In this episode of the Clinical Trials Spotlight, Andrew Pucker, OD, PhD, FAAO, talks with Tomi Luan, OD, PhD, about her career in ophthalmic drug development and the evolving landscape of clinical research. They discuss the challenges and opportunities of bringing new treatments to market, the importance of collaboration and innovation, and advice for clinicians interested in exploring careers in the industry.
Andrew Pucker, OD, PhD, FAAO:
Welcome to Clinical Trials Spotlight, the podcast where innovation, research, and patient care comes into focus. I’m Andrew Pucker, Chief Development Officer at Mintra Health, and your host for this series exploring the latest developments in optometry and ophthalmology clinical trials. Each episode, we’ll sit down with leading clinicians, researchers, industry experts, and innovators shaping the future of eyecare. From emerging innovations in study design, patient outcomes, and regulatory insights, we’ll take you behind the scenes of the clinical research transforming optometry and ophthalmology.
Whether you’re a clinician, researcher, industry professional, or simply passionate about advancing vision science, this podcast is designed to bring you thoughtful conversations and practical insights from across the ophthalmology and optometry community. Clinical Trials Spotlight is co-produced by Mintra Health and Ophthalmology 360 and Optometry 360. Thank you for joining us. Let’s get started.
In today’s episode, we’re joined by clinical research leader Tomi Luan, OD, PhD. She brings extensive experience in guiding therapeutic programs from early development through clinical trials and towards commercialization. As a representative of the sponsor side of the industry, Tomi has a unique perspective on the complex journey of bringing a new drug to market. Tomi, thanks for being here. Could you please introduce yourself today?
Tomi Luan, OD, PhD:
Hi, Andrew. Thanks for having me. I am an optometrist and PhD-trained in glaucoma basic research. I’ve been in industry since 2000, I think. It’s been about … more than 25 years now with small companies, larger companies, mainly in ophthalmology, glaucoma, front of the eye. I’ve also done some other clinical development work with regards to work on getting a weight loss medication launch as well as a type 1 diabetes cell-based therapy that wasn’t launched, but it was very exciting to work on it.
Andrew Pucker, OD, PhD, FAAO:
That’s awesome. You have a great and very vast background. What are you working on today?
Tomi Luan, OD, PhD:
Yeah, so I am Senior Vice President of Clinical Development with Claris Biotherapeutics. It is a biotech company where we have a growth factor and our focus is all front of the eye, cornea. We’re focused on cornea. Currently, looking to identify a treatment for limbal stem cell deficiency where there’s a high unmet need and there’s no FDA-approved drug right now. Patients are usually treated with palliative care. Then once it gets very advanced, they go on and get corneal limbal stem cell transplants, which with itself has a lot of concerns. We’re hoping to come in and provide early intervention and help with this much needed population.
Andrew Pucker, OD, PhD, FAAO:
It sounds exciting. It also sounds challenging. I’m sure you learned a lot at this company and with all the other things you’ve worked on, but what kind of initially got you into drug development? What was your inspiration? How’d you make the jump?
Tomi Luan, OD, PhD:
Yeah, so I graduated from SUNY Optometry and then immediately after graduation did a residency at the West LA VA focusing on outlet disease and geriatrics. But really what spurred me on was I grew up in Rochester, New York and Bausch + Lomb was in my backyard. I remember after the first year of optometry school, just knocking on their door and saying, “Hey, can you use an intern?” There I was, and that’s when it opened my eyes to realize optometrists, we could do more than eye exams and refractions and prescribe. I could actually work in a bigger project, I guess, where you’re looking to identify new drugs or new therapies to help with these patients. That’s really what launched my career. After I finished my residency, I joined Vistakon as a research optometrist working on contact lenses for about a year. Then I transitioned over to Alcon and that’s where I got into drug development.
Andrew Pucker, OD, PhD, FAAO:
I think you got in much earlier than most clinicians, so that’s awesome. How’d you get your foot in the door? I always like to get people’s initial entry into industry because that’s one of the biggest sticking points for people.
