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Ep 33: Legal Issues in the Gene Editing Space: Lisa Taylor Ash, General Counsel at Shape Therapeutics
64 Plays6 months ago
How do you leverage your legal career to launch your own consultancy? What are the winning tactics to be an effective in-house lawyer? Is it possible to merge your love of science with your passion for law?
Lisa Taylor Ash, General Counsel at Shape Therapeutics, has the answer to all of your questions. After leading two different legal teams through major acquisitions, starting her own consulting firm, and returning to the GC role, Lisa created effectiveinhouse.com, a website that features legal tactics, samples, and interviews with top in-house counsels across a variety of industries.
Hear Lisa as she explains how she was able to position her career at the forefront of cutting-edge biotech, offers practical advice for lawyers hoping to start a company, shares lessons she wishes were taught in law school, and more.
Check out some of Lisa’s favorite posts from effectiveinhouse.com below:
Minimize Legal Risk
https://effectiveinhouse.com/minimize-legal-risk
Interview with Brett Pletcher, Former GC of Gilead
https://effectiveinhouse.com/interview-brett-pletcher
Interview with Brandon Etheridge, GC of the Baltimore Ravens
https://effectiveinhouse.com/interview-brandon-etheridge
Read detailed summary: https://www.spotdraft.com/podcast/episode-33
Topics:
Introduction: 0:00
Leading legal through two major acquisitions: 2:48
Developing personalized medicines: 8:56
Lessons for lawyers dealing with M&A: 12:11
Leaving large companies after an acquisition: 14 :06
Launching an independent consulting firm: 15:51
Offering practical advice for starting a consulting business: 19:39
Returning to an in-house role at Shape Therapeutics: 24:37
Legal issues related to gene editing: 30:47
Building public trust in gene therapy companies: 32:57
The future of AI and gene editing: 35:41
Creating an essential legal resource at effectiveinhouse.com: 36:51
Book recommendations: 41:35
What you wish you had known as a young lawyer: 44:03
Connect with us:
Lisa Taylor Ash - https://www.linkedin.com/in/lisa-taylor-ash-17b1b611/
Tyler Finn - https://www.linkedin.com/in/tylerhfinn
SpotDraft - https://www.linkedin.com/company/spotdraft
SpotDraft is a leading CLM platform that solves your end-to-end contract management issues. Visit https://www.spotdraft.com to learn more.
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Transcript
Startups and Legal Pitfalls
00:00:00
Speaker
When a company is first starting, they often don't have the capital to access legal guidance. And so you see founders making some kind of like easy mistakes that could be avoided. And so just trying to point founders to like, what are those key things you should get right early? Make sure you get your IP correct. Make sure you get your funding document correct. And kind of like, who are the lawyers that you should work with on some of those big, very early make or break company decisions?
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Speaker
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Speaker
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00:01:27
Speaker
Have you considered leveraging your legal career to launch your own consultancy? What experiences can you draw on as you build your business? When is it right to turn back to an in-house role?
Career Insights: Lisa Taylor-Ash
00:01:39
Speaker
Today, we're joined on the abstract by Lisa Taylor-Ash, the General Counsel of Shape Therapeutics, which is using programmable RNA medicines to repair the genetic causes of diseases. Pretty amazing. Maybe one of the coolest company's product offerings that I've had the pleasure of being able to speak to a GC from.
00:02:00
Speaker
Lisa has deep experience in healthcare, biotech, and pharma, including previous stints as a lawyer at companies were acquired by Celgene and AbbVie for $9 billion and $21 billion respectively. So large M&A experience here, and we're going to be chatting a little bit about that today.
00:02:18
Speaker
She's also the author of effectiveinhouse.com, one of the ways that we got put in touch. And she built a business helping startup founders navigate their early rounds of financing and growth. We're going to be talking about both of those initiatives that she's worked on, businesses that she's built herself throughout the course of the podcast. Lisa, thanks so much for joining us today. Thank you so much for having me. I'm excited to talk about all of these topics. Lots to dig into.
00:02:46
Speaker
Absolutely. Well, look, based on your background and the companies that you've worked for, I expect you have a love of something that maybe a lot of the government or poli sci or history majors who usually get involved in law struggle with a little bit. And that's the more traditional sciences. Did you know that, you know, back at the beginning of your career that you wanted to have a career at the intersection of law and the sciences?
00:03:14
Speaker
I actually did. I feel really fortunate that I got exposed to that as a possibility through some friends of my parents, actually. So I knew I liked science, but I knew I didn't want to be a doctor. I don't like blood. I knew I didn't want to be a bench scientist. I didn't like being in the lab, but I loved what science could do. And so in college, I studied biology and clinical science. I liked both.
00:03:37
Speaker
And then I had learned that there was this path where you could combine them. And it was really in law school that I really understood the possibility of health care law specifically with working with biotech and pharma as an option and regulatory law specifically where you can work with the FDA and CMS about how do you get drugs approved and paid for. And I just thought that was a really cool way to combine things that I enjoyed. And I also had a pretty transformative experience when I was in college.
