Hi, Tracy, thank you so much for joining me, and I just hello to folks that are watching our conversation about the fifteenth annual DEFARM Conference and for those of you who are new to DEFARM, DEFARM is a conference that we launched fifteen years ago thanks to Pfizer and Johnson and Johnson who approached us to say we need a conference very specific to clinical trial operation executives that really challenges how we do clinical trials and to work
towards modernizing them, to work towards being far more patient centric and reporting on innovation that we'll truly modernize clinical trials. And so originally the concept was around disruption and how do we disrupt the way we do clinical trials and the idea of let's really rethink the way we're doing trials because we're only just getting more complex and more expensive, and so you know, we all know that this this
is the background of what everybody's working in. I think the beauty of DEFARM is, you know, Tracy, I know you put together sixty five advisors, which is extraordinary for any conference, but that we have this wonderful group of very dedicated clinical trial operation leaders among academics and FDA and patient Advocacy, among others. Some of these incredible tech
companies and service companies that guide our programs. So welcome, and I really wanted to hear from you as we launch our first in a series of conversations around defarm, because it has so many parts to it so that people can customize and really get what they specifically need.
I wanted to.
Hear about the research and what industry leaders are talking to you about that's really challenging right now that we'll be addressed at the conference.
So let me let you shook you away. Good morning. Yes. I think first and foremost on everyone's mind, especially when we started our research, was how the geopolitical landscape was going to impact R and D and specifically clinical trial operations. The ability to connect with the FDA and be aware of what the FDA needs are Rightfully, so, things have shifted. There's a lot of change, and there is a need to be responsive to those changes and be on top
of what's happening. I think for the next topic that came up and directly related to what I just mentioned, is really operating models. What's going to be the most
optimal way to manage your resources? As you're trying to pivot and shift and be ready to respond to how you will execute clinical trials will be forward very big focus laser focus on streamlining operations, streamlining workflows, finding efficiencies, finding ways to make those processes more automated so that you can focus your resources on tasks that really require concentration around making decisions that will impact speed, delivery, equality,
patient centricity, sites centricity, automation, acceleration of timelines clearly still very very important. You mentioned it earlier. Protocol complexity. You know, how to manage that, how to shift, how to reverse that trend, What ways can we make it less burdensome for sites and patients.
Yeah, and that's been an issue forever. So I'm excited that you know that's going to take central stage.
And I think you know, as we think about innovation in this space, people still want to innovate and still want to focus on that, but there's an ROI attached to that need to be able to you know, at the end of show, results show impact on those key things of accelerating timelines, debating sites, and getting patients the right patients enrolled in your trials. AI agentic AI GENI yes, we all want to use it, or the industry wants to invest and use it, but in places where they
know that it's making a difference. And we're going to have lots of sessions really talking about where it's making a difference. You know, I mentioned a little earlier, a refocus on site centricity, a refocus on how to work with sites to problem solve around those challenges. I think the collaboration angle of that. In fact, we are actually the day before DEFARM having our Site Partnership Summit that will look specifically at LEAs to collaborate and address those challenges. So, yeah,
those are the top issues. The only other piece that's quite clear, it has been in the past couple of years, is still around what does your talent growth development need to look like? What are the roles and responsibilities going to need to have for skill sets moving forward, say two or five years from now. And there's a real focus from leadership around how do we make how do we what's the strategy to that, and then how do we execute on that strategy?
Yeah, and I think that just to building what you were saying, I think that you know, the two questions that come to my mind are you know how leadership is looking at that, especially with AI, and then you know folks that are in the trenches, what do they need to know now to make sure that they are a step ahead. So that's I think really important part of UPDFARM. So tell me about how you know is DEFARM twenty twenty five going to address some of these issues.
Well, we have two days to accomplish all of this. I'm excited about it and there are lots of I think some really innovative sessions that we'll be talking about on our weekly content focused podcasts. Now that every year we kick off d farm with our patient keynote, and you honestly can say that our patient keynote this year is going to probably bring down the house again. Her
name is Victoria Gray. She is the first recipient of Crisper therapeutic for cycle cell disease, and I think she'll do a wonderful job of not only sharing her journey but also giving a call to action for industry. She's a wonderful patient advocate since her treatment and that is very invested in and working alongside industry to have these therapies be more available accessible to patients. And then our keynotes are in direct response to the feedback that we're
received from the advisors. We're very fortunate to have Scott Gottlieb talking specifically about the geopolitical landscape, the impact potentially on R and D, how industry will continue to work with FDA as things continue to shift and priorities are shifted. So that's very exciting, and we're also excited to have
Ken Frasier, former chairman of MERK. I think clearly leadership during times of uncertainty and how to continue an innovative path forward are areas that he can certainly speak to, both from a professional and personal endeavors that he's involved in.
