Welcome to the Woman of the Week podcast, a weekly discussion that illuminates the unique stories of women leaders who are catalyzing change throughout the life sciences industry. You can check out all our podcast episodes here.
Over the past two decades, Jamie MacPherson has learned to lean in and take roles that earlier in her career she thought were beyond her grasp. No longer content waiting to “tick all the boxes,” and after several successful stints at larger biopharma companies, she is embracing the leadership challenges that start-up companies afford to broaden her skill set and make a difference for patients.
“A lot of times we, as women, offer more than what the position requires and we can learn through the position and grow into the role and beyond, in my case,” MacPherson says.
Today, as vice president of regulatory affairs and quality at Sparrow Pharmaceuticals — an emerging clinical-stage biopharmaceutical company focused on therapies to counter disorders of corticosteroid excess — she’s bringing more than 20 years of regulatory experience as well as recently honed quality expertise to oversee the company’s lead product SPI-62. The oral, small molecule treatment designed to target the source of active intracellular corticosteroids in key tissues is in phase 2 clinical trials, and MacPherson is looking forward to evaluating clinical outcome assessments that will help inform the next stages of development.
“Typically, someone with my title would report to the chief medical officer, who would report to the CEO,” MacPherson says. “At Sparrow, I report directly to the CEO. I’m on the executive leadership team. The impact and the breadth of scope of knowledge and opportunities available to me are very attractive. Having that direct line, I’m hoping to learn more and get exposed to more. In addition to my regulatory and quality responsibilities, I’m getting involved in things like patient advocacy, HR activities and communications.”
While tackling these various functions, MacPherson stays committed to making an impact in the organization as well as for patients, whose voices and perspectives she believes should be considered as part of the regulatory process.
“It’s no longer about just a lab value ... it’s really about how a product helps the patient,” MacPherson says. She looks forward to taking the evolving voice of the patient one step further and understanding whether patients agree with what the industry is looking at in terms of markers of improvement.
In today’s WoW episode, MacPherson shares her views on making an impact, emerging regulatory trends and why the patient perspective is integral to drug development success.
Welcome to the Woman of the Week podcast, a weekly discussion that illuminates the unique stories of women leaders who are catalyzing change throughout the life sciences industry. You can check out all our podcast episodes here.
Join us for the second annual WoW Virtual Event — A Seat at the Table: Secrets to the C-Suite and Beyond
Taren: Jamie, welcome to our WoW podcast program.
Jamie: Thank you very much for having me, Taren.
Taren: It’s my pleasure. Jamie, you currently are the VP of Regulatory Affairs and Quality at Sparrow Pharmaceuticals. Can you please share some of your career highlights that led to your position and then tell me about your current position?
Jamie: Sure. So I’m actually PharmD by training and that really afforded me the opportunity to get in the door, as they say. Early in my career, I was able to join right into regulatory affairs at an entry level and basically, I volunteered for everything. My goal was to learn as much as possible in order to be able to progress. I knew early on that I did want to lead the group and teams at some point and so, really I tried to learn as much as possible in order to give me the basis for doing so.
From there, I continued to apply for jobs that had increasing responsibility and eventually, people management experience. At Genzyme and Alexion, I became a people manager, and I expanded my responsibilities into global regulatory affairs. So not just focused on US responsibilities, but really working with folks around the world. And that afforded me some different experiences and enabled me to feel more comfortable going into more of a startup environment. And also those experiences really broadened my network and that eventually led me to Akcea.
At Akcea I really found my max, really small company environment, the startup feel really gave me a lot more breadth of experience. I was able to wear multiple hats. I did things like the day-to-day work but also, was able to step back and create strategy and really set strategy. And so having those different focuses of my job really was with my needs.
But I have to say, at first, I actually turned down the job at Akcea when I was first offered and approached about the position, primarily because I didn’t feel like I could do it. I felt like it was really a large position and I was a little bit intimidated, to be honest. But a couple of years later, fortunately, the position was still available. The team had grown a little bit more and I ended up taking the position, which I was very thankful for.
Taren: Well, I’m glad that you did take it and you stepped up and you found the courage to do so. Sometimes those roles do feel beyond our grasp. But yet, when you think about it, you don’t need to tick off all the boxes; you can grow into the position. Did you find that to be the case for yourself?
