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Implications for the Future of Drug Development in Emerging Economies

On May 7, Cytel and Certara conducted a virtual panel discussion on new opportunities and implications for the future of drug development in emerging economies. The speakers included highly acclaimed key opinion leaders and industry experts who spoke about new sources of research funding being channeled towards emerging economies and the need to understand its strategic priorities to properly assess future opportunities for growth.

Our first panelist, James Orbinski is a professor at York University's Dahdaleh Institute for Global Health Research. James is an experienced medical doctor, a humanitarian practitioner, a best-selling author and a leading scholar in global health. After extensive field experience with Médecins Sans Frontières / Doctors Without Borders (MSF), Dr. Orbinski was elected MSF’s international president from 1998 to 2001. He launched its Access to Essential Medicines Campaign in 1999, and in that same year accepted the Nobel Peace Prize awarded to MSF. Our moderator from Cytel, Principal Scientist, Edward Mills began the virtual panel discussion by asking James a series of pertinent questions on the issues around the current pandemic. Continue reading this post for the Q&A.

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Edward Mills (Ed): Given your experience in working abroad, you are surely in contact with your network of family and friends around the world. What are you hearing from individuals in some of the poorest settings (let us say in Africa) about the public health response and the day to day life in the current pandemic?

James Orbinski (JO): I have several friends in Malawi who I have been working with for the past 15 years. There is a young gentleman there I speak with almost every day. He runs the orphanage where I had first met him when he was only 12. Their number one concern is the prevention and control of COVID-19. At the orphanage specifically, they are facing severe impacts in terms of food shortages, employment loss and presence of active cases in their community. There is also immense instability across their country as the government has sought to impose a rigorous lockdown. Massive protests from people have led to the Supreme Court of Malawi ruling that requires the government to reevaluate its lockdown strategy. This paints a picture for you of one reality, but various dimensions of that reality are present throughout the developing world.

The next big issue is the adverse effect of the pandemic on the delivery of health care services. For example, with the extended lockdowns, lasting upwards of three months, we will perhaps see a steep rise in tuberculosis (TB) mortality. It is predicted that 1.4 million people would die over the next five years in addition to the 1.5 million that die every year of TB. This is an incredibly impactful global pandemic and more so in the developing world.

Ed: You have been involved in the Access to Medicines campaigns, as well as in development of drugs and vaccines through Drugs for Neglected Diseases Initiative (DNDI), MSF, Dignitas. How does the COVID response either resemble or differ in terms of what you have been experiencing?

JO:When MSF launched its Access to Essential Medicines Campaign in 1999, the world was a very different place than it is now. We have certainly come a very long way in terms of building a common understanding of global interdependence, and not simply in terms of vulnerability to a particular set of zoonotic diseases like COVID-19, but also in terms of our ability and our willingness to work across sectors, around common objectives. In the late 90s, one of MSF's main roles was to advocate and introduce the concept of equity to global public health thinking, and introduce the concept that treatment is not independent of prevention, as in the case of HIV. 20 years later, the concept of equity today has reached a new salience.

On April 24, 2020, WHO along with its partners, launched the Access to COVID-19 Tools Accelerator, or the ACT Accelerator. This initiative is focused on developing drugs, diagnostics and vaccines around the principle of equitable access to new healthcare technologies. I could not have imagined such an initiative back in 1999. The world really has changed radically over the past two decades. However, there are some key challenges around this ACT Initiative. First is funding and second is governance and an appropriate mechanism for determining which healthcare technologies are appropriately investigated, which ones are supported and when, and where and how access is insured?

Ed: A lot of your work during the HIV epidemic involved getting access to medicines and its distribution, simplification of services and getting healthcare technologies into the most rural environments. Have you been wondering about that in this current climate?

JO: Absolutely. Since we started DNDI, the focus has been on the most neglected diseases, and bringing the best of science and global health policy to bear on those particular diseases. These diseases were neglected because there was not a viable market for the products that could be developed to address them. In the simplest of terms, poor people don't have money, therefore, there is not a lot of money to be made from poor people.

However, in the current situation, the pandemic poses a risk to virtually everyone across the globe. The challenge now is to bring the best of science to bear and include communities in the developing world. It is critical to ensure that the outcome of that scientific enterprise is appropriately targeted to the most vulnerable people in the world.

We don’t have any treatment or vaccines for COVID-19 yet and neither do we know the nature of immunity in its case, and we know there is going to be mutation. This, by definition, is a challenge of the global commons, and it requires a very systematic and targeted strategy.

Ed: What kind of strategic partnerships would you like to see occurring at this time?

JO: The ACT Accelerator initiative by WHO is exactly the kind of partnership that is necessary in this context. It is quite focused on developing appropriate healthcare technologies, drugs, diagnostics and vaccines, and is doing so with a very clear and unequivocal commitment to equitable access to those healthcare technologies.

Ed: How do you envision the health care delivery systems? Should we come up with effective interventions or effective vaccines? In the poorest countries, we always see a shortage of health care workers. Have you been wondering about shifting roles in the context of this pandemic?

JO: The way I think about this is very simple. There is the actual technology itself, and then there is the system for delivery of that technology. To ensure an equitable access, the technology and the system for delivery must match the contextual reality in which it will be delivered. The system itself has to reach to the farthest corners of community. It cannot simply be a highly structured, for example, tertiary care system. It must also be a community-based system. The development of a technology, whether it is a diagnostic drug or vaccine, should be stable enough to be used in the farthest reaches of a society, where the most vulnerable people exist.

These are very simple and almost generic concepts but are fundamental to this idea of equitable access to healthcare technology. To conclude, this is all about wise self-interest. In the sense, that, unless everyone has access to new technologies, everyone is vulnerable to variations and perturbations in the evolution of this pandemic. No single person can ensure its own wellness without considering and being aware of and acting to ensure the wellness of others. So, it is in our self-interest to develop appropriate strategies around equitable access to new healthcare technologies for COVID-19.

Get access to the virtual panel replay by clicking on the button below.

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