Why the Small Details Reveal Everything About Your CDMO Partner with Frank Sorce

1 00:00:01,600 - > 00:00:04,080 SPEAKER_00: You're evaluating C DMO partners. 2 00:00:04,240 - > 00:00:06,719 What are some of the non-negotiable criteria you'd 3 00:00:06,719 - > 00:00:08,320 advise that they validate first? 4 00:00:08,560 - > 00:00:11,519 Thinking things like quality of track record, tech transfer, 5 00:00:11,599 - > 00:00:14,240 capability, capacity, supply chain resiliency. 6 00:00:14,400 - > 00:00:17,359 What are some of those important things to take a look at before 7 00:00:17,359 - > 00:00:18,320 you even get to pricing? 8 00:00:18,640 - > 00:00:19,839 SPEAKER_01: There's a number of things. 9 00:00:19,920 - > 00:00:23,679 And a lot of it is depending on, I always say, kind of know 10 00:00:23,679 - > 00:00:24,480 thyself first. 11 00:00:24,559 - > 00:00:27,679 Where are you in the development landscape with your program? 12 00:00:27,920 - > 00:00:29,679 The early stage, mid-stage. 13 00:00:29,920 - > 00:00:31,600 Do you think you have a blockbuster? 14 00:00:31,760 - > 00:00:34,079 Is it rare disease type product? 15 00:00:34,240 - > 00:00:35,679 Kind of knowing all those things. 16 00:00:35,759 - > 00:00:39,119 And the non-negotiables are going to be equipment matchup. 17 00:00:39,439 - > 00:00:42,079 Done some work here in our own facility. 18 00:00:42,240 - > 00:00:45,520 Maybe it's bench top, maybe it's into phase one, just a little 19 00:00:45,520 - > 00:00:48,560 bit of a GMP operation in your facility. 20 00:01:02,880 - > 00:01:05,040 SPEAKER_00: I'm your host, Jonathan Kaskey. 21 00:01:05,280 - > 00:01:08,560 Technology and market trends are bringing change at an ever 22 00:01:08,640 - > 00:01:12,560 accelerating rate, and no person, team, or company can 23 00:01:12,560 - > 00:01:14,079 afford to be left behind. 24 00:01:14,239 - > 00:01:17,680 Here, we dive into the strategies and tactics that our 25 00:01:17,680 - > 00:01:20,719 guests use to tackle these challenges and create new 26 00:01:20,719 - > 00:01:24,400 opportunities, and how you can do the same in your own 27 00:01:24,400 - > 00:01:25,359 organization. 28 00:01:26,640 - > 00:01:32,000 This episode of Pharma Sessions is sponsored by Exont, makers of 29 00:01:32,000 - > 00:01:34,719 the X1 reporting platform. 30 00:01:35,439 - > 00:01:38,400 On today's episode of Pharma Sessions, I'm thrilled to 31 00:01:38,400 - > 00:01:41,760 welcome Frank Sorce, Chief Commercial Officer at UPM 32 00:01:41,760 - > 00:01:44,640 Pharmaceuticals and a seasoned commercial leader with deep 33 00:01:44,640 - > 00:01:46,959 experience across pharma manufacturing, business 34 00:01:46,959 - > 00:01:49,439 development, and strategic partnerships. 35 00:01:49,680 - > 00:01:53,359 I thought this could be a really cool conversation in that Frank 36 00:01:53,519 - > 00:01:56,879 has spent his career helping biopharma companies navigate 37 00:01:56,879 - > 00:02:00,319 decisions around development and manufacturing, which is 38 00:02:00,319 - > 00:02:02,239 important to any organization, right? 39 00:02:02,319 - > 00:02:04,959 So we're going to spend a lot of time about talking about 40 00:02:04,959 - > 00:02:07,760 selecting the right CDMO, structuring long-term 41 00:02:07,760 - > 00:02:11,520 partnerships, and how to maintain a focus on both 42 00:02:11,520 - > 00:02:16,560 quality, reliability, while balancing that with price, which 43 00:02:16,639 - > 00:02:19,360 of course comes up with all of these discussions. 44 00:02:19,599 - > 00:02:20,000 All right. 45 00:02:20,159 - > 00:02:22,000 With that, welcome to the show, Frank. 46 00:02:22,319 - > 00:02:23,680 SPEAKER_01: Jonathan, great to be here. 47 00:02:23,840 - > 00:02:25,759 Really excited for this conversation. 48 00:02:26,879 - > 00:02:27,680 Good to see you again. 49 00:02:28,000 - > 00:02:28,319 SPEAKER_00: Yeah. 50 00:02:28,560 - > 00:02:31,120 Two feet of snow outside of my window. 51 00:02:31,280 - > 00:02:32,319 How's how's your back? 52 00:02:32,400 - > 00:02:34,159 You do a lot of shoveling over the last couple of days? 53 00:02:34,400 - > 00:02:36,960 SPEAKER_01: I was on the snowblower for about three hours 54 00:02:36,960 - > 00:02:37,680 on Monday. 55 00:02:37,840 - > 00:02:41,280 I've got two neighbors that just don't seem to be able to do 56 00:02:41,280 - > 00:02:43,680 their own driveways in addition to my driveway. 57 00:02:43,759 - > 00:02:45,680 So I did my good deed for the year. 58 00:02:46,000 - > 00:02:46,400 SPEAKER_00: That's good. 59 00:02:46,479 - > 00:02:46,719 Yeah. 60 00:02:46,800 - > 00:02:49,840 Where I live, there's a lot of retirees, and I did mine, and I 61 00:02:49,840 - > 00:02:53,039 helped my neighbor shovel a path to his car and get his path out. 62 00:02:53,120 - > 00:02:54,560 But after that, that was like four hours. 63 00:02:54,639 - > 00:02:55,280 I'm like, you know what? 64 00:02:55,360 - > 00:02:57,280 My I feel like that's all I got in me. 65 00:02:57,759 - > 00:03:00,159 SPEAKER_01: Yeah, the vibrations in my hands were just about all 66 00:03:00,159 - > 00:03:01,680 I can take at that point. 67 00:03:02,879 - > 00:03:03,439 SPEAKER_00: Excellent. 68 00:03:03,599 - > 00:03:04,800 Well, thanks for joining. 69 00:03:04,879 - > 00:03:06,560 And let's just dive right in. 70 00:03:06,800 - > 00:03:10,639 So you've seen C DMO relationships from both sides of 71 00:03:10,639 - > 00:03:11,199 the table. 72 00:03:11,439 - > 00:03:13,840 Do you want to maybe start by sharing a little bit about your 73 00:03:13,840 - > 00:03:16,479 background and then we'll ask some questions about your 74 00:03:16,479 - > 00:03:17,199 experience here? 75 00:03:17,520 - > 00:03:17,840 SPEAKER_01: Sure. 76 00:03:18,000 - > 00:03:20,319 So I was calculating some things. 77 00:03:20,400 - > 00:03:24,560 So I'm in my 37th year here of pharma business. 78 00:03:25,039 - > 00:03:28,800 I started right out of school with Merck Sharp and Dome, spent 79 00:03:28,800 - > 00:03:32,800 about eight years in the Merck organization, got my master's in 80 00:03:32,800 - > 00:03:35,599 marketing through their education support program. 