Brandy Whalen (00:01.528)

Hello everyone. Today I'm excited to be joined by Paul Kim, a highly respected advisor with over 30 years of experience in DC, shaping FDA and public health policy. Throughout his career, Paul has advised patient advocates, global health science leaders, and emerging companies on navigating complex regulatory landscapes, developing legislative strategies, and securing critical funding. His expertise spans drug and device law,

rare disease innovation, public health, bio-defense, and much more. Paul, welcome to Katalyze. Thank you for joining the conversation today.

Paul Kim (00:40.594)

Thanks, Brandy. This is great. Thank you so much for making time for me.

Brandy Whalen (00:45.27)

Yeah, absolutely. So, you know, we would love to hear a little bit of your background, you know, with over 30 years of experience in DC, advising on FDA policy, public health. Can you share a bit about your career journey and how your work has evolved in shaping the future of drug and device regulation?

Paul Kim (01:03.085)

Absolutely. I will say now I'm in a place where as a solo consultant, I'm able to enjoy this field and interact with clients and issues in a way that is really optimal for me. I spent 20 years at a law firm leading their FDA and government strategies practices, and that was really great experience working with great people.

But it's in an institution, like any institution. And so being a solo practitioner, I just report to myself and I find that to be a real joy.

Brandy Whalen (01:37.166)

I bet I can only imagine.

Paul Kim (01:40.805)

And, you know, before that, as you pointed out, you know, I did work in the Congress on FDA and public health issues for the late Senator Kennedy, for Congressman Henry Waxman, now retired, for Senator David Pryor, late David Pryor of Arkansas, and, you know, managed to work on some really interesting laws and really interesting issues.

things that now looking with 2020 hindsight, you know, are I think almost like indicators or suggestive of the kinds of things that are changing in life science now. We're seeing some remarkable things happening. I know this is what we're talking about today. So it was a great journey. I spent some time at FDA as well for patient advocacy groups in the past and working for BioPharm itself, you know, on the ground in Europe.

But looking back, you just have to pinch yourself. The time goes so quickly. You think that, that was in 2002. And then you realize, my god, that was 20 years ago. So much, yeah, absolutely. And I know that that's one of the topics that we want to talk about today.

Brandy Whalen (02:36.206)

It's hard to believe, isn't it? And a lot has changed.

Brandy Whalen (02:46.732)

Yeah, no, absolutely. Just starting here, emerging life science companies often face regulatory hurdles. From your experience, what are the key challenges those companies encounter when navigating FDA regulations, and how can they better position themselves for success?

Paul Kim (03:06.079)

That's a great question, Brandy. And I think it depends really on where those companies are in their own life cycles. If they're an emerging company, becoming familiar and understanding, truly understanding what say the FDA's requirements are for their field, for their area is very, very difficult, can be. And being able to work with collaborators like principal investigators or...

former regulatory experts who used to work at the agency, patient groups, you know, who bring their own points of view, their own experiences, you know, that is just invaluable and is, I think, a part of the process of product development. But, you know, putting those pieces together can be an extraordinary challenge for any given company. For the more sophisticated, more experienced companies, the, you know, the big pharmas and others, you know, what the

biggest challenge for them may well be is when the requirements change. You have 30 years of experience in a given area, and suddenly the goalposts start to move, whatever. Maybe there's a judicial decision, or there's a change in administration, which increasingly, as you know, can modulate what those legal requirements are, even more so than changes in black letter law. Yeah.

Brandy Whalen (03:59.63)

Right. Yes.

Mm-hmm.

Brandy Whalen (04:18.05)

Hmm?

Paul Kim (04:19.093)

those can be extraordinarily challenging for them. And I think for the, ultimately for the consumers, the people we have to think about and care about and work for from day one, the patients and their families, it frequently feels I think that they are on the outside of a black box of product development.

Brandy Whalen (04:39.616)

Absolutely.

Paul Kim (04:40.919)

Yeah, and finding ways into that process. When you don't have capital, when you don't have that expertise necessarily, you only have the life experience and the knowledge of how that disease burdened you and your family. I think that challenge is a perennial one. And I know that sponsors and regulators, investigators are increasingly more sensitive to the need to account for patient perspectives.

Brandy Whalen (04:55.534)

Mm-hmm.

