WEBVTT 1 00:00:00.120 --> 00:00:03.680 Welcome to Farmer Talk Radio. This podcast is focused on 2 00:00:03.759 --> 00:00:07.360 optimizing the value proposition in small companies with limited budgets 3 00:00:07.480 --> 00:00:10.679 from the twenty twenty five Chief Medical Officer Summitt three sixty. 4 00:00:10.960 --> 00:00:15.720 For more information on the CMO Summit, editorials, podcasts, or webcasts, 5 00:00:15.960 --> 00:00:18.879 please visit CMO three sixty dot org. Thank you and 6 00:00:19.039 --> 00:00:19.960 enjoy the podcast. 7 00:00:20.440 --> 00:00:22.719 I'd like to introduce myself. I'm Luke dv I'm the 8 00:00:22.719 --> 00:00:25.640 CMO of twelve Therapeutics, which is a car t reg 9 00:00:25.719 --> 00:00:29.280 company based in London, and I've been there for a 10 00:00:29.320 --> 00:00:32.240 couple of years after a career in Big Farmer. Prior 11 00:00:32.280 --> 00:00:37.320 to that in academic surgery, and then a more recent 12 00:00:37.359 --> 00:00:41.359 gig for me is working's venture partner at SV Health Investors. 13 00:00:41.840 --> 00:00:44.399 And so if I can ask my fellow panelist to 14 00:00:44.439 --> 00:00:46.000 introduce yourselves to Jen. 15 00:00:47.560 --> 00:00:51.240 Hi, everyone, Jen Sida. I've been almost exclusively on the 16 00:00:51.240 --> 00:00:53.799 biotech side for the past twenty five years and the 17 00:00:53.880 --> 00:00:58.399 last nine of those with SSI Strategy, and with that team, 18 00:00:58.520 --> 00:01:03.079 I've held three CMO roles, but also as part of 19 00:01:03.079 --> 00:01:06.760 the company, we do is not just sometimes place cmos 20 00:01:06.799 --> 00:01:11.799 in interim acting supplementary roles, but we also wrap around 21 00:01:11.920 --> 00:01:13.840 existing cmos, so we have a chance to work with 22 00:01:13.840 --> 00:01:17.640 about forty to fifty cmos per year, so we end 23 00:01:17.760 --> 00:01:21.640 up seeing a lot of what people do write and 24 00:01:21.680 --> 00:01:24.239 where people might go a little sideways in trying to 25 00:01:24.280 --> 00:01:27.319 really optimize their budgets. So have a little bit different 26 00:01:27.319 --> 00:01:28.040 perspective there. 27 00:01:30.000 --> 00:01:31.560 Hi, everyone, I'm John Goldberg. 28 00:01:32.040 --> 00:01:35.000 I was the CMO at a publicly traded biotech company 29 00:01:35.040 --> 00:01:35.719 called on Chorus. 30 00:01:36.760 --> 00:01:39.120 That's the operating part of my career. 31 00:01:39.599 --> 00:01:43.280 We went public like many other companies in twenty twenty 32 00:01:43.480 --> 00:01:47.120 October second, to be exact, and I think what I 33 00:01:47.200 --> 00:01:51.959 learned about optimizing the value proposition there really was around 34 00:01:53.120 --> 00:01:57.439 maybe as a company strategically not over investing in internal capabilities. 35 00:01:58.079 --> 00:02:01.239 But fast forward to now we'll have a chance to 36 00:02:01.280 --> 00:02:05.040 get into that more. I'm the chief medical officer at 37 00:02:05.480 --> 00:02:09.800 Raphael Holdings, which is a publicly traded but family controlled 38 00:02:11.240 --> 00:02:16.759 holding company based in Newark, New Jersey. We have recently 39 00:02:16.800 --> 00:02:21.120 completed a merger and a merger with Psychotherapeutics, and my 40 00:02:21.759 --> 00:02:24.479 colleague from Cyclo is here in the audience as well, 41 00:02:25.080 --> 00:02:27.159 so we can talk a little bit about how we're 42 00:02:27.199 --> 00:02:32.680 keeping that team lean as we approach the value proposition. 43 00:02:33.759 --> 00:02:37.240 And I'm Scott Harris. Excuse me. I'm the chief medical 44 00:02:37.280 --> 00:02:41.439 officer of Altimoun. We're a publicly traded company in the 45 00:02:41.800 --> 00:02:45.639 mass and obesity space. We have a JLP one dual 46 00:02:45.719 --> 00:02:49.280 receptor agonist with the trial readout coming up in this quarter. 47 00:02:50.120 --> 00:02:53.080 But I've been in biotech for twenty five years. I've 48 00:02:53.080 --> 00:02:56.520 been in both the public and private sectors. I've been 49 00:02:57.240 --> 00:03:01.439 the chief medical officer three private company, two of which 50 00:03:01.479 --> 00:03:04.120 were a venture back, one of which I actually founded 51 00:03:04.639 --> 00:03:07.680 and started with the Series A. And now I'm currently 52 00:03:08.479 --> 00:03:11.840 the chief medical officer of a public company. 