Tomi Luan, OD, PhD:
Well, I think, like I said, it was an internship that opened my eyes to these kinds of opportunities. Then I remember my last day of residency, there was a fax that came through from Vistakon indicating they needed a research optometrist and I just applied and I really had no experience at all, but her name is Sheila Hickson-Curran and Tim Poling. They were the ones at Vistakon at that time, flew me in for an interview and just saw potential in me and gave me that opportunity. But I think that was very fortunate that it happened to me.
But I think for other optometrists who want to get into industry, talk to people in your network who are already doing it already, like Andrew and myself. I mean, there’s a lot of things you can do. It’s not just drug development. It could be pharmacovigilance where they need expertise from optometrists. Something in the safety group, medical science liaisons, that’s also … That’s once a product is approved or a company is close to launching a product, they utilize folks like us with a scientific background, clinical background to go talk to doctors about the science. I think in short, just talk to people that you know are already in industry and really that’s how you can probably get in.
Andrew Pucker, OD, PhD, FAAO:
That’s great. It sounds like timing, you need to know some people. I love that advice. I actually work with Sheila now through the American Academy of Optometry. We’re helping with some research diplomates, which is a cool program that I’ve been involved with.
Tomi Luan, OD, PhD:
Wow, small world.
Andrew Pucker, OD, PhD, FAAO:
Yeah. All right. Well, let’s kind of get into today’s topic. Most people think about a clinical trial where they’re seeing patients in their practice or that sort of thing. What does the industry side look like? What are the sponsor’s motivations? What are they thinking about when they want to bring a new drug to market?
Tomi Luan, OD, PhD:
Right, Andrew. When you mentioned most doctors, when they think of clinical trials, they think about patients because they really are the key partners in order to recruit for a study. Without patients, you wouldn’t have a clinical study. The investigators on our study, they’re super important to the success of any program. But from a biotech or a pharmaceutical company, well, first you would assess what’s the unmet need? Is there a need out there for a product? It’s always nice when you have that need and it goes hand in hand that you have a compound that has a mechanism of action that is well-suited for a specific indication where there is a need. That’s where we focus on. You’ll see that larger companies, they are pretty broad. They have retina, front of the eye, back of the eye. Smaller companies are usually very focused. In our case, we’re talking about cornea. But yeah, I think it’s just looking for what the need is out there, how we can step in to fill that gap, to provide an additional tool for doctors to treat their patients.
Andrew Pucker, OD, PhD, FAAO:
I think the need is really an important point. We need to have a patient group that benefit from it, but also we need to, I think, demonstrate to the community that there’s a need because I’m sure you have to raise funds to keep your program going. Is that right?
Tomi Luan, OD, PhD:
Absolutely. Yes. Without money, you would not be able to run a clinical study because it’s extremely important. For a lot of companies, they raise funds based on even preclinical data, which means data on animals, for example. Then for some companies, they’re fortunate enough to be able to do exploratory or proof-of-concept study to get some data in humans and that would escalate the level of evidence.
Andrew Pucker, OD, PhD, FAAO:
It sounds like one of the biggest responsibilities for a company is one to first go get the question, is there the right patient population? Then it’s, I need to get money to do this study. What other big responsibilities does a sponsor typically need to consider?
Tomi Luan, OD, PhD:
I would actually say the first thing would be that they have a compound, like a potential drug. Once you have that, then you decide what indication could this drug and looking at its mechanism of action, what it’s suited for. That’s probably the first thing is the drug itself.
Well, then you also need to, as a company, bring on talent in order to execute a study. It does not take one, it actually takes a village. Some companies are smaller, but yet they’ll partner with a CRO, a clinical research organization to execute the studies. Others have their own set of talent within and expertise. That includes study managers who oversee the study, data managers, depending on different aspects of the study, like visual acuity specialists, imaging specialists, you have program managers. It really takes a lot, writers to draft a protocol.
Also I would say one of the key things is relationships with the thought leaders out there because that’s where the brain trust is. All these doctors that know what’s needed, the intricacies of the disease. As a company, we’re looking to say, “We’ve got this drug; this is a good indication for it. What assessments would we need and what endpoints to look at in order to generate data to demonstrate that the drug is safe and efficacious in this population?” That’s the bottom line is what FDA is looking for.
