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A conversation with Kindeva Drug Delivery Director and Bay Area Site Head, Keith Ung, about the 2022 acquisition of iPharma Labs Inc. by Kindeva and inhalation drug formulation.
This podcasts covers a range of topics including:
PLEASE LISTEN TO THE PODCAST THE TRANSCRIPT IS AI GENERATED AND SHOULD NOT BE SEEN AS EXACT.
John Price (00:16):
Welcome to coffee with a series of thought provoking conversations about complex drug delivery. Today, we will be talking with Keith O about the acquisition of I pharma by Ebba. I’m your host John Price. It’s my privilege to host Keith O on today’s episode of coffee with Ebba. Keith was formally CEO of I pharma labs, and currently his director and union city head at Ebba. He has over 25 years of experience in the inhalation and drug delivery device market. He holds a PhD in pharmaceuticals from the university of Sydney is contributed to a long list of technical publications and is an expert in formulation related to inhaled drugs. Keith, talk to me a little bit about, uh, the very formation, the, the beginnings of, of I pharma when you guys started and, and how you started and what brought that about.
Keith Ung (01:11):
Yeah, so, you know, I used to be in the other size of the, uh, uh, shoes. Um, we I’ve been working for nectar therapeutics and then transitioned to the bars. Uh, you know, really my focus is in, in, in those companies, you know, trying to get the product out from a proof of concept and then to, uh, a launch, really the challenge is that, you know, there’s a lot of innovation or activities happening at our site and areas that we’re working in, and we need to kind of figure out way how to move some of these project and, and in the, and I’m not a business development person, I’m not a business person, I’m a technical person. And my, um, approach is that if there are problems, there’s gotta be solutions, right? And we have to, you know, find ways to resolve these and be able to get to the answers quickly without, and spend so much money and time to it.
Keith Ung (02:00):
So what I see, there’s this, this gap that’s not there and the concept of, uh, trying to form a company just to help out small and big company pharma companies to kind of fill that gap, uh, it’s missing. And that really kind started out, sorry, about 15 years ago, but the time to, uh, to, to launch, uh, you know, this concept, wasn’t, uh, wasn’t there, wasn’t available. I ran into John Patton, which is one of the founder inhale therapeutics. And we actually were in these coasts and attending, uh, um, conference there. And he has a company he’s trying to get his, uh, inhale, uh, liquid insulins, uh, globally, you know, launched. And he’s having a hard time to find company that can really support their product concept and moving beyond commercializations. And, and because he is a VI, it’s a Virg company, he really have a hard time to find the small niche company to do that kind of work.
Keith Ung (03:01):
And he asked me to see if there’s an opportunity for me to start a company that could support that. And he knows what, what we can help out, you know, as, uh, you know, if we do create a company together and we do, we can definitely help out not just his company, but other companies. And really that’s really what I call it, their birth I pharma. And that’s what we’ve been doing is basically is to help out, you know, company that are that trying to create products, uh, you know, in, in the, uh, in the pulmonary space is that, uh, there are a lot of companies who don’t know anything about inhalation develop inhalation product, and that’s exactly what we creating this company is to help them guide them and then help them to find what it should be done in the right way, in the quickest way with the, the most efficient and cost effective.
John Price (03:47):
That’s great. You, you touched on this a little bit, but you know, what would your typical customer look like at, I, I, pharma, is it coming to you just with the API and doesn’t really, you know, knows that they want to treat, you know, maybe a respiratory disease or some other disease, and they’re not sure they want to deliver it, you know, how, how it’s gonna be delivered or they, they think, you know, it’s probably gonna be some sort of inhaled medication. We just don’t know if DPI’s right or nebulizer or whatever it is. Where are they at when kind of your typical customer comes into your, is it a little more varied than that?
