WEBVTT 1 00:00:00.280 --> 00:00:03.600 Welcome to Pharma Talk Radio. This podcast is focused on 2 00:00:03.799 --> 00:00:08.279 platform approaches to streamline combination product development from the twenty 3 00:00:08.279 --> 00:00:12.839 twenty five pod Partnership Opportunities in Drug Delivery Conference. For 4 00:00:12.960 --> 00:00:17.039 more information on the pod conference, editorials, podcasts, or webcasts, 5 00:00:17.320 --> 00:00:20.519 please visit Drug desh Delivery dot org. Thank you and 6 00:00:20.640 --> 00:00:21.600 enjoy the podcast. 7 00:00:21.960 --> 00:00:24.199 Our session today that we're going to have this panel 8 00:00:24.239 --> 00:00:28.600 discuss is on platform approaches for device and combination product development. 9 00:00:32.439 --> 00:00:35.840 We really want to start with each person briefly introducing 10 00:00:35.880 --> 00:00:40.240 yourself and really telling us what you think platform approach 11 00:00:40.320 --> 00:00:42.640 for device and combination product development means. 12 00:00:44.560 --> 00:00:49.039 Same great, I didn't realize by sitting here i'd go first, 13 00:00:48.840 --> 00:00:51.600 But I'm Monica Swiney. I had innovation and new product 14 00:00:51.640 --> 00:00:55.719 planning for a device's packaging and process at GILLIAD Sciences. 15 00:00:56.359 --> 00:01:00.880 And in terms of what does a platform approach really 16 00:01:00.920 --> 00:01:02.960 mean to us, I think that you know, first of all, 17 00:01:03.000 --> 00:01:08.040 it's it's a family of device. We talk about drug delivery, 18 00:01:08.040 --> 00:01:14.799 a family of devices that has sufficient optionality to enable 19 00:01:16.519 --> 00:01:19.799 I would say a vast majority of the pipeline that 20 00:01:19.920 --> 00:01:23.879 you see coming down the road. That's the first and foremost. 21 00:01:25.519 --> 00:01:31.159 I'm Tim Quigg, development director at Crux Product Design. I'd 22 00:01:31.200 --> 00:01:35.359 almost have two definitions for platforms. The first we could 23 00:01:35.400 --> 00:01:38.200 keep very simple, you know, and nine to describe a 24 00:01:38.239 --> 00:01:40.560 device that could be used for two or more assets, 25 00:01:41.000 --> 00:01:44.719 The more the better to kind of amortize the value. 26 00:01:45.120 --> 00:01:48.120 But I think the second could be maybe summarized a 27 00:01:48.159 --> 00:01:50.400 little bit more as a as a mindset of how 28 00:01:50.439 --> 00:01:55.400 do you generate data, generate usability data, whatever it might 29 00:01:55.480 --> 00:01:56.439 be that could. 30 00:01:56.239 --> 00:01:58.239 Be used across assets. 31 00:01:58.719 --> 00:02:01.159 And I think I've been a cross since twenty twelve 32 00:02:01.200 --> 00:02:05.239 and definitely seeing a pharma shift towards trying to leverage 33 00:02:05.280 --> 00:02:08.520 assets in more than one program, and I almost describe 34 00:02:08.560 --> 00:02:11.240 that as platformization. You know, how do we think a 35 00:02:11.319 --> 00:02:17.000 little bit broader than just the device alone. 36 00:02:17.639 --> 00:02:21.639 Hello, I'm shiaching Ole, director of Device and Combination product 37 00:02:21.639 --> 00:02:23.360 Development at Takeda. 38 00:02:24.719 --> 00:02:25.039 To Me. 39 00:02:26.400 --> 00:02:31.080 Platform in an ideal world is plug and play of 40 00:02:31.240 --> 00:02:36.120 the drug delby device in such a way that the 41 00:02:37.680 --> 00:02:44.240 drug delby device can a commonate range of drug product 42 00:02:44.319 --> 00:02:48.400 or medicinal product formulations, range of primary containers, and range 43 00:02:48.400 --> 00:02:51.000 of user populations. 44 00:02:51.919 --> 00:02:53.879 That's the ideal world. 45 00:02:54.159 --> 00:02:58.000 In real world, it can be more challenging than that, 46 00:02:58.599 --> 00:03:04.759 and it takes some efforts upfront before we can benefits 47 00:03:04.800 --> 00:03:06.120 of that, but it is possible. 