Speaker 1: Hi, Tracy, thank you so much for joining me, and
Speaker 1: I just hello to folks that are watching our conversation
Speaker 1: about the fifteenth annual DEFARM Conference and for those of
Speaker 1: you who are new to DEFARM, DEFARM is a conference
Speaker 1: that we launched fifteen years ago thanks to Pfizer and
Speaker 1: Johnson and Johnson who approached us to say we need
Speaker 1: a conference very specific to clinical trial operation executives that
Speaker 1: really challenges how we do clinical trials and to work
Speaker 1: towards modernizing them, to work towards being far more patient
Speaker 1: centric and reporting on innovation that we'll truly modernize clinical trials.
Speaker 1: And so originally the concept was around disruption and how
Speaker 1: do we disrupt the way we do clinical trials and
Speaker 1: the idea of let's really rethink the way we're doing
Speaker 1: trials because we're only just getting more complex and more expensive,
Speaker 1: and so you know, we all know that this this
Speaker 1: is the background of what everybody's working in. I think
Speaker 1: the beauty of DEFARM is, you know, Tracy, I know
Speaker 1: you put together sixty five advisors, which is extraordinary for
Speaker 1: any conference, but that we have this wonderful group of
Speaker 1: very dedicated clinical trial operation leaders among academics and FDA
Speaker 1: and patient Advocacy, among others. Some of these incredible tech
Speaker 1: companies and service companies that guide our programs. So welcome,
Speaker 1: and I really wanted to hear from you as we
Speaker 1: launch our first in a series of conversations around defarm,
Speaker 1: because it has so many parts to it so that
Speaker 1: people can customize and really get what they specifically need.
Speaker 2: I wanted to.
Speaker 1: Hear about the research and what industry leaders are talking
Speaker 1: to you about that's really challenging right now that we'll
Speaker 1: be addressed at the conference.
Speaker 2: So let me let you shook you away. Good morning. Yes.
Speaker 2: I think first and foremost on everyone's mind, especially when
Speaker 2: we started our research, was how the geopolitical landscape was
Speaker 2: going to impact R and D and specifically clinical trial operations.
Speaker 2: The ability to connect with the FDA and be aware
Speaker 2: of what the FDA needs are Rightfully, so, things have shifted.
Speaker 2: There's a lot of change, and there is a need
Speaker 2: to be responsive to those changes and be on top
Speaker 2: of what's happening. I think for the next topic that
Speaker 2: came up and directly related to what I just mentioned,
Speaker 2: is really operating models. What's going to be the most
Speaker 2: optimal way to manage your resources? As you're trying to
Speaker 2: pivot and shift and be ready to respond to how
Speaker 2: you will execute clinical trials will be forward very big
Speaker 2: focus laser focus on streamlining operations, streamlining workflows, finding efficiencies,
Speaker 2: finding ways to make those processes more automated so that
Speaker 2: you can focus your resources on tasks that really require
Speaker 2: concentration around making decisions that will impact speed, delivery, equality,
Speaker 2: patient centricity, sites centricity, automation, acceleration of timelines clearly still
Speaker 2: very very important. You mentioned it earlier. Protocol complexity. You know,
Speaker 2: how to manage that, how to shift, how to reverse
Speaker 2: that trend, What ways can we make it less burdensome
Speaker 2: for sites and patients.
Speaker 1: Yeah, and that's been an issue forever. So I'm excited
Speaker 1: that you know that's going to take central stage.
Speaker 2: And I think you know, as we think about innovation
Speaker 2: in this space, people still want to innovate and still
Speaker 2: want to focus on that, but there's an ROI attached
Speaker 2: to that need to be able to you know, at
Speaker 2: the end of show, results show impact on those key
Speaker 2: things of accelerating timelines, debating sites, and getting patients the
Speaker 2: right patients enrolled in your trials. AI agentic AI GENI yes,
Speaker 2: we all want to use it, or the industry wants
Speaker 2: to invest and use it, but in places where they
Speaker 2: know that it's making a difference. And we're going to
Speaker 2: have lots of sessions really talking about where it's making
Speaker 2: a difference. You know, I mentioned a little earlier, a
Speaker 2: refocus on site centricity, a refocus on how to work
Speaker 2: with sites to problem solve around those challenges. I think
Speaker 2: the collaboration angle of that. In fact, we are actually
Speaker 2: the day before DEFARM having our Site Partnership Summit that
Speaker 2: will look specifically at LEAs to collaborate and address those challenges. So, yeah,
Speaker 2: those are the top issues. The only other piece that's
Speaker 2: quite clear, it has been in the past couple of years,
Speaker 2: is still around what does your talent growth development need
Speaker 2: to look like? What are the roles and responsibilities going
Speaker 2: to need to have for skill sets moving forward, say
Speaker 2: two or five years from now. And there's a real
Speaker 2: focus from leadership around how do we make how do
Speaker 2: we what's the strategy to that, and then how do
Speaker 2: we execute on that strategy?
