Mickey (00:01)
Good afternoon, ladies and gentlemen. My name is Mickey. I am your host of the Beyond Page One podcast where we dive deep into the entrepreneurship of leading experts in their fields. Today’s guest is Kimberly and I’m so excited to have her. She’s a seasoned professional who brings the unique blend of biotech research and legal expertise to her work. Over 16 years of experience in the biotech industry. She’s contributed to groundbreaking projects like the Human Genome Project and has worked with government agencies and biotech companies.
She’s a trusted legal advisor. She does it all. Super excited to have her here. Kimberly, welcome to the podcast. Obviously it’s fantastic to have you here. To kick things off, can you share a little bit about your journey from working from biotech to becoming a senior consultant and what sparked your interest in blending science and law?
Kimberly Chew (00:49)
Well, first of all, thank you so much for having me on your podcast, Mickey I’m really glad we could make this happen. And yeah, I’ve had basically two careers. I’ve been very lucky. I started my career as a bench scientist way back in the day and just really wanted to discover something new and contribute things, you know, to basically the great walls of knowledge. And so I really had a passion for discovery.
So I worked on several biotech startups and was just really deeply involved in research on the research side. But over time, I really found myself just more increasingly involved with the legal teams as a scientist. And so that was more working with the patent attorneys and just thinking of a broad picture about what constitutes a patentable idea. And this shift sort of encouraged me
to think beyond what I was doing on the bench, which was optimizing assays and really considered the broader implications and understanding drug development and basically the pharma ecosystem. So my curiosity about scientific innovations to reach the world is where my interest was leading and I really wanted to.
you know, go more towards a broader scope and perspective and application of my talents. So it really led me initially to product liability litigation, where I witnessed, you know, how breakthroughs back in the day could later be scrutinized for, you know, and cause potential harm or be seen to be causing potential harm. And this experience has, you know, been pretty invaluable in my current role in advising in emerging technologies or people in the emerging spaces.
about how to mitigate your risk and best practices to manage your liability in these kinds of new areas.
Mickey (02:51)
Very cool. You’ve been involved in groundbreaking initiatives such as the Human Genome Project. How did your role in that project kind of shape your approach to both the law and the biotech side? know, yeah.
Kimberly Chew (03:05)
That’s an interesting question. Yeah, I always tell people that, yeah, I was part of the Human Genome Project. And that just is an indication of how old I am because it was so, I was quite young when it happened and when I joined the Genome Project. And so it brings back a lot of nostalgia. And it was just basically my first big effort of looking at collaborative research. It was a global effort.
So we collaborated with laboratories across the United States and worldwide. And I really felt that I thrived in a team atmosphere. And I just really felt a strong sense of purpose and love the idea of all of us collectively working towards a greater goal. And so it just, that experience taught me, you know, the value of being something larger, being part of something that’s larger than myself.
And I think that’s the biggest takeaway. So in the legal field, there are teams, they’re structured differently, but the collaborative spirit is still there, especially in my current firm at Hush Blackwell, where collaboration between different attorneys with different areas of expertise to service a client are really encouraged. so just the Human Genome Project instilled in me the importance of teamwork and the impact of
know, contributing to a collective vision. And it’s just profoundly influenced my approach to both law and biotech and shaping my career to emphasize collaboration and purpose-driven type work.
Mickey (04:32)
We’re home.
Yeah, no, that makes sense. Something that I’m very excited to talk to you about today is kind of the realm of the psychedelics aspect of it. So you’ve been deeply involved in the regulatory matters related to those emerging therapies. So what motivates you to focus on that in this area in particular? And how do you think it’s poised to change the mental health landscape?