48 00:03:09.199 --> 00:03:12.439 Hi, everybody, Brad Gould that I'm a director of Device 49 00:03:12.479 --> 00:03:16.280 and combination product development at ABVI, So I think at 50 00:03:16.280 --> 00:03:20.080 a high level, a platform approach is really a framework 51 00:03:20.800 --> 00:03:24.759 that that helps to streamline combination product development by more 52 00:03:24.879 --> 00:03:30.560 or less grouping assets together with with with common attributes 53 00:03:30.680 --> 00:03:33.680 and and a single route of administration and and exploiting 54 00:03:33.719 --> 00:03:38.080 those through a single platform vehicle. You know, I think 55 00:03:38.080 --> 00:03:41.639 there's maybe three important parts to it. To the framework, 56 00:03:41.680 --> 00:03:48.879 One the modular delivery system itself, uh two an efficiently 57 00:03:48.919 --> 00:03:55.039 scalable and flexible manufacturing capability, and and three a platform 58 00:03:55.120 --> 00:03:59.919 DHF as a repository for acid agnostic information. And it's 59 00:04:00.080 --> 00:04:02.680 the combination of those three things together that that that 60 00:04:02.719 --> 00:04:06.639 when when truly harnessed, can enable a platform approach to 61 00:04:06.680 --> 00:04:08.080 its full full end. 62 00:04:09.960 --> 00:04:14.719 Thank you so, Monica and Brad. I'm curious to know 63 00:04:15.280 --> 00:04:18.120 what you think are like the drivers for developing a 64 00:04:18.160 --> 00:04:22.600 platform and what really you think initiates the need or 65 00:04:22.639 --> 00:04:26.199 the desire to have one. 66 00:04:27.600 --> 00:04:34.279 Thank you. I appreciate that. So I know that at GILLIAD, 67 00:04:34.319 --> 00:04:38.800 the drivers historically have have come from the product teams, right, 68 00:04:38.879 --> 00:04:42.199 there's a specific asset that needs a specific you know, 69 00:04:42.639 --> 00:04:45.600 rout of administration and then we reactively act on that. 70 00:04:45.720 --> 00:04:49.040 And you know, now we are we are shifting to 71 00:04:49.199 --> 00:04:51.759 a platform approach, right, which is very different, and that's 72 00:04:51.759 --> 00:04:55.319 actually it is definitely driven by assets, but many assets 73 00:04:55.360 --> 00:05:00.240 that have you know, needs that are in common, and 74 00:05:00.839 --> 00:05:03.240 it is also being driven by the commercial org So 75 00:05:03.560 --> 00:05:06.079 a lot of my my day is also spent working 76 00:05:06.079 --> 00:05:09.279 with the commercial organization and the you know, understanding the 77 00:05:09.319 --> 00:05:14.199 competitive landscape and you know what they foresee as not 78 00:05:14.319 --> 00:05:17.319 just our first product at launch, but you know, the 79 00:05:17.360 --> 00:05:20.360 second and third products through life cycle management, and how 80 00:05:20.360 --> 00:05:24.199 can we how can we plan for that? And so 81 00:05:24.240 --> 00:05:27.079 I think that the ask comes from many directions and 82 00:05:27.120 --> 00:05:29.759 certainly an innovation we we sort of we generate some 83 00:05:29.800 --> 00:05:31.920 of that pool ourselves as well. You know, we're sort 84 00:05:31.920 --> 00:05:34.040 of posing the question even if they haven't thought about it, 85 00:05:34.480 --> 00:05:38.079 and helping to to co to co ide eight, if 86 00:05:38.079 --> 00:05:40.160 you will, what those needs might be so that we 87 00:05:40.160 --> 00:05:43.319 can act on them earlier. But I think that one 88 00:05:43.360 --> 00:05:46.399 thing I wanted to make sure that I helped add 89 00:05:46.439 --> 00:05:51.680 as well, because Brad had it made me think about 90 00:05:51.680 --> 00:05:55.240 this in terms of the platform development. What what also 91 00:05:55.319 --> 00:05:59.160 makes a platform right is definitely that sort of that 92 00:05:59.160 --> 00:06:02.639 that asset agnostic parts of the DHF that we can 93 00:06:02.720 --> 00:06:05.160 leverage further, right those or that that's the time savings 94 00:06:05.279 --> 00:06:07.360 that we're looking for, the time and the cost savings 95 00:06:07.399 --> 00:06:10.839 and establishing a platform that we're hoping for. But also 96 00:06:10.959 --> 00:06:16.720 there is maybe assets specifically you might use a specific 97 00:06:16.800 --> 00:06:21.160 asset to map out a design space, right that then 98 00:06:21.399 --> 00:06:24.480 can be can de risk future programs. 99 00:06:24.800 --> 00:06:25.000 Right. 