WEBVTT 1 00:00:02.080 --> 00:00:04.319 - There's a small circle of people who truly 2 00:00:04.319 --> 00:00:05.919 - understand what it takes to lead a health 3 00:00:05.919 --> 00:00:08.660 - system right now. The decisions are enormous. 4 00:00:08.960 --> 00:00:11.919 - The variables are constantly shifting, and the stakes 5 00:00:11.919 --> 00:00:14.099 - of getting a call wrong don't stay contained. 6 00:00:14.400 --> 00:00:16.774 - That's not a complaint. It's a structural reality. 7 00:00:17.234 --> 00:00:19.074 - And it's why the most effective c suite 8 00:00:19.074 --> 00:00:21.154 - leaders are deliberate about where do they go 9 00:00:21.154 --> 00:00:22.535 - to pressure test their thinking. 10 00:00:22.994 --> 00:00:25.974 - Becker's fourteenth annual CEO and CFO roundtable 11 00:00:26.274 --> 00:00:28.594 - brings together more than 1,500 12 00:00:28.594 --> 00:00:29.894 - executive level attendees 13 00:00:30.239 --> 00:00:32.799 - and nearly 400 speakers for four days built 14 00:00:32.799 --> 00:00:34.739 - around growth, financial sustainability, 15 00:00:35.280 --> 00:00:38.079 - workforce strategy, and the leadership questions that don't 16 00:00:38.079 --> 00:00:39.140 - have easy answers. 17 00:00:39.679 --> 00:00:41.840 - Join us November second through the fifth in 18 00:00:41.840 --> 00:00:42.340 - Chicago. 19 00:00:42.880 --> 00:00:44.820 - For the agenda and event details, 20 00:00:45.195 --> 00:00:47.355 - visit beckershospitalreview.com 21 00:00:47.355 --> 00:00:49.195 - and click on the events tab in the 22 00:00:49.195 --> 00:00:49.935 - upper right. 23 00:00:52.315 --> 00:00:54.554 - Hello. Thank you so much for tuning in 24 00:00:54.554 --> 00:00:56.975 - to the Becker's Oncology Leadership Podcast. 25 00:00:57.590 --> 00:01:00.649 - I'm Elizabeth Gregersen, a reporter here at Becker's. 26 00:01:00.710 --> 00:01:03.129 - And today, I'm talking to Jody Skiles, 27 00:01:03.429 --> 00:01:04.810 - doctor Jody Skiles, 28 00:01:05.189 --> 00:01:08.409 - medical director of the pediatric stem cell transplant 29 00:01:08.629 --> 00:01:11.769 - program at Riley Hospital for Children in Indianapolis 30 00:01:12.405 --> 00:01:15.045 - and the FACT Accreditation medical director for both 31 00:01:15.045 --> 00:01:18.165 - pediatric and adult stem cell transplant programs at 32 00:01:18.165 --> 00:01:19.305 - Indiana University. 33 00:01:19.844 --> 00:01:21.685 - Doctor Skiles, thank you so much for taking 34 00:01:21.685 --> 00:01:23.305 - the time to speak with me today. 35 00:01:23.844 --> 00:01:25.685 - Of course. Thank you for the opportunity to 36 00:01:25.685 --> 00:01:26.265 - be here. 37 00:01:26.799 --> 00:01:28.959 - Absolutely. And before we dive into our conversation, 38 00:01:28.959 --> 00:01:30.799 - because it's a good one for our listeners, 39 00:01:30.799 --> 00:01:32.319 - I would love if you could share just 40 00:01:32.319 --> 00:01:34.319 - a bit about your background and your role 41 00:01:34.319 --> 00:01:36.180 - at Riley Hospital for Children. 42 00:01:36.799 --> 00:01:37.299 - Sure. 43 00:01:37.920 --> 00:01:41.060 - So I have been on staff at Riley 44 00:01:41.465 --> 00:01:44.665 - since 2012 when I graduated from fellowship. So 45 00:01:44.665 --> 00:01:47.465 - my background training, I was internal medicine and 46 00:01:47.465 --> 00:01:48.605 - pediatrics trained 47 00:01:49.064 --> 00:01:49.805 - for residency, 48 00:01:50.505 --> 00:01:51.564 - at Indiana University, 49 00:01:52.105 --> 00:01:55.165 - and then I stayed on for pediatric hematology 50 00:01:55.385 --> 00:01:58.469 - oncology fellowship just on the pediatric side for 51 00:01:58.469 --> 00:01:58.969 - oncology. 52 00:01:59.349 --> 00:02:01.290 - And then I became a stem cell transplant 53 00:02:01.349 --> 00:02:03.770 - physician, and I have been here since 2012. 54 00:02:04.230 --> 00:02:05.670 - And I've been the medical director of the 55 00:02:05.670 --> 00:02:08.489 - pediatric program since 2018 and the FACT accreditation 56 00:02:08.629 --> 00:02:10.250 - director since 2023. 57 00:02:11.314 --> 00:02:11.814 - Perfect. 58 00:02:12.594 --> 00:02:14.594 - And I'm excited to share the reason that 59 00:02:14.594 --> 00:02:16.294 - you're on the podcast today. 60 00:02:16.754 --> 00:02:18.615 - In February of this year, 61 00:02:18.915 --> 00:02:21.555 - a 14 year old patient at Riley Hospital 62 00:02:21.555 --> 00:02:23.735 - for Children became the first 63 00:02:24.330 --> 00:02:26.969 - pediatric patient in the world to receive a 64 00:02:26.969 --> 00:02:29.069 - bone marrow stem cell transplant 65 00:02:29.530 --> 00:02:31.150 - using cells from a deceased 66 00:02:31.449 --> 00:02:31.949 - donor. 67 00:02:33.129 --> 00:02:34.909 - Doctor Styles, can you walk 68 00:02:35.289 --> 00:02:37.870 - our audience through what made this case different 69 00:02:37.930 --> 00:02:39.789 - and why this approach matters 70 00:02:40.944 --> 00:02:41.925 - for the industry. 71 00:02:43.425 --> 00:02:46.165 - Sure. It really is very exciting. 