Speaker 1: Yeah, and I think that just to building what you
Speaker 1: were saying, I think that you know, the two questions
Speaker 1: that come to my mind are you know how leadership
Speaker 1: is looking at that, especially with AI, and then you
Speaker 1: know folks that are in the trenches, what do they
Speaker 1: need to know now to make sure that they are
Speaker 1: a step ahead. So that's I think really important part
Speaker 1: of UPDFARM. So tell me about how you know is
Speaker 1: DEFARM twenty twenty five going to address some of these issues.
Speaker 2: Well, we have two days to accomplish all of this.
Speaker 2: I'm excited about it and there are lots of I
Speaker 2: think some really innovative sessions that we'll be talking about
Speaker 2: on our weekly content focused podcasts. Now that every year
Speaker 2: we kick off d farm with our patient keynote, and
Speaker 2: you honestly can say that our patient keynote this year
Speaker 2: is going to probably bring down the house again. Her
Speaker 2: name is Victoria Gray. She is the first recipient of
Speaker 2: Crisper therapeutic for cycle cell disease, and I think she'll
Speaker 2: do a wonderful job of not only sharing her journey
Speaker 2: but also giving a call to action for industry. She's
Speaker 2: a wonderful patient advocate since her treatment and that is
Speaker 2: very invested in and working alongside industry to have these
Speaker 2: therapies be more available accessible to patients. And then our
Speaker 2: keynotes are in direct response to the feedback that we're
Speaker 2: received from the advisors. We're very fortunate to have Scott
Speaker 2: Gottlieb talking specifically about the geopolitical landscape, the impact potentially
Speaker 2: on R and D, how industry will continue to work
Speaker 2: with FDA as things continue to shift and priorities are shifted.
Speaker 2: So that's very exciting, and we're also excited to have
Speaker 2: Ken Frasier, former chairman of MERK. I think clearly leadership
Speaker 2: during times of uncertainty and how to continue an innovative
Speaker 2: path forward are areas that he can certainly speak to,
Speaker 2: both from a professional and personal endeavors that he's involved in.
Speaker 1: I just love the even those two folks because you know,
Speaker 1: together on the same program, because I think Scott has
Speaker 1: such good insight into what's really going on behind the
Speaker 1: scenes at FDA and can really help answer questions and
Speaker 1: clarify number of issues. And I think the beauty of
Speaker 1: Ken Frasier is he was such an extraordinary CEO at
Speaker 1: MERK and his leadership on just about everything from leading
Speaker 1: in a flory of change, how do you pivot and
Speaker 1: adapt and how do you just keep the science going
Speaker 1: and keep your teams going and how do you just
Speaker 1: tackle the number of complex issues in this industry. So
Speaker 1: and then of course, you know, as you said, having
Speaker 1: Victoria is going to be really special and just to
Speaker 1: give us that insight into you know, what that was
Speaker 1: like being you know, the first recipient you know, for
Speaker 1: science that has truly changed her life and the lives
Speaker 1: of many people. But I know you have somebody else
Speaker 1: as well speaking that's always fantastic to hear about. So
Speaker 1: I'll let you touch upon that.
Speaker 2: Certainly. Ken Yetz will be joining us on the second
Speaker 2: day of the conference to really bring to life the data,
Speaker 2: the data and that's they're collecting now and reporting out
Speaker 2: on a patient protocol, impact on patient burden and a
Speaker 2: site burn.
Speaker 1: Ken's focus is going to be on protocol complexity data
Speaker 1: and what changes we can make.
