Fierce Pharma Sits Down with Ora

Sponsored by: Ora

“My vision for Ora is actually a vision that extends to you and to everyone else: that we help people live in a fully sighted world. That is our North Star. It drives where we invest money, what we do operationally, and the services we provide to our customers. We want to bring products, be them pharmaceutical agents or medical devices, to customers, patients, and research sites,” said Jeanne Hecht, chief executive officer of Ora, Inc.

Hecht recently sat down with Fierce Pharma Publisher Rebecca Willumson to discuss how Ora, the world’s leading full-service ophthalmic research organization, supports their customers and site partners to bring new products to those who have vision-related illnesses. The past year has seen much growth and global expansion at Ora, including increased investment in European operations and the launch of a new office in China. Recent challenges due to COVID-19 are accelerating the creation of virtual trial offerings, as well as novel endpoints and capabilities, to ensure the continuation of ophthalmic clinical trials and new solutions for patients.

For more on Ora’s heritage, values, and innovations in ophthalmology, watch the above video.


Rebecca Willumson: Hello everyone. I'm Rebecca Willumson. I'm the publisher of Fierce Biotech. I'm here today with Jeanne Hecht, CEO of Ora Clinical. Jeanne, thanks so much for joining me today.

Jeanne Hecht: Thank you for having me.

Rebecca Willumson: To kick us off, can you tell us a little bit about Ora? When was it founded? What's your focus? I know you joined Ora as CEO in 2019. Can you tell us about your background and kind of what led you to this position?

Jeanne Hecht: Ora is over 40 years old. We were created by the founder, Dr. Mark Abelson. He is a visionary in the field and had a goal of bringing new products to patients who have vision related illnesses. Dr. Abelson started the company adjacent to his research practice and then it grew to the ophthalmic development research firm that we are today.

Jeanne Hecht: We provide both services, as well as some technologies, specifically in the form of endpoints for ophthalmology diseases and are spanning the US, Europe and Asia. I came to join this amazing company in 2019 as CEO, but actually joined in 2018 as a Board of Directors member. I was one of the members who was supporting the growth and strategic objectives of the organization as a board member, and then was asked to join the company in 2019. My history and my experience is specifically in the pharmaceutical services, pharmaceutical life science space. I spent 16 years at a large contract research organization, also spent some time running a medical imaging organization and then came to Ora in 2019, and I'm so excited to be here. Most of my experience actually prior to joining Ora was in oncology. Coming to the ophthalmology space has been an amazing learning opportunity for me, and is something that just really resonates. I'll probably share more of that as we talk through today.

Rebecca Willumson: What would you say is your vision for the company? What have you accomplished already in your time as CEO and what are you hoping to build in the future?

Jeanne Hecht: My vision for Ora is actually a vision that extends to you and to everyone else. That we help people live in a fully sighted world. That is our North Star. It drives where we invest money, what we do operationally and the services we provide to our customers. We want to bring products, be them pharmaceutical agents or medical devices, to customers, patients, and research sites. What have I been doing to get that vision out there, is specifically focusing on the employees, focusing on the location where we have the employees, focusing on how we can better support our customers, and looking at our R&D and where are we investing our R&D dollars to support the development of new novel endpoints to help ophthalmic products get approved faster, because there are patients who are counting on it.

Jeanne Hecht: We also spent the year launching our core values of clarity, so Customer service, Leadership, Accountability, Results oriented, Innovation, Teamwork, and You. We have a real focus on our employees. It's about building a longstanding organization because with our happy employees and engaged employees, we provide better services to our customers. Some accomplishments outside of launching our core values has been our expansion into China this year. We actually completed our first dry eye program in China and are in the process of establishing our office in China currently. We've also doubled down on our investment and are spending several million dollars in Europe, and looking to ensure that we have the right people in the right roles to support global ophthalmic development services across all of Europe. We've also been focusing on our virtual trial offering. With the coronavirus that hit us, now, we started working on this in 2019, but now that we have this before us, it's about accelerating, working at a faster pace. For us, virtual trial offering isn't just about tech-enabled operations. It's actually about designing end points that could be collected at a patient's home. That is an area where we are spending a lot of time. I'd also like to say that we've commercialized one of our new offerings, our EyeCup, which is a handheld imaging device to take images of the eye and allow that to be done at a patient's home, which is part of our virtual trial offering. When I think about the future, my heart, my mind, is focused on the patients, the research sites, our customers, and most importantly, our patients and our employees. I really want us spending time thinking about the type of people we want to support, both currently and in the future, and making sure that we're creating longstanding relationships and opportunities for people to create really meaningful careers at Ora.

Rebecca Willumson: Talk to me a little bit about how Ora is innovating through technology-enabled operations.

