Beth Weinberg - Episode 13 - Regulatory Voices

Conner: Hello everybody, thank you for joining me on another episode of Regulatory Voices. Today I'm very happy to be joined by Beth Weinberg. Thank Beth, thank you for joining me today.
Beth Weinberg: Thrilled to be here. Thank you.
Conner: before we get into everything, it'd be great if you could give everybody a bit of a high level overview of yourself, your career and what you're doing today.
Beth Weinberg: Sure, yeah. so I am currently the chief regulatory and safety officer at apneed, and we're small biotech based in Cambridge. we have a drug under development for the treatment of sleep apnea. today is actually our IPO date, so it's an exciting time for apneed. We've submitted our NDA and are well on our way to commercialization. I have more than 30 years of experience in industry. I'm a pharmacist by training. I spent most of my career at Lilly in lots of different parts of the organization. I went to several small biotech since and I'm loving my time in biotech. It's completely different and lots of fun.
Conner: I'm looking forward to diving into it today. Looking back at your career, do you think there was such a thing as an ideal regulatory career path?
Beth Weinberg: I never even knew what regulatory was, Connor. You know, I I came as a pharmacist. I graduated from pharmacy school on a Saturday morning, walked into Lilly Monday morning in clinical research, 'cause that was really all I knew about industry. I didn't really know that there was such a thing as regulatory and certainly didn't think I would ever be there. regulatory when I started at Lilly was where a bunch of very serious, you know, PhD men from the labs went. before they retired for a couple of
Conner: Mm-hmm.
Beth Weinberg: years. And it it was a very different model. you know, just kind of people who sat in the corner and processed documents and and didn't necessarily get involved in strategy. That's has evolved significantly over time, obviously. It's a very different career path now, a very different role.
Conner: Were there any particular experiences earlier on your career that created like a strong foundation that informed how the rest of your career went?
Beth Weinberg: I mean when I first started, I worked in the phase four clinical trial space. So I've always been sort of drawn to later phase development and especially commercialization kind of activities. I worked with the marketing team a lot to develop phase four, you know, clinical plans. and and I loved it. You know, it's a really marketing are fun people, right? They're it's very exciting, it's very dynamic and fast-paced. not so much on the early IND phases of of regulatory, right? And so I think I've always been drawn to that. And so it was fairly natural that my first regulatory role was an ad promo, because it it would, you know, again, drew me to that space of the commercial space and and how we could influence and and you know help patients at the same time as helping the business.
Conner: Something you've said in a few of our conversations and a little bit in one of your presentations you did with raps was begin with the end in mind. what does that mean to you and mean in regulatory affairs?
Beth Weinberg: Yeah, so again, the the commercialization space is where we're going, right? We all hope and aspire that our drug that we took from an early IND baby phase, you know, will become a blockbuster. And so thinking about how the marketing team and and how the organization wants to promote the drug at the end of the day, you know, that's ultimately where we want to go. And so how do you get there? You know, so you can say these things because your label says this and and how do the Do the things get in the label because you did this in your clinical program? And so thinking about that continuum of data flow and the opportunity to influence all along the way in regulatory, I think is a really rewarding experience and really you know, just again, what we all want to do. We all want to see the products be successful and help patients.
Conner: Speaking of the commercial side of things, you've spoken frequently quite positively about Ad Promo as an early regulatory experience.
Beth Weinberg: Yeah. Yeah.
Conner: What does Ad Promo teach that other fac functions may not?
Beth Weinberg: Yeah. I I mean, you know, it really is the culmination of all of the hard work. And so in in ad promo, first of all, it's very tangible. You see the piece that the sales
Conner: Mm-hmm.