72 00:02:47.025 --> 00:02:47.525 - So 73 00:02:47.985 --> 00:02:50.224 - our patient is a 14 year old who 74 00:02:50.224 --> 00:02:53.425 - was originally diagnosed with acute myeloid leukemia in 75 00:02:53.425 --> 00:02:56.120 - the fall of twenty twenty five, And 76 00:02:56.580 --> 00:02:58.599 - he received his upfront chemotherapy, 77 00:02:58.900 --> 00:03:00.199 - but, unfortunately, was 78 00:03:00.500 --> 00:03:03.139 - refractory to chemotherapy. His disease did not get 79 00:03:03.139 --> 00:03:05.400 - into remission as quickly as what we expected, 80 00:03:05.780 --> 00:03:07.620 - and that made him eligible to receive a 81 00:03:07.620 --> 00:03:08.599 - stem cell transplant. 82 00:03:09.884 --> 00:03:12.384 - So we proceeded to his stem cell transplant 83 00:03:12.604 --> 00:03:15.104 - according to sort of standard of care. 84 00:03:15.564 --> 00:03:16.064 - We 85 00:03:16.525 --> 00:03:19.104 - found an unrelated donor through the NMDP 86 00:03:20.044 --> 00:03:23.344 - and received those donor cells, and his original 87 00:03:23.724 --> 00:03:24.224 - transplant, 88 00:03:25.259 --> 00:03:26.400 - his first transplant 89 00:03:26.699 --> 00:03:27.759 - happened in 90 00:03:28.139 --> 00:03:29.840 - late December, early January. 91 00:03:30.459 --> 00:03:33.439 - Unfortunately, that donor cells did not grow. 92 00:03:34.620 --> 00:03:35.120 - His 93 00:03:35.579 --> 00:03:38.219 - the patient's immune system rejected those stem cells 94 00:03:38.219 --> 00:03:39.164 - from coming in, 95 00:03:39.564 --> 00:03:41.724 - And so that forced us into a situation 96 00:03:41.724 --> 00:03:43.584 - where we had to be 97 00:03:44.044 --> 00:03:46.284 - very nimble in trying to find a new 98 00:03:46.284 --> 00:03:48.604 - donor for him. And, really, when you're in 99 00:03:48.604 --> 00:03:49.504 - that situation, 100 00:03:49.884 --> 00:03:53.250 - it really is life and death scenario where 101 00:03:53.250 --> 00:03:55.409 - if a patient's stem cells fail to engraft 102 00:03:55.409 --> 00:03:56.229 - with a transplant, 103 00:03:56.770 --> 00:03:59.489 - you really need new cells in very quickly 104 00:03:59.489 --> 00:04:01.969 - in order to not allow that patient to 105 00:04:01.969 --> 00:04:03.509 - succumb to infections. 106 00:04:04.055 --> 00:04:06.455 - Primarily viral infections, can really become a big 107 00:04:06.455 --> 00:04:08.314 - problem when you don't have an immune system. 108 00:04:08.775 --> 00:04:10.775 - And so we were in a situation where 109 00:04:10.775 --> 00:04:12.935 - we were looking for a backup donor and 110 00:04:12.935 --> 00:04:14.314 - looking to move very quickly. 111 00:04:15.254 --> 00:04:16.774 - Because we know that this is something that 112 00:04:16.774 --> 00:04:19.254 - can happen in transplant, we always enter into 113 00:04:19.254 --> 00:04:20.529 - a stem cell transplant 114 00:04:20.830 --> 00:04:22.590 - with a plan a and at least a 115 00:04:22.590 --> 00:04:24.830 - plan b, hopefully, also a plan c and 116 00:04:24.830 --> 00:04:25.330 - d. 117 00:04:25.790 --> 00:04:27.569 - And in this patient situation, 118 00:04:28.670 --> 00:04:30.910 - his plan b that we went to mobilize 119 00:04:30.910 --> 00:04:33.375 - and activate, that plan fell through. 120 00:04:33.774 --> 00:04:36.014 - For a variety of reasons, that that plan 121 00:04:36.014 --> 00:04:37.074 - did not work out. 122 00:04:37.454 --> 00:04:38.274 - And, unfortunately, 123 00:04:38.735 --> 00:04:40.495 - this patient did not have a plan c 124 00:04:40.495 --> 00:04:43.134 - or d. And so we found ourselves in 125 00:04:43.134 --> 00:04:44.654 - a situation where we were reaching out to 126 00:04:44.654 --> 00:04:46.654 - NMDP to say, can you please help us 127 00:04:46.654 --> 00:04:49.519 - mobilize a replacement donor very quickly? 128 00:04:49.980 --> 00:04:51.899 - And they were very willing, but the best 129 00:04:51.899 --> 00:04:53.419 - that they could do was, like, a four 130 00:04:53.419 --> 00:04:54.480 - to six week timeline 131 00:04:54.860 --> 00:04:57.519 - in order to get a backup donor mobilized. 132 00:04:58.139 --> 00:05:00.379 - And we knew that if we waited for 133 00:05:00.379 --> 00:05:02.459 - that timeline to happen, that our patient would 134 00:05:02.459 --> 00:05:03.120 - not survive. 135 00:05:03.564 --> 00:05:05.245 - And so we had to put on our 136 00:05:05.245 --> 00:05:08.205 - thinking caps and become innovative, and we were 137 00:05:08.205 --> 00:05:10.545 - aware of a company called Osteom, 138 00:05:11.805 --> 00:05:14.384 - that they had been working to bring forward 139 00:05:14.605 --> 00:05:17.105 - the option for deceased donor stem cell transplants, 140 00:05:18.280 --> 00:05:19.980 - through a clinical trial process. 