Keith Ung (04:24):
We, we have two groups of clients that one, they basically have, you know, strong product pipelines in the respiratory space, well known, you know, the top five companies, right. And they’re in the same situation as Nevas, when I was working there is that they’re, they have resource constraints because the COVID and things related to that they have, uh, um, and so they’re looking at the best way to accelerate their program forward by utilizing resources outside. And we’re here to support that. That’s reason why our business actually did quite well since the, uh, COVID, you know, is hitting. And two, uh, there’s a, these are kinda what I call the, the infant, uh, companies who either is a single product company or, or they have a product that is in the, um, uh, different administration, uh, either injectable or, uh, infusion, right. And they found that maybe the, uh, uh, their drug is actually is, gives a more it’s for COVID, or it could be lung inflammation treatment for asthma, severe asthma.
Keith Ung (05:29):
They found that to be, you know, a good indication for that. And they want to tap into that space. That’s when these are the group that basically they don’t know anything about respiratory disease and a pulmonary development of primary product, how expensive it can be and so forth. And we tend to, you know, um, spend the, the time to invest into educate them. Right. And, and one of the things that, you know, they come up with an API or a direct solution are in a, in a liquid format. And they, it may not necessarily, uh, stuff that compounds are in the formulation may not necessarily translatable into the pulmonary product because those things are, you know, you don’t know the safety, what happened, the land in the lungs, we can do it, right. So it’s, it is becoming a huge risk optical for them to submit, uh, proposal to do a clinical trial.
Keith Ung (06:17):
So we tend to say, you need to reformulate your drug to make sure use excipient as been approved for respiratory drugs. And that’s basically, that’s the first thing that we let them know rather than just take and test it without, you know, and the second part is that, you know, you want to do approve a concept, just take off, off the shelf device and then, uh, reformulate this formulation, the simplest ways. And so you can actually get it to the clinical side and do a clinical study, cuz you look at the, um, efficacy, right. Or you hitting the therapeutic target or not. And then, you know, if it does hit that mark, then you have a very strong case to proceed to the next step. So we wanna make sure that they take the shorts path, the most efficient path. Um, and, and the only thing you do that you really have to kind of educate them on that.
Keith Ung (07:02):
And that again, you have to come around to the point that they don’t understand in term what’s required to, uh, what are the requirements to put into a submission to the FDA, allow them to do a clinical trial. So that’s what we do is spent the time to educate it. And I think what, what, what the value came out is that they, they walk away that, yeah, these guys are really here to help. They’re not here just to know, to make, you know, make money as much as possible. And that’s, that’s what we are trying to differentiate what we do versus what our competitor does. Right. And over the year for the past five years, we have cases that we tried our approach. We end up, they went with bigger, well defined competitor, like, you know, um, and they went to them and of course two years later it kinda came back and because they ran to some of those issues.
Keith Ung (07:47):
And, and so it’s, you know, we basically, essentially we don’t have business development person <laugh> so I play the business development person. So we’re more, I, I, I stated myself as a, we’re more of a passive, my approach is that, you know, we, we basically sell, we basically educate, we listen to what they’re looking for. We basically try to educate them, but, and then that’s it. And then we just basically just, uh, wait for them to respond it. We don’t necessarily, I don’t have the resources just to, to follow up on that. So, so the really that’s, uh, that kind of give you the, the sense of what typical customers are, are coming after it’s EV every size, every, you know, all startup Virg companies. So they, they, you know, that’s what we, the purpose of us is just to, to be, and we strategically locate in the bay area is because the bay area has a lot of, uh, incubators startup companies, right. A lot of direct development company and feedback we got is that you guys just right there, we just come and visit. You can actually set the drug without having to ship it, get there in overnight. And some of the compounds are very sensitive to, uh, uh, to cold change. And, you know, you require a varied, my 60 degrees, uh, you know, and here the versus is very, they can actually just most time they can just drive and drop it off. <laugh> right. Without
John Price (09:00):
<laugh> stick it in the Thermi in a way they go great. And you, you, you, you kinda got the full spectrum there from, you know, the, the smallest little startups to some of the big ones. And you’re really, it sounds like very early in, on that, that formulation stage of, of, you know, doing some of the testing and the analytical work. Can you gimme a sense of what, like a typical project at if pharma for like a biologic or macromolecule might look like?
