New Medical Approaches to Treating Hearing Loss: Interview with Celia Belline and Peter Markham

medical treatment hearing loss therapeutics
HHTM
November 28, 2022
Biotechnology and pharmaceutical companies are increasingly investing in the development of therapeutics to treat hearing disorders. In just the past few months, the industry has witnessed the FDA approval of Pedmark, a new drug to treat ototoxicity associated with pediatric patients 1 month or older, as well as the acquisition of Akouos by Eli Lilly for nearly $500M dollars.
In this episode, Dr. Brian Taylor sits down with Celia Belline, CEO of CILCare and Peter Markham, CEO of CBSET, to discuss the future of pharmaceuticals and regenerative medicine in the identification and treatment of hearing disorders.

Full Episode Transcript

Brian Taylor 0:10
Hello, and welcome to another episode of This Week in Hearing. I’m Brian Taylor and today’s topic is the use of medications to treat hearing disorders. It’s notable that the first hearing disorder drug Pedmark, was approved by the FDA just a few months ago. This new drug is designed to reduce the ototoxicity associated with cisplatin in pediatric patients one month or older. And of course, you know, given this breakthrough, it’s a major milestone in the field of hearing disorders. And with us today to discuss this and other important topics, is the CEO of CILcare, who is Celia Belline, and also the CEO of another company called CBSET. And that’s Peter Markham. Both of them are CEOs of their of their respective companies. And we’re so glad that you could be with us today, on This Week in Hearing. Welcome to the broadcast.

Celia Belline 0:59
Thank you, Brian.

Peter Markham 1:00
Thank you very much, Brian.

Brian Taylor 1:02
So I don’t know who wants to go first. Celia, I’ll, we’ll start with you. Tell us a little bit about yourself and your interest in this topic.

Celia Belline 1:11
I’m Celia Belline, and I’m the CEO of CILcare. But I’m the co founder. So we are three founders, three women, and we founded the company in 2014. And our objective was really to support research and development of therapeutics. So it can be drugs, biologics, gene therapy, cell therapies, or even implantable devices in the field of hearing disorders. Our background, for the three founders, we all come from big pharmaceutical company. And we really think that this was a neglected area of pharmaceutical company at the time, we left the big pharmaceutical company. And there was a huge gap in between, you know, discovery at the bench and the clinical research that was expected and and really, that patient was waiting for. And that’s why we really decided to bring some solutions for the different players in hearing disorders to help them accelerate their development in preclinical to clinical research, and bring more drugs to the markets.

Brian Taylor 2:15
Nice. And Peter, can you tell us a little bit about yourself and you’re interested in this topic?

Peter Markham 2:20
Yeah, excellent. I’m Peter Markham. I’m the CEO of CBSET and I founded the institution in 2006 with Dr. Eleazar Edelman, who’s the director of the institute of medicine and engineering science at MIT. And we founded the institution to help innovators and companies and individuals, researchers translate their technologies faster into into clinical grade products. And so we really service the gap between early research and first and man trials. Our institution specializes in in anything that involves minimally invasive or invasive surgical techniques and complex system pathology. So we look at the we look at the local effect of toxicity of therapies, when they’re delivered to specific targets. And about five years ago, Celia approached me and she had ideas for doing GLP compliant research and hearing and GLPs are the are the, the regulatory requirements to do safety assessment prior to first unmanned trials. And she said that she needed a partner that could do GLP trials in hearing and at our institution was very interested because because hearing a lot of unmet medical needs and hearing, but also it involves exactly the tools that are in our institution specializes in, and that’s minimally invasive surgical techniques and, and complex system pathology. So we’re, we’re doing things like counting hair cells, you know, to understand the toxicity of, of certain compounds or doing cell implantation of cell or gene based therapies, combination products that involve, you know, a device and a drug. And hearing was really an unmet need, and could we could leverage all of our skills. So that’s how we we came to partner together.

Brian Taylor 4:20
And it it’s, I know, being on your website, it’s truly an international company, it seems like you have activities happening about four or five different locations around the globe, which is kind of interesting. And I know this is kind of a this is a topic of great interest in our field, among hearing care professionals. It’s kind of a new topic. It seems like there’s a lot going on that we don’t know about in our little field of hearing care. So maybe tell us a little bit about how CILcare CBSET is different from others that are in this space.

Celia Belline 4:56
There not a lot in the in this space. That’s that’s First thing, you know, our background is really, I come from clinical development. So our first focus is really patient and patient’s needs. So we first look at the disease, and then we think about how to address this disease. And we do the same with our partners. So we actually really build a services offer that allows our partners and clients to do all the preclinical work and the understanding of their drugs or technologies, before they go to human so to patients in, in clinic, in clinical phases. So that’s the way we think is really first about the clients and the patients. So what will help our clients to bring something that matters for the patient? Okay,

Brian Taylor 5:59
Peter, did you have anything that you wanted to add?