00:04:02
Speaker
And I did a program in Tanzania where I got exposed to a GSK program. GSK is a big multinational pharmaceutical company and they were providing free antiretroviral therapy to children who had been born with HIV. And so just really, you know, very high impacts are on the ground. What's the possibility of science? So how it could impact lives all over the world. And so just really thought that this was an industry that I wanted to be involved in.
00:04:27
Speaker
That's an amazing introduction to healthcare and pharma. You've been lucky after sort of building expertise around healthcare and regulatory and going in-house to have been involved in a couple of pretty large acquisitions. And so you've gotten to see companies both, I would say maybe like the very small seed stage and then also these large multinationals just to sort of set the stage for this part of our conversation. Can you talk us through the two big transactions that you were a part of?
00:04:57
Speaker
Yeah, absolutely.
M&A Expertise and Insights
00:04:58
Speaker
So the first transaction on both sides, I was the company that was acquired the smaller biotech company that had created a singular innovative product, or in the case of Juno, kind of a platform of products around CAR T cell therapy. But at pharmacyclics, we were developing a novel therapy called Ibrutinib, which is for a variety of different types of cancer of blood cancers. And we joined the company right as they were launching the first drug and helped
00:05:24
Speaker
really get the commercial team up and ready, get it approved and reimbursed by CMS. And then about a year in, you know, the drug and the company were doing really well and Abby acquired us. And that was my first experience of the acquisition and then the subsequent integration, which I stayed for part of. And I think my biggest takeaway from that just as a high level for people was that when you're the small company, sometimes it's easy to be really intimidated and think that the big company is going to know everything and tell you how you weren't doing things the right way.
00:05:53
Speaker
But really as a small company, you know, you're the expert on your product and the big company has a ton of resources and global reach and lots of things they can leverage.
Exploring CAR T Cell Therapy
00:06:02
Speaker
But that doesn't mean they know everything about your product and what you're really focused on as a small company. And I think that lesson stayed especially true during my second acquisition where I was at Juno Therapeutics and we were developing very novel, something called CAR T cells, which were one of the very first personalized medicines. This is also for a type of blood cancer.
00:06:21
Speaker
And what Juno would do if you, if you'll hear me going into the science for a little bit, cause it's just so cool. I wouldn't, I wouldn't know what CAR T cell therapy. Is that right? Is off the bat. So please, yes. Okay. So the simplest way to think about it is that when you have cancer, we all actually have cancer all the time, but normally the immune system identifies those cells that are growing abnormally and destroys them and clears them up. So you don't actually get aggressive cancer.
00:06:49
Speaker
But for cancer that progresses, your immune system becomes blind to the cancer. Basically, it can't see it and destroy it. And so what we do is we take a patient's T-cells at Juno, so you would actually do a blood draw, get your T-cells, which are a kind of immune cell, genetically engineer them in our manufacturing facility so that they have the ability to recognize the cancer, the ability to insert a receptor so they can see the cancer in the blood.
00:07:16
Speaker
Then you grow those cells, grow a bunch of them up, ship it back in a vial, back to the patient. The patient's doctor injects the patient's own T cells back into them, and then your system fights the cancer directly. So really exciting project, amazing efficacy, and that it could really help people who are otherwise going to die from their cancer, sometimes cure them. And so obviously very important to be careful about our language with the FDA and everything, but really tremendous power of these drugs.
00:07:45
Speaker
And so, and also it was one of the very first personalized drugs. This is not just a pill that you make in a factory that goes to everyone, right? We're taking Tyler's cells, genetically engineered Tyler's cells and sending Tyler's cells back to Tyler. So you have to make sure that you don't send Lisa's cells back to Tyler as an example. And so it was really important from a personalized medicine standpoint, there were novel legal issues around privacy, safety, manufacturing, what kind of data you got about patients. And so when Celgene came in and acquired us,
00:08:15
Speaker
Yes, they were the big company. Yes, they have a ton of oncology experience, but we really were the experts in what it meant to have one of these first personalized drug products and all the legal issues that came with that. So in both integrations, yes, of course, there was a lot of combination. There was a lot of following the bigger companies approach to big ticket items like SEC reporting or things like that, that they're really, they have whole teams that work on that.
00:08:40
Speaker
But when it came to the product side of things, I think it's really important when you're the company being acquired to be clear about your expertise, your confidence in issues you've looked at, and make sure that you advocate for that approach during the integration and don't just kind of take whatever the acquiring party says is going to be the way it's done.
00:08:56
Speaker
I've got a couple more questions and integration, but this whole idea or concept of personalized medicine or personalized drugs is fascinating. How long did it take to develop a therapy like that? Is this something that started in the 90s and is sort of just coming to fruition today, right? Like how long did that take? And also how common, I mean, we'll talk a little bit about what SHAPE is doing also later on perhaps, but
00:09:24
Speaker
how many companies are there out there or how many different types of therapies are there for different types of cancer today? Like is this something that is common or is this still a very sort of novel treatment that's targeted only towards very specific conditions? Yeah, it's still pretty new. So maybe the answer CAR T cell therapy was first kind of thought of people had always known that your immune system could fight and detect cancer. And so it was kind of always since the 70s and 80s, how do we figure out how do we train your immune system to do this?