Keith Ung (09:25):
Yeah. So, you know, the, the, the, the space in, in monoclonal antibodies is also targeting various different diseases. Everybody get an example, RNA, right. Um, uh, that’s another, uh, space there’s R I there’s mRNA and so forth. And it, it’s becoming a more like a, really a platform rather than a, uh, a single molecule to target certain disease. It’s a platform that we have worked with company who, who has developing mRNA R AI, and they have four different treatments with the same, uh, strands of, you know, this RNA. And, uh, so it’s really, it’s clearly, it’s a platform base and the therapy, the therapeutic, uh, the dosing, everything is gonna be different. It, it can range from few milligram to, you know, 30 to a hundred milligram in the lungs, right. And really comes down to, you know, what are available, what devices can deliver, and then, you know, uh, how effective it is.
Keith Ung (10:23):
And we’re, we’re here. You know, that’s, that’s what we do is that we’re, we’re partner with them to kinda provide a combination that, that given the most successful outcome rather, and just here to tell us what to do, and then we’ll do it. So that’s not our philosophy. Our philosophy is that we would try to guide you, get you the, you know, the best combo devices and, and give you the best output that will give you the, um, the most, uh, therapeutic dose in a single sitting versus, um, uh, another devices that it’s, uh, more efficient, right. So we basically try to target that. And our, and, and, and the other one is that we’re trying to educate is that you don’t need to pick the best device right now. You just basically want to demonstrate doesn’t work or not. Once you have that data that clinically proven that it works, then that’s defined the product. That makes a lot of sense through which a device that makes a lot of sense that will cover besides just the EF, but the cost of goods and then user friendly and so forth. Right. So,
John Price (11:21):
So deciding that, that kind of technology piece, you know, whether it’s a DPI PM, D I obviously, there’s a lot of variables that go into that, you know, is there, is it pretty common, like dosage form is often driving that? Or is it, you know, more of a cost of goods or does it really depend on, on the molecule itself and, and storage conditions and shipping and handling, and
Keith Ung (11:44):
Yeah, so the dosage form, the delivery system will be based on the, the, uh, dose that you can get to the, you know, get to the patient, right? You talk about microgram scale dose. So that would fit into the MDI I format. You it’ll fit into the, uh, ism, uh, you know, devices, right? Uh, when we talk about dosage that are in milligram scale, or, you know, a hundreds of milligrams scale, then those two format will not fit. You know, uh, you have to go into the, uh, nebulizer or a dry powder. And of course the cost between those different formats can be significantly different. They’re not talk, we’re not talking about 20 or 30% difference in cost and development. We’re talking about maybe two to three X. So it’s, it’s, it’s, there’s gonna be some economic impact in terms of, you know, uh, development costs and so forth.
Keith Ung (12:35):
So we tend to say, okay, first, first question, we have clients that come visit us. They have this compound to say, we’d like to go in the clinic. We’d like to use this, you know, device right. Way, say, okay, before we get to that, tell us about what’s your disease group, what’s your, uh, what’s your therapeutic dose or intended to target, right? And then we can then help you guide you to select with format, because otherwise you can applicant choose pick a device. Certainly you make you range the challenge with the, uh, concentration challenge, right. You, you know, um, and also the, uh, size, the container may not fit the entire dose and so forth. So you have to think about all these things before you actually come up with the selection what’s available. And then once you have that, you need say what’s available out there, right? So I think in our side that we need to try to catch up what our other people are, develop, what devices are. Other people are developing, that we can all, we can bring those in house right at that time. So I think these, we have to continue to learn ourself what other people are doing, what are availability is outside. And so though, when we actually engage with the new clients that we gotta prepare to have that conversation or discussion, and why we think, you know, a and B is better than C so sure.
