Woman of the Week: Reneo Pharmaceuticals’ Ashley Hall

Ashley: Honestly it was the people, which I think personally is a really important part of my career for me and is who you work with. It makes such a difference in your daily life because, at least for me, I put so much into this career that it’s all consuming. Getting to work with good people is really key for me at this point.

The founders, Mike Grey and Niall O’Donnell, I’d heard very good things about them. I had not worked for them or with them before. Greg Flesher, my boss, the CEO of the company, he and I just really hit it off and I knew I wanted to work for him. I thought that was really the initial draw, him and Mike Cruse, I wanted to be part of their management team.

Then I really, really wanted to go back into either oncology or the rare disease space. I was excited to see the opportunities that Reneo had with mavodelpar. I did a lot of diligence on the company before I started and I thought the program looked really well along and had a nice regulatory history, which is important to me as a regulatory affairs person. I liked what I saw, and I knew that I could contribute. Those were the key drivers for me. It’s been a great experience. I think Reneo has been my favorite job so far.

Taren: Fantastic. You just classified yourself as a regulatory affairs person, but your title is chief development officer. Tell me how those two reconcile themselves.

Ashley: It’s interesting. I started my career in regulatory affairs. My background is in science and I’m also a lawyer. The regulatory affairs part really fit nicely for me. I spent most of my career doing that. When I was at Esperion, like I said, we really were starting the company from, I think I might have been employee #24. So, we were really growing the company. I started at a time point where there was a lot of overall development that needed to be done. I just kept working through regulatory affairs and was fortunate enough to have a really good mentor. I started overseeing more and more departments and ultimately was promoted into the chief development officer role. At one point or another I think I had 10 different departments that reported up through me all the way from project management to research and development.

I think my regulatory affairs background really taught me how to develop drugs. You work on everything in the regulatory affairs role from chemistry manufacturing controls, what they call CMC, as well as all the R&D and the clinical trials. I think I just really went all in on learning everything. So, I learned the full scope of development and was lucky enough to have someone help me with my career and move me into the C-suite.

Taren: That’s interesting. It sounds like you were a conductor, right? You’ve got all these different teams and they all have to work – no pun intended – in concert. And you’re the traffic cop there, right?

Ashley: Yeah, I think that’s an interesting way to look at it. My overall job is to develop a drug and get a label and then other people come along and commercialize and launch the drug. If you think about it, I don’t know how many people read drug labels, but having written several of them, it’s a small piece of paper in the end and all of the different data that goes into there comes from all these different functions and departments. It actually to me makes total sense that a regulatory person who ultimately is responsible for the labeling can learn and put all of these things together into this one ultimate vision of a label. Yeah, I think that’s a really good way to describe it.

Taren: Let’s hope everybody is reading the drug labels, Ashley, otherwise we’re in big trouble.  

Ashley: I hope so.

Taren: Working in rare disease really requires a special sense of resiliency almost because the patients are just so underserved and they’re in need of treatments that are just not there yet. What keeps you and your team going during times of stress and disappointment?

Ashley: I like this question. You’re right, the rare disease patient community is actually truly amazing. They’re really involved in the process of their disease and trying to find treatments for it. It’s really an amazing group of people. I think that the stressful aspects of just trying to enroll trials where there’s few patients and you have to go to many different countries, all of that, interestingly for me, I actually thrive on that. I’m one of those people who I think I might stress the small stuff but I for some reason don’t stress the big stuff.

When real challenges occur, especially in drug development, it’s like a rollercoaster – I don’t know… that to me kicks me into high gear and I tend to just go and lead and try to figure something out.

It’s funny, my head of R&D, he calls me The Fixer. I think that’s where I kind of shine the most is in areas where it’s like things happen, and you don’t know what to do and no one’s ever done it before. That’s where I shine. I have to sort of worry about when the small stuff starts bothering me. But the big stuff is where I shine the most. I think the team and the patients is really what ties it altogether for me. When you look at these patients that have these horrible diseases and how strong they are, I think there’s no way I’m going to quit on them, if that makes sense.