100 00:06:25.079 --> 00:06:27.680 It may not have been done specifically with that next asset, 101 00:06:28.120 --> 00:06:31.079 but it may have been with a sufficiently large concentration range, 102 00:06:31.480 --> 00:06:36.600 sufficiently large pH range or viscosity range that the next 103 00:06:36.600 --> 00:06:39.000 asset that comes along, even though you haven't done those 104 00:06:39.279 --> 00:06:41.399 that testing that will have to be done in every 105 00:06:41.439 --> 00:06:44.199 single for every single asset that goes through for stability 106 00:06:44.720 --> 00:06:48.079 and and you know, functionality over over the time of 107 00:06:48.120 --> 00:06:51.199 the shelf life, you've sufficiently de risked it that you 108 00:06:51.480 --> 00:06:55.639 that the executional risk of the program is diminished. 109 00:06:57.720 --> 00:06:59.720 Okay, thanks set that you took a lot of my 110 00:06:59.800 --> 00:07:03.800 thun there, but that's okay, I deferred, so no, I think, yeah, 111 00:07:03.839 --> 00:07:05.920 I share a lot of the same thoughts on what 112 00:07:05.959 --> 00:07:09.519 the drivers are So the first is obviously timeline acceleration, right, 113 00:07:09.600 --> 00:07:14.079 So from a financial aspect, it's it's getting product to 114 00:07:14.600 --> 00:07:17.439 market as quickly as possible and improving the bottom line. 115 00:07:17.800 --> 00:07:21.480 But from a human aspect, it's getting our therapies to 116 00:07:21.519 --> 00:07:24.759 our patients as quickly as possible. So there's really multiple 117 00:07:25.000 --> 00:07:31.399 benefactors of that timeline savings. Another driver's cost, so specifically 118 00:07:31.519 --> 00:07:34.720 in development costs. This is an area where you know, 119 00:07:34.720 --> 00:07:37.920 our leadership and management teams have it's it's been a 120 00:07:37.959 --> 00:07:40.560 growing process getting everyone to pull in the same rope. 121 00:07:40.800 --> 00:07:44.759 There's a lot of early investment required to establish a platform, 122 00:07:45.399 --> 00:07:48.560 but ultimately that that early large investment, you know, pays 123 00:07:48.600 --> 00:07:52.720 dividends and in the savings for the corresponding leveraged asset 124 00:07:52.800 --> 00:07:57.360 programs that come downstream. You know, a third driver is 125 00:07:57.399 --> 00:07:59.639 probably technical risk. I think you hit on this right. 126 00:07:59.720 --> 00:08:03.879 So in a in a normal serially executed UH combination 127 00:08:03.879 --> 00:08:07.560 product development program, there's going to be challenges that are 128 00:08:07.680 --> 00:08:12.600 encountered during verification, clinical trial, et cetera. You know, a 129 00:08:12.639 --> 00:08:16.600 platform development program, you know, really more or less neutralizes 130 00:08:16.680 --> 00:08:20.000 those those risks by you know, bringing them up front 131 00:08:20.120 --> 00:08:22.800 and off the critical path should they arise from a 132 00:08:22.879 --> 00:08:26.399 from a specific asset development program, and I think from 133 00:08:26.399 --> 00:08:29.319 a technical perspective, right, all the drivers sort of stem 134 00:08:29.399 --> 00:08:32.519 from this this, this, this, this one area where where 135 00:08:32.559 --> 00:08:38.240 you have this overlapping probabilistic you know, cluster of assets 136 00:08:38.600 --> 00:08:41.759 that can all be harnessed by a single route of 137 00:08:41.759 --> 00:08:46.279 administration and a single delivery system opportunity. 138 00:08:46.559 --> 00:08:46.879 Thank you. 139 00:08:47.080 --> 00:08:51.360 Here, I hear a lot of need to have alignment 140 00:08:51.519 --> 00:08:55.240 amongst amongst you know, your teams too in both of 141 00:08:55.279 --> 00:08:58.159 your responses as well, which I think is a common 142 00:08:58.200 --> 00:09:00.440 theme we've heard throughout with the communication and that we 143 00:09:00.720 --> 00:09:04.399 really need to have between our formulators and our development 144 00:09:04.519 --> 00:09:07.720 and our commercial teams. So yeah, I think that's good 145 00:09:07.720 --> 00:09:13.559 to highlight there too in terms of kind of limitations 146 00:09:13.559 --> 00:09:17.360 from technical and non technical and watch outs for any 147 00:09:17.399 --> 00:09:21.480 of our combination platform development. I'd be interested to hear 148 00:09:22.000 --> 00:09:25.000 Tim and Scherish about kind of your thoughts there and 149 00:09:25.039 --> 00:09:27.000 maybe where you can leverage a platform and where you 150 00:09:27.039 --> 00:09:29.919 cannot from your experiences. 