81 00:03:36,159 - > 00:03:40,319 And after that stint of eight years or so, I moved on into the 82 00:03:40,319 - > 00:03:44,879 sort of the contract sales business, which at that time was 83 00:03:44,879 - > 00:03:49,439 a very early Sinios for a couple of years and a very early IQ 84 00:03:49,599 - > 00:03:52,000 via, which were under different names at that time. 85 00:03:52,319 - > 00:03:52,639 Sure. 86 00:03:53,039 - > 00:03:56,800 And we supported Large Pharma in putting boots on the ground for 87 00:03:56,800 - > 00:03:59,120 them, sort of supplementary sales forces. 88 00:03:59,439 - > 00:04:02,159 And one of those clients was Reliant Pharmaceuticals. 89 00:04:02,319 - > 00:04:06,240 And I ended up joining them directly here in the Northeast 90 00:04:06,240 - > 00:04:07,919 as the regional business director. 91 00:04:08,000 - > 00:04:11,120 And we started that company, launched it, and then eventually 92 00:04:11,120 - > 00:04:14,400 sold it to Glaxo in the mid-2000s. 93 00:04:14,639 - > 00:04:18,399 And just took a little time off, and then I joined UPM 94 00:04:18,399 - > 00:04:22,879 Pharmaceuticals for my first tour of duty as an individual 95 00:04:22,879 - > 00:04:24,639 contributor in business development. 96 00:04:24,720 - > 00:04:28,240 And I also managed the marketing function right from day one. 97 00:04:28,399 - > 00:04:32,160 So I spent 12 years with UPM, individual contributor, 98 00:04:32,319 - > 00:04:34,959 eventually became VP of BD in marketing. 99 00:04:35,120 - > 00:04:40,079 They had a reorganization around 2019, and I moved on. 100 00:04:40,480 - > 00:04:45,839 I worked at Synergy Pharma, which is a high-powered CMC 101 00:04:46,000 - > 00:04:50,000 medical writing regulatory consulting firm based in 102 00:04:50,000 - > 00:04:50,959 Framingham. 103 00:04:51,199 - > 00:04:57,199 And I started their BD operation in 2021, and I was enticed to 104 00:04:57,199 - > 00:05:03,360 come back to UPM the sort of end of 2024, and started my second 105 00:05:03,360 - > 00:05:06,160 tour of duty last March 2025. 106 00:05:06,399 - > 00:05:09,680 So I've seen a lot across the industry. 107 00:05:10,079 - > 00:05:11,519 SPEAKER_00: So you're you're a pharma lifer. 108 00:05:12,000 - > 00:05:12,560 Yeah, I am. 109 00:05:13,279 - > 00:05:14,639 Both sides of the fence. 110 00:05:14,879 - > 00:05:15,519 That's great. 111 00:05:15,680 - > 00:05:19,199 So so with all of that history, I'm sure you have a lot of 112 00:05:19,199 - > 00:05:19,839 experience. 113 00:05:20,000 - > 00:05:22,639 It sounds like starting in marketing, right? 114 00:05:22,720 - > 00:05:26,240 And then moving over to manufacturing and CMC consulting 115 00:05:26,240 - > 00:05:27,680 and back to C DMO. 116 00:05:27,920 - > 00:05:30,959 When a pharma, because most of my listeners are at pharma 117 00:05:30,959 - > 00:05:34,319 companies, when the pharma company first begins the C DMO 118 00:05:34,319 - > 00:05:37,040 selection process, what do you think are some of the biggest 119 00:05:37,040 - > 00:05:41,199 misconceptions they tend to have about how that decision should 120 00:05:41,199 - > 00:05:42,000 be made? 121 00:05:42,399 - > 00:05:46,319 SPEAKER_01: I think some misconceptions are we can do 122 00:05:46,319 - > 00:05:48,160 this now remotely. 123 00:05:48,319 - > 00:05:53,040 We can go online, we can look at websites, we can see ads and 124 00:05:53,040 - > 00:05:57,040 journals, we can get corporate decks, and we can do a lot of 125 00:05:57,040 - > 00:05:59,920 that vetting from 30,000 feet apart. 126 00:06:00,079 - > 00:06:02,800 And I think COVID, a lot of people did virtual tours and 127 00:06:02,800 - > 00:06:05,519 they said, Hey, we did okay, we made a selection and we're and 128 00:06:05,519 - > 00:06:09,120 it's working out for us, but you still got to get to the sites. 129 00:06:09,439 - > 00:06:10,480 And why is that? 130 00:06:10,800 - > 00:06:15,759 Because you can only observe so much from a remote location. 131 00:06:16,639 - > 00:06:21,199 Just pulling into the parking lot of a CDMO, you'll start to 132 00:06:21,199 - > 00:06:23,439 make judgment on this organization. 133 00:06:24,079 - > 00:06:25,360 Is the grass cut? 134 00:06:25,519 - > 00:06:27,680 Is the security booth in good shape? 135 00:06:27,839 - > 00:06:29,360 Is the front door clean? 136 00:06:29,519 - > 00:06:32,240 Is the the mulch kept where it's supposed to be? 137 00:06:32,399 - > 00:06:36,480 You make these you start to make a judgment as soon as you get on 138 00:06:36,480 - > 00:06:38,240 the premises on the property. 139 00:06:38,480 - > 00:06:41,199 Right through to the meeting room they put you in, through 140 00:06:41,199 - > 00:06:47,040 the tour, the meeting of people, all those intangibles are 141 00:06:47,040 - > 00:06:48,319 important to the selection. 142 00:06:48,480 - > 00:06:50,800 And of course, do they have the right equipment? 143 00:06:50,959 - > 00:06:52,000 Is the place clean? 144 00:06:52,079 - > 00:06:55,600 Is there all those things that you kind of take for granted? 145 00:06:55,680 - > 00:06:58,560 But those are all obviously very important in your decision 146 00:06:58,560 - > 00:06:58,720 making. 147 00:06:59,120 - > 00:07:01,759 SPEAKER_00: So you're saying attention to detail in the small 148 00:07:01,759 - > 00:07:04,959 things is a good indicator that carries through to the important 149 00:07:04,959 - > 00:07:06,079 parts of manufacturing. 150 00:07:06,399 - > 00:07:08,879 SPEAKER_01: If they don't take care of the small things, how 151 00:07:08,879 - > 00:07:10,720 are they going to take care of the big things? 152 00:07:10,879 - > 00:07:12,720 Is there soap in the soap dispenser? 153 00:07:12,879 - > 00:07:14,079 Why go in the men's room? 154 00:07:14,160 - > 00:07:14,319 Right. 155 00:07:15,360 - > 00:07:20,480 Those little details about the organization will help you in 156 00:07:20,480 - > 00:07:21,360 your decision making. 