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.

It’s not every day that you walk into a job interview for one position and are immediately redirected to another department. But for Diane Stroehmann this fortuitous turn of events is what set her up for a successful career in regulatory affairs.

Fresh out of college with a degree in biology and a minor in chemistry, Stroehmann was job hunting and landed an interview with a pharma company for a finance position — it was a position outside her comfort zone, but bills needed to be paid.

“I walked in ready for my interview, they looked at my CV and they laughed, and I thought, ‘Oh, this is not a good start,’” Stroehmann said. “They walked me straight to clinical research, and I talked to the head of (the department), and by the end of that interview I had a job. This was my foray into the pharmaceutical industry.”

After several years working in a research capacity, Stroehmann leaned into her insatiable curiosity and found that the variety of learning opportunities in regulatory affairs suited her personality perfectly.

“I was a sponge and I wanted to learn more,” the now vice president of regulatory affairs and global patient safety, said. “When I moved to a job where my title was regulatory affairs associate, I got to do a little of everything. The company brought me in for my experience with the chemistry manufacturing section of submissions, but I got to learn labeling, I got to learn negotiations with the FDA, I got to learn the publishing side, I got to learn the true strategy side of things. There are just so many facets to regulatory affairs. Also, I got to work with so many different departments — clinical, biostats, medical affairs. I really enjoyed the variety as well as the collaboration with all those different teams. I really feel like that’s why I stayed in regulatory, and it’s really been the foundation of every career step I’ve made since that time.”

Since those early days, Stroehmann has led the submission and approval of several drugs as well as biologics and devices. In fact, while at Kythera she oversaw the team that was charged with leading Kybella through the regulatory process for an aesthetic indication, which included not just the NDA but a 17-person FDA advisory committee review. 

Along with receiving a unanimous vote, their strategy and plan were lauded by the Pink Sheet as a best-in-class blueprint as to how to work with the FDA on clinical outcomes assessments.

“To get that recognition and to be highlighted for all that hard work was quite an amazing experience,” she said.

Stroehmann continues to use this experience for how she works with the FDA as vice president regulatory affairs and global patient safety at Ironwood Pharmaceuticals. Recently, the company reported positive top line phase 3 results for pediatric patients for its flagship and blockbuster IBS product Linzess.

“If Linzess is approved for children 6-17 years, it will hopefully fill that unmet need for all these kids who suffer with (functional constipation) today. So, we’re really looking forward to talking to FDA about our supplemental NDA application, which will actually be submitted later this year,” she said.

In this Woman of the Week episode, Stroehmann shares the complexities involved with pediatric clinical trials, the rewards of taking a stretch assignment and turning it into a career-defining moment, and why she believes more women in STEM can open the door for future generations of women.

Welcome to WoW, the Woman of the Week podcast by PharmaVoice powered by Industry Dive.

In this episode, Taren Grom, editor and chief emeritus at PharmaVoice, meets with Diane Stroehmann, vice president regulatory affairs and global patient safety, Ironwood Pharmaceuticals.

Taren: Diane, welcome to the WoW podcast program.

Diane: Taren, thank you so much for having me today.

Taren: I’m excited to dig in. First of all, let’s talk about what initially drew you to the field of regulatory affairs. I see this as a constant theme throughout your career.

Diane: Sure. So I have to admit, when I first started out, I had no clue what regulatory affairs was, what it meant. Going back to fresh out of college, I had a science degree, and I actually had a job lined up in pharma with a big pharma company and it fell through at the last minute, and I thought ‘oh gosh, I need a job, I need to pay my bills.’ And so I hooked up with a contracting company and they actually sent me to a pharmaceutical company, but to work in the finance department of all places and I thought, okay, short term I can do this. I walked in ready for my interview, they looked at my CV and they laughed, and I thought, “Oh, this is not a good start.” They walked me straight to clinical research and I talked to the head of clinical research, and by the end of that interview I had a job. And so that was my foray into the pharmaceutical industry, which also I didn’t know much about at all. It was a great couple years working in clinical research, and I started to get exposure to regulatory affairs.

