WEBVTT 1 00:00:00.200 --> 00:00:03.879 Welcome to Farmer Talk Radio. This podcast is focused on 2 00:00:04.080 --> 00:00:09.039 balancing between concentration and volume when developing patient centric biologics 3 00:00:09.039 --> 00:00:12.080 from the twenty twenty four our pod Partnership Opportunities in 4 00:00:12.160 --> 00:00:16.640 Drug Delivery Conference. For more information on the pod conference, editorials, podcasts, 5 00:00:16.719 --> 00:00:20.800 or webcasts, please visit Drug desh Delivery dot org. Thank 6 00:00:20.839 --> 00:00:22.120 you and enjoy the podcast. 7 00:00:23.280 --> 00:00:27.640 Okay, so, welcome to this panel session. I'm Christian Jones, 8 00:00:27.719 --> 00:00:32.039 chief commercial officer at Naniform, and I'm a patient. Well, 9 00:00:32.320 --> 00:00:35.119 I guess we all are right in this room, and 10 00:00:35.719 --> 00:00:39.920 to me, patient centricity is about providing options to patients. 11 00:00:41.560 --> 00:00:43.960 We don't always know what we want though as people, 12 00:00:44.439 --> 00:00:48.640 so necessarily we don't necessarily know what a patient centric 13 00:00:48.719 --> 00:00:52.479 medicine should look like, but it means very different things 14 00:00:52.520 --> 00:00:54.679 depending on whether we're talking about chronic. 15 00:00:54.399 --> 00:00:56.240 Disease or acute illnesses. 16 00:00:57.960 --> 00:01:01.520 Today we're going to talk about patient centricity, but with 17 00:01:01.640 --> 00:01:07.560 the perspective of high concentration formulations versus higher volume drug 18 00:01:07.599 --> 00:01:13.120 delivery for biologics. I'm going to start off with this 19 00:01:13.239 --> 00:01:16.000 slide and I'd just like to talk about how payers 20 00:01:16.120 --> 00:01:19.359 view patient centricity. I think this is quite a nice 21 00:01:19.400 --> 00:01:24.120 example of remickaide from J ANDJ. You can see that 22 00:01:24.879 --> 00:01:28.760 in the EU five markets the biosimilar took seventy two 23 00:01:28.799 --> 00:01:32.879 percent of the of the dollar share and fifty one 24 00:01:32.920 --> 00:01:38.280 percent in the US. But as the patient centric form 25 00:01:38.359 --> 00:01:41.560 came forward in a subcutaneous injection, that took a rapid 26 00:01:41.599 --> 00:01:44.359 share of the market up to twenty seven percent already, 27 00:01:44.359 --> 00:01:47.599 and it'd be fascinating to see what happens as that 28 00:01:47.680 --> 00:01:51.840 was recently launched in the US moving forward if we 29 00:01:51.920 --> 00:01:57.599 go to the next slide. So this is a bit 30 00:01:57.599 --> 00:02:00.120 of a complex slide, and if you want to a 31 00:02:00.159 --> 00:02:02.680 little bit more detail about what this actually means, come 32 00:02:02.719 --> 00:02:05.959 and talk to me afterwards at Naniform booth. But we 33 00:02:06.000 --> 00:02:11.280 analyzed all of the exclusivity public relationships around high concentration 34 00:02:11.960 --> 00:02:16.479 formulations in subcutaneous monoclonal antibody delivery, and you can see 35 00:02:16.520 --> 00:02:18.400 here that the race is on to try to lock 36 00:02:18.439 --> 00:02:22.479 in exclusivity around certain technologies in this space with the 37 00:02:22.520 --> 00:02:29.639 colored bars representing different solution providers. But you know, one 38 00:02:29.680 --> 00:02:32.360 technology isn't always the answer for one target, and there 39 00:02:32.360 --> 00:02:35.560 are even examples there's one company that's actually locked in 40 00:02:35.599 --> 00:02:38.439 two different technologies for the same target, but it's a 41 00:02:38.520 --> 00:02:42.360 very very complicated space, but people are really trying to 42 00:02:42.400 --> 00:02:46.199 develop the most patient centric forms by accessing innovation. And 43 00:02:46.240 --> 00:02:49.199 with that, I'd like to move on to the discussion today, 44 00:02:49.759 --> 00:02:54.919 and I'd like my panelists here to introduce themselves and 45 00:02:55.039 --> 00:02:59.159 also to say what they believe patient centricity means to them. 46 00:02:59.439 --> 00:03:00.879 So perhaps we could start with Nick. 47 00:03:01.960 --> 00:03:04.840 Sure, Thanks Christian, So I'm mixed Schill. I head up 48 00:03:04.879 --> 00:03:05.759 the product. 