Paul Kim (05:07.107)

to develop endpoints reflecting patient experience. I think that's changing in for the better. So I think that's where I would end right with that question.

Brandy Whalen (05:14.886)

Yeah, no, I think that that's a really interesting, because that is something that I think gets overlooked often, is bringing that audience into the mix. And where would you recommend, like for a company, to engage with the actual potential patients?

Paul Kim (05:34.455)

Yeah, and you'll find that they've become more sophisticated, right? We now have, you know, people who are tasked with

allied development or patient engagement, know, and they, their titles reflect that their missions and their job descriptions reflect that. think that is great. So it's not allocated to, you know, on one side, medical affairs, you know, where they're just dealing with the protocols and standing up trials or a post-hoc on the commercial side, you're trying to sell drug, right. And trying to get endorsement. And so, so I think that is a maturation, if you will, of product development and a good one.

Brandy Whalen (05:43.618)

Hmm?

Brandy Whalen (06:07.308)

Yeah, absolutely. It's nice to see that focus kind of shifting, especially earlier in the process. know, kind of thinking about public health policy and innovation, which is incredibly integral to innovation and new drugs and devices. How have recent public health initiatives and policies influenced the development of life sciences? And where do you see the biggest areas for improvement?

Paul Kim (06:37.441)

Yeah, boy, Brandy, this is such a timely question. know, we're all of us coming emergent out of this post pandemic experience, right? And everybody knows how to do a nasal swab for a test, right? Everybody knows what the importance of immunization is or discounts that, you know, right? And I think, yes, and everything has to be seen, I think, in a post COVID lens. And one of the things that I think is on

Brandy Whalen (06:39.502)

Yeah, that's, yeah. Yeah.

Brandy Whalen (06:53.056)

Right, right.

Brandy Whalen (06:58.39)

Mm-hmm.

Paul Kim (07:02.137)

upside, the good news, right, is the extraordinary success of the mRNA vaccines. You know, I think before 2020, I would have said it'll take 18 months to stand up a vaccine that's responsive to an emergency strain that threatens global health, right? And we did it in half that time. I mean, it's extraordinary story, right?

Brandy Whalen (07:21.506)

Yeah. Hmm?

Paul Kim (07:24.853)

know, Nobel-worthy news and science. But, you the downside was the public health response. And as you noted, you know, just how the communities responded. think the failures and the successes of public health authorities to communicate effectively with the public, you know, we've learned a lot, but, you know, I think if we come out to a second strain, another challenge, you know, comparable to COVID-19.

Will we do as well? I think we might do worse, I think, in many ways in terms of emerging with a communal response that is actually geared to the most effective public health response. I think there are more people who are going to sit out. We're going to have a harder time working through the misinformation.

Brandy Whalen (08:02.339)

Yeah.

Paul Kim (08:11.233)

We have multiple channels of authority or quote unquote authority. You know, those things are going to be extraordinarily challenging and you have to hope that the next virus, the next pathogen is not more lethal. know, and it sounds like doom and gloom, I know, but you know, that's I think the takeaway from your very, very good question. Those are the takeaways I get, like what's going to happen next and how we're going to respond.

Brandy Whalen (08:25.688)

rights.

Brandy Whalen (08:37.824)

Yeah, it was really interesting, right? The public response to the vaccine and just what the, you know, what is the responsibility of public health agencies and, you know, what do you think was the huge misstep, I guess, in that?

Paul Kim (08:58.615)

You know, it's a great question. You know, we think about swine flu, you know, from the 70s as the federal missteps. You know, we just, we dropped the ball, you know, we ended up not to use any sportsmen force, but we ended up, on the 10th yard line behind. And, you know, here, you know, we had this modern miracle of this effective vaccine and, you know, that we had such skepticism about its deployment.

And we had so many questions. I think that what blunted the effect of deploying a vaccine, something commensurate with the experience that we had with polio or smallpox, for example, right? Where neighborhoods would line up for the soft vaccine. Why didn't that happen? Which, Brian, I think you again put your finger right on the right question, really the most important question. I think the masking, the isolation, the public health interventions really

generated such skepticism and concern like, do we really need to isolate at our homes? Probably not. I think a lot of that was probably not timed well or gradiated well, metric well. Whereas the vaccine was sort of like a one stop shop solution, go get your shots. And I think we have to think about how we try to deploy all those countermeasures, all those

interventions simultaneously, you what was most important? Probably getting in people's arms. I mean, and granted that came after the isolation and so forth. So, you know, I hate to do this Monday morning quarterbacking, but, but I think you put your finger right on like, well, geez, you know, what was it that didn't make this miracle feel and look like a miracle to everybody?

