PharmaVoice 100 Dr. Trish Hurter is positioning Lyndra Therapeutics to do something that has “never been done before:” create drug formulations that allow for weekly — or longer — dosage administration. With several drugs in the pipeline and positive clinical data in hand, she is well on her way to changing the modality of treatments for schizophrenia, opioid use disorder, malaria and more.

Hurter came out of retirement after a successful career at Vertex Pharmaceuticals, where she was instrumental in bringing several life-saving drugs to market, to join Lyndra. As an engineer, she was attracted by Lyndra’s “cool” technology to revolutionize how drugs are administered. Built on groundbreaking work out of the Langer Lab at MIT, and backed by more than 20 patented innovations in design, engineering and material, Lyndra’s goal is to produce revolutionary ultra-long-acting oral formulations that provide steady, consistent drug release for the entire dosing period, which reduces the peaks and troughs of daily dosing, and could improve patient adherence.

Undaunted by the hard and complicated endeavor, Hurter sets big, hairy audacious goals for herself and her team, believing that by setting the bar high everybody rallies and performs beyond expectations.

She was also drawn by the company’s diverse culture, which was purposefully built to represent a 50/50 gender balance and one that encompasses several core values, such as ensuring every voice is heard, resiliency to the core, and teamwork — because drug development is a team sport.

“We believe diversity drives innovation — diversity of thought, diversity of perspective, diversity of background — we have very diverse patients who we're trying to treat,” Hurter says. “It's good to have a diverse company, we have to understand patients’ needs to make products and conduct clinical trials that meet those needs.”

Listen to the podcast or you can also read the transcript of the conversation below. 

Taren: Dr. Hurter Welcome to the WoW podcast program.

Trish: Thank you very much. It's great to be here and feel free to call me Trish.

Taren: Okay, Trish, it's great to reconnect with you. You were named a PharmaVoice 100 last year. And I'm so glad to be able to have you be part of our WoW podcast program. In our interview with you last year, one of the traits that came out was your penchant for setting big, hairy, audacious goals, and then pursuing them fearlessly on behalf of patients. So let's start there. That’s quite a leadership trait, is that something that’s innate for you or is this a skill you learned along the way to the C-suite?

Trish: The big, hairy, audacious goal is a concept that came from the book called “Built to Last” by Jim Collins. I was introduced to this while I was at Vertex, and that seemed like a great thing. And I applied it within my own department to set some really amazing goals that actually we over-achieved on, and I was really surprised by just the fact that you set this goal, everybody rallied around it, and you actually get it done, you know, beyond your expectations. So that was really cool. It's something that I just continue to do. Maybe if I can tell you a little about what we're doing at Lynda, you'll understand why it's really important. We're trying to develop a dosage form that nobody's ever done before: making a pill that will stay in your stomach and deliver your medicine for a week, or even as long as a month. And it's really hard. And it's really complicated. And so, you know, unless we're willing to stick our necks out, and set BHAGs — big, hairy, audacious goals, we'll never get there, basically. And yet, we find that if you set a really high goal, and it seems unachievable, sometimes it helps coalesce people, and you find out that you actually got there. And, because these goals are so audacious, it takes the pressure off a little bit, because everybody knows that you can't really change the world in five years. But if you actually make progress towards the goal, then you feel really good about it. And then the other thing is, if you set a bunch of really aggressive goals, you might make some of them. And then you surprise yourself with that. Whereas if you just set very baseline boring goals, because things always do go wrong no matter what, you're not going to achieve those either and you're going to be way, way further behind than you would have been. I like to stick your neck out, try to do hard things, surprise yourself by how much you're actually able to achieve and celebrate when you do. And if you don't, then say don't worry about it, we learned a lot of stuff, it was great. Let's work on plan B and move forward.

Taren: So can you update me on the company's candidate, LYN-005, a once-weekly oral treatment for schizophrenia?