00:09:54
Speaker
But there was early work at the National Institute of Health at Memorial Sloan-Pettering at big research facilities showing that this was possible. I'm probably going to get my dates wrong, but in the 90s, early 2000s. We won't hold you to it. Yeah, no one fact-checked me. But years and years and years of ideas. And then there was a lot of development at these big academic medical centers for a long time.
00:10:16
Speaker
really iterating on the process, figuring out what could work. And then it really combined, we got the tools that we needed to be able to do this. So maybe in theory, you would thought, oh, wouldn't it be great if we could engineer our immune system to recognize cancer? But until we fully sequenced the human genome, developed a lot of editing tools that we now use for routine genetic editing, you couldn't actually make it happen. So it was really the confluence of the ideas and then the tools to be able to do the actual physical genetic edit that enabled these therapies to come forward.
00:10:46
Speaker
And right now, CAR-T cell, there are a few companies that do it in blood cancer, and there are a whole wave of additional companies that are trying to do it in what we call solid tumor. So if you think about like lung cancer or kidney cancer, any kind of cancer that's not like a leukemia or a lymphoma, lots and lots of companies are trying to figure out how to get it to work for those more. If you think about a tumor, you know, it's a big combination of cells, so it's harder for your immune system to get in there and recognize it and fight all of those in a solid tumor cell.
00:11:16
Speaker
Again,
M&A Integration Lessons
00:11:17
Speaker
I'm brushing through a whole bunch of really complicated science. It's really exciting and I think the future of this field is going to be really, really exciting. Hopefully we'll be able to cure all the cancers.
00:11:28
Speaker
That would be incredible, especially given the percentage of people today that that end up getting cancer at some point in their lifetime. I read a book a couple of years ago on sort of the history of cancer and cancer research. And I was shocked by, of course, that dovetails or aligns with longer life expectancy. Right. Yeah. But my biggest takeaway was, you know, I or at least someone very close to me is very, very likely to get cancer in my lifetime. Right. Just given the sort of statistics, I think it was like
00:11:57
Speaker
a third of American men and a quarter of American women or something to that effect. Maybe it's higher. Yeah. Fascinating work that the businesses that you've worked for are doing. No wonder that the transactions are so large. I'm really interested to hear about your experience because you were a leader on the integration, I think in both cases, in both the Celgene and the AbbVie acquisitions. Any lessons that you learned
00:12:25
Speaker
that others who are about to engage in some sort of M&A transaction might be able to learn from? One of the things that I've learned from going through both transactions is that legal issues, we're lawyers, we think that legal issues should drive everything, but legal issues very rarely actually impact deal dynamics unless it impacts value.
00:12:45
Speaker
And so I think during a deal, being really clear with your business partners about risks that you see that impact value or risk that you see that could impact the synergy that's expected from the M&A is really the way to be effective in communicating with your business partners. If you say like, Oh, there's an IP risk, you know, that's not necessarily, even though from a legal standpoint, you're like, Oh my goodness, this IP risk is very real and we should be really worried about it.
00:13:11
Speaker
The deal team is really focusing on those business drivers. What are sales going to look like? How does this integrate with our overall product strategy? And so I think just educating around how those risks could impact future integration or valuation is the way to really have a seat at the table. And then after the acquisition integration, I think what we talked about before is just if you are, and I can only speak to being a small company in the transaction, being the acquired party.
00:13:39
Speaker
Just because you're not the bigger company doesn't mean that you don't know what you're doing. So just making sure that you're educating, advocating, explaining. And in some cases, you know, it ended up like our policies ended up controlling the day, even though the bigger company had more policies, had more detailed policies. Like if we had more specific things for our target, for the patients and the doctors that were going to be using our products, then in some instances, our policies ended up still staying in effect because they were more nuanced and more tailored to the specific issue.
00:14:07
Speaker
Why after both of those integration processes were complete, did you decide that you wanted to go back and try something different? In other words, instead of staying at the big company and being there for a long time, maybe having great RSU packages and stipends and such, why did you decide you wanted to get back into the fold and go and work for smaller companies again? I think it was too bold.
00:14:34
Speaker
One is that I love the cutting edge science. And I don't want to say that big pharma doesn't do the cutting edge science because they do. They have great R&D teams. But the purpose of the bigger company is really is on later stage assets, commercial products. And I really loved being at the forefront of what was the next big thing in science and medicine. And I think that broadly speaking, biotech tends to do that. And then from a personal career development standpoint, when you're at a small company, you get to wear so many hats.
00:15:02
Speaker
You get to focus on all the different kinds of law. You get to partner with so many functions. And that's really what attracted me to in-house practice in general and is what keeps me motivated. I love learning new areas. Whereas I think people, and again, broad brushes at Big Pharma things can be different depending on the company and the role. But I think it is more like a law firm. You might be part of like a several hundred person legal team where you have very deep issue specific knowledge.
00:15:31
Speaker
privacy, but you're covering 50 products, but you're dealing with privacy for all 50 products. Whereas I like just personally dealing with all of the issues on one product. And so I think it's just about finding the right fit for you. And I'm willing to take the risk on biotech. Big Pharma is definitely more stable.