49 00:03:05.479 --> 00:03:08.680 Development and commercialization team at Kaimanox, which is a life 50 00:03:08.680 --> 00:03:13.319 science services provider, So I would say the definition of 51 00:03:13.599 --> 00:03:16.639 patient centricity is pretty straightforward, but I think it starts 52 00:03:16.639 --> 00:03:21.240 with asking a few questions around understanding the disease journey 53 00:03:21.319 --> 00:03:24.439 of a particular patient population and such questions you may 54 00:03:24.479 --> 00:03:26.919 ask if you're developing a product, is what is the 55 00:03:26.960 --> 00:03:29.800 existing standard of care, what is it not getting right, 56 00:03:29.840 --> 00:03:33.599 what unmet need needs to be filled? And where Honestly, 57 00:03:33.919 --> 00:03:36.199 if you were a patient, would you actually want to 58 00:03:36.280 --> 00:03:38.400 use this product? And to me, that's kind of the 59 00:03:38.439 --> 00:03:42.120 most important question to ask, because I've encountered some products in. 60 00:03:42.039 --> 00:03:45.599 My career thus far that I don't know who created. 61 00:03:45.280 --> 00:03:47.719 This, but they obviously didn't think about who was going 62 00:03:47.759 --> 00:03:51.680 to use it, and that is a very difficult scenario 63 00:03:51.840 --> 00:03:52.960 to be in if you're a patient. 64 00:03:53.280 --> 00:03:56.479 Now, don't get me wrong, novel therapeutics should get the 65 00:03:56.520 --> 00:03:57.960 market as quickly as possible. 66 00:03:58.039 --> 00:04:00.800 Right If there is truly an unmet need in that space, 67 00:04:00.879 --> 00:04:04.240 we need to get a new therapy as quickly as possible. However, 68 00:04:04.280 --> 00:04:07.199 it needs to at least be usable. Maybe not patient 69 00:04:07.280 --> 00:04:12.599 centric to a t, but at least usable. Thanks Nick, Lindsey, Yeah, 70 00:04:12.599 --> 00:04:13.000 thank you. 71 00:04:13.719 --> 00:04:17.720 I'm Lindsay Crawford. I am in drug product development at Vizor, 72 00:04:18.399 --> 00:04:23.040 and to me, patient centricity is keeping in mind the 73 00:04:23.120 --> 00:04:26.480 patient through all those phases of development, remembering them from 74 00:04:26.519 --> 00:04:29.160 the beginning all the way through that commercial product, and 75 00:04:29.600 --> 00:04:33.040 it's thinking about what would be best for the administration 76 00:04:33.160 --> 00:04:35.600 of the product, but also what's going to give them 77 00:04:35.600 --> 00:04:38.120 the lifestyle that they deserve to have while they're taking 78 00:04:38.120 --> 00:04:41.680 this treatment. How can they travel, how can they live 79 00:04:41.720 --> 00:04:44.439 their normal life? What will make the best for them? 80 00:04:45.079 --> 00:04:47.399 Super thanks and Danny. 81 00:04:47.519 --> 00:04:50.759 Hello, Daniel, just say I lead the early engagement or 82 00:04:50.800 --> 00:04:55.279 the vice ability team at GSK, part of the packaging 83 00:04:55.360 --> 00:05:00.839 design and the vice solutions. To me, patients interest is 84 00:05:00.920 --> 00:05:08.399 really engaging early with our discovery colleagues. Again, working with 85 00:05:08.560 --> 00:05:12.000 the right target product profile to make sure that we 86 00:05:12.120 --> 00:05:17.720 understand that the patient needs bringing some early formative human 87 00:05:17.800 --> 00:05:22.240 factor study, not waiting till before phase three to start 88 00:05:22.279 --> 00:05:25.439 thinking about what the device should be. So really the 89 00:05:25.480 --> 00:05:29.680 early engagement is patient centric super. 90 00:05:31.319 --> 00:05:32.399 My name is Egan. 91 00:05:32.720 --> 00:05:39.480 I'm head of injection systems for Taketa, So patient centricity 92 00:05:39.800 --> 00:05:43.639 for me, in general, I think it is some deep 93 00:05:43.839 --> 00:05:50.240 understanding of the patient population, user, user conditions and use 94 00:05:50.399 --> 00:05:57.240 conditions and if this is in general term conditions contacts 95 00:05:57.279 --> 00:06:04.839 of developing a UH drug product delivery solutions. But if 96 00:06:04.839 --> 00:06:09.439 I can be laser focused on these bio logic development 97 00:06:09.920 --> 00:06:14.600 and I would say in this case is the the 98 00:06:15.120 --> 00:06:21.720 you know, high performance challenges associated with these high volume, 99 00:06:21.959 --> 00:06:25.560 high viscusity discussion formulation. 