53 00:03:12.840 --> 00:03:18.199 So this this topic feels very cogent to today's Everything 54 00:03:18.240 --> 00:03:21.199 that we've heard today actually just about the kind of 55 00:03:21.199 --> 00:03:26.560 bear market that we're operating in and this sort of 56 00:03:26.159 --> 00:03:30.520 tough funding environment, the elevated expectations of what we have 57 00:03:30.599 --> 00:03:34.159 to deliver in terms of data packages in order to 58 00:03:34.159 --> 00:03:36.919 make compelling investment opportunities. 59 00:03:37.479 --> 00:03:38.400 We've also heard. 60 00:03:38.280 --> 00:03:41.159 Quite a lot about how to articulate our stories in 61 00:03:41.199 --> 00:03:44.360 the best possible way in order to make to make 62 00:03:44.439 --> 00:03:49.120 them interesting to investors. It's sort of another story that 63 00:03:49.159 --> 00:03:51.919 I heard first thing at breakfast was how there's a 64 00:03:52.000 --> 00:03:55.840 forty percent vacancy rate in Kendall square at the moment, right. So, 65 00:03:55.879 --> 00:03:58.520 I thought that really brought it home to me just 66 00:03:58.719 --> 00:04:01.960 how tough a our it is that we're all pracing 67 00:04:02.039 --> 00:04:04.919 it now with the sort of wealth of different perspectives 68 00:04:04.919 --> 00:04:07.280 we've got on the panel. I wanted if maybe Scott, 69 00:04:07.319 --> 00:04:09.639 you could start off by reflecting on how things are 70 00:04:09.639 --> 00:04:13.360 different now and the difference in the story that we 71 00:04:13.400 --> 00:04:15.400 need to be able to tell in order to make 72 00:04:15.400 --> 00:04:16.959 a compelling investment proposition. 73 00:04:18.720 --> 00:04:22.720 Well, the downfall of the markets are very recent. It's 74 00:04:22.759 --> 00:04:26.639 a little hard to tell, although we've seen these rises 75 00:04:26.720 --> 00:04:30.360 and falls periodically. You know, we saw this during the 76 00:04:30.360 --> 00:04:33.079 pandemic when the markets took a hic and then the 77 00:04:33.079 --> 00:04:38.600 biotech market went zooming because of the promise of developing 78 00:04:38.639 --> 00:04:44.600 COVID vaccines with a lot of schizophrenic investors. There's really 79 00:04:44.680 --> 00:04:47.399 nothing that we can really do about it. I think 80 00:04:47.439 --> 00:04:51.439 that the value proposition for you here and listening to 81 00:04:51.600 --> 00:04:54.560 us speak is what we can tell you you can 82 00:04:54.600 --> 00:04:58.839 do to create your own value for your own companies. 83 00:04:58.920 --> 00:05:02.199 And I'm happy to make other comments, but I'll pass 84 00:05:02.240 --> 00:05:04.399 it over to John and see if he wants to 85 00:05:04.399 --> 00:05:04.920 add to that. 86 00:05:06.199 --> 00:05:07.360 Thanks, Thank you, Scott. 87 00:05:08.000 --> 00:05:09.920 So I think For me, the canary in the coal 88 00:05:09.959 --> 00:05:13.639 mine was I was first time head of development and 89 00:05:13.720 --> 00:05:17.439 it was it was citsy of twenty twenty one and 90 00:05:18.079 --> 00:05:23.360 we were holding our first investor call and the street 91 00:05:23.439 --> 00:05:27.480 did not like it, and in retrospect, knowing what I 92 00:05:27.560 --> 00:05:31.079 know now, that was pretty obvious we didn't. We had 93 00:05:31.079 --> 00:05:35.439 a call, we had our analysts call in and we 94 00:05:35.519 --> 00:05:39.000 basically said that, you know, patients had psychokine release syndrome 95 00:05:39.000 --> 00:05:42.399 when they got injected with a virus and maybe somebody's 96 00:05:42.439 --> 00:05:45.079 tomb had gotten smaller. We were really psyched about it. 97 00:05:45.120 --> 00:05:47.639 We thought we had executed very well. But I think 98 00:05:47.680 --> 00:05:51.759 the lesson there, aside from the fact that it was sparked, 99 00:05:52.120 --> 00:05:55.319 things were starting to get very hard from an oncology standpoint. 100 00:05:55.800 --> 00:05:57.240 You needed to have response data. 101 00:05:57.240 --> 00:05:59.920 But the lesson for us was you have to understand 102 00:06:01.279 --> 00:06:04.920 what the stakeholders are expecting to hear, and we did 103 00:06:04.959 --> 00:06:08.079 not understand that. The market at that point was you 104 00:06:08.199 --> 00:06:11.160 have to have responses, and perhaps for good reasons in 105 00:06:11.199 --> 00:06:12.480 the ancalitic virus field. 