Peter Markham 6:02
Yeah, I think that, you know, so. So, hearing has been an under serviced medical need for a long time. And, you know, for a variety of reasons, and one of them is that is that if people want to sacrifice a sense that they would sacrifice, perhaps hearing over sight, and, and but hearing is a comorbidity of a lot of other diseases. And as your as you said, in the beginning of the program, hearing loss can be a side effect of, of treatment of other diseases, for instance, cancer, cisplatin with cancer, resulting in hearing loss, and so you give away hearing, and we shouldn’t be giving away hearing because hearing is incredibly important. Without hearing, we wouldn’t have speech without speech, we wouldn’t have communication. And without communication, we’re really not a society, the society wouldn’t have developed it as a whole in the way that it has without hearing and evolution protected hearing. So the, the, your hearing is your, the hardest bone in your body, located in the other hardest bone in your body and a place where nothing can get to it. And so because it’s because it’s so precious, and in a biological situation where it’s not accessible to therapies, it’s hard to treat. And it’s very complex. And so and so the interest for us is translating technologies that are being applied in other medical areas into Hearing Research. And as you can imagine, there’s a lot of ways to do that now, where particularly combining devices, and cells, devices and drugs, you know, selling gene based therapy, novel models of administration directly into the cochlea, and, and being able to address hearing in a way that it wasn’t present before. And so our institution, we’re dedicated to translating technologies. And the benefit that we provide to hearing to the field of hearing is we have knowledge of the regulatory approval pathway of other technologies that enables its use in hearing. And so that’s where we’re really focused in it. And, and it’s fun. It’s, it’s interesting, new, a lot of the a lot of the things that we’re doing have no regulatory pathway and no predicate to compare to. And so from a scientific perspective, it’s interesting from a medical perspective, it’s important. And, and, and it’s just a, you know, it’s just a great emerging market to be part of.

Brian Taylor 8:42
And it’s good to know, I, one of the things that struck me that you mentioned a moment ago was that you accelerate the development of auditory therapies. Can you tell us a little bit more about what you mean by accelerating the development and maybe give us an example?

Celia Belline 8:57
Yeah, so the idea is, is you know, so in the, in the different technologies that we address today, there is a big part that is about gene therapy. And here you are, we are called, we are talking about inherited hearing loss most of the time, at least, the first intent. And the second thing is really what Peter started to mention, which is this hearing disorders that are linked to other diseases, and it can be cancer because there is the oto toxicity of the chemotherapeutics that are used for treating cancer. But there is also huge prevalence of hearing loss within diabetes patient, for instance, within chronic kidney disease patient within neurodegenerative disease patients. So the hearing loss is the third risk factor for the evolution of from my cognitive impairment to dementia. So that’s something that we try to address as well. And so to to accelerate that kind of things. What we do is that we develop models and techniques that enables our partners or clients to today As the efficacy of those new technology or drugs, on this very specific pathology, so what will make what will help drugs to reach the market is to select the first is to diagnose Well, I would say the disease, so to understand where is the cause of hearing loss, and then to finally find the right mechanism of action target and drug to be able to address that specifically. And so we’re talking about, you know, neuropathy, synaptopathy. So Hidden Hearing loss, so this difficulty of hearing noise, for instance, we have the hearing loss with the noise and there are several consequences of of hearing loss and causes of hearing loss that we try to address the best. And that, for that, you need to have a very good understanding of the of the disease and the underlying mechanisms on the disease as well.

Brian Taylor 10:58
Peter, did you have anything you wanted to add?

Peter Markham 11:01
Yeah, I think the certainly, you know, gene therapy is, is up and coming and for hearing, it’s a target, and it’s a target that’s isolated from the rest of the body, in some way. And so from a side effect profile, potentially, gene therapy can be used, you know, because you have an isolated organ to treat. But in addition to that, you know, we’re developing devices and so, so bio resorbable materials, polymers, can be used to help repair injury to the tympanic membrane, the current technologies that are used for, let’s say, cochlear implants may be able to be used for drug delivery, for restorative hearing loss versus just putting a wire in and, and having an artificial way to connect the signals. There’s, you know, there’s, there’s chronic ear infections and children that, that, that potentially can be really, you know, treated with, with long term local drug delivery, delivery versus systemic where the systemic drugs don’t get to the ear, and you have to dose so high that you end up with systemic toxicity, trying to treat a local problem. So there’s a lot of opportunities to combine technologies to treat hearing loss, and it’s just a really exciting field.