Jeanne Hecht: We do the basic that everyone does, right? We're able to support remote monitoring, risk-based monitoring, that has really helped our clients stay and their projects continue to progress as we worked through the coronavirus situation. We're also focusing on virtual trials. For us in ophthalmology, it's a little bit different than several of the other therapeutic areas, right? Most of us measure improvement and how a product is enhancing a patient's ability or seeing a therapeutic effect by being able to read more lines on that eye chart. We're looking at ways in which we can bring that eye chart home. In addition to that, as I mentioned earlier, we are supporting the EyeCup, which is our medical imaging handheld device, so that patients can take pictures in the home environment of the improvements in redness or debris in their eye.

Jeanne Hecht: We've also been focusing on bringing to our customers and our patients and our research sites, the ability to use telemedicine and have things like e-Informed Consent as well as other supportive items to the overall clinical trial operations. Lastly, but something that I've really been focusing on – and this comes out of some round tables that we had with our ophthalmologist and our research nurses – is focused on transportation, looking at ways which we can use tech-enabled solutions to support bringing patients to their research visit, to their clinical visit, to the clinical site, so that we're able to keep the clinical trials on target from a recruitment and data fidelity perspective. So I would say those are most of the areas. I've also needed a partner in crime, as I say. I hired a Chief Digital Officer, Nazi Haji, who is working alongside me and my Chief Operating Officer, Jim Golando, as well as all of the members within Ora who are supporting these efforts to make sure that we are really keeping technology at the forefront.

Rebecca Willumson: You touched on this a little bit already, but talk to me about your global operations. What do they look like and how does that serve the global ophthalmology market?

Jeanne Hecht: The global ophthalmology market based on sales is $60 billion with the largest market obviously being the United States with almost $30 billion. We have substantial operations here in the United States. But when we look to Europe, which has almost a $14 billion market, we have operations in an office in the UK, so in London. We've got staff scattered across a number of countries across to Europe supporting the delivery of the ophthalmic drug and device development efforts. Lastly, I also mentioned that we have a focus on Asia and I spent several years there in my career, living and working. Asia is about a $7 billion market. For us, it's really important that we've got people there. We've got people in Japan, and we also now have people in China. Last but not least, we also have our operations in Australia where we're supporting our customers' efforts in delivering the clinical trials in Australia.

Rebecca Willumson: I have one final question for you before we close. I think it's one that's probably been on everyone's mind over the past few months. COVID-19 has had a major effect on clinical trials. How is this affecting Ora specifically, and how are you addressing the challenges with your research sites?

Jeanne Hecht: Yeah, that's a great question. When we look at the peak of COVID-19, and I don't think this data is shocking to anyone, about 90% of our sites stopped recruiting. I'm glad to say that now we are down to where it's just a marginal number. Less than 5% of our sites are not recruiting currently for ongoing or future trials, so really, we're back up to operations as normal now.

Jeanne Hecht: We also had a challenge where our research sites, due to many of the stay at home orders, were only allowing remote monitoring visits, which was something easy for us to pivot to. We have the right technology to be able to support that and we've got the right staff to be able to deliver that. Now, it really does differ by region and we had a wonderful round table a couple of weeks ago with about 10 ophthalmologists, and then we had a subsequent round table with almost the same number of research nurses and site directors. In the discussions with all of them, I was very curious and I wanted to help and listen and understand how we could support those businesses staying in operation in order to support the patients. When I think about what we were doing, first, we placed people actually in region.

So you'll hear from some of our upcoming really important research partners, talk about how I allocated staff to go and live in a region for 12 weeks to be able to ensure those clinical trials stayed on track. In addition to that, you'll also hear where we supported many of our research sites with those onsite staff. You'll also hear, as I mentioned earlier, we're focusing on transportation support for our research sites, to bring the patients to the research site, because many of the patients don't want to get on public transportation. They're worried about trains or buses. This is a global effort that we're doing, and this came actually at a specific request from a physician in France.

Jeanne Hecht: We have a team that actually works remotely, and that team focuses on scheduling patients. We have them actually calling patients to prescreen and schedule patients and pre-schedule patients for our physician and research sites, so that when those sites actually reopened, the patient flow was there and we have the patients' visits schedule. So there was a lot of work that we did leading up to the reopening efforts that we've seen of late and that we're continuing to do to support our research sites. Last but not least, many of our research sites requested support with PPE. That's another thing that we've done, is provide PPE to some of our research staff and we'll continue to do so as we move through the next several months.

Rebecca Willumson: I think that's all that I have for you today. Jeanne, thank you so much for joining and thank you for a great conversation.

Jeanne Hecht: Great. Wonderful. Thank you. I really appreciate the opportunity to share the story of Ora and the good work we do.