Brandy Whalen (10:44.31)

Yeah. You know, and I think about just kind of going back to something that you said, just pivoting this conversation a bit, but it was really incredible how fast this was able to come to market. mean, obviously some of the challenges was supply, distribution. So as we kind of move along in this conversation, thinking about that aspect and kind of pivoting to the future, like

Paul Kim (11:03.981)

Yes, absolutely.

Brandy Whalen (11:14.602)

not to be again doomsday, but you know, it's likely that this is going to happen again. And how do you see technology innovation? Like what we're seeing with companies like Katalyze, it seems to me like things will be able to move faster on at least that side of things. Like walk me through your perception of this.

Paul Kim (11:17.069)

Mm-hmm.

Paul Kim (11:20.685)

Yes, yes.

Paul Kim (11:38.945)

Yeah, I think that's exactly right. part of the problem that we have now is, you know, we need to preemptively socialize. We need to be engaging in conversation with skeptical people, people who are naysayers, as well as people who are open, receptive to uses of these kinds of technologies. Explain why they're being used. Explain how they can make an improvement in your lives. You know, really bring it home.

You know, having worked on the Hill, my bosses used to always talk about the critical importance of getting back to constituent within the same day. Like they would not have it if you were like letting that lie that that stuff doesn't belong at the bottom of the pile. It belongs at the top of the pile. And I think for innovators, the challenge is, you need to make that part of your day job, not only part of your day job, but top of your top of your pile. You know, that's incredibly challenging now as we talked about.

But I can't see any way to avoid that. If you want to avoid somebody basically saying, no, I'm going to close the door to this, or this is not part of my solution set, or this is not important to my family. When you get that reaction, working your way back out of it or digging yourself out of that, I don't see how you can do that. Once people have made up their minds about things, I think it's very hard to turn them around.

Brandy Whalen (12:52.534)

Yeah, absolutely. And I mean, I guess this kind of like carries into the into the manufacturing innovation sector, right, where you start to bring in some of these new technologies to improve your processes, you know, with with the rise of AI and health care. Like, how do you see AI transforming regulatory science, particularly in drug approval process and device regulation?

Paul Kim (13:17.689)

It's a great question. If we take today as a benchmark, I think the latest numbers coming out of the FDA, for example, is I think we've gotten maybe 300 or 400 drug or biological product submissions with AI.

And for devices, know, I think that's 700, 800, know, closer to a thousand. So, you know, as we all feel like it, we are really literally just at the crest of this wave is just beginning to hit. And, you know, there's no question, I think that the agency itself in isolation completely lacks the capacity.

Brandy Whalen (13:43.852)

Yes.

Paul Kim (13:52.985)

to address this, right? And we hear Dr. Kauff, the current commissioner, talk about the need for partnership, right? Finding ways to validate through the use of health systems and being equivocal, not being conclusive in understanding whether something works well or works as described or as intended. And I think that gets to a really fundamental question of when the FDA clears or approves a product.

For AI, for drugs, for everything else under the sun, for regulated product, it's pretty categorical. The thing has gotten a seal of approval. But to your question for AI, I think not just because we're talking about maybe black boxes or generative models, which you need to have special expertise to really interrogate, I think inherently we're looking at products that are now reaching marketplace for use by health system providers, patients, consumers, that are inherently experimental.

Brandy Whalen (14:25.71)

Right.

Brandy Whalen (14:47.118)

Mm-hmm.

Paul Kim (14:47.411)

because of the sheer novelty, as you said, of the underlying technology. And so that requires, to get back to our earlier conversation, a level of trust and engagement that may well be unprecedented, right? You know, we used to be in a very paternalistic medical culture and increasingly self-empowered and consumer and patient empowered. But at the same time, these tools are now coming into play where not even the FDA, I think, could say with conclusive confidence, it's 100%.

Brandy Whalen (14:59.725)

Yeah.

