You Can’t Hide from the Patient
UCB’s CMO, Iris Loew-Friedrich, on how the total proliferation of a patient-centric culture is the only way to make progress.
It wouldn’t be too unfair to describe the general pharma industry’s adoption of patient centricity as, at best, ‘tentative’. Many companies still appear to be on the fence, despite passionate words from key executives. Very few companies have fully aligned these initiatives with commercial performance. Yet there are bold, resolute pockets of strength and commitment and UCB is well-known for being one of those pockets. Iris Loew-Friedrich, Chief Medical Officer, describes in an interview with eyeforpharma Chairman, Paul Simms how there really is no hiding place at UCB when it comes to patient centricity. The concept is embedded so deeply that patient insights are present at every stage in clinical development and beyond.
Indeed, Loew-Friedrich begins by describing the ‘wait’ for patient centricity across the industry as shameful, admitting that she is “absolutely embarrassed” that it has taken over 20 years to finally embrace this way of working.
Some of these colleagues were almost in tears once they realized what we are asking from the patient. You had to collect the right data to satisfy regulatory needs, to satisfy scientific needs, to satisfy payer needs, and to generate information for physicians. It was an absolute burden to patients.
She offers an interesting example from a few years ago where her colleagues in clinical development were asked to outline the patient experience from start to finish, as would happen in one of their studies. She refers to the exercise as “eye-opening”, as it began to dawn on her co-workers just what had been heretofore demanded of patients participating in trials. “Some of these colleagues were almost in tears once they realized what we are asking from the patient. You had to collect the right data to satisfy regulatory needs, to satisfy scientific needs, to satisfy payer needs, and to generate information for physicians. It was an absolute burden to patients,” she recalls, adding that it was apparent that lengthy forms containing patient-reported outcomes were “nowhere near patient-relevant”.
But now, she has progressed to the stage where she recently gave a presentation at Clinical Excellence Europe called ‘The Aspiration: Patient-Preferred Clinical Trials’.
The physician now describes her personal mission as to “lead UCB’s Development and Medical Practices to create solutions with proven superior and sustainable value for patients suffering from severe diseases”. She also oversees UCB’s Patient Affairs function and believes that “walking in the patient’s shoes” has fundamentally transformed how the company operates its business.
This is not to say that the company feels it has yet won the war. Centering the drug development process around patients is still a “struggle”, as clinical trial recruitment rates remain more or less static despite significant progress by pro-active organizations such as UCB and others.
To enhance recruitment is important, but that's not our primary goal. Our primary goal is really to engage and partner with patients on what’s important to them and make sure that this is reflected in our endpoints.
Loew-Friedrich admits the shift has been slow, and true measurements of the patient-centric approach on the more difficult aspects of clinical trials, such as recruitment and retention, have not yet even been established. Yet this is described as “somewhat secondary”, given the focus remains firmly on actual patient experience and providing value.
“To enhance recruitment is important, but that's not our primary goal. Our primary goal is really to engage and partner with patients on what’s important to them and make sure that this is reflected in our endpoints. In addition, data collection for the patient-relevant endpoints should come with minimal effort for the patient”.
The regulators have even come on board; Friedrich speaks of “unprecedented open-mindedness” on their behalf, with patient involvement now standard at all steps of the review and approval processes at some agencies. This openness is not as evident with payers, however, and it is her belief that the payer environment is still dominated by “cost concerns and cost minimization”. A more value-based approach is beginning to slowly materialize, but will take time, she believes.
“I think that if you come forward with a credible patient-relevant outcome measure, that there is willingness to take this into account in an overall value-based approach. Is that the standard with the payers? No, I don’t think so, not yet, but the door is open.”
Novel, holistic approach
For every UCB, there is another company only just starting its long journey to patient centricity. When challenged on how she would do it if she was to start all over again, Loew-Friedrich identifies two key elements of her approach that are not only unique, but, in her view, crucial to embedding the concept across the entire spectrum of drug development, from planning to execution.
