body injector, developed by Enable in partnership with Flex, may be the answer.
Enable Injection’s enFuse™ drug delivery technology is set to redefine the standard of wearable injection devices (Figure 1). However, unlike many disruptive new medical device concepts, which often demand a change to practice, enFuse does not. It achieves great strides towards the goal of infrequent, large-volume injections of biologics, is easy to use and has wide-ranging benefits that are immediately evident. It can deliver large doses – up to 50 mL (Figure 2) – of the most viscous biologics subcutaneously, with no needle in sight and with minimal to no discomfort.
enFuse allows health facilities to treat more patients who either choose or need treatment in the clinic, freeing up nursing time and increasing patient throughput and saves healthcare systems money whilst doing so. It allows pharmaceutical companies to decrease their drug development time and extend their commercialised products’ lifecycles. It allows patients to potentially skip the infusion centre once therapy has been established and self-administer their prescribed biologic at home or work, in a way that is easier, more comfortable and more convenient than intravenous (IV) administration and, most importantly, enFuse allows them to have agency over their own treatment and improve their quality of life.
Armed with the smallest, most advanced connected technology platform available for delivery of high-volume biologic drugs, Enable Injections is showing all the tell-tale signs of a start-up that can meet the demands of the rapidly expanding industry for large-volume wearable injectors. Enable has an in-house manufacturing facility, as well a partnership with major international contract manufacturer Flex for the large orders anticipated, and a swiftly increasing number of development projects and feasibility studies.
enFuse is a technology that could result in better patient care in terms of improved compliance that will likely lead to better outcomes and enhanced patient satisfaction.
RISING DEMAND FOR COMBINATION PRODUCTS
A new, patient-centric way to administer the ever growing number of large-molecule biologics, as presented by enFuse, is sorely needed. Thus, combination products have been trending in the pharma market to catch up with this unmet need. According to Grand View Research, the drug-device combination market is expected to reach US$178 billion (£127 billion) by 2024. The research firm says it expects an “unprecedented adoption rate of these combination products” as a consequence of their many benefits.
THE ENABLE – FLEX PARTNERSHIP
Anticipating the high adoption rate of this new technology, Enable Injections sought out the world’s largest medical device contract manufacturer, Flex. Flex’s expertise in the miniaturisation of electromechanical pump systems, precision plastic moulding and connectivity technology supports present and future generations of the innovative enFuse delivery device platform, developed by Enable based on dozens of human factors studies for ease of use and patient comfort.
“According to Grand View Research, the drug-device combination market is expected to reach US$178 billion (£127 billion) by 2024. The research firm says it expects an “unprecedented adoption rate of these combination products” as a consequence of their many benefits…”
In particular, Flex’s skill at miniaturisation ensures one of enFuse’s major differentiators: its small size. The 10 mL device is about the size of an Oreo cookie, which makes the wearable large volume injector comfortable for any sized person to wear while carrying on with their day-to-day, no longer tethered to an IV at an infusion facility (Figure 3).
Flex’s singular, rigorous quality system, conditioning know-how and large-scale manufacturing capabilities made the company an ideal partner to address manufacturing complexity and scalability. Their collaboration and joint engagement to establish material handling, pre-control of critical variable signals and manufacturing requirements during the design phase set the stage for successful manufacturing from the very beginning. In addition, Flex has experience in combination on-body devices, ISO 11608 and regulatory requirements. Flex and Enable’s partnership also helped to develop a competitive cost of goods across unique components, precision plastics, automated assembly and device packaging.
Through to this partnership, Enable’s enFuse device boasts a full suite of digital health and connectivity capabilities, powered by Flex Digital Health’s fully HIPPA compliant BrightInsight™ platform. These features provide avenues through which usage and compliance insights can be gleaned and patient’s outcomes can be improved. This innovation expands market opportunities, allowing Enable’s pharma partners to provide greater therapeutic value to their patients by facilitating a more outcomes-based approach to treatment decisions.