Beth Weinberg: reps are going to go out with, you know, perhaps the next week. And so there that's personally very rewarding, I think, to a regulatory professional to see, you know, hey, this is all the work we've done over these last several years and this is where it's going. so it's really valuable to to have the previous experiences that that lead you to ad promo. it it teaches you more about the business side of things because you know we'd all like to think that we're quite altruistic and do this because you know we want to help patients and of course we do. Ultimately the companies have to make money so that they can reinvest and and continue to innovate. So seeing this that side of the business I think is really exciting as well. I think it gives you an opportunity Adprome was one of the few places where regulatory sort of has an equal voice. regulatory doesn't always have an equal voice in clinical development or, you know, some of the other earlier i earlier clinical research. So, you know, MLR is a is a three-way street, right? So, you know, it really is medical, legal, and regulatory, and everyone has an equal voice. So that's really rewarding to a regulatory professional who may in other situations kind of be marginalized or you know kind of overruled on some issues, but it it's not the case in Ed Promo.
Conner: And you've you mentioned that it you know, it's obviously at the end of the process, you're going commercial
Beth Weinberg: Yeah.
Conner: and that's a piece that you know, there are many people in regulatory who don't want to do commercial regulatory. by doing ad promo work, how does that people how does that help people understand the practical value of the label itself?
Beth Weinberg: Yeah, I mean it it's the again, the culmination of everything that we do. And so if you've spent all of your time in early development and then the IND phase, first of all, almost everything you've worked on has probably not succeeded, right? So so
Conner: Mm-hmm.
Beth Weinberg: at least by the time you get to the commercialization phase, you've seen success. and and I just think it's people who haven't had that experience can't always understand. why certain wording is important in labeling, why certain things are important in in clinical research. So when you think about the the continuum of the message and of the data flow, you you don't get that. You don't see the end. You know, if you stop at a phase two program, you really have no idea what's going to be impactful and and what's going to influence the label and ultimately the ad promo activities.
Conner: And you you've touched on it a little
Beth Weinberg: Okay.
Conner: bit, but if we could like hone in a bit on something you told me before, which was labelling is the bridge between commercial thinking and regulatory strategy, if we could dive
Beth Weinberg: Yeah. Yeah.
Conner: into that a little bit, 'cause I feel like these things ad promo, labelling, they do get brushed down there a little bit and maybe aren't they're
Beth Weinberg: Yeah.
Conner: a bit underestimated.
Beth Weinberg: Yeah. Yeah. I think that, you know, both labeling and strategy used to be much more administrative, right? And used to be very you know, kind of operational. And I think that there is a lot of strategy that can go into labeling and that is just now being realized. You know, people who are who are not just saying, Okay, what do you want me to type? You know, that are really doing their research and really paying attention to precedent labeling, to environmental issues, to you know, understanding the data. Bring your labeling person in as early as possible, right? They should be sitting next to you during the phase three readouts and even before that, you know, to understand the issues so that they can craft a label that is going to be you know commercially helpful and viable. and favorable versus, you know, just kind of a straightforward, you know, here are the results of the studies kind of thing. So those the the strategic labeling people add a lot of value, and I think that's just coming up now as a as an opportunity in career development.
Conner: And when we look at career development in general, it's always really good to see people who've tried ad promo, labeling, reg CMC, clinical reg strategy, and they kind of find their way or they evolve into say a a small biotech mindset or they touch in different things. Do you have any observations or opinions on why sometimes people are specializing a bit too early in their careers? As w I'm noticing on my side of recruitment, there are some people who are just done. one thing for say ten years and it's much harder to branch out into other areas, whereas ten, fifteen years ago it was a lot easier.
Beth Weinberg: Yeah. Yeah. I mean, you get comfortable doing what you're doing, right? So it's it's pretty easy to just say like, I know what I'm doing every single day. And there are certain times in your career that that may be all you can do, right? As a mom of young kids, like that may be all you can handle is doing the same thing, right? And and then you come to a point, an inflection point in your career where you want to and perhaps need to branch out. I but there's a balance, like you're saying, you you get sort of pigeonholed and stuck into one area, and then it's difficult to branch out. So there is a a fine line between when is the right time to try something else, and it's not always comfortable to try something else, right? And and I think of careers as kind of Venn diagrams and and you
Conner: Mm-hmm.
