Inspiring Inclusion: The Power of Pivotal Moments 

This year, TransCelerate honored International Women’s Day, and the theme of “inspiring inclusivity” by gathering a panel of distinguished thought leaders within biopharma R&D for a discussion on “Inspiring Inclusion: The Power of Pivotal Moments.” 

TransCelerate COO Allison Cuff Shimooka moderated the event. Panelists were Esther Krofah (Milken Institute Health), Joni Rutter (NCATS/NIH), Janet Woodcock (formally of the FDA), TransCelerate Board Member Rob Goodwin (Pfizer) and TransCelerate CEO Janice Chang. They shared invaluable insights from their personal and professional journeys towards creating a more inclusive environment within the biopharma and healthcare industries. Read on for some key takeaways. 

• Leaders should have an attitude of openness, humility, and a willingness to listen to others’ perspectives. 

The adage “Walk a mile in someone else’s shoes” is a core component of nurturing an inclusive experience. Actively engage with others that come from different backgrounds to gain a better understanding of the people around you and how they perceive the world. 

For example, Esther Krofah shared how she responded when colleagues asked her how she felt being a Black woman in America during the pandemic.  

“For many of us, especially if you’re coming from the background where you’re in a population that’s typically underserved, it’s not just about one moment. It’s all the moments, and you live it every day. George Floyd, what happened during the pandemic in 2020, that confluence of both the social challenges that erupted, as well as a health emergency…It may be acute for you, but this is the context in which we get up and take care of our families, and go to work, and lead organizations, and identify issues. And what that, in some ways, reflects is that we just need to be cognizant of who you have around the table because they bring those experiences.” 

Janet Woodcock underscored the need to have difficult conversations, and shared experiences from her career at the FDA and the distrust the agency experiences, due to a distrust of government.  

As she advised, “We have to include and listen to those who are experiencing these negative feelings and try to figure out what are they, where are they coming from, why are they experiencing this. Engage with them as well as with the sort of people who are trying to push forward.” 

“Resiliency comes from even when you get the pushback, that’s when you develop bigger ears and a smaller mouth,” elaborated Rob Goodwin. “You spend more time listening and understanding. When you can do that and engage, then you can understand more about the things you need to do to be more resilient. It starts with us. We have to demonstrate that every day. What are the words we choose? How do you put [these learnings] into action? The quote ‘Be strong in the saddle’ is applicable. When it gets hard, you must stay on and ride, and demonstrate that you can do it. It starts at leadership.”  

• The healthcare system has an opportunity to address infrastructure challenges faced by physicians and front-line care providers and improve patient care. This can help build trust between healthcare providers and patients. 

The panelists encouraged attendees to approach inclusion as a business imperative, not a moral one. 

“All these communities just want a simple answer to, ‘I’m sick. Can I get access to an intervention, a product, a therapy, a vaccine that’s helpful for me? And was I included in that clinical research?’” Esther said. “On the business side, as you’re making decisions about sites, ‘Do those providers have experience with these medicines? Can they talk to their communities effectively about these medicines?’ If they’re never included in the research, we know the timeline from research and studies to intervention could be upwards of 10 years. Communities might never have access to the latest therapeutic or benefit from it. It’s really for me about changing it from a moral conversation to a business conversation,” she concluded. 

Joni Rutter highlighted how infrastructure barriers within clinical trials and healthcare can contribute to non-inclusivity. For example, positive findings on new ways of operating from some sites may not be widely shared or implemented at other locations. Stakeholders should consider all the infrastructure needed for support.  

“If you look at the electronic health records at one site, they’re completely different at another site,” said Joni. “Implementing something even within an electronic health record is a major deal. How we start to drive infrastructure development towards supporting these ideas is really a critical need. How do we make that change so that it does get into the care?” 

“This new model can ensure that providers have the support, have the education, have the right incentives to really help us build that trust. We can’t get to the patients in many ways without the providers,” Janice Chang added. 

• Include diverse perspectives in clinical trials to drive progress and ensure that solutions are relevant and effective for all communities. 

A lack of diversity in healthcare and clinical trials is not a new issue. Yet the COVID-19 pandemic shone a spotlight on how it is a detriment to patient care.  

 “We would talk about inclusivity in clinical research, but unless you’re measuring it and really understanding it, you need a baseline,” said Rob. “Pfizer made a conscious effort to publish 10 years’ of data on our clinical trials…It set a baseline for us and a call to action. When we were developing the vaccine, what we realized is that it must be for everyone. We got intentional about the sites we were choosing, making sure they were in the right areas, asked to offer after-office hours or on weekends. I think that was a moment for me. If we can do that for COVID, why aren’t we doing it for everything else?”  

“There’s a scientific imperative here, particularly for genetics,” elaborated Janet. “If you just study a certain somewhat homogeneous population, you’re not going to understand basic variability and what drives it and so forth. I think that’s true in drug development as well.” 

How can diverse perspectives be represented in clinical trials? Engaging and actively listening to each of the groups that have a role. Even small changes can drive impactful results.  

“It’s not about helicoptering in,” said Joni. “It’s about engaging them. We supported groups and communities that we wanted to be at the table. We also made sure that our consent forms were in another language.”  

By engaging the Hispanic communities in translations, the NIH discovered that “study” had a negative connotation in Spanish, eliminating the option for direct translations. 

• The power of collaboration is driving meaningful change in healthcare across all stakeholders. 

Janice stressed that engaging all stakeholders is necessary to chart a path of converging clinical research and clinical care. “Right now, we’re managing diseases, but how do we get to managing health?” she asked. 

For TransCelerate, that means developing publicly available, pragmatic solutions for a variety of industry stakeholders and roles to accelerate the development of medicines   

“There will be required actions by other parts of the ecosystem like regulators, sites, patient groups, and policymakers,” Janice continued. “I think that we’re starting to have that conversation, but we’ve set that bold vision, and we are going to achieve it one step at a time, in a very pragmatic way.” 

Wrapping up the panel, each panelist provided some personal thoughts on how to better integrate clinical research within clinical care: 

• Modernize the healthcare system to make access to care available for all. Clinical research is not widely included as a core curriculum in medical training. As such, many healthcare providers are unaware that clinical trials could be an option for their patients. 
• Improve access for patients. Many patients only have access to innovative, cutting-edge research if they live in proximity to a medical school or research center. Most care around the world happens in rural communities, where healthcare settings lack resources of their urban counterparts.  
• Remove barriers that hinder stakeholder capabilities. Providers and care staff are burnt out, experiencing difficulties in EHR systems, and have other barriers. 

“Change is hard,” Janice continued. “But every day I get to see our member companies working across the ecosystem, coming together and doing the right thing, and demonstrating the courage to challenge ourselves, to say, ‘Why are we doing that? Why are we not doing it differently? What’s the barrier?’ Be resilient about ‘let’s keep pushing forward, let’s keep pushing forward one step at a time.’”  

For even more insights, watch the full event below or read how some of female leaders approach inclusion.