Given the additional investment and personnel required to conduct a clinical trial like this, why is it important to continue these efforts?
Dr. Freedman: When we work with these community hospitals, we learn more about what they need to run successful trials, and then we can proactively provide those resources. It’s an ongoing investment. At new sites, clinical monitoring tends to be more intensive, so yes, it will require additional personnel time. Initially, it will be more expensive. So, the question becomes, what’s the business rationale for doing this?
First and foremost, it’s about doing the right thing for patients. It’s also an opportunity to increase access and grow the market for a particular product. It’s a win-win for patients and for companies.
That’s why it makes sense to invest long-term, and as we build trust within more of these communities, the return on investment will grow over time. We shouldn’t be competing with other companies around health equity. All companies can work together to solve this issue because one company can’t solve it alone.
What led to the expansion of the work from the U.S. to Africa?
Dr. Mohan: In going out to these underrepresented community-based hospitals, we had the right intent. But there were many companies working on drugs for COVID-19 during that time. As the pandemic started slowing down in certain areas and then picking up in others, we had to chase the virus across the country, from state to state, to find patients.
But eventually, enrollment in the trial started slowing down. We then thought about going to other countries that didn’t have access to Actemra. We went to certain South American countries, as well as to South Africa and Kenya, to enroll patients. The most surprising opportunity was in Kenya, because Kenya had never been part of a phase 3 global clinical trial before, at least not that we knew of. Our efforts were motivated by a continued desire to find underserved Hispanic and Latino American patients, as well as Black patients, whether they’re from the U.S.,South America or Africa.
What were your takeaways from the work you did in Africa?
Dr. Freedman: There was skepticism about whether we could conduct these clinical trials successfully in other countries. Since then, Genentech has done many more trials in Kenya. Several institutions in Africa have the infrastructure to conduct certain kinds of clinical trials. Through this experience, I was struck by how few patients had access to medicines, in part because the drugs weren’t even approved in the countries where they lived.
It takes a very long time to get drugs approved in Africa. There’s an opportunity to speed up drug approvals and increase access. The reimbursement model probably just needs to be different in Africa than the rest of the world. Africa represents about 20% of the world’s population, but only 2% of Africans end up in clinical trials.
I think Africa presents probably the biggest clinical trial opportunity over the next 20 to 50 years, because it has a large and rapidly growing population, and those citizens represent such a big part of the population who don’t have access to our drugs today. We have to solve that together. But I think companies are still very cautious about what they do there.
How have these experiences shaped your future goals?
Dr. Freedman: I was at Genentech for nearly 4 years, and I felt that my team and I played a major role in driving changes that eventually became more self-sustaining. More clinical trials are now focused on underrepresented populations. There’s also a broader recognition of the importance of Africa in pivotal trials.
I came to realize that there’s something more I can do around health equity outside the company where I can add even more value. So right now, I’m working with some former Genentech colleagues on a new business model for access to drugs in Africa. First, we need to find investors that believe in this, and we need to collaborate and partner with other institutions and pharmaceutical companies to make it happen. I don’t know how far it’s going to go, but I am motivated to do something more impactful in this space.
Dr. Mohan: I’m really proud to work for a company that prioritizes addressing barriers to health care access for underserved patient populations. I’m currently leading a study called CATORI (Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives) that aims to understand patient barriers to accessing care from a specialist such as an oncologist, neurologist or ophthalmologist. This study exemplifies our commitment to advancing health equity as it’s a non-interventional trial focused on patient perspectives. It will inform how we conduct future clinical trials to improve representation for this group as well as other underrepresented populations.
We’ve made significant progress in advancing health equity through our inclusive research efforts and aim to embed the best practices we’ve learned across all our trials, so they are representative of the patients and populations that experience disease. We are also seeking opportunities to work with external stakeholders across different sectors. As Jamie mentioned, no one company can do this work alone, and cross-sector partnerships will enable us to unlock sustainable and scalable solutions.
I believe organizations like Optum and Genentech can work together so all patients get the best possible care.
Disclaimer: At the time of the interview, Dr. Jamie Freedman was not employed by Genentech. The interview represents the opinions and views of Dr. Freedman and does not necessarily represent or reflect the views, opinions, policies or positions of his former employer Genentech. The interview represents the opinions and views of Dr. Shalini Mohan, a current employee of Genentech, but does not necessarily represent or reflect the views, opinions, policies or positions of Genentech.