151 00:09:31.279 --> 00:09:31.600 Thank you. 152 00:09:34.960 --> 00:09:40.399 I think when when we talk talk about anything about platforms, limitations, challenges, 153 00:09:40.960 --> 00:09:42.799 or you know, benefits, we are going. 154 00:09:42.679 --> 00:09:45.679 To see a team here. 155 00:09:46.240 --> 00:09:49.120 Most of us are going to talk about the same things, 156 00:09:49.120 --> 00:09:52.159 because that's how shared and common. 157 00:09:51.919 --> 00:09:53.919 The challenges and pain points. 158 00:09:53.639 --> 00:10:00.960 Are, UH, which is good in a way that I think, UH, 159 00:10:00.960 --> 00:10:05.519 this is a shared pain across the industry that I 160 00:10:05.559 --> 00:10:09.480 believe that collectively we can address. When when I think 161 00:10:09.519 --> 00:10:15.480 about any watch outs or limitations from the technical perspective, 162 00:10:15.840 --> 00:10:19.200 the first thing that I always wonder about is what 163 00:10:19.360 --> 00:10:22.000 exactly is platform? Do we all think about the same 164 00:10:22.039 --> 00:10:26.000 thing when it comes to platforms. We don't have a 165 00:10:26.039 --> 00:10:28.879 specific definition about drug delivery device platforms. 166 00:10:29.320 --> 00:10:29.960 UH. 167 00:10:30.000 --> 00:10:32.200 All of us can come up with different variants of 168 00:10:32.840 --> 00:10:38.759 this definition. Last year, for one conference, in my understanding, 169 00:10:38.840 --> 00:10:43.639 that was the first time that five different companies UH 170 00:10:44.000 --> 00:10:45.039 device suppliers and. 171 00:10:46.480 --> 00:10:49.360 Pharma company UH companies, they came together. 172 00:10:49.879 --> 00:10:52.080 I was part of that effort, and I see some 173 00:10:52.159 --> 00:10:55.080 of those colleagues here. Jacob Blangy from if Somebody is 174 00:10:55.120 --> 00:10:58.960 here but Burgess is somewhere here, from shl Ron Foster 175 00:10:59.080 --> 00:11:04.000 from Amgen, Jeff Given from MERKUH and they have been 176 00:11:04.039 --> 00:11:07.240 in this space for you know, three four decades, And 177 00:11:07.840 --> 00:11:09.799 they also could not agree. 178 00:11:09.480 --> 00:11:11.200 On a specific definition. 179 00:11:11.639 --> 00:11:14.200 And then collectively we were brainstorming for about six months 180 00:11:14.799 --> 00:11:18.440 before we came up with a very simple yet comprehensive 181 00:11:19.000 --> 00:11:20.279 definition for platforms. 182 00:11:20.639 --> 00:11:23.519 So that's where we start. That's where the disconnect is. 183 00:11:24.360 --> 00:11:27.759 So the first you know watch out or limitation is 184 00:11:28.759 --> 00:11:29.799 the definite definition. 185 00:11:29.919 --> 00:11:31.879 First we need to, you know, define for. 186 00:11:31.919 --> 00:11:35.080 Ourselves what exactly we mean by platform and then then 187 00:11:35.120 --> 00:11:36.159 take it forward from there. 188 00:11:36.720 --> 00:11:38.039 So from technical. 189 00:11:37.639 --> 00:11:41.600 Perspective, once we know what we mean by platform, we 190 00:11:41.639 --> 00:11:43.519 also need to make sure that you know we are 191 00:11:43.519 --> 00:11:47.360 not and I'm talking from the farmer perspective, the internal 192 00:11:47.759 --> 00:11:49.240 technical watch out is. 193 00:11:49.879 --> 00:11:51.600 To avoid silos. 194 00:11:51.639 --> 00:11:57.159 For any given theopeutic program team or asset team, their 195 00:11:58.360 --> 00:12:03.279 primary focus is taking their asset faster to the patient's 196 00:12:03.279 --> 00:12:07.919 clinical commercial so they are always laser focused on their 197 00:12:07.960 --> 00:12:11.480 specific effort and it's very easy to lose. 198 00:12:11.279 --> 00:12:15.240 The larger picture. So that is a big watch out. 199 00:12:15.639 --> 00:12:19.120 At the same time, when it comes to the technical 200 00:12:19.159 --> 00:12:23.039 watch outs, we also need to understand when we are 201 00:12:23.080 --> 00:12:27.120 thinking about a device or family devices as a platform, 202 00:12:27.279 --> 00:12:31.399 we need to broaden our perspective and take a realistic 203 00:12:31.399 --> 00:12:34.360 approach as to what range of formulations, what range of 204 00:12:34.600 --> 00:12:38.320 primary containers, what range of user populations would be suitable 205 00:12:38.639 --> 00:12:46.320 within the scope for given platform, and then start establishing platforms. 