Trish: We finished our first phase 2 study with that molecule last year, and we're going to start pivotal studies this year, which is pretty exciting. In order to do that, obviously, we had to scale up the manufacturing and, you know, get ready for making basically the commercial product to go into the pivotal trials. That's been, you know, a fun time, we had an interface end of phase 2to meeting with the FDA last year, which allowed us to agree on the revenue regulatory path forward, which is obviously essential. And the reason why we worked on this product is people that have schizophrenia, really struggle with adherence. And the problem is, if you don't stay in here and doadherent to medication, you'll end up having, you know, psychotic breaks and relapses and those, cause your, overall it really does damage to your brain. And over time, cognition decreases and your ability to function normally decreases. So if you stay stable on therapy, on the other hand, you can maintain a good quality of life. And so given the challenges with adherence with people with something like schizophrenia, having something long acting, which means you don't have to take the medicine as frequently makes it a lot easier to stay adherent. And that's basically why we're working on it. That’s a really interesting program. And we're hoping to get that into the hands of patients within a few years, basically two to three years from now. 

Taren: Well, that's certainly an unmet need in the marketplace. I wish you success with that program.

Trish: Thank you.

Taren: And let's talk about another program that also is meeting a big unmet need. And that's the July 2021, Fast Track designation of LYN-014, for an oral weekly, opioid use disorder treatment. Tell me about that program. And that news must have been very exciting.

Trish: That one's a really great demonstration of the value of our technology. It’s for opioid use disorder, which as we all know is a huge issue in America, and it's so easy to become addicted. If you go break a bone, and the doctor gives you three days worth of opioids, a huge percentage of those people will become addicted later. People aren't doing it on purpose, it just happens. And then you need to get treatment in order to get back to having a good life. Medication-assisted treatment, that seems to be the most effective way of helping people to get over their addiction. For example, if you take methadone every day, you have to go to clinic for observed dosing. Not many people have access to clinics, you can't really get your life back on track. If you're visiting a clinic every day, you can't really hold on to a job, if you make that appointment at the clinic every day. Plus, you're hanging out with other people who are struggling with addiction, which is not necessarily the most helpful thing if you're trying to break the habit. Our product is a once weekly level methadone. Going to a clinic once a week is much more feasible in terms of being able to live a normal life and live a high-quality life. This program is supported by the NIH and NAID. We even had a DEA inspection and the people from the DEA thought it was great that we're doing this program, it’s really helpful to them, helping us make sure we all have the right procedures in place for handling controlled substances, etc. Everybody we speak to, are really excited about the potential for this, and it's actually about to start dosing this quarter. We're doing the final meetings with the IRBs and all of those kinds of things. So that'll be exciting.

Taren: That is exciting. You mentioned you're working with a couple of different organizations, you're also working with the NIH, and the Bill and Melinda Gates Foundation, on some global and public health programs, tell me how this work ties into your pipeline, and all that you're doing to address public health equity, because as you just noted, opioid abuse is such a huge issue in our country, and we need to figure out a solution for it.

Trish: So the Gates Foundation, it's kind of funny, the reason I'm actually at Lyndra, is because of the Gates work. I grew up in Africa. And so the idea of helping to eradicate malaria, and helping women in Africa with HIV prevention, and not just women, women and men with HIV prevention, and giving women access to contraceptives so that they can plan their families in a good way, was very appealing to me. And that was one of the reasons why I decided after I officially retired from Vertex, and I was not supposed to take another job, I decided to join Lyndra. When I found out about Lyndra and everything they were trying to do, I was like, well, this is actually really cool. And if I'm lying on my deathbed one day thinking have I had an impact on the world, this would be a really nice thing to do. So that's actually why I'm here. And just to give you an example, the idea behind the malaria eradication program, is that if people have a low dose of ivermectin in their bloodstream thanthen if a mosquito bites them, the mosquito dies. So basically, every adult in the village in Africa that's got endemic malaria is given one capsule, and it lasts for two to three weeks, and anytime the mosquito bites they can’t transmit malaria from one person to another because the mosquito will die before it has a chance to do that. Plus, the mosquitoes can't reproduce because you're busy killing them. Basically, we can eradicate malaria mosquitoes. So I just thought that was a really cool concept. We're planning to dose in the second quarter, and that'll be our first bi-weekly or tri-weekly type dosage form. We are excited to see those data as well. Then there is the oral contraceptive, when I started looking at rates of unintended pregnancies, in Africa, they're pretty high, there's not really great access to contraception for women, and sometimes culturally women aren't encouraged to use contraception. So having something that discreet, and once a month, for example, would be really great. Even in America, rates of unintended pregnancies are about 45%, which is kind of shocking. And I think it just speaks to the lack of good contraceptive choices. The great thing about that program is we can obviously use it for both people in the developing world and people in more developed nations like the US and Europe. So,  another exciting program, and that one we're hoping to go in the clinic with, is our first prototype in the second half of the year.Exciting stuff.