Paul Kim (15:16.439)

Right? know, it's more than nothing. You know, that's a fundamental pivot. I think that's a fundamental change, not just in terms of the agency's inability to do it by themselves. With it, they do a drug review essentially by themselves. But now they're relying on community assets and knowledge and expertise, community experience. I think they need to start recasting how they talk about products.

Brandy Whalen (15:17.516)

Right? Yeah.

Paul Kim (15:39.297)

And I'm not even sure they can do that under the law. I mean, I think the way the law is written, I think Dr. Califf has said this, former commissioner Gottlieb, Scott Gottlieb has said this, the law is cast to address 20th century technologies. We may need to revisit that.

Brandy Whalen (15:52.59)

All

Yeah, yeah. So I guess, know, kind of even just thinking about the efficiency, right, in this process, because I think anyone who works in the industry understands how long it takes to get through the approval process, the many setbacks. honestly, just the, as you mentioned earlier in this conversation, the group of experts that you

have to enlist in order to make sure that everything runs smoothly. So do you see some opportunities here for AI to maybe improve efficiency in this process?

Paul Kim (16:38.231)

Yeah, I think there is, you know, and I'm worried about actually of all things, and maybe we're just too close to last Tuesday. But you know, what we see now is a wave that is going to inevitably mean more deregulatory approaches to the field. And right?

Brandy Whalen (16:54.168)

Right. Yes. Yes. Yeah.

Paul Kim (16:55.321)

And maybe that's good, right? Yeah. I mean, I don't think the agency was sort of in an aggressive regulatory posture, right? They weren't like saying, you know, we've got to put our stamp on everything. Whoa, whoa, whoa, slow down. You know, I think they were about engagement, reliance on stakeholders and partners, right? But I do think that a company that sort of deregulatory mindset, Brandi, is going to be, I think, real skepticism towards resourcing the agency, right? It's going to be less about big government. So they don't want government to get any bigger.

If that pushes down the agency's ability to hire, to contract for, to even show up, I'm thinking about travel budgets, to show up to meetings, to talk to people in the field, that'll be bad. And so I think folks in the field, this is paradoxical in a way, but.

Brandy Whalen (17:34.772)

Right? Yes, yes.

Brandy Whalen (17:41.006)

Right.

Paul Kim (17:47.417)

you know, we should probably be pushing for fully funding the FDA's travel budgets, right? Their ability to engage in these inherently collaborative regulatory postures. I don't think they're gonna move away from that. I think they understand the, they're never, they're not gonna get, think Dr. Cail said, we're not gonna hire 10,000 more doctors. Right? Yeah, yeah. So, you know, what is it, what's in our best interest? Possibly just making sure that the FDA doesn't lose 15, 20 % of

Brandy Whalen (18:06.21)

Right. Yeah. This is like not going to happen. Yeah.

Paul Kim (18:17.315)

budget. Because if they do, guarantee you they're just going to turn like a turtle. And a turtle can't hear or see anything inside its shell. I think in the short term, that might be a priority.

Brandy Whalen (18:30.006)

Yeah, no, absolutely. mean, I definitely see that. perhaps even just like using, it's hard because these agencies, it's like you said, like a lot has stayed the same. But being able to even just embrace AI as maybe even a collaborative tool for them to be able to get through some of these barriers that currently exist and perhaps might

Paul Kim (18:50.638)

Mm-hmm.

Brandy Whalen (18:59.138)

become even more so a barrier. That could be a place where it's like a little baby steps into entering into this new generation of innovation.

Paul Kim (19:13.113)

Absolutely, I think that's exactly right, Brandy. And I think that in a sense, it's a go slow, but it's also a need to sort of move very quickly on problems or issues we already know we have. mean, one thing is like, right, the technology is such that it's possible to do things that were beyond human capacity. we do, they, AIs and these systems and models can do things that we can't actually, not just things that we can do it faster or maybe more efficiently, it can do things that we can't do. And so, you know,

Brandy Whalen (19:40.451)

Right.