Jamie: I did, I did. And I think often we do that, particularly as women as we look at these job positions that are available, I do feel we feel the need to, as you say, tick all the boxes. But a lot of times we offer more than what the position requires. And too, like you said, we learn through the position and grow into the role and beyond, in my case.
Taren: Excellent. You started to talk about startups. You had mentioned you worked at Genzyme and Alexion which are far larger companies than Akcea and your current company, Sparrow. So what is it about this startup? You mentioned wearing a lot of hats. Does that give you energy in a different way?
Jamie: It does. And I think it’s the growth opportunity. I think as individuals, particularly in an industry and in our jobs, we want to know that we’re growing and learning, for me as well. And so, in a startup environment, really because there’s not a lot of people to do the work that needs to be done and so oftentimes, they look for folks who are willing to take on more. In the case at Akcea, I started as a regulatory professional and there was a need for someone to head up quality. And so, I sort of raised my hand and said why not me and then eventually, became part of my position.
Now, it’s two different leadership styles for me. One, because I grew up a regulatory expert, I am the SME, so I have that content knowledge. I would not say that for quality. So I lead a little bit differently relying heavily on the folks that are the quality experts who are on my team.
Taren: Interesting. How does that duality of leadership fit with your own style? Because as you said, you’re an SME in one area, but yet you’re still learning in the other area. So interesting.
Jamie: Yeah. It’s again, I mean, it’s not to say I don’t empower the regulatory folks that are on the team…
Taren: Sure.
Jamie: … but I do have to rely heavily on the quality experts. I did encounter some quality projects and worked with quality folks in the different experiences that I’ve had along the way, particularly around inspections. At Genzyme, I worked on a consent decree, so I was heavily involved with the quality folks on the team. And so having some knowledge and I like to say I can talk the talk, but certainly the details or the everyday activities, I rely heavily on my team.
Taren: Sure. You noted earlier that you’re a PharmD, which obviously was your entrée into life sciences. So what drew you to the science and chemistry to begin with?
Jamie: It’s funny. I reflect on that question that comes from parents, having children of my own approaching that age of ‘what do you want to be when you grow up?’
Taren: Right.
Jamie: So I really had to think about – I mean, the way I approached it was the areas that I enjoyed. So for me, chemistry, math, sciences, I excelled at it and I enjoyed it. It was something I was very interested in. And so looking at the different careers, I guess, that incorporated those aspects, I did come upon pharmacy.
I did when I was younger, too, also volunteer as a candy striper at one of our local hospitals in town. And my aunt, I used to go in with her, because she was a pharmacy tech in the hospital. So before my shift started, as a candy striper, I hung out with her in the hospital pharmacy. And so it was very cool the IDs and how they dispense the meds and would go with her to the floors and how she stocked the medicine cabinets. It kind of all came together in some ways and I decided that also helping people and bringing treatments to those in need was something I felt passionate about as well.
Taren: Wonderful.
Jamie: So it sort of fell into place, to be honest.
Taren: That’s wonderful. I love that you kind of got that family inspiration that piqued your interest. It’s amazing how sometimes those influences early in your life lead you to a career that you didn’t even think would be possible at the time, right?
Jamie: Yeah.
Taren: That’s a very neat story. Do you speak to your aunt about this? Do you say, ‘hey, you know, I’m been doing this now partly because of you.’
Jamie: I do, I do. Yeah. She’s a cool aunt, so we talk frequently.
Taren: That’s wonderful. So the other thing in going through your résumé in prep for our call today was that, I understand you have a passion for advancing treatments for rare diseases. So where does that passion spring from?
Jamie: Yeah. So to be honest, I wasn’t really aware of rare disease until my stint at Genzyme, which I’m sure you know was very big in rare disease. And really, what inspired me is the patients and their stories. Oftentimes it’s the rare disease aspect, but it’s also how serious and life-threatening these rare diseases can be. And so, having family members also who suffer from serious life-threatening diseases it’s oftentimes a journey for the patients, particularly in rare disease they don’t often get diagnosed right away. Most of the time, you hear the stories of taking 10 years for them to actually get a diagnosis. And then to have therapies that are effective and helping prolong their life and increase their quality of life is really something that is special.
And so, like I said, having family members, not necessarily with rare disease, but serious life-threatening diseases, I can make that connection and how it impacts families, how it impacts their lives, their quality of life and wanting to help.