141 00:05:20.520 --> 00:05:21.020 - And 142 00:05:21.400 --> 00:05:23.240 - we had been in conversation with them about 143 00:05:23.240 --> 00:05:25.400 - potentially opening that trial, but we had not 144 00:05:25.400 --> 00:05:28.199 - activated things for that trial yet. And so 145 00:05:28.199 --> 00:05:30.824 - I reached out to Osteem and asked, hey. 146 00:05:30.824 --> 00:05:32.345 - We have an urgent need. We have a 147 00:05:32.345 --> 00:05:34.185 - patient's life on the line. Can you help 148 00:05:34.185 --> 00:05:36.845 - us? And they were very gracious in saying, 149 00:05:37.064 --> 00:05:38.604 - yes. We absolutely can. 150 00:05:39.064 --> 00:05:41.144 - Let's get to work. And so from the 151 00:05:41.144 --> 00:05:43.129 - time that I reached out to them until 152 00:05:43.129 --> 00:05:45.209 - the time that we had cells available for 153 00:05:45.209 --> 00:05:46.990 - this patient, it was about a week, 154 00:05:47.769 --> 00:05:50.089 - to get through the process. And, and being 155 00:05:50.089 --> 00:05:52.009 - totally transparent, it was a crazy week. It 156 00:05:52.009 --> 00:05:53.389 - was lots of work. 157 00:05:54.009 --> 00:05:54.750 - I would not 158 00:05:55.175 --> 00:05:58.134 - advocate for doing, a deceased donor transplant under 159 00:05:58.134 --> 00:05:59.754 - that kind of stress and pressure. 160 00:06:00.855 --> 00:06:03.735 - Being proactive is always better, but, we were 161 00:06:03.735 --> 00:06:05.014 - able to get it done with a lot 162 00:06:05.014 --> 00:06:06.235 - of support from Oceum. 163 00:06:06.774 --> 00:06:07.274 - And, 164 00:06:08.180 --> 00:06:10.580 - and as a result, the patient survived and 165 00:06:10.580 --> 00:06:11.560 - is doing great. 166 00:06:12.980 --> 00:06:14.420 - Amazing. Thank you for, 167 00:06:14.980 --> 00:06:15.639 - kind of 168 00:06:16.100 --> 00:06:18.279 - giving us the overview, I know, as 169 00:06:18.980 --> 00:06:20.680 - comprehensively as you can. 170 00:06:21.985 --> 00:06:23.524 - I remember when the news broke. 171 00:06:24.305 --> 00:06:26.944 - It says four thousand children a year in 172 00:06:26.944 --> 00:06:29.345 - The US are diagnosed with blood cancers that 173 00:06:29.345 --> 00:06:30.324 - may need a transplant. 174 00:06:31.104 --> 00:06:34.004 - And the process you just mentioned obviously highlights 175 00:06:34.639 --> 00:06:37.360 - how finding a living living donor is still 176 00:06:37.360 --> 00:06:39.439 - one of the biggest bottlenecks, and like you 177 00:06:39.439 --> 00:06:41.300 - said, is a life or death situation 178 00:06:42.399 --> 00:06:44.240 - without the four to six weeks that you 179 00:06:44.240 --> 00:06:45.379 - can wait. Right? 180 00:06:46.639 --> 00:06:49.220 - How big of a dent do you think 181 00:06:49.485 --> 00:06:52.785 - deceased donor stem cell banking can realistically 182 00:06:53.165 --> 00:06:53.665 - make 183 00:06:54.845 --> 00:06:55.345 - in 184 00:06:55.805 --> 00:06:58.604 - this gap over the next five years? And, 185 00:06:58.604 --> 00:07:01.084 - you know, what would need to be true 186 00:07:01.084 --> 00:07:03.404 - for this type of process to scale beyond 187 00:07:03.404 --> 00:07:05.089 - just kind of a small number 188 00:07:05.629 --> 00:07:08.110 - of transplant centers or unique patients where it 189 00:07:08.110 --> 00:07:10.350 - just works out, just like you said, after 190 00:07:10.350 --> 00:07:11.329 - a crazy week. 191 00:07:11.949 --> 00:07:13.250 - What does that look like? 192 00:07:14.110 --> 00:07:16.050 - Yeah. I think it's a really good question. 193 00:07:16.750 --> 00:07:18.370 - And I think the the important 194 00:07:18.694 --> 00:07:20.375 - point is that, it's not 195 00:07:21.014 --> 00:07:23.175 - this this type of donor is not just 196 00:07:23.175 --> 00:07:25.194 - for children. It's also for adults. 197 00:07:25.974 --> 00:07:28.294 - Our patient was the first pediatric patient in 198 00:07:28.294 --> 00:07:30.454 - the world, but there now to date have 199 00:07:30.454 --> 00:07:32.154 - been 27 other patients 200 00:07:32.479 --> 00:07:34.899 - who have received a deceased donor transplant. 201 00:07:35.759 --> 00:07:38.399 - But you're a 100% correct that identifying a 202 00:07:38.399 --> 00:07:38.899 - donor 203 00:07:39.600 --> 00:07:40.100 - is, 204 00:07:40.959 --> 00:07:43.039 - by far the biggest bottleneck in getting a 205 00:07:43.039 --> 00:07:44.475 - patient successfully to transplant. 206 00:07:45.115 --> 00:07:47.514 - So there are about ten thousand patients who 207 00:07:47.514 --> 00:07:49.915 - undergo allo transplant in The United States every 208 00:07:49.915 --> 00:07:51.754 - year, and every single one of them needs 209 00:07:51.754 --> 00:07:54.095 - a donor. And so the NMDP, 210 00:07:55.115 --> 00:07:56.975 - they're they're really 211 00:07:57.839 --> 00:07:58.339 - outstanding 212 00:07:59.039 --> 00:08:02.259 - at finding a match for nearly every patient. 213 00:08:02.959 --> 00:08:05.360 - The problem is that finding a match is 214 00:08:05.360 --> 00:08:06.899 - only half of it. Right? 215 00:08:07.279 --> 00:08:09.824 - So just because you have a match in 216 00:08:09.824 --> 00:08:11.604 - the registry does not necessarily 217 00:08:11.985 --> 00:08:14.884 - mean that that translates to an available donor 218 00:08:15.264 --> 00:08:17.504 - who's willing to donate on the timeline that 219 00:08:17.504 --> 00:08:19.504 - the patient needs it. And I think that's 220 00:08:19.504 --> 00:08:21.345 - why it becomes such a big barrier is 221 00:08:21.345 --> 00:08:22.404 - because it's very 222 00:08:23.339 --> 00:08:25.680 - dependent on willingness, availability 223 00:08:26.060 --> 00:08:28.480 - of the donor, but also willingness and availability 224 00:08:28.699 --> 00:08:29.920 - of the donor center. 