Patients have a choice. Insulet
Corporation has an answer. With the increasing number of biologics and
therapies available to patients today, pharmaceutical and biotechnology companies
face a challenge in not only ensuring efficacious delivery of their drugs, but also
that patients will select their drugs over the many other options available.
This dynamic is creating a new future for subcutaneous delivery. Pharmaceutical
and biotechnology companies are being driven to utilize patient-centric
delivery devices that will fit volume requirements and ensure patient adherence.
Insulet’s Omnipod Insulin Management System has been improving the lives of
patients with diabetes for over a decade, and this technology platform now is
being used for improving drug delivery in other therapeutic areas. Drug
Development & Delivery recently interviewed Michael Graffeo, Vice
President of Business Development, Insulet Delivery Systems Group, to discuss
the importance of optimizing patient adherence to ensure improved clinical outcomes.
does Insulet see the role of wearable devices in the future of the drug
increasing number of injectable drugs and biologics coming to market, the route
of administration is set to play an important role during drug development.
More than 800 new highly viscous biologics are expected to come to market by
2025. These drugs require a device that allows for larger volume delivery over
a prolonged injection period. That’s where wearable devices offer a significant
benefit over traditional needles or autoinjectors. Across the global healthcare
system, there is also an increasing focus on patient centricity – enabling
patients greater freedom to live their lives without being restricted by their
drug delivery regimen. Insulet is working toward technologies that provide
better adherence, simplified delivery, and greater clinical efficiencies. The
least valuable drug is the one that’s not taken — so any innovation needs to
offer greater convenience, patient centricity, and therefore greater adherence.
The Omnipod Delivery System platform is designed to help to address these
benefits does Insulet bring to pharmaceutical and biotechnology companies
seeking to improve patient adherence?
more than a decade, Insulet has delivered intelligent, virtually pain-free subcutaneous
administration for drugs with complex dosing regimens often restricted by
conventional methods of injection. We have more than 85,000 patients worldwide
who count on the Omnipod Insulin Management System – and we are the only
wearable device manufacturer with that track record. For pharmaceutical and
biotechnology companies, this means we hear and understand patient needs, and we
have developed a proven device that is liked by those who wear it, and backed
by those who recommend it. We continue to increase the number of patients using
the Omnipod technology and enjoy positive feedback from long-term patients.
Initially, the Omnipod
System was designed to allow people living with diabetes to live their lives
and manage their diabetes with unprecedented freedom, comfort, convenience, and
ease. As the world’s first commercially available tubeless insulin delivery system,
Omnipod allows users to live untethered by tubing and without the stress and
anxiety of multiple daily injections. This same principle has now been applied
to other therapeutic areas in which drug partners require innovative and
patient-centric delivery options. For over 10 years, individuals with diabetes
have been counting on Insulet to provide a safe and reliable drug delivery
device. Pharmaceutical and biotechnology companies can have the same confidence
in the design, delivery, and satisfaction of Omnipod delivery for a variety of
therapies. In addition, the Omnipod platform is customizable depending on
does the industry look for from companies like Insulet in regard to wearable
A: The needs
of the industry – from pharmaceutical companies to the patient – are multi-faceted.
Safety and reliability are key components to any wearable technology – but
offering a patient-centric device is also important to ensure optimal
adherence. Practically speaking, delivery devices need to be flexible to allow
for commercially available drugs. This could mean providing a device that is
prefilled for time of use, activated at the time of filling, and/or developing
a continuous monitoring system to improve patient adherence. Consistency of
delivery is also a key safety factor to ensure the device does not over or
under deliver. Smart, wearable devices like Omnipod can include advances in technologies
like Bluetooth/remote patient monitoring to help track patient adherence.
Additionally, there are various dosing profile options offering data management
insights that can help both patient and healthcare professionals better
understand delivery and adherence information.
makes the Omnipod System patient centric?
Insulet, it is about making the lives of patients and users easier so they can
live life on their own terms with the ease of use they deserve. This means we
ensure the method of delivery is convenient, simple, trustworthy, and allows
patients to live a life free from self-injection. Patient centricity brings the
freedom to live life at home, without having to regularly go back to the
hospital or clinician.
In terms of development,
it’s about putting the patient at the center of all we do. Ultimately, if a
patient isn’t going to wear it, creating a device that will fit as much volume
as possible does not further adherence. We created our device with the patient
in mind. When it comes to the Omnipod platform, we have created the only
wearable, intelligent, subcutaneous delivery device commercially available.
The Omnipod platform has the
ability to modify dosing and delivery times, as well as monitor patient
adherence – making it a user-friendly and easy-to-use delivery system.
Additionally, for non-insulin delivery, Omnipod has a remote-less option for
preprogrammed dosing regimens. Its auto-cannula insertion means patients never
have to handle the insertion needle. Omnipod is discreet, tubeless, and
waterproof – reducing life interference and improving drug adherence.
Most importantly, we
deliver the Omnipod Insulin Management System to more than 85,000 users
worldwide. Their feedback enables us to make continuous improvements and
deliver a device that strives to address those needs. These insights have been
critical to the success of our business.
you believe delivery time matters when a pain-free and patient- centric device
years, the industry has focused on devices that inject medication in 30 to 60 seconds.
At Insulet, we believe that wearable technology changes the dynamic significantly.
Current perceptions linking injection pain or difficulty and delivery time are based on older technology,
such as autoinjectors or subcutaneous devices that require patients to hold
them in place. Moreover, studies have shown that patients have discontinued self-injection
for reasons, including: fear and frequency of the injections, and reactions
around the injection site. These ultimately make the injection experience uncomfortable
and patient adherence low.
When it comes to innovative
wearable technology, a device such as the Omnipod System offers virtually
pain-free delivery, with users wearing the device for up to 3 days. As an
industry, we need to better understand pain associated with delivery of
different drug types in order to develop
these more patient-centric and efficacious devices. Many of our Omnipod System
users have moved from multiple daily self-injection with a syringe or
autoinjector to wearing the Omnipod for up to 3 days. This push for faster
delivery is no longer relevant in the future of drug delivery.
experience does Insulet have working with top 20 pharmaceutical
has two existing commercial agreements and additional development agreements
with multiple other pharmaceutical companies. Each project requires different
modifications to be made to the delivery device, which we have the flexibility
does Insulet approach its partnerships with pharmaceutical companies?
primary goal is to reduce the burden of injectable medicines on patients and
improve outcomes through an increase in medication adherence. In order for this
to be achieved, Insulet approaches each relationship with potential partners as
a combined effort in which both
Insulet and the partner company work in tandem to develop solutions that
address patient needs and reasons for non-adherence. We consider ourselves to
be committed to developing unique delivery solutions that patients prefer. Using
our 15 years of commercial success in delivery drugs/therapeutics using our
Omnipod technology platform and combining that with our partners’ knowledge of
disease challenges and drug development, we work together to tailor customized
solutions to suit volume, formulation, delivery requirements, delivery
administration, and patient needs. Fostering partnerships and strong
relationships with pharmaceutical companies allows us to create a patient-centric
device that can help provide better outcomes for both patients and partners.