Taren: You’re right, it’s bridging that gap for these folks. Because there are – when you’re a rare disease patient, there just aren’t the therapies available as if you were in a – looking at a cholesterol medicine or something along those lines.
Jamie: Yeah, exactly.
Taren: So Sparrow, your current company, you’re working in some specific areas. What drew you to the company initially? Was it the pipeline? Was it the culture? Why make that leap to Sparrow?
Jamie: Two things. I mean, the first was the asset, the potential medical therapy. It’s a novel technology where we’re looking at hypercortisolemia and we’re also looking at autoimmune diseases as potential indications. And really it’s like I said, it’s novel. It has a different mechanism of action, and so, it has really the ability… I mean, if the hypothesis works out to be true, it really can have a huge impact in patient lives, patients who suffer from those conditions. So, again, it’s really the impact that attracted me.
And then I think the second thing is just the position at the company. So typically, someone with my title would report to the chief medical officer, who would report to the CEO. At Sparrow, I do report directly to the CEO. I’m on the executive leadership team. And so, it’s the impact and the breadth of scope or knowledge and that opportunity. So, having that direct line, I’m hoping to learn more, get exposed to more. I’ve already, in addition to my regulatory and quality responsibilities, I’m getting involved in things like patient advocacy. I get involvement in HR activities or in communication. We were just talking about being at conferences, and I’m working on this FAQ document for, what if we’re asked questions as we’re out at conferences, what do we say?
So again, it’s similar like I said before about the small company theme is really growing as a professional and learning as much as possible in our career.
Taren: That’s amazing because it does allow you to take a linear path, but at the same time, have all these different outshoots to give you a greater depth of experiences. That’s wonderful.
Jamie: And an impact to the company for sure, yeah.
Taren: Impact and that’s good… I’ve heard you say that several times. So what is it about making that impact? Why is that so important to you? Because you could just kind of – with all of your experience, you could just kind of go along. But impact seems to be very important to you.
Jamie: Yeah. I mean, I could, but I feel like – it’s a lot of my time, as you know, to work. And it’s taking away from families – and not in a bad way, but I mean, you spend so much time and energy in your career, in your job. I think you want to feel a level of satisfaction or accomplishment. And for me, it’s within function, within regulatory and quality, we do have our tasks and we get things done and we have our accomplishments. But I think as a person just continuing to grow and having more to offer, I think. And so, while we’re doing it, while we’re in it and giving our time, dedicating our time, I want to feel that I’m equally successful, I guess. And to me, it’s how I’m impacting the company and the goals and the team.
Taren: Fantastic. Speaking of impact and teams. Over your career, you have no doubt put together some pretty high performing teams. What are some of those keys to your success? What do you look for in those individuals when you’re putting together a team?
Jamie: Yeah, so I mean for me, I think, on my side, it’s being transparent. So it’s clearly outlining the position, what it is, sometimes what it isn’t, as well as the company – what it is, what it isn’t. And in that way, I’m looking for someone who’s onboard, where we’re being clear and open with one another right from the outset. And I think that sets the tone for the type of person that I’m looking for and who I’ll work well with.
The other thing I try to look for is folks who will complement my style. So I have a very, I say, direct, getting stuff done quick decision making… I like making decisions. And so, I know that about myself and so, what I look for are folks who will complement that style. So folks who can dive into the details and are very analytical. Folks who are thoughtful and maybe a little bit more pragmatic in making decisions. And then also folks who are people-oriented. So folks who like being part of a team, they want to contribute to the team, they care about the team. And in that regard, I think it well rounds out everybody and complements everybody style.
And then I think the final thing is, in thinking about it, is probably luck. A lot of it is probably just luck and my personality and who I attract in that regard.
Taren: Yeah, I think you’re a little humble there. I think luck favors those who are well-prepared. So I think you need to give yourself a little more credit than that. I was looking at the company’s profile and you are the only woman sitting in the executive team. Does that give you any different kind of perspective? Do you feel like any pressure in being the only woman on that E team?
Jamie: So I think it gives me a little bit of power. I do think I know – I don’t think – I know that women think very differently. And so, I do feel like I bring a different perspective to the team and I think with that comes power. I do feel a little bit of pressure as far as making sure I’m representing appropriately and making sure that I guess I’m being a leader for the other women in the company, for other women in the industry. So I think it’s a little bit of both, to be honest.