106 00:06:13.360 --> 00:06:15.560 So that was certainly a lesson for me. 107 00:06:16.120 --> 00:06:20.759 And then right sizing your clinical development program to deliver 108 00:06:21.000 --> 00:06:24.040 what you think the market is expecting which I hope 109 00:06:24.040 --> 00:06:26.639 I have the opportunity to do now. We're working with 110 00:06:26.920 --> 00:06:29.600 our new partner, Psycotherapeutics, and I'd. 111 00:06:29.439 --> 00:06:31.680 Love to add, even though it seems like the laboring. 112 00:06:31.720 --> 00:06:36.399 A point we heard a lot of today is how 113 00:06:36.439 --> 00:06:40.839 to really create more value from every milestone by actually 114 00:06:40.920 --> 00:06:44.160 building with the end in mind as early as possible, 115 00:06:44.480 --> 00:06:47.959 even if it's pipeline prioritization or into indication selection. Is 116 00:06:48.000 --> 00:06:51.680 this something that's truly solving an issue in the market 117 00:06:51.759 --> 00:06:54.399 as it stands, not just now, but in development the 118 00:06:54.439 --> 00:06:58.040 timeline until the drug would come to market. And we 119 00:06:58.120 --> 00:07:01.720 see a lot of companies that get very insulated thinking 120 00:07:02.040 --> 00:07:05.160 very early on, especially from an R and D mindset 121 00:07:05.240 --> 00:07:08.480 to CSO founder mindset, that this is our compound and 122 00:07:08.519 --> 00:07:10.519 we're going to build everything around it, and then maybe 123 00:07:10.800 --> 00:07:12.759 add a few bells and whistles about Okay, there's a 124 00:07:12.759 --> 00:07:14.920 big market and if we get a little piece of that, 125 00:07:14.959 --> 00:07:18.319 we'll be happy. Versus those that really take the time 126 00:07:18.399 --> 00:07:21.279 and effort, which is difficult to do, especially in that 127 00:07:21.720 --> 00:07:23.920 limited resource environment. You want to go, go, go and 128 00:07:23.959 --> 00:07:25.800 get to a milestone, but to take a step back 129 00:07:25.839 --> 00:07:30.399 and say, are we really telling a compelling narrative about 130 00:07:30.439 --> 00:07:34.759 how we're going to creatively approach this situation in something 131 00:07:34.800 --> 00:07:37.920 that will really solve an unmet need. And that could 132 00:07:37.959 --> 00:07:41.319 be looking like instead of focusing an incredible discipline to 133 00:07:41.560 --> 00:07:45.920 value a creative milestones, not just the next milestone. I 134 00:07:45.959 --> 00:07:47.360 know we heard a lot about that, but that could 135 00:07:47.439 --> 00:07:50.240 look like instead of every meeting about being about are 136 00:07:50.279 --> 00:07:53.199 we hitting that timeline for filling out and submitting the 137 00:07:53.199 --> 00:07:56.000 I and D, are we actually sitting back and thinking 138 00:07:56.000 --> 00:08:00.000 about how are we optimizing our own resources to creatively 139 00:08:00.160 --> 00:08:02.879 get the proof of concept as fast as possible in humans? 140 00:08:03.040 --> 00:08:06.040 Which is a very different conversation to have, and that 141 00:08:06.120 --> 00:08:08.279 might be for like a rare and complex a rare 142 00:08:08.279 --> 00:08:10.560 disease or and complex modality that I've worked a lot in. 143 00:08:11.399 --> 00:08:14.199 We can actually demonstrate we got early advice from multiple 144 00:08:14.279 --> 00:08:16.920 jurisdictions to de risk our strategies, so we have a 145 00:08:17.000 --> 00:08:21.199 higher chance of success of being clinically and commercially successful 146 00:08:21.480 --> 00:08:24.720 across our CDP because we got that input early, we 147 00:08:25.199 --> 00:08:27.959 maybe looked at different geographies to say how do we 148 00:08:28.000 --> 00:08:30.480 most efficiently get there? So I actually did want to 149 00:08:30.560 --> 00:08:32.200 challenge maybe one of the thoughts we heard of what 150 00:08:32.240 --> 00:08:36.240 makes a good CMO was have they done this multiple times? 