Taren: Absolutely. I love that. I love that he calls you The Fixer. You talk about having some job security there.

Ashley: I’m just one of those people who never gives up.

Taren: Are you a first-born by any chance?

Ashley: No, actually I have two older brothers. I am the youngest of us three, and I grew up in a family of only men.

Taren: Okay, now I know why you’re The Fixer – never mind, not to generalize, but now I get it. When we talk about the company’s pipeline, you received some positive results in March around a drug called mavodelpar. Tell me what this means for the company.

Ashley: Actually, we haven’t posted our results yet, but we had some exciting news. We released that we fully enrolled our pivotal study that we call PRIDE.  So now we have the study fully enrolled. We targeted about 200 patients. We are in approximately 13 countries. That’s a really big deal. This is not a lot of people because it’s obviously a rare disease. I’m really proud of the team. Honestly, I think we have one of the best clinical operations groups on the planet. We were smart.

We went into multiple countries and just have been working really hard for, I think it’s been maybe two and a half years, to get this study enrolled. Huge challenge with some amazing people on my team that just, they go at this every single day. But as you know, fully enrolling a study is a big deal for our industry. So now that we’re fully enrolled, we are going to run the trial out so we can firmly set our timelines. We’re super excited to put out topline data at the end of this year.

Taren: That’s terrific.

Ashley: For what I do it’s the most exciting thing to do. We love data, so we can’t wait to get the data.

Taren: Absolutely. I was going to say, in two years… now you started this I the middle of COVID, so hence, that probably took a toll too on the enrollment rates.

Ashley: Yeah, it was really hard to ramp up a study, a global study like that during a global pandemic. Again, kudos to my team and to our vendors as well for just persevering. We put a lot of virtual aspects into the trial to help the patients because they’re patients and they’re sick, but also to make sure that the study is convenient. I think that’s someplace where our industry is going is trying to make clinical trials easier for patients by providing concierge services and different things to help the patients get to their visits and make sure everything’s good. We’ve done all those things, put out all the bells and whistles for the trial, and we’re just in a great spot.

Taren: Fantastic. I was going to ask you about that because we are seeing trends where they’re trying to bring trials to patients rather than patients to the trials. And you think this is going to continue to evolve?

Ashley: Yeah, I really hope so. I mentioned before that I was running a cardiovascular outcome trial at my last company during the global pandemic when it started. That was a really long trial. We really had to do a lot of work to make it a hybrid virtual trial. I think some of the things that we learned from the global pandemic pertaining to clinical trials, decentralized trials and whatnot, is actually wonderful. I think there has been a lot of regulatory flexibility and I think that’s wonderful as well. The FDA and regulators, they have a hard job; they have to protect the public health, but I think they really allowed a lot of creativity. I for one even offered up to the FDA our experiences running this large trial so that they could learn the areas where we made really good decisions. Hopefully they look at that and said, ‘you know what, it can be done a different way sometimes.’ Right? I think it’s wonderful. I’m super into progress.

Taren: I love that. You have to be future facing because otherwise we just go back to the old way of doing things. The pandemic was horrific on so many levels but there were a couple of those silver linings that you just identified that can help ease the path for patients, I think.

Ashley: I work in the cutting edge of science, and I like that. So, to do that kind of job you have to be someone who paves the way. That’s, I think, probably one of my favorite things about my job is seeing creativity where I can and making things better.

Taren: Perfect. What are some of your goals for 2023?

Ashley: Like I said, we fully enrolled our study. So, from a Reneo perspective, we have a lot to do. Obviously, the biggest goal is to put out our topline data. That’s a huge task. We have to clean the database and then lock it. We have a bunch of regulatory submissions we need to do. We need to start working on our pre-marketing application submission packages and things like that. What we do is we pre-write the marketing applications and that way we can drop in the data and that way we can hopefully go as fast as we can so we can ultimately get a drug that works to our patients. We’re just working really, really hard on delivering the details that we need and the data that we need for the marketing applications with the hope that we have positive results.