100 00:06:26.439 --> 00:06:27.240 Thanks very much. 101 00:06:27.720 --> 00:06:30.240 Okay, So moving to sort of the first question for 102 00:06:30.319 --> 00:06:34.959 the panel, and I'd like to just ask e and 103 00:06:35.120 --> 00:06:38.519 Lindsey what do you consider as the current state of 104 00:06:38.560 --> 00:06:42.519 the art today when we think about injectable biologics and 105 00:06:42.519 --> 00:06:46.319 what are the limitations from a formulation and a device perspective. 106 00:06:46.360 --> 00:06:48.199 Maybe if you could you could. 107 00:06:48.079 --> 00:06:51.279 Start sure I can, I can pick it off and 108 00:06:52.120 --> 00:06:57.000 feel free to jump in and add so these when 109 00:06:57.079 --> 00:07:00.839 me talk about this, you know, particular on the volume 110 00:07:00.959 --> 00:07:05.079 and balancing the constitution and volume. You know, maybe we 111 00:07:05.480 --> 00:07:09.279 first immediately jump into the liquid formulation, but keep in 112 00:07:09.319 --> 00:07:13.319 mind many of these biologic products are still in the 113 00:07:13.480 --> 00:07:19.120 solid those forms. So the there are you know, available 114 00:07:19.600 --> 00:07:27.160 many available options for reconstitution and of these uh solid 115 00:07:27.240 --> 00:07:32.879 form and those kind of devices. But primary containers most 116 00:07:33.000 --> 00:07:36.000 likely to be like a wiles and the you know, 117 00:07:36.079 --> 00:07:41.519 the delivery devices will be a syringe or so. These 118 00:07:41.600 --> 00:07:46.040 kind of like A configurations provided the most flexibility in 119 00:07:46.120 --> 00:07:53.279 terms of delivering high high volume and vi viscus UH product. However, 120 00:07:53.680 --> 00:07:58.399 the limit, the limitation is the usability for uh self 121 00:07:58.480 --> 00:08:02.199 inject injection of care. This is most likely to be 122 00:08:02.439 --> 00:08:07.279 like at the clinic setting, so and a little bit 123 00:08:08.000 --> 00:08:12.759 more convenience to the to the users UH will be 124 00:08:12.800 --> 00:08:17.000 the you know those for uh the deal chamber uh 125 00:08:17.319 --> 00:08:22.199 syringes or chamber cartridges. So this uh you know, this 126 00:08:22.399 --> 00:08:26.319 kind of a device. Primary container can can be integrated 127 00:08:26.360 --> 00:08:33.480 with a few reconstitution options and enable the self injection 128 00:08:33.600 --> 00:08:37.200 at home. But the likely the limitation on the volume 129 00:08:37.600 --> 00:08:41.240 is like a T to M L and uh you know, 130 00:08:41.279 --> 00:08:45.399 the viscosity. You really cannot be very high because this 131 00:08:45.879 --> 00:08:49.480 normally require like a you know, uh the menu injection 132 00:08:50.240 --> 00:08:56.080 so and the other you know, more convenient uh uh technologies. 133 00:08:56.240 --> 00:09:00.039 Deliberate technologies will be like pre fiell syringe based and 134 00:09:00.039 --> 00:09:03.720 and if it is like you know, with a safety 135 00:09:03.960 --> 00:09:08.519 uh devices to go together, normally this is uh. The 136 00:09:08.559 --> 00:09:11.840 limitation will be you know, the on the volume and 137 00:09:12.480 --> 00:09:17.320 normally will below tom L and there are you know 138 00:09:17.720 --> 00:09:22.240 a few options above TWOML, but below like five IML. 139 00:09:22.519 --> 00:09:26.000 I would say I would have concerts regarding the you know, 140 00:09:26.120 --> 00:09:31.080 the menu injection is especially for home care and also 141 00:09:31.120 --> 00:09:34.799 these a you know patient you know discomfort associated with 142 00:09:34.879 --> 00:09:39.200 this kind of a large volume injection and our injectors 143 00:09:39.279 --> 00:09:44.879 with the carriage or prey fill syringe is available as well. 144 00:09:45.919 --> 00:09:50.720 And for like a very high volume, very high uh 145 00:09:50.919 --> 00:09:54.600 viscosity uh, this kind of formulation we have about it 146 00:09:54.919 --> 00:09:58.120 verse system available in recent years, we have a few 147 00:09:58.399 --> 00:10:05.440 commercialized per okay, yes, super and lindsay, yeah. 148 00:10:04.879 --> 00:10:05.720 I agree. 