Paul Kim (19:41.643)

It's not about reading a scan and detecting a cancer that a radiologist could detect. This is about other capabilities. So with that as a set of challenges, we already know about bias, the problems with the diversity of data sets in which they've been educated and trained. I think those issues are ones that inescapably have to be addressed early, because I think about the way that regulation changes. Regulation is this.

usually been predicated on disasters, right? Thalidomide, elixir of self-amidamide in the drug space, know, breast implants, medical device amendments of 76, you know, with, so there are always these products that, you know, run right into the wall at human cost. And we need to avoid that for these emergent tools and technologies. How do we do that? You know, I think it's about enabling these partnerships and conversations and, you know,

Brandy Whalen (20:12.312)

Right.

Brandy Whalen (20:28.43)

Hmm?

Paul Kim (20:38.037)

driving consensus as quickly as possible and aggressively as possible because we are setting standards globally. I mean, I think what we do matters globally. Yeah. So, you know, that is, I think, a problem to sustain if we are in a deregulatory world now, at least in the foreseeable future. You know, one that wants to see government smaller. And I think we just need to be understanding that the FDA gets the joke, at least from what I'm hearing, right?

Brandy Whalen (20:44.44)

Yes. Yeah.

Brandy Whalen (21:04.738)

Yeah, yeah, yeah, absolutely. Yeah, no, yes. I mean, I think you are, you are absolutely spot on, you know, and kind of thinking about like transitioning to kind of more like life science, rare disease, all these spaces, right? Especially in rare diseases. Because there really is, I think with all this information, all this data,

Paul Kim (21:07.235)

We need to start that. Yeah.

Brandy Whalen (21:33.25)

There's a real opportunity. I mean, you've spent a lot of time in this space. There's a real opportunity to start making a significant impact in rare disease that hasn't previously existed.

Paul Kim (21:43.309)

Yes.

Paul Kim (21:47.202)

Yes.

Exactly right, Brandon. And I think we can catalog the different ways, whether it's identifying and repurposing the models and molecules that have been previously tested in humans. Dr. Wegenbaum's project, which got ARPA-H funding, extremely exciting. The fact that the FDA is standing up this rare disease innovation hub to engage in these conversations, I think that's exactly just right. And again, thinking about the deregulatory environment and maybe the, that's going to slow things down or hinder things, I think, unfortunately.

Unfortunately, because as you said, these opportunities are just waiting for us to address. I think we've identified 9,000, 7,000 rare diseases. Clearly there are more.

and they're just waiting to be identified using these kinds of tools. And once you do that, can we modulate existing platform technologies, ASOs and other promising technologies for very rare and end of one diseases? Yeah, I think we can. We can treat it out. And so I think the regulatory tools are there. And I think the willingness is there. part of this, I think, is making this a priority.

And when I say making a priority branding, actually, it's not just about getting people to agree that there's a problem and that there's a solution set that can be brought to bear. It's really making sure you're not cut 15 % in appropriations.

Brandy Whalen (23:09.548)

Right, right. Yes, that it still has a place in the budget. Yeah, yes.

Paul Kim (23:13.783)

Yes, exactly. Very retail level. Yeah, exactly.

Brandy Whalen (23:17.398)

Yeah. And, know, Kenny, even just thinking about sticking on this rare disease topic, you talk, I can't remember what was the number again of the currently, as we know, of the number of rare diseases.

Paul Kim (23:29.209)

Yeah, 300 drugs and biologics for the AI, some component of AI, yeah, yeah.

Brandy Whalen (23:34.894)

But, you know, I'm thinking about drug personalization, right? Because all of these rare diseases, you know, it feels like we kind of treat them with what's already existing. It's almost just like a Frankenstein approach almost to treatment because there really isn't something that's, you know, it's hard to invest money into something that's like maybe affecting like

Paul Kim (23:39.277)

Yes.

Paul Kim (23:44.981)

Mm-hmm. Yeah.

Paul Kim (23:51.607)

Yes, exactly.

Brandy Whalen (24:05.23)

20 people or, you know, the small number of human beings. But with technology, perhaps there is a space where we start to see more of this personalization, which is truly what it's going to take to address some of these rare diseases.

Paul Kim (24:06.937)

Exactly. Yeah, yeah. Exactly.

Paul Kim (24:21.337)

100%, yeah, 100 % brandy. And I think there is the perceived understanding that there's no one to step in really to resource something like that. You have the clinicians treating patients, the patients at these centers of excellence, and then you have potentially applicable drug candidates or platform technologies that could be applied, but then.