I ended up moving on to another company where I also worked in clinical research, but they were short on folks in regulatory affairs and I kind of raised my hand and said, “Well, I’d like to learn more” and that’s when I really started to get a feel for it. I really enjoyed it and I thought, “I think this is what I want to do.” After that, I moved to a company where I used my background. I have a degree in biology but I also have a minor in chemistry, and I was able to work with that chemistry knowledge and the chemistry manufacturing sections of regulatory submissions. I got to start working with FDA. I just enjoyed every piece of it, like every bit of it, and I was a sponge and I wanted to learn more. And from there, I went to a full-fledged job in regulatory affairs. I think the part that drew me to it is really the variety.

When I moved to that job where my title was regulatory affairs associate, I got to do a little of everything. They brought me in for my experience with the chemistry manufacturing section of submissions but I got to learn labeling, I got to learn negotiation with the FDA, I got to learn the publishing side of things, I got to learn the true strategy side of things; and there’s just so many facets to regulatory affairs. And also, I got to work with so many different departments. You’re working with clinical, you’re working with biostats, you’re working with your medical affairs colleagues, you’re working with so many different groups; and I just really enjoyed the variety as well as the collaboration with all those different teams. I really feel like that’s why I stayed in regulatory and it’s really been the foundation of every career step I’ve made since that time.

Taren: It’s fascinating. I don’t think I really understood the vast expanse of regulatory affairs until you just laid that all out. So truly it was very serendipitous and good for them tapping you in that way, right? That’s amazing. Sometimes one door closes and another door opens up to a whole wide world. That’s fascinating. So tell me, how has the addition of global patient safety changed your role? Is that a new addition for you?

Diane: It’s not necessarily new for me. I really have always viewed safety as an extension of my regulatory role. I say that because when I started at a company called Medicis, which is where I had gone to do that full-fledged regulatory affairs role starting as an associate, I started working closely with the safety group. It was very small there; and in fact, regulatory took on a lot of the safety responsibility. I didn’t know any better; I just was happy to do the work and learn. Over the years, I realized oh that’s more of a safety role but I always thought of it as part of my responsibility.

Actually after I left Medicis, after being there for almost 10 years, I went on to a company called Kythera to be head of regulatory affairs. They also wanted me to build their whole pharmacovigilance team which is a safety team. From the ground up, they had one person and they were working off Excel spreadsheets to track safety. We built it all. He and I, we put together all the processes in place. We built a global patient safety database. We were getting ready for commercialization of our first product. It was a really exciting time and a lot of fun. And, again, I just feel like it’s an extension of my regulatory affairs role and I was really happy when I came to Ironwood Pharmaceuticals to be able to continue that type of work.

Taren: That’s fascinating. So you went from some place where you were for 10 years and then you went to a new place and you built pretty much the function from the ground up. That had to be a pretty big leap.

Diane: Yes and no. I guess I felt really comfortable in that role. They actually were really attracted to me because of my recent NDA approval experience and they needed someone to come in and help them get their NDA approved through the FDA. And so I joined them right before phase 3 data – phase 3 data is typically the data that’s the foundation of the regulatory submission. And that was the primary part of my role but very quickly once I started talking to them in the interview process and they realized that I had this whole background in safety. I ended up taking over research compliance there as well, which is making sure that we comply with all the good clinical and good non-clinical practices.

So it was a very meaty role. It was a really defining time for me, but I’ve never been so busy in my life and I never maybe enjoyed myself so much in a role. It was just so rewarding to build everything the way I felt it should be built instead of coming into something that already exists and having to make changes. My associate and I, we really laid out that foundation for safety and we built it up. Regulatory — I expanded the group and the same with the research compliance group there.

Taren: What a great opportunity. Great opportunity to pave a path for yourself as well as for others, but really to get to stretch your wings and put into practice all the things you had learned along the way. So let’s talk about that. You’ve been involved in a number of submissions and approvals for several drugs as well as biologics and devices. You said you’ve never been so busy nor so happy. So what are some of those other key highlights from those experiences?