157 00:07:21,680 - > 00:07:24,879 SPEAKER_00: I'm smiling because I like that maybe this is too 158 00:07:24,879 - > 00:07:25,439 much information. 159 00:07:25,519 - > 00:07:25,920 Maybe not. 160 00:07:26,240 - > 00:07:28,079 If I go to a restaurant and I go to the bathroom and the 161 00:07:28,079 - > 00:07:29,920 bathroom's dirty, I'm like, let's get out of here. 162 00:07:30,319 - > 00:07:31,360 Like I do not want this. 163 00:07:31,839 - > 00:07:32,319 Exactly right. 164 00:07:32,639 - > 00:07:33,920 And that totally makes sense, right? 165 00:07:34,000 - > 00:07:38,480 Because you need a clean facility where every last detail 166 00:07:38,800 - > 00:07:42,560 of the operational manual is followed to a D. 167 00:07:42,879 - > 00:07:43,680 It has to be. 168 00:07:43,920 - > 00:07:46,639 So what are some of the, let's say, again, you're in that 169 00:07:46,879 - > 00:07:49,759 you're for that pharma company, you're evaluating C DMO 170 00:07:49,839 - > 00:07:50,240 partners. 171 00:07:50,319 - > 00:07:52,800 What are some of the non-negotiable criteria you'd 172 00:07:52,800 - > 00:07:54,720 advise that they validate first? 173 00:07:54,959 - > 00:07:58,160 Thinking things like quality of track record, tech transfer, 174 00:07:58,240 - > 00:08:01,040 capability, capacity, supply chain resiliency. 175 00:08:01,199 - > 00:08:04,319 What are some of some of those important things to take a look 176 00:08:04,319 - > 00:08:06,079 at before you even get to pricing? 177 00:08:22,470 - > 00:08:22,790 SPEAKER_01: Yeah. 178 00:08:23,030 - > 00:08:24,790 So there's a number of things. 179 00:08:24,949 - > 00:08:28,790 And a lot of it is depending on, I always say, kind of know 180 00:08:28,790 - > 00:08:29,590 thyself first. 181 00:08:29,750 - > 00:08:32,789 Where are you in the development landscape with your program? 182 00:08:33,110 - > 00:08:34,870 Your early stage, mid-stage. 183 00:08:35,110 - > 00:08:36,870 Do you think you have a blockbuster? 184 00:08:37,029 - > 00:08:40,710 Is it is it a rare disease type product? 185 00:08:40,949 - > 00:08:42,470 Kind of knowing all those things. 186 00:08:42,629 - > 00:08:46,470 And the non-negotiables are going to be equipment matchup. 187 00:08:47,110 - > 00:08:49,830 Done some work here in our own facility. 188 00:08:49,909 - > 00:08:53,190 Maybe it's bench top, maybe it's into phase one, just a little 189 00:08:53,190 - > 00:08:56,549 bit of a GMP operation in your facility. 190 00:08:56,789 - > 00:08:58,230 Now I'm going to move. 191 00:08:58,470 - > 00:09:02,310 I want to make sure that the equipment we've been working on 192 00:09:02,310 - > 00:09:04,950 is a match for the equipment you're going to be working on. 193 00:09:05,190 - > 00:09:09,350 I don't want to change the manufacture of the equipment or 194 00:09:09,350 - > 00:09:12,950 the mechanism of which it performs its function. 195 00:09:13,269 - > 00:09:16,629 I really want to make sure I'm dealing with like for like. 196 00:09:17,029 - > 00:09:21,110 It may not be an exact match, but does the technology match 197 00:09:21,110 - > 00:09:21,350 up? 198 00:09:21,669 - > 00:09:25,110 Then I want to look at your inspection record. 199 00:09:25,509 - > 00:09:27,669 Where were you last inspected by? 200 00:09:27,830 - > 00:09:29,509 What are those health authorities? 201 00:09:29,750 - > 00:09:33,590 What do those inspections say about your facility? 202 00:09:33,750 - > 00:09:34,470 Did you pass? 203 00:09:34,629 - > 00:09:36,389 Did you get out of 483? 204 00:09:36,789 - > 00:09:40,149 I've got to have a clean track record from a regulatory 205 00:09:40,149 - > 00:09:40,629 standpoint. 206 00:09:41,029 - > 00:09:47,669 And then I'm evaluating how are you responding to my inquiry? 207 00:09:47,909 - > 00:09:50,070 How quickly are you getting back to me? 208 00:09:50,310 - > 00:09:52,950 How arduous is your CDA process? 209 00:09:53,110 - > 00:09:56,710 If I can't get the time of day when I'm approaching you or get 210 00:09:56,710 - > 00:09:59,509 some, what are you going to do when we sign a contract? 211 00:09:59,590 - > 00:10:02,149 Right now, bonded to you contractually. 212 00:10:02,389 - > 00:10:02,950 For years. 213 00:10:03,590 - > 00:10:04,470 For years, exactly. 214 00:10:04,549 - > 00:10:04,789 Right. 215 00:10:04,870 - > 00:10:07,669 I mean, you're not buying a batch, you're buying a 216 00:10:07,669 - > 00:10:08,389 relationship. 217 00:10:08,470 - > 00:10:11,830 And that's going to be a long-term, hopefully, good 218 00:10:11,830 - > 00:10:13,590 relationship for both sides. 219 00:10:13,750 - > 00:10:17,350 So I've got to have that sense that I'm important because if 220 00:10:17,350 - > 00:10:20,870 I'm not important today, I'm not going to be important tomorrow. 221 00:10:21,190 - > 00:10:22,230 SPEAKER_00: A hundred percent agree. 222 00:10:22,389 - > 00:10:26,310 And things like responsiveness and just I don't know how how 223 00:10:26,310 - > 00:10:27,990 you all are structured here. 224 00:10:28,389 - > 00:10:31,509 It's when I'm talking to people, I know that I'm not going to be 225 00:10:31,509 - > 00:10:36,629 ultimately working with the salesperson usually, but I want 226 00:10:36,629 - > 00:10:39,029 to at least meet the team of who I'm working with, right? 227 00:10:39,110 - > 00:10:41,190 And make sure that if I'm thinking this is going to be a 228 00:10:41,190 - > 00:10:44,470 multi-year relationship, this is going to be somebody who I trust 229 00:10:44,549 - > 00:10:48,549 who I who I can think will have my best interest at heart. 230 00:10:48,710 - > 00:10:51,269 And yeah, I think getting back to your first point, you kind of 231 00:10:51,269 - > 00:10:53,029 have to do that face to face. 232 00:10:53,830 - > 00:10:57,430 It's not that different from hiring employees, honestly, 233 00:10:57,509 - > 00:10:57,669 right? 234 00:10:57,830 - > 00:11:02,549 Like we do so much, we do so much virtually, but we just need 235 00:11:02,549 - > 00:11:06,389 to meet somebody in order to really get a sense of them. 236 00:11:06,710 - > 00:11:09,750 SPEAKER_01: Yeah, and I I will, you know, in the consulting 237 00:11:09,750 - > 00:11:11,750 world, it was very common. 