How do you pay for that? Certainly the health plan won't, right? Because it's inherently experimental, right? It's not commercially viable even under the Orphan Drug Act because it's for one, five patients, 10 patients, and nobody builds a commercial drug out of that. So yeah, I think you're right. Those are challenges that need to be answered. And there are great organizations like Nord with whom I work.

Brandy Whalen (25:00.301)

Right.

Paul Kim (25:09.343)

of the Ann Lorne Foundation, others who see this as their mission, but you need to find the audience, right? And as we talked about the retail politics, who will pay for that? How can we get that secure, that resource commitment to answer those patients' needs? Yeah, I think it's still a puzzle that hasn't been solved yet.

Brandy Whalen (25:26.75)

Yeah. And I think there is maybe even an opportunity for private sector, right? If there is like leveraging AI, generative AI, using these complex data models to be able to pivot quickly and make kind of carve that out as your niche, know, versus like what we're at currently where inherently it just doesn't make sense for a drug company to invest.

in that, but if it were to be kind of more of a focus, mean, obviously there is a need and to be able to kind of pivot that need quickly is important and might fall back into the hands of the private sector.

Paul Kim (26:06.393)

Mm-hmm.

Paul Kim (26:11.545)

Absolutely, and you know, we talked about this as being this field being just explosive and the applications and the creativity everything is inherently experimental, you know, you're right, you Can you get a VCs attention? I don't know like unless I can show them, you know, it's it's got a population of you know, 20,000 patients are well, know, they're well insured, know, it's a first world issue Yeah, it's it's a real struggle. Absolutely

Brandy Whalen (26:35.011)

Right?

It is, it is 100%. You know, just kind of thinking here.

to kind of the AI analytics conversation and just kind of taking your lens in this space of like where, what would be an optimal use case, I guess, for all these technologies and whether it be private sector, government, like where is this happy utopia?

Paul Kim (27:02.766)

Yeah.

Paul Kim (27:09.753)

I won't say single pair.

Brandy Whalen (27:13.548)

You get to, yes, you get to paint the future,

Paul Kim (27:20.333)

Yeah, I will say something which might be a little bit controversial, think, which is, look, the FDA is in a place now where it is about half funded with user fees, paid out of pocket by sponsors to support the product reviews. So medical devices, biologics and drugs, and other sectors.

And the risk, I remember in the early 90s when this first was done, the PEDUFA, the Prescription Drug User Fee Act of 92. So that shows you how old I am. But I do remember that one of the perennial concerns was that you start paying for stuff out of sponsors' pockets, you capture the agency, right? You can't trust the agency to do other than interest fees bidding because they're being paid for, their work is being paid for.

Brandy Whalen (27:53.518)

you

Paul Kim (28:06.571)

And thank goodness that has not been the case. I mean, you can point to any number of indicia you want, but we not only have sustained and increased innovation, but we also see rigor. We see real agency hardball calling shots, sometimes not in patient interest, but because this statute tells them to look at the data a certain way. And they call those shots and we've seen companies disappear, right? Because they got the...

the no from FDA. So when we look at this emerging field of AI applied across life sciences, across life science innovation, and the agency not being able to say authoritatively that they have the answer, I think that utopia, Brandy, might look like something that is emerging right now, which is multilateral engagement, standard setting,

trust and verify, transparency of data, skepticism about outcomes and claims, CIOs being way, well, I'm not sure that's the right approach. And I think the federal government being seen as a partner, not as an answer and not as the problem, but as a partner.

in working towards the right processes are, right? What the standards should be. This is still de novo, literally de novo for everybody. And I think, like you'd said, again, getting back to the retail politics of this, it requires sustained resourcing and a commitment. And that commitment could be part of like lawmaking. So Congress may have a role, unfortunately, to play in this, of setting out what the agency should be doing differently.

Brandy Whalen (29:44.024)

Yeah.

Paul Kim (29:53.145)

And I think those public private partnerships are inevitably going to be part of that fabric to ensure that when AI hits the field.