Diane: I think one of the highlights for me was also one of the biggest challenges for me. And just looking back and all we had to go through in order to get a product approved and we were able to be successful, it was just so rewarding. So when I joined the company called Kythera, it’s that same company I joined to head up regulatory, safety and research compliance, we were working on a product called Kybella also called Belkyra outside the US. They brought me in to lead the NDA submission as well as the NDS which is in Canada. I had just done that on two programs within the last year, felt very confident going in, we had great data, but to my surprise, within a few months of joining, we ended up taking global rights back from our partner Bayer and so they said, “Well, we would really like you to go around the world and get this product approved” which is a great opportunity but definitely a challenge. So this was an aesthetic indication for this product and in the US and Canada that’s well accepted. At that time in Europe and some of these other countries, you could not have an aesthetic indication; you had to medicalize it.

And so we really had to take some of the work that Bayer had done as well as our work and repackage it all. I call it the regulatory roadshow that we went on and we went to Europe and we met with some of the regulators. We went to Australia and we talked to the regulators there and put forth our proposal for our product. We actually were able to make great strides in those meetings despite the regulatory challenges we were going to have to face. But more importantly, when we went to Europe, we needed to find the regulatory agency that really was going to be the champion for our product. It’s what’s called the Reference Member State and they’re the ones who are going to help push the submission through.

When we met with Sweden, it just became so clear in the meeting that they really believed in our product, they really supported the data, and they were going to be our champion, and they really came through for us. I’m simplifying it; this was many, many, many months close to a year of work to get there; but, again, the biggest challenge I faced from a regulatory perspective and probably the most rewarding experience I’ve had to date.

Taren: I love that regulatory road show. So, again, what a great learning experience for you and being able to do something so unique within that role. So kudos to you and kudos for bringing it successfully over the finish line.

Diane: Thank you. I had an amazing team that was with me and that’s the only way we could get through it. I used to say we’re in the trenches together, that’s how we referred to putting the NDA together, and we just hooked arms and we pushed through again.

Taren: It’s a team sport, right?

Diane: It’s a team sport, exactly.

Taren: Fantastic. So now that you’re in Ironwood and one of the big products coming out of there is Linzess. And it continues to expand its indication base and the latest news from September was positive top line phase 3 results for pediatric patients. Tell me about how this addresses an unmet need for functional constipation for this age group, and what are some of the challenges in putting forward an indication for pediatric population?

Diane: Sure. Linzess is a great product that’s currently available for adults with IBS-C – irritable bowel syndrome with constipation or CIC which is chronic idiopathic constipation. There’s currently no indication in children or pediatrics. In fact, there’s no product approved for functional constipation in kids today. And so if Linzess is approved in children to adolescent, 6-17 years of age is what we studied in this phase 3 program, it will hopefully fill that unmet need for all these kids who suffer with this condition today. So we’re really looking forward to talking to FDA about our supplemental NDA application which will actually be submitted later this year.

Now in terms of running a clinical study for a pediatric population, it is a little bit different. There are different considerations than when you run studies for adults. Children are a vulnerable population so while safety is always important no matter what study we run, it is of the utmost concern in that population. And so there are additional measures that we put in place when we’re running a pediatric study. We will put additional maybe data safety monitoring committees, so then an outside group can monitor the safety information just in case any concerns arise along the way.

Other considerations, the studies themselves can be quite challenging to enroll, just a pediatric population. And sometimes we even have to consider do we need to change the formulation, the route of administration, are there other aspects or operational aspects to the clinical trial that we would do differently in kids like limiting the number of blood draws. Primarily we really need to make sure that the parents and the caregivers are well informed because they are speaking on behalf of the children and they really need to understand all aspects of this study, what it’s going to take to be a part of this study, not just for the children but also for themselves.

And one thing we use across a lot of programs here at Ironwood Pharmaceuticals is we develop and validate tools to be used in the study. A lot of our endpoints are quite subjective so we’re asking the patients for their feedback. When you’re working with children, you need to develop and validate these tools that are age appropriate. So some of them are questionnaires that the children themselves can answer, or we also need to develop questionnaires that the parents or caregivers can answer that they can easily understand and easily respond to. And there’s actually quite a bit of work that goes into developing these tools well ahead of even running the studies. I think those are the key points, the differences between running a study in kids and adults.

Taren: I find it fascinating because obviously when you’re dealing with children as you just enumerated, there are so many different considerations that have to be put into place. So when you get the parents’ consent, do you always have to get the child’s consent as well? Do they have to buy in?