238 00:11:12,149 - > 00:11:15,750 Say, listen, we're going to need support for this particular 239 00:11:15,750 - > 00:11:16,070 program. 240 00:11:16,629 - > 00:11:19,110 And they'd say, I want to meet the consultants, I want to spend 241 00:11:19,110 - > 00:11:20,310 an hour with them one-on-one. 242 00:11:20,629 - > 00:11:25,269 And you should bring that same level of diligence to the CDMO 243 00:11:25,269 - > 00:11:25,669 space. 244 00:11:25,990 - > 00:11:27,509 Who's my project manager? 245 00:11:27,830 - > 00:11:30,870 Can I go in a conference room one-on-one and talk to them? 246 00:11:31,350 - > 00:11:34,950 See what their experiences, see what have they worked on this 247 00:11:34,950 - > 00:11:39,029 kind of program before, and you know, really get that, like you 248 00:11:39,029 - > 00:11:42,950 say, it's an interview because it's a huge decision for the 249 00:11:42,950 - > 00:11:43,590 organization. 250 00:11:43,990 - > 00:11:45,830 SPEAKER_00: So along those lines, and you would 251 00:11:46,149 - > 00:11:48,549 essentially, I think what you were getting at when you were 252 00:11:48,549 - > 00:11:51,269 saying, hey, if I'm not going to get treated well before I sign a 253 00:11:51,269 - > 00:11:53,110 contract, what's it going to look like afterwards? 254 00:11:53,350 - > 00:11:56,710 It's sort of how do you separate a sales story from an 255 00:11:56,710 - > 00:11:58,950 operational reality? 256 00:11:59,269 - > 00:12:03,909 So what evidence should these sponsors be looking for to 257 00:12:03,909 - > 00:12:08,310 confirm that a site can actually execute beyond audits that 258 00:12:08,310 - > 00:12:10,070 you're you pass your slide deck? 259 00:12:10,310 - > 00:12:10,629 Sure. 260 00:12:10,950 - > 00:12:14,310 SPEAKER_01: This is you know, these are through conversations, 261 00:12:14,629 - > 00:12:16,870 and you may get some documentation. 262 00:12:17,029 - > 00:12:19,110 We deal in a solid oral world. 263 00:12:19,269 - > 00:12:22,070 Someone comes and says, Listen, I've got this concept. 264 00:12:22,230 - > 00:12:25,029 Do we want a modified release version of this particular 265 00:12:25,029 - > 00:12:25,669 molecule? 266 00:12:25,830 - > 00:12:27,269 What have you done before? 267 00:12:27,590 - > 00:12:30,789 Can you give me three examples of how you worked with a 268 00:12:30,789 - > 00:12:34,549 compound that was immediate release forever, and you 269 00:12:34,549 - > 00:12:38,310 modified that release rate and gave it sort of an advantage and 270 00:12:38,310 - > 00:12:41,269 extended its life cycle five more years? 271 00:12:41,430 - > 00:12:43,190 And we're going to benefit from that. 272 00:12:43,430 - > 00:12:45,590 Give me a concrete example of that. 273 00:12:45,990 - > 00:12:49,350 And if they're vague about it, there's a red flag there. 274 00:12:49,990 - > 00:12:50,070 Okay. 275 00:12:51,750 - > 00:12:55,190 We took it in, we did we perform these experiments, we scaled it 276 00:12:55,190 - > 00:12:57,029 this way, you use this equipment. 277 00:12:57,269 - > 00:12:58,389 Here was the outcome. 278 00:12:58,549 - > 00:13:00,230 They eventually got an approval. 279 00:13:00,389 - > 00:13:04,789 Whatever that case study is on that particular program, you 280 00:13:04,789 - > 00:13:07,830 want to say we've done it, not we can do it. 281 00:13:07,909 - > 00:13:09,830 And that's those are two different things. 282 00:13:10,149 - > 00:13:12,629 SPEAKER_00: And is that what you find people ultimately? 283 00:13:12,870 - > 00:13:15,350 I'm sure you're in competitive situations all the time, and 284 00:13:15,350 - > 00:13:17,509 some people select you and some people, some people don't, 285 00:13:17,590 - > 00:13:17,750 right? 286 00:13:17,830 - > 00:13:21,509 But for the ones with when they do select you, is that the 287 00:13:21,509 - > 00:13:21,909 reason? 288 00:13:21,990 - > 00:13:24,470 Is that trust building, or what is kind of the reason that you 289 00:13:24,470 - > 00:13:25,029 get selected? 290 00:13:25,350 - > 00:13:30,149 SPEAKER_01: Yeah, so there's it's a multi-factor decision. 291 00:13:30,470 - > 00:13:32,470 So is the equipment right? 292 00:13:32,789 - > 00:13:34,950 Can we grow within this organization? 293 00:13:35,269 - > 00:13:36,389 Can you scale? 294 00:13:36,710 - > 00:13:39,190 Take us beyond phase one or two. 295 00:13:39,509 - > 00:13:43,350 Do you have that experience with this particular modality? 296 00:13:43,590 - > 00:13:47,909 Have you worked on solid oral and taken this kind of a product 297 00:13:47,909 - > 00:13:51,190 forward with these parameters that we're giving you? 298 00:13:51,430 - > 00:13:54,310 And then, of course, your quality system. 299 00:13:54,710 - > 00:13:56,310 How is your quality team? 300 00:13:56,389 - > 00:13:58,070 How do they interact with operations? 301 00:13:58,149 - > 00:13:59,669 How will they interact with us? 302 00:13:59,909 - > 00:14:01,590 Can I check some references? 303 00:14:02,230 - > 00:14:05,669 Those are the, I guess, steps you gotta take in your 304 00:14:05,669 - > 00:14:06,230 selection. 305 00:14:06,549 - > 00:14:10,070 SPEAKER_00: And where does capacity fit into all of this? 306 00:14:10,230 - > 00:14:13,190 Because I'm sure there's always pressure in a manufacturing 307 00:14:13,190 - > 00:14:16,070 business that ownership wants to see more sales coming in, but 308 00:14:16,070 - > 00:14:19,110 then you ultimately need to be able to deliver on your 309 00:14:19,110 - > 00:14:19,509 commitment. 310 00:14:19,590 - > 00:14:21,990 So what what do you think are some red flags that farmers 311 00:14:21,990 - > 00:14:25,909 should be looking for that a C DMO may be either overcommitted 312 00:14:25,909 - > 00:14:29,350 or struggling operationally, even if they look strong on 313 00:14:29,350 - > 00:14:29,909 paper? 314 00:14:30,230 - > 00:14:34,789 SPEAKER_01: I think that you're probably gonna get that sense if 315 00:14:34,950 - > 00:14:39,430 it's very difficult to move to next steps in the negotiation. 