Taren: Fantastic. So speaking of being a leader in the company and for other women, what are some of the best leadership advice you provide to others? And then I’ll ask you, what’s the best piece of leadership advice you’d ever received?
Jamie: I think I would say a couple things. The first I would say is communication is key. I think a lot of the misinterpretations or quick snaps to judgment really focus around communication and the adequacy of communication. I really do think, especially in a world where remote is becoming the norm, I think the way we communicate, how we communicate, how often we communicate really can help not taking things personally, not snapping to a quick judgment and really picking up the phone and talking it through and hashing it out. I think that’s key.
I guess the second thing would be, if I were to tell my junior self 6 or 10 years ago, I would probably say similar to our earlier discussion, Taren, is not to self-limit. The worst that can happen – and I remember my parents and my grandparents saying this to me, “the worst can happen.” And I find myself saying this to my children, “the worst that can happen is they say no.”
Taren: Right.
Jamie: As a younger person, I think that’s just like, so traumatic, the answer no. But really, it’s really the worst that can happen and most oftentimes, I think we’ll be surprised in what it might evolve to, maybe not what it was meant to be or thought to be, but perhaps something even better. So those I think would be the two pieces of advice I would give.
Taren: That’s interesting that you say that even if you are told no, that could lead to something different or even better.
Jamie: Right.
Taren: So don’t limit – I love that. Don’t be self-limiting and oftentimes, that I feel women are. They don’t take the opportunity to stretch or to extend or don’t feel they’re capable of doing that. But at the same time, and we always say ‘if you don’t ask you’re never going to get it.’
Jamie: That’s right. And I think too, in my head I know I’ve oftentimes said, “oh, well, if they wanted me to or if they thought I was capable they would ask.” And I don’t think that’s necessarily the case. If you don’t advocate for yourself or wave your hand, nobody’s going to do it for you.
Taren: That’s right.
Jamie: That’s important.
Taren: That’s true. I mean, I think there are times when you have a mentor or sponsor specifically, who can be that voice for you when you’re not at the table, but at the same time, you need to let somebody know you’re available for that position. You have to let people know that you’re willing to take on that added bit of responsibility.
Jamie: That’s right.
Taren: You’ve also noted a couple of times that you have some children, a boy and a girl, I believe. How do you balance it all? Because you are an active mom. You’re active executive. You are going to conferences as you noted. How do you balance it all?
Jamie: Oh, that’s a question. I just try to do the best that I can. Some days or probably most days, I don’t feel very balanced. But I try to feel okay in every aspect, whether it’s work, kids, time away from kids, I just try to make it work. I don’t know if I have a silver bullet answer for you.
Taren: Listen, they often say too, having it all doesn’t mean you’re doing it all the time at the top. But I think that’s a really honest and transparent answer – I’m doing the best I can. I’m doing okay.
Jamie: Yeah.
Taren: And I think that’s really good, because that’s better than some other people are doing. So that’s awesome.
Jamie: Yeah. I mean, the kids are happy and healthy and at work is happy and health. My career is happy and healthy. So I think I’m doing okay.
Taren: I would say you’re probably doing more than okay. If everybody’s happy and healthy, you’re doing just great. So, because this is our WoW podcast program, I always ask – what is that wow moment that either changed the trajectory of your career or has left a lasting impression on you?
Jamie: We had an experience at Akcea where the asset that we were working on gaining marketing authorization for had some challenges – actually quite a few challenges – with the regulators along the way. And I remember this one particular time where we had just learned from an agency, we had an obstacle thrown at us from one of the agencies, and it was looking like we weren’t going to achieve our goal of marketing authorization. And I remember that around that time we had patients in, as we often did, to tell the story for a few things, as motivation to understand their journey, et cetera. And so, at the time, we sort of all knew, including the patients, that it wasn’t likely to happen. And instead of being angry or blaming or pointing fingers, the patients were so thankful for everything that we did, that we were a company that was trying to help them in several ways and that really stuck with me as a motivator, like what we’re doing really matters to people. Whether it’s successful or not, it really makes an impact for them and really helps them along their journey. Sort of like we were talking about before, maybe if this was a no, it sparked something else that may be able to help patients in a different way.
So that really stuck with me as like I said, motivation and kind of helped me to keep passionate about what we do.
Taren: That’s fantastic. Again it turned something that was a negative into a positive in a lot of ways.