One critical element of this new approach is the complete integration of patient input into clinical development plans. Indeed, UCB have rechristened their Target Product Profile as a Target Patient Value Profile.
This is not merely semantics, maintains Loew-Friedrich; rather, it is “a real evolution of the classical product-centric target profile towards an ambition to address relevant current and future patient needs in a differentiated way”. Clinical development programs need to be designed to test the hypothesis of patient-relevant differentiation. This can only be achieved in close collaboration with patients all along the way.
Primary mechanisms for this are ‘patient advisory boards, continuously engaged during a study and/or program’, plus collaborations with patient organizations, and open two-way conversations with patients; remembering that “no one patient can speak for all patients” and that various approaches to collect patient input are important. Technology is also critical. UCB are absolutely leveraging big data and learning what patients are discussing on social media in a bid to learn in real-time what patients need and want.
This holistic approach aims to provide a “360 perspective of patient needs. We are learning the common themes within unmet patient needs and integrating that into our Target Patient Value Profile.”
The second novel aspect of UCB’s approach is the concept of the “sprint”; as clinical development teams work on protocol design, they spend a week or two working closely with patient representatives, in the company of a facilitator, in order to jointly finalize the key elements of the protocol. This co-creation has been a major alteration to UCB’s protocol summaries, she stresses.
The evolution of UCB
So, has this yet been translated into tangible benefits for both company and patient? Loew-Friedrich agrees UCB has set a “high minimum standard” but with patient-focused performance indicators yet in development, the success cannot yet be quantified. To this end, more qualitative as well as quantitative research is necessary; patient surveys about their experience of a clinical trial will enable the company to see where there is room for improvement. The ultimate goal, though, is indeed to translate this into a performance indicator.
The appointment of former physician Jean Christophe Tellier as chief executive in January 2015 led to several organizational changes, including the expansion of its executive committees and the creation of patient value units. These changes were made with a view to driving Tellier’s vision that UCB would “walk the talk” in terms of patient centricity, focusing mission teams on people with a disease. It is Loew-Friedrich’s view that this has worked thus far, although she cautions that the organization is still evolving in its new incarnation.
“We have seen quite an impactful delivery of the patient-focused organizational design concept in UCB. But we are still working in an environment where many important stakeholders are still product and molecule-focused. In order to get it right for our external stakeholders, we have introduced transversal responsibility and accountability across different patient-focused missions so that we ensure consistency at molecule and product level without compromising our attention on patients.”
Another fundamental change to processes has been that of linking the historically separated areas of medical affairs and clinical development, a move that will nurture “cross-fertilization, external connectivity and further enhance patient focus”, Loew-Friedrich explains.
“There is a continuum from the scientific work that's carried out in discovery research, to early and late-stage development, to how we communicate the data. And there is opportunity to bring insights into patient and physician needs from medical affairs into research and development. It has always been my belief that pharma must be a very patient-, science- and data-driven business. This is the only way to provide relevant innovation and meaningful therapeutic advancement. In UCB, this is clearly understood and puts our scientific work along the entire value chain in an important and central position.”
An uphill battle
The general public remain wary, if not simply scared, of clinical trials. The death and injuries recorded in a first-in-human clinical trial in France, hitting global headlines, do not help. Pharma is fighting an uphill battle to regain patients’ trust and confidence.
Loew-Friedrich sees it as a problem of transparency, and says a vital component of that is the industry’s use of data, which is often now shared openly, albeit in a democratic and ethical way.
“If you had asked me 10 years ago whether we would be willing to share our data, I would probably have said, ‘our data is what we truly own’. My philosophy has changed completely and we have evolved towards making data transparency a priority. A few years ago, we established a process where we are prepared to share our clinical study data upon request by researchers", states Loew-Friedrich, adding that the inherent risks of this should speak to the company’s credibility and trustworthiness.
The reality is that business goals must embrace patient centricity. But if industry continues to reorient around the patient, public perception of big pharma will change for the better. And if we all believe this, it might just happen.