316 00:14:39,590 - > 00:14:42,230 Like it took me a month to get a proposal. 317 00:14:42,549 - > 00:14:43,669 What's going on there? 318 00:14:43,909 - > 00:14:46,470 I can't get in the facility to do my visit. 319 00:14:46,789 - > 00:14:48,950 QA audits are six months out. 320 00:14:49,190 - > 00:14:52,549 All of those are telling me he's got it maxed out. 321 00:14:52,710 - > 00:14:56,310 You don't want a ghost town when you go there, but you don't want 322 00:14:56,710 - > 00:15:00,470 a situation where bins are flying back and forth and you 323 00:15:00,470 - > 00:15:03,269 know it looks like chaos in the facility. 324 00:15:03,350 - > 00:15:07,269 And you know, you want it you want a brisk sense of movement, 325 00:15:07,509 - > 00:15:08,389 but not too much. 326 00:15:08,549 - > 00:15:12,389 But all of those things up front will tell you, hey, something's 327 00:15:12,389 - > 00:15:12,950 wrong here. 328 00:15:13,029 - > 00:15:15,430 They're they're just like I'm not gonna get a slot. 329 00:15:15,590 - > 00:15:18,789 Even if we consummate this relationship, I'll never get the 330 00:15:18,789 - > 00:15:21,110 slots and for manufacturing stuff. 331 00:15:21,509 - > 00:15:23,909 SPEAKER_00: We'll ship gears here to a little bit of where 332 00:15:23,909 - > 00:15:26,310 you think this this industry is headed. 333 00:15:26,549 - > 00:15:30,549 So maybe let's start to talk about I guess pricing and 334 00:15:30,549 - > 00:15:31,590 alternative models. 335 00:15:31,669 - > 00:15:34,389 So, what's your take on risk sharing or dynamic pricing 336 00:15:34,389 - > 00:15:35,909 models and CMO deals? 337 00:15:36,070 - > 00:15:37,830 Can you describe what that even is? 338 00:15:38,070 - > 00:15:41,509 And then when they create real realignment, when they become a 339 00:15:41,509 - > 00:15:42,789 trap for either side. 340 00:15:43,110 - > 00:15:46,710 SPEAKER_01: That is a buzz term right now, is dynamic pricing. 341 00:15:46,950 - > 00:15:50,789 And some organizations, and I think this is Can you define 342 00:15:50,789 - > 00:15:52,389 what it is before before getting into it? 343 00:15:52,710 - > 00:15:56,149 Yeah, yeah it's going beyond fee for service. 344 00:15:56,389 - > 00:15:59,190 Traditionally, we'd say a bat's going to cost you 50,000, 345 00:15:59,350 - > 00:16:03,990 stability time points 3,500, a development report is 7,000, and 346 00:16:03,990 - > 00:16:07,110 you got a Chinese menu of everything, and then it's 500 347 00:16:07,110 - > 00:16:08,710 grand, and that's what you pay. 348 00:16:09,110 - > 00:16:13,269 And with organizations, especially small clinical 349 00:16:13,509 - > 00:16:17,350 virtual companies, they can't raise the money they had been 350 00:16:17,350 - > 00:16:18,870 raising in the past. 351 00:16:19,110 - > 00:16:24,310 The last probably three years has been really tight in raising 352 00:16:24,310 - > 00:16:27,190 money in whatever fashion you're trying to do it. 353 00:16:27,430 - > 00:16:29,590 So they're unlimited budgets. 354 00:16:29,909 - > 00:16:35,669 So they'll say if we can meet these time frames, let's say you 355 00:16:35,669 - > 00:16:40,149 can get me in a clinic in three months versus six months, I'll 356 00:16:40,149 - > 00:16:42,149 give you a 25% bonus. 357 00:16:42,310 - > 00:16:47,269 So you'd be 25% cheaper on your price, but there's a kicker that 358 00:16:47,669 - > 00:16:48,789 would be worth it to you. 359 00:16:48,950 - > 00:16:54,310 So those are kind of scenarios that people are talking about 360 00:16:54,310 - > 00:16:54,870 right now. 361 00:16:55,190 - > 00:16:57,190 SPEAKER_00: And what's your take on those? 362 00:16:57,350 - > 00:17:01,350 Are they effective or is it uh like an overcomplication? 363 00:17:01,909 - > 00:17:05,589 SPEAKER_01: I think they can be really effective for both sides 364 00:17:05,750 - > 00:17:07,349 if they're well thought out. 365 00:17:07,669 - > 00:17:12,309 Because if I normally get $500,000 for this program, but 366 00:17:12,309 - > 00:17:15,190 if it's successful, I have an opportunity to make$550. 367 00:17:15,430 - > 00:17:19,750 That's another 10% that I normally would not have gotten 368 00:17:19,750 - > 00:17:22,230 if I just was a feed for service model. 369 00:17:22,630 - > 00:17:28,630 Now, certain organizations, if the program isn't successful or 370 00:17:28,630 - > 00:17:32,069 they have an adverse reaction that's just so severe they have 371 00:17:32,069 - > 00:17:35,990 to stop the program, you could be out a few dollars as well. 372 00:17:36,230 - > 00:17:40,710 It's a matter of you have to attract a number of clients to 373 00:17:40,710 - > 00:17:45,269 be in your portfolio so that you have a vibrant pipeline moving 374 00:17:45,269 - > 00:17:45,670 forward. 375 00:17:45,990 - > 00:17:47,990 SPEAKER_00: If you've been enjoying the conversations here 376 00:17:47,990 - > 00:17:50,789 on Pharma Sessions, you should know they're made possible by 377 00:17:50,789 - > 00:17:52,069 the team at Excent. 378 00:17:52,470 - > 00:17:56,150 XSunt helps life sciences companies turn complex data into 379 00:17:56,150 - > 00:17:57,829 clear, actionable insight. 380 00:17:58,069 - > 00:18:01,430 For years, Excent has made complicated data sets simple to 381 00:18:01,430 - > 00:18:04,630 help commercial, medical, and operations teams map what's 382 00:18:04,630 - > 00:18:08,309 happening, predict what's next, and make stronger decisions 383 00:18:08,309 - > 00:18:08,870 faster. 384 00:18:09,029 - > 00:18:12,150 And now there's an added AI layer that makes everything work 385 00:18:12,150 - > 00:18:12,789 so much better. 386 00:18:13,029 - > 00:18:15,829 I was actually pretty jaded about some of the AI approaches 387 00:18:15,829 - > 00:18:18,630 I had seen, but when XSunt showed me theirs, I actually 388 00:18:18,630 - > 00:18:19,990 left my job to come work for them. 389 00:18:20,150 - > 00:18:20,950 It's really awesome. 