Taren: Wonderful. When do you anticipate- let’s say all goes well with the clinical trials, when do you think you’ll be able to – and will the company bring the drug to market on its own?

Ashley: We are certainly working on that and planning for all of that. We have a really strong management team. We will go as fast as we can. I’m a pretty strong driver. One of my things is to move swiftly and efficiently. The fast as possible is what we’ll do. We will definitely be submitting marketing applications in 2024.

Taren: Wonderful. Thank you for that. You just noted that you’re a driver and you’re all about efficiency. What are some of your other leadership strengths that you bring to the table?

Ashley: I think on the leadership side, there’s so many different components, but I think probably for me the one area where I tend to shine, I think, is in just the vision. I’m one of those people who knows exactly what I want and how to get there. I think that’s really key. You have to set your intention. There’s a million different ways to do something. But you have to set your intention and then you can get there. I think that’s one of the things; I can see it. I see the big picture. I think that clear vision and strategic path, I just know it. It’s there for me, it’s palpable. I think that that is probably one of my good leadership strengths. I guess the other thing is, at least what people say to me, is that I’m a very real person. I think that’s kind of a cool compliment that people find me to be an accessible leader.

Taren: Perfect. Thank you for sharing that. As we look at the bigger picture and we think about what’s ahead, what are some of the trends that you’re tracking in terms of either the rare disease space or the regulatory space?

Ashley: I think in the rare disease space, the biggest challenge I think we have is to enroll trials. I know with the FDA particularly; they are willing to accept a single randomized control trial. They really want randomized control trial and that’s a little bit challenging. They also want confirmatory evidence of efficacy. I think that’s something that they’re really emphasizing in guidelines these days. I think from what I can see, the regulators are really asking you to look at the totality of all of your data, your mechanism of action, your efficacy, your safety and how it all fits together into a logical picture. I think combining your two questions into one, I see the rare disease space and the regulatory space, and it’s like this already, but sometimes people go in thinking, ‘it’s a rare disease and it’s an unmet medical need so I don’t have to do a bunch of stuff.’ But you do, right? You need the science, and you need the data, and you need to be science driven and I think that’s what the FDA is asking us to do in the rare disease space and put together a solid regulatory story. That’s what I like to do and that’s what I do, and I think that’s what the regulators are really asking us for.

Taren: Fantastic.

Ashley: A lot of people are what size trial do you need and how many people do you need? There’s no single answer to that. What you need needs to be logical, right? It needs to be science driven. How big of a trial you’re going to do needs to be based on sound statistics. I think doing randomized, a lot of people want to try open label studies and the FDA wants randomized control trials. I think, from my experience with global regulators, EMA as well, I really think they’re willing to work with industry on these things. But you have to be transparent.

Taren: I think that’s exactly right. Perfect, thank so much for sharing that. Something to look forward to. More transparency. It sounds like you’re really in favor of quantity over quality, right? As you said, it’s not how big the trial is, it’s the quality of the data.

Ashley: Yeah, exactly. If you take a step back, people are always like what’s the end point for this or that? There may not be a one size fits all. No one’s ever done it. There’re no guidelines for- The disease that we’re working on is primary mitochondrial myopathy. It’s a genetic mitochondrial disease that impacts your fatigue and your muscle weakness. There’s no roadmap for this. No one’s ever done this. That’s where you have to really think about what you’re trying to solve.

Taren: Got it. Perfect, thank you so much. Hence, The Fixer comes back into play. You mentioned earlier that at one point you were orchestrating ten or so different teams. In each of those teams has been comprised of strong teams, comprised with really strong team members. What are those qualities you look for when you’re looking to build out a high-performing team?

Ashley: Hiring good people is really key, especially when you’re in a role like mine and you have several different departments that have to work together. You really need to hire good people. For me, I look for good people, I think high-performing teams are usually ones that have a lot of trust in communication. Those are the two keys for that. I think people need to get together. I’ve worked in virtually for ten years now, so it’s been an interesting experiment. It’s mostly gone well. I think one of the keys is getting together and spending some quality time. One of the reasons I love my current job at Reneo is my boss, Greg, is really good at that, bringing people together and actually having people have fun. I think this has really helped people form trust and have the ability to communicate with each other. When you have those facets, and you actually want to work together then you’re going to have people perform at the top.

