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Pfizer: Putting The Patient At The Center Of Its Drug Development Universe

Wednesday, December 24, 2014   (0 Comments)
Posted by: Katie Trevathan
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From Life Science Leader
By Rob Wright

I first Met Freda Lewis-Hall, M.D., on May 5, 2011, in New York. Pfizer’s chief medical officer had just concluded her Healthcare Businesswomen’s Association (HBA) Woman of the Year (WOTY) acceptance speech in which she challenged attendees to recommit, reenergize, and reform themselves to “be everything the patients we serve need us to be, and then some.”

As we fast-forward nearly four years, her words seem even timelier today. And while much has evolved in healthcare since the delivery of her memorable message, one thing that hasn’t is patient need — a point punctuated by the shrill of an ambulance siren whirring past the chief medical officer’s East 42nd Street New York office.

During today’s discussion, Lewis-Hall states that, “In our medical organization, the patient has always been our North Star.” And though Pfizer has been implementing patient-centric programs and platforms for years, it wasn’t until 2013 that the company took patient-centricity on as a named strategy. Leadership realized that to better enable patient engagement throughout the entirety of the drug discovery, development, and delivery process, the company needed to be more systematic. “As an organization, we needed to organize our patient-centric thinking, systems, and processes to make it consistently part of what we do every day,” she states.

To Become Patient-Centric Requires Learning, Listening, And Collaborating
One of the first steps Pfizer took toward getting organized around patient-centricity involved — and still involves — learning and listening. “Our teams are looking for opportunities to understand better what patients, caregivers, and patient advocates can share as insights to help us clarify their needs, and then to help us better meet them or to problem-solve,” Lewis-Hall states.

While some of these insights have been gained through positive experiences, she admits others have been learned through Pfizer misses. “Exubera would be a good example,” she says. The first U.S. insulin option indicated for type 1 and 2 diabetes not administered via injection (it was an inhaled insulin), Exubera received FDA approval in January 2006. However, this once-anticipated blockbuster was withdrawn from the market in October 2007. Its removal was not the result of drug safety concerns, but the lack of consumer demand. “This amazing science, incredible engineering, and true breakthrough frankly did not resonate with patients and their lifestyle,” Lewis-Hall says. “We realized we hadn't asked all the right questions of the right patients at the right time, and yet we continued pushing forward.” As a result, Pfizer took a $2.8 billion charge when it wrote off the drug, including $661 million of Exubera inventory.

One of Lewis-Hall’s favorite examples of a Pfizer miss turned patient-centric opportunity occurred shortly after she joined the company. “It was an ’aha’ moment for me,” she recounts. “Patients volunteer for our clinical trials, travel many miles, spend hours devoting themselves, and are committed to the work we do. At the end of the trial, we say ‘bye-bye,’ often without as much as a thank you.” To rectify this rather nonpatient-centric approach, a member of the Pfizer team tested the notion of establishing a platform that would thank clinical trial volunteers, as well as provide them the opportunity to get summary results from the trial. “In this way, they understood what their hard work and commitment had won in terms of advancing science around the disease,” Lewis-Hall attests. In addition, by providing a platform to stay connected to Pfizer, patients naturally began to take a more active and engaged role in the field of drug development. Now known as Pfizer Link, Lewis-Hall describes this online community as a key patient-centric engagement tool and a “clinical trial alumni association" for people who have graduated from a Pfizer clinical trial. Participants are given access to current information on diseases and conditions of interest, including suggestions and tools for disease management, opportunities to participate in future clinical trials, and registries.

As for patient-centric lessons learned, Lewis-Hall references collaborations such as the $58 million agreement between Pfizer and the Cystic Fibrosis (CF) Foundation to discover new treatments for people with the most common mutation of CF (Delta F508), and Lung- MAP, a lung cancer master protocol trial. “These are full-on meta-collaborations,” she affirms. “Lung-MAP includes the NIH through the NCI [National Cancer Institute], the FDA, Friends of Cancer Research, and five companies [Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune]. It’s also fully integrated to include patient input from beginning to end.” Lewis-Hall believes these metacollaborations demonstrate that patientcentricity is not an activity for biopharma companies seeking a competitive advantage, but a presage of a new norm for how industry and regulators can and should operate. “The FDA has fielded a series of patient-centric public meetings, and the EMA [European Medicines Agency] has pilots to include patient input to the CHMP [Committee for Medicinal Products for Human Use] on benefits vs. risks,” she states.

Capture Your Existing Patient-Centric Best Practices
If you are like Pfizer, you have developed and implemented patient-centric initiatives guided by patients. But how are you capturing these best practices so you can replicate them? “We saw various leadership-championed initiatives growing throughout Pfizer as best practices,” Lewis-Hall testifies. “But in a place this size and with so much going on, we realized continued success meant putting some structure around it.” In 2014, Pfizer created the office of global patient affairs. Headed by Roslyn Schneider, M.D., this group is charged with collecting, synthesizing, developing, and implementing a framework to better involve patients across all of Pfizer. This framework (i.e., structure) is designed to build “capabilities, systems, processes, and platforms for sharing in order to make this a part of everyone's day,” Lewis-Hall says.

