Speaker 1: Welcome to Farmer Talk Radio. This podcast is focused on
Speaker 1: biomateial implants to reduce patient burden and improve adherence from
Speaker 1: the twenty twenty four pod Partnership Opportunities and Drug Delivery Conference.
Speaker 1: For more information on the pod conference, editorials, podcasts, or webcasts,
Speaker 1: please visit Drug dash Delivery dot org. Thank you and
Speaker 1: enjoy the podcast.
Speaker 2: Our topic today is biomaterial implants for reducing patient burden
Speaker 2: and improving adherence. I'm joined by four fellow colleagues and
Speaker 2: the drug delivery and the device field and let's get started.
Speaker 3: So there was.
Speaker 2: A similar session earlier on a similar topic, but I
Speaker 2: think we'll have a different perspective perhaps, But before we start,
Speaker 2: maybe we'd just give a general introduction to what we
Speaker 2: mean by biomaterials and implants. So there's a biomaterial in
Speaker 2: this setting is basically any material that's coming in contact body.
Speaker 2: Of course, for a therapeutic application, we have special requirements biocompatibility,
Speaker 2: maybe bioorotability, but an implant in the general sense could
Speaker 2: be any parental depot that's giving a long sustained release
Speaker 2: of an API. But we also have sort of a
Speaker 2: classical definition of an implant. I'd like to sort of
Speaker 2: ask the panel premier perspective, what do you think of
Speaker 2: when you think of an implant versus a other type
Speaker 2: of long acting injectable.
Speaker 4: So I'm Jamie Sean with Pfizer, I head the Global
Speaker 4: Biopharmaceutics Group for introduction. Yeah, so I think I told
Speaker 4: the group at one time that from my classical perspective,
Speaker 4: something which can be injected is a depot injection or
Speaker 4: a long long acting injection, while something which actually has
Speaker 4: to be inserted or could be you are too implant,
Speaker 4: it is an implant. However, that definition is getting blurred,
Speaker 4: and I think the USB and the regularty Agency is
Speaker 4: kind of don't differentiate it that way. However, there is
Speaker 4: an impact in terms of how we define implant as
Speaker 4: to how it is going to be designed and developed,
Speaker 4: and we can.
Speaker 3: Talk about that later.
Speaker 2: The other thoughts.
Speaker 5: Yeah, I think classically we start with that to that point,
Speaker 5: jam In, you know, an injectable with a fixed geometry
Speaker 5: is something that would be defined as an implant. But
Speaker 5: if you expand it and taking into consideration the USB
Speaker 5: definition is it's injected, it's probably localized at a certain site,
Speaker 5: and from that site, it's doing a sustained delivery of
Speaker 5: an active agent. Not necessarily the active agent is being
Speaker 5: a you know, a control release, but it's some other
Speaker 5: mechanism that is helping you to control the release or
Speaker 5: control the solution of that drug and getting into the
Speaker 5: systemic circulation. And in the broader definition, that's how it
Speaker 5: falls into an implant classification, even if it is injected
Speaker 5: and not inserted. So that's what we were talking about
Speaker 5: earlier as well, and.
Speaker 2: In the title of our panel discussion is why in
Speaker 2: the definition of why we want to actually use a
Speaker 2: bio material implant, so for reducing patient burden and improving
Speaker 2: the adherence. I'm curious, Aileen Eric, if maybe you can
Speaker 2: give some examples of use cases that are justifying the
Speaker 2: use of biomterial implants in your work.
Speaker 6: Sure I can go first. My name is Eileen Sadly.
Speaker 6: I am a senior scientist that APPY. I work on
Speaker 6: a drug delivery and combination product. Just for introduction, The
Speaker 6: reason we use implant is for localized and control drug delivery,
Speaker 6: especially for hard to reach tissues in the body such
Speaker 6: as retinal diseases, as well as oncology applications. That makes
Speaker 6: the impluse super important.
Speaker 7: Uh. Hello, I'm Eric Almquist. I'm the co founder and
Speaker 7: CEO of Pendent Biosciences. I have a little bit different
Speaker 7: perspective from everybody else up here. We are the drug
Speaker 7: delivery company that works with my colleagues here and as clients.
Speaker 7: So you know, from our perspective, we really are driven
Speaker 7: by our clients' needs. So you know, from from most
Speaker 7: of my experience and creating these delivery devices, it's really
Speaker 7: driven by taking and existing therapeutic that's already commercialized or
Speaker 7: on the market and really improving the patient experience or
Speaker 7: the provider experience by by delivering a a more efficacious
Speaker 7: dose or longer lasting dose.