149 00:10:05.759 --> 00:10:08.480 I think the you know, the current kind of ideal 150 00:10:08.519 --> 00:10:11.159 scenario is that it's alone enof volume, Like we said, 151 00:10:11.519 --> 00:10:14.320 you typically find that it's like two mills for maybe 152 00:10:14.320 --> 00:10:18.440 a subcutaneous injection, and I think the challenge that we're 153 00:10:18.480 --> 00:10:21.120 facing is that with some of these products that require 154 00:10:21.200 --> 00:10:25.440 a higher dose, the volume either needs to be higher 155 00:10:25.480 --> 00:10:27.039 than that or you have to have a very high 156 00:10:27.080 --> 00:10:30.639 concentration of your product. And with those high concentrations, you 157 00:10:30.759 --> 00:10:33.720 tend to run into those challenges where you not only 158 00:10:33.799 --> 00:10:38.279 have technical challenges during administration with high viscosity, but you 159 00:10:38.279 --> 00:10:42.919 can also have manufacturing challenges with those high viscosities as well. 160 00:10:43.240 --> 00:10:48.000 And so I think overcoming those challenges from the technical 161 00:10:48.039 --> 00:10:51.960 perspective will really be transformational for what we can do 162 00:10:52.000 --> 00:10:52.519 in the future. 163 00:10:53.080 --> 00:10:58.639 Super great answers. So turning from what's today you know 164 00:10:58.720 --> 00:11:01.120 a parent and what we can use to perhaps what's 165 00:11:01.120 --> 00:11:05.240 on the horizon, Danny, I am keen to understand your 166 00:11:05.279 --> 00:11:08.519 perspective with respects to what do you see coming that's 167 00:11:08.559 --> 00:11:10.159 going to be really exciting in this field. 168 00:11:11.039 --> 00:11:17.320 Yes, I'll split in two different technologies and some of 169 00:11:17.360 --> 00:11:20.840 the internal processes in the industry, some of the changes, 170 00:11:20.919 --> 00:11:24.399 and we're fortunate to have a lot of great example 171 00:11:24.440 --> 00:11:29.799 here at pub this week on the processes. I've been 172 00:11:29.840 --> 00:11:35.120 hearing a lot of the same team around formulation, packaging, 173 00:11:35.360 --> 00:11:39.759 device coming in together our early alignment with clinical and 174 00:11:39.799 --> 00:11:43.679 commercial to design the right product. To me that this 175 00:11:43.720 --> 00:11:46.759 is really exciting, you know, this is the early engagement, 176 00:11:46.799 --> 00:11:48.000 the time to start. 177 00:11:49.000 --> 00:11:49.679 As far as. 178 00:11:49.600 --> 00:11:55.720 Technology, usually with the help of some of the excipients, 179 00:11:55.879 --> 00:11:59.159 you can formally probably around one hundred and one fifty 180 00:11:59.279 --> 00:12:00.159 two hundred. 181 00:12:00.080 --> 00:12:03.960 The most make PROMIL. Some of the new nano. 182 00:12:03.799 --> 00:12:08.639 Micropowericles and polymer technology are helping us to push some 183 00:12:08.759 --> 00:12:12.360 of the boundaries up to four or five and maybe 184 00:12:12.559 --> 00:12:16.200 even six hundred MAKEPROMIL. So a lot of work to 185 00:12:16.279 --> 00:12:20.879 do to make sure here we form stable drug product 186 00:12:20.919 --> 00:12:22.960 in the end and it can be delivered properly. 187 00:12:23.039 --> 00:12:25.600 But a lot of the exciting work in that film 188 00:12:26.440 --> 00:12:30.120 absolutely and e any thoughts on that too. 189 00:12:31.320 --> 00:12:36.600 In the device technology area, so there were recent years 190 00:12:37.600 --> 00:12:42.440 development of a large volume of architectures, so large volume 191 00:12:42.759 --> 00:12:45.960 above two mL and below like five m L. There 192 00:12:45.960 --> 00:12:50.480 are so many A few device vendors also are presenting 193 00:12:50.519 --> 00:12:58.120 their technologies here in this conference and to overcome just 194 00:12:58.799 --> 00:13:02.399 inject volume larger than five amml or even like a 195 00:13:02.679 --> 00:13:08.639 you know, very viscous uh formulations. The body deliverer technologies 196 00:13:08.720 --> 00:13:11.679 are you know on the horizon. Actually there are like 197 00:13:11.879 --> 00:13:17.159 two three commercialized products on the market already with one 198 00:13:17.480 --> 00:13:22.840 just withdraw recent today. So on body deliverse system has 199 00:13:23.159 --> 00:13:28.759 seems you know, provided the UH the most potential for 200 00:13:29.159 --> 00:13:37.039 large volume UH and from formulations UH the standpoint, there 201 00:13:37.080 --> 00:13:44.000 were so many new advanced formulation technologies are available in 202 00:13:44.120 --> 00:13:45.440 the development already. 