John Price (13:42):
Okay. That, that, that makes sense. Now that you, that, that if R is, you know, part of Kindeva, you know, what can you offer new customers that you may not have been able to, to offer previously, obviously were a larger company than, than just I pharma. And there’s probably some overlap, but I’m guessing you work in some areas that we didn’t typically work in before, but what do you see that, that Kindeva kind of brings to, to this AC acquisition that, that maybe you didn’t have before, that, that you’re looking forward to now?
Keith Ung (14:11):
Well, it’s a good question. Um, I think, yeah, one of the, uh, things that we can offer, and that’s one of when I sent the email out to announce the, uh, the acquisition, you know, um, with our existing clients is essentially their concern. Is that, what does that mean to their current project? Their timelines so forth that can slow down is the cost and go up and so forth. You know, communication them is really to assure them that nothing changed. The, uh, the work will be still done at I farm here. Um, now we have this, uh, uh, Kindeva, um, resources, availability. We can actually accelerate and help out beyond what we can do. What we can do is, uh, basical. We are able to get to, to client to certain point, allowing to do, do a phase one study Fe ability to phase one study, right.
Keith Ung (14:54):
And we essentially lose anything we can because we can’t support anything beyond phase one. So we can’t manufacture, we can’t do G we can’t do drug product release testing because we don’t have the GMP capability can, can give all other site, uh, Minnesota that can fulfill those. And so it makes, it makes the transition from what we support to phase two phase three, much easier, because now we’re within the same organizations. And what their concern is about from, um, from a risk management standpoint is that they ask us, develop a, a, a, you know, a product at our site, help them define what that product definition is that included all the methodology development, uh, and qualification, and then transition that to our competitor that will support the clinical program. That’s all like six to 12 months, potential time gap because of the risk of, uh, transferring the acid, the method and the knowledge, everything, right.
Keith Ung (15:55):
And so they see that as to be a bigger, so we have in the past, it’s lost contract because of that, they saw that as a, as a, a huge risk that they unwilling to take and that pathway, and that’s the reason why didn’t. So now I think with that acquisition, you know, it can think as a, as a one organization, we should be able to support all the way to launch. As I said before, in the beginning, when we, when I envision start Nihar, it’s really is more on the feasibility innovation front, right? It’s a great area because it’s the area that I, I enjoy working because it’s very dynamic. There’s nothing boring about it because every time every molecule comes in, there’s always new challenges. How do we overcome that? And so it’s very dynamic. So I built a group that, that enjoy that kind of work, and not everybody enjoy that kind of work, because things are moving so quickly from day to day because the, um, the, the program changes so dynamically, and we have built these groups of great scientists that can position handle that kind of changes with, you know, and then be able to adapt to these changes.
Keith Ung (16:59):
And that’s what we built the, the business itself has had. We can only get to certain level and, and we’re, we can generate. We can, you know, it’s really the, the business. What I see is only existed and we have X number of customer continue to, to fill in that. And so if we lose one customer, because we complete the feasibility, we have to find another company to fill, to, to sustain the, uh, let’s say, the expenses, the cost and everything, right. The payroll then. So we’re, we’re, we’re essentially solving a lot of problem. You know, we’re getting $200,000 contract, and then we are losing millions of dollars contract because we unable to fulfill what beyond the downstream that we can offer. I think that’s where this single organization with pars, that we’d be able to fulfill that. Now we can continue to have the continuity and build that relationship, be able to get them and, and keeping in mind is a lot small company.
Keith Ung (17:51):
One product is that their goal is they want to get to a, certain to phase one they’re gonna sell or lighten the company to a big pharma. And so you can’t rely on them beyond that. Right. But it’s really the big, big player. The big pharma has a deep pipeline de capital. They have investment or continue to build the pulmonary pipeline. And that’s what we want. And these are the companies that tend to shy away from us because we can only offer that portion. And so they’re okay to, to set us some feasibility work, but they’re not okay to send us the development program because we don’t have the infrastructure to, to, uh, support them beyond what we can.