Brian Taylor 12:30
And I want to echo that, I think for anybody out there, that’s an audiologist or a hearing aid dispenser, who en t, you know, the fact that we have, hopefully, in the near future, many more choices with regard to treatment, I think that’s really exciting. You know, in our, in my little field, we talked an awful lot about over the counter hearing aids, as, as a disruptive force, well, this is much more potentially disruptive, you can think about the you know, delivering medications directly to the, to the, to the ear. So,

Celia Belline 13:08
yeah, and the future is probably the combination, actually, because the hearing aids are something that is absolutely needed on the market, you know, but it will not solve the disease cause. And so there is really a synergy between between the different devices that are proposed, and that will be proposed and optimized also in the future with other technologies and drugs that will actually treat different things of the ear problems that we can culture,

Brian Taylor 13:34
that’s a great point that these things would be used in combination.

Celia Belline 13:36
absolutely it’s an add-on that yeah, most of the therapeutics that are going to be actually developed will be developed, at the end. add on to a hearing aids potentially.

Peter Markham 13:48
Yeah, so we want to we want to eliminate the tough choices. So the tough choices is do I treat? Do I treat my cancer and lose my hearing? Do I do I choose a cochlear implant for my child knowing that that’s an irreversible situation where if it’s removed, you’ll no longer have hearing and not be able to restore hearing in that ear? Should I do it in one ear or two ears. There’s a lot of decisions that we’re making that were where we’re, we’re potentially sacrificing hearing. And we don’t have to make those decisions in the future if we employ the right technologies to advance the therapies that we’re able to develop that.

Brian Taylor 14:31
That’s right, really exciting times. Let’s talk a little bit about your strategic alliance between CILcare and CBSET. I know that you recently celebrated your fifth year anniversary, so congratulations for that. And but tell us a little bit more about why you formed this strategic alliance between the two companies.

Peter Markham 14:52
Sure. So So when Celia approached us and in 2006 She had a She had an extraordinary vision. And, and her devotion to the, to the field to have hearing loss and tinnitus and the other hearing related diseases was extraordinary. And she came with, she came with a group of scientists who were experts in their field. And, and had been involved in the in the development of therapies for hearing loss. And, and that’s the specialization that we needed to be able to put together a series of, of tools to service the translational research necessary in hearing. And so we saw that as an extraordinary opportunity, because because in order to hire the people that have the expertise, you know, from the onset and build it from nothing, it would have taken much longer from Celia’s perspective, she came to an institution that had the GLP compliant research, we had the platform, we had the expertise, we had the regulatory knowledge and in developing other technologies, like technologies for other for other therapeutic areas, and, and so plugging the CILcare’s scientific expertise and CBSETs regulatory expertise in building a GLP compliant platform that wasn’t available in the United States, it’s time was an opportunity for both organizations, and we’ve been highly successful. And, and some of the, some of the therapies that we brought through GLP safety assessment are now in clinical trial. So we’re happy to have had success through COVID. It’s, it’s a growing market, and it’s an it’s a market that has longevity, and there’s a lot of a lot of space to innovate in this field, which is very interesting to both parties. See, if you want to go

Celia Belline 17:00
Yeah, I think I can make some, some ideas, especially on the you know, it’s really a mindset, we want it to go fast. And the best way to go fast is to, to partner with the best partner. And so to do that combination of we bring the, you know, the expertise and the vision, as Peter says, said on hearing and and we we have real good and establish and very successful partner with us to move forward in this in this field of hearing. So we don’t reinvent the wheel, we just combine forces to go faster and support better our partners and clients. So that’s really what we wanted, then it was, you know, kind of cultural marriage as well, because you know, that this is something we are used to, I think really create the feeling of being a team very quickly, in between CILcare. And CBSET was something also I think extraordinary in the journey that people are actually still living together.

Brian Taylor 18:05
I as we as we wrap things up, one, and it’s not often that we have a CEO on our on our, on our broadcast, let alone two CEOs. So thank you for taking time out of your busy schedules to be with us. But I wanted to kind of pick your brain about the future of hearing healthcare, and kind of get your perspective on how you think how you think the future is going to unfold with some of these new emerging technologies from companies that are coming from yours. So what do you think? What’s your crystal ball say about hearing healthcare?

