Most companies involve consumers as early as possible in the development of a new product or service. A company would not bring a new beverage, for example, to market without first having found out if it meets people’s taste preferences. This just makes sense – and is a business critical success factor.
CAMPAIGN: The TBL Quarterly
In the pharmaceutical industry, working with the end customer is easier said than done. Nevertheless, Research and Development (R&D) teams across Novo Nordisk have now started partnering with patient leaders through a specialised unit within Novo Nordisk R&D. The unit works to better understand what truly matters, and ‘what great looks like’, from a healthcare consumer (aka ‘patient’) perspective.
”We have, for example, expanded our understanding of the fact that there is no such thing as ‘one size fits all’,“ says Camilla Krogh Lauritzen, director of R&D Communication and Patient Partnering at Novo Nordisk. ”People living with diabetes, whether it's type 1, 1.5 or 2, have unique perspectives on their experience, and we cannot capture the multifaceted aspects if we are not having a conversation with them directly.”
Camilla continues: “Patient leaders are in a unique position to capture as well as share the many nuances of a disease area, allowing us to draw key overall conclusions, which can then be further uncovered and validated by surveying a particular group, for example.”
The partnering unit is currently drilling into one of the key conclusions, namely that people with type 1 diabetes want treatments that reduce their daily awareness of living with diabetes.
“It is clear that irrespective of who you are, being afflicted with type 1 diabetes takes up mental bandwidth 24/7,” says Camilla. “This matches another key conclusion – that the implied psychological burden of type 1 diabetes is in fact considered bigger than any physical downside of being afflicted by this disease.”
As is the case with any research and development, finding out what this means for the design of future products is critically important.
“From past experience, I know that it is key to capture and internalise insights and advice from patient leaders into R&D if one wants to be ahead of the curve and the competition.”
No such thing as ‘can’t be done’
In 2014, a group of Novo Nordisk colleagues led by Camilla set out to prove the concept of ‘patient partnering in medicines R&D’ and break the traditional flow by bringing the patient from the end of the pharmaceutical pipeline to the beginning. It was the start of a new partnership model at Novo Nordisk and an opportunity to learn from patient leaders representing hundreds to thousands of people affected by diabetes, obesity and other serious chronic conditions.
“At first, people told me that building such a partnership with patient leaders couldn’t be done,” says Camilla. “In addition, there were no specific guidelines, procedures or contracts in place in Novo Nordisk enabling the set-up of this kind of partnership model, and some thought it was unclear how it would benefit our research and development.”
The six-month pilot project brought together 13 patient leaders – disease experience experts – representing people living with type 1 diabetes, diabetes complications, obesity and adult growth hormone deficiency. It demonstrated the win-win value of working together – from the perspective of both researchers and patient leaders.
“At the end of the pilot project, it was clear to everyone involved that this was just the beginning of something mutually valuable. ‘Can’t be done’ had become ‘let’s do this’, for both the researchers and disease experience experts involved,” Camilla says. “After the last meeting of the pilot project, one of the disease experience experts, Tanner Barton, said that if we were ever looking to do something more systematic, for real, he would be interested in being involved.”
Two months later in August 2015, when the R&D Patient Partnering unit was formally established, Tanner became the first member of what is now known as DEEPs – Disease Experience Expert Panels.
Everyone at the same end of the pipeline
Today, DEEPs are being recruited across six therapy areas – type 1 and 2 diabetes, obesity, haemophilia, growth hormone deficiency and diabetes complications. Each panel is to be comprised of five to eight disease experience experts who are patients themselves and are also global, regional or national patient organisation leaders: essentially people who represent and can speak on behalf of their patient community.
After only a few meetings, the DEEP partnerships have so far provided Novo Nordisk’s product development teams with a better understanding of how to include the experiences of people living with chronic conditions in eg treatment development and trial design.
Novo Nordisk’s Chief Medical Officer, Alan Moses, has been involved with patient partnering and the DEEPs from the beginning. His experience on the panels underlines his belief that insights into the ‘non-obvious’ elements of living with a disease can provide new approaches to designing a clinical trial, developing a device, or gathering specific information from patient interactions that might otherwise have been missed.
“Perhaps the most important learning from the DEEP experience is how valuable the patient perspective can be across the entire development process,” says Alan. “When scientists have an opportunity to interact with disease experts who are very knowledgeable about drug development, the opportunities can be almost unlimited.”
These insights are especially true for people with chronic conditions, like diabetes, haemophilia and obesity.
“Chronic diseases often impose a unique burden on the person living with the condition and the family because of their life-long implications,” Alan says. “Gaining insights into the ‘pain’ points that a chronic disease imposes on a patient, family or workplace requires a level of understanding that is diminished by not having their voice available.”
A DEEP dive into type 1 diabetes
Andreas Linderoth Norlin, project vice president at Novo Nordisk, sees the value of DEEPs personally and professionally. Andreas was one of the researchers taking part in a type 1 diabetes DEEP meeting to discuss a new treatment that aims to preserve the functioning of insulin producing beta-cells in people newly diagnosed with type 1 diabetes.
“Being a part of the type 1 diabetes disease experience expert panel is an inspiration; it makes it easy to go to work in the morning,” says Andreas. “Listening to and learning from the perspectives of people living with the disease helps us make sure we are not missing anything by only focusing on the regulator and medical professionals. Already, we are putting our learnings from disease experts into our project plans.”
At the meeting, five diabetes disease experience experts and 12 research and development leaders engaged in a series of conversations about the emotional impact of living with type 1 and 1.5 diabetes, their disease journey since diagnosis, and their wishes for innovations in treatment, including a cure.
One of the key values of having everyone in the room is the opportunity to clarify perspectives. When type 1 diabetes disease experts were asked how big a role diabetes plays in their lives, the response made it clear the question isn’t that simple: “Sometimes my diabetes is ‘this’ small [places thumb and index finger close together] in relation to my life and sometimes is it this big [holds hands far apart]. Which time are you talking about?”
The closing question of the day was: 'What would it take to make your life feel like it did before you were diagnosed?’ The responses were wide-ranging and highlighted less intrusive devices (ie fewer injections or blood sugar testing), higher energy levels, less time thinking about and managing blood sugar levels, and most importantly: the elimination of hypos, when blood sugar levels become too low and present a serious health risk.
“There were five disease experience experts and each presented a unique perspective,” says Andreas. “The experiences are very personal and being part of a DEEP meeting makes it obvious that there isn’t only one approach to improving treatments.”
Camilla recalls that in the beginning, people inside the company were doing the work that led to the establishment of the patient partnering unit. There was a passion and a belief that partnering with disease experts would create mutual benefits.
“There is a hashtag used on social media by many in the type 1 diabetes community - #WeAreNotWaiting. It is a call to action to take innovation and ideas into the public domain,” says Camilla, “I love this. It is a reminder to the industry as a whole that the time is now. It is why we are one of the first pharmaceutical companies to systematically engage disease experience experts in R&D across multiple disease areas.”
 Type 1.5 diabetes is a non-official term that is sometimes used to refer to a form of type 1 diabetes known as Latent Autoimmune Diabetes in Adults (LADA). It refers to the fact that the condition is a form of type 1 diabetes that can share some features that are more commonly associated with type 2 diabetes (http://www.diabetes.co.uk/type15-diabetes.html).
 The process of testing new medicine in humans to document safety and efficacy.