Letter from Mike Hooven
18 MAY 2020
The current state in which we now live is one we could not have imagined three months ago. The Coronavirus pandemic is impacting the way we live our lives, as a global community, and as a country, on both corporate and personal levels. It is now more important than ever to find a way to continue our lives closer to home, including taking prescribed therapies. This current situation is raising the stakes on the importance of our work at Enable Injections.
Due to the Coronavirus pandemic, the availability and safety for patients to receive infusions at a healthcare facility or via a home health care provider has changed swiftly. Patients may be faced with being unable to receive their therapeutics in the way they previously received them. Pandemic measures have caused healthcare resources to shift and facilities to refocus care. Limits on social contact and mandatory distancing have impacted patient care in unprecedented ways.
Even before the Coronavirus pandemic, Enable Injections had a goal to change the future of healthcare by finding a solution for patients to receive their therapy outside of the clinic. Enable will continue to press on in our development of innovative infusion technologies in conjunction with our pharmaceutical partners to achieve this goal.
In the weeks and months to come, all of us at Enable will be committed to continuing forward with an unwavering and unrelenting focus on our goal – to improve the lives of patients and to change the future of infusion that will someday bring infusion closer to home.
Contact us to learn more about the enFuse patient-focused technologies under development.
Enable Injections is pleased to share several notable events this February, including adding a new executive to the Enable team, new published articles (Forbes is writing about Enable!), and a new award.
Donald Kirkpatrick Joins Enable as COO
We are delighted to announce Donald Kirkpatrick has joined Enable Injections as Chief Operating Officer. Don is responsible for Product Development and Operations for the enFuse® on-body platform.
Don has over 30 years of experience in healthcare operations and product development. He joined Enable from Baxter Healthcare, where he was most recently the Head of External Contract Manufacturing, responsible for global leadership of external finished product manufacturing of electromechanical, disposable, pharmaceutical, and biologic products. Don previously served as Director, Operations Strategy where he led Operations strategy development for global plastics processes across the Baxter manufacturing plant network, as well as operations strategy and diligence for Mergers & Acquisitions, outsourcing and third-party manufacturing.
Prior to Baxter, Don held research & development, product development, operations & RAQA positions in the medical device and IVD industry at Haemonetics, Teleflex Medical, and Arrow International, including positions in the US, China, and Japan. Don earned a Bachelor of Science in Mechanical Engineering Technology from the University of Massachusetts and a Master of Business Administration from Boston College.
Drug Delivery Designed to Improve the Patient Experience
Citation: King J, “Drug Delivery Designed to Improve the Patient Experience”. ONdrugDelivery Magazine, Issue 105 (Feb 2020), pp 52-55.
Enable Injections takes a look at the delivery challenges of novel therapies for chronic diseases using a specific patient’s story as an example, going on to highlight the ways in which a novel device approach could make all the difference for patients.
Chronic illness touches everyone, it seems. Whether it is a family member, friend or co-worker, many people have some understanding of how difficult life can be while managing a chronic disease. The biotech revolution has led to many novel therapies that are changing lives. But these new therapies may come with delivery challenges that make it difficult for a patient to receive treatment. When a patient shares stories of the rigours they endure to manage their disease, it highlights the motivating factor behind novel technology like the enFuse on-body infusor platform.
A REAL PATIENT WITH A REAL STORY
The Enable Injections team recently spent time with a patient who introduced an interesting perspective on her infusions. Megan has managed a chronic autoimmune disease for more than 15 years. She is passionate about helping others who live with similar autoimmune diseases – especially young people, because she was diagnosed at the age of 18.
Megan was initially prescribed 28 pills per day for treatment, which proved to be difficult to manage and ineffective. While planning her life around her dosing schedule, she lived in a mental fog due to fatigue and was unable to travel or do other activities she loves.
At the age of 23, she began seeing a new doctor who said to her: “You are a young person and you deserve to live your life.” Megan said hearing those words was life-changing, as she thought she would never feel well again. Her new doctor prescribed a new therapy via IV administration, and she began feeling better. Even though she was required to take an afternoon off work for each treatment, she didn’t mind the inconvenience. She began to think of the three hours tethered to the IV as “me time” because the hospital infusion centre was comfortable and, over time, she came to know the staff. However, each infusion had the potential for its own challenges.
Read more at OnDrugDelivery.
enFuse® Wins a GOOD DESIGN Award
Enable Injections is pleased to announce the enFuse® has won a GOOD DESIGN® Award 2019.
Founded in 1950, GOOD DESIGN® is the world’s most prestigious, recognized, and oldest Design Awards program organized annually by The Chicago Athenaeum Museum of Architecture and Design in cooperation with the European Centre for Architecture, Art, Design and Urban Studies.
Forbes Is Talking about Enable Injections
New Forbes article, February 2020 – “Marketing to 100-Year-Olds: How Longevity Will Transform Finance, Healthcare and Education”
To learn more about Enable Injections and the enFuse® On-Body Platform, contact us.
Throughout 2019, SAP has helped to spread the Enable Injections story and the potential for the enFuse to impact patients. We are delighted to be partnering with SAP and leveraging their software solutions as we grow, scale, and prepare for commercialization.