Diane: It depends on the age of the child.

Taren: Okay.

Diane: So the very young children obviously can’t consent for themselves. They’re not quite understanding what’s going on and so they are not able to. But when we work with older kids – yes. We make sure that all the tools are appropriate for them to clearly understand. For our study, for the pediatric functional constipation indication, it’s in 6-17 year olds so we had quite a wide range so we needed to make sure that the tools really were appropriate for that complete range of patients and their caregivers.

Taren: Fantastic. Well thank you for sharing that information because I don’t know that everybody understands all those particulars that go in creating a pediatric study. And it is so complicated and it is matrixed and there are things that have to be thought about well beyond what we would do for a normal clinical trial for adults. So thank you for giving us a glimpse into that world and we wish you success with the next stage in the NDA.

Diane: Thank you.

Taren: Yep. It’s exciting. You enumerated earlier you’ve had a lot of different experiences in all phases of pharmaceutical development from discovery to clinical to marketing and labeling. Can you name like one of your favorite roles out of all of your time being in the industry, and what are some of the key lessons you learned from these experiences?

Diane: It’s hard to name a favorite role only because I really have joined aspects of each role. You learn from each one and you take those learnings with you and hopefully you apply them to the next role. A highlight I would say from my experience here, a more recent highlight at Ironwood Pharmaceuticals, is we had the opportunity to modify a box warning in our Linzess label based on non-clinical and clinical safety data and not many companies get to do that. So the fact that we were able to open up that dialogue with FDA to have multiple rounds of discussion, to be very clear about what data could support this and why and it was all scientifically justified, it was really a huge accomplishment to be able to adequately describe the safety profile in the label. Some companies probably just wouldn’t take that on and so I’m just very proud to be a part of the group who was able to achieve that.

Taren: That’s very interesting. I think you’re right, not every company would be willing to take that on. So what was the… what gave you all… why do it, I guess, is the question.

Diane: We wanted to make sure that the product was being fairly and factually characterized in the labeling. And we knew we had data that supported a change to the labeling. The product has been on the market for 10 years; and when the product was initially approved, there was some data that was available at the time that was the only data available.

There was some non-clinical data, when I refer to non-clinical I mean animal data, that may have caused the agency some concerns so we were required to have what’s called a box warning in our labeling, which just gives additional warning and precautions type of information to physicians which is very important to communicate. Once we had additional data that suggested that that information was not accurate, we wanted to work with FDA to make sure we were getting the right information across to physicians and most importantly to the patients who take our product or maybe considering taking our product.

Taren: Well, that makes sense. 10 years of real-world data would certainly change the landscape of from that original non-clinical data, from the animal data.

Diane: Yeah. Real-world data, but also additional clinical data as we’ve been running additional studies since the original approval. We had quite a wealth of data actually to put in front of the agency to support this change to the labeling.

Taren: Well, again, kudos to you all. So let’s talk a little bit about your leadership style. You noted earlier that you locked arms through that regulatory process, so you have built some pretty high-performing teams. What are some of your keys to success? What do you look for in team members?

Diane: Thank you for this question. I actually get asked it quite often. I really enjoy discussing this topic because one of my favorite things to do is to build teams and to mentor those on my team. And so one of the most important aspects of team building for me is looking for someone who is a good cultural fit as well as a good technical fit. So while regulatory and safety roles can often be quite technical, even if the individual is this amazing subject matter expert, if they’re not going to be a team player then they’re not going to be a good fit.

And so on my teams, I promote open and honest communication. I definitely encourage collaboration. I value accountability, but very important, the collaboration communication piece, not just within our team, our internal team, but with the other teams that we work with because as I mentioned earlier, within regulatory, we must work with all these different functions in order to be successful.

I guess another learning for me over the years has been I also need to be realistic and recognize that something isn’t working. Whether it’s an individual who might be in a role that isn’t the right fit, or maybe I need to rethink the structure of a team. Those can be really uncomfortable conversations with folks, but they’re essential to maintaining a high-performing team. So those should not be delayed.

Taren: Absolutely. I think those are some of the hardest conversations leaders have, right? And being able to manage those expectations as well as those employee expectations, it’s hard. So how do you manage that? What are some of the things you do to ease the way?