203 00:13:45.519 --> 00:13:48.000 So in the UH yesterday and today. 204 00:13:47.720 --> 00:13:54.840 There are a few printations regarding the nanoparticles microsphere suspensions. 205 00:13:54.840 --> 00:13:57.840 So these you know, these are very very exciting and 206 00:13:57.879 --> 00:14:02.720 then you know quickly these formulation concentration can be like 207 00:14:02.759 --> 00:14:08.120 a double even like a triple from you know traditional formulation, right, 208 00:14:08.480 --> 00:14:12.360 so it can be even rich above neck six hundred 209 00:14:12.480 --> 00:14:16.679 milligrams per amal or a thousand mediagram per depending on 210 00:14:16.759 --> 00:14:20.519 the technology we are talking about. Another thing to U 211 00:14:20.759 --> 00:14:24.679 technology to enable these a large volume injection is that 212 00:14:24.679 --> 00:14:30.399 that the enzyme development. So just an example, where would 213 00:14:30.399 --> 00:14:36.440 be like the HOLOGYM to improve the dissipation of the 214 00:14:36.679 --> 00:14:40.960 liquid in the subculteneous tissue and then in a very 215 00:14:41.120 --> 00:14:44.840 large bollets UH deliverery. 216 00:14:45.600 --> 00:14:50.039 Yeah absolutely, obviously you know all these innovations, they're they're great. 217 00:14:50.159 --> 00:14:52.879 But with with with innovation comes challenges as well. So 218 00:14:52.919 --> 00:14:57.320 we have to really think technically, regulatory wise, and commercially 219 00:14:57.320 --> 00:14:59.720 how to address them to make sure that these innovations 220 00:14:59.720 --> 00:15:04.759 can to market for the benefit of patients. Final question 221 00:15:05.000 --> 00:15:09.600 really is around what's got the potential to completely disrupt 222 00:15:09.639 --> 00:15:13.120 the future of drug delivery in the biologic space. You know, 223 00:15:13.159 --> 00:15:15.519 we see what's going on now, but what is the 224 00:15:15.519 --> 00:15:20.039 panacea in this space and what are the barriers that 225 00:15:20.080 --> 00:15:21.720 we need to overcome to enable this? 226 00:15:21.759 --> 00:15:24.799 And perhaps lindsay if you could give your thoughts on. 227 00:15:24.759 --> 00:15:27.080 This, sure, sure, And I think you just alluded to 228 00:15:27.120 --> 00:15:30.679 some of that as well. I think part it's really 229 00:15:31.080 --> 00:15:33.080 a combination of things that I think have to come 230 00:15:33.120 --> 00:15:37.679 together to really kind of overcome and transform how we 231 00:15:37.759 --> 00:15:42.159 can think about these high concentration, large volume products. I 232 00:15:42.240 --> 00:15:44.919 think there's definitely a formulation component to it, and what 233 00:15:44.960 --> 00:15:47.879 can we do with the formulation. Is there different excipients 234 00:15:47.919 --> 00:15:50.240 we can think about using. You know, we have those 235 00:15:50.240 --> 00:15:55.000 eccipients that we've traditionally seen with our products, but how 236 00:15:55.000 --> 00:15:58.000 can we introduce new excipients into that market to help 237 00:15:58.039 --> 00:16:01.360 with some of those technical challenges. Combine that with things 238 00:16:01.440 --> 00:16:05.799 like modeling early on with different routes of administration and 239 00:16:05.919 --> 00:16:08.840 doing this all from an early stage can help us, 240 00:16:08.960 --> 00:16:13.240 you know, understand the combination of those things in product 241 00:16:13.320 --> 00:16:16.279 development so we can get them to a commercial state. 242 00:16:17.639 --> 00:16:20.519 Super and Nick, you've got a lot of experience in 243 00:16:20.519 --> 00:16:24.200 consulting in this space and understanding the product development strategies 244 00:16:24.200 --> 00:16:26.799 around some of these types of products. What's your thoughts 245 00:16:26.799 --> 00:16:29.480 around what could disrupt in the future and how to 246 00:16:29.600 --> 00:16:30.919 overcome some of the barriers. 247 00:16:31.120 --> 00:16:31.320 Yeah? 248 00:16:31.360 --> 00:16:34.679 Sure, And I think first I've let's talk about some barriers, right. 