Andrew Pucker, OD, PhD, FAAO:
I think there’s a couple of key points I want to hit on. I think it is interesting that a lot of companies come up with a new compound and they don’t even know what indication it might work for. It could be a corneal disease or sometimes you might even use the same medication compound for retinal disease. They might have multiple paths towards a product and you need to first sort that out. Then also it really takes a village to get this work done. You may have a small company, you could outsource a lot of that to a CRO or you may build your own team, which I think you’ve been doing. What do you think works best or is it just different for every company or you’ve kind of seen it all?
Tomi Luan, OD, PhD:
Yeah, in terms of bringing it in-house and building an internal team or outsourcing, I think it just depends on the company. I mean, the best world is if you have funding and you have the finance to do it would be to bring it internally. Because you bring it internally, you have more control over timing, quality is important, ownership. Naturally, if you’re part of a company, you’re just more motivated to help that program succeed. Whereas if you’re farming it out, that’s not to say that the CROs are not also looking to be successful, but they have a lot on their plate. They have other clients that they’re working on as well. For me, I think bringing it internally is the best option to move swiftly and in a quality manner.
Andrew Pucker, OD, PhD, FAAO:
Yeah, I think that makes a lot of sense. It’s really going to be company-dependent, bandwidth-dependent, all those sort of things. Going along those lines, you got into the business a little while ago. Kind of thinking back, what misconceptions that you may have learned along the way about industry or things that you think that people don’t understand that you’d like them to know more about?
Tomi Luan, OD, PhD:
That’s a tough question, Andrew. Misconceptions, I don’t know if it’s a misconception, but you see that some drugs get approved and they’re really expensive. They’re very costly. People tend to think, “Oh, pharmaceutical companies making a lot of money.” They probably do, but still you need to consider the cost of development. I mean to run a clinical study and there are risk to it because I think what I heard is maybe 80% of studies do not meet their endpoints and studies cost millions of dollars to execute, even smaller ones. I think overall it is a huge financial responsibility. It’s a huge responsibility on a company because there’s a lot of risk. We’re all in it because ultimately what we want to do is provide innovation, come with new drug, and if everyone is risk averse, we wouldn’t have any of that for our patients.
Andrew Pucker, OD, PhD, FAAO:
Yeah, I think not everyone understands the cost that goes into developing a drug. We just mentioned it takes a whole village, so you’re paying a whole village worth of people’s salaries potentially for a decade to bring something to market. That I think is a huge cost-driver for these products and companies unfortunately do need to recoup their money and be profitable and all that. In a perfect world, everything would be free, but that’s just not how things work these days.
Tomi Luan, OD, PhD:
I think maybe another misconception is people may think, oh, it only takes a period of months or years, just the duration it takes. But our study that is planned, it’s a 6-month readout, but it’s a 2-year follow-up. FDA requires not just for you to demonstrate the efficacious, but how safe it is. They sometimes require longer follow-ups and every subject visit just adds up to that amount.
Andrew Pucker, OD, PhD, FAAO:
Even dry eye, which I think is one of the faster programs, you still need to have a year follow-up on those subjects, at least in 1 study. Long-term studies such as gene therapy, those have to be 5 years. That’s 1 study. After you do your maybe initial study, like your phase 1/2, something like that, that takes you a couple of years, and then you need to do this 5-year study, and then maybe you can get a special program through the FDA where you can sell that drug a little early, but still it takes a long time to bring a drug to market, even a contact lens. We kind of hit on this a little bit, but what do you think you need to see in a new compound that makes it scientifically worthy to move forward as a drug potentially?
Tomi Luan, OD, PhD:
Well, I think the first thing in my mind, and I’m not in the early development piece, but to me, safety is always important. You want to demonstrate that it is as safe as it can be in animals before getting into humans. Then certainly you have to have a mechanism of action of some sort, whether it’s for the eyes, I guess anti-inflammatory is a big one, or anti-fibrosis or for glaucoma drugs that it is effective in lowering IOP. Since I talked about glaucoma, there’s lots of medications out there. There’s a lot in our toolbox.
