WEBVTT

1
00:00:00.240 --> 00:00:03.279
<v Speaker 1>Hi, Tracy, thank you so much for joining me, and

2
00:00:03.480 --> 00:00:07.000
<v Speaker 1>I just hello to folks that are watching our conversation

3
00:00:07.160 --> 00:00:11.160
<v Speaker 1>about the fifteenth annual DEFARM Conference and for those of

4
00:00:11.160 --> 00:00:14.160
<v Speaker 1>you who are new to DEFARM, DEFARM is a conference

5
00:00:14.199 --> 00:00:18.039
<v Speaker 1>that we launched fifteen years ago thanks to Pfizer and

6
00:00:18.640 --> 00:00:21.480
<v Speaker 1>Johnson and Johnson who approached us to say we need

7
00:00:21.519 --> 00:00:26.839
<v Speaker 1>a conference very specific to clinical trial operation executives that

8
00:00:27.000 --> 00:00:31.760
<v Speaker 1>really challenges how we do clinical trials and to work

9
00:00:31.800 --> 00:00:35.719
<v Speaker 1>towards modernizing them, to work towards being far more patient

10
00:00:35.840 --> 00:00:41.479
<v Speaker 1>centric and reporting on innovation that we'll truly modernize clinical trials.

11
00:00:41.960 --> 00:00:45.119
<v Speaker 1>And so originally the concept was around disruption and how

12
00:00:45.119 --> 00:00:47.880
<v Speaker 1>do we disrupt the way we do clinical trials and

13
00:00:47.960 --> 00:00:51.520
<v Speaker 1>the idea of let's really rethink the way we're doing

14
00:00:51.560 --> 00:00:54.439
<v Speaker 1>trials because we're only just getting more complex and more expensive,

15
00:00:54.840 --> 00:00:56.920
<v Speaker 1>and so you know, we all know that this this

16
00:00:57.000 --> 00:01:00.359
<v Speaker 1>is the background of what everybody's working in. I think

17
00:01:00.439 --> 00:01:03.240
<v Speaker 1>the beauty of DEFARM is, you know, Tracy, I know

18
00:01:03.320 --> 00:01:07.719
<v Speaker 1>you put together sixty five advisors, which is extraordinary for

19
00:01:07.760 --> 00:01:10.920
<v Speaker 1>any conference, but that we have this wonderful group of

20
00:01:11.480 --> 00:01:16.760
<v Speaker 1>very dedicated clinical trial operation leaders among academics and FDA

21
00:01:17.040 --> 00:01:20.400
<v Speaker 1>and patient Advocacy, among others. Some of these incredible tech

22
00:01:20.439 --> 00:01:25.480
<v Speaker 1>companies and service companies that guide our programs. So welcome,

23
00:01:25.519 --> 00:01:27.799
<v Speaker 1>and I really wanted to hear from you as we

24
00:01:27.920 --> 00:01:31.840
<v Speaker 1>launch our first in a series of conversations around defarm,

25
00:01:31.879 --> 00:01:34.519
<v Speaker 1>because it has so many parts to it so that

26
00:01:34.560 --> 00:01:37.719
<v Speaker 1>people can customize and really get what they specifically need.

27
00:01:38.239 --> 00:01:38.840
<v Speaker 2>I wanted to.

28
00:01:38.760 --> 00:01:42.439
<v Speaker 1>Hear about the research and what industry leaders are talking

29
00:01:42.480 --> 00:01:45.359
<v Speaker 1>to you about that's really challenging right now that we'll

30
00:01:45.400 --> 00:01:46.719
<v Speaker 1>be addressed at the conference.

31
00:01:46.799 --> 00:01:51.000
<v Speaker 2>So let me let you shook you away. Good morning. Yes.

32
00:01:51.280 --> 00:01:54.079
<v Speaker 2>I think first and foremost on everyone's mind, especially when

33
00:01:54.079 --> 00:01:57.719
<v Speaker 2>we started our research, was how the geopolitical landscape was

34
00:01:57.760 --> 00:02:01.439
<v Speaker 2>going to impact R and D and specifically clinical trial operations.

35
00:02:02.079 --> 00:02:05.879
<v Speaker 2>The ability to connect with the FDA and be aware

36
00:02:05.920 --> 00:02:09.080
<v Speaker 2>of what the FDA needs are Rightfully, so, things have shifted.