249 00:16:34.960 --> 00:16:39.440 So at Kimbox, we obviously worked with quite a few companies. 250 00:16:40.320 --> 00:16:42.279 I don't know the exact number, but it's probably close 251 00:16:42.320 --> 00:16:45.879 to one hundred and fifty various pharma and advice companies. 252 00:16:45.879 --> 00:16:48.240 And I think some of the common themes that I 253 00:16:48.279 --> 00:16:50.879 see first of all is fear of risk. 254 00:16:51.200 --> 00:16:51.440 Right. 255 00:16:52.240 --> 00:16:54.360 I can't tell you in the last year how many 256 00:16:54.360 --> 00:16:58.120 times I've had a biologic sponsor come to us and say, Hey, 257 00:16:58.200 --> 00:17:01.200 we have this great new asset, we really need an 258 00:17:01.240 --> 00:17:04.400 injection system to use with it. We're going off the shelf. 259 00:17:04.400 --> 00:17:06.160 We're going as simple and as risk free as you 260 00:17:06.240 --> 00:17:08.119 possibly can. What can you give us, what can you 261 00:17:08.160 --> 00:17:10.039 help you know, what connections can you make for us? 262 00:17:10.599 --> 00:17:12.519 And well that's great. I mean I understand, right. 263 00:17:12.720 --> 00:17:14.759 The thought is we do not want to take additional 264 00:17:14.880 --> 00:17:19.720 risk during a complex biologic development program in order just 265 00:17:19.759 --> 00:17:24.039 to differentiate, because maybe the drug is supposedly the differentiator. 266 00:17:24.119 --> 00:17:25.680 Right, does this drug work better. 267 00:17:25.480 --> 00:17:28.079 Than anything else out there, Well, then you really don't 268 00:17:28.079 --> 00:17:32.400 need a custom autoinjector that has a different geometry than what's. 269 00:17:32.240 --> 00:17:34.079 Already out there, because who cares, right. 270 00:17:34.160 --> 00:17:36.519 The patient's more concerned about whether or not the drug works, 271 00:17:36.519 --> 00:17:39.240 and I think sometimes we really do forget about that. 272 00:17:40.279 --> 00:17:41.960 A couple of years ago, I was working. 273 00:17:41.640 --> 00:17:45.440 With a particular product and we did a patient research 274 00:17:45.480 --> 00:17:49.279 study and there was a gentleman who, in this particular. 275 00:17:48.880 --> 00:17:50.839 Case had all sort of collitis that he. 276 00:17:50.839 --> 00:17:55.079 Was asked various questions about different delivery systems and what 277 00:17:55.160 --> 00:17:59.160 his preferred autoinjector was, and he kind of he looked 278 00:17:59.160 --> 00:18:02.079 at the moderator and just responding pretty flat, lay, well, 279 00:18:02.079 --> 00:18:05.799 whichever one, whicheveryone delivers a drug that will stop me 280 00:18:05.839 --> 00:18:08.119 from having to find a bathroom every ten minutes. And 281 00:18:08.200 --> 00:18:10.319 I thought that was it just kind of you know, 282 00:18:10.480 --> 00:18:11.960 I did a double take on it as well, because 283 00:18:11.960 --> 00:18:15.279 he's right, But I think is the product can the 284 00:18:15.279 --> 00:18:18.559 product be used, Yes, does the patient care about the 285 00:18:18.599 --> 00:18:21.039 real little minution that maybe the engineers care about? 286 00:18:21.279 --> 00:18:25.240 Maybe not right? I think the second thing that I see. 287 00:18:25.119 --> 00:18:27.359 Quite a bit is folks trying to solve a chemical 288 00:18:27.400 --> 00:18:30.640 problem by mechanical means. Right, So, Hey, we have this 289 00:18:30.680 --> 00:18:32.960 great new biologic, we need to formulate this at two 290 00:18:33.000 --> 00:18:35.920 hundred meg per mill We're going to deliver five mel tenml? 291 00:18:36.000 --> 00:18:38.440 What can we possibly do here to deliver this product? 292 00:18:39.119 --> 00:18:43.559 And sometimes I think they lose sight of what exactly 293 00:18:43.559 --> 00:18:47.240 are you trying to accomplish. Are you trying to go 294 00:18:47.279 --> 00:18:50.319 to more or less frequent dosing and that's why you're 295 00:18:50.319 --> 00:18:52.880 trying to deliver twenty AML of a biologic or tenml 296 00:18:52.960 --> 00:18:55.039 or whatever it is. And if that's the case, what 297 00:18:55.119 --> 00:18:57.240 is that duration? Is it once a month? Is it 298 00:18:57.279 --> 00:18:59.039 every two months? Is it every six months? Is it 299 00:18:59.039 --> 00:19:01.039 once a year? Because I know there are some