By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
So how does a lawyer become head of patient advocacy at one of the largest biopharma companies in the world? In Liz Lewis’s case, it started at the Washington, DC-based law firm, Epstein, Becker and Green where she represented healthcare and life sciences companies and served as cochair for the firm’s pharmaceutical practice group. In 2002 she left the firm to join Takeda where she is currently chief counsel and head of patient advocacy at Takeda Oncology. Although her primary responsibility is setting Takeda Oncology’s global legal strategy, in her patient advocacy role she works closely with cancer patient advocates to support access to oncology therapies. Lewis sat down with me to share how she helped enhance Takeda Oncology’s patient advocacy organization.
A “Listening Tour”
“When I came into this role I didn’t have to build the patient advocacy program from scratch; we had a long history dating back to when we launched our first product, VELCADE [bortezomib], in 2003,” Lewis shares. VELCADE is primarily used to treat people with multiple myeloma (a cancer of the plasma cells). But due to treatment innovations over the years, the myeloma patient experience had dramatically changed (i.e., patients living longer). So, Lewis decided to enhance the existing patient advocacy program, starting by conducting an environmental assessment.
She refers to this as her “listening tour,” which required a two-pronged approach — internal and external. Internally, she looked at what the company’s priorities were versus the needs of patients, as well as the company’s existing footprint. As Takeda Oncology had evolved into a global operation, she wanted first to understand what going “global” meant for patient advocacy. She also compared how the patient advocacy function had traditionally engaged with the rest of the company and how that may (or may not) have been evolving. “We quickly identified that patient advocacy was playing an active role in the R&D organization, particularly around clinical development,” Lewis states. “Recently, we announced the launch of the INSIGHT-MM study, which will be the largest pharmaceutical company-sponsored study of its kind in multiple myeloma, with the goal of enrolling a minimum of 5,000 patients 18 years or older with newly diagnosed or relapsed/refractory multiple myeloma globally. The steering committee for this project included one of Takeda’s patient ambassadors, who also happened to be a physician.”
To begin internal dialogue, Lewis admits to employing a communications template. “I wanted the conversation to be very consistent from one person to the next so we could understand the insights we were hearing,” she explains. When conducting her listening tour, Lewis shared with people (in advance) the purpose of the conversation, but not the template itself. “I felt it was very important to try to capture first impressions,” she confides. “If they had the template in advance, it had the potential to bias some responses.” Some of the categories of the template included:
- ENGAGEMENT i.e., How do people currently engage with patient advocacy?
- EXPERIENCE i.e., Based on their function, what has been their experience either at Takeda or a previous organization?
- VISION i.e., What role should patient advocacy play at Takeda?
- EXPECTATIONS i.e., Is advocacy meeting their expectations?
- OPPORTUNITY i.e., Where could advocacy play a larger role?
When it came to utilizing the listening tour to enhance Takeda Oncology’s patient advocacy organization, Lewis began that process by meeting with a lot of internal groups like medical affairs, market access, sales, corporate communications, and clinical and their leaders to understand how they have engaged with Takeda’s advocacy unit. “We sought first to understand if Takeda’s patient advocacy was meeting their needs, and if there was more we should do,” she explains. Because the myeloma patient experience had changed so much, one of the first things Lewis’s advocacy organization did was conduct a patient “journey” mapping exercise. “We wanted to make sure we understood what the current patient experience was and how we could potentially support and advocate for patients within our company,” she says.
“Then we looked at the activities we had traditionally done as an advocacy organization and assessed those activities to determine whether we were doing was truly supporting the patients.” The team also met with external advocacy organizations Takeda had worked with in the past, as well as some in oncology with whom they had not previously worked. The goal of these meetings and the format of the discussions were similar to the internal conversations: to understand from these organizations what their experience working with Takeda Oncology had been, whether the group was meeting their expectations, and to uncover any potential opportunities.
Completing the listening tour took a few months. Some of the deliverables of these meetings included a revised advocacy organization structure and new vision and mission statements that reflected the global positioning of this function. “We didn’t want just a new advocacy platform,” Lewis states. “We wanted to better educate the organization on the overall advocacy function and how best to support patients.” The new structure was pressure tested before implementation by meeting regularly with those involved in the listening tour. “These meetings were a great barometer to assess the impact,” she says.
