Rare Collective

Ask Not What Patients Can Do For You…

By January 17, 2019 No Comments

Interview with Jean Campbell, November 19, 2018

At a high level, what is appropriate for a pharmaceutical company to expect from a patient organization?

There are lots of ways to collaborate, but it all comes down to one thing: the patient organization will help you understand what it’s like to live with the disease. This helps the company understand what needs to be done to develop a therapy and get it to the patients who need it. A company should never begin its relationship with a patient community by telling the patients what it will do for them. Instead, the company should begin by asking the patients what they need. This kind of information is different than what the scientists and clinicians might tell you. It can guide everything from clinical trial design to post-launch patient support programs.

But even during this process, a company should maintain some distance. Patients may be reluctant to speak their mind in front of a company employee for various reasons: they might be afraid to offend the developer of a therapy, even when that kind of criticism would be constructive. A director of patient advocacy can structure an information-gathering project so that the patients’ experiences and needs can come through clearly.

Before the company sets its expectations for the patient organization, the company must learn what the goals of the organization are. Some are built around specific missions, and those missions may or may not involve drug development. This kind of early diligence and planning is also part of the role of a company’s director of patient advocacy.

Let’s put ourselves in the shoes of a patient organization. What does the world look like from their perspective?

Small organizations, even those that have been around for a while, can be naïve about how to interact with pharma. They might be excited about the prospect of a treatment or cure, and they’ll provide the pharmaceutical company with anything they can to make their dream real. As they begin to build a relationship with a pharmaceutical company, they may not be aware of some IRS and general limitations placed on non-profits, which in some instances could jeopardize their reputation or even their non-profit status.

The pharmaceutical company, on the other hand, as a for-profit entity with financial resources, has a responsibility to understand what the best practices are for working with patient organizations. That’s a key role of the patient advocacy function within a pharmaceutical company.

As part of a company’s patient advocacy function, what are some principles that help them maintain a healthy and appropriate relationship with patient organizations?

Even if the patient organization is enthusiastic, the company’s director of patient advocacy still needs to ensure that all interactions with a patient advocacy organization are conducted in a transparent and ethical manner; for example, one company should not be the sole source of funding for an organization). Additionally, it’s essential to maintain a respectful distance—if both sides face risks if the organization is perceived as pharma’s mouthpiece or if the patient advocacy organization feels beholden to the pharmaceutical company. If the organization depends on a single pharmaceutical company for funding, they might naturally feel reluctant to encourage the work of other companies or researchers. Of course, there are all sorts of reasons why this is a bad outcome: the company’s drug might fail, but there are also lots of diseases where a therapy isn’t one-size-fits-all: different patients may need different drugs.

How can pharmaceutical companies build support across the entire patient community?

In some rare disease communities, many individuals may not be members of any patient advocacy organization or social media platform. There are often instances where members of the same patient advocacy organization might not agree with everything its leadership does. A pharmaceutical company shouldn’t let itself become a source of division among the community, nor should it show favoritism if there are multiple patient advocacy organizations. A company’s neutrality can pay dividends when it’s time to recruit a clinical trial or testify before the FDA about the value of patient-reported outcomes, because the pharmaceutical company may need to work with the entire patient community. A skilled director of patient advocacy can help the company navigate this type of challenge.

What about cases where the patient organization isn’t so open or friendly?

Sometimes patients fear that the company doesn’t understand their needs and just wants to make some money. This is a possibility in cases where the patient organization is well-established but the pharmaceutical company is a newcomer to the space: the patients have built a solid, supportive community on their own, and they’re cautious about outsiders who make big promises about the future while asking for their help today.

The pharmaceutical company’s director of patient advocacy will identify these hurdles—and this is the important part—before they become problems! Pharmaceutical companies and patient organizations operate on different timelines. Avoid at all costs a situation where the company is pressed for time—say, before and FDA hearing or preparing for launch—only to learn that the patient organization isn’t ready to cooperate in the way the company hoped. Like any relationship, it takes time to identify the real problems and to resolve them.

How can a company earn and preserve the trust of the patient community?