151 00:08:36.399 --> 00:08:37.559 But I want to know have they done it the 152 00:08:37.559 --> 00:08:41.000 same way every time versus right now? You might need 153 00:08:41.000 --> 00:08:43.159 to be able to do that a little bit more creatively. 154 00:08:43.399 --> 00:08:44.960 So I think more of the thrust of that was 155 00:08:44.960 --> 00:08:48.879 about de risking and optimizing those individual kind of choices 156 00:08:48.919 --> 00:08:51.639 along the way and being disciplined to sticking to that 157 00:08:51.720 --> 00:08:54.440 value accretion milestone. 158 00:08:55.799 --> 00:08:59.360 So you know what I'm hearing is three major changes. 159 00:08:59.399 --> 00:09:02.639 One is a discipline from investors looking at the end 160 00:09:02.639 --> 00:09:07.200 in mind and not only to the next development milestone, 161 00:09:07.240 --> 00:09:12.360 but through to approval, through to reimbursement and revenue. Secondly, 162 00:09:12.399 --> 00:09:17.440 the macroeconomic limitations with and limitations in investment. And then 163 00:09:17.519 --> 00:09:21.720 thirdly this political context that we now all live in, 164 00:09:22.159 --> 00:09:25.080 which is thrown up a whole load of other uncertainties. 165 00:09:25.440 --> 00:09:29.720 I'm just wondering whether you see any particular I don't 166 00:09:29.720 --> 00:09:32.000 know if you could riff on the you know that 167 00:09:32.360 --> 00:09:35.240 on those themes, you know, what are the particular challenges 168 00:09:35.240 --> 00:09:38.240 that you see? Do you see any particular solutions to 169 00:09:38.279 --> 00:09:41.679 that at the moment in this current environment. 170 00:09:42.559 --> 00:09:44.720 I think that there are themes that run true. I 171 00:09:44.799 --> 00:09:49.559 think there are things that you can do. The first 172 00:09:50.080 --> 00:09:54.360 is value is not a continuous process. It doesn't gradually 173 00:09:54.399 --> 00:09:59.840 go up or gradually go down. It's generally driven by catalysts. Okay, 174 00:10:00.320 --> 00:10:02.440 now it's hard to see this as a private company 175 00:10:02.440 --> 00:10:05.360 because you don't have those external metrics. But as a 176 00:10:05.600 --> 00:10:08.519 public company, you can look at your stock price in 177 00:10:08.639 --> 00:10:12.519 market capitalization not only every day but by the minute. 178 00:10:13.000 --> 00:10:17.159 So what drives that value? If it's not continuous, it's catalysts, 179 00:10:17.279 --> 00:10:20.399 or you can call it milestones, as Jen said, So 180 00:10:20.440 --> 00:10:24.360 what are those milestones. Well, generally they're your data readouts, 181 00:10:25.200 --> 00:10:28.480 and depending in the marketplace, that data readout is typically clinical. 182 00:10:28.559 --> 00:10:31.600 But during the pandemic, when we had a vaccine company, 183 00:10:31.759 --> 00:10:35.879 we read out a pre clinical rats study on an 184 00:10:35.919 --> 00:10:42.120 internasal covid vaccine. Based on preclinical data, the stock popped, 185 00:10:42.159 --> 00:10:44.519 our market valuation went up to a billion, and we 186 00:10:44.639 --> 00:10:48.679 raised two hundred million dollars on direct financing. But it 187 00:10:48.759 --> 00:10:56.039 depends on you where you are in development. But you 188 00:10:56.080 --> 00:10:59.559 can also create value based on announcements for example, you 189 00:10:59.639 --> 00:11:05.159 had a successful FDA meeting for example, that can also 190 00:11:05.279 --> 00:11:10.720 drive value as well. So it's really important to also 191 00:11:10.799 --> 00:11:16.440 recognize in the process that words matter. What you say 192 00:11:16.679 --> 00:11:21.799 publicly clearly matters. We had an example from John. I 193 00:11:21.879 --> 00:11:25.120 remember we had a successful readout and I mentioned that 194 00:11:25.240 --> 00:11:28.759 one of our patients had an elevation of ALT and. 195 00:11:28.759 --> 00:11:29.639 The stock dropped. 196 00:11:29.639 --> 00:11:31.960 You could watch a drop by the minute from the 197 00:11:32.000 --> 00:11:35.320 time actually made an announcement. I thought it was irrelevant. 198 00:11:35.320 --> 00:11:38.600 I've seen it hundreds of times in phase one trials, 199 00:11:38.960 --> 00:11:42.919 but the market was poised to react, So consequently what 200 00:11:42.960 --> 00:11:47.120 we said really matters. The bottom line is what you 201 00:11:47.200 --> 00:11:54.919 say in your presentations matters. Every word, every title matters. 