37
00:02:09.120 --> 00:02:11.479
<v Speaker 2>There's a lot of change, and there is a need

38
00:02:11.520 --> 00:02:14.360
<v Speaker 2>to be responsive to those changes and be on top

39
00:02:14.400 --> 00:02:17.120
<v Speaker 2>of what's happening. I think for the next topic that

40
00:02:17.199 --> 00:02:20.120
<v Speaker 2>came up and directly related to what I just mentioned,

41
00:02:20.199 --> 00:02:23.479
<v Speaker 2>is really operating models. What's going to be the most

42
00:02:23.639 --> 00:02:28.800
<v Speaker 2>optimal way to manage your resources? As you're trying to

43
00:02:28.840 --> 00:02:32.759
<v Speaker 2>pivot and shift and be ready to respond to how

44
00:02:32.879 --> 00:02:37.039
<v Speaker 2>you will execute clinical trials will be forward very big

45
00:02:37.120 --> 00:02:44.280
<v Speaker 2>focus laser focus on streamlining operations, streamlining workflows, finding efficiencies,

46
00:02:44.680 --> 00:02:48.520
<v Speaker 2>finding ways to make those processes more automated so that

47
00:02:48.560 --> 00:02:52.039
<v Speaker 2>you can focus your resources on tasks that really require

48
00:02:52.439 --> 00:02:58.000
<v Speaker 2>concentration around making decisions that will impact speed, delivery, equality,

49
00:02:58.560 --> 00:03:04.520
<v Speaker 2>patient centricity, sites centricity, automation, acceleration of timelines clearly still

50
00:03:04.639 --> 00:03:10.360
<v Speaker 2>very very important. You mentioned it earlier. Protocol complexity. You know,

51
00:03:10.400 --> 00:03:12.879
<v Speaker 2>how to manage that, how to shift, how to reverse

52
00:03:12.919 --> 00:03:16.439
<v Speaker 2>that trend, What ways can we make it less burdensome

53
00:03:16.560 --> 00:03:18.199
<v Speaker 2>for sites and patients.

54
00:03:18.520 --> 00:03:22.000
<v Speaker 1>Yeah, and that's been an issue forever. So I'm excited

55
00:03:22.039 --> 00:03:24.439
<v Speaker 1>that you know that's going to take central stage.

56
00:03:24.639 --> 00:03:26.639
<v Speaker 2>And I think you know, as we think about innovation

57
00:03:26.879 --> 00:03:30.080
<v Speaker 2>in this space, people still want to innovate and still

58
00:03:30.080 --> 00:03:32.599
<v Speaker 2>want to focus on that, but there's an ROI attached

59
00:03:32.599 --> 00:03:35.520
<v Speaker 2>to that need to be able to you know, at

60
00:03:35.520 --> 00:03:39.680
<v Speaker 2>the end of show, results show impact on those key

61
00:03:39.719 --> 00:03:44.360
<v Speaker 2>things of accelerating timelines, debating sites, and getting patients the

62
00:03:44.479 --> 00:03:51.280
<v Speaker 2>right patients enrolled in your trials. AI agentic AI GENI yes,

63
00:03:51.360 --> 00:03:53.599
<v Speaker 2>we all want to use it, or the industry wants

64
00:03:53.639 --> 00:03:56.280
<v Speaker 2>to invest and use it, but in places where they

65
00:03:56.319 --> 00:03:58.319
<v Speaker 2>know that it's making a difference. And we're going to

66
00:03:58.360 --> 00:04:01.639
<v Speaker 2>have lots of sessions really talking about where it's making

67
00:04:01.680 --> 00:04:04.280
<v Speaker 2>a difference. You know, I mentioned a little earlier, a

68
00:04:04.360 --> 00:04:07.599
<v Speaker 2>refocus on site centricity, a refocus on how to work

69
00:04:07.599 --> 00:04:11.919
<v Speaker 2>with sites to problem solve around those challenges. I think

70
00:04:12.080 --> 00:04:15.400
<v Speaker 2>the collaboration angle of that. In fact, we are actually

71
00:04:15.439 --> 00:04:20.000
<v Speaker 2>the day before DEFARM having our Site Partnership Summit that