John Price (18:31):
Okay. That, yeah, that makes sense. You know, you, you’ve got a, it sounds like a very agile, flexible group there. And now, you know, with the KVA piece, we more seamless, as you said, you know, fewer transitions needed from, from one company to the next, as, as a drug makes its way through the, the different phases. So that makes sense. So, so yeah, that, that, thank you for that. You know, what do you see, just looking ahead a little bit, what do you see in the respiratory space? You know, historically medicine has largely been the domain of small molecules in, in respiratory, but that seems to be moving a little bit more into some larger molecules, biologics, peptides. I’m just curious of your thoughts on this.
Keith Ung (19:11):
Yeah, I think, um, the biologics has been going up, up and down over the years, you know, when, back in the, uh, in the night and the early 2000, when insulin got approved, you know, the, the biologic molecules were kind of take it off. And then of course when the sale didn’t go that, well, then the whole thing kind of collapse, you know? Um, so now things are starting to pick it up. I, I see that, you know, before the pre COVID is that the biologic, uh, starting to, you know, kind of starting to ramp it up, human lungs are, are one effective ways to get the drugs in their system. So it’s not just treat in the lung, but use them lung as a portal to get the drug to, to the brain, get the drug to the heart. So different regions of, and what have been shown is that, uh, um, you can actually reduce the toxicity of the drug in the body, given it through the pulmonary pathway, rather by oral or by, you know, and the only other way is to get in most efficient ways is infusion.
Keith Ung (20:09):
You can actually get directly to the blood. That’s what it is all about. Absorptions and, you know, into the blood and get into a different re uh, target the tissues that you’re targeting for. But, so, so I think that’s where there’s a lot of interest is one is there’s high re in high, rapid, uh, intake, uh, response. Uh, you can, for example, migraine is that you can, if you give oral dose, it takes about 45 minutes. If you miss that window, we have talking to, I’ve spoken to people who actually, you know, taking these oral dosage and then they miss their window about 10 to 15 minute. They can suffer, you know, quite dramatically, right. Just basically just want to, uh, hide in the corner, keep away from all the noises. But, you know, given, given the, uh, the same classification drug by pulmonary route, you’re, you know, the, the, uh, the effectiveness can be minutes.
Keith Ung (20:59):
You can, you know, you can hit to the, to the, the brain sensing, you know, right there minutes rather than 45 minutes, uh, response time. And also the dose that you’re given through pulmonary route is also, you know, can be much lower because the efficiency, the, uh, the, uh, it much, much be absorption, uh, uh, uh, is much higher than, uh, uh, oral intake. So there’s many, uh, many benefit through that, you know, from their, and right now, I think there are certain diseases like CF, right? Cystic fibro. So, you know, there’s a lot of drug being developed for, for that classification. And that needs to be given as not a small molecule long could be. We have, you know, clients is actually developed trying to develop a cure. So they’re using it attenuated virus to, as a way to give, see they can actually cure the, uh, this, uh, this disease that you, you know, kids are born with, right?
Keith Ung (21:49):
Cystic fibrosis, the life span of cystic fibrosis used to be what age, 30 to 32 years of age right now, because of different direct therapy. Now they’re improved. Now. It can be a size, age, 40. They can know survive survivability. So it’s improving over the year, but there still, isn’t a direct diet. It’s a cure right now. It’s all about treatments, right. And maintain maintenance and so forth. And so I think, I think in just the, uh, the biological space in terms of drugs, that there’s many opportunities there. I think it’s, it’s people are exploring. Companies are exploring. Yeah. Find ways, reason why the, um, pulmonary route is probably what they’re exploring, because it seems to be one is the COVID is changing in the past people. When they get the treatment, they have to go in the clinic, you have to get the infusion, right.
Keith Ung (22:41):
And that’s the most efficient way because they’re pumping, you know, milligrams and hundreds of grams of milligrams actually milligrams scales of drug into the body. And because of COVID has somehow closed on some of the clinic because of, uh, you know, you know, influx of sick patient. Now they can’t get their treatments. And the question is that, how can you overcome that? Can you develop a ways that you can actually put into the device that they can just take home and then take their dose right. With that, and to go to the clinic, walk in the clinic, to get their, their dose. So that in a way kind of changed the, uh, the mindset about therapy, why, you know, pulmonary will be the best way to go and so forth. So it’s, it’s exploring IPF F you know, another, these are not necessarily a lot of, um, are not really target the, uh, the existing, uh, diseases like, uh, asthma, C O P D.