00:15:51
Speaker
As a result of those experiences, you had the opportunity a few years ago to launch your own consultancy, advising startup founders. And it's a little different, I think, than maybe what other folks have done and that you didn't stand up your own law firm. Tell us about why you wanted to launch your own business first. First of all, I was just super fortunate after the Juno acquisition to have some flexibility and not need to take another role immediately. So I want to definitely say there was luck involved in that.
00:16:19
Speaker
And, you know, I had a lot of friends that were more on the business side, on the operational side, that would just ping me with a lot of these questions of like, how do I do this? Or how do I approach this? And so it kind of naturally started with friends who were at other companies just asking me questions. And I realized that, you know, I had this wealth of experience of seeing development from an early-stage clinical asset through a commercial launch.
00:16:42
Speaker
regulatory impact financing strategy. And so I thought that there was kind of a niche market available, which is something we'll talk about with effective in house as well. I kind of like seeing like, where is there a niche market that no one is quite sitting in. And so I started my own consulting practice. And I was very clear, I'm not providing legal advice. I did not want to do that as like a law firm or a legal firm by consulting advice. And
00:17:06
Speaker
I ended up working with almost 40 companies in a wide range of technologies, medical device, cell therapy, health tech, digital tech, very cool uses of how technology is making healthcare, how technology is making drug development, how medical devices are evolving with better AI and monitoring. It was really fun and really cool to get to see such a wide range of technology at its earliest stage.
Consultancy Launch Post-Acquisition
00:17:34
Speaker
just an idea with a few founders who are working on things. And so it was really fun to iterate and help point them in the right direction on some of those early issues. 40 companies, that's a ton. Over what period of time? It was like 18 months. And some of those would be super limited transactions, like five hours meeting with the founders to just say, here's a law firm you could use on this topic. Here's some advice on your pitch deck.
00:17:58
Speaker
And here are some big things to avoid early mistakes. I think part of the other reason why I did it is that when a company is first starting, they often don't have the capital to access legal guidance.
00:18:11
Speaker
And so you see founders making some kind of like easy mistakes that could be avoided. And so just trying to point founders to like, what are those key things you should get right early? Make sure you get your IP correct. Make sure you get your funding document correct. And kind of like, who are the lawyers that you should work with on some of those big, very early make or break company decisions that I thought I had the perspective on and could share with them. Where did you find that most of your business came from? Was it coming from your own network?
00:18:40
Speaker
referrals from other GC friends. Where did you find most of the business was coming from? Mostly. It started out on my own network and then through some of the early companies I got connected into venture capital firms that were investing in these companies and then those VCs were like, oh, can you help this other portfolio company that I just did a feed around in? It just became this whole network where it was a little bit of referral either through the startup founders themselves or through the VC.
00:19:09
Speaker
And then also through my network, we talked about small engagements. One of my biggest engagements was a former person on the commercial team that I'd worked with at a prior company reached out. Their company had some really exciting phase two data and they were getting ready to think about how to build out a compliance and a program for their drug to actually become commercial. And so they wanted a lot of help thinking through some of those early things on how do you design a compliance program? How do you think about regulatory issues and connecting them with the right law firms to help them do that?
00:19:38
Speaker
VC firms, that's very smart. Part of us talking about this, I think, is that there are a lot of folks who maybe are out there in the market right now, might be between jobs, or who are thinking about standing up as sort of consultancy. I actually had my own privacy consultancy for a little while, and there are some practical lessons I think that you learned very quickly in the few months of running your own business. I had great clients, but when are you going to invoice? If it's net 30 or net 90, or that means when cash flow looks different.
00:20:06
Speaker
Do you have practical advice for others, maybe in particular folks with GC experience who might be looking at launching their own consulting businesses?
00:20:17
Speaker
Yeah. Maybe just to slightly clarify the question, just because I think more people should do this. You don't have to have GC experience, right? I wasn't GC when I did this. So I think it's all about, you said you did privacy related work. It's about finding what is your area of expertise and what value could you bring? If you are going to provide legal services, make sure you check with your state bar association to be very clear about what you need to do there, just as a very obvious, important reminder.
00:20:41
Speaker
I think, you know, the tactics on invoice and all that, you kind of just have to figure out and work it out based on your own client. But I think the biggest point I have is you have to trust your gut a lot and like who you work with because there were definitely some early things where I was like, Oh, they're not going to get funded or they're, you know, I don't like how they're approaching this. And then I think at the start I was like, Oh, well I'm trying to build this. I should work with them anyways. And that was always the thing where like, you know, they don't end up paying you or it's
00:21:11
Speaker
some sort of trust your gut on who you work with. And I think the other one is really, even if it's going to be a small engagement, think about it as a long-term relationship. So make sure you're clear about what value you're bringing, articulate what that value is and be very clear and direct upfront about what you're worth. I think I've seen other people smart and kind of be like, Oh, well, you know, just afraid to like ask for the hourly rate or afraid to just get out there. And it's like,
00:21:37
Speaker
I think it's all about confidence. Here's the value I bring. Here's how much I charge. Here's how I think we could start working together to build our relationship. And a longer term vision I have is X, Y, and Z if it works out for both of us. And I think just going in really clear and direct at the start solved a lot of those problems. But it's definitely a skill set. At the start, I was much worse at it than I was about a year in where I was like, here's the deal. You want to work with me? X, Y, and Z are going to happen. At the start, it was much
00:22:05
Speaker
much more wandering, I think. I think it just works better when you're clear and transparent about what you can add and what you expect in return.