Taren: I'm glad you didn't retire. Obviously, you've mentioned Vertex a couple of times. So, Trish, you are obviously in that hotbed of big biotech explosion in that Boston area. What's that environment like?

Trish: I joined Vertex in 2004. And at the time, it wasn't really a very hot company. It was 500ish people. I mean, it was a really cool company that hadn't really done great things yet, so I was there at the perfect time in terms of helping to grow the company. It was a huge amount of fun. The first drug was Incivek for hepatitis C and then followed up with a number of CF drugs. The most recent being Trikafta, which is a truly miracle drug and as you know, essentially cures a genetic disease with a pill you swallow. Part of what we did with Trikafta was do continuous manufacturing, we were the world's first continuous drug product manufacturing plant. We actually got that going in time for Orkambi, which is one of the other CF drugs, but then used it with Trikafta to go from the first milligram discovered to drug approved in three and a half years, which is basically a world speed record. And that drug is just amazing, you can see testimonials from CF patients all over the place about how happy they are to be on it, and how life changing it is. The cool thing about this and how it relates to Lyndra is that we built this continuous drug product manufacturing plant, which is modern manufacturing, for pharmaceuticals. Traditionally, pharmaceutical manufacturing is actually not very modern at all. And so that was a lot of fun, but it really set me up well for Lyndra. At Lyndra, we're also using modern manufacturing, because we have such a unique dosage form, that we have to invent everything, including how it's manufactured, the machines, and the robots and all that kind of thing. But at the end of the day, instead of having just a pill, which is a nonideal way of dosing medicine, we have this really awesome way of dosing the medicine that makes the medicine the best it can be. If you take a daily pill, you get these peaks and troughs, when you swallow the pill it gets absorbed pretty quickly. So you get the equivalent of a sugar rush after drinking Coca Cola. And then the levels drop during the day. And by the end of the day, they're pretty low, and really not being that efficacious. And then you do the same thing again, the next day, that's not the best way to deliver medicine, you really want to just deliver it at a nice slow and steady concentration right at the target therapeutic concentration. And then of course, people forget to take the medicine. So that means it's even less, less optimal. At Lyndra, we're taking all the stuff that I built a Vertex — the regulatory, preclinical, clinical, the manufacturing and bringing it together to really change how people take medicine, and have a huge impact on health outcomes. It was really synergistic, everything that I learned at Vertex I can apply at Lyndra to do great things.

Taren: That's exciting. And now you've been CEO of Lyndra for going on just about three years.

Trish: Yes, close to three years, I joined Lyndra sort of unofficially in May of 2019, and officially became the CEO in September. I had a lovely four-month transition period, which was really great in terms of getting a chance to get to know everybody and figure out what was what and figure out a plan of action.

Taren: That's great. What has been your biggest aha moment of running the company?

Trish: The first day I walked into Lyndra was pretty funny. Obviously, when I was interviewing for the job, I met some people but I didn't meet the whole team, because having a CEO is something you don’t tell everybody until it's a done deal. But the first day at the company I went to a science meeting, and I walked out with such a huge smile on my face, because I just loved the energy of the team. And it felt great. It was a super diverse team, with a lot of really young people totally digging in and very excited to be there contributing. And I was like, wow, this is really awesome. It's just so nice to just walk in and there's already a great culture and a great team. We spent a lot of time over the last year or so articulating that in words. It wasn't that we were saying we want the culture to be this, let's write it down. It was like, this is the culture, how do we describe it in words. It was more like discovering what words we needed to use to describe it. For example, our core purpose, which is also part of the BHAG theory is that you want to have a core purpose that everybody understands: to reinvent medicine for a healthier world. And then we have our core values, one of which is to value every voice which basically speaks to every team member, whether you're a co-op or an intern, or have been in industry for 30 years — everyone has good ideas and speaks up and contributes. The second one is resilient to the core, which is sort of a play on words about our dosage form, which has a flexible core in the middle of it. But it's really talking about resilience.