products 300 00:19:01.039 --> 00:19:03.960 that are in development or currently are on the market 301 00:19:04.000 --> 00:19:06.680 that are advertising once you get to a maintenance state, 302 00:19:06.759 --> 00:19:09.519 you're going to be delivering this product once a year. 303 00:19:09.680 --> 00:19:12.759 So from that perspective, even though maybe it's not the 304 00:19:12.799 --> 00:19:17.519 most patient centric or patient friendly option, what's against loading 305 00:19:17.599 --> 00:19:19.440 up ten mls into a syringe and putting it on 306 00:19:19.440 --> 00:19:21.880 a syringe pump and deliver that subque. They can do 307 00:19:21.880 --> 00:19:25.359 that in a doctor's office. It's done once per year. Yes, 308 00:19:25.400 --> 00:19:27.960 it's not elegant, it's not glamorous, but it works. It 309 00:19:27.960 --> 00:19:30.160 gets a job done, and the patient burden going to 310 00:19:30.200 --> 00:19:32.079 an office once per year is really not that big 311 00:19:32.079 --> 00:19:35.599 of a burden. So that's kind of another consideration. And 312 00:19:35.640 --> 00:19:38.200 I guess finally, on the innovation side, and we've been 313 00:19:38.200 --> 00:19:41.039 talking about this a lot at this particular conference, is 314 00:19:41.079 --> 00:19:43.759 of course GLP one. Everyone wants to talk about GLP one. 315 00:19:44.559 --> 00:19:47.160 So kind of like other things that happen in society, 316 00:19:47.240 --> 00:19:49.880 do you have a particular hot topic that then drives 317 00:19:49.920 --> 00:19:53.319 innovation in an associated space. So in this case, I 318 00:19:53.359 --> 00:19:55.200 don't have a crystal ball and tell you what some 319 00:19:55.240 --> 00:19:58.039 of the innovators in the GLP space will come up 320 00:19:58.079 --> 00:20:00.559 with next, but I would be shock if they did 321 00:20:00.559 --> 00:20:05.039 not drive innovation and new delivery technologies around a GOLP 322 00:20:05.160 --> 00:20:07.680 one molecule because there will be a push to differentiate 323 00:20:07.680 --> 00:20:11.680 in that space. Patients will need different options versus what's 324 00:20:11.680 --> 00:20:14.039 out there, and especially as the molecules. 325 00:20:13.559 --> 00:20:16.799 Themselves start to evolve and become more potent. 326 00:20:16.920 --> 00:20:19.079 I think you're going to see a lot of different 327 00:20:19.160 --> 00:20:22.039 delivery systems that are introduced based on the funding that 328 00:20:22.079 --> 00:20:26.319 are off the revenue of these GOLP molecules, and whether 329 00:20:26.359 --> 00:20:30.720 that's formulation, chemistry, whether that's just a novel inter or 330 00:20:30.759 --> 00:20:35.039 i'm sorry, connected delivery device. Maybe it's taking a GOLP 331 00:20:35.200 --> 00:20:38.640 one merging with a device that then monitors patient adherence compliance. 332 00:20:38.680 --> 00:20:41.359 I know we have folks that love talking about connectivity, 333 00:20:41.839 --> 00:20:44.920 but is connectivity of value? Well, in this case, if 334 00:20:44.920 --> 00:20:46.319 it's linked to an app that. 335 00:20:46.200 --> 00:20:48.759 Then allows for a patient. 336 00:20:48.480 --> 00:20:51.799 To be tracking their weight loss progress and motivates them 337 00:20:51.799 --> 00:20:53.720 to keep doing more and eventually weans them off a 338 00:20:53.799 --> 00:20:55.240 GLP one, maybe. 339 00:20:55.000 --> 00:20:57.200 That's a great application for that type of technology. 340 00:20:57.319 --> 00:21:00.319 So I think the future of all this, I think 341 00:21:00.440 --> 00:21:02.319 is I think it's gonna be on the back of 342 00:21:02.319 --> 00:21:05.400 the GLP want just because that's where the revenue is, 343 00:21:05.440 --> 00:21:06.960 and I think the company's doing it will want to 344 00:21:06.960 --> 00:21:08.200 innovate just to protect. 345 00:21:07.960 --> 00:21:08.559 Their market share. 346 00:21:10.079 --> 00:21:14.759 Absolutely great views there, Nick, and I think just to 347 00:21:15.519 --> 00:21:19.319 close and to wrap up, it's clear that there are 348 00:21:19.400 --> 00:21:23.119 some super exciting innovations in development soon to hit the market. 349 00:21:24.119 --> 00:21:27.640 Whilst we think we know what patients want, often patients 350 00:21:27.640 --> 00:21:29.480 don't actually realize what is possible. 