There’s no one-size-fits-all strategy for working with patient communities, but an experienced patient advocacy team has a toolkit of resources and strategies that will help a pharmaceutical company have a positive and productive relationship with patients. Involving patient organizations early in the process – even before clinical trials begin – helps to establish a strong foundation of trust. Members of the Rare Collective can share practical steps to achieve this goal based on their experience.

This early involvement makes it easier to handle potential hurdles such as trial design, corporate merger or sale of the therapy, pricing strategy, and—perhaps most challenging—the decision to end development after a failed trial. In these situations, even companies that claim to be “patient centered” can get distracted unless an internal patient advocacy function is focused on the community. Without a trusted partner in the company, the community will interpret these events based on other sources such as the news media or social networks.

There have been several cases recently where patient organizations have made public statements criticizing a pharmaceutical company for the high price of a newly launched drug, even when that drug is clinically effective. How can a director of patient advocacy prevent this kind of problem?

This is a situation where the burden of communication is especially heavy on the company. In my experience with such cases, communication is key.

That is why it is extremely important for the patient advocacy function to have a seat at the table with the company’s senior leadership, so that the voice of the patient is truly heard and incorporated into the entire company plan. If I can be so bold to say, this is where a company’s patient advocacy team should be led by a Vice President who actively participates as a member of the senior leadership

It sounds like patient advocacy requires a lot of expertise at an early phase of drug development, when small companies often don’t have the resources to spare. Are there things a small company can do early on to prevent missteps and build a foundation for a future director of patient advocacy?

Patient advocacy is a function that can be performed by a consultant at an early stage. But if you go down that path, it’s essential to give oversight to a seasoned and well connected consultant, even if that person doesn’t execute every project. Because so many of a company’s activities can touch the patient community, there’s a risk of duplication, gaps, and conflicting messages if the outside consultants are managed by multiple internal leaders who may not all be versed in patient advocacy best practices.

Having spent nearly 30 years in the rare disease space and eight years as a patient advocacy consultant, I’ve gained a real appreciation for the importance of having a strong and coordinated vision for the patient advocacy function. I’ve had a few experiences where I was brought into the process later than usual, and it took a lot of extra time and resources to get back on track by following well-intentioned, but uncoordinated projects. Even a small investment up front becomes invaluable once the company starts building a relationship with the patient community. This same logic applies to bringing in a communications, data, pricing, or market development consultant, depending on the precise situation at hand.

What are some key factors a company should consider when deciding how to staff the patient advocacy function?

Even if a company isn’t ready for a full time hire, it’s important to devote some resources—even just a light engagement with a knowledgeable consultant—to the patient advocacy role. That function will eventually morph into a full-time hire. An experienced consultant should have access to a deep collegial network of patient advocates, and should be able to help the company find the right match when they’re ready.

For me, this is one of the benefits of being a co-founder and board member of  Professional Patient Advocates in Life Sciences (PPALS). PPALS is a non-profit organization that represents individuals who work in the Patient Advocacy function within a biotech or pharma. PPALS also provides a career development course of study in partnership with Sanford Research for these individuals. PPALS trains patient advocates to help them perform the roles we discussed—and much more, too!

In addition to PPALs, are there other resources you could recommend for companies that are just starting to think about the patient advocacy role?

BioNJ White Paper https://bionj.org/patient-advocacy-white-paper

Orphanet Journal of Rare Diseases: Principals of interactions with biopharmaceutical companies https://ojrd.biomedcentral.com/articles/10.1186/s13023-018-0761-2

Patient Involvement and Engagement https://link.springer.com/epdf/10.1186/s40900-017-0065-z?author_access_token=LCKWq-shVFdrV51B7PUEnm_BpE1tBhCbnbw3BuzI2RNsne4l85zb1-GCXtQ08lpRHg3JEZmItGN8lQGE3EpaizEytoNFTJtqH92lCqs0j5ARnGia82JsBhIeElvfcNxRAvQhdKwFelQNHkDkjMjINw%3D%3D

The members of the Rare Collective have been immersed in these questions for decades, and we would be happy to share our experiences with you!

David Lapidus is the Founder of LapidusData, and his proprietary models and data collections systems serve as the backbone of commercial infrastructure throughout the product lifecycle.

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