Lexitas CEO Jeanne Hecht On Trends and Challenges In Ophthalmology Clinical Trials
Lexitas recently welcomed our new CEO Jeanne Hecht, who has spent her career in leadership and board positions at top healthcare companies. As an industry executive for over 20 years, Jeanne has witnessed massive change in the healthcare industry at large – and is especially excited about the immense opportunities in ophthalmology. She shares her thoughts on current ophthalmology challenges and trends, the important role that pharmaceutical service providers play, and how clinical trials can serve as a care option for patients.
What are the biggest challenges in the ophthalmology industry right now?
One of the biggest challenges the industry is facing is difficulty with fundraising. While the entire global markets are in flux, pharmaceutical companies, including those in ophthalmology, are struggling to raise money, and often encounter longer fundraising timelines or delayed deals.
Clinical trials have also gotten more complicated. Research centers everywhere are short on skilled technicians, clinical research coordinators, and physician researchers, which are crucial for trial success. At the same time, new clinical trial technologies and software options are emerging faster than ever, and teams must constantly assess which tools to bring into their workflows, ignore, or reconsider later on. And yet, despite so many new technologies, ophthalmology companies are still struggling to reliably capture and track trial endpoints – especially as these data points are becoming more complex to define and analyze.
As companies are pressured to move faster, they’re also dealing with financial and resource constraints. This tension compounds challenges that the industry has long dealt with: how to decrease total cost of care and hospitalizations while increasing patient satisfaction. It’s a tricky landscape for pharmaceutical companies to navigate, especially with all these dynamics at play.
What major trends are you seeing in the ophthalmology industry?
The first big trend, which I also highlighted as a challenge, is funding difficulties and long deal cycles. However, there’s some positive news for ophthalmology in particular. Within pharmaceutical development, ophthalmology development is the second fastest growing area, right behind oncology. And year-over-year, the overall ophthalmology industry is growing 7%.
There are a couple of key reasons why ophthalmology is booming, despite the larger macroeconomic downturn. For one, ophthalmology trials don’t experience as many late-stage failures as other therapeutic areas. And, much of our industry’s growth is focused on new product development in large population areas such as ocular allergy and dry eye. Ophthalmology companies are also gaining momentum in the device market, developing products like intraocular lenses, lasers, and more. In fact, about 40% of CRO spend in ophthalmology development is for device R&D.
Another key ophthalmology trend is optimizing workflows at research centers. I mentioned before that many new technologies have emerged in this space. But often, these address only a portion of the trial workflow. Companies are beginning to look at how they can improve the patient’s experience throughout the entire trial – from initially thinking through ideal patient profiles, to actual trial participation. In some cases, companies and development partners are exploring how to bring the trial directly to the patient, whether through hybrid or decentralized trials.
While this new trial model can evolve in many different ways, there’s a huge push towards bringing endpoint assessments to patients’ doors, and leveraging software or technology like virtual reality (VR) to capture these endpoints. Companies are also starting to incorporate real-world data, using this existing evidence as a surrogate endpoint or even to support a new arm of a clinical trial.
What advice do you have for companies conducting trials in the ophthalmology space?
It’s really important for companies to choose a development partner who can oversee the entire trial. This includes providing key CRO services – like imaging – in-house, and integrating with external partners to manage the end-to-end trial in one place. When assessing a CRO, companies should not only look at their services and speciality areas, but also how well they operate – including communication, timelines, project management, and budgeting.
It’s also important that companies sincerely enjoy the CRO they partner with. Afterall, they’ll spend a lot of time together throughout the trial. It’s not always about dollars and cents but about the people on the other side of the CRO who make the experience enjoyable and seamless.
A second tip is to work with a pharmaceutical development partner that focuses on a specific niche or therapeutic area, like ophthalmology. Doing so offers immense value: these experts can provide specialized guidance to a client throughout the entire trial process – including helping them define and refine their investment thesis. Specialized development partners also attract and employ the best talent for their specific niche. In a time where resources and talent are fragmented and difficult to hire, working with experts is one less thing to worry about.
Can you elaborate on your paper on Clinical Research as a Care Option (CRAACO) and the research pioneering this new approach?
Despite a focus on patient care throughout many touchpoints in healthcare, we still lack a patient-first approach to research in the clinical trial world. That’s because many companies are dealing with the so-called “triple aim” challenge – how to decrease cost of care and hospitalizations, while increasing patient satisfaction. As a result, companies often worry that patient-centric trial programs will cost too much, and forgo these initiatives altogether. This “triple aim” has proven very difficult for healthcare systems in the past. But I was curious about a new approach: what if putting patient care first was the answer? This sparked the idea
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