202 00:11:56.000 --> 00:11:59.720 What you say to investors matters, what you say in 203 00:11:59.759 --> 00:12:04.960 your press releases matters. So always go and look as 204 00:12:05.039 --> 00:12:08.039 if you're looking from the outside in and don't get 205 00:12:08.039 --> 00:12:12.120 interiorized into your message or value. Take the look at 206 00:12:12.159 --> 00:12:15.840 value from the outside and be realistic, be brutal, and 207 00:12:15.879 --> 00:12:17.120 don't drink your own kooid. 208 00:12:19.519 --> 00:12:21.399 Yeah. 209 00:12:21.440 --> 00:12:24.919 Absolutely, I certainly learned that lesson not to drink the 210 00:12:25.039 --> 00:12:28.559 kool aid. And certainly what I'm doing now, Raphael is 211 00:12:28.600 --> 00:12:31.279 trying to be a very honest broker of the data 212 00:12:31.320 --> 00:12:35.000 that we have. Our principle is a very successful man. 213 00:12:35.039 --> 00:12:40.000 He's extremely enthusiastic about the whole biotech sphere. But that 214 00:12:40.120 --> 00:12:42.039 means that he can maybe look at things with a 215 00:12:42.039 --> 00:12:44.559 different lens. So part of my job is as an 216 00:12:44.639 --> 00:12:48.600 advisor to say, you know, this actually isn't very pressive 217 00:12:48.720 --> 00:12:52.759 mouse data, No, we should not invest in this that 218 00:12:52.879 --> 00:12:56.960 kind of thing because someone who's really a generalist investor 219 00:12:57.039 --> 00:12:57.600 is seeing it. 220 00:12:58.279 --> 00:13:02.960 But turned to him and say, is what we do. 221 00:13:03.200 --> 00:13:05.360 What we can do for you, what is going to 222 00:13:05.399 --> 00:13:08.840 create value is we have this great new alliance. We 223 00:13:08.960 --> 00:13:12.279 have this, we have a Phase three trial that's fully enrolled. 224 00:13:13.200 --> 00:13:15.360 We're going to execute the heck out of this. We're 225 00:13:15.399 --> 00:13:18.639 going to make sure that the team has everything that 226 00:13:18.679 --> 00:13:22.240 they need to bring this home and have this you know, 227 00:13:22.360 --> 00:13:25.519 actionable information. That's what we can do, and do it 228 00:13:25.559 --> 00:13:29.080 with a lean team because the team that we've joined 229 00:13:29.080 --> 00:13:32.879 with is lean, but they're amazing. So that's what I 230 00:13:32.919 --> 00:13:34.720 can offer, you know. And that's one of the things 231 00:13:34.759 --> 00:13:37.559 we talked about was execution is obviously part of this. 232 00:13:38.519 --> 00:13:40.480 Yeah, I want to kind of riff on that execution 233 00:13:40.759 --> 00:13:45.360 piece a little bit. Where we see cmos doing well 234 00:13:45.440 --> 00:13:48.799 early is a kind of radical discipline not just to 235 00:13:49.000 --> 00:13:53.480 the right milestones, but also and in prioritization. But do 236 00:13:53.519 --> 00:13:55.200 they have the right seat at the table where these 237 00:13:55.240 --> 00:13:58.519 decisions are being made, and how is the organization actually 238 00:13:58.559 --> 00:14:03.840 making decisions to remain agile and to not swirl on decisions. 239 00:14:03.840 --> 00:14:06.519 The amount of time, energy and money lost on decisions 240 00:14:06.519 --> 00:14:10.440 swirl is you know, really, I mean probably calculable. I 241 00:14:10.440 --> 00:14:12.159 haven't done it, but we see that a lot in 242 00:14:12.200 --> 00:14:15.759 these early stage companies. And sometimes it's due to the 243 00:14:15.879 --> 00:14:18.639 shift of moving an early stage from an R and 244 00:14:18.720 --> 00:14:21.440 D organization to a clinical organization, but you also see 245 00:14:21.440 --> 00:14:24.480 it from a clinical to a commercial organization. There's new 246 00:14:24.480 --> 00:14:27.080 decision makers at the table, there's new skills, and the 247 00:14:27.200 --> 00:14:30.399 value that's being created is coming from a new group 248 00:14:30.399 --> 00:14:34.039 of leaders that wasn't there previously. And so we don't 249 00:14:34.039 --> 00:14:37.200 see companies adapt quick enough in their governance and their 250 00:14:37.200 --> 00:14:39.360 decision making and who's sitting at the table, and it 251 