Key takeaways from an important conversation about IRD research

On October 18th, 2024 20/20 Onsite, Sano Genetics, and Clinical Enrollment announced the launch of a new partnership to offer a comprehensive solution for identifying and screening potential participants for Inherited Retinal Disease (IRD) clinical trials. (Read more here.)

Sonali Bloom, CEO of 20/20 Onsite, Bryan Manning, Founder and CEO of Clinical Enrollment, and Lindsey Wahlstrom-Edwards, Head of Patient Engagement and Strategic Partnerships for Sano Genetics, participated in a panel discussion led by Jessica McKenzie Mays, Vice President, Life Sciences for 20/20 Onsite about the partnership and why it benefits participants and sponsors. Here are the takeaways:

Jess Mays (JM): In one sentence, please tell us what your company does.

Sonali Bloom (SB): 20/20 Onsite is expanding access to eye care and clinical research by bringing eye assessments directly to the point of need for patients, sponsors, CROs, and sites.

Bryan Manning (BM): Clinical Enrollment is a full-service patient recruitment firm. Before founding Clinical Enrollment I launched and ran the IRD-focused organization Two Blind Brothers through which my brother, Brad, and I have donated millions of dollars to research.

Lindsey Wahlstrom-Edwards (LW): Sano combines genetic testing, recruitment, and long-term engagement in one platform, accelerating enrollment and simplifying operations for precision medicine teams driving breakthroughs for patients.

JM: Thank you! Part of this concept was born out of work 20/20 Onsite has been conducting for the last few years in unique patient recruitment and pre-screening initiatives in IRD. Sonali, can you talk about that work?

SB: Our work came out of a want to better identify patients sooner, and our model offers a unique alignment of what’s best for the sponsor, trial design, and the patient. We push the boundaries on what was possible by creating a standalone patient screening protocol can be doing work before sites are up and running to shorten recruitment timelines once sites are ready to receive patients.

Then, we bring a spectrum of eye care professionals and advanced testing equipment into the project - not just ophthalmologists, who are a resource in very short supply! We also involve and can deploy optometrists and ophthalmic technicians.

And the model is working. We see patient satisfaction and dedication to the study spike after driveway treatment. We knew there was something here we needed to make more accessible to others who want the same results, meaning a significant number of patients pre-qualified before the study opened for enrollment.

JM: Bryan, we knew when conceiving this idea that patient identification is key. Of course, there’s the “tried and true” method of combing EHRs, but Clinical Enrollment knows there’s a better way. Can you discuss your model at Clinical Enrollment and why it works?

BM: First of all I come to this work with a very unique perspective - that of a patient. I myself have Stargardt’s disease and so when I think about recruitment I always do so in consideration of how I myself would want to be treated. To reach the patients that we all need for these trials, we have to start by meeting them where they are. Clinical sites do a great job of bringing in the patients in their network, but in a world where we are running five times as many clinical trials compared to just five years ago, those lists are simply over-taxed and we all know not properly representative of the populations we aim to treat.

These patients all live and interact on the internet and we can use geo-targeting and algorithm based advertising to speak directly to them. We use story driven content to stand out and begin to tell the story of hope for a better future. From there we treat patients the way that I’d want to be treated - with all the education needed to make informed decisions and a concierge representative to personally walk them through every step of the process.The results are accelerated enrollment, more patients from more diverse backgrounds, lower screen fail rates, and greater retention.

JM: Lindsey, obviously in certain disease states the genetic markers are key for patient inclusion and exclusion. What Sano does is go beyond a simple yes/no both in the initial identification of potential patients and through follow-up. What does this look like?

LW: At Sano, we aim to improve access to genetic testing to understand treatment and research opportunities. There’s a big opportunity to innovate in precision medicine. We are seeing a shift in how drugs are made, like what we saw in oncology, and we need to ensure everyone has access. Drugs that are developed using genetic information are two to three times more likely to succeed in trials. Medicines are being developed with 80% of data coming from a subset of population that makes up just 16% of the global population. And that’s a problem. 70% of potential participants in the US live 2 or more hours away from a major medical center. That’s another problem. What are our data missing? There is a big opportunity to grow and contribute to the advancement of science, but also ways to do that better and more inclusively for our participants.

And with opportunity comes responsibility. We take that seriously. Getting people ready for genetic testing means ensuring they understand what information they will or may receive - including primary diagnoses and secondary findings - and the implications of being in possession of that information. Genetic counseling is a key piece of the process, as is genetic education. But there is a shortage of counselors in this country, one that will be exacerbated as precision medicine research and approvals continue to grow. We are testing new methods of giving all participants baseline information about genetic testing before a counseling visit, which has shown some exciting results both in terms of participant satisfaction and average duration of a counseling session. Through online educational modules co-designed with a genetic counselor we have been able to cut the average counseling session length in half, which has the potential to nearly double the capacity of the workforce.

JM: Bryan, Sonali, and Lindsey: When you think about why this three-part partnership is essential, what’s the one thing you feel is most important to highlight?

BM: When it comes to getting treatments and cures to patients, minutes matter. Patients like me will never not want to hear about trials that can benefit them and their care. And, on the human side, through this partnership patients will be treated with the education, care, and humanity they deserve. This solution will save your trials time, money, and ultimately get your treatments into the hands of patients like me.

LW: We talk a lot about diversity and the term is often used to imply racial and ethnic diversity. What I love about this solution is that we can address those aspects of diversity while also addressing diversity that comes with urban/rural disparities, socioeconomic disparities, and the needs of people who are differently abled. The partnership reduces participant burden which helps participants get access to potentially life-altering treatments while also improving diversity – in the broad sense of the term – in your cohorts while also shortening screening timelines.

SB: When a patient walks into the ophthalmology office for a clinical trial, the best way to ensure an effective execution of that trial is for that patient to be as thoroughly pre-qualified as possible. This meaningfully accelerates enrollment.Imagine if half of your IRD trial was enrolled before the first site even started enrollment? That is the impact we can have by bringing assessments directly to patients at their point of need.

We eliminate the access barriers - getting to rural areas, communities that don’t have easy access to assessments, and eye care deserts. There is a huge benefit to sponsors and CROs, like Lindsey said, through materially faster enrollment and a more diverse participant pool. And there is a great human benefit in that patients who lack access to care and have challenges including low vision can more easily participate in a trial. It’s a win, win

Would this partnership help to further your 2025 goals? If so, please get in touch below!