From The January 2017 Issue
Inside Takeda Oncology's Patient Advocacy Program
This past summer, during the BIO International Convention in San Francisco, I had the opportunity to sit down with Liz Lewis. Named by the Boston Business Journal as one of the top “20 Women to Watch” in 2014, Lewis’s legal career has spanned more than 25 years, during which she represented numerous healthcare and life sciences companies. In 2002, she was a partner at Washington DC-based law firm Epstein, Becker and Green serving as co-chair for the firm’s pharmaceutical practice group. It was that year she made a rather bold move — she left the firm to join Takeda’s oncology organization.
Over the years, Lewis rose through the ranks and now holds the position of Takeda Oncology’s chief counsel and head of patient advocacy at the top 20 Big Pharma. Our meeting during BIO, along with a subsequent follow-up discussion, resulted in the development of a feature article appearing in the January 2017 issue of Life Science Leader magazine. However, after combing through our conversations, there seemed to be some additional insights, which we decided to incorporate into this "Beyond The Printed Page" article. Enjoy.
1. Could you provide some insight as to how Takeda Oncology facilitates appropriate patient advocacy interactions?
We have what we refer to as branded and non-branded programs. In our non-branded programs, they’re not about our product/s, but about the disease (i.e., multiple myeloma). All of our slide decks have been evaluated through a rigorous review system to ensure they are independent, balanced, and talk about the disease in a scientific manner, that is truthful, nonmisleading, and appropriate for a patient to deliver to a patient audience. Such forums often focus on the patient’s experience, not the drugs they take. The speakers we engage to deliver this information are referred to as ambassadors, and to these individuals we provide specific guidelines. For example, they can talk about their experience (as a patient). They can’t guide other patients in what they should be doing or what drugs they should be taking. We believe very strongly that these programs are not a “detail” of our products.
Within our speakers bureau we also have branded programs, which do talk about our branded products. Again, when a patient is delivering these programs, they’re not sales reps, they’re not physicians. Their role is not to convince other patients to take the product or to talk about how great it is. They talk about their experience and maybe some other challenges they have had. Oftentimes, we’ll have an ambassador who will come in and discuss their experience as a patient, and their talk will be part of a program involving a physician who will then give a presentation on the product. But an important point to take away is that Takeda Oncology never wants to put its patients in a compromising position. Further, it doesn’t look great from a drug company’s standpoint if there is the appearance that patients are being used to sell products. This is really about patient education and the patient experience, not about the product.
2. How is having a legal background an advantage in your patient advocacy role?
It’s an advantage for both me and my employer. Takeda Oncology is basically the legacy Millennium organization which was acquired in 2008. Our president and CEO, Christophe Weber, talks about the “pillars” of what’s most important to Takeda — put the patient first, trust, integrity, reputation, and then the business will follow. When you think about engagement with patients and you think about looking at the pillars of Takeda, always ensuring that we are acting from an ethical standpoint with integrity, putting patients’ first means not doing anything to inappropriately compromise either patients or ourselves. Having a legal background is certainly helpful with that, because that is how lawyers are wired to think. Beyond the explicit legal issues, lawyers think about how things really look. What’s the perception? When engaging with patients, that’s something really important to consider (i.e., ensuring there is always a level of trust and integrity).
Another thing having a legal background helps with (at least in my experience at Takeda) is providing a really broad view of what the business is. From an advocacy perspective, there are many key stakeholders, both internal and external, and this is something lawyers deal with on a daily basis. There are people in the clinical organization who are developing our clinical trials, and as such, they have a stake in engaging with patients. Similarly, there are individuals in our medical affairs group designing observational studies who want to engage with patients. And while patient involvement and input is critical to both, when you’re in a legal role that spans the organization, it provides you with a much broader perspective. If you grow up in a specific function (i.e., clinical, medical affairs) you tend to take a very functional view. Having a legal perspective ensures we think about how patients fit into our business across everything, and that we are really looking at it holistically.
3. How Were The “Takeda Pillars” Derived, And How Do These Align With Patient Advocacy?
As Takeda transitioned to a more global organization, Christophe Weber came in as the head of the organization and helped define it from a global point of view. These pillars were very consistent with how we look at patient advocacy in the U.S. While the pillars of putting the patient first, trust, reputation, integrity, and then the business will follow are important, it’s up to us to apply what those actually mean. In patient advocacy, what we involve patients with is helping us [Takeda] to better understand their patient journey, as we think about developing our products. For years in multiple myeloma, what we heard was that people thought our product was efficacious. But the first version of VELCADE (bortezomib) was an IV regimen, and for years we heard about struggles with patient transportation, taking time off work, etc. in order for the patient to travel to the clinic once or twice a week for an injection. As we thought about these challenges, while striving to put the patient first, we continued working toward developing a more convenient alternative. Last November, Takeda received FDA approval for NINLARO (ixazomib), the first oral proteasome inhibitor to treat multiple myeloma, essentially addressing a lot of the challenges we had been hearing about from patients.