225 00:08:30.540 --> 00:08:32.620 - So you can find a donor somewhere out 226 00:08:32.620 --> 00:08:34.379 - there in the world through the registry, but 227 00:08:34.379 --> 00:08:36.779 - whether or not the timeline aligns with the 228 00:08:36.779 --> 00:08:37.754 - patient's needs 229 00:08:38.235 --> 00:08:39.535 - is very questionable, 230 00:08:40.554 --> 00:08:42.394 - and often is not as fast as what 231 00:08:42.394 --> 00:08:43.934 - we would like for it to be. 232 00:08:44.315 --> 00:08:45.995 - And there are patients who die every year 233 00:08:45.995 --> 00:08:47.434 - because they can't get a donor on the 234 00:08:47.434 --> 00:08:48.575 - timeline that's needed. 235 00:08:50.029 --> 00:08:51.790 - So we are working to fill the gap 236 00:08:51.790 --> 00:08:54.129 - from a number of different fronts. But when 237 00:08:54.269 --> 00:08:57.230 - when you're looking specifically about the option for 238 00:08:57.230 --> 00:08:59.549 - deceased donor transplants, I do think that there 239 00:08:59.549 --> 00:09:01.330 - is a gap that needs to be filled. 240 00:09:01.790 --> 00:09:04.290 - And I do think that deceased donor transplant 241 00:09:04.350 --> 00:09:05.490 - has huge potential 242 00:09:06.084 --> 00:09:08.424 - for not only helping to fill that gap, 243 00:09:08.485 --> 00:09:10.404 - but I would even go so far as 244 00:09:10.404 --> 00:09:12.725 - to say that this could be the preferred 245 00:09:12.725 --> 00:09:14.725 - way that we do transplants in the future 246 00:09:14.725 --> 00:09:17.205 - once we have enough data to say data 247 00:09:17.205 --> 00:09:19.759 - and longevity of data to say that this 248 00:09:19.759 --> 00:09:22.480 - really is a viable alternative source of cells, 249 00:09:22.480 --> 00:09:24.179 - and it might even be preferable 250 00:09:24.720 --> 00:09:26.639 - and more cost effective at at the end 251 00:09:26.639 --> 00:09:27.379 - of the day. 252 00:09:28.480 --> 00:09:28.980 - So 253 00:09:29.360 --> 00:09:31.200 - right at this moment in time, you know, 254 00:09:31.200 --> 00:09:34.000 - Oceum has been building their deceased donor bank 255 00:09:34.000 --> 00:09:35.220 - for several years. 256 00:09:36.264 --> 00:09:38.504 - I don't know exactly how many deceased donors 257 00:09:38.504 --> 00:09:40.044 - that they have available 258 00:09:40.345 --> 00:09:42.424 - at any given time, but the number is 259 00:09:42.424 --> 00:09:43.565 - growing every day. 260 00:09:44.345 --> 00:09:47.304 - So for con for, you know, context, the 261 00:09:47.304 --> 00:09:47.804 - NMDP 262 00:09:48.264 --> 00:09:48.764 - has 263 00:09:49.144 --> 00:09:49.644 - somewhere 264 00:09:50.480 --> 00:09:53.139 - near or around the ballpark of 20,000,000, 265 00:09:54.720 --> 00:09:56.579 - donors that are part of the registry. 266 00:09:57.519 --> 00:09:59.440 - I think ASEAN, the last time that I 267 00:09:59.440 --> 00:10:02.079 - talked with them, had somewhere north of a 268 00:10:02.079 --> 00:10:02.579 - thousand, 269 00:10:03.464 --> 00:10:06.184 - deceased donors that are banked. And so right 270 00:10:06.184 --> 00:10:08.584 - at this moment in time, there's not an 271 00:10:08.584 --> 00:10:11.065 - outstanding chance that you would search the registry 272 00:10:11.065 --> 00:10:13.084 - and find a perfect match for a patient, 273 00:10:13.144 --> 00:10:15.065 - but you can search the registry and find 274 00:10:15.065 --> 00:10:17.159 - an acceptable mass match for a patient. 275 00:10:17.959 --> 00:10:19.579 - One of the things that we have 276 00:10:20.199 --> 00:10:22.120 - been working toward in the field for probably 277 00:10:22.120 --> 00:10:24.059 - the last ten years is utilization 278 00:10:24.440 --> 00:10:26.699 - of donors that are not a perfect match 279 00:10:26.839 --> 00:10:28.459 - that we know we can overcome 280 00:10:28.919 --> 00:10:31.259 - a slight mismatch from a patient, 281 00:10:32.254 --> 00:10:33.955 - with the use of additional chemotherapy. 282 00:10:34.735 --> 00:10:36.735 - The problem with that approach, it works very 283 00:10:36.735 --> 00:10:39.554 - well for getting stem cells to grow. However, 284 00:10:39.934 --> 00:10:42.095 - the downside is that it's associated with more 285 00:10:42.095 --> 00:10:44.815 - toxicity, both in terms of side effects from 286 00:10:44.815 --> 00:10:45.795 - the extra chemotherapy 287 00:10:46.600 --> 00:10:48.860 - and side effects from the degree of mismatch 288 00:10:48.919 --> 00:10:50.379 - between the patient and the donor. 289 00:10:50.759 --> 00:10:51.259 - So 290 00:10:52.039 --> 00:10:53.100 - for my patient, 291 00:10:53.879 --> 00:10:56.220 - the the donor that we received from Osteem 292 00:10:56.519 --> 00:10:58.279 - was not a perfect match, but it was 293 00:10:58.279 --> 00:11:00.120 - an acceptable match, and that's how we were 294 00:11:00.120 --> 00:11:01.179 - able to move forward. 