Diane: Sure. So I really truly do have open and honest communication with my team; I’m somewhat of an open book. I also meet with my direct reports often so we’re having those conversations. It could be more of a strategic conversation about a filing we’re doing or a safety analysis we’re doing. But I also build in time for the softer skills. Maybe they’re a new manager and I want to make sure that they have the support they need – do they need some guidance on maybe how they themselves would have a tough conversation with someone they’re managing. I actually had this conversation recently and it is uncomfortable, and so I wanted to give that person some advice about, “Well, let’s think about how we can help that person, what are some of the things that they’re missing on right now and what can we do to support them” because this is somebody who is really truly giving their all and wasn’t necessarily meeting the mark. But it’s important to have the conversation but also not to delay the conversation and to have it often. So I’ll check in with folks and maybe it’s a light touch at first, and if I don’t see improvement we’re going to continue to have that conversation and we’re going to dig in a little bit more.

I am a little bit spoiled here at Ironwood Pharmaceuticals, so I have such strong teams that I’m not having too many of the difficult conversations, I have to say. But I’m also always looking at ways to continue to develop those folks whatever it may be in terms of professional development we can do. It may be outside of Ironwood Pharmaceuticals, but just giving those opportunities is really, really important.

For example, someone on my safety team really had to get outside her comfort zone recently and she spoke on a panel at a conference. She was very nervous and was really reticent to do it and I encouraged her – ‘I think this is going to be really great visibility for you, and I really think you should think long and hard about it.’ She thought about it overnight and said she’d do it. She’s so proud of herself. I’m so proud of her, but I’m so proud that she was so happy that she actually put herself out there and did it. And so those are the type of things I like to encourage my team to do so they can continue to grow and to develop.

Taren: Wonderful. And there’s nothing like that first time having to speak in front of a group like that to build your confidence too.

Diane: Absolutely.

Taren: So now she’s going to be doing it all the time. Fantastic.

Diane: Yep, she’s going to be in high demand, I’m certain.

Taren: That’s wonderful. That’s great. So working in the regulatory space there, in the regulatory arena, are there any trends that you’re tracking? What do you see coming down the pike in terms of regulators, regulatory actions, or shifts?

Diane: Sure. So you actually mentioned this earlier in our talk, real-world data and evidence to support regulatory approvals as well as safety analyses. This is very much a hot topic and something I’m watching closely, especially as some products have been recently approved with supplementary real-world data particularly when there may have only been a single pivotal clinical trial and trying to understand how that real-world data could be used to support the approvals.

It could range for something… When I say real-world data, it could be electronic health records, claims data, billing activities, things like that that can help supplement some of the analyses that we are including that are more driven from the clinical studies. In fact, we’re already starting to incorporate real-world data in some of our safety analyses within the global patient safety group and so definitely tracking that closely and to see how we continue to build off of that.

I would say the other area that I’m watching closely is PDUFA7. PDUFA is the Prescription Drug User Fee Act, and this is where companies pay money to FDA when you file an application and yearly product fees. But with that comes a whole slew of regulation. And so it was recently reauthorized but it was the user fee portion, and now it’s going to be going back to Congress and they may be making changes to some of the regulations. So I’m watching that very closely to see if it has any impact for us at Ironwood Pharmaceuticals.

Taren: Sure. I can’t believe we’re at PDUFA7. I remember it was PDUFA2, so that’s how long I’ve been around.

Diane: It goes by fast.

Taren: It does. Well thank you for providing those terms. We started talking about real-world data and it started coming to the forefront several years ago, but I do see that it is gaining a great deal, more momentum, and especially aligned with technology advancements because it’s so much easier to gather data and analyze the data.

Diane: Yes, absolutely. And in fact one of my team members just went to a conference this morning and was bringing back some of that information about additional tools we might leverage in some of these analyses where this data could be more readily available to us. Some of the claims data and things that are…and they’re starting to use artificial intelligence in this area which is just fascinating. It’s just seeing if we can really leverage that information, whether it supports a regulatory filing or whether it helps inform a more robust design for a clinical study. I think there’s a lot of applications for it.