206 00:12:46.639 --> 00:12:51.000 It takes a lot of investment upfront in terms of resources, efforts, 207 00:12:51.200 --> 00:12:56.039 funding to even startup platform, but then benefits our image 208 00:12:56.159 --> 00:12:58.159 once you have it in such a way that you 209 00:12:58.159 --> 00:13:03.559 could leverage the platform, could benefit from radius timelines, you 210 00:13:03.559 --> 00:13:07.559 could benefit from radious risk. You could benefit also from 211 00:13:07.960 --> 00:13:12.480 the consistency efficiency as well. So in my opinion, first 212 00:13:12.519 --> 00:13:17.360 understanding what you what you mean by platform, define your boundaries, 213 00:13:17.399 --> 00:13:19.519 and then develop those platforms. That would be the first 214 00:13:19.559 --> 00:13:27.039 step when I look externally for buy from a company. 215 00:13:27.840 --> 00:13:32.279 The technical watchouts or limitations would also be your partnership, 216 00:13:32.559 --> 00:13:35.799 whether your device supplier also has the mindset of platforms, 217 00:13:37.039 --> 00:13:39.759 if there is an opportunity to partner in such a 218 00:13:39.799 --> 00:13:43.240 way that there is mutual learning UH and UH you know, 219 00:13:43.480 --> 00:13:48.799 development and advancement of platforms. Another external limitation in my 220 00:13:48.879 --> 00:13:53.919 opinion is industry consensus. I don't think that any one 221 00:13:53.919 --> 00:13:58.320 particular company can advance the platforms be uncertain limitations. So 222 00:13:58.600 --> 00:14:01.559 there is need for and there is opportunity to UH 223 00:14:02.159 --> 00:14:06.440 broader consensus and partnership within this industry to first align 224 00:14:06.440 --> 00:14:12.799 on platforms and then address the more challenging aspect, which 225 00:14:12.840 --> 00:14:16.200 is the regulatory alignment. At this time, we don't have 226 00:14:16.240 --> 00:14:19.559 any specific regulatory position. There is no regulatory guidance from 227 00:14:19.600 --> 00:14:21.080 any of the regulatory agencies. 228 00:14:21.720 --> 00:14:22.840 But I don't think that. 229 00:14:22.720 --> 00:14:26.240 We can ask for that or vouch for that unless 230 00:14:26.320 --> 00:14:31.799 we as the industry have some position on the platform. 231 00:14:31.879 --> 00:14:34.759 So that is one you know limitation as well, and 232 00:14:34.799 --> 00:14:38.080 then once we have that position, we can you know, 233 00:14:38.120 --> 00:14:42.759 strive for regulatory you know position as well. From non 234 00:14:42.799 --> 00:14:46.440 technical standpoint, I think getting business. 235 00:14:46.039 --> 00:14:48.600 Buy in is the biggest challenge. 236 00:14:49.759 --> 00:14:52.720 So first, once you do your technical due regions and 237 00:14:53.600 --> 00:14:56.159 define platforms and define. 238 00:14:56.600 --> 00:14:58.159 What you will do, how you will do it. 239 00:14:58.960 --> 00:15:05.480 The no technical challenge is to convince your decision makers 240 00:15:05.519 --> 00:15:07.559 in your organization as to why you would do it. 241 00:15:08.279 --> 00:15:11.080 And I think you know that is a watch out 242 00:15:11.240 --> 00:15:13.639 or you know, a non technical challenge. 243 00:15:13.639 --> 00:15:18.879 In my opinion, i'd agree with a lot of that. 244 00:15:19.360 --> 00:15:23.159 I think it's nuanced time. Many of these challenges relate 245 00:15:23.200 --> 00:15:28.120 to communications and group understanding. We have some clients would 246 00:15:28.120 --> 00:15:33.480 treat platforms as purely externally procured devices you off a shelf. 247 00:15:34.039 --> 00:15:37.039 Some that have internally developed platforms. 248 00:15:36.399 --> 00:15:38.120 That they tread as their workhorse. 