Speaker 4: I have one example or use case or an area
Speaker 4: where actually it kind of really kind of showed like
Speaker 4: where implants can significantly benefit, and this is an ocular
Speaker 4: drug delivery to back of the eye. I think some
Speaker 4: of you might know that at one time there were
Speaker 4: really no drug products for the back of the eye,
Speaker 4: and at that time, if you had an infection, they
Speaker 4: would basically give a systemic antibiotic or oral antibiotic, but
Speaker 4: very small fraction of that goes to the back of
Speaker 4: the eye during the AIDS epidemic. There were this CMB
Speaker 4: infections in the back of the eye and folks were
Speaker 4: losing eyesight. At that time, they were using some of
Speaker 4: the anti viral agents systemically, but a company developed an
Speaker 4: implant which would be implanted into the eye into the
Speaker 4: victory as known as vitrosert. But it was a fairly
Speaker 4: large implant, and slowly that company developed another next generation, Reticert,
Speaker 4: and then Medidior, and as it kind of evolved, it
Speaker 4: became which was an implant which was to be inserted
Speaker 4: into something which can be injected. So the definition gets blood.
Speaker 4: But why do we do that? That's because you can't
Speaker 4: really do frequent injections into the eye. The best you
Speaker 4: can do is once a month, but you can't go
Speaker 4: as So the idea was to kind of have an
Speaker 4: implant which can deliver the drug for more than a
Speaker 4: year a year to three years, and so that's the
Speaker 4: driver one of the really good example of why implants
Speaker 4: are needed for certain conditions.
Speaker 2: Yeah, I think I've also worked in a molecular drug delivery,
Speaker 2: and I think going from that example, one of the
Speaker 2: most beautiful examples I've seen is this refillable port delivery
Speaker 2: system that was commercialized by roch Genentech, and it's interesting
Speaker 2: reading all the papers about that and seeing the presentations,
Speaker 2: like how many iterations and how many problems there were
Speaker 2: to solve. And I think that gets to a topic
Speaker 2: that we've discussed prior to this panel, which is that
Speaker 2: developing these long acting implants or injectables can be very complicated,
Speaker 2: and anyone who's worked in that field sort of sympathizes
Speaker 2: with each other about that process. And I'm curious to
Speaker 2: hear from the panel what is it that's complicated or
Speaker 2: difficult about developing a long acting biomaterial implant.
Speaker 4: So I think classically, from an implant perspective, you don't
Speaker 4: want the implant to be intrusive or physically to beg
Speaker 4: so that means that implant, when you design an implant,
Speaker 4: the drug has to be very potent. It's better also
Speaker 4: if the drug is a long half life, and so
Speaker 4: I think portent to the drug is important. Secondly, finding
Speaker 4: the right material for the implant and the right design
Speaker 4: of the implant asually, to be honest, there are very
Speaker 4: few materials which can be used in implants, and we
Speaker 4: can talk about that later, So that's kind of thing. Secondly,
Speaker 4: it's sort of a design not just the formulation but
Speaker 4: also the design of the implant, which requires bioengineering principles.
Speaker 4: So it's a very challenging you know, design from a
Speaker 4: first in man implant is well, it's almost has to
Speaker 4: be commercializable.
Speaker 5: I think, you know, maybe it can relate to everybody.
Speaker 5: So because you guys are here at the last you know,
Speaker 5: panel discussion, and the biggest trait that it needs is
Speaker 5: the patients and these are long acting delivery systems and
Speaker 5: it needs a lot of patients during the development. So
Speaker 5: the design factory is definitely one of them, which is
Speaker 5: you know, highly challenging because you're looking into the drug factors,
Speaker 5: you're looking into the excpient or the biomterials that you're using.
Speaker 5: And then the second part is the process that comes in,
Speaker 5: and the process is equally challenging, and the patience comes
Speaker 5: in because now you're looking at the clinical development of
Speaker 5: these implants and then you're going to test the patients
Speaker 5: of the organization as a whole, because you're not looking
Speaker 5: at just uh, the developability of that, but you're looking
Speaker 5: at the clinical outcomes coming from that and how long
Speaker 5: an organization can can sustain in that competitive space to
Speaker 5: you know, be patient with you and say, okay, keep
Speaker 5: doing what you're doing, even though it takes long time.