Celia Belline 18:44
Yeah, so you we are today we are really, in addition to the gene therapy, or genetic therapy, I should say, or cell therapies that are really breakthrough technology that can see images of solutions or can bring solutions to hearing disorders. We are also very much focused on this interlink in between hearing loss or hearing disorders, I should say an auditory signature of patients and that’s something I think, audiologist will be very interested in and other diseases. And I really think and this is what we see also in the literature today that we’ve gotten to use the auditory signature of patients or digital auditory signature as a prognostic factor of the evolution of other diseases. And that is also extremely important. It’s it’s it’s a sense that give you in advance an alert on what’s going wrong within your body. And this is something that I think it’s going to be very useful in the future. So this monitoring of the auditory function of anybody along the life is going to be you know a game changer in the prediction of the evolution to chronic disease. Yeah, before

Brian Taylor 20:03
I want to, that’s really intriguing. You call it a digital auditory signature. Yes. And tell us more about what you mean by that.

Celia Belline 20:12
We are trying to do that kind of thing, you know, because in preclinical we are using a battery of tests to really diagnose very precisely, the disease that we cause to our different models. So it’s using ABR we’re using DPOAE, we’re using CAEP EP, we are using, you know, ecochleography. Lots of things, to diagnose the animals. And this is something that should be translated. And this is something we’re working on right now try to really have a battery of tests in human that can also give you like you have with the {inaudible}, you know, the digital auditory signature of the patient. And it might not be you know, a matter of hearing threshold, it might be something different, you see, you know, I don’t know, an interpeak that is longer, latency of the wave I, that kind of things. And all those things will give you, you know, an auditory signature digital auditory signature of the patient, and that can predict it if its wrong, something that is going to happen in your brain, in inflammation in your body, or, you know, that kind of things.

Brian Taylor 21:20
That’s really interesting. And I mean, it’s much more it’s way beyond the traditional pure tone audiogram, which I think many of our viewers know, is a very primitive tool for identifying hearing disorders. So thank you for sharing that, Celia, Peter, what’s your take on the future?

Peter Markham 21:36
Well, I think not only the therapies will change, but also the ability to image and to assess hearing in different ways. And so Celia is measuring, you know, talking about signal measurement, potentially having a having a baseline auditory functional tests that you can, that you can assess over time to assure that you’re, you know, you’re remaining and go good health, and specifically when you get to, you know, to be older. But in addition to that, the technologies are evolving from an imaging perspective, from a measurement perspective, from a sensitivity perspective. And, and what used to be large is now becoming very small. And as soon as it gets very small and very sensitive, it will become particularly useful in, in this in the small structures of the ears. And so, so we’re also developing the imaging technologies to be able to allow the clinicians to assess the disease earlier and in a more in a more accurate manner. And perhaps, you know, that will help the field overall field as well.

Brian Taylor 22:55
Well, I think there’s many, many aspects of, of diagnosis, identification, treatment of hearing disorders that, you know, we can look forward to as hearing care professional. So, thank you so much for spending some time with us, Celia Belline, and Peter Markham CEOs respectively of CILcare and CBSET. Thank you for being on the broadcast. We really appreciate

Celia Belline 23:21
it. Thank you very much for inviting us.

Peter Markham 23:24
Thank you Brian.

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About the Panel

Brian Taylor, AuD, is the senior director of audiology for Signia. He is also the editor of Audiology Practices, a quarterly journal of the Academy of Doctors of Audiology, editor-at-large for Hearing Health and Technology Matters and adjunct instructor at the University of Wisconsin.

 

Celia Belline has over 20 years’ experience in the pharmaceutical industry. She worked as the global head of clinical trial logistics and supply chains in Sanofi R&D, was a permanent member of clinical strategiccommittees, and the Director of projects dealing with major chronic diseases associated with aging, where she developed her interest and expertise in hearing disorders. She trained at ESSEC and London Business Schools, in addition to holding several master’s degrees in project management, industrial strategy and health environment. In 2014, Celia along with Drs. Sylvie Pucheu & Marie-Pierre Pasdelou, founded CILcare, a Smart R&D platform dedicated to the acceleration and development of novel therapies to prevent and treat ear disorders, with offices in Boston, MA, France, and Denmark.

Peter Markham is an independent consultant (President, CBSET, Lexington, MA) specializing in preclinical medical device translation and safety assessments. Peter has 30 years of management and regulatory experience in GLP contract research. Prior to cofounding CBSET in 2006, he was general manager of the Worcester/Southbridge division of Charles River Laboratories, a multi-disciplinary pre-clinical business unit which serviced the Toxicology, Pharmacology, Surgery, Metabolism, Pharmacokinetics, and Bioanalytical Chemistry markets. Previously, he served as a senior executive in leadership roles at various research companies including Genzyme Transgenics, Primedica, BioDevelopment Laboratories, and Arthur D. Little. He has broad expertise in both drug and device development with over two decades of scientific leadership in drug metabolism, pharmacokinetics, bioanalytical chemistry, and the application of these scientific disciplines to the development of combination products. Mr. Markham holds a BS and MS in Bioanalytical Chemistry from University of Massachusetts.

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