The other thing to consider is the competition out there. What’s already out there and can you be superior to that product or minimally non-inferior? You have to consider what’s currently available as well. We’re working on limbal cell deficiency where there is not an FDA treatment right now. We’re first out, I would say. There’s a lot to learn in that as well, just to learn endpoints and even the patient population.
Andrew Pucker, OD, PhD, FAAO:
I think safety is a really key point, especially in vision care. In a cancer trial, people are potentially going to die from cancer and you have a greater risk tolerance, like you’re okay with bad side effects, potentially conditions that would pop up that you really wouldn’t want, but in the end, maybe you’re less likely to die from that. But in vision care, let’s take glaucoma as an example. We don’t want a drug that’s going to make you go blind because we’re trying to prevent blindness. Generally, eye care drugs need to be super, super safe and safety in, as we said, ophthalmology I think is key.
Tomi Luan, OD, PhD:
I think also tolerability because the eye, I think it’s the most innervated organ in the body. Is that correct, Andrew? We’re not used to having anything that would even sting a little bit. I mean, there are some drugs out there that do sting a little bit when you put it on, but for the most part, we are so intolerant to that in the ophthalmology world.
Andrew Pucker, OD, PhD, FAAO:
Yeah, the cornea is the most highly innervated tissue, at least one of the most highly innervated tissues, and you’re very sensitive to that. If you had a contact lens that made your eye burn all day, you’d never wear that. There’s no point in developing that contact. You just mentioned that you’re developing a totally new compound. What is the sequence of events that you would see? You decide that we want to move this drug forward. What does an early clinical development look like maybe through approval?
Tomi Luan, OD, PhD:
Sure. Not necessarily even about the program I’m working on, but typically for a clinical development program, you would start with a PK study in healthy volunteers because you want to understand the systemic absorption and just the pharmacokinetics and pharmacodynamics in the body. You usually do that in a phase 1 facility where you lock people in for a week or 2, and they’re very carefully monitored for safety, and we just do a lot of … A serial blood draw on those patients to understand that. That’s a PK study.
Then you may move into a phase 1/2 study, which is a smaller study where you’re trying to understand. In that study, it would be in your patient population. With glaucoma, it would be glaucoma patients trying to understand the efficacy of it. Also, again, safety. How safe is it in this population? Is it lowering IOP? That’s in a smaller group. It may not even be a randomized control trial, could just be an open-label exploratory trial to better understand. You may also do dose ranging to understand what’s the optimum dose, the optimum and safe dose.
Then once you have your phase 1/2 studies done and you have a pretty high level of confidence that the drug does have an efficacy signal safe enough, then you would expand it to a pivotal or randomized controlled trial, a phase 3 trial, a regulatory trial. Those are the same terms, and this is typically negotiated with FDA ahead of time to let them know what your plan is in order to secure the data that’s needed to support the safety and efficacy for an NDA, which is a new drug application.
Usually, the FDA has required 2 of those, like 2 well-controlled randomized controlled trials. I think lately I’ve been reading some papers floating around that they may accept 1 single trial. I think sponsors are looking into that as well. But yeah, so once you have the pivotal trials, that supports your new drug application. You may also need to do safety studies because FDA requires, for typical programs, at least 300 subjects that are exposed to the drug at the concentration and at the dosing concentration that is going to market. It may not be in your subject population. Like ours, this limbal stem cell, it would take us so long to get that data. FDA may allow a surrogate disease condition, and that means you have to do a safety study, a large safety study in order to get all those numbers.
Then once or when drugs are close to being approval, sponsors typically work with the key opinion leaders out there to get real world data. You’ll call it phase 4 or post-marketing studies or investigator-initiated trials to learn more about this drug usage potentially in a different population that it wasn’t approved for. I think that’s it, phase 1 through 4.