Speaker 5: There are a lot of values behind it from from
Speaker 5: the market perspective, but the patients is a key thing
Speaker 5: that many times we see a lot of challenges and difficulties.
Speaker 3: In these developments.
Speaker 6: Yeah, just to echoat, I think one of the most
Speaker 6: important problem we face, usually especially for chronic diseases like
Speaker 6: inflammation in the eye retinal diseases is basically balancing between
Speaker 6: the release profile and the material degradation. You don't want
Speaker 6: to have and people get multiple injection for chronic diseases,
Speaker 6: you don't want you want to factor that in. You
Speaker 6: don't want to have multiple implants in their eye. That
Speaker 6: becomes a burden. And secondly, as it was also mentioned,
Speaker 6: is that it takes a long time for making an implant,
Speaker 6: and especially degradeable implant, one of the requirements is to
Speaker 6: show the degradation. And these days with competitive landscape, if
Speaker 6: you want to have like six months or one year
Speaker 6: even delivery, you should show that degradation, which usually takes
Speaker 6: longer than the release profile. So that makes the timeline
Speaker 6: very long, and that also makes you wonder about the
Speaker 6: competitive market.
Speaker 7: So from the other side of the table, by the
Speaker 7: time these guys come to us, that means they've already
Speaker 7: tried the traditional technologies, the plgas, the standard materials that
Speaker 7: everybody is very familiar with.
Speaker 3: So we get all the hard stuff.
Speaker 7: So we're subject subjected to the market shifts the interests
Speaker 7: of our clients. You know, it was maybe small molecules
Speaker 7: ten years ago, fifteen years ago.
Speaker 3: Now it's biologics.
Speaker 7: So our challenge is to fit find the solution for
Speaker 7: the target product profile we're presented with and make something
Speaker 7: work in a time frame that's that's reasonable for our
Speaker 7: clients to continue moving forward.
Speaker 3: Otherwise the market shifts again.
Speaker 2: So given how long it can take to develop some
Speaker 2: of these products, do you have any suggestions from your
Speaker 2: own experience on what you could do to streamline, Like
Speaker 2: what should you do? What should you do early on
Speaker 2: because you don't get as many shots on goal when
Speaker 2: you're cycle the time is multiple months. What has been
Speaker 2: successful in your experience or in hindsight.
Speaker 4: This really I mean, I think there's no single part,
Speaker 4: but I think ideally you know you what you want
Speaker 4: to take into the first in human or first in
Speaker 4: patient study is sort of a commercializable truck product because
Speaker 4: in this case you won't be able to establish bio
Speaker 4: equivalents that easily because if it's a local implant, if
Speaker 4: it's a systemic implant, yes you can do bi equivalents,
Speaker 4: but it's risking right because there's high variability. So whatever
Speaker 4: you need to do in terms of design, in terms
Speaker 4: of pre clinical work, in terms of peak and safety,
Speaker 4: you want to do it in the right model, animal model,
Speaker 4: Get the right design, and then kind of make sure
Speaker 4: that you have good line of sight as to can
Speaker 4: you can you scale up the process, Is it going
Speaker 4: to be robust? Is it going to perform appropriately before
Speaker 4: phase one? Probably even the ideal you would want to
Speaker 4: wait for an oral solid I would wait till phase
Speaker 4: two be but in this case you will have to
Speaker 4: do it ahead of time. Now that's not well received
Speaker 4: by the asset team because they would want to go fast,
Speaker 4: and so that's where the challenge occurs.
Speaker 5: Yeah, I certainly echo that, and I think to Sean's
Speaker 5: to Erx's point as well. You know, the broader the
Speaker 5: TPP in the beginning, the better it is, because then
Speaker 5: the scientists and the development team has more room to
Speaker 5: come up with a narrower scope as they go, and
Speaker 5: this progress and all of these factors that Jamie just
Speaker 5: mentioned over the period of time, you would be narrowing
Speaker 5: it down as you go more closer towards the final product,
Speaker 5: but not necessarily.
Speaker 3: You know you're you're going to define.
Speaker 5: At that point, you probably have the definition and vision
Speaker 5: way ahead of your products. So even when you have
Speaker 5: your TPPS, you probably have the vision of the product
Speaker 5: that you want to deliver to a patient. So in
Speaker 5: terms of your final presentation, but in terms of that
Speaker 5: development pathway that you know, you go with the broader
Speaker 5: scope and then you kind of narrow it down as
Speaker 5: you go. And then next part of that is they're
Speaker 5: taking an incremental step of success and not jumping through
Speaker 5: because many times you see this that you know probably
Speaker 5: end up taking a bit more risk than it's required
Speaker 5: and then end up having a more challenging situation because
Speaker 5: you know there's a study which needs to be done
Speaker 5: from the feasibility point of view, but it's it's it's
Speaker 5: not must, it's good to have, but sometimes skipping something
Speaker 5: like that can become far more challenging down the line.