295 00:11:02.495 --> 00:11:05.235 - And I think one of the real benefits 296 00:11:05.454 --> 00:11:08.014 - in addition to the timeliness and availability of 297 00:11:08.014 --> 00:11:10.654 - getting a donor that's a deceased donor is 298 00:11:10.654 --> 00:11:12.735 - also the fact that on the front end, 299 00:11:12.735 --> 00:11:14.034 - the day that you order 300 00:11:14.829 --> 00:11:17.709 - the mobilization of the cord from Osium to 301 00:11:17.709 --> 00:11:20.029 - your center, you know the minute that you 302 00:11:20.029 --> 00:11:21.629 - place that order what the cell dose is 303 00:11:21.629 --> 00:11:24.029 - going to be. And that's just not true. 304 00:11:24.029 --> 00:11:25.889 - When you have an unrelated donor, 305 00:11:26.589 --> 00:11:28.634 - you get whatever cell dose you get And 306 00:11:28.634 --> 00:11:30.154 - by the you know, there are things that 307 00:11:30.154 --> 00:11:31.434 - you can do to stack the duck in 308 00:11:31.434 --> 00:11:32.875 - your favor, but you never know what you're 309 00:11:32.875 --> 00:11:34.554 - gonna get until the cells show up to 310 00:11:34.554 --> 00:11:36.495 - your to your site. And 311 00:11:36.875 --> 00:11:39.455 - that was, I think, part of the contributing 312 00:11:39.514 --> 00:11:40.654 - problem for 313 00:11:40.959 --> 00:11:43.279 - my patient whose first transplant failed is that 314 00:11:43.279 --> 00:11:44.879 - the cell dose was not as much as 315 00:11:44.879 --> 00:11:46.480 - what we needed it to be for the 316 00:11:46.480 --> 00:11:47.779 - condition that we were treating. 317 00:11:48.240 --> 00:11:51.299 - And when I ordered the donor from Osteem, 318 00:11:51.440 --> 00:11:53.120 - I knew the minute that I asked them 319 00:11:53.120 --> 00:11:54.480 - to ship it that I was gonna have 320 00:11:54.480 --> 00:11:56.715 - enough cells. And and in fact, I had 321 00:11:56.715 --> 00:11:58.555 - enough sales and some sales left over in 322 00:11:58.555 --> 00:11:59.995 - the bank that if he he should ever 323 00:11:59.995 --> 00:12:01.615 - need a boost of sales in the future, 324 00:12:01.754 --> 00:12:03.595 - we still have some leftover in the freezer, 325 00:12:03.595 --> 00:12:04.495 - which is incredible. 326 00:12:06.075 --> 00:12:08.634 - Absolutely. And, you know, you kind of alluded 327 00:12:08.634 --> 00:12:09.375 - it to 328 00:12:10.600 --> 00:12:12.220 - what it took to be operationally 329 00:12:12.600 --> 00:12:13.100 - ready 330 00:12:13.399 --> 00:12:14.059 - for this. 331 00:12:14.679 --> 00:12:17.960 - If, you know, this or if slash when 332 00:12:17.960 --> 00:12:19.659 - this becomes more common 333 00:12:19.960 --> 00:12:22.840 - to, you know, have a patient from no 334 00:12:22.840 --> 00:12:25.735 - donor match to transplant in days instead of 335 00:12:25.735 --> 00:12:27.415 - the weeks or months that we talked about 336 00:12:27.415 --> 00:12:27.915 - previously. 337 00:12:28.774 --> 00:12:30.875 - For health system leaders that are listening 338 00:12:31.175 --> 00:12:33.754 - to this podcast and thinking about 339 00:12:34.455 --> 00:12:36.875 - what this might do for their own programs, 340 00:12:37.509 --> 00:12:40.069 - What did it take operationally to be ready 341 00:12:40.069 --> 00:12:42.569 - to act, and what should leaders be building 342 00:12:43.110 --> 00:12:45.669 - to make sure that they're ready should they 343 00:12:45.669 --> 00:12:47.610 - find themselves in a similar situation? 344 00:12:48.230 --> 00:12:50.389 - Yeah. It's a really good question. So what 345 00:12:50.389 --> 00:12:51.764 - it took to be ready, 346 00:12:52.784 --> 00:12:53.284 - is 347 00:12:54.065 --> 00:12:55.585 - there was a lot of frankly, there was 348 00:12:55.585 --> 00:12:57.284 - a lot of paperwork that needed to happen. 349 00:12:57.585 --> 00:12:59.664 - So number one, there needed to be contracts 350 00:12:59.664 --> 00:13:02.965 - established with ACM through our health care organization. 351 00:13:03.450 --> 00:13:05.690 - We had to set up contracts for, you 352 00:13:05.690 --> 00:13:08.190 - know, materials transfer, those sort of things. 353 00:13:08.570 --> 00:13:10.809 - And then the other thing that, was a 354 00:13:10.809 --> 00:13:13.149 - lot of work in getting set up was, 355 00:13:14.570 --> 00:13:17.710 - because deceased donor stem cells are not considered 356 00:13:17.929 --> 00:13:20.995 - an they're not considered an investigational product by 357 00:13:20.995 --> 00:13:21.654 - the FDA, 358 00:13:22.355 --> 00:13:24.754 - but because there there isn't a lot of 359 00:13:24.754 --> 00:13:27.394 - data around it, many institutions will still want 360 00:13:27.394 --> 00:13:29.554 - any infusion of deceased donor stem cells to 361 00:13:29.554 --> 00:13:30.294 - go through 362 00:13:30.809 --> 00:13:32.910 - their institutional review board process 363 00:13:33.370 --> 00:13:35.690 - so that it's reviewed and has a formal 364 00:13:35.690 --> 00:13:38.009 - stamp of approval that this is, you know, 365 00:13:38.009 --> 00:13:40.490 - to make sure that we're communicating properly to 366 00:13:40.490 --> 00:13:43.289 - patients, that this is still considered something that 367 00:13:43.289 --> 00:13:44.590 - is a new