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Biden’s Executive Order for Studying Women’s Health: How to Not Squander This Opportunity

Given our questionable track record of driving consistent progress, it’s important that we create a roadmap to optimize the success for this exciting moment.

There are innumerable examples of when we have been faced with moments of great opportunity to make progress and failed to meet the moment. Just a few years after the global Covid-19 pandemic, the fast development of life-saving vaccines was juxtaposed against several unsolved problems, such as a growing shortage of healthcare providers, a mental health epidemic, hospital closures and overflowing emergency departments

We now find ourselves at one of those same crossroads. Last month, President Biden signed an executive order aimed at advancing the study of women’s health. This is an initiative largely considered to be long overdue. But, given our questionable track record of driving consistent progress, it’s important that – as a nation and an industry – we create a roadmap to optimize the success for this exciting moment.

Inclusion is paramount 

When it comes to research into the issues affecting women, we must look comprehensively across all demographics. Historically, certain groups have been left out of research, which means we do not always have enough data to give us an accurate picture. For example, when it comes to clinical trials, nearly 75% of participants are white. With nearly 40% of the U.S. population belonging to a racial or ethnic minority, that statistic shows clinical trial participation – one small piece of the system-wide problem – is not at all representative. 

But it’s not just participants, or patients. The people delivering care, running clinical trial sites and making the decisions are not representative either. Research shows that physician race influences the race of the clinical trial participants, and trial leadership by minority physicians is well below that observed among white physicians, especially in FDA-regulated clinical trials funded by industry. It is nearly impossible to ensure all clinical research is diverse, equitable, and inclusive, if those characteristics aren’t prioritized in the leadership roles conducting the studies themselves. 

To address racial disparities among clinical investigators, major changes must be both implemented and monitored. This is not limited to strategies, policies, incentives, and reforms. We know that trust is essential to the success of population health, and minority patients benefit from being cared for by minority doctors. 

As we look to this exciting opportunity in front of us, we have to ensure that future research considers all impacted groups so that we can determine needs accordingly. 

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Intentional design should be prioritized 

Healthcare is complex. So many times, we have seen the development of a new, exciting tool aimed at solving one of the many problems facing the larger system, only to watch it fail. This results in a waste of time, money, resources and productivity. That’s why it is so important to build solutions around clearly-identified needs, audiences and where there is a system in place to support them. 

We don’t need to start from scratch; there are already outstanding examples of companies questioning whose voices are missing from the design process, and demonstrating how to be more intentionally inclusive. For example, in 2021, a global medical technology company launched a first-of-its-kind project aimed at capturing more insights about the experiences of people of color in order to identify ways the company can better support communities that aren’t getting relevant care due to mistrust, social determinants of care, inconsistent access to health insurance, biases, lower income and other factors. They will use those insights to design tools that support Philips’ goal of improving access to care for 400 million people per year in underserved communities by 2030.

A strong foundation supporting strategic innovation needs to be in place now 

The President’s executive order promises billions of dollars in new funding for women’s health research. The findings of that research will help identify needs and gaps in women’s healthcare, and solutions to address those gaps will inevitably emerge. But without a solid foundation that ensures those solutions are adopted across the system – e.g., by physicians – they will fail to drive change. We must start fortifying that foundation now to ensure inclusion and intentional design are a natural part of any future development, and that there is a clear pathway to get those developments into the hands of the women who need them. 

First, we need to ensure that we have a way to support female innovators. It’s well-documented that much of the innovation in women’s healthcare has been spearheaded by women founders, yet these entrepreneurs face significant hurdles — from obtaining venture capital to navigating a predominantly male-driven business ecosystem.

Second, companies that are focused on designing solutions must prioritize the infrastructure needed to get those solutions into the hands of the people who need them. More than 30% of all drugs launched in recent years have failed to meet market expectations. That staggering data point demonstrates just how important it is for companies and organizations that set out to address a healthcare problem to have a solid plan in place to get that solution into the hands of the people who need it. 

For example, a focused and inclusive approach to market research can significantly enhance the effectiveness of marketing strategies, ensuring a successful launch and long-term success of a drug, digital tool or therapy in a competitive market. If companies simply look to their own networks to gather insights about a perceived problem and neglect to collect feedback from a broader community of healthcare professionals, when it comes time for those professionals to prescribe that new therapy, you may learn – too late – that they already have an effective solution. Building a strong foundation begins long before any solution is designed, yet it is critical to its future success. 

Third, we need to redefine the patient experience and address access and diversity challenges in healthcare. Innovations – e.g., drugs, digital health solutions – can have varied responses across ethnic groups, so it’s critical to put structures in place to ensure the right people are part of the design and trial processes. Without the collection of this data and input from all populations, that innovation may not even make it through regulations.  

Looking ahead, there are many reasons to be optimistic and hopeful about our ability to start closing the healthcare gaps; President Biden’s executive order is one of them. The real evidence will be in our ability to take the right steps – and include all the right stakeholders – along the way.

Photo: Malte Mueller, Getty Images

Shelli Pavone is President and Co-founder of Inlightened. She has more than 20 years of commercial experience in healthcare and is dedicated to partnering with clinicians and innovators alike to help shape the future of the industry. Shelli was named a Forbes‘ Next 1000 and is a graduate of The Ohio State University, with a BS in Psychology.

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