Andrew Pucker, OD, PhD, FAAO:
I think that’s a good point. You’re right, Tomi, things are evolving at the FDA. Your indication matters a lot. You kind of laid out the more typical path. If you have a really rare condition, there’s only 200 people with these in the world, maybe you can negotiate with the FDA to where you only need to see 10 people for the pivotal trial. That’s a possibility. Then yeah, you’re right. In the winter, the FDA changed their stance and now a single pivotal trial actually is an option. I have an article coming out on that in a month or 2, which I’m happy to send you, but it kind of goes through the theoretical framework for making a pivotal trial that only has 1 study and it could potentially lead to approval in dry eye. I think it’s an interesting thing because to still meet the draft guidance, for example, for dry eye, you need to have 800 to 1,000 subjects in your single pivotal trial. Is that feasible? It’s a debated topic, but I think there is a push towards making things more streamlined.
Tomi Luan, OD, PhD:
Yeah, I look forward to having that available and reading that, Andrew. But to my knowledge, I don’t think there’s been any program that’s undergone that 1 study successfully yet.
Andrew Pucker, OD, PhD, FAAO:
Not in dry eye that I know of for sure. Though if you have a rare condition, you might be able to get away, say, gene therapy with a little bit of finessing with the FDA. But yeah, that’s very debatable. Okay, so you’ve kind of seen it all. What are some of the biggest challenges along that pathway that you’ve seen? Maybe is it drug delay or what have you seen as issues?
Tomi Luan, OD, PhD:
I think enrollment is probably the top barrier that I would think for any clinical trial because sponsors want to get these studies quickly recruited and completed because every day that passes, and I don’t know the numbers, but there’s a lot of money, a lot of money on the table to execute a study, as I mentioned. Every day that you’re running this trial, and if you can’t enroll quickly, that’s money that’s being spent.
I think obviously there are indications that are easier to recruit for, maybe glaucoma and dry eye, but I’ve worked on glaucoma studies where it’s the second, maybe largest population of patients that are the prevalence, I guess a high prevalence, but yet there’s still a challenge is because there are inclusion/exclusions that are built into a protocol. You just can’t enroll anybody with glaucoma. They have to meet specific eligibility criteria. In order to do that, you weed out a lot of patients as well. To find the right patients for the studies and that meet the criteria, it takes time and it could sometimes. I mean, there’s studies that they just can’t enroll, so then they can’t complete their studies. That has happened.
Andrew Pucker, OD, PhD, FAAO:
Yeah, that definitely happens. That’s one of my main jobs at the CRO is to look at the inclusion/exclusion criteria to say if we can do this or not. Sometimes you go after this very specific subject. They’re maybe the perfect person for your mechanism of action, but you can’t find them. There’s 2 in the world and that’s a killer.
Tomi Luan, OD, PhD:
Yeah. I think the goal is to obviously find the appropriate population, but you also want to consider clinical heterogeneity of a real-world setting, just like you said. Patients with glaucoma typically are older and they have other comorbidities, and if you exclude glaucoma patients with say cataracts, for example, you’re going to exclude a lot of patients. We have to just thoughtfully think through what is acceptable and exclude those that absolutely, that would confound the outcomes potentially.
Andrew Pucker, OD, PhD, FAAO:
I think that’s a great point. You’re kind of linking it to real world. You have this drug and maybe your inclusion criteria are really tight, and then you get an approval, and then the drug makes it to the real world, and then no one seems to think it works, and that’s because they’re prescribing it maybe just to any glaucoma patient in our example here. But we have a trial that had these super strict criteria, and that might be bad for a company too. Is that true? You get it approved and then you don’t sell anything?
Tomi Luan, OD, PhD:
Yeah, you have to consider the label. That’s a key thing. If you are enrolling such a niche population, FDA may give you a label that’s very limited. When you have a limited label, then it’s not going to be reimbursed ultimately, and then therefore patients can’t access it. I think that’s probably top of mind for companies is what label you’re going to get and what kind of reimbursement.
Andrew Pucker, OD, PhD, FAAO:
You’ve had a lot of probably accomplishments in your career. What are some of the most rewarding things that you’ve been involved in?