Beth Weinberg: hope that there's enough overlap between what you've been doing and what you're going to do. that you have some, you know, kind of self satisfaction and and that you bring value to the table right from the beginning, while you're expanding, you know, and and growing in your career. But you know, it you get out of your comfort zone, it's n it's not always fun.
Conner: In your RAPS presentation, you described yourself as a drug developer who specializes in regulatory affairs. What does that distinction mean to you?
Beth Weinberg: Yeah, I mean I I just think my my experience is broader, you know, so whether it it's experience that I've actually had, like in clinical research or medical affairs, or whether it's things that I've just absorbed over time, I've a lot of opinions about a lot of things, you know, and and I've earned that seat at the table so that when people are talking about something that's not necessarily a regulatory topic, I I'm very comfortable vocalizing my opinion or my, you know, input. I it brings a different level of credibility, I think, having had these other experiences and and not only experiences in terms of like I've done this job, different therapeutic areas where things might be, you know, applicable, different kinds of companies and different structures of organizations, where things could be you know, w where I bring different experiences and opinions to the table. It just it It just makes you better. It makes you broader in your experience and and really better at your regulatory job and better as a contributor to a bigger team.
Conner: And obviously with regulatory intersecting and cross functional work with all these other groups, what functions should future regulatory leaders lean and learn from in the future?
Beth Weinberg: Yeah, I think there's a lot of value in you know, some project management experience. I don't know that that's where I would tell people to go directly, but having some
Conner: Mm-hmm.
Beth Weinberg: experience in project management is pretty helpful, right? just being able to manage your own time and understanding the intersections. You know, regulatory is often the intersection of various different functions and various, you know, activities. but understanding the Formalizing that understanding and you know being able to see it from a broader project management standpoint, I think is helpful. I think an another place that's probably underrated is alliance management and alliance activities. you know, there's a lot of alliance work. I did a lot of work in alliances when I was in Big Pharma and and continue to do a lot of you know partnership activities in biotech. And it's it really gives you a different perspective. You learn a lot from the other company or other companies that you're working from, and then you know, you tend to be a bridge informally or formally between the two companies. And and then those experiences again just sort of help, you know, broaden your perspective and and your opportunities for for influence.
Conner: And for those who that might be a new term for, could you quickly give like a brief definition in context of alliance management and alliances in general?
Beth Weinberg: Yeah. Yeah. Sure. So yeah, you know, often perhaps a small company developed a a drug or, you know, discovered a drug and then a a larger pharma partner, larger biotech p they partnered together. And and there's usually some sharing of responsibilities between the two companies. And so an alliance manager usually works with a counterpart at the other company and and you know sets up the structure of the organization, the decision making structure, the escalation process, you know, the there's a financial component, of course, who's gonna pay for what. and and just the philosophies of the companies kind of meshing the the philosophies. You know, a an early phase company who's never dealt developed a drug might have a very different kind of regulatory philosophy or drug development philosophy than a you know big pharma company that's done this a a million times. And so y you learn a lot. from a little company. You learn, and this goes into the conversation that I think we'll have about biotech too, there is not one right way to do things in in pharma and biotech and in and regulatory certainly. And little companies don't have a lot to lose, right? So so they tend to be much more aggressive on the on a lot of things, you know, on their development strategy, on their regulatory strategy. And big pharma could learn from it.
Conner: Don't think I could have asked for a smoother transition to the next topic, Beth.
Beth Weinberg: Yeah.
Conner: way to actually dive into that. Obviously, you've got your Eli Lilly career, you've got your biotech career, and obviously,
Beth Weinberg: Sure. Yeah.
Conner: as we know, they're big pharma biotech, they're presented as opposites. Large companies
Beth Weinberg: Right.
