By Ed Miseta, Chief Editor, Clinical Leader
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When Lori Abrams was named director of advocacy, diversity, and patient engagement for Global Development Operations at Bristol-Myers Squibb (BMS), she had no one to manage. In fact, her first assignment was to create the department she would oversee. “The first thing I realized was there didn’t seem to be many such departments for me to benchmark against,” she notes. “I went around to a lot of pharma companies trying to find someone to talk to, but an advocacy position focused on clinical trials just didn’t seem to exist.”
Undeterred, Abrams set about building the department the way it would best serve patients. She was able to pull from her experience working as a patient advocate (and common sense), and she used a lot of trial and error along the way. She also engaged with patient advocacy groups, asking a lot of questions about how pharmaceutical trials could best meet the needs of patients. With three employees now on her team (and two on a work rotation) overseeing all patient aspects of drug development for all therapeutics, it’s safe to say she has come a long way.
The Advocacy, Diversity, and Patient Engagement Group collaborates with disease-based and minority-focused advocacy organizations as early as Phase 1 to learn about the patients and caregiver’s daily challenges as well as their concerns about clinical trial participation. The group also meets to understand what secondary endpoints may be important for the patient. By connecting with patients and advocacy organizations, we are also able to drive recruitment, educate patients on current studies, identify participation barriers, understand the special needs of the patient population, and identify study sites and investigators.”
A key aspect of her job is bringing awareness and accessibility of clinical trials to patients, hopefully leading to increases in enrollment. To that end, understanding the journey of a patient is vital. For example, how many visits did they have to make? How invasive were the tests? How many times did the clinic have to draw blood? She believes the relationships nurtured through advocacy can help companies get the answers they need to understand the priorities of those affected by the disease. She believes these answers will also help pharma and bio companies improve their understanding of investigational therapies across broad and diverse populations.
CHALLENGES TO OVERCOME
From her first day, Abrams knew a key component of her new job would be to design and deliver a clinical trials advocacy team that would remove or minimize barriers that prevented greater participation in clinical trials. To be successful, that team would have to collaborate across the BMS enterprise, including operations, research, medical, legal, regulatory, market access, and other departments to ensure the strategies she put in place were understood and synergistic with other business goals and objectives.
“As a former protocol manager, I knew that changes to company culture, specifically those that may bring new sites or recruitment tactics, would be a challenge,” she says. “I think that was probably my biggest concern coming into the position. At the same time, I felt I was building a team with the capacity and credibility to apply and translate patient, caregiver, and competitive insights, in order to effect change that would make our trials more appealing.”
One of the biggest challenges Abrams faced took her well over a year to identify. It was the notion that some diseasefocused and minority-focused advocacy organizations could not deliver everything they promised or what her company desired. Thus, she says it’s important to quickly identify the strengths of a patient advocacy group (PAG). “Once you fully understand those strengths, you only ask them to do what you know they are equipped to succeed at,” she says. “If there is something you know they are not equipped to do, find another organization to perform the task.”
She also stressed the importance of maintaining those PAG relationships. “When you give your word to patients, it’s important to keep it, even if it is not the popular thing to do. Building trust and credibility with these organizations can be a challenge. If there is distrust that exists right from the start, relationships are incredibly more difficult. While this challenge can be overcome given enough conversations, they can take a long time, depending on the PAG.”
DEFINE SUCCESS EARLY
Projects often fail simply because key decision makers don’t identify the characteristics of success for the endeavor. Abrams took the time early in the process to define what success in her position would look like. First, she wanted to have a seat at the decision-making table at every appropriate step in the trial development and execution process. Today, consistently getting that invite is one measure of success for her group.
Second, there are metrics she can monitor to measure aspects of trial success from her perspective. How many ethnic minority physicians who are new to BMS have become investigators in the last six months? Have her advocacy tactics allowed the company to reach a more diverse patient population? If so, how does randomization look? And most importantly, have PAG insights helped to improve protocol designs? These are all areas that Abrams attempts to monitor and better understand.
“To be successful in this role, I also learned early on to embrace change, seek innovation, and take risks when necessary,” she notes. “Quick wins in the beginning, supported by data and/or early adopters, also helped to bring the department needed credibility. The early development of an advocacy guidance document in collaboration with our legal department was also critical. In addition to providing clear definitions of what our group could and could not do, it delineated the differences between clinical trials advocacy, medical advocacy, and commercial advocacy.”
Finally, Abrams notes advocacy, diversity, and patient engagement encompass an enormous body of work. Therefore, be careful not to try and accomplish everything at once. She recommends establishing objectives, prioritizing them, and sticking to the plan. When doing so, be sure to maintain flexibility as business priorities shift.