72
00:04:20.240 --> 00:04:25.279
<v Speaker 2>will look specifically at LEAs to collaborate and address those challenges. So, yeah,

73
00:04:25.319 --> 00:04:28.040
<v Speaker 2>those are the top issues. The only other piece that's

74
00:04:28.160 --> 00:04:30.240
<v Speaker 2>quite clear, it has been in the past couple of years,

75
00:04:30.480 --> 00:04:34.800
<v Speaker 2>is still around what does your talent growth development need

76
00:04:34.879 --> 00:04:38.600
<v Speaker 2>to look like? What are the roles and responsibilities going

77
00:04:38.639 --> 00:04:42.480
<v Speaker 2>to need to have for skill sets moving forward, say

78
00:04:42.480 --> 00:04:44.600
<v Speaker 2>two or five years from now. And there's a real

79
00:04:44.639 --> 00:04:48.120
<v Speaker 2>focus from leadership around how do we make how do

80
00:04:48.160 --> 00:04:50.399
<v Speaker 2>we what's the strategy to that, and then how do

81
00:04:50.399 --> 00:04:51.639
<v Speaker 2>we execute on that strategy?

82
00:04:52.199 --> 00:04:54.319
<v Speaker 1>Yeah, and I think that just to building what you

83
00:04:54.360 --> 00:04:56.079
<v Speaker 1>were saying, I think that you know, the two questions

84
00:04:56.079 --> 00:04:58.639
<v Speaker 1>that come to my mind are you know how leadership

85
00:04:58.720 --> 00:05:02.800
<v Speaker 1>is looking at that, especially with AI, and then you

86
00:05:02.839 --> 00:05:05.279
<v Speaker 1>know folks that are in the trenches, what do they

87
00:05:05.279 --> 00:05:07.720
<v Speaker 1>need to know now to make sure that they are

88
00:05:08.120 --> 00:05:11.439
<v Speaker 1>a step ahead. So that's I think really important part

89
00:05:11.439 --> 00:05:14.920
<v Speaker 1>of UPDFARM. So tell me about how you know is

90
00:05:14.959 --> 00:05:18.399
<v Speaker 1>DEFARM twenty twenty five going to address some of these issues.

91
00:05:18.480 --> 00:05:20.240
<v Speaker 2>Well, we have two days to accomplish all of this.

92
00:05:20.480 --> 00:05:22.879
<v Speaker 2>I'm excited about it and there are lots of I

93
00:05:22.920 --> 00:05:25.720
<v Speaker 2>think some really innovative sessions that we'll be talking about

94
00:05:25.959 --> 00:05:30.160
<v Speaker 2>on our weekly content focused podcasts. Now that every year

95
00:05:30.199 --> 00:05:33.720
<v Speaker 2>we kick off d farm with our patient keynote, and

96
00:05:33.759 --> 00:05:36.399
<v Speaker 2>you honestly can say that our patient keynote this year

97
00:05:36.439 --> 00:05:38.519
<v Speaker 2>is going to probably bring down the house again. Her

98
00:05:38.560 --> 00:05:42.360
<v Speaker 2>name is Victoria Gray. She is the first recipient of

99
00:05:42.720 --> 00:05:47.519
<v Speaker 2>Crisper therapeutic for cycle cell disease, and I think she'll

100
00:05:47.519 --> 00:05:50.120
<v Speaker 2>do a wonderful job of not only sharing her journey

101
00:05:50.160 --> 00:05:53.279
<v Speaker 2>but also giving a call to action for industry. She's

102
00:05:53.319 --> 00:05:56.600
<v Speaker 2>a wonderful patient advocate since her treatment and that is

103
00:05:56.800 --> 00:06:01.399
<v Speaker 2>very invested in and working alongside industry to have these

104
00:06:01.439 --> 00:06:06.279
<v Speaker 2>therapies be more available accessible to patients. And then our

105
00:06:06.399 --> 00:06:09.079
<v Speaker 2>keynotes are in direct response to the feedback that we're

106
00:06:09.120 --> 00:06:12.560
<v Speaker 2>received from the advisors. We're very fortunate to have Scott

107
00:06:12.600 --> 00:06:17.680
<v Speaker 2>Gottlieb talking specifically about the geopolitical landscape, the impact potentially

108
00:06:17.720 --> 00:06:20.079
<v Speaker 2>on R and D, how industry will continue to work

109
00:06:20.079 --> 00:06:23.639
<v Speaker 2>with FDA as things continue to shift and priorities are shifted.