Conner: are, you know, they're people associating with systems, resources, training, clearly defined responsibilities. Biotech is flexibility, pace, autonomy, or ownership. you've experienced both, and we've both discussed that. There are two mistakes that can happen quite often, which is either moving too early or staying too long. why do you advocate for starting a career in large pharma first, where possible?
Beth Weinberg: Yeah. I I just think that most people who come to to regulatory don't really know what they're doing, right? Don't know what regulatory is. They might have a general idea like, I know the phases of drug development and I know there are FDA interactions along the way and things like that. But you have to start someplace where there's coaching and mentoring and systems and, you know, formal processes. I've you biotech, you know, depending on how advanced and how mature the biotech is. You know, it could be kind of ten people or it could be a hundred people, but there's no way that they have the systems and the resources that that, you know, big pharma does. And so coming to Big Pharma, you have the support that you need as you're starting your your regulatory career or starting your career in in pharma in general.
Conner: Think it's a given as well that there's all these training sessions, there is literal educational units internally, there is these systems, the historical knowledge you can lean on. But I think something that me and you've discussed before, and I've discussed with other people is the internal mobility that can be given is very unique. You know, describe what that's like. You know, I appreciate it was you it's a while back for when you were there, but what was that like when you were told, Okay, you can go to this? Because I feel like that's something that. Doesn't really get highlighted as much, it's more just an after the fact it's acknowledged.
Beth Weinberg: Yeah. Yeah, I mean it's it's you know, the big companies have lots of opportunities, right? And again, you know, thinking about the Venn diagram, you may have worked with somebody in on one team and and you know, that person has moved to a different project and and you may be able to transition there either in the same function or, you know, cross functionally. And I think that, you know, many companies tend to be home have homegrown talent development. Right. And and do move people around a lot. And those are great opportunities because you have the comfort and the stability of you know the same organization that you've been with for a number of years. and you may even know some of the same people, and the systems are familiar to you. So that so there's a lot of there's a lot to be said for moving into a new role in a space that's comfortable and safe for you because you have that internal kind of stability. but you're still being challenged and still moving into a new opportunity. And and you just don't get that. I I also don't know that people you know, that the next generation, like my my kids and my daughter who's in regulatory, you know, I don't think she'll stay with the same company for twenty-five years. I mean, that's just not what the generation yeah, exactly. It's just not what's
Conner: Yeah.
Beth Weinberg: happening, right? So So I I hope that people still take those opportunities within the companies, you know, while they're there to whether it's to do a short term assignment, whether it's to, you know, kind of cover for maternity leave or something in another area, you know, there there could be less formal opportunities to you know to to take different assignments and do different
Conner: So following on from that then, something I think we see a lot of in big companies as well is mentorship programs, coaches, and just experienced colleagues sharing what they've done in their career. How valuable and important is that earlier in your career to have access to those things?
Beth Weinberg: Yeah, I mean it's really important. It's it's you know, i in biotech you're an N of one or two, and in the bigger companies you have again a formal coaching system, you know, a formal perhaps mentoring system. Someone is telling you day to day what to do and how to do it, right? and it's important. That again, it goes back to why I say that that's what that's where people should start, right? They should start in the companies with those kind of support systems, you know, to be able to to learn enough. to to be able to do your job and do your job well kind of day to day.
Conner: What did your years in Big Pharma give you that you continue to rely on till today?
Beth Weinberg: I mean the job is the same. The regulatory, the r regs are the same, the processes are the same in big pharma and in biotech. I mean, you I I learned the fundamentals of drug development. I learned the fundamentals of regulatory specifically. you know, I learned how to how to work in the FDA system and and in other, you know, countries as well, in in Europe and and Japan to some extent, but you know, largely I was an FDA focused person. so I learned, you know, kind of at at the basics how to do the job and how to you know, just kind of work in the regulatory process, I guess, you know, and in in FDA. the the difference, because I know what you're gonna say next, the the difference is again, there there aren't the systems, you know, in biotech. There just tend to not be as much formality. in in decision making, in processing things, in, you know, kind of running your day-to-day business in in biotech. But the rules are the same, the standards are the same and and you still have to do things the same way.