00:14:39.360 --> 00:14:42.080 should only be the people necessary and not just continually 252 00:14:42.120 --> 00:14:45.759 adding folks on shifting that maybe from CSO founder to 253 00:14:45.879 --> 00:14:49.360 CMO and COMO then in handshake with the CEO later 254 00:14:49.440 --> 00:14:52.080 in that stage. Is that that decision making process and 255 00:14:52.120 --> 00:14:54.879 governance see that it doesn't sound really sexy. We see 256 00:14:54.919 --> 00:14:57.519 that as a huge driver of companies that are successful 257 00:14:57.559 --> 00:15:00.240 early on versus companies that are not. So take a 258 00:15:00.320 --> 00:15:02.240 look at that, and hand in hand with that is 259 00:15:02.240 --> 00:15:05.159 some of the program management. So I think sometimes that's 260 00:15:05.279 --> 00:15:09.279 underthought early on as well. But having robust program management 261 00:15:09.360 --> 00:15:12.080 so those decisions that get made are appropriately cascaded, that 262 00:15:12.200 --> 00:15:15.240 risks are escalated and discussed at the right forums, that 263 00:15:15.320 --> 00:15:17.559 actions can be taken in tract, and the impact of 264 00:15:17.559 --> 00:15:20.360 those on other divisions when you're adding a bunch of 265 00:15:20.399 --> 00:15:23.720 new functions is approaching. You know, your clinical your clinical 266 00:15:23.720 --> 00:15:28.559 stage and clinical trials is massive. So not the sexiest answer, 267 00:15:28.600 --> 00:15:31.279 but something really practical that we see making a difference. 268 00:15:32.320 --> 00:15:35.159 So what I'd really like to hear from you guys 269 00:15:35.279 --> 00:15:40.399 is how you resource and how you execute in order 270 00:15:40.440 --> 00:15:43.799 to get to these value and inflection particularly in the 271 00:15:43.840 --> 00:15:49.360 title with the limited budgets, right, short runways, cautious use 272 00:15:49.399 --> 00:15:53.360 of that cash, how do you build? Where are the pitfalls? 273 00:15:54.200 --> 00:15:56.519 Just hints and tips. 274 00:15:57.960 --> 00:16:04.559 So I would advise this group that your most valuable data, 275 00:16:05.399 --> 00:16:09.759 your most valuable asset is your data, and you may 276 00:16:09.799 --> 00:16:15.240 not be treating it as well as you should. For example, 277 00:16:16.200 --> 00:16:19.039 is your data stored in the cloud, is it backed up? 278 00:16:20.240 --> 00:16:24.639 Is it encrypted? Can other people access it? In that 279 00:16:24.759 --> 00:16:29.679 cloud who is monitoring your data. I'm going to tell 280 00:16:29.720 --> 00:16:33.519 you that through Phase two studies, I employ my own 281 00:16:33.639 --> 00:16:37.759 monitors because I want to train them. I want them 282 00:16:37.759 --> 00:16:44.320 to be accountable to me. CROs are useful organizations, but 283 00:16:44.399 --> 00:16:48.480 at the level that I want better data, I monitor 284 00:16:48.559 --> 00:16:51.159 my own data. I have never done a study in 285 00:16:51.200 --> 00:16:56.080 my career where outsource medical monitoring. The decisions are just 286 00:16:56.759 --> 00:17:02.559 really too important. And lastly, within Ultimune, I've created my 287 00:17:02.600 --> 00:17:06.920 own data management with five programmers and a data manager, 288 00:17:07.440 --> 00:17:10.519 and consequently we create our own data sets and generate 289 00:17:10.559 --> 00:17:15.480 our own tables. I think everybody has a story where 290 00:17:15.480 --> 00:17:18.839 they ask for the ro biometrics group to get a 291 00:17:18.880 --> 00:17:22.000 table and you got it back two weeks later at 292 00:17:22.000 --> 00:17:25.160 a cost of two to three thousand bucks. When you're 293 00:17:25.200 --> 00:17:28.359 doing this internally, you can reach in, ask the question 294 00:17:28.480 --> 00:17:32.319 and get it essentially for free by two o'clock that afternoon, 295 00:17:32.839 --> 00:17:34.640 and you know the quality is there and they're going 296 00:17:34.720 --> 00:17:37.279 to give you what you want, rather than having that 297 00:17:37.319 --> 00:17:40.759 table come back and not really answering your own question. 298 00:17:41.400 --> 00:17:45.200 So I think data is extremely important. The value that 299 00:17:45.240 --> 00:17:48.519 you can create for your company is how you manage 300 00:17:48.559 --> 00:17:51.480 that data and treating it like a prize. 