Because again, when you're trying to do hard things, you're going to have setbacks, you're going to have obstacles, and you need to bounce back the next day and come up with new ideas and figure out how to solve the problem. And then the third one is all about teamwork. So it's how we contributeI contribute, how we deliver. And we really have a strong ethic of working together. As we all know, drug development is a team sport, and we need to be able to work together well in order to succeed. So that's really the description of the culture. We had such a great team. And such a great culture, this was very heartwarming to me and made me happy, so I basically agreed to take on the job. And now my job is obviously to nurture and continue to keep that culture alive.

Taren: That's excellent. And I love those core values as part of that mission. The company also has a very unique look about it in terms of it being very gender balanced with your leadership team. How did this come about? Was it purposeful, or was it coincidental? 

Trish: It was very purposeful. I mean, the founding CEO was a woman, Amy Schulman. She founded the company along with Bob Langer and Giovanni Traverso, and Andrew Bellinger. Right from the beginning, she purposefully made sure to build a diverse team. And then of course, that self-perpetuates. Because if you walk into the team, as somebody who's either LGBQT or ethnically diverse or a woman, and you have a leadership team and employees are like you, and you're like, hey, this is a company I want to work for. And, so, it's really easy for us to hire women and people from different backgrounds, because, everybody sees they’re welcome here, no matter where you came from, or what your perspective is, or what your identity is. Considering that we're mostly scientists and engineers, having over 50% women in the company, and it's not just the leadership team, it's at all levels, including the board, I think, is pretty unique. And it's definitely what makes Lyndra who we are. We believe that diversity drives innovation — diversity of thought, diversity of perspective, diversity of background. We have very diverse patients who we're trying to help treat. And so it's good to have a diverse company to really understand the needs of those patients and make products and do clinical trials in a way that meets the needs of those patients. 

Taren: It is so important. And I, you articulated it so nicely, that diversity of thought really does drive innovation. And I would imagine, as you said, having that different look about the company, it helps you when you're looking to recruit talent, as we know, there is it's very competitive now to get good people in. So how are you looking to grow and nurture your talent pipeline?

Trish: That's one of the things with a new startup company, you are aggressively doing all these exciting things, and it's easy lose sight of the fact that you need to spend time on learning and development. And we have a new head of HR who joined us recently. And she's awesome. She's an Energizer Bunny. And she says a number one goal is to put in place some great learning and development opportunities for our employees. For example, this year, we signed up with LinkedIn learning, we also have a mentoring program that we're doing. We are making it a point to ensure that we develop and grow our employees, because we have these people who coming out of school who are basically unicorns and they're progressing really, really quickly. We have a guy who's a VP, and he's only been out of school for six years. But we can't forget that we also need to give him the support he needs, he’s naturally a really great leader and manager, but we need to give him the tools to make sure that he's successful. That’s definitely a huge focus for this year.

Taren: If this gentleman's been out of school for six years or so, you obviously identified him as a high potential. What are those traits you look for when you are looking to promote or trying to nurture those high performing individuals?

Trish: That's a good question. Obviously, people who have energy and passion for what they're doing. And, people who really embody the core values, especially the resilience value and value their every voice and people who are willing to speak up and share their ideas. Another example, is another young engineer who works for us, I think he's only been out of school for two years. He's a bachelor level engineer. But he's one of our key technical leads. And while he was a co-op, he actually came up with this idea of developing an artificial stomach to test our dosage forms. And that was his co-op project that has evolved into how we can starttest our dosage forms, we have several of these things. Now they are automated and robotic, and they run in parallel, and they are how we test dosage forms. And that was his co-op idea that he then put into action and then he became a full time employee. He took the idea all the way to automation, fruition and multiplication, so to speak. I think it's about picking people that have that drive and that passion to do great things.