Another reason why I like rare diseases, I feel like actually probably across this industry almost anything I’ve done, it’s a really passionate group of people. I don’t know if we have the reputation in our industry that we necessarily should because I’ve worked with just amazingly committed people to what we’re doing to the patients and everything. I think another thing about a high-performing team is you just have to monitor toxicity. I like working with happy people and so that’s one of the key things I work on when I hire people as fit. If you have someone who’s toxic, it just isn’t going to work. As a leader you have to deal with that right away is what I’m trying to say. One toxic person can just really kill a team to be honest. It’s fun, happiness, trust, those things. I guess the way I like to lead teams is just having good energy and a good vibe about it. Does that make sense?

Taren: Yes, it does, absolutely. You touched on a couple of things there. Certainly, the industry’s reputation. I agree with you. We talk to so many people who are so passionate, so driven for patients. And yet the industry just doesn’t have that, I don’t think the general public understands what goes into some of this. All they see is prices. All we can talk about is the prices of drugs and what goes into it.

Ashley: We work 24/7 on this. All the people that I work with, everyone on my team, we really genuinely care.

Taren: That’s wonderful. You had mentioned earlier somebody who had been a mentor to you. Is this somebody who had a particular influence on your career?

Ashley: Yeah. It’s a really good question. I’m thinking maybe I’m really lucky because I’ve had a lot of really great mentors in my career. My first regulatory boss, her name is Lisa, she’s actually one of my boss friends to this day. She was a great initial regulatory boss. She kind of brought me out of my shell. I might have been a little more shy back then. She’s a funny person, really smart and a really good writer. I think she also made it fun. She really championed my career and helped me grow.

Honestly, I feel a lot of people have, and some really strong women, Linda Peters from Medimmune, she put me through an executive woman’s leadership program, and it was amazing. I also had an executive coach for a really long time, Dina Litman, and I think she really helped my career, and I loved having an executive coach.

And then my last boss, Tim was a great mentor. He really championed my growth. Obviously going from regulatory affairs to the C-suite was a big deal. My current boss, Greg, is a great mentor. Maybe I’m just really fortunate I’ve had some great bosses and some great people in my life that really helped me with my career.

Taren: Fortune favors those who are prepared to take advantage of those opportunities.

Ashley: That’s exactly what my father always said to me. I didn’t realize it was a quote, but he always would luck favors the prepared mind. It’s my favorite quote and it’s exactly how I function. I love that.

Taren: Excellent. Moving into that C-suite, it put you in some rarified air. Do you consider yourself to be role model?

Ashley: That’s an interesting question. I would love to think that I could influence people in a positive way. I think I’m a role model in the sense of I really want, I genuinely want people to be the best version of themselves that they can be. But I also really appreciate the individuality of people. I think there’s a lot of different ways to be. There’s no one particular way to be. Obviously, no one would have to be just like me. I think that if people see something in me that wants to make them be a better version of themselves, then that’s a very good thing.

Taren: It is a very good thing. I’m going to advise you to take that “think” out of there. You are a role model. You mentioned early on in our conversation that you were a lawyer and that you came from a family of all men. What drew you to the life sciences industry? You could have been a lawyer for anybody?

Ashley: I always loved science. I was one of those people, I read a lot of books when I was young. I grew up in Lake Tahoe and everybody was skiing, and I was reading. I loved to read biology books. I just always loved science. I have a very philosophical father and so he was very well read and had a lot of books. I just always loved science. He said he wished he could have been a doctor, so I really latched on to being a doctor when I was young just because my father was very influential over me. I set out a course for studying science and was going to go to medical school.