Kimberly Chew (05:03)
Yeah, that is a great question. For me personally, I am first generation. My parents were both immigrants. And so I’m part of that first generation family immigration experience where both of my parents came from pretty tough backgrounds. And from an era where basically trauma and PTSD were just seen as something you
live through. There was no treatment. There was no idea that treatment was available or that it was even to be sought after. And I just saw firsthand how trauma to one member of the family affects the entire family unit and can be really crippling on so many levels. And I also saw basically how mental health struggles are stigmatized. And if you leave it unaddressed, just leads to lots of
what seems to be silent suffering, but again, it comes out in other ways where the whole unit is crippled. And I really feel that, you know, the increase in research in psychedelics and in order to focus on these kinds of unmet need areas, now, things like PTSD and major depressive disorder have been very inspiring. I really wanted to be a part of that.
And so psychedelic substances like MDMA and psilocybin, when they got breakthrough therapy designation status from the FDA, that’s a regulatory designation that expedites the development of drugs and devices, mostly drugs though, demonstrating a substantial improvement over available treatments. I was really inspired and just awestruck that regulatory agencies were willing to take a look at psychedelics.
in this regard. So I wanted to help support entities in this space, like researchers, drug developers, healthcare practitioners that were interested in this space and trying to find a way to get medicines to those who are suffering and to find healing. So that was my big, I do have a very personal story that’s behind the scenes, behind this whole thing.
Mickey (07:30)
Yeah, that’s really, really cool. So where is this currently at right now? The psychedelic medical and mental health space, is it readily available? Are we still pushing through regulations right now?
Kimberly Chew (07:50)
Yes. So the big news in the psychedelic world that happened last year, we were all hopeful at the beginning of 2024 that MDMA assisted psychotherapy would gain FDA approval. It had gained breakthrough therapy designation status and then was given priority review, I believe in January of 2024. But it did not gain FDA approval and it was in part because of
problem of functional unblinding. So just to back up a little bit, it’s possible to experience a quote trip while taking a placebo, but it’s rare. So most participants in a clinical trial knew if they were being administered a drug or placebo. And it’s actually, you know, this kind of functional unblinding is pretty, it’s a common issue in psychoactive compounds. And
The FDA knew about it, but it just ends up being one of those scientific questions that remain unanswered about how you’re gonna address it. How could you address it in a clinical trial involving a psychoactive compound? So because of this functional unblinding, the FDA was concerned about biased results. Many of these psychedelic trials rely on self-reported outcomes like changes in anxiety, self-reported changes in anxiety,
self-reported changes in mood improvement or spiritual experience. So if a participant knew or suspected that they received a placebo, they may report less of an improvement due to disappointment, even if they experience some benefit. And so this could diminish the efficacy of the placebo group. It also undermines just basically the double blind design of the trial.
Mickey (09:41)
Thank you.
Kimberly Chew (09:45)
which is crucial for reducing bias. If participants and researchers, in many of these clinical trials also, there’s self-reported outcomes as well as the researcher who is observing the participant can obviously take notes and monitor the participant for changes. And if either one, the participant or the researcher become aware of who is
actually in the treatment group and who’s in the placebo group, that can change your expectations and influence where the results you’re obtaining are biased. So that was probably, I mean, there were other issues that were brought up during the advisory committee meeting that was held, I believe, in June of 2024. That was the big, so basically what’s happened is,
the FDA has come back and told the drug sponsor for MDMA-assisted psychotherapy that they should conduct additional phase three clinical trials. So that’s put that drug back probably a couple of years in terms of whether it can be approved. And the next set of drugs that are in the psychedelic arena, I mean, there are several that were given breakthrough therapy designation by the FDA is probably psilocybin. And that’s probably
I would think they’re starting phase threes this year. I believe they actually, yeah, they’re in phase three this year. And so we’re talking a couple years until that comes through for FDA on the federal level, right, for FDA approval.
Mickey (11:21)
Yeah.
That’s very interesting. What’s a pivotal moment that you’ve encountered where a company that you’ve worked with or for had to make a tough decision around regulatory compliance? And how do you guide them through that challenge?