To better understand the type of information this group is trying to capture, Lewis-Hall shares two examples, the first of which is related to Xeljanz (tofacitinib), the company’s compound for rheumatoid arthritis. Xeljanz originally received FDA approval for rheumatoid arthritis in November 2012. A year later, the FDA approved a supplemental new drug application (sNDA) including additional patient-reported outcomes data. Says Lewis-Hall, “We worked to include things that are not usually part of a clinical trial.” As examples, she lists the eight domains (i.e., vitality, role physical, role emotional, physical function, bodily pain, social function, mental health, and general health) of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36) used on the Xeljanz sNDA that now appear in the label. “That's a soup-to-nuts example of listening to patients about what's important to them, including it in clinical trials, collecting and analyzing the data, and then sharing it back with the patient community.”

For the second example, Lewis-Hall references Pfizer’s fieldwork on understanding smoking cessation. “What are the differences between smokers and patients who'd like to quit?” she asks. “How do you define someone who's ready to quit or who's not? How do you understand what drives the urge to smoke?” To better understand these questions, the Chantix (varenicline) team used validated scales and a brief questionnaire that clarified smoking urges. They also used a withdrawal scale explaining what kinds of symptoms people experience when withdrawing from nicotine. “These were included as part of the supportive prescribing information, and are two examples of responding to what patients say they care about when considering their options,” she says.

Questions To Ask When Becoming Patient-Centric
If your goal is to make your organization more patient-centric, Lewis-Hall suggests asking the following questions: “How do you take the desire on the part of patients to be able to tell you what's important to them? How do you identify or develop tools to collect this information? How do you ensure their validity or go about validating? How do you utilize the tools? How do you communicate the information back to patients, while systematically teaching the different teams working across other areas in your organization?”

She adds that the key to being patientcentric isn’t just finding and using patient-centric tools, but understanding when they are appropriate to deploy. Ruminate on the following example: “We had some special challenges in a sicklecell disease study,” she states. “This is an emergency-room-based study where patients have to be in crisis. It's a unique population, many of whom have been ill all their lives and are experiencing agonizing pain.” In trying to figure out how to meet these patients’ needs while creating a manageable study, Pfizer deployed tools not often used in the clinical setting, such as ethnography and medical anthropology. “We worked with the physicians, patients, and advocates so they all better understood and articulated the patient’s journey,” Lewis- Hall shares.

How Patient-Centric Are You?
You are probably curious about what metrics Pfizer uses to measure the success or failure of its patient-centric best practices. Lewis-Hall says the first important metric is reach, which is measured by determining which of the company’s programs are deploying patient-centric systems developed by the company. “Over time we want to see more of the organization deploying what we believe to be successful strategies that include patient input."

Another key metric is patient engagement, and she says there are a lot of ways to measure this. For instance, you could measure how many patients are using tools developed by Pfizer, such as mobile apps. “We have an app in Australia where patients can have prescribing information on their cell phone and the immediate ability to click through to our medical information centers with either a call or an email in case they have questions,” she relates.

Another patient engagement measure Pfizer considers is the number of patients using the Blue Button technology launched by the U.S. Departments of Veterans Affairs and Health and Human Services that enables Pfizer trial participants to download their own electronic clinical data collected in the trial. Pfizer also considers the number of patients enrolling on Pfizer Link and the number of questions being submitted through the company’s Get Healthy, Stay Healthy portal. But just measuring engagement is not enough. Lewis-Hall says the company is also seeking to measure satisfaction after engagement. “We ask what patients thought about the information they received,” she states. “Did it satisfy your needs? Would you come again for more information?” According to Lewis-Hall, engagement satisfaction is a measurement you should be doing continuously.

One of the metrics most exciting to the Pfizer team is the intent to act. Instead of just measuring how many patients asked for and were given information, Lewis- Hall says the intent to act is one of the best measures of effective engagement. “If I talk to you about how to stay healthy if you have diabetes and have to travel overseas, your intent to act becomes an important opportunity for us,” she states. “We're tracking and using that feedback as direction for improving engagement.” If you are using patient input to help shape clinical trials, you should measure how many protocol changes there are over time and compare that number to similar trials that didn’t have patient input. “Want to measure how well you are listening or meeting patient needs?” Lewis-Hall asks. “Compare the number of patient suggestions to how many you actually incorporated.” Pfizer’s chief medical officer advises to make sure you are matching the correct tool with the correct target. “We have measures for pre-study, in-study, post-study, and in-market or in-community to determine if we hit the mark,” she clarifies.

Finally, don’t use the excuse “We are a small or virtual company and outsource everything” as rationale for why you don’t have to or can’t implement or measure patient-centric programs. “Our model isn't outsourced as much as it is partner-sourced,” Lewis-Hall explains. “From the very beginning, we have the opportunity with our partners to align, gain agreement, and confer our concerns, enthusiasms, and mechanisms for patient engagement from inside the Pfizer walls to all the people who help us do the work outside the walls of Pfizer as partners and collaborators.” In other words, if you want to put the patient at the center of your drug development universe, take an active role in developing, adopting, capturing, and measuring your patient-centric initiatives — even if you are in a fully outsourced model.

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