351 00:21:30.039 --> 00:21:31.240 And I'd like to. 352 00:21:31.279 --> 00:21:33.000 Sort of, you know, ask you all to think back 353 00:21:33.039 --> 00:21:37.559 to Steve Jobs, right as somebody reminded me of this 354 00:21:37.640 --> 00:21:41.200 last night when I was at dinner gentlemen from Novnordisk, 355 00:21:41.480 --> 00:21:45.240 and he said, look, you know, Steve Jobs created the 356 00:21:45.240 --> 00:21:50.240 iPhone by putting lots of innovation together in a single device. 357 00:21:51.079 --> 00:21:53.640 But people at that time didn't realize that they wanted it. 358 00:21:54.519 --> 00:21:57.000 They didn't realize what was possible until they had it, 359 00:21:57.359 --> 00:22:00.519 and now people can't really do without it. And I 360 00:22:00.519 --> 00:22:03.200 think that's also something that we should think about when 361 00:22:03.200 --> 00:22:06.160 it comes to drug delivery. Often, you know, we think 362 00:22:06.200 --> 00:22:08.359 we know what the patient wants, or perhaps we have 363 00:22:08.440 --> 00:22:13.200 perspective of what is required for patient centricity, but sometimes 364 00:22:13.200 --> 00:22:15.200 we need to go outside the box and think what 365 00:22:15.240 --> 00:22:17.680 could we do to make something that you know, nobody's 366 00:22:17.680 --> 00:22:20.240 ever thought of before. Let's try to push the boundaries 367 00:22:20.279 --> 00:22:22.680 of science and innovation. And I think that's why we're 368 00:22:22.680 --> 00:22:24.680 all here, that's why we're all invested, is to try 369 00:22:24.680 --> 00:22:29.279 and make better patient, better products for patients. So let's 370 00:22:29.279 --> 00:22:32.000 continue to do that. Let's continue to innovate for the 371 00:22:32.039 --> 00:22:33.119 benefit of patients. 372 00:22:33.519 --> 00:22:34.319 Thank you very much. 373 00:22:41.839 --> 00:22:45.400 I think first of all those who are standing in 374 00:22:45.440 --> 00:22:47.559 the back of the room please come on forward. There's 375 00:22:47.640 --> 00:22:50.920 plenty of room up front. But I also first of 376 00:22:50.920 --> 00:22:53.039 all thank you to the panel. Maybe another round of 377 00:22:53.039 --> 00:23:01.599 applause for the panel, But we do have time for questions, 378 00:23:01.799 --> 00:23:04.960 and so i'd love for us again. You know, life 379 00:23:05.000 --> 00:23:09.240 is not a passive event. Please engage. Let's ask questions 380 00:23:09.279 --> 00:23:13.319 of the panel and step forward. There's a microphone here, 381 00:23:14.200 --> 00:23:16.400 but I might ask the panel maybe to respond to 382 00:23:16.440 --> 00:23:21.440 something when we talk about balancing between concentration and volume. 383 00:23:23.240 --> 00:23:24.759 The user population is. 384 00:23:24.720 --> 00:23:29.599 Not homogeneous, right we have we have for example, pediatrics, right, 385 00:23:29.680 --> 00:23:32.599 we have different user populations. I wonder if the panel 386 00:23:32.599 --> 00:23:36.359 can perhaps respond to their thoughts around some of those 387 00:23:36.640 --> 00:23:41.799 particular opportunities, and maybe we can use pediatrics as a 388 00:23:41.880 --> 00:23:46.000 launch point or whatever whatever you would like to share. 389 00:23:47.680 --> 00:23:50.799 To me at some point to understand the patient and 390 00:23:50.839 --> 00:23:55.960 the patient journey. Nick touch on some of the points 391 00:23:56.000 --> 00:24:03.839 around volume of injection and frequency of injection. Again, you know, 392 00:24:03.920 --> 00:24:06.720 it's ideal if you can design to the molecule, if 393 00:24:06.799 --> 00:24:09.799 you can add half life where they don't need you. 394 00:24:09.799 --> 00:24:11.000 Know, as frequent dosing. 395 00:24:11.519 --> 00:24:15.319 Sometimes you need different technology where you need to extend 396 00:24:15.319 --> 00:24:19.680 the half life. But it's really important to understand also 397 00:24:19.720 --> 00:24:23.000 from a sustainabilities timepoint and a reimbursement. 398 00:24:23.039 --> 00:24:24.279 We haven't really touched on this. 399 00:24:25.160 --> 00:24:28.680 These are all impotant factors and sometimes we're so focused 400 00:24:28.720 --> 00:24:32.160 on the device and the technical aspect. But maybe there's 401 00:24:32.200 --> 00:24:35.039