Getting Close To Patients
Of course, interacting with patients in the biopharmaceutical industry has always been limited due to regulations and the use of intermediaries (e.g., physicians and nurses) to share product information. “To try to bridge the gap between company and patients, Takeda created a 12-member Patient Leadership Council (PLC) to gain input from patients to help our decisions reflect their needs and expectations and to include clinical trial design and patient education resources. “In 2002, we started working closely with advocacy organizations,” she explains. “We learned there was a lack of information about what multiple myeloma was, and patients struggled to have informed discussions with physicians about their disease.” As a result, Takeda Oncology developed an ambassador program (see section titled “Patient Ambassadors") where patients were engaged to educate other patients about the disease. During the development and implementation of the ambassador program, the company recognized that some patients were much more engaged in the myeloma patient community than others. “Some patients, not necessarily ambassadors, were actually blogging about their disease,” she explains. “Others held strong and valuable opinions about how to improve our clinical trial programs.” In other words, the company discovered that there were patients with much to contribute beyond that of the role of ambassador. So, the company created the PLC, which comes with a year commitment from each member.
“For the PLC we look for patients who are leaders in the multiple myeloma community and engaged in advocacy, education, and empowerment of patients who could provide meaningful insights,” she states. “For example, in this group we have a patient who’s a former physician. We have another patient who has significant expertise in government policy and access. Another member is a former teacher who is really driven to help educate others.” Lewis shares that some of these patients came to Takeda’s attention as a result of their desire to share their personal multiple myeloma journey with other patients. Others were identified by their treating physician. “If we are looking to get input from patients on how to improve clinical trial protocols, for example, we are looking for a patient with a certain type of experience,” she clarifies. “Having someone on the PLC who has a medical background or actually participated in a clinical trial is someone with significant knowledge that can help us.”
In addition to its focus on patients, Takeda Oncology also concentrated on building and delivering a global advocacy expertise internally. “We created a global oncology patient advocacy council [GPAC],” she continues. That group has about 15 Takeda employees working together to help not only build the infrastructure to better execute a global oncology patient advocacy presence but also to gain alignment between internal and external stakeholders (e.g., patient advocacy organizations). “Internally we talk about what the objectives are for oncology patient advocacy from a global perspective,” she elaborates. “The really interesting thing about patient advocacy is that once you step outside the United States, every place seems to think about it a little differently.” While Lewis says there are laws and regulations that shape how a company’s patient advocacy organization should act, for Takeda (within the United States at least), GPAC has been helpful in shaping how the company should think (i.e., incorporating cultural norms).
According to Lewis, getting patients involved in Takeda’s patient advocacy efforts really goes back to developing a relationship geared toward understanding their interests and skillsets, as well as what they are willing and able to commit to. “And all of that has to be done within the constraints of working in a highly regulated environment,” she asserts. “When a patient initiates contact with us, it becomes a priority to understand what they have to say and identify any opportunities for future engagement.”
One of the most important components of Takeda Oncology’s patient advocacy initiative is its patient ambassadors, of whom the company currently has about 30. Ambassadors speak at educational seminars and medical meetings, patient events, and to patient support groups about their experience to create awareness of multiple myeloma. Every year the company conducts multiple live, unbranded educational programs, many of which involve patient ambassadors sharing their stories.
Ambassadors are compensated for their time and travel expenses, something Lewis believes important to making such an initiative successful. “Your group of advisors or speakers should be a well-rounded representation of patients,” she explains. “If you don’t compensate people fairly who might have to take time away from their jobs to conduct a program, then your initiative may include only the more affluent who can afford to serve.” According to Lewis, in many of Takeda Oncology’s programs the company is looking for patients not only to help educate other patients but also advocate on those patients’ behalf, while also providing the company with honest feedback on how to continuously improve.