00:22:12
Speaker
Another sort of practical question there, do you have a perspective on taking equity as opposed to sort of being paid for your services, how you make that decision or call? I think that's an interesting one. I struggle with that one sometimes myself too. And I think a lot of people, even maybe if they don't have consultancies, maybe they have a couple of sort of advisor like gigs where they're counseling someone that they struggle with that as well sometimes. Yeah.
00:22:38
Speaker
Yeah. And the companies struggle with it as well. I think it's hard for companies to know which engagement warrants equity, which doesn't. The way I approached it is that I almost always started out with a cash just hourly or fixed engagement as you get to know people. Because for it to be equity, I think both sides need to be comfortable that this is a longer relationship. You're taking a bet on the value of the company. You have to believe in that.
00:23:04
Speaker
And I think you have to prove that you are a good fit in working with them before you make that pass. So usually how I would start is say, first, when I was doing the consulting, if we're working, let's do the first three months at an hourly rate. We'll work together with how things are going. And then I'd love the opportunity to discuss equity in the future if it makes sense for both of us. So just start with cash. And then at the beginning, open the door to equity if you think it's something that you're interested in. So that's how I approached it.
00:23:33
Speaker
maybe like a quarter or less, I ended up doing some, some combination of equity or all equity and cash, but mostly cash, because I think you're taking, especially with a very early stage companies, you're taking a big flyer on equity and you want to make sure, you know, you can still pay the bills. So I think especially if it's your full time business, it's not just one thing on the side, right? Oh yeah. It's just one thing on the side and you don't care. Like shoot for the moon, go for equity, making relationships there.
00:24:02
Speaker
That's why I still have a few of them ongoing right now and it's all equity because it's not my primary. That's great advice.
00:24:10
Speaker
Quick announcement before I let you get back to the episode. Spotdraft just released our annual compensation report for in-house legal professionals. If you're wondering how your compensation compares to your peers across industries, years of experience, and more, make sure to check it out. Find it at salary-report.spotdraft.com or head to the link in the description. Now, let's get back to the episode.
00:24:37
Speaker
What led you, you know, you've built this, you built up a consulting business. It was going well. What led you to decide that it was time to go back in house?
Innovations in Gene Therapy
00:24:46
Speaker
And I also, I'm also curious, like, tell us a little bit about what SHAPE does too here. Cause I gave a very brief summary at the intro, but as we've learned, you understand and can explain the science a lot better than I can. Yeah. So.
00:25:01
Speaker
the founders at Shape were people I had worked with previously at Juno Therapeutics. So I knew them, I had relationships with them, and I thought that the science that they were working on was so cool. Yeah. So that's the short answer is like the science was so interesting. Again, I love being at the forefront of cutting edge technology. And I thought that's what Shape was trying to do. Really interesting legal and regulatory issues as well, which we can talk about a little bit more as I describe what we do. But that's the short story is people I knew, and it was really cool science and
00:25:29
Speaker
The consulting side is great because you get exposed to so many things, but you don't ultimately have control or that like direct influence over what actually happens. And I kind of miss having that kind of deeper in the weeds kind of product specific approach to developing something new and bringing it to patients. So that's why I did shape. All right. So I'll do my best to explain what shape does. So we're a gene therapy company.
00:25:58
Speaker
And so we'll go back to high school biology for a minute if you'll bear with me. So if you remember there's DNA and DNA turns into RNA and then RNA turns into proteins that fuel your body. So we try to edit RNA, that middle step. So we're not making a permanent edit to DNA or your genome, which is what like companies that use CRISPR, if you've heard about that at all, CRISPR edits DNA, the permanent change to like the core software of your body is how we think about it.
00:26:28
Speaker
RNA is more of like a transient protein. RNA is what was based on the COVID vaccine, if you recall, where they would just deliver RNA into your body. And that creates a protein that helped you develop an immune response to COVID to help you fight it more effectively.
00:26:43
Speaker
And what we're trying to do is with genetic diseases, there's usually a mutation that causes either protein to be created like a misfolded or misshaped protein that doesn't do its job accurately. Or there's a mutation that prevents the protein from being developed at all. There's something called like a stop codon that prevents your body from actually making the proteins it's supposed to be making that can be caused by a mutation.
00:27:08
Speaker
or your body is making too much of a bad protein, where in some part of cellular system you're making too much of something that you actually don't want to have around. So what we try to do is we develop a guide RNA, which is a little piece of RNA that would bind to the target RNA that's already in your body. And then we recruit enzyme that's already in your body, it's called ADAR, and it comes and it edits that RNA and fixes the issue.
00:27:32
Speaker
So we either correct the protein so that it's created the way that it's supposed to, we make the protein in the first place if it was being stopped from being made by a mutation, or we introduce a mutation to make less of a bad protein. So that's all the different ways that we can edit your RNA to try to fix a very wide range of genetic diseases.