Keith Ung (23:29):
These biologics are targeted very specific disease group. There still are, um, drugs are not available or are still trying to help people to maintain their lifestyles, increase their, you know, their life qual quality of life. And that’s included, you know, not just, you know, cystic fibrosis, but also pathic fibrosis. These are what we call the, uh, you know, the IPF or the PAH or people with this, uh, IPF are considered be a life sentence. Once you diagnose IPF, is that you have about two to three to five, two to five years of lifespan, because it’s a, it’s a disease that is, you know, there’s no cure, right. Unless you find a way to get a lung transplant most time it’s, it’s not possible. And so, so these are like, once, you know, once you have that, it’s a sad thing. And then, then in that case is that how can we develop a drug that will help them to improve that quality of life with the next three to five years? And that’s what we, and so what we do over the years, developing these drugs are trying to help PA you know, these patients to enhance the quality of life, you know, as long as possible so that they can, you know, stay in the same time, maybe buying some time, maybe somebody will come up with a cure.
John Price (24:43):
Yeah. That, that, that’s great. There’s, there’s a lot there, you know, and I think traditionally, you know, especially you think of a inhaled medicine, you know, you think you’re treated a respiratory thing, and I, you know, even working in the, the industry, it’s, you know, it makes sense. It’s like, well, you can deliver things to the lungs that, you know, just need to go into the body. You know, it doesn’t, yeah. Doesn’t, you know, you can avoid some of that first pass. You don’t need as, as large of a dose, you’re not going into all the stomach acid, you know, there, there are benefits to, to, to delivery that way. And, and that’s interesting to hear as well, kind of along the same lines, um, as, as far as new molecules coming out in the future, how about new devices that you’ve seen for these? What do you see kind of on the horizon? What are some of the new things you’ve seen out there that, that you think, um, have some merit or, or are at the, at the least interesting, I guess
Keith Ung (25:36):
What, what I, what we, over the years, what I’ve found out and also with my collaborators and, you know, um, you know, friends in the industries that we share the same interests is that we feel that you can spend a lot of time to develop a device, but you don’t have a direct to go with it. It’s not gonna go anywhere. What we feel that the most effective ways to, uh, you know, to, to, to put the focus in is really design the best formulations. And then you can, then you have a better choice of picking any devices out there not having to pick the best device that gives you the best perform. So the formulation is really the driving it’s the, in, in the driver’s seat and, and really the device, I see that as more as a secondary in that case. So you can focus on design the best formulation, for example, park engineering, using spray, right.
Keith Ung (26:25):
To do that work right to, to come up with the best formulation are really important. Once you have that, then you can pick any off the shelf device. And then what, what makes sense? What’s the cheapest way to, to go forward with that. And, and so you have to really just finding a device and then design that device to work with your formulation. So you can do either way. The question question is that what’s the most efficient, most, most effective way to do that. And that’s what we’re trying to educate our clients is to focus on the, in the formulations. And then you have a better choice, you know, to choose what’s out there, rather trying to design something that’s a lot more costly, more expensive and time, uh, investment that needs to be,
John Price (27:03):
Yeah, it seems like if we’re forcing the device first, you might be inviting complications that you could have just avoided by, by focusing on that formulation first. So, okay. Okay. I that’s, uh, I really appreciate your time, Keith. I, it’s been very informative. Welcome to KVA. We’re we’re glad to have you on board and, uh, yeah, that that’ll wrap it up for now. Thank you for listening to coffee with Kindeva, a series of thought provoking conversations about complex drug delivery. Join us next time. As we continue the journey into the fascinating world of Kindeva Drug Delivery.
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