Because ambassadors are speaking as representatives of the company, the materials have to be developed and approved in a very specific manner. “When a patient is delivering a program, they are not sales reps or physicians,” Lewis reminds. “Their job is not to convince other patients to take the product or to talk about product benefits. Their job is to talk about their personal, non-medication-related experience and maybe some other challenges [e.g., getting to the clinic].”
That said, because they are speaking on behalf of the company, Lewis employs an agreement very similar to what is used to manage Takeda’s physician speaker bureau. “We engage our patient ambassadors a little differently than we do our leadership council,” she explains. “We like to have our ambassadors under an agreement for a pre-specified period of time.” Takeda also closely monitors ambassador speaker programs to ensure they are meeting company standards for quality. This proves useful when deciding whether to renew an ambassador agreement when it comes due. “The environment changes all the time,” Lewis reminds. “For example, we just brought a new drug to market. So we need to continuously think about what our needs are balanced against the needs of the patient to adequately determine what the size of the ambassador bureau should be.” As for what Lewis looks for in ambassadors, it’s not only having a strong desire to educate but also finding those patients who possess strong public speaking skills. “We want people who are comfortable enough to be able to share their story publically and committed to doing it in an appropriate manner that is consistent with our highly regulated industry,” she explains.
Lewis adds that these kinds of patient advocacy initiatives don’t happen overnight. “It really begins with listening to patients and getting a perspective that may be different from that of investigators or physicians with whom they speak,” she counsels. “But by actively engaging with myeloma patients, you will be able to develop programs that give you an opportunity to create meaningful education for patients.”
Patient Advocacy: More Than A Survey
Before Liz Lewis, chief counsel and head of patient advocacy at Takeda Oncology, joined the company in 2002, the organization was already well engaged in patient advocacy. “When I walked into the legacy Millennium pharmaceuticals organization, I was the lawyer in charge of helping to build a legal function that could serve our commercial organization,” she explains. “We were just launching our first oncology drug, VELCADE, so there were a lot of questions around how to engage with patients.”
At the time, patient advocacy within biopharma was an emerging function. Lewis had to determine how to play in a space where there really weren’t any defined rules yet, but there was most certainly significant scrutiny. “Putting patients first means listening to them in order to understand their concerns, priorities, and needs, and then weaving that insight into the drug development and commercialization processes,” she says. For example, not long ago Lewis received an unsolicited email from a patient who had worked with the company on an adherence program. At the end of the program, the patient was asked to complete a survey. In the email, the patient explained that a lot of companies ask him to complete surveys. “But he said what we did differently was, after he submitted the survey, we actually sat down with him and asked a lot of in-depth follow-up questions. He said, ‘You really thought about my answers and cared about what I thought,’” recalls Lewis. “That’s why we decided that to truly understand a patient’s journey we had to do more than just conduct a survey.”
Want to understand how to better design a clinical trial? Don’t bring in patients just to give advice on protocols. “While protocols need to achieve meaningful clinical and scientific endpoints, trials also need to be designed so they aren’t too onerous for the patient,” she states. A simple, yet profound question Lewis says to consider when designing a trial is, “Does what we are asking make sense for the patient?”
Don't Burden Patients With Advocacy Work
At Takeda Oncology, the company has a number of components to its patient advocacy initiative. For example, it employs patient ambassadors, folks with multiple myeloma who go out and speak to other patients on behalf of the company. Takeda also has a global patient advisory council (GPAC) consisting of employees throughout Takeda’s global organization, and a patient leadership council (PLC) consisting of multiple myeloma patients who advise Takeda on its patient engagement efforts. “It is important to remember that we are working with a patient population that has cancer,” says Liz Lewis, chief counsel and head of patient advocacy at Takeda Oncology. “We certainly don’t want their work with us to ever become a burden.”
In other words, developing an effective patient advocacy program requires flexibility. “We aim for a mix of live meetings, calls, and then, in some circumstances, one-on-one conversations if something comes up,” she shares. “We have frequent touches with our PLC members, at least quarterly, where we might be doing a group call. Once a year we do try to get everybody together.” Lewis believes that once you develop rapport in working with a group of external patient advocates, having in-person meetings becomes less important. “We find we’re actually able to quite effectively connect via conference calls,” she concludes.