110
00:06:23.800 --> 00:06:26.360
<v Speaker 2>So that's very exciting, and we're also excited to have

111
00:06:26.480 --> 00:06:31.240
<v Speaker 2>Ken Frasier, former chairman of MERK. I think clearly leadership

112
00:06:31.319 --> 00:06:35.319
<v Speaker 2>during times of uncertainty and how to continue an innovative

113
00:06:35.399 --> 00:06:38.800
<v Speaker 2>path forward are areas that he can certainly speak to,

114
00:06:39.199 --> 00:06:42.560
<v Speaker 2>both from a professional and personal endeavors that he's involved in.

115
00:06:42.680 --> 00:06:45.519
<v Speaker 1>I just love the even those two folks because you know,

116
00:06:45.959 --> 00:06:48.959
<v Speaker 1>together on the same program, because I think Scott has

117
00:06:49.000 --> 00:06:52.240
<v Speaker 1>such good insight into what's really going on behind the

118
00:06:52.240 --> 00:06:57.399
<v Speaker 1>scenes at FDA and can really help answer questions and

119
00:06:57.920 --> 00:07:00.439
<v Speaker 1>clarify number of issues. And I think the beauty of

120
00:07:00.759 --> 00:07:04.680
<v Speaker 1>Ken Frasier is he was such an extraordinary CEO at

121
00:07:04.800 --> 00:07:09.879
<v Speaker 1>MERK and his leadership on just about everything from leading

122
00:07:10.040 --> 00:07:12.680
<v Speaker 1>in a flory of change, how do you pivot and

123
00:07:12.759 --> 00:07:17.000
<v Speaker 1>adapt and how do you just keep the science going

124
00:07:17.079 --> 00:07:19.519
<v Speaker 1>and keep your teams going and how do you just

125
00:07:19.639 --> 00:07:23.319
<v Speaker 1>tackle the number of complex issues in this industry. So

126
00:07:24.079 --> 00:07:26.279
<v Speaker 1>and then of course, you know, as you said, having

127
00:07:26.360 --> 00:07:28.959
<v Speaker 1>Victoria is going to be really special and just to

128
00:07:29.000 --> 00:07:32.399
<v Speaker 1>give us that insight into you know, what that was

129
00:07:32.519 --> 00:07:35.360
<v Speaker 1>like being you know, the first recipient you know, for

130
00:07:36.279 --> 00:07:39.120
<v Speaker 1>science that has truly changed her life and the lives

131
00:07:39.120 --> 00:07:41.800
<v Speaker 1>of many people. But I know you have somebody else

132
00:07:41.959 --> 00:07:45.279
<v Speaker 1>as well speaking that's always fantastic to hear about. So

133
00:07:45.319 --> 00:07:47.079
<v Speaker 1>I'll let you touch upon that.

134
00:07:47.720 --> 00:07:50.120
<v Speaker 2>Certainly. Ken Yetz will be joining us on the second

135
00:07:50.160 --> 00:07:53.000
<v Speaker 2>day of the conference to really bring to life the data,

136
00:07:53.199 --> 00:07:55.720
<v Speaker 2>the data and that's they're collecting now and reporting out

137
00:07:56.199 --> 00:08:00.879
<v Speaker 2>on a patient protocol, impact on patient burden and a

138
00:08:00.879 --> 00:08:01.720
<v Speaker 2>site burn.

139
00:08:01.879 --> 00:08:05.920
<v Speaker 1>Ken's focus is going to be on protocol complexity data

140
00:08:07.079 --> 00:08:09.639
<v Speaker 1>and what changes we can make.

141
00:08:09.959 --> 00:08:13.319
<v Speaker 2>The latest research that they're looking at directly how these

142
00:08:13.800 --> 00:08:16.839
<v Speaker 2>how the you know, trial design and protocols within those

143
00:08:16.879 --> 00:08:21.759
<v Speaker 2>trials are impacting how patients view the trials and help

144
00:08:21.800 --> 00:08:24.319
<v Speaker 2>Burns him that may be and one impact that I

145
00:08:24.360 --> 00:08:26.519
<v Speaker 2>can have can make some shifts.

