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Combination Products: Success Is All about the Partnerships

At Enable Injections, we have developed a novel wearable, large volume subcutaneous infusor called the enFuse™.  The enFuse is a fascinating design, elegant in its simplicity. As an engineer myself, I marvel at the creativity and skill that has gone into designing and building this innovative delivery device.  Enable employees have spent thousands of hours optimizing our technology with the patient in mind.  We are all passionate about delivering a superior technology that changes patient lives.   The FDA classifies the enFuse as the device constituent of a combination product, which means that in order for the enFuse to deliver on that promise, it must be combined with a drug therapy.  Since Enable is a device company, not a drug company, this means that partnerships are critical to our mission.

Combination Products: Success Is All about the Partnerships

The Importance of Partnerships

Alliances and partnerships have become pervasive in global industries in the past 20 years. In the biopharmaceutical industry, innovation-based partnerships are a key means of growth. In Q1 of 2019 alone, PricewaterhouseCoopers measured 52 Pharma and Life Science deals worth a staggering $147.3 Billion!  Most, if not all, of the top 20 pharmaceutical companies have created internal Alliance Management organizations solely structured to help ensure that these alliances deliver the value intended. I was fortunate enough to be a part of one of the first, the Office of Alliance Management at Eli Lilly and Company in 2000.

Why have so many companies invested so much into the competency of Alliance Management? It is because strategic alliances are difficult and often fail. Based on a 2015 Vantage Partners survey, only 41% of strategic alliances fully achieve their stated objectives.  When two organizations combine with different cultures, capabilities, incentives, working styles, operating practices, and risk profiles, the collaboration is bound to have challenges. Without the right expertise and support, the alliance relies on luck to achieve its goals.

While all alliances are challenging, additional challenges emerge when companies in different industries partner. For example, much has been made of the tech titans entering the healthcare space. Pharma and other healthcare companies are now partnering with companies like Google, Amazon, IBM and others that grew up in the world of technology. Putting these companies together is like mixing oil and water.  On one hand, the risk averse, highly-regulated companies have rigid processes to manage quality and patient safety and have lengthy product development life cycles of 10 years. On the other, companies that are bred and trained to take risks operate by moving quickly to stave off extinction. These two different types of companies speak different languages with different acronyms that could fill volumes. These types of counter-cultural partnerships require real work to ensure the relationship works well and achieves its goals.

Partnerships with Combination Products

We face similar challenges in the combination product realm. Device companies are staffed with engineers and human factors experts, among others. Pharma companies are life science-based, with chemists, biologists, clinicians, toxicologists and the like. Product design and development processes and development cycles are vastly different. We, too, use different language and acronyms and typically work at a different pace.  But at the core, we find commonality in our focus on patients.  That is where the magic happens. Whatever differences and challenges we have can be simplified by being reminded of our common bond and the impact we can only have by working together.

We have done a couple of things at Enable to try to maximize our partnership success. First, we have augmented our device expertise by bringing in staff with pharmaceutical backgrounds. Having the combined expertise in-house allows us to more easily consider multiple perspectives, translate terminology, and predict intentions and incentives. We spend a lot of time educating each other, which helps us immensely as we work with our pharma partners. Second, we have invested in establishing an alliance management competency. Many of our partners, unfortunately, don’t allocate their alliance management resources to device partnerships, so we believe by assuring we are implementing best practices in support of the relationship, we can maximize success and ensure that our joint innovation reaches its intended target – the patient.  We are still growing and evolving but have established a solid foundation.

One last thought on the topic of partnerships.  We tend to think broadly about the partnerships that will be necessary to deliver our disruptive technology:  the four P’s – Pharma, Patients, Physicians and Payers. We will have to work effectively with all four if we are to be successful.

We are working to ensure we have active and continuous dialog with each of them.  We don’t have all the answers yet and only by working together will those answers be developed. However, patients must remain at the center. While not a “consumer-facing” company, our enFuse device will soon be used daily by millions of patients around the globe. We have conducted many, many, studies to ensure we really understand them – what is important to them, what they worry about, what they like and don’t like about their current treatment options, and how they would use our device. We have made many adjustments and improvements over the years to ensure that our device is designed to be intuitive and convenient with the ultimate goal of making patients’ lives easier.

It is a journey that won’t end for us. Engineers are always seeking to improve upon designs and patients will continue to challenge us to find new ways to make treatment easier. Personally, I can’t wait to see what’s in store and I am looking forward to having millions of patients benefit from what our team has developed. And it will all happen through the partnerships we develop and nurture.

 

Author: Andy Eibling, CSAP, VP, Business Development and Alliance Management, Enable Injections