Taren: That's cool. I've never heard of that before, an artificial stomach. And did that have to be approved by the FDA? Or is it?

Trish:

No, it's more of a characterization tool, doing human clinical trials is very time consuming, expensive and inefficient. And it’s also very hard to get great data, because you can't image somebody's stomach while they're having this dosage form in it miniature. So with an artificial stomach, we can do all those kinds of things. We can look at things like artificially changing the size of the pylorus, which is the opening at the bottom of your stomach and changing the contrattraction action waves. Maybe one person's got more vigorous stomach action, another person's got less vigorous stomach action, we can simulate all those things in the lab, we can try different designs of our dosage form and see if we change this feature or that feature if we make the arms more or less flexible. For example, we make the collar more or less stiff, what does that do to change the gastric retention? And then once we come up with a new product concept that we think is worth testing in the clinic, then go ahead and test it in real people. But we can do a lot of testing in the lab a lot more quickly and a lot more efficiently.

Taren: I would imagine that was a bit of a surprise for you, that win. We talked about being more efficient and cutting down on waste. That’s amazing. 

Trish: It's definitely something that we are pushing forward really hard. I think it's essential to have things like that. And it's not just that, if you come visit our lab, we have all kinds of neat testing devices that have been designed by our engineers, and then built by engineers, that are all totally custom built for our unique dosage form insert. If you look at our dosage form it opens up out of the capsule it's got six arms attached to it. So it looks like a star or a flower. So it's not your typical pill, so you can't do typical pill testing. So we need to have different ways of testing it and testing it for robustness to fatigue. As the core flexes, for example, does it tear or does it maintain its robustness. We need to maintain robustness for a week starting out and then going as far as a month. It's great to have these fixtures in the lab and even just the manufacturing process. For example, how do you assemble these pieces together? We have robots, we call pick and place machines, that pick up little pieces and put them into a pack puck and we have a laser welder that welds it and then it gets encapsulated. But again, it's not powder that we are pouring into a capsule, it's this star shaped thing that needs to be folded and then put into the capsules. We have fixtures that were again designed by our engineers that do that automatically, because there are no machines available in the world to do that. We have to invent everything. And all the people who are inventing these are young mechanical engineers who are either co-ops or one or two years out of school. They're really smart, creative and innovative people.

Taren: Fascinating. I have to just giggle a little bit for one second there you almost sounded like you were a Boston native not from Africa. 

Trish: My South African accent combined with living in Boston for a really long time plus hanging out with a lot of Irish people. So I'm pretty Boston.

Taren: That was fun. Thank you for sharing that. That's fascinating. You know, sometimes when we talk about drug development, we don't think about those other components and we think about it just from the drug or the molecule itself not even taking into consideration all those other factors. So thank you for sharing that. We have to talk about the biotech industry. And in the financing piece of this a little bit, it took a bit of a beating at the end of last year. What did you hear from the investor community? Is there room for optimism as we go into 2022? Or are we looking at some, continuing tough times? 

Trish: That's a really good question. It's interesting, because, obviously, being a small biotech that needs to raise money in the current environment is a little daunting. But I guess I tend to be somebody who is just genuinely optimistic and I feel like I've seen these cycles come and go, and we always bounce out of them again, so I feel like we will recover. It's just a case of how soon. I also feel like if you have a really great company that's doing great things, we're going to find investors that are willing to invest. There’s a lot of money out there and people need to invest in something and so I feel like a company like ours, which is really cool and has clinical data and with a very beautiful de-risked product and in this moment that is something that they investors will still want to invest in so hopefully I'm right.

Taren: Hopefully you are right. You talked a little bit about the pipeline earlier, what are some of the key objectives on your list to achieve for 2022?

Trish:The first thing is getting the our lead product into pivotal trials, that's a huge goal for this year and then along with that we're starting to build out the commercial manufacturing. We're going to start building out the GMP aspects and things like that. And then we're also really excited about expanding the remit of the platform. We have our first bi-weekly product being dosed in the second quarter and then hopefully our first attempt at a monthly product being dosed in the second half of the year, so continuing to evolve the platform and show what it can do.