4. What Metrics Do You Use To Measure How You’re Doing Regarding Patient Advocacy?
We track how we’re doing in various ways. The first way is direct input and feedback from patient ambassadors and members of our patient leadership and global patient advisory council (PLC and GPAC respectively). In addition, we solicit feedback on all of our programs, and we incorporate that feedback into how we are doing. We also look at external metrics to try and get a sense of how we rank and what we’re doing. For example, there are a couple different reports (e.g., the STAR report) that rank different companies as to how they are doing from a patient advocacy standpoint. But with external metrics, sometimes it’s hard to really understand what those metrics might mean. One of the challenges s with these types of rankings is that the quality of the data is dependent on the quality of the service that is gathering the input and where it is being collected from. If you are a smaller company in a smaller-disease area, and they’re going to a population that’s outside that area, it can skew the results a little bit. For that reason, we also develop and measure our success against internal key performance indicators (KPIs).
5. What Is One Of The Biggest Challenges In Working With Patient Advocacy Organizations And How Has Takeda Overcome Those Challenges?
There is always the inherent challenge of “we” being industry and “they” being advocacy, and there is tension between collaboration and independence. It is always essential for advocacy organizations to remain independent. We strive to ensure, in everything that we do, that that advocacy organization is indeed independent. One of the challenges often faced is communication. A relationship with an advocacy organization is like any other relationship; you have to be able to have difficult conversations in order to effectively engage. I always believe if you put the patient first and really come at it from that perspective and listen to the concerns on either side, that you can forge open lines of communication. There has to be some give and take. Communication and education are so important here, because if you fail to try to understand the perspectives of the other side it’s fairly easy to take a standoffish and unproductive position. At Takeda we strive to have long-standing dialogues with advocacy organizations, and we really push for that conversation to be on substantive issues. There are advocacy organizations in multiple myeloma that are really engaged in research, which we’ve supported. But having that sort of meaningful conversation requires an investment of years, not days. But it is worth the investment, for advocacy organizations have a view into patients that we don’t (and can’t) possess.
6. What Do You Say To Those People Who Want A Silver Bullet For How To Get Good At Patient Advocacy?
There are no such simple solutions. We’ve reached 40,000 patients with our programs. The trick to having really good patient advocacy is to have really good programs. Meaning investing in the development of high quality, meaningful material and selecting experienced individuals with the expertise to deliver the material appropriately. And if you do all of this well, not only will you deliver high quality and meaningful patient educational programs, but you will develop a level of trust and goodwill within the patient and advocacy community. Start with integrity while allowing for advocacy organizations to maintain independence. That, I think, really is the key to developing meaningful relationships not only with the advocacy organizations, but also with patients.
7. What Advice Do You Have For Someone Trying To Create A Patient Advocacy Organization Within Their Company?
The most important thing to do is to go out and talk to people. For example, focus on talking to the external advocacy organizations, patients and internal stakeholders, because an advocacy function will likely need to engage such entities. Until you go on a “listening tour” (for more be sure to read the January article, it’s going to be hard to create something that brings value to all parties involved. There’s not a one–size-fits-all patient advocacy organization.
8. What Questions Would You Suggest For Folks To Incorporate On Their Listening Tour?
Where are there unmet needs? Are there things that are working well? Are there things that they are struggling with? Are there things that they understand well, things that maybe you don’t understand well? Those are all good questions to start with. The piece that is always interesting when you’re thinking about building an advocacy organization within a biopharmaceutical company is the dual role advocacy plays, such as externally facing by engaging with advocacy organizations and patients, and then internally facing to ensure that the voice of the patient is heard within the company, and those insights being incorporated into what the company is doing. For example, it’s like when we start thinking about things that might impact the patient beyond the product itself (e.g., is it covered by insurance?). When engaging with patients, if we think about trying to aggregate their experience (e.g., what medical might need to know about versus what marketing might want to understand about a patient experience), we are doing a real disservice to patients, and ourselves, if we approach an engagement as a market-research activity and are only seeking to capture quantitative data. Patients are people, with pretty strong perspectives on the experiences that they’ve gone through. Done well, advocacy helps with determining what the true value of that experience is. Try to understand what it means to be a patient including understanding how difficult a treatment is, not in terms of just the side effects, but in terms of living with the disease and the treatment. Seek to understand the humanistic element.
9. What Is The Insight Multiple Myeloma (MM) Study?
It’s a large observational study with the goal of enrolling 5,000 patients (18 years of age or older with newly diagnosed or relapsed/refractory multiple myeloma) over three years, and following those patients for at least five years. It will track patterns in disease presentation, patient characteristics, treatment, and outcomes. We hope to understand patient real-world experience with multiple myeloma. The study plans to enroll patients at more than 150 study sites in 15 countries across Asia, Europe, Middle East, South America and North America. This observational study has a steering committee, and one of the members of the steering committee is a patient who happens to have a medical background. This is a great example of how Takeda’s patient advocacy organization collaborated with our medical group to help successfully develop a noninterventional study that includes a patient perspective.