146
00:08:27.120 --> 00:08:30.399
<v Speaker 1>But he's always phenomenal and you know, whenever he speaks,

147
00:08:30.920 --> 00:08:33.679
<v Speaker 1>the feedback from the audience is they're just always so

148
00:08:34.159 --> 00:08:38.080
<v Speaker 1>pleased because they can walk away with information that they

149
00:08:38.120 --> 00:08:41.159
<v Speaker 1>could do something with. So I just love Ken for that.

150
00:08:41.360 --> 00:08:44.159
<v Speaker 2>So fantastic and there's nothing that speaks great. I mean,

151
00:08:44.200 --> 00:08:46.679
<v Speaker 2>the data is always so illuminating when he kind of

152
00:08:46.799 --> 00:08:48.559
<v Speaker 2>he only made you know, you can point out four

153
00:08:48.639 --> 00:08:50.639
<v Speaker 2>or five pieces of data that really can drive a

154
00:08:50.799 --> 00:08:53.759
<v Speaker 2>change and behavior in terms of how trials are executed.

155
00:08:53.799 --> 00:08:57.080
<v Speaker 2>It's you know, you have a huge GYMP, so very exciting.

156
00:08:57.519 --> 00:08:59.399
<v Speaker 1>Can you tell us about some of the leadership panels

157
00:08:59.440 --> 00:09:00.919
<v Speaker 1>that you've been putting together this year?

158
00:09:02.159 --> 00:09:05.080
<v Speaker 2>Yes, we have four. Day one we'll be looking at

159
00:09:05.639 --> 00:09:08.519
<v Speaker 2>the need to sort of expand your global footprint for

160
00:09:08.559 --> 00:09:11.960
<v Speaker 2>clinical trials, just in response to the shift happening in

161
00:09:11.960 --> 00:09:13.360
<v Speaker 2>the geopolitical landscape.

162
00:09:13.639 --> 00:09:16.799
<v Speaker 1>So many companies are looking at working with sites outside

163
00:09:16.840 --> 00:09:20.320
<v Speaker 1>the US as well, and so yep, I get it.

164
00:09:20.440 --> 00:09:23.639
<v Speaker 1>That's important. So you said you have four, so that's one.

165
00:09:23.919 --> 00:09:26.799
<v Speaker 2>Yes, and then day three is Chuck Bolt. You know,

166
00:09:26.840 --> 00:09:30.919
<v Speaker 2>we'll cook off with looking at disrupting you know, how

167
00:09:30.960 --> 00:09:33.519
<v Speaker 2>that trend is affecting, what's actually happening, What are the

168
00:09:33.600 --> 00:09:37.399
<v Speaker 2>choices that farm responses are making, and why we know

169
00:09:37.480 --> 00:09:40.600
<v Speaker 2>in the past as these shifts happen and they change,

170
00:09:40.600 --> 00:09:42.879
<v Speaker 2>but I think for now, in response to this type

171
00:09:42.919 --> 00:09:45.600
<v Speaker 2>of global environment, it's very important to be thinking about

172
00:09:45.600 --> 00:09:50.519
<v Speaker 2>what's optimal for how your organization approaches its strategy manages

173
00:09:50.559 --> 00:09:54.159
<v Speaker 2>its resources to execute those strategies. And then we also

174
00:09:54.279 --> 00:09:58.039
<v Speaker 2>have a session looking at protocol complexity. Are the ways

175
00:09:58.080 --> 00:10:00.080
<v Speaker 2>to reverse that trend? Ken is actually going to to

176
00:10:00.159 --> 00:10:02.320
<v Speaker 2>be on that panel as well.

177
00:10:02.759 --> 00:10:06.279
<v Speaker 1>Oh good, excellent, Yeah.

178
00:10:06.039 --> 00:10:08.879
<v Speaker 2>And the final leadership panel as looking at the future

179
00:10:08.919 --> 00:10:13.600
<v Speaker 2>of oncology research. With the crunch in funding issues through

180
00:10:13.799 --> 00:10:19.080
<v Speaker 2>NIH and the overwhelming need for research sites for clinical

181
00:10:19.120 --> 00:10:22.399
<v Speaker 2>trials and oncology, how do we fill the gap? That

182
00:10:22.440 --> 00:10:23.480
<v Speaker 2>will be one of our.