Kimberly Chew (11:38)
Yeah, sometimes it could be the compliance end can be a little difficult because you’re trying to convince, you know, explain to your client, this is where communication is so important. You’re trying to explain to your client the importance of developing this procedure or a policy or a committee. And that requires extra work. They’ve never done business that way before. And so I advise all kinds of entities and not just in the psychedelic space.
Mickey (11:50)
Yeah.
Kimberly Chew (12:08)
One of the more memorable experiences I’ve had is trying to get the client to understand what a conflict of interest meant. And so we would have conversations, we would have emails and phone calls where it would seem like they would understand what I was trying to say. So in their case, I was trying to get them to separate their finances. So there was a research entity and a corporate entity and they’re basically getting the finances from the same place.
I was trying to tell them that in order to avoid a conflict of interest, you should develop a policy, put in a committee to evaluate conflicts of interest, and you really need to separate out your finances. All these things are difficult to do when you’ve been doing business for so long a certain way. And so I would think that, okay, well, they understand what I’m trying to say, and they will move the conversation forward. But the next conversation we would have, it would be very clear that they didn’t understand what I was talking about.
Mickey (12:50)
Yeah.
Kimberly Chew (13:06)
what conflict are you talking about? Right? It was just more of a, okay, how are we going to make it work? And so I think I really made more of a breakthrough by being able to kind of push through this obstacle by actually developing a visual aid. This is more just a flow chart of flowing, drafting out, right? In visual aid format, bubbles of where the money was flowing and how, yeah, that because it came out of this one pot, there is going to be a conflict.
and explaining why this is problematic and how it might later lead to liability, lead to scrutiny and so forth. So I think that finally helped. And so then, yeah, they agreed that they’re going to make recommendations to at least start with a committee. And I thought, okay. But that was pretty hard, I would have to say. It’s interesting when you really rely on communication.
trying to find different ways to communicate with your client the importance of a particular item. Yeah, I mean, there’s other issues that go on in terms of trying to get a client to understand the gravity of a situation that they might be facing. And they think I’m talking to attorneys, so what I’m doing is not a big deal. No, no, no, that’s not what I said.
Mickey (14:04)
Yeah.
Yeah. Well,
It’s interesting because like how do you help companies position themselves, you know, within such an emerging market that’s always going to be changing to not only do things legally, but ethically as well, right?
Kimberly Chew (14:40)
Yeah, yeah, I think the ethics piece is definitely, it’s really important. It’s paramount in any endeavor, but especially in a healthcare space. And it’s one of those things of, I always think that knowledge is power and hopefully even going back to, know, historically why these regulations were put in place or why these policies are important.
because of historical wrongs that have gone on. I always think that’s like an important thing to point out generally from an educational perspective. And then hopefully that education will really make an impact on my audience and on my client.
Mickey (15:25)
So given your expertise and you’ve touched a lot on a lot on this already so maybe if you if you want to move on after this if I ask it and let me know but given your expertise kind of in the clinical trials how do you advise your clients to balance the innovation and the necessary compliance and the ethical standards and what role does like you know obviously the communication is a huge piece of it but are there marketing strategies that you know you you help them with that play that balance between
Kimberly Chew (15:35)
Okay.
So I don’t, the marketing I’m really more concerned about usually is my own marketing of my practice. don’t really, I mean, in terms of advising clients, generally what happens is I have to advise them straight up, you know, I have to convince them to let me see their marketing materials. And so this happened with a few of my clients where they will actually release the marketing materials to me. And then I will advise, Hey, you don’t actually have the, um, this
This is not advice, right? The sentence you say here looks like you’re giving health advice and you don’t have a license to do that. So you should not, you should really modify and I will give them modifying language to try to get them to change their, either their marketing materials or in this case, it was a company that’s focused on delivering knowledge to high school students. And so giving some advice about how to
Mickey (16:33)
Yeah
Kimberly Chew (16:53)
modify the language so that we’re not hitting up against, you know, basically violating any regulations. It ends up being, I mean, because they really want to say what they want to say. And like, oh, it’s more compelling if I say that has this and give it a health claim. And I like, okay, well, I know if you want to do this health claim, you’re going to have to couch it in such a way that it is rooted, your site to the studies that you’re talking about.