It doesn't come crashing down in a fluidomide sort of way. And I know that's a doomsaying way of saying it, but we want to instill confidence in how this is applied. We want to have understanding and comprehension. And to get back to COVID again, if you don't have them buying in at that fundamental level, they will always look askance at how we're using the technology. And we cannot afford that. And this goes back, in a sense, to the 70s and recombinant DNA. And one of the one things that happened was the Asulomar conference, where the

Brandy Whalen (30:06.754)

you

Paul Kim (30:31.373)

the scientists themselves said, well, we're gonna take it slow and be transparent and we're gonna be accountable. And I think from the commercial side, the developers, we need to be willing to make that kind of commitment as well. It's not gonna be the Wild West. We're not gonna be disruptive for the sake of disruption. No, no, we're gonna be social actors, partners in this. So it may not involve chaining ourselves.

But it may involve signing on to agreements, concordances, That kind of multilateral assurance that nobody's going to stick somebody else in the eye when the other one's not looking. I just want to play here.

Brandy Whalen (31:01.49)

Mm-hmm.

Brandy Whalen (31:09.772)

Yeah, no, no, but it's so true. mean, it's something that you said a couple of times was transparency. And I do think that that is one of the more beautiful things that can come up this right across the board, because we all know that transparency breeds trust.

Paul Kim (31:25.657)

Yes, yes, yeah. And that includes, I think, know, exposing yourself to a level of accountability that isn't required under SEC, you know, right? Or, you know, under commercial law. No, no, this is about really building those foundation blocks for the field. And sometimes that may require some discomfort.

Brandy Whalen (31:27.842)

the more information you have.

Brandy Whalen (31:48.098)

Yeah, absolutely. Yeah, yeah. And just being inherently ready for that and doing the right thing, right? Everyone's not because you have to, but because you know it's for the greater good.

Paul Kim (31:57.091)

Right, right.

Paul Kim (32:04.654)

Well said.

Brandy Whalen (32:06.232)

Paul, this has been an absolute pleasure and fascinating conversation. I feel like we could probably carry this on for another hour. I'm wondering if you could just, as we kind of wrap this conversation, knowing that this field is changing and changing rapidly and technology really fueling that change.

Paul Kim (32:11.043)

That's true.

Brandy Whalen (32:35.926)

and this need to kind of come together, not only as private, but also government agencies. Could you leave us just with kind of maybe three pieces of advice to our listeners of how we can best kind of move forward in this age?

Paul Kim (32:56.663)

Yeah, I will go back Brandy to the lessons I learned from my bosses. I think about what a Henry Waxman or a Ted Kennedy would say about what comes next for the field. And the first thing that they always did to accomplish their lawmaking was, and I think this is true also for what we're talking about, which is appropriate regulation.

for the field, for AI and life sciences. I think one is like, there is no partisanship here. That there are commonly held goals and that we do need to reach across the aisle and in this case across sectors to recognize that, to validate that, to acknowledge the good intentions of other actors and then to work towards understanding how to meet what they need as well as what you want. That...

spirit of collaboration, you know, in their case it was bipartisanship, in our case it would be multi-sectoral cooperation, collaboration, has to be sort of a mutually understood and acknowledged foundation for what comes next. And then I think that the rest of it honestly is process, right? It's about sharing your knowledge, arguing your case, You know, everything else comes from that, but without it,

you know, without that sort of, yes, I understand what you're trying to do. I see the value what you're trying to bring to the market and to patients. But, you know, here's what I'm saying, you know, that conversation, you know, right? How do you, how do you convene that? How do you have that? How do you make sure everybody is involved who needs to be involved? Yeah, that's a, that's a difficult, you know, I don't know if that's an AI czar, you know, you know, you know, that's a level of detail I'm not sure about, but.

Brandy Whalen (34:29.356)

Yeah.

Paul Kim (34:48.151)

I think this kind of conversation, this kind of socialization is wonderful, Brandy. I think you're doing a public service, right? Because, you know, we add to these voices, maybe something like this will happen.

Brandy Whalen (34:58.358)

Yeah, absolutely. No, that was a, that was fantastic. Thank you for leaving us with that. That was, that was beautifully said. So we need collaboration amongst all players, sectors, and you know, I guess preparing for the future. It's fantastic. Paul, thank you so much for, for joining Katalyze today and I look forward to talking to you again.

Paul Kim (35:26.953)

anytime Brandy, it was a delight.

Brandy Whalen (35:29.272)

Thank you.