Speaker 2: The latest research that they're looking at directly how these
Speaker 2: how the you know, trial design and protocols within those
Speaker 2: trials are impacting how patients view the trials and help
Speaker 2: Burns him that may be and one impact that I
Speaker 2: can have can make some shifts.
Speaker 1: But he's always phenomenal and you know, whenever he speaks,
Speaker 1: the feedback from the audience is they're just always so
Speaker 1: pleased because they can walk away with information that they
Speaker 1: could do something with. So I just love Ken for that.
Speaker 2: So fantastic and there's nothing that speaks great. I mean,
Speaker 2: the data is always so illuminating when he kind of
Speaker 2: he only made you know, you can point out four
Speaker 2: or five pieces of data that really can drive a
Speaker 2: change and behavior in terms of how trials are executed.
Speaker 2: It's you know, you have a huge GYMP, so very exciting.
Speaker 1: Can you tell us about some of the leadership panels
Speaker 1: that you've been putting together this year?
Speaker 2: Yes, we have four. Day one we'll be looking at
Speaker 2: the need to sort of expand your global footprint for
Speaker 2: clinical trials, just in response to the shift happening in
Speaker 2: the geopolitical landscape.
Speaker 1: So many companies are looking at working with sites outside
Speaker 1: the US as well, and so yep, I get it.
Speaker 1: That's important. So you said you have four, so that's one.
Speaker 2: Yes, and then day three is Chuck Bolt. You know,
Speaker 2: we'll cook off with looking at disrupting you know, how
Speaker 2: that trend is affecting, what's actually happening, What are the
Speaker 2: choices that farm responses are making, and why we know
Speaker 2: in the past as these shifts happen and they change,
Speaker 2: but I think for now, in response to this type
Speaker 2: of global environment, it's very important to be thinking about
Speaker 2: what's optimal for how your organization approaches its strategy manages
Speaker 2: its resources to execute those strategies. And then we also
Speaker 2: have a session looking at protocol complexity. Are the ways
Speaker 2: to reverse that trend? Ken is actually going to to
Speaker 2: be on that panel as well.
Speaker 1: Oh good, excellent, Yeah.
Speaker 2: And the final leadership panel as looking at the future
Speaker 2: of oncology research. With the crunch in funding issues through
Speaker 2: NIH and the overwhelming need for research sites for clinical
Speaker 2: trials and oncology, how do we fill the gap? That
Speaker 2: will be one of our.
Speaker 1: Oh fantastic And you know, when you think about fifty
Speaker 1: percent of all trials are in oncology, it's pretty pretty major.
Speaker 1: So so nice, so right, So, just to recap, we've
Speaker 1: got a good sense of who the keynotes are and
Speaker 1: the leadership panels are. And then Tracy, you and I
Speaker 1: are going to continue doing a series of conversations for
Speaker 1: folks to fill them in on the different sections of
Speaker 1: defarms so we can properly address and give people insights
Speaker 1: into what they can expect. At the fifteenth annual conference.
Speaker 1: So I just want to say thank you so much
Speaker 1: for giving us that initial intro and we look forward
Speaker 1: to bringing more to our listeners here.
Speaker 2: Welcome.
Speaker 1: So Tracy, before we completely finished, gives us the dates
Speaker 1: please for Deform.
Speaker 2: Yes, we are back in Philadelphia at the Loew's Philadelphia
Speaker 2: Downtown Hotel on September sixteenth and seventeenth, which is a
Speaker 2: Tuesday and a Wednesday. The program runs on day two
Speaker 2: until five o'clock. Encourage people to make their travel plans
Speaker 2: based on that, because just like last year, the amount
Speaker 2: of content in the afternoon between two and five pm
Speaker 2: is phenomenal. Would love to have your participation all the
Speaker 2: way to the end.
Speaker 1: Okay, wonderful. And then I just want to add that
Speaker 1: on the Monday, we have the as you said earlier,
Speaker 1: the Partnerships with Sites conference, and we also have the
Speaker 1: Clinical Research as a Care Option Conference, which is going
Speaker 1: into its tenth here, and that conference looks at how
Speaker 1: we can bring patients closer to clinical research and clinical
Speaker 1: research closer to patients by getting clinical research where the
Speaker 1: patients are in the care systems and how do we
Speaker 1: do that and so lot to celebrate there as well.
Speaker 1: And then the website for people to get more information is.
Speaker 2: Debonalconference dot com. All right, thank you,