Jamie: Right.
Taren: You’ve been involved in the regulatory space for close on 20 years or so. Are you noticing any trends that are happening with the regulators? Do you find that they’re adopting to new sciences a little bit more quickly? What’s happening in that space? What are you noticing?
Jamie: Yeah. The one thing I’m noticing is, sort of along the same theme is the patient voice. So I really do think that the agencies are considering, and not just considering but really also trying to work into development the patient perspective and the patient voice. It has been trending this way, and no longer about just a lab value, if a medication or potential therapy impacts a lab value. It’s really about how it helps the patient. And then one step further is, how it helps the patient but do patients agree with what the industry is looking at as markers of patient improvement. So they’re really involving patients in the development of these therapies and really want to understand the patient perspective, if that makes sense.
Taren: Yeah, it does. That’s very interesting. So how do you even bring that to bear when you’re putting together a package for the FDA or an EMA or any of the other worldwide regulatory agencies? Because so much of it is based on data. It’s based on qualitative measures. And now we’re talking subjective information. How does that translate into a dossier?
Jamie: So I’ll let you know when I get there. But I mean, what we’re doing at Sparrow at the moment is we’re working with clinical outcomes assessments. And so particularly, with the division at FDA getting their feedback on exactly how we’re getting the patient voice. So it’s a lot having to do with protocols regarding patient interviews and really getting the feedback of what matters to them as a patient. We as industry and physicians can theorize, but the agencies are really like wanting their voice. So we’re putting together protocols that are able to guide interviews with patients in order to get that feedback.
Taren: How long have you all been working on this? Is this fairly new, recent?
Jamie: Yeah. It’s fairly new. Yeah. So we’re about to kick off our phase 2 programs and as part of that, we’re evaluating clinical outcomes assessments.
Taren: That’s interesting. So I haven’t really spoken to anybody about this before. So getting this so early on in the clinical trial process is also new, I would imagine. Usually doesn’t that happen around phase 3 but you’re doing it phase 2.
Jamie: That’s right. By the time you get to phase 3, you really want – you’re testing hypotheses. Right now we’re in the exploration phase. So getting that input as part of our clinical studies proof of concept. By the time we get to phase 3, we want those measures pretty much defined at the outset. And so this is like a precursor to our phase 3.
Taren: Fantastic. And when you’re looking at those assessments from the patient, like as we said, some of them are subjective. What are some of the things that patients are looking at? And it’s got to be more than ‘I just feel better,’ but does it depends upon the category?
Jamie: That’s right. So it depends upon the condition. So for hypercortisolemia, for example, patients complain of sleeping, brain fog, and different sort of aspects that impact their life based on the fact that they have high cortisol levels. So we’re asking for more details and asking them to take a look back over the course of time with different validated instruments to help us understand whether our therapy really impacts those measures that are important to them.
Taren: So you’re working, it’s not just a paper diary, but you’re also working with the device or diagnostic to track those measurements?
Jamie: That’s right. That’s right. So there are certain tools that are available to track those markers that have been used primarily in other conditions. And so, what’s new is that we’re bringing them into the hypercortisolemia arena.
Taren: Fantastic. It sounds like you’re embarking on a lot of new initiatives to move the science forward. So congratulations to you and the team at Sparrow.
Jamie: Thank you very much.
Taren: It’s been delightful to speak with you, Jamie. Thank you so much. And we’ll look forward to how your phase 2 trial turns out. When do you start to initiate that?
Jamie: So we’re in the process of initiating three phase 2 studies. Actually, I think all three are ready for screening patients.
Taren: That’s a big year. Wow!
Jamie: It is a big year. A lot of work.
Taren: A lot of work. So, let me ask you, has COVID slowed down at all or are you still able to tap into those patient populations?
Jamie: It has. I think primarily at the sites, the resources at the sites I think are constrained due to COVID. And so, we are seeing a bit of a challenge there.
Taren: Well, I wish you good luck and as COVID starts to lift – or I don’t even know where we’re going with COVID – but that will all to be determined too, I wish you great success this year and we’ll look forward to seeing some positive results come out. And thank you for spending some time with us for our WoW podcast program.
Jamie: Thank you very much, Taren. I really enjoyed the discussion. Thank you for having me.
Thanks for listening to this episode of WoW, the Woman of the Week podcast. For more WoW episodes visit PharmaVOICE.com.