At 2020 On-site, our Industry and Scientific Advisory Board (IASAB) meets quarterly to gather insights, share ideas, and debate critical business concepts that will help identify patient needs, product opportunities, and market challenges associated with the provision of vision-related assessments for clinical trials and safety surveillance.
We recently shared our conversation with board member Dr. Adam Ramsey, OD, and are back this month with a brand new interview, this time with Beth Marsh, IASAB member and Vice President of Sales & Marketing for Ophthalmology at Apellis Pharmaceuticals.
Beth is an experienced commercial marketing and business development executive. She has been a key initial team member in five ophthalmic start-up organizations and has successfully launched several ophthalmic products.
In her new role with Apellis, Beth is leading the build-out of the US Ophthalmology division in advance of a potential product to treat geographic atrophy. Prior to this, Beth was Global Product Strategy Lead for development-stage programs within the Ophthalmology Franchise at Shire/Takeda. She has also held leadership roles for companies such as J&J, Novartis, Santen, and Akorn.
Tell us about yourself - why do you have a passion for innovation in ophthalmology?
Beth: I have spent my entire career in ophthalmology — it’s all I’ve ever done. For the most part, I have worked on the commercial side of the business, including sales, marketing, and development. I’ve also spent some time in business development with both large and small companies, as well as startups. I’ve had my own consulting business for a while where I helped small companies find their next round of funding.
Being on the development side of the business really exposed me to “Understanding areas of unmet needs and matching small companies to larger ones to move development-stage programs forward to help patients.” And that’s a really exciting place to be.
Most recently, prior to my work here at Apellis, I worked for a company called Shire in what was called “Pipeline Commercial Strategy.” So, not working on the development side but working within that pipeline to understand the market for products and what patients will be served by those products.
What other topics within the clinical research space are you passionate about?
Beth: For me, it really is looking beyond just one area. At Apellis, we focus on solutions for retina diseases. My background is both in back of the eye and front of the eye, so what I really like to think about clinical development is, “What is the unmet medical need for patients throughout the eye?”
At 2020 On-Site, we think a lot about retina diseases. I would also like to think that I can bring to the board clinical research solutions for front of the eye diseases as well that have unmet medical needs. We have an opportunity to create medications that will help patients — but we need to get to those patients.
I had the opportunity to read Dr. Ramsey’s conversation with 2020 On-site and his great ideas about diversity; for me, one area of diversity focus should be women. Representation of women within the ophthalmic industry, as eye care professionals, and also female patients in the clinical trials. I’ve spent a lot of time with an organization called OWL: Advancing Diversity (Ophthalmic World Leaders) which is a diversity organization and it really has given me an extra focus on diversity as a whole and women in particular.
What is something specific that Sponsors and CROs can do to start the conversation about diversity, push it forward, or create an action item from the conversation?
Beth: That’s a good question! I think it’s all over the map. The first thing that comes to mind is that these services are available to all different kinds of companies and we really need to open up our thoughts and ideas to answer the question: “Where are those patients and how do we bring those patients in?” No matter what they look like, sound like, act like: “How do we get to them?”
We need to think beyond the urban, busy academic institution that’s currently enrolling patients. It’s really about going TO the patient. COVID-19 put a bright spotlight on continuity of care. We want to make sure that care isn’t interrupted at any time and especially within a clinical trial so we need to get to those patients — which is the essence of everything that 2020 On-site does.
If we go out to see patients, some of that solves itself because we can be intentional in our diversity of patient populations and we’re not waiting to see which patients are present at the clinic. I don’t think we should be limited in thinking about how 2020 On-site’s services can be utilized.
When you think about the future of ophthalmology and the use of decentralized clinical trials, do you see the protocols staying the same and new people coming in that are fitting into those protocols, or do you see a world in which protocols start to get designed differently?
Beth: Companies have to drive this and they’re trying to manage two things: to efficiently create a trial and preserve the integrity of their data. This includes managing and limiting missed visits in order to gain as much data as possible. It’s critical for the companies leading the research to take the lead to change protocols that result in fewer missed visits and better more complete patient care and data collection.