Interestingly, one of my professors at UCSD who was my favorite professor; I was the top of her class in biochemistry. I asked her for a letter of recommendation for medical school and she said that she would write me a letter of recommendation for medical school and a letter of recommendation for law school. I was like law school? She said that I should be a lawyer and that’s how I was going to change the world. She asked me to really think about it. I also went on rounds with one of the doctors I was doing an internship for and realized I’m probably not the best person to help actual sick people because I don’t like blood, guts and things like that. That’s sort of how my career got into regulatory or life sciences. I love science, I also like to argue so the lawyer part is good.

Taren: Ashley, that’s funny. I guess you have to be able to tolerate bloods and guts if you’re going to go into being a doctor, right?

Ashley: It was eye-opening. I was like wait a second, these people are really sick. I like the science part and the medicine part but not necessarily the actual sick part.

Taren: That’s very funny. That’s great. Dad wasn’t disappointed, was he? I hope not.

Ashley: He was a little bit actually. He’s one of those dads that, I know he’s really truly proud of me, but he doesn’t tell me, he tells everybody else.

Taren: I love that. God forbid, he tells you, right? What’s the one thing that most people don’t know about you?

Ashley: There’s probably a lot of things, but the one thing that people probably don’t know about me, is I actually left home when I was 15. I tested out of high school, and I ran away to college.

Taren: You were a prodigy.

Ashley: I didn’t have the greatest of all childhoods. I had already been taking care of myself for so long that basically I went, and I could just live on my own. I was good at money. I had a bank account; I had been working since I was 12. I saved up a bunch of money and I felt like I would get more out of college. Interestingly one of my counselors and one of my teachers, my favorite teacher, Dick Wingle, from North Tahoe High, they all told me, Ashley you should just go. You should just go to college at this point. So, I did. I paid my way through nine years of college completely on my own working in the five-star food industry where I was both a waitress and a chef.

Taren: Wow. That’s incredible. You talk about bootstrapping your way through. How resilient you had to be and how smart you had to be to figure that out at such a young age.

Ashley: It was hard to even rent an apartment because I wasn’t old enough to sign a contract, to sign a lease. I was actually very honest about everything. I found people that would help me because of that, I think.

Taren: You have to be resourceful in ways and really think outside the box.

Ashley: I think most people see me now and have no idea that I came from such a difficult background. In fact, I’ve even had people comment, it seems like I came from a more perfect scenario, which I did not.

Taren: What impact do you think that has had on your career? Do you think it’s made you more resilient? Has that lead to some of your leadership strengths? This is a tough conversation to have. I’m curious.

Ashley: I think I am extremely perseverant. It’s been one of those things. I guess I always knew what I wanted, and I knew what I didn’t want. I was enormously committed to hard work. I worked really hard. Even at UCSD, I worked full time. I think there’s not a lot of people that had to do that. I worked full time then; I worked full time through law school. I’m just used to working really, really hard. I think I’ve been very fortunate for that. Hard work.

Taren: Most people come out of having such a difficult or challenging childhood don’t often, are not as optimistic as you and upbeat as you and embody joy and fun like you do. You may have been bruised but you weren’t broken for sure.

Ashley: Exactly. I definitely had some down times, especially it was difficult to pay my tuition because I had to pay all my tuition without loans for my first degree. It’s like one of those things- I remember someone broke in my car because I couldn’t afford to part on campus because it was expensive. So, I parked off campus and walked really far. Somebody broke into my car, and I didn’t have enough money to fix the window they broke. I wasn’t about to drive around with duct tape. I called my dad, and he said go to the junkyard and find the same car and take out the window and then I’ll tell you how to put it back in. So, I did. I actually can change stuff on cars.

Taren: So glad you become a MacGyver.

Ashley: You kind of have to, right? Survival.

Taren: Survival of the fittest and you came out on top. You’re a tough cookie. Thank you so much for sharing that personal side of you. We don’t often get that, and I really appreciate it because it really adds such a dimension to you and to your career. It puts things in alignment for our listeners that not everything is perfect and yet you still come out on top. Good for you. I don’t mean that in a patronizing way either.

Ashley: I appreciate it. I really do.