PROPERLY ENGAGE WITH PATIENT ADVOCACY GROUPS
For many individuals, engaging with patient advocacy groups might be considered one of the most difficult aspects of the job. For Abrams, the work she did with these groups in the past (see sidebar on next page) prepared her well for the role. “This is probably the easiest component of my job,” she says. “There are several methods for identifying the appropriate disease-focused and minority-focused advocacy groups. Once we have developed our strategic plan, we can reach out to the organizations we have not worked with in the past. Generally a preliminary call is made where we identify the goals of the PAG and loosely discuss ours. If there are synergies, we move ahead and begin to build a relationship.”
First BMS will identify patient advocacy groups applicable to a study, collect information on the groups from peers, and narrow the list down to the top prospects. Abrams will then conduct preliminary calls to determine if the objectives of BMS and the PAG align, understand their focus (i.e., education, clinical research, policy), whether they have the experience and bandwidth to collaborate, and their track record of collaborating with pharma.
Abrams often advises colleagues that, when working with PAGs, the “devil is in the details.” While everyone agrees it is important to engage patients throughout the process of drug development, how that patient engagement is designed into day-to-day operations is not always clear. Advocacy campaigns can drive awareness of a clinical study, but there are many steps that fall between awareness and enrollment.
“Campaigns should be designed to help us generate data that will illuminate the many steps of our patients’ journeys, so we can document how and where their engagement makes a difference,” says Abrams. “Initially this effort might only make a difference to one patient, but we have to look at the bigger picture and understand that ultimately it will make a difference for all of the patients that follow. The pharmaceutical industry is analytical, data-driven, and objective. It has to be. But the patient experience is physical, emotional, and personal. It is the role of the patient advocacy department to bridge these two worlds in order to bring medicines to market that have a demonstrable benefit to patients from all walks of life.”
HIRE THE RIGHT DIRECTOR
Any company starting a clinical trial patient advocacy department wants it to get off the ground smoothly and efficiently. But what kind of person should pharma companies look for when hiring a director of patient advocacy? And what skills and background should that person possess?
While a strong understanding of business and specifically drug development is a good background to have, Abrams notes the first trait she would look for is someone who can build relationships based on trust, mutual respect, empathy, and understanding the business from the perspective of the patient and caregiver. These are critical traits, and she believes savvy external stakeholders can quickly assess the authenticity of such a person.
“The individual needs to have the ability to work across an enterprise and break down boundaries,” she notes. “A good portion of my job is problem solving, building alliances, and bringing about meaningful outcomes. If you are not empathetic to that patient point of view, this is a very difficult thing to do.”
Taking risks and trying new ideas and new tactics is also critical, especially as the patient environment continues to change and patients become more informed about clinical trials and the drug discovery process. “I need to have the self-confidence to fail, but get right back up to fight another day,” she adds. “In that regard, having the support of management is also very important. Without that support, many of my efforts would be futile.”
While there is no typical day in her position, Abrams does spend a good amount of time focusing on:
- internal stakeholder management
- advocacy team/issues
- external relationships (managing existing relationships and building new ones)
- participation in external advocacy and/or diversity work streams
- innovative brainstorming with multiple stakeholder groups
- keeping up with the BMS book of work/business goals.
Team members spend most of their time developing strategies and tactics to engage patients in protocols, developing communications for advocacy organizations, refining relationships, and reviewing and modifying study materials to be more patient-friendly.
Adds Abrams, “Ultimately, we need to be able to look back and ask if we did everything we could to make patients aware of our trials and make those trials as user-friendly as possible. Our focus must be on the patient. Only by having that mindset will we be able to function in this role and meet the goals we have set for ourselves. It can be difficult at times, but we have the benefit of knowing that everything we do will make a difference in the life of a patient. And that has been my goal since I started at the NIH.”
From Patient Activist To Director of Advocacy
Lori Abrams did not begin her career in Big Pharma by going the conventional route. She does not have a degree in biology, chemistry, or engineering. In fact, when she started her career in the life sciences industry she did not have a degree, and science would not have been her first choice of major. But when a couple of close friends contracted the HIV virus, she decided to become part of the effort to find a cure.
That drive led her to take a job at NIH where she served as study coordinator. She then worked for the Henry M. Jackson Foundation as senior protocol coordinator, managing HIV/AIDS clinical trials for the military. By 1998 she was managing multiple global Phase 3 clinical trials on HIV/AIDS compounds for Bristol- Myers Squibb (BMS), later becoming an associate director in the R&D learning department. Along the way she obtained a B.S. degree in health science, a master’s certificate in organizational development, and completed several BMS leadership programs.
“At the end of 2011, someone recommended I apply for a new position the company was creating to oversee advocacy, patient engagement, and diversity in the clinical trial space,” she says. “I felt this was the role that would allow me to truly make a difference in the lives of patients. I applied for the job not even fully aware of what exactly it would entail. When the company became aware of my role as a patient advocate and activist in Washington, D.C., I was quickly offered the position.”