Enable Injections CFO, Tim Flaherty, has appeared many times at SAP events to share the Enable story. In addition, SAP produced a video sharing the patient perspective.
This week, the enFuse story appeared on Forbes.com. Please read below for the link and an excerpt written by Tricia Manning-Smith, SAP:
This Pharma Startup Could Transform How Chronic Diseases Are Treated
By Tricia Manning-Smith, SAP
The needle is so tiny, you almost have to hold it up to the light to see it. It’s the size of three hairs held together. This miniscule needle, and its supporting medical technology, might change the future for many chronic disease patients.
Yet, because the needle is hidden inside an unprecedented med-tech device, patients will never actually see it. A patient will stick the yo-yo sized device on her abdomen and the needle stays hidden inside. She then simply pushes a button to self-administer her medication.
“There’s nothing like it in the world,” said Tim Flaherty, CFO and spokesman for Enable Injections. He explains that the startup company’s device is currently undergoing clinical trials before attaining the final FDA approval.
Flaherty shows the device to visitor Megan Starshak, a chronic disease sufferer, as they tour the company’s Cincinnati, Ohio-based research and production facility. “The device doesn’t feel clinical and scary,” said Starshak. She knows a great deal about needles and pain.
When Starshak was 18, a doctor diagnosed her with the chronic autoimmune disease, Ulcerative Colitis (similar to Crohn’s Disease). Since then, Megan has tried every treatment available to ease her symptoms, which include chronic fatigue, urgent bowel movements and abdominal pain.
“My highest pill count per day was 28,” said Starshak who now visits a clinic for a nurse-administered IV that injects medication directly into her veins. “At the time, the IV was my last option to avoid surgery.”
Many of us have someone close to us who receives intravenous (IV) therapies at a hospital or healthcare facility. For example, we heard last week of a ten-year-old boy who needed his monthly infusion for his rare disease, but he missed his appointment. It wasn’t the first time. He told his infusion nurse that he was not sad when his mother forgot the infusion appointment. He didn’t remind his mom because he hates going to get his IV infusion. But a few days later, when he began to show symptoms and felt poorly, they had to return to the hospital to make up the infusion.
On that makeup infusion, the boy was so upset that the whole procedure had to be delayed while one of the hospital therapy dogs was called to help. Eventually, the boy received his IV treatment with no other issues and was able to leave for home about six hours after he arrived at the hospital. As usual, he would have to make up his schoolwork, and would plan to return to the infusion chair in two weeks for yet another infusion.
For those of us at Enable Injections, these are the stories that move us to do what we do – we are working to provide patients with a new way to receive their therapy.
Enable Injections and Growth
Enable Injections, Inc., founded in 2010, has been developing the enFuse®, an innovative on-body infusor. Enable believes that the enFuse is one of the promising technologies emerging in medtech, specifically because it is designed to allow patients to self-administer therapeutics at home which may have otherwise required a visit to a healthcare facility.
Pharmaceutical companies partner with Enable Injections for specific therapeutics to be delivered via the enFuse. Enable’s first partnership began in 2014, and now, halfway through 2019, Enable has six partnerships.
To prepare for the rapid growth needed to serve these partnerships and the ones to come, Enable’s leadership decided to invest resources for implementing an Enterprise Information Technology (IT) system. While still in the start-up phase, Enable chose SAP to help guide and scale the growth of the company and became the earliest adopter of the SAP system.
Why SAP and Why So Early?
Enable decided on SAP’s Enterprise IT system because of its 1) phased approach, 2) seamless integration plan, 3) flexible module implementation, and 4) pharma industry positioning, and 5) scalability. SAP is an enterprise software globally known for helping businesses to scale and grow efficiently. About 85% of Enable’s pharmaceutical partners use SAP.
With Enable’s enFuse serving as the device constituent part of a combination product, the product development process through approval and beyond performs more seamlessly with partners when using the same Enterprise IT system.
When a potential partner asks which Enterprise IT system we use and whether we have controls and manufacturing software systems, we answer SAP. To date, every pharma partner has been pleasantly surprised, based upon the stage of the company.
One reason Enable Injections chose SAP is for its capability in tracking manufactured products according to FDA regulations.
Enable wanted to avoid beginning with a smaller capable ERP system and switching to a more robust system later. Enable started with SAP’s S4 Hana model to prevent having to switch in 3 or 5 years to a different package.
The SAP Implementation Details
To implement the SAP package, Enable utilized a phased approach1. Enable used a software leasing company2 to spread the licensing over 36 months. The S4 Hana model offering includes implementing financials (phase 1), quality / onboard training and human resources (phase 2), product lifecycle management, plant maintenance, recruiting, onboarding, and warehouse management (phase 3).
Enable Injections engaged with SAP to leverage its Life Science best practices and implement a platform to support the company’s projected growth with potential to scale to a multi-billion-dollar manufacturing company.
We look forward to making a difference for patients.
Jennifer King, Marketing Manager, Enable Injections
Tim Flaherty, EVP & CFO, Enable Injections
1: Dickinson + Associates: https://www.dickinson-assoc.com/
2: Winthrop, https://www.winthropresources.com/