therapy, 368 00:13:44.975 --> 00:13:46.735 - and that we don't really have long term 369 00:13:46.735 --> 00:13:48.575 - data on the outcomes. But what we do 370 00:13:48.575 --> 00:13:51.375 - have for early data is very promising. They 371 00:13:51.375 --> 00:13:53.375 - wanna make sure that we're communicating that properly 372 00:13:53.375 --> 00:13:54.995 - to patients and that we're tracking 373 00:13:55.535 --> 00:13:57.295 - outcomes, that we don't just do a deceased 374 00:13:57.295 --> 00:13:59.215 - donor stem cell transplant and then pray that 375 00:13:59.215 --> 00:14:01.500 - everything is fine, and it's not until you 376 00:14:01.500 --> 00:14:02.940 - do 50 of them that you realize that 377 00:14:02.940 --> 00:14:05.339 - there's a problem. Right? The only way that 378 00:14:05.339 --> 00:14:07.579 - that happens in a systematic way is through 379 00:14:07.579 --> 00:14:09.679 - the process of of having an IRB 380 00:14:10.379 --> 00:14:10.879 - approval 381 00:14:11.259 --> 00:14:14.264 - for tracking patients. And so our institution, like 382 00:14:14.264 --> 00:14:16.184 - many others, really wanted this to go through 383 00:14:16.184 --> 00:14:17.725 - the IRB approval pathway. 384 00:14:18.105 --> 00:14:21.004 - So getting a institutional approval to proceed 385 00:14:21.544 --> 00:14:23.225 - was part of it and then writing the 386 00:14:23.225 --> 00:14:25.865 - consent documents to explain all that I just 387 00:14:25.865 --> 00:14:27.360 - explained to you to a patient, 388 00:14:28.079 --> 00:14:29.919 - and having them sign all of those documents 389 00:14:29.919 --> 00:14:32.480 - and having everything squared away for that, those 390 00:14:32.480 --> 00:14:34.480 - were the things that took a lot of 391 00:14:34.480 --> 00:14:36.320 - hours in that one week of time from 392 00:14:36.320 --> 00:14:37.600 - the time that we knew that we had 393 00:14:37.600 --> 00:14:39.120 - a potential donor to the time that we 394 00:14:39.120 --> 00:14:40.954 - were ready to move and ship the cells. 395 00:14:41.219 --> 00:14:43.336 - I think Aseem would have been more than 396 00:14:43.336 --> 00:14:45.718 - willing to put the cells bring the cells 397 00:14:45.718 --> 00:14:48.100 - to us literally the next day. But from 398 00:14:48.100 --> 00:14:50.217 - the institutional side of things, we still needed 399 00:14:50.217 --> 00:14:52.334 - to get our ducks in a row. So 400 00:14:52.334 --> 00:14:54.451 - I think when we think about what it 401 00:14:54.451 --> 00:14:56.039 - could look like for another institution 402 00:14:56.919 --> 00:14:59.720 - to mobilize access to this type of donor 403 00:14:59.720 --> 00:15:00.220 - source, 404 00:15:01.000 --> 00:15:02.919 - if you really wanted to be proactive so 405 00:15:02.919 --> 00:15:04.440 - that you don't have a really rough week 406 00:15:04.440 --> 00:15:06.539 - like I had and, like, my patient waiting, 407 00:15:07.240 --> 00:15:08.839 - it would be to reach out to Oceum 408 00:15:08.839 --> 00:15:10.839 - in advance and say, what can we do 409 00:15:10.839 --> 00:15:11.659 - to be prepared 410 00:15:12.284 --> 00:15:12.784 - for 411 00:15:13.404 --> 00:15:15.585 - being able to offer cells 412 00:15:16.044 --> 00:15:17.804 - if we end up in a similar situation 413 00:15:17.804 --> 00:15:19.565 - like this? Or if you wanted to be 414 00:15:19.565 --> 00:15:21.565 - super proactive, you can actually sign up to 415 00:15:21.565 --> 00:15:22.945 - be part of the clinical trials. 416 00:15:23.325 --> 00:15:25.450 - So you could reach out and say, Assiim 417 00:15:25.450 --> 00:15:29.049 - is running formal clinical trials that are more 418 00:15:29.049 --> 00:15:30.990 - than just an expanded access program, 419 00:15:31.690 --> 00:15:33.769 - and they are recruiting sites now. So you 420 00:15:33.769 --> 00:15:35.610 - could reach out to them and say, we 421 00:15:35.610 --> 00:15:37.549 - would like to be a site. Can we 422 00:15:37.929 --> 00:15:40.909 - get onboarded for being a clinical trial site? 423 00:15:42.225 --> 00:15:42.725 - Perfect. 424 00:15:43.184 --> 00:15:45.184 - I'm gonna shift gears a little bit as 425 00:15:45.184 --> 00:15:46.805 - we wrapped up the conversation. 426 00:15:47.504 --> 00:15:49.665 - We've kind of zoomed in on this, you 427 00:15:49.665 --> 00:15:52.245 - know, specific case, but I'd love to just 428 00:15:53.279 --> 00:15:54.259 - pick your brain 429 00:15:54.959 --> 00:15:56.899 - for a kind of broader perspective 430 00:15:57.279 --> 00:15:57.779 - on 431 00:15:58.159 --> 00:16:00.579 - pediatric oncology, transplant programs, 432 00:16:01.759 --> 00:16:04.019 - the pressures that they're facing right now. 433 00:16:04.639 --> 00:16:06.695 - As you've got an audience of health system 434 00:16:06.695 --> 00:16:08.154 - leaders, is there anything 435 00:16:08.534 --> 00:16:09.195 - you feel 436 00:16:10.695 --> 00:16:13.014 - is not getting enough attention, whether that's, you 437 00:16:13.014 --> 00:16:15.434 - know, access pressure, funding, staffing? 