Taren: That’s an amazing story. Thank you so much. After all of that, I’m going to ask you the wow. What is that one moment? Please don’t tell me was somebody breaking into your car.

Ashley: I’ve had good wow moments. I think one of the biggest moments of learning that I had; I have a little story. I was doing this personal growth thing where I was doing low ropes and high ropes courses. During this week I had to pick a teammate. Actually, you got one teammate, right and it was kind of random. But this person picked me to be their teammate. I didn’t know them at all. One of the things that we were supposed to do is one of those trust falls, and you’re supposed go on this tall, actually really high thing, and fall back into 12 people’s enlaced arms. Everyone was supposed to do this. You and your partner, the partner would stay on the ground and the other person would go up on the big stand to fall backwards. You’re supposed to communicate. There was like a little dialogue that you had to say. Because you were going to fall backwards and you couldn’t see so your partner was like your eyes on the ground, if that makes sense.

Here I am with this person, this random person I never knew before who picked me to be their partner. She could not get the dialogue. It was simple. It was like, I’m ready to fall now, or something like that, just simple dialogue but you had to do it exactly perfect. I wanted to get it over with because I was super scared. There’s a lot of people, there’s like probably 40 people that had to cycle through. I would go up there. She would blow it on the dialogue. The coach would send me back down. I got really mad. I was really annoyed. The coach comes over to me and he goes “you’re really mad.” I’m like “Yup. She can’t do this.”  He goes, “no, no, you’re the one that’s failing.” I was like “No, I’m not. She’s failing.” He was like “No, you’re failing.” I was like “No, I’m not. I can do the dialogue, I’m ready to go, she can’t remember like four things.” 

She’s standing there and he goes “Nope, you’re a failure.” I was like “I don’t understand why you’re telling me I’m failing when this has nothing to do with me; it’s her.” He goes “You’re a team.” I said “okay.” He goes “If she fails, you fail.”

It was the first time in my life where I realized that I was a team and that if my team fails, I fail. I told you, my story. I’m a survivor, a soloist. I just had kind of done so many things by myself for so long that I didn’t realize the true meaning of a team until that one moment. Then I realized I got to get her to do this, right? I need to help her.

The coach left and I looked at my teammate, my partner and I said how do you memorize things? What’s going on? Are you nervous, what’s happening? We had this long chat and I realized she was a really nervous person. She had stage fright and all these other things. I was like do mnemonics; how do you memorize? I prepped and prepped and prepped and prepped and prepped her and we finally go up there and she finally does it and I finally fall backwards into these 12 stranger’s interlaced arms and basically, I learned that that is a core of a teammate. It’s not just me. I have to help, everybody has to succeed, and I have to help my team succeed or I fail. To me that was like I think the most transitional part of my life in terms of going from being just a sole survivor to someone that really has to partner with people and lead.

Taren: That is a great wow moment. That is amazing. I thank you so much. That is really, it gets to the core of who you are and gets to the core of what this podcast is about. It’s about those stories that bring to life what it means to be part of a team, what it means to be part of a bigger ecosystem. Thank you so much for sharing that. That’s something. Have you ever gone back up into the tree again?

Ashley: We had to do all kinds of stuff in those days. Some of it was just crazy. Yeah, we really needed a teammate to get through that week and do, like I climbed a 60-foot pole and all kinds of stuff and jumped off of it onto a trapeze. Anyways, I haven’t done another trust fall, but I learned a lot that week, learned a lot about teamwork.

Taren: I think one fall is enough, right?

Ashley: It was really high too. It wasn’t just a short fall.

Taren: That would be terrifying. You obviously have, you’re no longer a sole survivor, you are now like a champion of teams. That is quite the journey that you have taken through your life and through your career. I can’t thank you enough Ashley for being part of our WoW Podcast Program. Thank you so much for being so transparent and authentic with us and so many great insights. I wish you great success on going forward and look forward to seeing what’s next.

Ashley: Thank you and thank you for championing women. I think it’s a wonderful thing and I really enjoyed talking to you today.

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