301 00:17:53.519 --> 00:17:57.279 Yeah, if I could add to that, because the way 302 00:17:57.319 --> 00:17:59.720 that you get that data is through your clinical protocol. 303 00:18:00.400 --> 00:18:03.680 And we heard a lot yesterday and today as well 304 00:18:03.759 --> 00:18:08.359 about how to design protocols that maybe don't have a 305 00:18:08.440 --> 00:18:12.480 million billion end points in them or data points, but 306 00:18:12.599 --> 00:18:16.079 at the same time being responsive to science and being 307 00:18:16.119 --> 00:18:20.480 responsive to new endpoints like patient reported outcomes. I think 308 00:18:20.519 --> 00:18:23.480 this is this is somewhere in the early stage where 309 00:18:23.480 --> 00:18:25.640 the chief mountical officer certainly can have a lot of 310 00:18:25.640 --> 00:18:30.359 input to say, you know, that patient doesn't really care 311 00:18:30.519 --> 00:18:34.640 if you see that specific kind of t sell in 312 00:18:34.880 --> 00:18:36.880 that part of their tumor when you buy and see 313 00:18:36.920 --> 00:18:39.720 it on you know, three times in the first week, 314 00:18:39.960 --> 00:18:42.799 but that will cost a lot of money. And if 315 00:18:42.839 --> 00:18:45.640 the patient doesn't respond, then you're never going to do 316 00:18:45.680 --> 00:18:47.839 the assay anyway, because your company's not going to be 317 00:18:47.920 --> 00:18:51.200 able to raise capital. I'm being a little facetious, but 318 00:18:52.039 --> 00:18:55.519 I think it's important to remember the end points that 319 00:18:55.559 --> 00:18:58.279 the patients will care about are probably the same endpoints 320 00:18:58.319 --> 00:19:01.039 that regulators and more importantly, the. 321 00:19:02.640 --> 00:19:03.839 Payers will care about. 322 00:19:03.920 --> 00:19:09.279 So I think really a focus on trial design is 323 00:19:09.440 --> 00:19:12.119 important in a company with a limited budget. 324 00:19:13.480 --> 00:19:16.079 I like those answers and I'm going to go a 325 00:19:16.119 --> 00:19:21.839 totally different direction here with not just thinking about some 326 00:19:21.920 --> 00:19:26.279 of those concrete things, but also as a CMO, prioritizing 327 00:19:26.319 --> 00:19:28.400 your time that what you're spending things on. And I 328 00:19:28.400 --> 00:19:30.559 think it's a big bit of a fallacy of a 329 00:19:30.640 --> 00:19:35.000 lean team early on that cmos by nature and training, 330 00:19:35.039 --> 00:19:37.200 are high performers, and there are a lot of things 331 00:19:37.240 --> 00:19:39.640 we are supposed to be experts out and a lot 332 00:19:39.680 --> 00:19:41.920 of things we can do. It doesn't mean we should 333 00:19:42.000 --> 00:19:44.279 be doing all of them all of the time. And 334 00:19:44.319 --> 00:19:46.920 then we see a lot of companies or cmos that 335 00:19:47.000 --> 00:19:50.119 struggle early on because they can be the medical monitor, 336 00:19:50.160 --> 00:19:52.839 because they can write the protocols, because they can talk 337 00:19:52.880 --> 00:19:54.880 to the KOLs, because they can do all of this, 338 00:19:55.200 --> 00:19:57.160 that they think that they should do that and are 339 00:19:57.200 --> 00:20:00.200 either burning themselves out and don't have any time time 340 00:20:00.279 --> 00:20:03.359 to sit back and creatively think about the protocol or 341 00:20:03.400 --> 00:20:06.480 creatively think about how to manage their own data, or 342 00:20:06.799 --> 00:20:10.240 having the time for the investor conversations that are really critical, 343 00:20:10.599 --> 00:20:13.319 and almost they reach a point of being underwater before 344 00:20:13.359 --> 00:20:17.160 then getting help or delegating or finding creative ways, whether 345 00:20:17.160 --> 00:20:21.279 it's insourcing, outsourcing, appropriate vendor management, which we all know 346 00:20:21.359 --> 00:20:23.319 takes a little bit of time to get up and going, 347 00:20:23.359 --> 00:20:25.359 so it becomes a bit more work before less work. 348 00:20:25.559 --> 00:20:28.119 So it's almost thinking early, how are you going to 349 00:20:28.119 --> 00:20:30.920 prioritize your time not just today, but