183
00:10:24.440 --> 00:10:27.240
<v Speaker 1>Oh fantastic And you know, when you think about fifty

184
00:10:27.240 --> 00:10:31.120
<v Speaker 1>percent of all trials are in oncology, it's pretty pretty major.

185
00:10:31.679 --> 00:10:34.360
<v Speaker 1>So so nice, so right, So, just to recap, we've

186
00:10:34.399 --> 00:10:36.200
<v Speaker 1>got a good sense of who the keynotes are and

187
00:10:36.240 --> 00:10:39.240
<v Speaker 1>the leadership panels are. And then Tracy, you and I

188
00:10:39.279 --> 00:10:42.559
<v Speaker 1>are going to continue doing a series of conversations for

189
00:10:42.600 --> 00:10:45.120
<v Speaker 1>folks to fill them in on the different sections of

190
00:10:45.200 --> 00:10:48.919
<v Speaker 1>defarms so we can properly address and give people insights

191
00:10:48.919 --> 00:10:52.480
<v Speaker 1>into what they can expect. At the fifteenth annual conference.

192
00:10:52.559 --> 00:10:54.200
<v Speaker 1>So I just want to say thank you so much

193
00:10:54.240 --> 00:10:57.600
<v Speaker 1>for giving us that initial intro and we look forward

194
00:10:57.679 --> 00:11:00.120
<v Speaker 1>to bringing more to our listeners here.

195
00:11:00.120 --> 00:11:00.480
<v Speaker 2>Welcome.

196
00:11:00.519 --> 00:11:03.759
<v Speaker 1>So Tracy, before we completely finished, gives us the dates

197
00:11:03.799 --> 00:11:04.759
<v Speaker 1>please for Deform.

198
00:11:05.240 --> 00:11:08.759
<v Speaker 2>Yes, we are back in Philadelphia at the Loew's Philadelphia

199
00:11:08.759 --> 00:11:12.399
<v Speaker 2>Downtown Hotel on September sixteenth and seventeenth, which is a

200
00:11:12.480 --> 00:11:16.360
<v Speaker 2>Tuesday and a Wednesday. The program runs on day two

201
00:11:16.639 --> 00:11:21.240
<v Speaker 2>until five o'clock. Encourage people to make their travel plans

202
00:11:21.279 --> 00:11:24.519
<v Speaker 2>based on that, because just like last year, the amount

203
00:11:24.519 --> 00:11:27.559
<v Speaker 2>of content in the afternoon between two and five pm

204
00:11:27.720 --> 00:11:30.720
<v Speaker 2>is phenomenal. Would love to have your participation all the

205
00:11:30.759 --> 00:11:31.360
<v Speaker 2>way to the end.

206
00:11:31.799 --> 00:11:33.840
<v Speaker 1>Okay, wonderful. And then I just want to add that

207
00:11:33.879 --> 00:11:36.879
<v Speaker 1>on the Monday, we have the as you said earlier,

208
00:11:36.919 --> 00:11:40.799
<v Speaker 1>the Partnerships with Sites conference, and we also have the

209
00:11:40.919 --> 00:11:44.440
<v Speaker 1>Clinical Research as a Care Option Conference, which is going

210
00:11:44.440 --> 00:11:47.639
<v Speaker 1>into its tenth here, and that conference looks at how

211
00:11:47.639 --> 00:11:51.279
<v Speaker 1>we can bring patients closer to clinical research and clinical

212
00:11:51.279 --> 00:11:54.879
<v Speaker 1>research closer to patients by getting clinical research where the

213
00:11:54.919 --> 00:11:57.279
<v Speaker 1>patients are in the care systems and how do we

214
00:11:57.320 --> 00:12:00.559
<v Speaker 1>do that and so lot to celebrate there as well.

215
00:12:01.000 --> 00:12:04.279
<v Speaker 1>And then the website for people to get more information is.

216
00:12:04.799 --> 00:12:08.120
<v Speaker 2>Debonalconference dot com. All right, thank you,