249 00:15:38.200 --> 00:15:40.559 You know, if a drug can go into that platform, 250 00:15:40.720 --> 00:15:43.720 let's leverage it. We can save time we can kind 251 00:15:43.720 --> 00:15:47.480 of amortize that investment. I think one of the biggest 252 00:15:47.559 --> 00:15:51.919 challenges we've found is that it's very hard to kind 253 00:15:51.919 --> 00:15:55.240 of identify that jumping off point for a platform. A 254 00:15:55.279 --> 00:15:58.200 lot of asset teams and formulation teams don't want to 255 00:15:58.240 --> 00:16:01.840 be the guinea pig for a platform. They have specific requirements, 256 00:16:01.879 --> 00:16:06.200 They have therapeutic area requirements for their end user, and 257 00:16:06.240 --> 00:16:09.399 they don't want to water down those requirements to be 258 00:16:10.320 --> 00:16:15.480 more ubiquitous for a speculative, crystal ball future ambition that 259 00:16:15.679 --> 00:16:18.759 might not actually have a business case even defined yet. 260 00:16:19.200 --> 00:16:22.000 So I think some of the successful platform projects that 261 00:16:22.000 --> 00:16:24.799 we've seen have started life not as a platform, and 262 00:16:24.840 --> 00:16:26.879 that's it's sort of been a bit more of a 263 00:16:26.919 --> 00:16:31.440 gradual process to understand how much can we make universal here. 264 00:16:32.600 --> 00:16:34.799 I think that comes at a direct trade off, though, 265 00:16:34.840 --> 00:16:38.799 of just almost setting a little bit more realistic expectations 266 00:16:38.799 --> 00:16:41.679 of what you can and can't achieve with a platform. 267 00:16:42.159 --> 00:16:42.799 I think if. 268 00:16:42.639 --> 00:16:47.000 I choose an example as basic as a fill volume change, 269 00:16:47.360 --> 00:16:49.639 a lot of the time you might suddenly change a spring, 270 00:16:49.799 --> 00:16:53.360 you might have a different plunger rod length, the combat 271 00:16:53.440 --> 00:16:56.639 kind of free flight and glass fracture risk and suddenly 272 00:16:56.679 --> 00:16:59.919 that platform might have mutated into quite a different variance, 273 00:17:00.279 --> 00:17:03.879 so much so that some of those initial perceived benefits 274 00:17:03.919 --> 00:17:08.759 are diminished. We've also seen that on the manufacturer and 275 00:17:08.960 --> 00:17:12.000 scale up side of things, that again, this sort of 276 00:17:12.960 --> 00:17:17.279 white whale platform that resolves all scale up challenges is 277 00:17:17.319 --> 00:17:20.880 a nice ambition, but you might find that your fill 278 00:17:20.920 --> 00:17:25.000 finish requirements are different, Your supply chain is so fundamentally 279 00:17:25.039 --> 00:17:28.440 different that yes, you've saved time and effort on the 280 00:17:28.480 --> 00:17:31.559 design side, but you actually have very different supply chains 281 00:17:32.039 --> 00:17:34.920 for a single platform. And I think the reason I 282 00:17:34.960 --> 00:17:38.559 cite that is we've seen some businesses and business units 283 00:17:38.599 --> 00:17:42.880 outside of device groups maybe expect too much from a platform, 284 00:17:43.200 --> 00:17:44.519 and I think we have to be a little bit 285 00:17:44.559 --> 00:17:48.400 cautious about how much we add hype to that platform 286 00:17:48.519 --> 00:17:51.440 and over promise. Yes, of course it can save some 287 00:17:51.640 --> 00:17:56.279 development effort, but I personally don't see it's shaving years 288 00:17:56.279 --> 00:17:59.839 off every development project, and would advise a little bit 289 00:17:59.880 --> 00:18:04.119 of cultion there from reality. 290 00:18:04.160 --> 00:18:07.440 Thank you. I want to build upon the regulatory piece 291 00:18:07.480 --> 00:18:09.759 that you spoke of, because I know, Brad, we had 292 00:18:09.759 --> 00:18:12.079 a lot of prediscussion and then you brought up the 293 00:18:12.519 --> 00:18:16.839 regulatory hurdles that we're facing, and I'm just curious, do 294 00:18:16.920 --> 00:18:19.680 you have any thoughts on how we as an industry 295 00:18:19.759 --> 00:18:22.440 can try to try to overcome some of those hurdles 296 00:18:22.480 --> 00:18:24.599 when we think about platform approaches. 