390 00:18:21,109 - > 00:18:24,150 So if you want to understand your market, your customers, or 391 00:18:24,150 - > 00:18:26,630 your performance with more clarity than ever, check out 392 00:18:26,630 - > 00:18:28,069 excent.com. 393 00:18:28,150 - > 00:18:31,509 That's xs-unt.com. 394 00:18:31,910 - > 00:18:34,309 All right, let's jump back into the episode. 395 00:18:34,630 - > 00:18:38,549 That seems like a really tricky spot to put a C DMO in because I 396 00:18:38,549 - > 00:18:41,750 mean, you know if trials fail all the time, right? 397 00:18:41,910 - > 00:18:44,950 It's baked into the pharma model that only a certain percentage 398 00:18:44,950 - > 00:18:46,069 are gonna make it out. 399 00:18:46,230 - > 00:18:46,549 That's right. 400 00:18:46,710 - > 00:18:50,950 I'm not so sure that it's baked into the C DMO model that half 401 00:18:50,950 - > 00:18:54,230 of your whatever percentage of your contracts are gonna fail 402 00:18:54,230 - > 00:18:54,470 out. 403 00:18:54,710 - > 00:18:58,789 So I would bet you don't really have the medical science 404 00:18:58,789 - > 00:19:01,509 expertise on staff to try to make those decisions. 405 00:19:01,670 - > 00:19:02,470 Not that you even can. 406 00:19:02,549 - > 00:19:05,430 SPEAKER_01: Like no, no, you don't, and you never seem like a 407 00:19:05,430 - > 00:19:06,069 huge risk. 408 00:19:06,309 - > 00:19:07,829 It is a big risk. 409 00:19:08,150 - > 00:19:13,269 But if the market prevails in that direction, you have to deal 410 00:19:13,269 - > 00:19:13,670 with it. 411 00:19:13,829 - > 00:19:16,390 You can't stick your head in the sand and say it doesn't exist. 412 00:19:16,470 - > 00:19:19,109 You're gonna have to say, okay, how we how can we make this 413 00:19:19,109 - > 00:19:19,349 work? 414 00:19:19,509 - > 00:19:23,029 And that's where you you get to the negotiation table and you're 415 00:19:23,029 - > 00:19:24,470 trying to make a big deal for everybody. 416 00:19:24,710 - > 00:19:24,870 SPEAKER_00: Right. 417 00:19:24,950 - > 00:19:27,990 You're almost like a VC trying to create a little portfolio of 418 00:19:27,990 - > 00:19:31,269 uh companies so that if if some of them fall out, you have some 419 00:19:31,269 - > 00:19:31,750 successes. 420 00:19:32,069 - > 00:19:32,789 That's exactly right. 421 00:19:33,269 - > 00:19:35,829 All right, so then try and think of a way to ask this without 422 00:19:35,829 - > 00:19:40,069 getting super super political, and these things are changing by 423 00:19:40,069 - > 00:19:40,789 the minute, right? 424 00:19:40,870 - > 00:19:44,870 But let's just say there's there's all this geopolitical 425 00:19:44,870 - > 00:19:47,829 manufacturing reshoring pressure, right? 426 00:19:47,990 - > 00:19:52,150 And then there's also risk that tariffs may be there one day, 427 00:19:52,309 - > 00:19:54,630 may not be there another day, who knows, and who knows what 428 00:19:54,630 - > 00:19:57,109 it's going to be by the time this thing even comes out. 429 00:19:57,349 - > 00:20:01,029 So, how much do you think what are you seeing companies like 430 00:20:01,190 - > 00:20:05,670 how much are they factoring that into their decisions around 431 00:20:05,990 - > 00:20:09,430 where to manufacture trade-offs between cost, speed, supply 432 00:20:09,430 - > 00:20:12,230 chain reliability when they're choosing sites these days? 433 00:20:12,549 - > 00:20:15,109 SPEAKER_01: I think it's definitely in the thought 434 00:20:15,109 - > 00:20:18,789 process should we make this product in the US? 435 00:20:19,109 - > 00:20:19,910 That's there. 436 00:20:20,150 - > 00:20:23,190 There were a number of opportunities that we looked at 437 00:20:23,190 - > 00:20:29,109 last year where big pharma got our pricing, looked at it and 438 00:20:29,109 - > 00:20:31,190 said, we're just gonna leave it where it is, right? 439 00:20:31,589 - > 00:20:36,309 And wait, we we think that we can do it, and even if we put 440 00:20:36,309 - > 00:20:40,230 the tariff in there, it's still less expensive for us to make it 441 00:20:40,230 - > 00:20:43,430 ourselves than to use a US supplier. 442 00:20:43,750 - > 00:20:47,750 It's just not worth it because obviously they do it themselves 443 00:20:48,069 - > 00:20:51,589 in a particular country where labor is less expensive than 444 00:20:51,589 - > 00:20:54,870 North America, they're gonna have lower margins there. 445 00:20:55,029 - > 00:20:57,349 It's not gonna be as expensive if they do it in the U.S. 446 00:20:57,509 - > 00:21:02,870 And when they factor in 10% or 15% tariff, it just makes sense 447 00:21:02,870 - > 00:21:05,349 to just hold pat with what you don't. 448 00:21:05,509 - > 00:21:08,950 There's another contingency that's sort of, for lack of a 449 00:21:08,950 - > 00:21:11,190 better term, maybe more patriotic. 450 00:21:11,509 - > 00:21:15,190 And they're like, Listen, let's do this, let's build a facility 451 00:21:15,190 - > 00:21:17,349 here, let's move the product to the U.S. 452 00:21:17,910 - > 00:21:20,789 United States people work on products that they're actually 453 00:21:20,789 - > 00:21:21,509 going to consume. 454 00:21:21,750 - > 00:21:25,670 And then give them pride in making something, bring that 455 00:21:25,670 - > 00:21:27,430 whole concept back. 456 00:21:27,750 - > 00:21:29,190 SPEAKER_00: Are you seeing that really happen? 457 00:21:29,430 - > 00:21:29,990 SPEAKER_01: I am. 458 00:21:30,150 - > 00:21:33,509 I am seeing folks that say, listen, let's do it here. 459 00:21:33,670 - > 00:21:35,430 Let's get the best price we can. 460 00:21:35,509 - > 00:21:38,630 And depending on the dosage form, you get a pretty 461 00:21:38,630 - > 00:21:40,150 competitive price right now. 462 00:21:40,390 - > 00:21:43,029 In this solid world, there's a lot of capacity in the 463 00:21:43,029 - > 00:21:43,670 marketplace. 464 00:21:43,829 - > 00:21:47,029 If you're in a antibody drug conjugate, it might be tighter. 465 00:21:47,190 - > 00:21:49,349 If you're in a monoclonal, it might be tighter. 