Opinion: Brain Health Matters; We Must Not Lose Momentum
08 Jan 2024
Drug ApprovalExecutive Change
Pictured: Conceptual drawing of the right and left sides of the brain/iStock, Warrenrandalcarr
The brain and its cognitive abilities shape our human experience. They give us our ability to function, to think, to feel. While CNS drug discovery is challenging, we are seeing momentum in scientific and treatment breakthroughs, and the need for solutions has never been greater.
The World Health Organization estimates that one in three people will develop a neurological condition in their lifetime. Data show that in the U.S. alone, neurological diseases are a leading cause of disability, costing the health system more than $800 billion per year, and this is only expected to increase.
As CEO of a biopharmaceutical company committed to better brain health, I am encouraged by recent progress and see tremendous potential to help millions of people. I believe we can harness recent momentum into a watershed period of innovation for patients, but it will only happen if we foster investment in R&D, continue to advance novel treatments that address what matters most to patients and drive collaboration across the ecosystem.
Barry Greene
Increased Capital and R&D
Over the last 30 years, we have made key advances, such as using medical imaging to visualize the brain and its structure and the discovery of neural plasticity and genetic mutations responsible for certain conditions. This greater scientific understanding is fueling new trends in drug discovery.
According to the Morningstar Global Brain Health Innovation Index, the number of neurology drug candidates increased by nearly 50% between 2011 and 2022. In parallel, investments in neuroscience-focused companies increased significantly from $299 million in 2012 to $1.67 billion in 2022. Importantly, we are also seeing more approvals and breakthrough treatments. Together, these factors signal that as a research community and industry, we are shifting from intermittent to incremental progress. We need to continue these encouraging trends in R&D and capital allocation to make greater progress. And of course, we’ll see how the IRA affects incentives.
While this progress is encouraging, critical gaps in areas of significant need remain. Take cognitive disorders associated with neurodegenerative diseases, for example. The effects of cognitive impairment can have a dramatic influence on daily life and are a main driver of disability in certain neurodegenerative disorders. Despite the burden, there are few R&D programs focused on addressing the cognitive aspects of these diseases. Cognition is an area of research on which our company, Sage Therapeutics, is focused. We see the potential to make a positive impact by helping these communities.
It’s also important that we continually pioneer new approaches to treat brain health conditions that may be underserved by the current landscape, but where the needs are equally high for patients.
A Catalyst for Change
Last year, we saw an important innovation in treating postpartum depression (PPD) when the FDA approved Sage and Biogen’s Zurzuvae, the first and only oral treatment option specifically for this disease. While this new treatment can bring hope for many women and families, the approval also helped bring national attention to recognizing PPD as a serious medical condition. PPD is different from the “baby blues” and is driven by biologic issues and not moral failings.
The awareness of the challenges women face—stigma, the burden of untreated PPD symptoms and inconsistent standards of care—has energized communities and stakeholders across the ecosystem. That energy is turning into a movement, with actions to address systemic gaps and prioritize maternal mental health through better policies and healthcare standards to support screening, diagnosis and access to treatment for women. In fact, the American College of Obstetricians and Gynecologists recently updated its guidelines for PPD screening and treatment.
PPD is just one example of a need that was not being widely prioritized. The response to this breakthrough treatment speaks to the potential impact we can have by championing underserved patient populations.
What we learned in PPD can be applied to other brain health conditions. Innovation in neuroscience is driven by a demand for effective treatments, and I hope it will be a catalyst for even greater change and inspiration for other communities.
Collaboration is Key
Many advances in science and medicine do not happen singularly but through collaboration. Traditional M&A, partnerships and licensing deals between large pharmaceutical companies and small to midsize biotechs are a longstanding model. Collaborations can be a win-win scenario when they leverage complementary capabilities to advance new treatments for patients.
With the J.P. Morgan Healthcare Conference once again upon us, it’s a natural time to reflect on dealmaking. In fact, according to IQVIA, deals in neurology have been among the top areas of focus in recent years. In 2022, neurology deals were among the highest areas for dealmaking of any therapeutic area, and 2023 concluded with a couple of blockbusters.
As FTC deal scrutiny continues (and we see how the IRA further plays out), there will be some headwinds on the horizon. Despite these, we need collaboration to continue so we can collectively meet the brain health challenges in front of us.
And collaboration goes beyond dealmaking. It includes fostering dialogue and continued education to ensure that our ecosystem—from healthcare practitioners to regulators to payors to policymakers—evolves at pace with innovation and biologic understanding. In coming together, we can better sustain momentum in brain health and deliver for patients.
Looking to the year ahead and beyond, our call to action for continued investment, new solutions and collaboration remains clear. The stakes are high. The challenges are complex. What we do next will shape the future of brain health. We must work together like people’s lives depend on it—because they do. And I believe that if we forge ahead with urgency and focus, we will usher in a pivotal era of better brain health for millions of people.
Our global economy certainly needs better solutions and patients are waiting!
Barry Greene is CEO of Sage Therapeutics and has more than 30 years of biopharmaceutical industry experience. Prior to joining Sage, he served as president of Alnylam Pharmaceuticals, Inc. Barry is a member of the board of the Pharmaceutical Research and Manufacturers of America (PhRMA).
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