Speaker 5: So having that kind of very methodical approach in this
Speaker 5: overall development, going step by step, and then when you
Speaker 5: go from that translation from pre clinical to clinical, that
Speaker 5: would significantly improve the confidence of the product. And then
Speaker 5: that's how you probably see better success with that.
Speaker 6: Just to add to that, one thing that we learned
Speaker 6: along the way is, as you mentioned, also not only
Speaker 6: having the right animal model would help a lot showing efficacy,
Speaker 6: but also the right model for the adverse events, like
Speaker 6: even inducing them into animals and having the true exhaustive
Speaker 6: basically all the experiments that can be done to induce
Speaker 6: that and to see how that adverse event can first
Speaker 6: in the first place, show up even in the smallest
Speaker 6: number of patients, just to know about it and just
Speaker 6: to have an idea if that's going to be a
Speaker 6: problem later on.
Speaker 3: For us, it comes down to two things.
Speaker 7: We need very clear communication and direction from our partners.
Speaker 7: We are not the drug experts. We don't know as
Speaker 7: much about the API as you guys do. And any
Speaker 7: other thing, of course, is the financial support. You know,
Speaker 7: we we can move as quickly as our resources allow
Speaker 7: resources allow us to. So you know, we have many
Speaker 7: different options available to us, and you know we can
Speaker 7: go slower, go faster.
Speaker 2: So I'm curious what sort of gaps in biomaterial or
Speaker 2: implant or long acting injectbal technologies do you all see
Speaker 2: that leave you wanting more like that you would look
Speaker 2: for startups or other companies to be developing for your
Speaker 2: next project or your current project.
Speaker 4: Well, the one thing which comes to my mind is
Speaker 4: the material, the components of the implant, and you could
Speaker 4: classify them as metallic or the polymeric, right, And if
Speaker 4: you look at polymeric implants, either institute gel or the
Speaker 4: pre formed implant, PLG is kind of like the standard
Speaker 4: polymer which everybody uses because it's well characterized, safe, etc.
Speaker 4: And I remember that there were a lot of other
Speaker 4: polymers evaluated and has been studied, like caprolacton, polyarthesters, polynhydrites,
Speaker 4: but unfortunately none of those polymers have kind of reached
Speaker 4: the stage where they have become sort of like a
Speaker 4: standard alternate to PLGA. And so I think there is
Speaker 4: a gap in terms of having new biomaterials which are
Speaker 4: as safe compatible like PLGA, which perform as well. And
Speaker 4: PLGA is its own issues in terms of the diffusional release,
Speaker 4: the erosinal release, and not ability to control release as well,
Speaker 4: and for metallic implant also there are limited choices and
Speaker 4: limited companies which have the ability to do that. So
Speaker 4: I think those are the things which I think I
Speaker 4: see as one of the gap into the materials available.
Speaker 5: Yeah, I think PLGA came maybe in early eighties or
Speaker 5: even earlier than that. But after that, if you see
Speaker 5: any biodegraded polymer which is approved by the FDA for
Speaker 5: any pharmaceutical application is very less especially an injectable space
Speaker 5: if we talk uh and certainly I think that is
Speaker 5: one of the key challenges to have a suitable biocompatible
Speaker 5: material and if possible a biodegradable material for an implant delivery,
Speaker 5: that would definitely make it more appealing, especially for the pharma.
Speaker 3: Companies to go and try these things.
Speaker 5: One of the challenges possibly in that one is the
Speaker 5: excipient approval pathway from the regulatory agency can be you know,
Speaker 5: a chicken and egg kind of a situation, whether you
Speaker 5: know who would be the first one to go and
Speaker 5: then try that out and and do that. But there's
Speaker 5: a lesson or multiple lessons to be learned from a
Speaker 5: device side and a device industry, because they have been
Speaker 5: quite successful using different biocompatible materials metal or non metal UH.
Speaker 5: And I think some kind of a cross collaboration between
Speaker 5: a pharma company and a device company can be really
Speaker 5: helpful in that and in that space to come up
Speaker 5: with those injectable you know, implants and more suitable biomaterials
Speaker 5: to be used for this kind of application for drug delivery.