438 00:16:16.375 --> 00:16:18.534 - And through the same veins, is there anything 439 00:16:18.534 --> 00:16:20.490 - you see in the future that leaders might 440 00:16:20.490 --> 00:16:22.490 - need to tackle when it comes to closing 441 00:16:22.490 --> 00:16:26.110 - care gaps within pediatric oncology and transplant programs 442 00:16:26.169 --> 00:16:26.750 - like this? 443 00:16:29.129 --> 00:16:32.110 - That is a heavyweight question. One. Yeah. 444 00:16:32.730 --> 00:16:33.230 - So 445 00:16:33.690 --> 00:16:35.850 - I'll start with, you know, pressures in the 446 00:16:35.850 --> 00:16:38.164 - field right now and challenges that we're facing. 447 00:16:39.264 --> 00:16:41.365 - Really, in the field of stem cell transplant, 448 00:16:41.904 --> 00:16:44.144 - obviously, we've talked about donor access. But I 449 00:16:44.144 --> 00:16:46.245 - think you can't talk about, 450 00:16:47.184 --> 00:16:49.550 - challenges and shortfalls in stem cell transplant without 451 00:16:49.550 --> 00:16:51.629 - talking about what it takes to pull off 452 00:16:51.629 --> 00:16:52.929 - a transplant successfully. 453 00:16:53.629 --> 00:16:56.910 - And, really, that starts with having health care 454 00:16:56.910 --> 00:16:58.529 - team members that have experience. 455 00:16:59.710 --> 00:17:02.210 - We the nursing shortage is profound 456 00:17:02.590 --> 00:17:04.054 - across all health care systems. 457 00:17:04.674 --> 00:17:05.974 - And then when you're 458 00:17:06.275 --> 00:17:09.974 - trying to deliver these these highly advanced therapies 459 00:17:10.115 --> 00:17:11.335 - that are highly toxic, 460 00:17:12.355 --> 00:17:15.095 - having an experienced skill set of nursing 461 00:17:15.559 --> 00:17:18.299 - and nurse practitioners and physicians and coordinators, 462 00:17:18.679 --> 00:17:19.740 - all of those people 463 00:17:20.679 --> 00:17:21.819 - not being new 464 00:17:22.440 --> 00:17:24.700 - is really critical. And so I think, 465 00:17:25.240 --> 00:17:28.359 - health care systems valuing the experience that they 466 00:17:28.359 --> 00:17:30.974 - have and their existing team members and working 467 00:17:30.974 --> 00:17:33.295 - to retain. I know everybody wants to retain 468 00:17:33.295 --> 00:17:33.954 - their nurses, 469 00:17:34.575 --> 00:17:36.575 - but, and everybody is working on the short 470 00:17:36.575 --> 00:17:39.535 - fallings that we have in staffing. But in 471 00:17:39.535 --> 00:17:42.674 - a field like this, where experience is sometimes 472 00:17:42.734 --> 00:17:45.055 - the difference between life and death, we have 473 00:17:45.055 --> 00:17:45.795 - to prioritize 474 00:17:46.710 --> 00:17:49.349 - retaining experience. So I think that's probably one 475 00:17:49.349 --> 00:17:50.250 - really big thing. 476 00:17:51.589 --> 00:17:52.250 - I think 477 00:17:52.789 --> 00:17:54.730 - in terms of, you know, 478 00:17:55.750 --> 00:17:58.490 - other system challenges, I think, you know, 479 00:17:58.795 --> 00:18:00.795 - the cost of these type of therapies of 480 00:18:00.795 --> 00:18:03.835 - advanced therapeutics, like stem cell transplant, CAR t 481 00:18:03.835 --> 00:18:05.615 - cell therapy, gene therapy, 482 00:18:06.394 --> 00:18:09.434 - both inside and outside of cancer care require 483 00:18:09.434 --> 00:18:12.335 - really innovative thinking and budgetary planning. 484 00:18:12.839 --> 00:18:13.960 - And I think, you know, we're in the 485 00:18:13.960 --> 00:18:15.880 - midst of these conversations with our own health 486 00:18:15.880 --> 00:18:18.599 - care system right now of, you know, health 487 00:18:18.599 --> 00:18:20.779 - care as a whole is really struggling financially 488 00:18:20.839 --> 00:18:22.859 - right now. And there are lots of reasons 489 00:18:22.919 --> 00:18:24.919 - for that, but I think, 490 00:18:25.984 --> 00:18:28.644 - being strategic in what we invest in 491 00:18:29.105 --> 00:18:29.605 - and, 492 00:18:30.785 --> 00:18:31.285 - being, 493 00:18:31.664 --> 00:18:33.525 - you know, thoughtful about 494 00:18:34.144 --> 00:18:36.404 - where we place our dollars and cents, 495 00:18:37.345 --> 00:18:39.605 - in order to provide care to patients 496 00:18:40.065 --> 00:18:40.565 - and, 497 00:18:41.220 --> 00:18:44.819 - specifically, to provide equitable access to care is 498 00:18:44.819 --> 00:18:46.679 - another really big piece of things. 499 00:18:48.099 --> 00:18:49.960 - And that requires having 500 00:18:50.500 --> 00:18:51.720 - proactive conversations 501 00:18:52.259 --> 00:18:53.880 - with public payers specifically, 502 00:18:55.184 --> 00:18:57.825 - in order to ensure continued equitable access to 503 00:18:57.825 --> 00:18:58.325 - care. 504 00:18:59.265 --> 00:19:00.644 - I think in terms of 505 00:19:01.025 --> 00:19:03.265 - what we're, like, looking at in the field 506 00:19:03.265 --> 00:19:05.125 - and closing gaps in 507 00:19:06.304 --> 00:19:08.625 - care as they currently exist of, 508 00:19:09.259 --> 00:19:11.579 - where the science is versus where we wanna 509 00:19:11.579 --> 00:19:13.919 - be. When we really think about what therapeutics 510 00:19:14.059 --> 00:19:16.460 - are available to us, I think we have 511 00:19:16.460 --> 00:19:18.079 - amazing tools in our toolbox 512 00:19:18.700 --> 00:19:21.500 - and working to move those tools a little 513 00:19:21.500 --> 00:19:23.659 - earlier in care so that patients don't come 514 00:19:23.659 --> 00:19:24.240 - to us 515 00:19:24.765 --> 00:19:25.505 - with, you 516 00:19:26.445 --> 00:19:30.205 - know, existing organ damage or existing toxicity that 517 00:19:30.205 --> 00:19:31.664 - makes their care more complicated 518 00:19:32.445 --> 00:19:33.265 - would be beneficial 519 00:19:33.644 --> 00:19:35.964 - for patient care. The rub and the challenge 520 00:19:35.964 --> 00:19:37.964 - in that is that those advanced therapeutics are 521 00:19:37.964 --> 00:19:38.625 - more expensive. 