Mickey (17:07)
Yeah.
Kimberly Chew (17:22)
and mention that this is not your work. will have to, know, transparency is gonna have to be the way to go. And there’s only certain health claims that you can really, you should really make about this. It’s one of, it is one of those, yeah, it is one of those things. But oftentimes I will go onto clients’ websites and look and like, that’s not, and then have to call them. Yeah, this is not so great, yeah.
Mickey (17:34)
Yeah.
Yeah, hey, I knew that
Kimberly Chew (17:52)
You might want to rethink this thing. And yeah, sometimes people are really committed to a certain way that they want their marketing to be. But it is pretty important because there are fines from the FTC that are not to be laughed at. Like you cannot, it will end a business. You really, yeah, yeah.
Mickey (17:59)
Yeah.
Yeah, I will close the doors.
What, what do you foresee as the most promising advancement in the psychedelic therapies and regenerative medicine space in the coming years?
Kimberly Chew (18:22)
Well, I mean, there’s a lot that is so basically in psychedelics, I mean, what has been happening more recently, I would say is really recently is there’s more and more interest in the shorter acting compounds. So esketamine, which is market aspervato, it’s a Johnson and Johnson product. was just recently, like late January of this year, been
by the FDA as a monotherapy for treatment resistant depression. Before it had been approved in 2019 to be used in conjunction with the oral depressant, but now it’s being approved as a monotherapy. You don’t need to be on antidepressant with it. And Spravato requires only two hours of medical monitoring in the clinic, which is far less length of time than let’s say psilocybin or MDMA.
which is multiple hours. Meaning, the other thing that was kind of big news is that GH Research announced a phase two success for one of their short acting psychedelic compounds that they’re trialing in the EU. And they’re actually trying an intranasal form of 5-MeO-DMT for the treatment of treatment resistant depression. And 5-MeO-DMT actually has, I mean, just minutes, so like less than an hour of
Mickey (19:20)
Yeah.
Yeah.
Kimberly Chew (19:49)
So
It does seem like there’s more focus, and also for both of these, escadamine and for GH research’s compound, there has been no therapy. That’s a psychotherapy component. That was also mentioned as kind of a little bit of a sticking point, it seems, with the MDMA NDA application was that the psychotherapeutic component was not standardized. And so it does seem that
know, in psychedelics that there is more of a lean towards these shorter acting compounds as well as being able to use these compounds without psychotherapy as being part of the treatment. I mean, I guess we’ll see, you know, how efficacious this is because there’s a lot to be said about durability. It is known that esketamine doesn’t have a multi-year durability effect. I mean, I don’t know about 5-MeO DMT, but
I mean, the other compounds, obviously MDMA and psilocybin have been anecdotally reported to have multi-year durability effects. I mean, there’s a lot to be said for that. And so there may be a space for all of these compounds as well as the novel, what they call second or third generation psychedelics, which are not part of the classic psychedelics that you think of like MDMA or psilocybin or psilocin DMT.
but they are analogs. And so there are lots of entities that are developing analogs with non-hallucinogenic effects, with the idea that they will be able to act shorter. I mean, that’s the goal, right? This to have them shorter acting, non-hallucinogenic and potentially safe enough that you don’t need to have it administered in a clinician’s office. And so that would just drive down costs and so forth. So we’ll see how that turns out. I mean,
it’s the big hope, right? That’s a longer term play. But in terms of regenerative medicine, stem cell research and tissue engineering CRISPR and bioengineered organs for testing are really anticipated to revolutionize that treatment landscape. But I do think overarching all of these, the biggest revolution we’re seeing is the use of artificial intelligence tools.
Mickey (21:48)
Yeah, of course.