Taren: Is the intention to commercialize these drugs yourself or partner? 

Trish: So we are kind of doing both. For the drugs that are in this CNS space, the psychiatry drugs in particular, there's a reasonably small prescribing market and the patient population is something that's tractable for a small company to commercialize. And we feel like that's something that we can drive much more enthusiastically and with more vigor than if we partner with some large company who might be less interested in the product. So those ones we are planning to commercialize ourselves and focus on are the CNS area. We are not only doing risperidone for schizophrenia as an oral weekly, we plan to follow up very quickly on with aripiprazole, which is the active ingredient for Abilify which is also used in schizophrenia and bipolar disorder which is very complementary to risperidone. So, we can bring the second product along very efficiently. Because a lot of what we built for risperidone is applicable to aripiprazole so we just have to change out the active portion and a lot of the infrastructure is already there so it's a very efficient way to bring a product forward. We think we can launch that one about a year after risperidone. But then in parallel, because we want to have a broad impact, and obviously we're a little company we can't do everything ourselves that's why we are partnering with, for example, NIH on the opioid use disorder programs and the Gates Foundation on the global health programs. We can have a combo where some of them we do ourselves and then some of them we partner with others. We still do the manufacturing of everything because that's the core of our technology and our knowhow, from the clinical to the regulatory to the commercialization — all those aspects which take a lot of effort we'll partner on those other programs that are not part of our core CNS program. 

Taren: Sounds like a sound strategy. You had a really successful career at Vertex before you retired and then became un-retired and became the CEO of Lyndra. What advice can you share with other women who want to progress their careers and to reach the C-suite themselves?

Trish: That's a really good question. I certainly never intended to become a CEO, it wasn't like I had this life plan of moving to America and becoming a pharmaceutical CEO. For me it was always just doing whatever I was doing at the time in the best way that I possibly could. And then being willing to seize opportunities as they arrived. So I think being nimble, flexible and resilient is important. For example, when I was in In South Africa I got this opportunity to come to America and do my master's degree in West Virginia, and I didn't know what West Virginia was like. And I wasn't very good at geography and then I landed in West Virginia and discovered it wasn't really the place I wanted to be long term so then I just researched all the grad schools in America and figured out where a good one would be and ended up at MIT for my PhD. I started in the paper industry, and I wound up getting laid off because my company got bought by another paper company. So even though I had a lovely time for my first sort of six-seven years of my career there, I switched and did something else. I wound up in pharmaceuticals. And then went to Vertex, which was a pretty bold move for me. I went there and there was nobody else who knew anything about drug formulation, I was still very new to the industry, I didn't know much either so I just sort of jumped in with both feet and made it work. I relied on a lot of other people and asked a lot of questions. Just being nimble, flexible and resilient is really important. One of my favorite things is the saying: make it happen. This was good advice someone gave me at the beginning of my career. The difference between people who are successful and people who aren’t is people who are successful make it happen. They don't make excuses about why they couldn’t, they just figure out a way to get it done, whether they get help, they get it done. The third piece of advice I give is build your network. When I got laid off early in my career, it became really clear to me that you need to keep a network going so that when you need help you can have help. It's just something that I have always done. I try to help others when they need help and when you need help, people will help you. This has been a really strong source of moral support and opportunities. It’s also very nice having a wide group of work colleagues and friends that are supportive of you and you are supportive of them.

Taren: Absolutely and you know speaking of the network I think it's even more important for women because there just aren't that many women CEOs. So what does that peer group look like for you? Are you in contact with other women who are in the CEO positions?