297 00:18:26.640 --> 00:18:31.359 Yeah, so I appreciate bringing this up so realistically, right, 298 00:18:31.400 --> 00:18:36.480 if any of us on stage were privy to information 299 00:18:36.920 --> 00:18:40.000 that you know, spelled out the secret sauce of a 300 00:18:40.039 --> 00:18:44.640 platform leveraging submission, that's you know, trade secret. That's a 301 00:18:44.640 --> 00:18:48.279 competitive advantage, and it's probably not something that we talk 302 00:18:48.319 --> 00:18:51.200 about here today, let alone share with each other. So 303 00:18:51.440 --> 00:18:53.480 I think we need to as an industry, if we're 304 00:18:53.480 --> 00:18:56.880 going to really move this space forward, really really focus 305 00:18:56.960 --> 00:19:01.200 on you know, a common message to the agency, uh 306 00:19:01.279 --> 00:19:05.720 and and really try to establish you know, a single 307 00:19:05.759 --> 00:19:09.640 point of view uh to to pull back a guideline 308 00:19:09.839 --> 00:19:12.680 such that everyone can kind of, uh, not only work 309 00:19:12.720 --> 00:19:16.200 towards the same end, but also then open up the 310 00:19:16.319 --> 00:19:17.559 walls of dialogue. 311 00:19:19.440 --> 00:19:21.880 So anyone else have thoughts on the regulatory hurdles? 312 00:19:23.079 --> 00:19:25.240 I think maybe just a thought at a and a 313 00:19:25.319 --> 00:19:28.240 question back to you, Brad, you know, and there is 314 00:19:28.279 --> 00:19:31.799 some precedent, right if we think about like platform autoinjectors. 315 00:19:31.880 --> 00:19:34.200 You were alluding to auto injectors before. And you know, 316 00:19:34.319 --> 00:19:37.920 so for example like SHL and ibsomet have auto injectors 317 00:19:37.920 --> 00:19:40.119 that can be used for a lot of different indications 318 00:19:40.119 --> 00:19:43.559 and are used for a lot of different indications. And 319 00:19:43.759 --> 00:19:46.680 you know, part of the benefit of perhaps working with 320 00:19:46.720 --> 00:19:50.119 a supplier like that is they do have an established package, 321 00:19:50.359 --> 00:19:52.640 right that you can help, that you can put as 322 00:19:52.640 --> 00:19:55.920 part of your submission of the combination product that's been 323 00:19:56.039 --> 00:19:59.000 it's been tested that they're dv is tight, you know. 324 00:19:59.119 --> 00:20:02.480 And and so there's some precedent I think that maybe 325 00:20:02.480 --> 00:20:04.880 gives us guidance as to where we might start with 326 00:20:04.960 --> 00:20:08.440 our with any internal development. But I wonder Brad, sort 327 00:20:08.440 --> 00:20:10.960 of in your your opinion sort of where does that 328 00:20:11.000 --> 00:20:14.119 stop an end right and if if you think about 329 00:20:14.160 --> 00:20:15.920 that precedent and how it might apply. 330 00:20:15.920 --> 00:20:19.680 To I think the answer is there's platforms and then 331 00:20:19.680 --> 00:20:20.440 there's platforms. 332 00:20:20.519 --> 00:20:20.720 Right. 333 00:20:20.759 --> 00:20:23.519 I think a lot of folks in the room have 334 00:20:23.599 --> 00:20:28.799 on their websites, UH platform suppliers, platform manufacturers, et cetera. 335 00:20:29.720 --> 00:20:33.160 That means something very different to everyone. And I think 336 00:20:33.319 --> 00:20:36.359 you know, the ultimately the end goal here isn't just 337 00:20:37.039 --> 00:20:41.519 the device, it's the full platform expression, right that the 338 00:20:41.559 --> 00:20:44.400 full model of the device, the manufacturing and the regulatory 339 00:20:44.400 --> 00:20:49.759 piece is kind of all working uh together to streamline 340 00:20:49.799 --> 00:20:53.599 a submission process. So I think, you know, with regard 341 00:20:53.640 --> 00:20:56.759 to the you know, the devices that are available, I 342 00:20:56.759 --> 00:21:00.559 think it's appropriate that they're described as platforms. But ultimately 343 00:21:01.480 --> 00:21:04.319 than how each one of our companies interacts with those 344 00:21:04.400 --> 00:21:08.680 those those those vendors and partners and progresses forward. That's 345 00:21:08.799 --> 00:21:12.880 really probably where you know, the sharing stops, and the 346 00:21:13.079 --> 00:21:16.880 and the and the competitive advantage remains internal. And i'd 347 00:21:16.920 --> 00:21:20.119 really moving forward like to see a more transparent dialogue. 348 00:21:20.160 --> 00:21:22.480 And I think that that's probably probably only fostered by 349 00:21:22.799 --> 00:21:25.119 uh uh, you know, the agency being a little bit 350 00:21:25.160 --> 00:21:26.559 more forthcoming with the guidance. 