Speaker 6: Yes, material is definitely one of the biggest gap. There
Speaker 6: is only a handful of them that has been have
Speaker 6: being tested so far, and it's mainly p g A
Speaker 6: that people use in the industry. And also one of
Speaker 6: another bigger gap that I can mention is implants for
Speaker 6: biologics that it's very hard to develop, especially with the
Speaker 6: degradable implants, and that's another area of interest. If can
Speaker 6: be developed into degredible implants.
Speaker 7: Make them as a surprise. I'm going to say materials
Speaker 7: as well my shameless plug here for self promotion. You know,
Speaker 7: from from my experience UH independent, we have seen a
Speaker 7: significant s gift and the openness UH for our drug partners.
Speaker 3: To be interested in alternative materials.
Speaker 7: I think the interest in hydrophilics and large molecules is
Speaker 7: largely driven that. As much as we can twist and
Speaker 7: poke and prod PLGA. Sometimes it's just not going to
Speaker 7: work and UH and I and we do see a
Speaker 7: shift in the in the willingness of our partners to
Speaker 7: be open to new materials.
Speaker 2: And I second that maial new materials for formulation with
Speaker 2: biologics is something that we look a lot for as well,
Speaker 2: not only for compatibility with the biologic and giving the
Speaker 2: sustained or release profile you want, but also having the
Speaker 2: ability to potentially, you know, sterilize. How do you sterilize these?
Speaker 2: And you know, we we hate doing a septic manufacturing,
Speaker 2: but it's almost the only option if you're working with
Speaker 2: any sort of particulate or implant. So one thing I've
Speaker 2: always been on the lookout for are long acting solutions
Speaker 2: for biologics that are like an in situ, in situ
Speaker 2: forming depot that maybe you can sterile filter and UH
Speaker 2: and get the right balance of release no burst, long release,
Speaker 2: no burst, and good tolerability. So that's on my wish list.
Speaker 2: Reach reach out to me later if you have something
Speaker 2: in terms of yeah, what about what about like device
Speaker 2: like implantable devices sort of deep refillable depots. I mentioned
Speaker 2: that this this like a port. How about applying those
Speaker 2: to other tissues or other sort of devices that have
Speaker 2: a sort of smart, sort of mechanical release. Any have
Speaker 2: any of you looked at those.
Speaker 4: So my so I I haven't really worked directly with them,
Speaker 4: but I know that for ocular applications that have in
Speaker 4: several implants designed. One is the port system which you describe,
Speaker 4: which gene and Tech developed where you could refill it.
Speaker 4: There was another delivery system which was like a micro
Speaker 4: electrical mechanical system where you actually was electrically driven pump
Speaker 4: to pump the fluid into the vitreos. But also I've
Speaker 4: seen papers and some work on pumps for bringing delivery local,
Speaker 4: localized delivery to the parts of the brain. Those are
Speaker 4: very you know, unique examples.
Speaker 3: I haven't.
Speaker 4: I don't have experience working with them per se.
Speaker 5: Yeah, I think limited experience in that space. But but
Speaker 5: you're looking at instead of having a passive chemical based
Speaker 5: diffusion based system, we are looking at a physical stimuli
Speaker 5: coming in either an electrical uh, you know, signal or
Speaker 5: something like that. And I think there are a lot
Speaker 5: of you know, probably a couple of areas, the therapeutic areas,
Speaker 5: maybe the contraceptives is one of them, where we have
Speaker 5: seen some of those applications, especially with metallic implants. Hope
Speaker 5: to see a lot more on the type one and
Speaker 5: type two diabetes space. We have just had that amazing
Speaker 5: discussion right before this one, and seeing something in that regard,
Speaker 5: I think either I think, just continuing to that wishless
Speaker 5: part is if a metallic implant or a biocompatible implant
Speaker 5: is inserted and if it is refillable, then that that
Speaker 5: takes a lot of these design and then formulation challenges
Speaker 5: off the table and possibly it can provide a much
Speaker 5: longer delivery.
Speaker 3: So something to look for.
Speaker 2: We have about five minutes left. We could open the
Speaker 2: floor to the audience if anyone has any questions for
Speaker 2: the panel.
Speaker 8: Hi Stephen Russell, Chief clos Circuito Bionics. I think for me,
Speaker 8: it's pretty obvious if you have a localized delivery problem,
Speaker 8: why an implant would be a really good option.