466 00:21:49,589 - > 00:21:54,390 But if you can get a competitive price and make it here, some 467 00:21:54,390 - > 00:21:55,990 people really want to do that. 468 00:21:56,470 - > 00:21:57,910 SPEAKER_00: So that's really fascinating. 469 00:21:57,990 - > 00:22:00,630 I remember this is what they I'm trying not to be overly cynical 470 00:22:00,789 - > 00:22:04,309 here, but one thing I remember from business school was a 471 00:22:04,309 - > 00:22:07,109 survey where they asked people, I think it was jeans, they're 472 00:22:07,109 - > 00:22:09,509 like, how much extra would you pay if a pair of jeans was 473 00:22:09,509 - > 00:22:10,710 manufactured in the US? 474 00:22:10,870 - > 00:22:14,630 And people said all of these numbers, and then then they did 475 00:22:14,630 - > 00:22:15,750 an actual experiment to see. 476 00:22:16,150 - > 00:22:18,150 How much people were really willing to pay for? 477 00:22:18,390 - > 00:22:19,670 And the answer was zero. 478 00:22:20,230 - > 00:22:20,789 SPEAKER_01: Different story. 479 00:22:20,870 - > 00:22:21,029 Yeah. 480 00:22:21,589 - > 00:22:22,390 Totally different story. 481 00:22:23,509 - > 00:22:24,069 SPEAKER_00: But it's good, right? 482 00:22:24,150 - > 00:22:25,990 If people are willing to put their money where their mouth 483 00:22:25,990 - > 00:22:26,470 is, right? 484 00:22:26,630 - > 00:22:30,150 And but I think that the the smaller that delta gets, right, 485 00:22:30,230 - > 00:22:33,430 the easier it is to make that business case right to your 486 00:22:33,430 - > 00:22:35,509 leadership and increase manufacturing here. 487 00:22:35,829 - > 00:22:38,150 So let me ask you about another topic, Frank. 488 00:22:38,309 - > 00:22:42,230 Continuous manufacturing adoption versus traditional 489 00:22:42,230 - > 00:22:43,910 batch processes. 490 00:22:44,230 - > 00:22:46,789 Can you explain what this is and whether this is a trend that 491 00:22:46,789 - > 00:22:48,309 people should be paying attention to? 492 00:22:48,789 - > 00:22:52,309 SPEAKER_01: It's probably been the concept of continuous 493 00:22:52,309 - > 00:22:56,710 manufacturing has been talked about for like 15 years, I've 494 00:22:56,710 - > 00:22:57,269 heard it. 495 00:22:57,589 - > 00:23:01,109 And a lot of the big pharma companies would only speak to a 496 00:23:01,109 - > 00:23:04,870 CDMO if you had this technology versus the batch. 497 00:23:05,109 - > 00:23:09,509 The concept, and this is my understanding of it, we've never 498 00:23:09,509 - > 00:23:11,269 done that here at UPM. 499 00:23:11,509 - > 00:23:15,910 So I'm not an expert by any means, but it's just supposed to 500 00:23:15,910 - > 00:23:20,390 be a more efficient way of making a product and taking a 501 00:23:20,390 - > 00:23:25,589 little bit of risk out of if you make one big batch and it fails, 502 00:23:25,750 - > 00:23:26,789 you lose the whole thing. 503 00:23:26,870 - > 00:23:30,150 And you may have a very expensive active ingredient, and 504 00:23:30,150 - > 00:23:32,870 now you're you're out that money, and now you're gonna 505 00:23:32,870 - > 00:23:35,509 fight on who's gonna pay for it, whose fault was it? 506 00:23:35,750 - > 00:23:39,670 The finger point and start, the legalities come in versus a 507 00:23:39,670 - > 00:23:44,069 continuous process where you can stop it, got an issue, we only 508 00:23:44,069 - > 00:23:46,950 lose a little bit of product or a little bit of drug product, 509 00:23:47,109 - > 00:23:50,470 and then it continues, and it's also a little bit more efficient 510 00:23:50,630 - > 00:23:53,509 where you're not maybe moving room to room. 511 00:23:53,750 - > 00:23:57,430 You do your blending here, you do your milling right next to 512 00:23:57,430 - > 00:23:58,069 it, right? 513 00:23:58,309 - > 00:24:01,829 You do your sizing, and now you do your encapsulation or 514 00:24:01,829 - > 00:24:05,269 compression, and it's right in not one little room, but a 515 00:24:05,269 - > 00:24:08,789 bigger room, but it's all contained there versus moving it 516 00:24:08,789 - > 00:24:10,950 to different parts of the facility where there's some 517 00:24:10,950 - > 00:24:11,829 risk, obviously. 518 00:24:11,910 - > 00:24:13,349 Yeah, if you do that. 519 00:24:13,910 - > 00:24:19,990 So I haven't seen a ton of CDMOs doing that or offering that, and 520 00:24:19,990 - > 00:24:22,470 that's just from my vantage point. 521 00:24:22,870 - > 00:24:25,589 SPEAKER_00: That's this whole conversation is so interesting 522 00:24:25,589 - > 00:24:28,150 to me because I spend most of my time talking to commercial 523 00:24:28,150 - > 00:24:29,829 people and medical people, right? 524 00:24:29,910 - > 00:24:32,150 Where it's it's so it's it's a bit. 525 00:24:32,309 - > 00:24:35,509 I mean, we're talking about data all day long, but it's removed 526 00:24:35,509 - > 00:24:37,829 from the actual concept sometimes of like, well, 527 00:24:37,910 - > 00:24:40,789 somebody's got to get all this stuff into an actual pill that 528 00:24:40,789 - > 00:24:43,750 people can get into their bodies. 529 00:24:44,150 - > 00:24:47,910 And for me, it seems like magic because one of my strongest 530 00:24:47,910 - > 00:24:53,670 college memories in an academic setting is trying to complete 531 00:24:53,670 - > 00:24:58,390 organic chemistry labs and just failing over and over to the 532 00:24:58,390 - > 00:25:00,870 point where I was like, I'm following the directions. 533 00:25:00,950 - > 00:25:03,509 I feel like you know, like Harry Potter and Potions class. 534 00:25:03,589 - > 00:25:05,829 Like I just can't get the thing to work and I'm staying late. 535 00:25:05,910 - > 00:25:10,230 The TAs are getting like annoyed that they have to pay, and I'm 536 00:25:10,230 - > 00:25:13,509 just like not being able to synthesize these things. 537 00:25:13,589 - > 00:25:18,069 So it really is amazing that you all can do this at scale, at 538 00:25:18,069 - > 00:25:21,509 consistency, where somebody can go into CVS at the end of the 539 00:25:21,509 - > 00:25:24,230 day, get something, and not have to think twice before they put 540 00:25:24,230 - > 00:25:24,870 it in their mouth. 