351 00:21:28.039 --> 00:21:33.480 Than other hurdles. I think we've also seen is over 352 00:21:33.640 --> 00:21:35.759 recent years is kind of disruptions in some of our 353 00:21:35.799 --> 00:21:40.880 supply chains, which can really impact you know, primary container 354 00:21:40.920 --> 00:21:42.720 closures that we might be putting into some of these 355 00:21:42.720 --> 00:21:46.480 combination products, and it kind of begs the question of 356 00:21:46.559 --> 00:21:50.559 dual sourcing for some of these How do you feel 357 00:21:50.920 --> 00:21:54.640 some of these alternative primary container closures can be implemented 358 00:21:54.680 --> 00:22:00.720 within a platform as well? So Rader Tim thoughts, sure, Yeah. 359 00:22:00.559 --> 00:22:05.799 So I think it's more it's when when folks get 360 00:22:05.839 --> 00:22:09.759 started on a common platform combination development program, a lot 361 00:22:09.799 --> 00:22:12.039 of the focus tends to be on the device and 362 00:22:12.039 --> 00:22:16.680 and neglects, uh the primary container. But in most cases 363 00:22:17.079 --> 00:22:20.480 the primary container is an integral part of the delivery system. 364 00:22:21.079 --> 00:22:24.319 And so you know, I think, you know, dual sourcing 365 00:22:24.359 --> 00:22:26.960 primary containers is absolutely appropriate. But I think the key 366 00:22:26.960 --> 00:22:30.279 piece is that the vetting and the sourcing and the 367 00:22:30.359 --> 00:22:34.440 verification UH and the inclusion of those multiple options is 368 00:22:34.680 --> 00:22:37.160 is done at the outset of the platform development program, 369 00:22:37.200 --> 00:22:39.079 not at the not at the tail of it, because 370 00:22:39.400 --> 00:22:41.759 if it's the latter, if it's at the tail, really 371 00:22:41.960 --> 00:22:44.880 you know, you're the team is risking the repetition of 372 00:22:45.000 --> 00:22:47.759 all a lot, a lot of the design control and 373 00:22:47.920 --> 00:22:50.359 and perhaps even verification testing that was done on the 374 00:22:50.359 --> 00:22:52.880 first container, and and really negating a lot of the 375 00:22:52.880 --> 00:22:55.799 timeline savings that the platform program was was meant to 376 00:22:55.799 --> 00:22:56.920 accomplish in the first place. 377 00:22:58.279 --> 00:23:00.079 I'd very much agree. I think. 378 00:23:01.720 --> 00:23:06.400 Historically you might have chosen your primary presentation, your primary container, 379 00:23:06.839 --> 00:23:12.200 and almost treated the secondary supply as a theoretical element 380 00:23:12.279 --> 00:23:13.400 that you consider. 381 00:23:13.079 --> 00:23:14.400 But maybe keep to one side. 382 00:23:14.440 --> 00:23:16.839 And when I think about the economies of scale, when 383 00:23:16.839 --> 00:23:17.880 you're going through DV. 384 00:23:18.480 --> 00:23:19.359 Being able to do. 385 00:23:19.279 --> 00:23:24.160 That with multiple primary containers and secondary supply options, I 386 00:23:24.160 --> 00:23:28.079 think that's where you get the savings. So I think 387 00:23:28.680 --> 00:23:31.200 as we've seen that supply disruption, I think it has 388 00:23:31.279 --> 00:23:33.279 been a little bit of a shot across the boy 389 00:23:33.599 --> 00:23:34.240 we should. 390 00:23:34.000 --> 00:23:34.480 Be doing this. 391 00:23:34.640 --> 00:23:37.839 And I think it's easy whenever it's a fast paced 392 00:23:37.839 --> 00:23:41.400 development to consider this is optional, it's extra. 393 00:23:41.519 --> 00:23:42.240 We don't have to. 394 00:23:43.039 --> 00:23:45.640 But I think that can be quite short sighted and 395 00:23:46.279 --> 00:23:47.200 genuinely catchy eyed. 396 00:23:50.599 --> 00:23:53.599 I think a common thing we've heard in responses in 397 00:23:53.640 --> 00:23:56.599 this panel has been getting the business buy in and 398 00:23:56.640 --> 00:24:01.400 stakeholder alignment. And that's certainly very important. And you know, 399 00:24:01.920 --> 00:24:05.240 what do you think is the most important aspects to 400 00:24:05.279 --> 00:24:08.519 get that alignment? And maybe is there processes in place 401 00:24:08.519 --> 00:24:11.240