a month from 350 00:20:30.960 --> 00:20:33.200 now when the trial is actually kicking off. You know, 351 00:20:33.519 --> 00:20:35.519 when the data is coming in, you're going to need 352 00:20:35.519 --> 00:20:38.480 that time available. Are you going to be surrounded and 353 00:20:38.519 --> 00:20:40.160 are you arguing? And do you have a seat at 354 00:20:40.200 --> 00:20:42.319 the table for getting the budget that you need or 355 00:20:42.359 --> 00:20:44.640 the time that you need, and is everyone aligned to 356 00:20:44.720 --> 00:20:47.480 what those key milestone drivers are so you can be 357 00:20:47.519 --> 00:20:50.039 focused on that and have the time for that instead 358 00:20:50.039 --> 00:20:53.160 of that kind of period of overwhelm. So I want 359 00:20:53.200 --> 00:20:55.279 to how to bring your best self and what is 360 00:20:55.359 --> 00:20:58.039 most critical for the CMO to do sometimes requires that 361 00:20:58.119 --> 00:21:01.119 extra discipline of time. Also just a little bit to 362 00:21:01.640 --> 00:21:04.200 pre as comment, I think we do really well when 363 00:21:04.200 --> 00:21:06.839 we also have some time for the milestones that really 364 00:21:06.880 --> 00:21:10.599 matter in our children's lives, personal lives, whatever those things are, 365 00:21:10.680 --> 00:21:12.960 so we can actually come back refresh and creative. I 366 00:21:13.000 --> 00:21:14.799 know you don't always get that luxury of time, but 367 00:21:14.839 --> 00:21:15.599 it's an important point. 368 00:21:15.599 --> 00:21:19.839 I wanted to make brilliant points. Scott was just wanting 369 00:21:19.920 --> 00:21:23.359 to pick up on your comment about insourcing some of 370 00:21:23.359 --> 00:21:27.960 the work, because one of the counter points that I've 371 00:21:28.079 --> 00:21:30.799 heard from colleagues at this conference is just how hard 372 00:21:30.839 --> 00:21:33.240 it is to hire at the moment and how hard 373 00:21:33.279 --> 00:21:36.160 it is to justify that headcount. So running really lean, 374 00:21:36.720 --> 00:21:39.400 so it'd be really and actually then that also speaks 375 00:21:39.440 --> 00:21:43.880 to your spot there with SSI about how you resource 376 00:21:43.920 --> 00:21:46.480 that in alternative ways. So I'm just really interested in 377 00:21:46.559 --> 00:21:47.200 that theme. 378 00:21:48.920 --> 00:21:52.039 Well, there's a lot of tension in the job, and 379 00:21:52.079 --> 00:21:54.480 what I mean by that is not an emotional tension, 380 00:21:54.920 --> 00:21:58.279 but decision making tension. Try to be lean and mean, 381 00:21:58.359 --> 00:22:01.559 but not over exert yourself. Try to run with a 382 00:22:01.599 --> 00:22:04.160 small team, but now expand it enough to do the 383 00:22:04.160 --> 00:22:08.400 core functions. I mean, we could be go on schizophrenically 384 00:22:08.440 --> 00:22:12.000 here for hours talking about that. I'm being going to 385 00:22:12.079 --> 00:22:17.480 this conference now for fourteen or fifteen years. I think 386 00:22:17.519 --> 00:22:21.440 the first one of these that I attended with about 387 00:22:21.640 --> 00:22:24.480 one eighth of the amount of people here, was like 388 00:22:24.519 --> 00:22:28.519 in twenty eleven, and I remember the conference organizers standing 389 00:22:28.599 --> 00:22:32.240 up and saying that the CMO position is the loneliest 390 00:22:32.279 --> 00:22:35.920 position in the world. And I've thought about that through 391 00:22:35.960 --> 00:22:38.720 the years. And what it means is that when you 392 00:22:38.720 --> 00:22:41.240 go to bed at night, who's going to console you? 393 00:22:42.200 --> 00:22:45.000 What are you going to do about your problems? So 394 00:22:45.799 --> 00:22:48.000 the answer is is that a dynamic and you have 395 00:22:48.039 --> 00:22:51.880 to decide for your own situation, bosting your own resources. 396 00:22:51.920 --> 00:22:55.039 If you don't have the money to hire a biometrics team, 397 00:22:55.720 --> 00:22:58.799 don't do it. But I'm telling you that if you can, 398 00:22:58.920 --> 00:23:02.400 you're going to create This is the topic of the session. 399 00:23:02.440 --> 00:23:03.880 You're going to create value. 400 00:23:04.160 --> 00:23:04.359 Right. 401 00:23:04.759 --> 00:23:08.000