Trish: So, it's actually kind of funny, but from my perspective, it seems like there are quite a lot of women CEOs, because I know so many of them. Part of the reason for that is because I’m on the board of Synlogic, and Aoife Brennan is the CEO, and she’s another fantastic CEO. When the whole COVID pandemic thing happened, Joanie Morrison, another female CEOs, who I knew from my network, started a COVID CEO forum, which was originally founded with Atlas Ventures company CEOs, then they expanded it to everybody. And, we had I think over 100 CEOs in that forum. We're all helping each other out to figure out how to manage through the COVID pandemic rather than each of us trying to figure it out on our own. As a small company, we were sharing policies and procedures and for example, we got a COVID testing program up and running as a pilot program then expanded that and we still use that to this day. So it was a really great forum. And actually, in that forum, there are a lot of women CEOs and they are very visible. It’s just interesting. I think they seem more involved and have been more, from my perspective anyway, proactive in terms of managing the COVID pandemic in the way that’s best for employees. So, it's just sort of interesting. I looked up the statistics the other day, and I think there's something like 23% of biotech CEOs are women. I think that number has increased. I think it's one of those things like the more women CEOs there are then the more women CEOs you get. Women start to network and support each other and develop and it kind of grows across the pool. 

Taren: Absolutely I find that whole concept of having COVID CEO kind of cohort fascinating. What are some of the things that you found to be most interesting because as you look to leadership traits and going into COVID and coming out of COVID was there anything struck you as you know particularly interesting, like wow I learned that about myself or I found that I had this in common with so many other folks.

Trish:The people who were in the COVID CEO forum were very data based, very science based so we did what we thought was the right thing based on the science and based on the data. I think when COVID first happened, the initial thought was oh maybe we should all just hunker down, not hire, and find a way to weather the storm and hopefully it will be gone in three months so we can go back to normal. Instead of doing that we went the other way we said no, we're just going to keep going and try to prevail despite the COVID pandemic. And that is what we ended up doing and we did it very successfully. For example, at one time people were saying masks weren’t impactful, but we did a lot of reading and clearly masks are effective, so we got masks sent to us and we did social distancing and initially only had no more than 10 people on site at one time, we did split shifts. Then once we got testing, we started testing our employees every week and then were able to have a few more people on site. And then you as we got vaccinations and went back to more normal for a while until Omicron hit. It was just a very science-based, data based group that just didn what appeared to be the right thing at the time. And all of these companies have actually done quite well. For ourselves, for example the risperidone phase 1 study was due to start in March or April of 2020, and we only started about a month late and then we were hoping to start the phase 2 study in the middle the year before COVID happened, and then we still did in August and we were fully enrolled by the end of the year which is to me kind of incredible that we're able to maintain that pace despite all the COVID complexities. The team was amazing.

Taren: We’ll keep our fingers crossed … you followed the science and you followed the data and you have great outcomes, ironic right how that works.

Trish: To date we've still not had a work-related transmission of COVID. We’ve had people catch COVID from their family over the holidays and things like that. After a holiday, we’ll test three times a week and if anybody has had exposure we say please don’t come back to work till you have a negative test. We haven’t had a single work-based COVID transmission. 

Taren: Kudos to you. You’ve had a very successful career and you’ve given me some pretty good insights about remaining flexible, nimble and resilient but what is some of the best leadership advice you’ve ever received?

Trish: Well my very first job was in the paper company, I met with this section leader who seemed like a very high up person at the time and he was the one who gave me that ‘make it happen’ advice. That was really great advice. Beyond that I think it's more about observing other leaders and seeing what I like about what they do and what I don't like about what they do, which has been the best learning advice for me. For example, one of the things I strongly believe in is when you ask people to take risks and stick their necks out and then, when things go wrong, the worst and most odious thing you can do, is have 2020 hindsight and look backwards and say oh you should have known that would have happened or you should have done this to prevent it or whatever … that's just so obnoxious. One of the things I really strive to do is set audacious goals. We try to do hard things and sometimes it works out and sometimes it doesn't. If it doesn't work out, okay what did we learn? We definitely want to learn from what happened and if you can avoid doing it in the future, great. Be forward looking and not backward looking. I think this is one of the things that is really important for good leaders to do.

Taren: Absolutely, that's why they say God put the eyes in the front of your face so you can look forward. In terms of your career did you have a mentor as you were coming up?