I just love the even those two folks because you know, together on the same program, because I think Scott has such good insight into what's really going on behind the scenes at FDA and can really help answer questions and
clarify number of issues. And I think the beauty of Ken Frasier is he was such an extraordinary CEO at MERK and his leadership on just about everything from leading in a flory of change, how do you pivot and adapt and how do you just keep the science going and keep your teams going and how do you just
tackle the number of complex issues in this industry. So and then of course, you know, as you said, having Victoria is going to be really special and just to give us that insight into you know, what that was like being you know, the first recipient you know, for science that has truly changed her life and the lives of many people. But I know you have somebody else as well speaking that's always fantastic to hear about. So I'll let you touch upon that.
Certainly. Ken Yetz will be joining us on the second day of the conference to really bring to life the data, the data and that's they're collecting now and reporting out on a patient protocol, impact on patient burden and a site burn.
Ken's focus is going to be on protocol complexity data and what changes we can make.
The latest research that they're looking at directly how these how the you know, trial design and protocols within those trials are impacting how patients view the trials and help Burns him that may be and one impact that I can have can make some shifts.
But he's always phenomenal and you know, whenever he speaks, the feedback from the audience is they're just always so pleased because they can walk away with information that they could do something with. So I just love Ken for that.
So fantastic and there's nothing that speaks great. I mean, the data is always so illuminating when he kind of he only made you know, you can point out four or five pieces of data that really can drive a change and behavior in terms of how trials are executed. It's you know, you have a huge GYMP, so very exciting.
Can you tell us about some of the leadership panels that you've been putting together this year?
Yes, we have four. Day one we'll be looking at the need to sort of expand your global footprint for clinical trials, just in response to the shift happening in the geopolitical landscape.
So many companies are looking at working with sites outside the US as well, and so yep, I get it. That's important. So you said you have four, so that's one.
Yes, and then day three is Chuck Bolt. You know, we'll cook off with looking at disrupting you know, how that trend is affecting, what's actually happening, What are the choices that farm responses are making, and why we know in the past as these shifts happen and they change, but I think for now, in response to this type of global environment, it's very important to be thinking about what's optimal for how your organization approaches its strategy manages
its resources to execute those strategies. And then we also have a session looking at protocol complexity. Are the ways to reverse that trend? Ken is actually going to to be on that panel as well.
Oh good, excellent, Yeah.
And the final leadership panel as looking at the future of oncology research. With the crunch in funding issues through NIH and the overwhelming need for research sites for clinical trials and oncology, how do we fill the gap? That will be one of our.
Oh fantastic And you know, when you think about fifty percent of all trials are in oncology, it's pretty pretty major. So so nice, so right, So, just to recap, we've got a good sense of who the keynotes are and the leadership panels are. And then Tracy, you and I are going to continue doing a series of conversations for folks to fill them in on the different sections of defarms so we can properly address and give people insights into what they can expect. At the fifteenth annual conference.
So I just want to say thank you so much for giving us that initial intro and we look forward to bringing more to our listeners here.
Welcome.
So Tracy, before we completely finished, gives us the dates please for Deform.
Yes, we are back in Philadelphia at the Loew's Philadelphia Downtown Hotel on September sixteenth and seventeenth, which is a Tuesday and a Wednesday. The program runs on day two until five o'clock. Encourage people to make their travel plans based on that, because just like last year, the amount of content in the afternoon between two and five pm is phenomenal. Would love to have your participation all the way to the end.
Okay, wonderful. And then I just want to add that on the Monday, we have the as you said earlier, the Partnerships with Sites conference, and we also have the Clinical Research as a Care Option Conference, which is going into its tenth here, and that conference looks at how we can bring patients closer to clinical research and clinical research closer to patients by getting clinical research where the patients are in the care systems and how do we do that and so lot to celebrate there as well.
And then the website for people to get more information is.
Debonalconference dot com. All right, thank you,