522 00:19:39.029 --> 00:19:41.029 - So trying to balance, you know, who really 523 00:19:41.029 --> 00:19:43.190 - needs these therapies and how can we integrate 524 00:19:43.190 --> 00:19:45.850 - them in a way that financially makes sense 525 00:19:46.230 --> 00:19:48.950 - both for patients and health care systems is 526 00:19:49.109 --> 00:19:50.950 - it's a big challenge if I'm being really 527 00:19:50.950 --> 00:19:51.450 - honest. 528 00:19:53.015 --> 00:19:55.255 - And then within the science of where it 529 00:19:55.255 --> 00:19:58.455 - currently exists within I'll speak specifically to cancer 530 00:19:58.455 --> 00:19:59.914 - because that's what I do. 531 00:20:00.215 --> 00:20:03.095 - Mhmm. You know, we've gotten pretty good at 532 00:20:03.095 --> 00:20:04.394 - using advanced therapeutics, 533 00:20:04.934 --> 00:20:06.955 - like cell therapy and gene therapy 534 00:20:07.414 --> 00:20:07.914 - for 535 00:20:09.380 --> 00:20:12.900 - hematologic malignancies, so leukemias, lymphomas, that sort of 536 00:20:12.900 --> 00:20:15.940 - thing. But there are still very large challenges 537 00:20:15.940 --> 00:20:18.019 - that exist in the realm of solid tumors, 538 00:20:18.019 --> 00:20:20.500 - which are actually much greater in number than 539 00:20:20.500 --> 00:20:21.640 - hematologic malignancies. 540 00:20:22.545 --> 00:20:23.045 - So, 541 00:20:23.505 --> 00:20:26.225 - we're working to we're working with our bench 542 00:20:26.225 --> 00:20:29.025 - scientists to advance to next generation CAR T 543 00:20:29.025 --> 00:20:30.404 - cell therapies that can 544 00:20:30.705 --> 00:20:32.085 - address some of those shortcomings. 545 00:20:33.664 --> 00:20:35.025 - And then the other thing that we really 546 00:20:35.025 --> 00:20:36.545 - have to figure out is how to deliver 547 00:20:36.545 --> 00:20:37.285 - this care 548 00:20:38.089 --> 00:20:39.070 - less expensively. 549 00:20:39.769 --> 00:20:40.730 - Mhmm. So, 550 00:20:41.210 --> 00:20:43.450 - we are you know, that's another area where 551 00:20:43.450 --> 00:20:45.210 - science is working so that we can do 552 00:20:45.210 --> 00:20:47.450 - this therapy and not break the bank in 553 00:20:47.450 --> 00:20:48.190 - doing it, 554 00:20:49.049 --> 00:20:51.769 - because there will be ways to streamline this 555 00:20:51.769 --> 00:20:53.150 - therapy moving forward 556 00:20:53.565 --> 00:20:54.784 - that will be less 557 00:20:55.244 --> 00:20:57.184 - costly and less labor intensive, 558 00:20:58.524 --> 00:21:00.845 - and that will help provide equitable access to 559 00:21:00.845 --> 00:21:01.744 - care as well. 560 00:21:02.204 --> 00:21:02.704 - So 561 00:21:03.164 --> 00:21:04.845 - those are just some of the musings off 562 00:21:04.845 --> 00:21:06.684 - the you know? Yeah. Off of what I 563 00:21:06.684 --> 00:21:08.220 - see every day, but I think, 564 00:21:08.779 --> 00:21:10.380 - that there are gaps to be filled is 565 00:21:10.380 --> 00:21:11.200 - not a question. 566 00:21:11.980 --> 00:21:14.140 - Absolutely. And, you know, that's what I love 567 00:21:14.140 --> 00:21:16.299 - about having these conversations on the podcast because 568 00:21:16.299 --> 00:21:18.079 - you are able to share, you know, 569 00:21:18.460 --> 00:21:20.619 - your musings based on what you're seeing, and 570 00:21:20.619 --> 00:21:22.619 - I know that it resonates with, you know, 571 00:21:22.619 --> 00:21:26.115 - other oncology leaders across the country. So I'm 572 00:21:26.115 --> 00:21:28.595 - so grateful, doctor Scowles, that you took the 573 00:21:28.595 --> 00:21:30.694 - time to come on the podcast to share 574 00:21:31.075 --> 00:21:33.075 - more details behind this case, but also just 575 00:21:33.075 --> 00:21:35.474 - your insights. Overall, I hope we can connect 576 00:21:35.474 --> 00:21:36.375 - again soon. 577 00:21:37.349 --> 00:21:39.130 - Absolutely. Thank you for having me. 578 00:21:39.509 --> 00:21:41.349 - And thank you to our listeners for tuning 579 00:21:41.349 --> 00:21:44.009 - in to Becker's Oncology Leadership Podcast. 580 00:21:44.549 --> 00:21:45.990 - I invite you all to check out even 581 00:21:45.990 --> 00:21:50.170 - more Becker's Healthcare Podcasts at breccarspodcasts.com. 582 00:21:50.464 --> 00:21:52.224 - Thank you again to doctor Styles for joining 583 00:21:52.224 --> 00:21:53.904 - me, and thank you to our listeners for 584 00:21:53.904 --> 00:21:55.845 - tuning in. Have a good day.