00:27:53
Speaker
So something like CRISPR wouldn't work to solve this sort of challenge, basically, or that sort of genetic mutation or issue. Yeah, it's a great, I think that there is room and this is like a very cutting edge, controversial topic. It kind of depends on what you're trying to edit. So if you think about, we're trying to edit a bunch of neuro targets. So we publicly disclose like Alzheimer's and Parkinson's where it's really hard to make edits in your brain.
00:28:21
Speaker
It's really hard to get big proteins like CRISPR to your brain. And if you think about making an edit to your DNA, buy a bacterial protein like CRISPR. And again, I'm not the scientist, so any scientists listening. But one of our questions that I think the industry has is, if your DNA is edited by CRISPR,
00:28:42
Speaker
your body puts up protein signals that say, hey, my DNA was edited by bacteria. And sometimes your immune system goes through and clears those cells. So is that really going to be a permanent and effective edit? Or will your body clear out the edited cells? Whereas because we're using a fully human system, we're relying on your own editing mechanisms that exist in your body for all sorts of everyday purposes.
00:29:05
Speaker
the hope is that it would provide a longer term edit that wouldn't be cleared by your body because it's not a foreign edit if you think about it. It's not a bacterial program edit. What does this look like from a therapeutic perspective? Are you going to the hospital every six months or a year or something for a blood transfusion? What does it look like from a patient perspective? It's very early. We're not even in the clinic yet, so I can't promise anything. The cool thing is even though we're editing your RNA,
00:29:33
Speaker
We basically, when we deliver, we're getting really technical now, Tyler, but you actually. When you deliver, what we deliver actually, it would be like a shot into your body and what we would deliver is a virus. The virus goes to the cell that we're trying to edit. So let's say it's a muscle cell or a neuron or a heart cell. The virus infects the cell and delivers
00:30:03
Speaker
a piece of DNA. The DNA codes for the guide RNA that then helps make the edit. So as long as that DNA that got delivered by the virus is in the cell, then you don't ever need another injection because that DNA is there and it will produce the guide RNA and it will cause the edit. That's the hope.
00:30:22
Speaker
So in cells like neurons or in heart tissue that don't divide a lot, it would probably only be a one-time treatment because you just deliver it once. And then the cells have the DNA package needed to make the guide RNA, to make the edit. It's only like your skin that's changing all the time. Like our therapy probably wouldn't be the right approach because then your skin cells are dividing constantly. So then you would need, maybe it's still the right approach, but then you'd need more doses to be delivered.
00:30:48
Speaker
And I really wanted to understand this because I want our listeners to understand what some of the novel legal issues are that you find most interesting in this space. And I don't think you can really understand that unless you actually understand at least a little bit of the science behind or how this works. So with that, what are some of the legal issues that you're working on that, of course, you can talk about in the gene editing space that you find most interesting?
00:31:18
Speaker
So given that we went way deeper on science than I thought we were going to, and we're going to keep going with that a little bit. Well, right now we're, you know, we're preclinical. We haven't even treated any humans yet, but we're working to get there, you know, as quickly as we can. I think what's really exciting is that right now, if you think about how drugs are developed, they're developed for big buckets of disease, Alzheimer's, Parkinson's, different types of cancer. There's not really drugs that are made for you, Tyler, or for me, Lisa. They're not N of one therapies are what we call them.
00:31:48
Speaker
our system is all dependent on just making that little guide RNA that we deliver. We can make that guide RNA edit whatever we need it to edit, right? And so the whole goal, the ultimate goal is that we create this really big platform where yes, we could treat big bucket diseases that are common mutations, but we could also just as easily make that guide RNA edit a mutation that like you're the only person in the world that has.
00:32:11
Speaker
And so I think this comes back to like the personalized medicine approach. Those are some really interesting legal issues to think about. How is our drug development and regulatory framework set up to right now we do it on huge clinical trials, huge diseases, common approaches. But as we advance drug development, how do we say, well, we know exactly what Tyler's mutation is. We know exactly how to fix it.
00:32:37
Speaker
We have a safe way to do that based on all these other things where we've shown that we've treated big, big indications safely. What's the path to do that? I think that's really fun to think about and we're just at the start of it, but it's something that we're excited to think about with the FDA and other regulatory authorities around the world.
00:32:55
Speaker
Maybe a last question. What's the role of companies that are developing these therapies, especially if maybe existing regulatory frameworks or processes don't quite work, building trust in the therapies? And I think that the past few years have even maybe made some people question whether or not they should trust. I don't think necessarily rightly so, right? But some people out there question whether they should trust sort of the existing regulatory processes, which are
00:33:25
Speaker
for bigger and our run on large clinical trials. What's the role of companies like SHAPE or other pharma companies in, I don't know, almost readying the public, I guess, and building trust in a totally new paradigm? Yeah. I think it actually does go back though to we just need to build trust in the processes with the regulatory authorities. I don't think there's any contemplation that we would try to bring this forward.
00:33:52
Speaker
Um, without that, I think it's, that's why it's interesting. There's a legal standpoint and that you need to go to the FDA. We need to go to EMA, the European equivalent and educate about what we're trying to do. How do we show that it's safe? Cause it shouldn't be rolled out to that end of one until we really have proven that it works for a bigger group or until we have, uh, you know, an informed consent and a trial policy that would let, you know, you Tyler decide if you want to try something like this. I think that's kind of.