Speaker 3: But for more systemic delivery.
Speaker 8: Now that we have so many drugs at least in
Speaker 8: my diabetes space, like GLP one agnes that are given weekly,
Speaker 8: and there was a recent failure of an implant to
Speaker 8: give a GLP one in tarsia that wasn't approved, what
Speaker 8: are the specific circumstances where you would want an implant
Speaker 8: to give a drug systemically as opposed to.
Speaker 3: Locally.
Speaker 4: Yeah, I think in my experience what I'm aware of
Speaker 4: is and systemic. All say it was primary to reduce
Speaker 4: patient burden, right adherence. One of the oldest implant is
Speaker 4: the zolax implant by Estra Zeneca, which is like a
Speaker 4: very small implant implanted using a broker. And then there
Speaker 4: was an implant being developed for prosted cancer where it
Speaker 4: was like a long duration I think duration is imported.
Speaker 4: At one time one could not have assumed that you
Speaker 4: could get a long acting in the injectable that will
Speaker 4: work for six months or provide sustained pKa profile for
Speaker 4: six months. But now there are several process once every
Speaker 4: three months. Then the question is do you really want
Speaker 4: to design an implant in that condition? For systemic You're
Speaker 4: asking the right question.
Speaker 2: I think the contraceptives are pretty a good example where
Speaker 2: systemically acting implant could be used. And we talked about
Speaker 2: the broad definition of an implant from USP, so like
Speaker 2: the anti virals, those are also systemic. So I think
Speaker 2: it just depends, I know, from our perspective, or depends
Speaker 2: on that on the application. I think a long acting
Speaker 2: non implant we I usually like to think they're probably
Speaker 2: easier to manufacture and than a solid form.
Speaker 4: Yeah, well, the long acting injectibles typically the the design
Speaker 4: comes on from the API. How do you design the
Speaker 4: API to right solubility and the right PK characters characteristics
Speaker 4: in the implant? It's more forgiving, right, It's really the
Speaker 4: design of the implant which controls released, not the API.
Speaker 4: So there's a different ways in which you look.
Speaker 5: At this, maybe a slightly different perspective on that. I
Speaker 5: think necessity actually was a key driver in that when
Speaker 5: when Jamie talks about Gozarelin or Soladex implant or lhr
Speaker 5: H when they came in the early eighties and nineties,
Speaker 5: the shorter half lives actually kind of pushed the industry
Speaker 5: and said, we have to make something so these patients
Speaker 5: don't have to go through the burden of multiple injections
Speaker 5: in a day, which was almost impossible at that point.
Speaker 5: And as it grew it people understood the application and
Speaker 5: benefits of a long acting injectables and implants, and it
Speaker 5: kind of widened it reputic areas. Over the period of time,
Speaker 5: we saw the emergence not in an endochronology uh and uh,
Speaker 5: you know, in which mainly with the large and ghrge analogus.
Speaker 5: But as we grew further, we saw like this could
Speaker 5: be a very beneficial when you have patient therapeutic adheren
Speaker 5: such an issue. So that's where the you know, all
Speaker 5: of the C and S drugs came into the impact.
Speaker 5: And then now we saw the chronic administration and then
Speaker 5: drug design and that's where the viral anti viral drugs
Speaker 5: started coming in. So we are seeing more and more
Speaker 5: chronic application with the systemic circulation.
Speaker 3: With these kind of drugs.
Speaker 5: And I think it's more about at what point the
Speaker 5: industry would decide that this is a chronic administration and
Speaker 5: an implant or a long acting can be really helpful,
Speaker 5: thank you.
Speaker 2: I think also it really depends on your molecule and
Speaker 2: it's you know, it's it's safety profile. So like if youse,
Speaker 2: you know, slap an FC or lipid on a molecule
Speaker 2: and it's active, then you if you don't have a
Speaker 2: sustained release, you'll get a very high SMAX you could
Speaker 2: have toxicity. So in some of those instances, having a
Speaker 2: sustained release could give you could allow you to get
Speaker 2: the best best of both worlds, long acting and good tolerability.
Speaker 6: So some indications like antipsychotics also benefits a lot, and
Speaker 6: more recently for low income countries, vaccine application for multiple
Speaker 6: doses that would release all those adds up to the
Speaker 6: important stuff.
Speaker 2: Long acting and how do you reverse it if it
Speaker 2: gets too high? All right, Thank you everyone, and thanks
Speaker 2: to the panel. Thank you, great discussion.
Speaker 6: Thank you.
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