Taren: Agreed. It’s going to be interesting to see what the next couple of years bring given the advancing technology as well as the interest in that real-world data and how the two are going to intertwine and bring us to maybe even new and different levels for patient outcomes.

Diane: Absolutely.

Taren: So we talked earlier about you having a biology and a chemistry degree, but what primed your initial interest in this field? Would you always have a love of biology?

Diane: I think I did, starting from at least my high school days which seems so long ago now. And I always love science and math. I actually always thought I would go into medicine and I think some point along the way in college I wasn’t so sure anymore. So even though I moved away from that path, I still had a really strong interest in science and I wanted to use that as the foundation of whatever career I chose.

The other piece is I spent a lot of time in the lab in college which made me recognize that I really didn’t want to spend time in the lab as a career. So I was kind of trying to figure out what did I want to do with this biology-chemistry degree and really what better opportunity than a career in the pharmaceutical industry, in particular regulatory affairs and patient safety. So I feel like I was always meant to find this path. Even after working in regulatory affairs for 10 years, there was always more to learn. I even continued my education and received a master’s degree in regulatory affairs. So I really feel like I get to leverage that scientific background, but also keep learning along the way.

Taren: And that’s one of the hallmarks of a great leader is that insatiable curiosity and that never-ending desire to keep learning what’s next. So I love that, I’d love to hear that. And I think that there’s so much science in biology where we’re seeing more women adopting that as a career, which is really heartening because obviously as we look at STEM and we look at the gender gaps within some of these roles, it’s encouraging to see more women stepping into these positions. You talked earlier about being a mentor as well. Are you currently a mentor in helping other women reach their career goals?

Diane: I am. I’ve had many women reach out to me and not necessarily just in regulatory, even in the development organization. I’ve had women I’ve worked with in the past who were in finance departments even who would reach out to me and I would help mentor them. I don’t have those relationships so much anymore. But it was just so wonderful to talk with them especially as a working mother and I think a lot of women struggle with that and feeling guilty –are they really spending enough time at work, are they spending enough time with their families, and kind of working through that with them, using my own experience to help guide the conversation. But being a mentor I feel is more rewarding for me than the mentee. I certainly hope that they get a lot out of it. But some of the times it’s also connecting them with others whether it be others in Ironwood Pharmaceuticals, there’s some women here who I help mentor, or even outside of the organization.

Taren: That’s awesome. And I love that because I think that’s part of that giving back and paying it forward, if you will…

Diane: Yes.

Taren:  … giving back and paying it forward both ways. Sorry, oxymoronic there, but, yes. So I love the fact that you are mentoring those others. Did you have a mentor as you were coming along or somebody who helped sponsor you?

Diane: I did. And what’s a little ironic about it is I didn’t realize he was a mentor until we no longer worked together. And it was a man actually, and he was the head of manufacturing of all things. I worked with him quite a bit because I was working on the chemistry manufacturing side of regulatory for several years with him and he really just helped guided me and mentor me along the way. It was very early start to my career and he was almost more like a father figure, but he really had a lot of faith in me and encouraged me to take on more at that company. I ended up leading the regulatory group and all with his support. And if anything, I regret that I didn’t recognize it at the time, but he did take me under his wing but I also think I sought him out.

Throughout my career, even though I didn’t have a lot of formal mentor relationships with me being the mentee, I think I tend to seek out people and seek guidance from them on different topics. And I think it’s important to leverage lots of different folks in your network for that. There’s not one person that’s necessarily going to be the end-all-be-all in terms of helping mentor you and guide you through your career. There’s a CFO that I got quite close to at a company who really helped guide me especially as an executive leader at a company and helped me start thinking about things differently and not always about my technical role, but my more strategic role at a corporate level. And that was a relationship where I still am in touch with him today because he helps fill that part of the mentoring relationship for me.

Taren: How ironic since when you first started you went in for a finance role.

Diane: I know.

Taren: And then regulatory.

Diane: And I’m not a finance person. I will not purport to be a finance person but, you know what, that doesn’t mean I can’t learn from my finance colleagues, right?

Taren: Of course. You can learn from anybody, right?

Diane: Exactly.