00:34:21
Speaker
what we saw as a result of the COVID vaccines, there was a lot of discussion about what level of individual choice should be contemplated in our regulatory regimes. And I think to the trust part, another legal issue that we work on a lot as well is just how AI is totally transforming drug development. We have really exciting public tools that come from Google, like AlphaFold that show you how any protein folds in the whole world.
00:34:46
Speaker
It made up proteins, anything you can create. And what we do at Shape is we have a huge data science team. We have machine learning experts. And what we're trying to do is develop, have the AI be able to say, this is what the guide should look like. Instead of it being in a wet lab experiment where it takes scientists years and years to figure out what's the exact guide that works for this exact type of mutation, you just feed all that data into the AI. And the AI says, here's 10 guides that should work. Go test them.
00:35:15
Speaker
And so how do you think about that with intellectual property, with copyright based on those training data sites? That's came from trade secrets, just like the ethics of it eventually. Any edit in your genome that you want to make in 20 years, who decides? That's way farther than anything I'm thinking about right now, but there are things that really include legal and ethical issues that we'll have to confront in the not so distant future.
EffectiveInHouse.com: A Resource for Lawyers
00:35:42
Speaker
Okay, I lied. One last question on shape. Would this be possible without large machine learning and large data sets without AI broadly, do you think? Or is this going to happen or at least is it going to happen in a sort of like reasonable timeline, not like 55 years, right? Because of AI.
00:36:04
Speaker
I think it could happen without because right like shape was founded before we had a whole machine learning data science team where like you can do it scientifically, but I think through other advisory companies that have the do AI as well. I think the biggest change is that instead of that slow hypothesis driven drug discovery, like the scientist has an idea about a pathway and then you do an experiment in the lab and then you get the data from that one experiment and then you do the next experiment and that just takes time.
00:36:32
Speaker
The AI lets us run lots of experiments simultaneously and comes up with new ideas that, you know, so quickly that maybe humans wouldn't have thought of. And so I think it really is a very cool example of biology and computer science coming together to create something new and to do things faster. It's probably the biggest setback that we'll have.
00:36:53
Speaker
leaving shape behind for just a second. I want to ask you about your newest venture, which is part of the way that we got connected. It's called effectiveinhouse.com. Tell us a little bit about what you started and why you decided to launch this resource for in-house lawyers. Yeah. So as part of, we didn't do a whole bio, but Shave is my fourth in-house company. I started out as a big law firm prior to that, but always knew I wanted to be in-house.
00:37:21
Speaker
And I just kind of kept seeing the same repeating themes now that I've been in-house at four different companies, brought on in-house legal teams, trained those legal teams of in-house law is its own practice. It's different than being a law firm lawyer. It's different from being a subject matter specialist. You really have to understand what your business is doing. You have to be a partner in that business. You can't be
00:37:45
Speaker
you can't be viewed as a problem to that business. And so I just kept finding myself saying the same things over and over to my legal teams. And my husband told me that I had to stop talking about it and just do it. And so I had the idea of creating a resource that would be focused on some of these core lessons that I've learned throughout my in-house career that would hopefully help other in-house lawyers. The other thing is I love learning. We're lawyers, right? We like learning from books. We like reading things.
00:38:14
Speaker
I kept finding that there wasn't a good resource out there where I could say, I wanted to Google, how do I approach this meeting with my executive team to discuss a complicated legal issue? How do I approach presenting to the board? How do I approach the trade-off between legal risk and business value?
00:38:32
Speaker
in a contentious meeting with my marketing team that wants to do something that I don't think we should do. And I wanted to have resources that were in writing and you can go to effective in-house and check it out. I have a matrix about how you think about legal risk versus business value and how you communicate that to your business team. And then I wanted to learn as well. When you're at a small in-house company, you don't have a huge legal team to learn from.
00:38:55
Speaker
A big part of it was being able to interview other lawyers that are in-house about how they approach issues, what they've learned, and be able to share that with the community as well. Do you have an idea about how you want it to evolve over time or are you just ready to see where it leads? I think I'm just going to see where it leads. I'm just going to keep doing it while it's fun. I'm learning a ton. It helps me connect with great people like you to talk about these projects and what it's like to be in-house and
00:39:24
Speaker
You know, my goal, and I'm actually, I went to Harvard Law School and I'm talking to them about, you know, maybe figuring out some sort of class, but my goal would be to just expose lawyers earlier to what it means to be an in-house lawyer. I think law school sets you up on such a trajectory of litigation, law firms,
00:39:43
Speaker
Here's the path based on our curriculum from the 1850s. I haven't done property law in my entire career. I don't know if you have, and yet I spent a whole semester of learning about it. I want there just to be more resources and more discussion of what it means to be in an house where available to all practitioners, no matter what stage of their career.
00:40:03
Speaker
If you had to make a recommendation, and I know this would be tough for me if someone came to me and said, Hey, like what, you know, one or two episodes of the abstract and someone listened to, but if there were one or two posts or interviews on effectiveinhouse.com that you think folks should start with. Yeah. Where, where should they begin?
