Solving the problem of biologic delivery: Large volume wearable injectors
This is a guest post from Michael D. Hooven, President & CEO, Enable Injections Inc.
The oxpecker perches on the backs of zebras and eats the ticks and parasites that live on their skin. The bird gets its food, and the beasts get pest control. It’s an example of mutualism at its best – both parties benefit greatly from the relationship.
Likewise, biologics, those large volume, often viscous drugs that are proliferating for treatment of a host of diseases, from cancers and autoimmune disorders to rare diseases, benefit greatly from an emerging drug delivery technology — large volume wearable injectors (LVWI).
Biologic drugs consist of mega-molecules that are hundreds of times the size of conventional small molecule drugs. They are frequently composed of a heterogeneous mixture of more than 1,300 weighty amino acids. That creates three main challenges for pharmaceutical companies seeking to develop the next blockbuster biologic:
- Biologics are hard to take
- Biologics are hard to make
- Biologics can be expensive
Despite these difficulties, targeted as they are to particular genes or proteins, biologics can offer promising treatments due to their higher specificity and potentially fewer side effects..
Commercial success, however, hinges on overcoming the challenges they pose. LVWIs hit on all three fronts.
LVWIs: Patient-centered, stress-free wearable drug delivery
Until LVWIs are more widely adopted, biologics will remain hard for patients to take. For one, there’s the issue of convenience. My neighbor has been on a biologic drug, Herceptin, for five years and may be on it for many more years. Every Saturday morning she drives to the University of Cincinnati for a three hour IV infusion. When a device like the Enable Injector, an LVWI, becomes available for large volume biologics, she will be able to simply take a standard vial out of the fridge, insert it into the device, put the device on, push one button and a few minutes later throw it away. It’s a tremendous benefit to a patient’s quality of life. My neighbor would get back every Saturday morning.
Then there’s the issue of injection discomfort and fear. Developed based on pain-free subcutaneous injection technology, treatment with an LVWI device is easy and comfortable, removing the stress from self-injection that often results in non-compliance.
As former U.S. Surgeon General C. Everett Koop famously quipped, drugs don’t work if patients don’t take them.
A patient-centered approach to delivering biologics is widely expected to improve adherence to therapeutic regimens and impact outcomes positively. For pharma companies, that is the bottom line in successfully navigating the outcome-based models that health systems are moving toward.
LVWIs: Speeding time to market, extending life cycle
For formulation teams developing injectable biologics, the new drug delivery technology makes development of stable, bioavailable, clinically relevant formulations easier, faster, and less costly. It can shave months off development time, bringing differentiated products to market faster, cheaper.
LVWIs can also give new life to expiring biologics, extending their life cycles.
Eliminating the hospital saves health systems a bundle
Finally, not only can it be more convenient for patients and caregivers to administer treatment at home, but that ability promises tremendous health system savings by eliminating the high cost of health provider-mediated infusions.
Healthcare personnel shouldn’t mind. With no needle in sight, the CDC’s estimated 385,000 U.S. needlestick injuries (a million worldwide), costing from $500 to $3,000 or more per injury for testing alone, could be substantially reduced.
It’s no wonder partnerships between pharmaceutical companies and LVWI developers to create patient-focused, differentiated combination products are proliferating. It can change the conversation from drugs being overly expensive to a focus on value and improved quality of life for patients. Besides, like the oxpecker and zebra, they’re better together.
About the author:
Michael D. Hooven, President and CEO of Enable Injections, Inc. is an acknowledged industry expert on wearable large volume drug delivery technology. The founder of five medical device companies, he has more than 30 years of experience in the medical device industry in a broad variety of technical and clinical areas. Prior to founding AtriCure (NASDAQ:ATRC) and Enable Medical, Mike headed all internal product development at Ethicon Endo-Surgery and held Engineering positions at Siemens/Pacesetter and at Cordis Corporation. He earned a Bachelor of Science in Physics and a Master of Science in Mechanical Engineering from the University of Michigan.
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