PROGRESS TOWARDS MARKET
After the companies collaborated on design, the work transitioned back to Enable in 2017 to prepare the versatile platform for clinical trials. As demand from pharma increases, Enable will provide clinical builds and initial production from its Cincinnati HQ and then transfer high volume production to Flex.
“When large volume production of enFuse units is required, it can be quickly integrated into any one of Flex’s international production facilities with Class 8 cleanrooms…”
A Growing IP Portfolio
A series of granted patents and pending applications in the US, Europe and Asia-Pacific for Enable Injections’ enFuse On-Body Delivery System technology solidifies the company’s position as a leader in the large volume wearable drug delivery market. The most recently granted is a relatively rare utility patent issued by the US Patent and Trademark Office.
Development And Feasibility Studies
Enable has engaged with most pharma companies, from small start-ups to well-established global players. Extensive feasibility studies evaluating device performance and patient acceptance have been conducted, resulting in several development projects to date. Discussions are ongoing with current and future pharma partners to extend the collaboration to more products in the near future.
From the beginning, the development of enFuse focused on final product costs to maximise return on investment (ROI) for Enable’s pharma partners. Utilising Flex’s strength in global supply chain management and a continuous improvement mindset, the companies have developed a five-year strategy to ensure timely market entry of a product at a competitive price.
Built-In Technology Transfer
In drug development, time is always of the essence. As the patent life of newly discovered drugs continues to shrink, drug developers are forced to minimise drug development time. One bottleneck that often delays time to clinic is technology transfer. Manufacturing transfer expertise is essential to quickly ramp-up production for launch execution. In the event of earlier than expected regulatory approvals or accelerated adoption, special expertise and flexibility in production ramp-up speed is required.
The close collaboration between Enable and Flex ensures minimal production delays. When large volume production of enFuse units is required, it can be quickly integrated into any one of Flex’s international production facilities with Class 8 cleanrooms. Technology transfer is built in for rapid response to pharma needs.
INTEGRATE DELIVERY EARLY IN DRUG DEVELOPMENT
“Nearly 60% of pharmaceutical combination product experts say that the time to add the delivery device constituent is in early stages of drug development…”
The enFuse platform is available now for faster drug development and for investigational use. Nearly 60% of pharmaceutical combination product experts say that the time to add the delivery device constituent is in early stages of drug development. Introducing a delivery platform at the early clinical stage provides an opportunity to engage patient populations that much sooner, improving the product’s ability to meet patient needs and thereby improving the likelihood that the outcomes align with the expectations of governments and payers. It also enables the pharmaceutical company to answer contextual questions regarding the patient sooner, and thus decrease cycle time for new product development.
An early start will also reward formulation teams. Today’s more advanced technologies and wearable devices can reduce time to market by months or even years. They provide the means to more easily:
- Deliver drug product in high volumes
- Deliver much higher viscosities
- Address biologics’ greater propensity to precipitate out of solution.
PATIENT TREATMENT EXPERIENCE
From the patient perspective, how a drug is delivered (method, frequency, device, etc) is often the defining element of the treatment experience. In today’s clinical trials, the patient should always be at the centre. It’s become much more important to have the treatment experienced by someone representative of the target patient population. Physiological data is of course gathered, but patients are now reporting back on how the treatment experience feels, how it could be made easier for them and what they liked and disliked about it.
In pharmaceutical company patient panels, enFuse was preferred to many other delivery methods, primarily due to its comfort and convenience.
The result of the Enable – Flex partnership is an advanced, patient-centric biologics delivery platform that is an effective therapeutic solution to delivering high volume biologic drugs. The world’s ageing population and rising incidence of chronic diseases has made the need for a product like enFuse inevitable. The need to reduce healthcare expenditures along with the increasing popularity of point-of-care treatments are also fundamental shifts underlying the rapid growth in the drug-device combination products market.
Looking forward to advances in on-body delivery device combination products, we can expect more connectivity to improve user experience, disease management, provider and caregiver interaction and communication with an electronic health record (EHR). Now and in the future, pharmaceutical companies can employ these innovative products with very low risk and cost of entry.