Taren: This is mentoring that is situational mentoring. And I think that’s really important to keep in mind too. So if you don’t have a particular skill set, you seek out somebody who does and ask for their guidance and advice. Perfect. When we talk about mentoring and sponsoring, there’s two different things obviously and it’s so important to have both in your camp to move forward. So let me ask you, what is some of the best leadership advice you’ve ever received?

Diane: I think the best leadership advice I’ve received and has really stayed with me from early in my career to now is to not be afraid of putting myself out there and having the courage to lead and to trust in myself. There’s particularly useful advice early in my career where maybe I didn’t have quite the confidence more from even a technical perspective, but sometimes it’s getting outside your comfort zone and putting yourself out there and raising your hand and saying, “Hey, I’d like to lead this.” And so I’ve used this advice multiple times especially as I volunteered to take on maybe a new project or even lead a new department which I’ve done, opportunities that have been very rewarding for me and continued to help me to develop myself. And now I share that same advice with my team members.

Taren: Fantastic. Now, if there was a magic wand and you could wave it, what is the one thing you would change about either your role or the industry or your specific functional area?

Diane: Sure. I think what I’d really like to see is an increasing number of women in STEM. That can certainly open the door to more opportunities for women in pharma, research and development, and ultimately lead to more leadership roles for women in pharma which are just really lacking. I am encouraged, I have three nieces who are all brilliant and all chose STEM careers and none of them chose pharma and that’s okay, but I’m so proud to see them taking this on. So I think the numbers are increasing but it’s still not where it needs to be, and so I’d really like to see more women having the courage to take on a STEM career.

Taren: Love that. And go girls.  

Diane: That’s right, yes.

Taren: Go, go, go. Good for them. Well, sadly, we’re coming to the end of our time together so I’m going to ask you our wow question. What is that wow moment that either changed the trajectory of your career or has left a lasting impression on you?

Diane: I think the wow moment for me – or how others probably would think is the wow moment for me – is when I was at Kythera, that’s the company where we went and sought the aesthetic indication for the product called Kybella, and we needed to go to an advisory committee in front of FDA. This was with the dermatology division and they hadn’t had an advisory committee in, I think, seven years and so they actually needed to put a whole new committee together for us. It was 17 people on this committee so it was quite large. Advisory committees, I feel, are as much work, maybe even more work in some ways than putting an NDA together, maybe because I’m more comfortable putting an NDA together, I’ve done so many, but advisory committees are a huge amount of work. They’re on a public stage and you need to know that information at the tip of your finger.

And so we spent many, many, many months preparing for that and we got a unanimous vote in favor of our product, which was outstanding and unexpected and just overwhelming all at the same time. But not only that, I mean we had worked so closely with FDA all along, the clinical development program and putting the NDA together and they were quite supportive of us FDA during the ADCOM which I’m certainl won favor with the panel. But afterwards the Pink Sheet wrote up several articles about how to work with FDA with quotes from FDA and they highlighted us and our program.

Taren: Amazing.

Diane: And it was so surprising that they would put that forward, but they said this is how you should work with FDA. And I have to admit, it’s how we work with FDA at Ironwood Pharmaceuticals and it’s how I’ve worked with the FDA at other companies. But to get that recognition and to be highlighted like that for all that hard work that, that was quite an amazing experience.

Taren: Well, congratulations. It is quite a shout out. You’re great. And to be noted as this is the best in class and this is how to do it right. Well, congratulations to you.

Diane: Thank you. And the reason I chose that as my wow moment because I still have people who reach out today to say, “How did you do that? We had a very favorable label from FDA” and I said, “You know, it’s working closely with the agency, setting expectations early, having that open communication, communication throughout the process; and to me, that’s just part of being a successful regulatory professional. And so, again, just so proud to have that on my résumé and to have had that experience.

Taren: I think right there, those are four really great tips because not everybody does it that way. You would think, “Oh, this is the way everybody should do it” but not everybody does so thank you for outlining part of your secret sauce for us. Appreciate it.

Diane: I wish I knew the secret sauce.

Taren: Well, it feels like you’ve got a lot of the ingredients, so that’s fantastic. Well thank you so much, Diane, for spending some time with us for our WoW podcast program and sharing some of those insights into the regulatory process and how important it is to the overall drug development process, so thanks for sharing with us.

Diane: Thank you, Taren. Thank you for having me today. 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.