00:40:20
Speaker
So there's, I think one of my favorite posts was one that I had, that I talk about all the time with my team and if my business is, which is a tactics post, which is about how to balance legal risk with business value. I really tried to have it be tactical with what do you say to your team? How do you show them how you're making these trade-offs? And so that would be a tactic. And then for interviews, one of my favorite interviews was with Brett Fletcher, who is the GC of Gilead, you know, fortune 100 biopsy, pharma company, thousands and thousands of employees.
00:40:50
Speaker
products that transformed medicine and HIV treatment specifically. He was there for something like 15 years, and just full of great tactics and insights about what it means to be a leader at a big company like that. And if you're looking for a more fun way in, I have an interview with Brandon Etheridge, who is the GC of the Baltimore Ravens NFL football team. So that was really fun as well to get to talk to him about what are similarities between our jobs? What are differences? And it's funny, it's all
00:41:18
Speaker
I think it's so much more similar than people think, despite the big differences in our industries. That's another one. I actually have read that one and I really enjoyed that one. I'm going to have to check out the one with Brett Fletcher. That sounds really interesting. And we can link to these in the show notes too. Just a couple more questions for you. You know, I'm a big reader. I travel all the time for work. I like to read while I'm traveling, as opposed to trying to send emails on the plane.
00:41:43
Speaker
Sounds like you're a big reader as well. What's a good book that you've read or a few good books maybe that you've read recently? So you set me up perfectly because I actually have an effective in-house post about this. So check those out. But the one that I'll just call out such an old school book is from the 60s. It's called Effective Executive.
00:42:07
Speaker
You can maybe guess where I got inspiration for the name for effective in-house based on that, but it really is full of tactics. How do you think about how you spend your time, what you prioritize, and it's meant.
00:42:19
Speaker
broadly for executive. But I think it's really just how do you manage your own time and how do you think about what you should work on the ads value to your business. So it's from the 60s, you have to get over some like antiquated language about, you know, having your secretary type up your notes on her typewriter. But if you can look past that part, I think there's a lot of very practical tips on how to do things. And then I have some other great ones that I like, Adam Grant, all of his books, I think are fantastic. But anyway, there's a post on that.
00:42:47
Speaker
For fun, I love reading a wide mix of things. If you like adventure travel books, I just read this book called High, and it's all about the Himalayas. So it weaves like a personal travel narrative with the history of India, Pakistan, Nepal, Tibet, and Bhutan. And it's just really well done. It's like a combination of history and this woman's travels throughout the region. So highly recommend that one.
00:43:14
Speaker
Yeah, I'll be in India very shortly. So I might actually buy that one for this trip. It is really good. I learned so much about the history, but I have a hard time just reading like pure dense history. And so what I liked each chapter, she woven, you know, her experience talking to, talking to someone at the temple along with like the history of the region. So it was like a nice mixture. Um, so made it more approachable. And I learned a lot about the region.
00:43:44
Speaker
We'll have to talk offline about your trip to India. I loved my trip to India. So fantastic. Yeah. And my final post is that I love sci-fi. So if people have not read Dune, don't just watch the movie. Please go read the book. It's one of my absolute all time favorites.
00:43:59
Speaker
So anyways, I hit you with a lot of books there, but I love reading, so I can talk about that all day. Very cool. As we start to wrap up, Lisa, I've got just sort of one last question for you, something that I like to ask most of, if not all of our guests. And that's, you know, if you could look back on your days of being a young lawyer, just getting started, having just graduated from law school, what's something that you wish you'd known then that you know now?
00:44:25
Speaker
I kind of mentioned this earlier about educating people on what it means to be an in-house lawyer, but I think I was so convinced that being a lawyer meant you had to write briefs and write memos and dig into the details of case law, which I frankly hated. When I first joined velocity, we started last law, I was like, oh, maybe I made a mistake and this isn't what I want to do.
00:44:45
Speaker
because I did not like doing those things. And luckily I got exposure to other areas of law kind of through reaching out and kind of creating my own path during law school. But I think it's really knowing that if you like business problems, if you like a specific area, you can really forge your own path and work on those things as a lawyer that is part of a company's mission. And you can really impact and
00:45:11
Speaker
influence how that company moves forward and delivers products to patients, consumers, whoever you're serving. But you can really have a big influence without having to ever write a brief or a memo or use Westlaw. Well, this has been fantastic. Your passion for patients and the products that the companies you worked for are building really comes through. Thank you so much for joining this episode of The Abstract with me, Lisa.
00:45:41
Speaker
Absolutely. I loved it. Thank you so much. And to all of our listeners out there, thanks so much for listening and we hope to see you next time.
00:45:54
Speaker
If you enjoyed this episode, I'd recommend that you give my interview in Season 2 with June Aro, Head of Strategic Legal Initiatives at the UC Office of the President, a listen. We talk about how to build a culture of inclusion, ethics, and compliance for your organization. You can also subscribe so you get notified as soon as we post a new episode. And if you liked this one, I'd really love to hear your thoughts, so leave a rating or a comment.
00:46:18
Speaker
If you'd like to reach out to us, our LinkedIn profiles are in the description. See you all next week.