Tomi Luan, OD, PhD:
I would say the most rewarding thing would be interacting with various leaders in the field. It centers around people, the doctors that I’ve worked with, the coordinators, our vendors, CROs. Yeah, just the number of people I’ve been able to network with globally. I have built relationships with people in Asia, in Europe through the course of my career that have now become friends and that I can pick up the phone if I have a question about a glaucoma issue. I think that’s key, and I’m very blessed to have that. But I think more the tangible things are to be part of a team that has delivered, made available a drug for patients and doctors to use. Moxifloxacin was, and maybe still is a blockbuster, so I was part of that team to get that approved. Patanase and Patanol, that was also another key drug in our toolbox.
Andrew Pucker, OD, PhD, FAAO:
Yeah. That’s fun. I help a small part of MIEBO, and whenever a commercial comes on, I help with that. That’s cool. People in the world actually know what that is, and some people benefit gratefully from those sort of treatments.
Tomi Luan, OD, PhD:
I think the other thing is just excitement. Right now, working on limbal stem cell, as I mentioned, and just there’s nothing out there right now and patients are struggling, doctors, not sure, they don’t have any tangible treatment that they could use. Just the excitement of doctors out there that are knowing that there is a need and to partner and to be a part of this, to be a part of this bigger picture.
Andrew Pucker, OD, PhD, FAAO:
Awesome. We’re getting close to the end. I just have a couple more questions for you. If you were to advise a new biotech company, what advice would you give them? They have a new compound, it’s like 3 smart people in a compound. What would you tell them to help them get started?
Tomi Luan, OD, PhD:
That’s kind of where we were. We were 4 smart people at Claris several years ago and a compound. I think it’s to understand, really, to fully understand the science and the data. Everything is data-driven, so ensure that you’re not drinking the Kool-Aid. Reach out to others in the field, your doctors, share and talk about it because sometimes what you keep seeing day after day makes sense to you, but then a fresh pair of eyes just reveals possibly a different indication or something that you’ve missed. I think it’s just lean on experts out there because we’re not. I would say nobody is really an expert, but lean on your networks and reach out for conversations.
Andrew Pucker, OD, PhD, FAAO:
I think that’s smart. No one knows everything. I know that for sure. I got that during my PhD. I definitely don’t know everything. There’s just a lot of good things out there and networking and question everything in science.
Tomi Luan, OD, PhD:
Exactly. Just to be able to filter, know who to talk to, the right people, and to filter the information you get because you talk to many people, you’ll get a lot of input and to really consider and think through the ones that are relevant to what you’re trying to drive.
Andrew Pucker, OD, PhD, FAAO:
Then if you met a young clinician and they asked you, “How do I become you?” What advice would you give them? We talked about getting our first job. Is there any other advice you would give them?
Tomi Luan, OD, PhD:
Again, I think it’s just reaching out to those who have already taken those steps ahead of you for that advice. If I were wanting to be in your shoes, for example, Andrew, as you’re the Chief Development Officer, then I would ask you how you got there. It’s really just, I think, conversational. Then on the tangible side it’s the skill sets. If you’ve been seeing patients for many years and now you want to transition over into the drug development world, what kind of skills that you would need? Maybe instead of trying to go and obtain those skills if you don’t have it, depending on where you are in your profession, leverage the skills that you already have because well, you probably already have a skill set or experience that you may not be in this role, but a similar role in an organization, in a drug development organization.
Andrew Pucker, OD, PhD, FAAO:
Oh, that’s great advice. Thanks for giving that. With that, I’d like to thank Tomi for joining us today.
Tomi Luan, OD, PhD:
Oh, thank you, Andrew. It was a lot of fun talking to you. Hopefully, we’ll have more optometrists who are interested in this, interested in the development and just increasing awareness of disease and sharing data out there. That could be clinical development, clinical trial managers, medical science liaison, or even pharmacovigilance. There is plenty of opportunities for any of us if we’re interested.
Andrew Pucker, OD, PhD, FAAO:
Yeah, that’s awesome. I like to promote what I call alternative careers in vision care. That could be what you’re doing, what I’m doing. There’s a whole bunch of other things out there and we just need to keep learning. With that, I’d like to thank you all for joining us today on this episode of Clinical Trials Spotlight. If you enjoyed today’s episode, please subscribe and share the podcast with colleagues and others passionate about advancing ophthalmology and vision science and patient care. Thanks for listening. We’ll see you next time.
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