Trish: I've had various mentors. In my very first company, there was a really nice engineer who's about five years ahead of me who took me under his wing and Tim sort of showed me the ropes about what management likes, what management doesn't like. And that was really really helpful and we are still good friends. He's the godfather of my daughter. Then once I got to Vertex this was the first time there was a woman who was in leadership. Vicky Sato was the president of Vertex and I was very impressed by that and it was one of the reasons I joined Vertex, I really was happy to have a woman in leadership. Then she actually ended up leaving Vertex the year after I joined, which I was a little bit sad about. Then another woman who was senior to me suggested we get together with her for drinks and chat every now and again and so we started doing that and she's really been a hugely helpful mentor to me throughout my time at Vertex and now at Lyndra. She actually was instrumental in introducing me to Aoife Brennan which is how I got on the board of Synlogic and she actually introduced me to Amy, which is how I became CEO of Lyndra. When we started having drinks 15 years previously, I never thought oh one day Vicky could become a great mentor and help me be a CEO. It was the furthest thing from my mind that's why I say just know your networks. Don't do it for any sort of short-term purpose, do it because it's great and then you know sometimes it really helps and pays off in the long run.

Taren: Absolutely and build that network before you need it as you noted earlier because when you need it, it's hard to get it up and running in an instant.

Trish: Right. Amy Schulman who was the CEO of Lyndra, recruited me to be the CEO and to be her replacement and now she’s the executive chair and she’s somebody who provides me with a lot of advice and support and coaching and everything else. Another really successful woman who has been very helpful to me. 

Taren: What are you doing in your company to help women, I know you said it's a 50/50 gender balanced organization, which is again highly unusual especially in the biotech space especially when you’re dealing with so many engineers, is there anything specific that you all are doing to help women? 

Trish: I really like to think about diversity as being not just a woman thing, but all aspects of diversity. One of the great things about diversity is there is diversity and inclusion and inclusion is the important part. If you have inclusive leaders, then basically everybody's going to do their best. If you have an inclusive leader who's listening to people’s ideas and encourages people who are more introverted to speak up as well as the extroverts. Then that makes everybody perform better and it's a nicer place to work for everybody — whether or not you are considered to be part of a diverse group, or even groups that are considered not diverse groups, for example white males who are straight. People don't think of those people as being a part of diversity, but they are. And even people who are white, men who are straight, are very diverse. I mean some are tall, some are short, some are fat, some are thin. Diversity is just saying everybody is able to contribute, everybody can do their best work because they are listened to and they feel appreciated. So, that's really core for me. I really don't want it to be the women versus the men kind of thing. It’s got to be a win-win not and not a we win and you lose kind of thing. Our diversity and inclusion team is one team that supports all kinds of diversity. We don't have a women's group, or an ethnic diversity group, or an LGBQT group. Obviously, we have some activities that are sometimes more special to one particular form of diversity or another. But, it's one team. 

Taren: I think that's such a fascinating and interesting way to look at it. Thank you so much for articulating it so beautifully. There's diversity even among the diverse. So that's great. Finally, my last question. Tell me about an accomplishment or a WoW moment that either shaped your career or changed the trajectory of your career. 

Trish: When I was at Vertex, we really kind of grew as a company and we hired great people and developed our capabilities internally and became a fully integrated pharmaceutical company and we worked on all these cystic fibrosis drugs and we were trying to go faster and faster. And every time we came up with another drug, we tried to do it faster and the continuous manufacturing that we built allowed us to do … I was telling you earlier about Trykapta and get that really fast. Basically, all of that experience, I was head of regulatory and I did preclinical and manufacturing and everything else, really set me up to be able to help Lyndra get to where it needs to go. Lyndra is going to change how people take medicine, which is really cool so I think it's really the culmination of everything that I've learned in my career just coming together in the most amazingly appropriate way to set up to do this thing that I think is going to be transformational. I think that's really exciting and keeps me going.

Taren: I would say yes and congratulations to you. What a wonderful set of steps you've taken and the progress you're making with the pipeline to meet an unmet patient need is just tremendous. Thank you Trish for being part of our WoW podcast program. It was wonderful to speak with you and I want to wish you continued great success.

Trish: Thank you very much, I really appreciate it.

Thanks for listening to this episode of WoW, the Woman of the Week podcast. For more WoW episodes visit pharmavoice.com.