Trials are very expensive and companies need to run efficiently, and they have fewer people to get the work completed. So if they feel like it’s going to take more time or money, that might be more of a challenge, but if they think about how it helps generate more data and creates a more streamlined approach for the patient...that goes a long way. But, you’re probably going to have to bring the sites along a little bit kicking and screaming, I’m guessing.
Jessica Mays (2020 On-site): That was the main takeaway at the conference I just went to!
Beth: Well, think about it! First of all, if you’re the clinical study coordinator, you’re running a lot of studies, you’re really busy. Some do sequential (clinical studies), some do multiple studies at the same time. They are also looking for efficiencies but they also have this down, so anything that comes in that disrupts the status quo could be a potential roadblock to adoption.
You have to think economically, you have to think from a patient perspective, and then think about data collection. But, the industry is will likely need 2020 On-site to provide case studies and examples, “Here’s a company who did it, and here’s how it worked.”
Ophthalmologists are skeptical about how successful they can be on our mobile vision clinics (MVCs). What do you think their biggest worries are about?
Beth: It probably comes down to making sure that they feel that 2020 On-site can fulfill all of the specifications, procedures, and protocols that they have put in place. It’s a pretty rigorous process for a company to choose a particular site for a clinical trial.
They need to understand is how seamlessly [2020 On-site] is fitting into those procedures and protocols that they’ve put in place. I truly think that it’s the responsibility of the companies to help the sites feel they have seamlessly integrated mobile vision clinic into the protocols, “we’ve incorporated this into the protocols,” so you can feel confident. At the end of the day, even though they are clinical trial sites, these physicians are first and foremost managing patients and patient care, so it’s imperative that 2020 On-site help the investigator via the company, knowing that, in fact, patient care is #1 and it’s not being compromised in any way.
What would you say if you were talking to an ophthalmologist today who says, “I think that’s a terrible idea (to put things on a vehicle like an MVC).” What is your counterpoint to the skepticism of why this is something that’s worth talking about?
Beth: We’re all looking right now for what good can come from COVID-19, and one of those things is attention to missed visits and how that compromises care and data collection. It’s challenging for the ophthalmologist and the clinical study team to encourage compliance and adherence. Positioning 2020 On-site with the ophthalmologists as a way to help patients receive the care they need is critical. Better care happens when patients are seen on a regular basis, especially those patients with sight-threatening diseases.
What COVID-19 did is put a fine point on missed visits. As retina specialists have said to me, “We never closed.” During COVID-19, retina care was essential and they never stopped seeing patients. However, the patient’s caregiver may have said, “I don’t feel comfortable taking you to a doctor’s office.” So they had these missed visits, and sometimes missed visits become lost to follow-up and that’s really tragic. I think physicians are thinking that way; they’ve always known that lost patients to follow-ups are an issue and they’ve put mitigations in place, such as calling patients, helping with transportation, etc. And what worked during the pandemic will certainly translate, whether there’s a pandemic or not.
What’s one takeaway or lesson you would want to tell sponsors or CROs when they are starting an ophthalmology clinical trial?
Beth: I would recommend, where possible, clinical trials to mimic real-world experiences - everything from patient selection, diagnosis, and treatment. As a commercial leader, I see the end result of the clinical trial and the applicability of that trial data to the patients who will be best helped.
What topics do you feel are important to discuss at the next board meeting?
Beth: At our last meeting we focused on the back of the eye/retina opportunities, likely due to the number of advisors who are retina specialists. I would like to see 2020 On-site advisors discuss some opportunities for glaucoma trials and anterior segment disease trials. I’ve previously spent a great deal of my career in that space, so, I’d certainly like to talk about that!
Conclusion
If you enjoyed this conversation about clinical trials from Beth’s perspective, subscribe to our newsletter so you can make sure to catch the latest board member interviews! You can also learn more about our entire board and submit a topic or question for our next meeting here.