541 00:25:25,029 - > 00:25:26,630 So it really is it's amazing to me. 542 00:25:26,950 - > 00:25:27,750 SPEAKER_01: Myself as well. 543 00:25:27,829 - > 00:25:31,589 You know, when I started on the sponsor side, say, you know, in 544 00:25:31,589 - > 00:25:34,470 sales and marketing, you didn't even think about how it was 545 00:25:34,470 - > 00:25:34,789 made. 546 00:25:34,950 - > 00:25:37,269 You're like, what was the inactive ingredients? 547 00:25:37,349 - > 00:25:40,309 Or you just said, hey, doc, take this uh once a day and your 548 00:25:40,309 - > 00:25:41,190 blood pressure goes down. 549 00:25:41,430 - > 00:25:44,470 It costs uh a dollar a day versus two dollars for the 550 00:25:44,470 - > 00:25:45,190 competitor. 551 00:25:45,349 - > 00:25:50,789 And then when I got into UPM in 2007, a head was spinning. 552 00:25:50,950 - > 00:25:53,029 About how smart these people are. 553 00:25:53,190 - > 00:25:55,190 They are in brilliant people. 554 00:25:55,990 - > 00:26:00,069 And and it also when someone says, Why does it cost so much? 555 00:26:00,230 - > 00:26:02,069 Why do these products cost so much? 556 00:26:02,309 - > 00:26:05,829 If you were in the bowels of a manufacturing facility, a 557 00:26:05,829 - > 00:26:09,190 development operation, and you saw the work that was being 558 00:26:09,190 - > 00:26:13,190 done, this how many sleeves were rolled up, and the intelligence, 559 00:26:13,670 - > 00:26:17,910 intelligence of these people, you may think a little bit more 560 00:26:17,910 - > 00:26:18,870 about that statement. 561 00:26:19,109 - > 00:26:19,829 SPEAKER_00: That's fascinating. 562 00:26:19,910 - > 00:26:22,549 I mean, it really is very it's important work because it it 563 00:26:22,549 - > 00:26:23,589 just can't go wrong. 564 00:26:23,750 - > 00:26:25,750 That's different than a lot of jobs, right? 565 00:26:25,910 - > 00:26:26,710 Where that's right. 566 00:26:27,190 - > 00:26:30,069 All right, so let's wrap up with just a couple closing questions 567 00:26:30,069 - > 00:26:30,470 here, Frank. 568 00:26:30,710 - > 00:26:32,630 This has been super interesting for me. 569 00:26:32,870 - > 00:26:36,069 But looking back across your career, what's one lesson about 570 00:26:36,069 - > 00:26:40,069 C DMO selection that pharma leaders can usually only learn 571 00:26:40,069 - > 00:26:41,430 after something goes wrong? 572 00:26:41,750 - > 00:26:46,470 SPEAKER_01: Yeah, I I think the the lesson is defining success 573 00:26:46,710 - > 00:26:47,509 up front. 574 00:26:47,990 - > 00:26:50,150 What are you looking for in the partner? 575 00:26:50,470 - > 00:26:53,509 You know, what are those non-negotiables that are really 576 00:26:53,509 - > 00:26:57,750 important to you, the selection team, and the folks that have to 577 00:26:57,750 - > 00:27:00,230 work with the CDMO on an ongoing basis? 578 00:27:00,950 - > 00:27:03,109 You need to define that all up front. 579 00:27:03,349 - > 00:27:08,150 And then you need to go out and vet those things and make sure 580 00:27:08,150 - > 00:27:11,430 all the boxes are checked that are important to you. 581 00:27:11,750 - > 00:27:16,789 And you have to go to the sites and see the people, meet the 582 00:27:16,789 - > 00:27:22,470 people, and in the end, you gotta use your gut and say, I I 583 00:27:22,470 - > 00:27:26,150 think all three of these can do it, but I just have a feeling 584 00:27:26,390 - > 00:27:29,349 XYZ C DMO is the right choice for us. 585 00:27:29,589 - > 00:27:33,269 And then you know, you could always defend that 586 00:27:33,269 - > 00:27:37,029 decision-making process if something goes wrong, and you'll 587 00:27:37,029 - > 00:27:40,470 you'll sleep at night because you did your due diligence. 588 00:27:40,950 - > 00:27:42,309 SPEAKER_00: Yes, I love that. 589 00:27:42,470 - > 00:27:47,190 That's been my take to a number of kind of big decisions where 590 00:27:47,190 - > 00:27:48,549 to work, uh, various things. 591 00:27:48,710 - > 00:27:52,950 It's like if I get bit by something that I wasn't 592 00:27:52,950 - > 00:27:55,430 expecting, I'm actually okay with that, right? 593 00:27:55,589 - > 00:27:58,390 Like I you do what you can, you figure out what you can. 594 00:27:58,549 - > 00:28:02,069 It's like you never want to go into something with a concern, 595 00:28:02,150 - > 00:28:04,069 and then that's the thing that gets you, and you're just like, 596 00:28:04,150 - > 00:28:05,750 yeah, I should have listened to myself. 597 00:28:05,910 - > 00:28:06,309 SPEAKER_01: I knew it. 598 00:28:06,789 - > 00:28:07,990 I absolutely knew it. 599 00:28:08,150 - > 00:28:10,309 You don't want to be kicking yourself down a road. 600 00:28:10,549 - > 00:28:11,109 SPEAKER_00: Well, awesome. 601 00:28:11,190 - > 00:28:12,069 Well, let's leave it there. 602 00:28:12,150 - > 00:28:15,269 So trust trust your instincts, do your due diligence, trust 603 00:28:15,269 - > 00:28:20,309 your instincts, and you will end up with a happy and fruitful 604 00:28:20,309 - > 00:28:22,710 partnership with your C DMO of choice. 605 00:28:22,950 - > 00:28:25,670 And Frank, thank you so much for your time today. 606 00:28:26,069 - > 00:28:27,109 Pleasure, Jonathan. 607 00:28:27,190 - > 00:28:28,069 Thank you. 608 00:28:28,710 - > 00:28:33,990 This episode of Pharma Sessions is sponsored by Xunt, makers of 609 00:28:33,990 - > 00:28:36,710 the X1 reporting platform. 610 00:28:37,430 - > 00:28:41,029 And that's a wrap on today's episode of Pharma Sessions with 611 00:28:41,029 - > 00:28:42,549 me, Jonathan Kaske. 612 00:28:42,710 - > 00:28:45,349 If you enjoyed today's conversation, don't forget to 613 00:28:45,349 - > 00:28:48,069 hit follow or subscribe and share it with someone else in 614 00:28:48,069 - > 00:28:50,710 the pharma world who might need to hear it. 615 00:28:50,950 - > 00:28:54,789 For more on pharma trends, career growth, and business 616 00:28:54,789 - > 00:28:58,950 strategies, connect with me, Jonathan Kaske, on LinkedIn. 617 00:28:59,109 - > 00:29:01,589 Until next time, thanks for listening.