Kimberly Chew (22:15)
in order to decrease time and costs of drug development to market. The average time to develop a therapeutic right now is 10 to 15 years with an average cost of $1.3 to $2.8 billion. Those are $20, $20, $25. So, and there’s a high average, there’s a high failure rate on these. So on average, only about one in 10 drugs that enter clinical trials successfully are brought to market.
Mickey (22:25)
Wow.
Yeah.
Kimberly Chew (22:45)
So these AI algorithms are being used to accelerate drug discovery, optimize potential drug candidates, predict toxicity and pharmacokinetics, as well as optimize clinical trials and overall reduce failure rates. So AI tools are widely regarded as one of the most promising advances in life sciences and are just revolutionizing R &D diagnostics and treatment in so many areas. So I think those are probably the leading trends that I’m
I know, keeping an eye on it is affecting, yeah.
Mickey (23:16)
Yeah, so
we were walking and now we might be running very quickly. Right? Yeah, that’s very cool. Yeah, the advancements in technologies are sometimes scary as well, right?
Kimberly Chew (23:22)
Yes, yes, yes, yeah, yeah.
They are. I
So I advise all my companies that we need to be proactive about these regulatory strategies because there is as exciting as AI is. are trying to, the regulatory agencies and, now, state and federal are trying to wrap their arms around how we kind of, you we can’t just have the wild west. AI in a big sense is a black box.
And so you don’t know exactly how it’s giving you bias results, if it’s giving you bias results. And so I often counsel my clients that they really need to prepare for regulations. I mean, the FDA just came out in January with two different guidelines for drug developers. California has enacted in fall of 2024 an AI related piece of legislation that affects.
healthcare, use of AI tools in healthcare, which could affect clinical trials depending on what you’re doing with your AI tool. So in overarching, all of these AI tools still need to comply with existing laws. And lots of people are not, you that’s why I advise my clients on of just like, you still need to comply with privacy laws and AI works with such big data sets that hopefully anonymized, but there’s always the risk of being, you
de-identify, mean, re-identified, there’s always that possibility. There has been, that has happened as a test case that that could happen. And so it’s a risk about, you know, anyone who wants to use an AI tool. So anyway, it’s just one of those things that it’s hard to really keep your arms wrapped around it and, cause it’s a moving target. And so, yeah, keeping up to date on the regulations and policies out there.
are really important for companies who are hoping to utilize the advances of AI tools.
Mickey (25:26)
Yeah, no kidding. So finally for our listeners, for listeners who might be inspired in inspiring entrepreneurs and professionals entering the biotech or law field, what’s one piece of advice that you would give to them to help them succeed in just a rapidly evolving industry?
Kimberly Chew (25:50)
God, well one piece, yeah, one is kind of hard. I would say, you know, embrace innovation and stay informed and uphold ethical standards, high ethical standards, as well as develop resilience. Now, resilience and perseverance are just key traits that will help you navigate the complexities of these fields. But maybe the biggest piece is,
is a collaboration. Knowledge is important, but fostering collaboration with your peers, mentors, industry leaders, and building trust is even more important. But collaboration is really, I feel, one of the greatest ways to widen your world and your perspective.
Mickey (26:36)
That’s fantastic advice.
Kimberly Chew (26:38)
Thanks.
Mickey (26:40)
I’m saying I better myself. Honestly, really. Thank you so much for taking the time today to chat with me. I’m gonna link your social media, anything like that below as well. If our listeners have any questions, they can maybe directly reach out to you. Feel free to answer them. Again, thank you so much for the opportunity. It’s really cool to see this side of the world. It’s not something I’m, you know.
Kimberly Chew (26:43)
appreciate that,
Thank
Mickey (27:07)
even reading about. it blew my mind. I’m sure our listeners will be intrigued as well. So thank you so much.
Kimberly Chew (27:13)
Thank you. The pleasure is all mine. Thank you so much, Mickey.