Conner: Were there any habits from Big Pharma that you had to unlearn?
Beth Weinberg: I think the biggest thing is just having to rely on myself. You know, there there weren't layers of you know, kind of supervisors and and others that, you know, would challenge my decisions, would ultimately make the decision. I make the decision. I mean the buck really does stop here and and at times in you know different companies I've had supervisors and and leaders in the organization who do have FDA experience or, you know, who have many years in biotech who are at least a sounding board. but at the end of the day, you know, I am the the head of regulatory and so I I really make the the decisions day to day.
Conner: When would you say someone is generally ready to move from big pharma into biotech?
Beth Weinberg: Yeah, it's a hard question. I think when you know that you can stand on your own, right? When you can handle the ambiguity that comes with, you know, not having things sort of, you know, very specifically laid out and and very process oriented. but you have to be able to make decisions on your own. You have to be able to influence, you have to be able to you know, kind of manage up. as as well because you're probably not managing down, right? Or th you probably
Conner: Yeah, yeah.
Beth Weinberg: don't have a lot of support people. So it it really is that when you can say, you know, day to day I can do this job on my own
Conner: I appreciate this is a bit of a leading question with kind of the answer implied, but is readiness better measured in years' experience or what someone has actually delivered?
Beth Weinberg: I think it's the latter, clearly. I mean, I you know, you have to you have to have done enough things in that same you know, ideally it's in the same therapeutic area or at least the same phase of development. You know, you have to have kind of done the things many times before you're comfortable, I think going to a smaller company. Yeah, I do think there's a there is a time and role component because those two things kinda go together, right? So i if you had done lots of things in two or three years, that's probably okay. But, you know, realistically it takes more years to kind of accumulate those experiences.
Conner: Something I wanted to dive a little bit more into is obviously you've gone to a smaller company, you're you're now ahead of regulatory, you've you you know you understand your limited resources. How did that affect the way you approach regulatory strategy and leadership?
Beth Weinberg: Yeah. I I mean what I learned again is that there's not one right way to do things. I'm used to having a team, right? As a global regulatory coordinator, you know, I would have had a CMC regulatory person, my labeling person, my Reg ops person, you know, and all of those people sat probably within, you know, one or two floors away from me. it's not the case. So I've had to build much more of a matrix organization. So I may have one or two people who report to me, but I also have s consultants that I use either fairly regularly or sort of ad hoc, to be able to get the work done day to day.
Conner: And I know that there's, you know, a point where people can move you know too early in their career or they can stay too long. Is there a way to know which situation
Beth Weinberg: Yeah.
Conner: you're in?
Beth Weinberg: I I I it's a hard question. I think that if you are finding that, you know, nothing is exciting anymore to you, I think a lot of it's really personal. You know, it's like I've been doing this same thing, I'm at the same level, I I never get promoted, you know, I I feel stagnant in my career. I think that's the time to make some decisions, whether it's to move internally as we discussed, you know, if you are in a big organization have other opportunities, you know, or move to a biotech. But I I mean it's hard. It's it's hard. It's not comfortable to make
Conner: Yeah.
Beth Weinberg: any kind of change, right? And you know, there are lots of different considerations. There are financial considerations, you know, you may make a lot more base salary and bonus in a biotech, but the equity is uncertain at that. You know, and and really sort of you have no idea if you're ever gonna make money on on stock or, you know, options. but day to day you may might do better financially.
Conner: And I appreciate that many of this is, you know, c context dependent on
Beth Weinberg: I appreciate that again if this is
Conner: person to person. But you know, if I were to like ask you, what do you think is the difference between healthy stability and becoming too comfortable?
Beth Weinberg: Hmm, that's a great question. I I think that as long as you feel like you're still contributing, whether it's, you know, in a more routine way in the things that you've done for a long time, that's also personally satisfying, right? Like I've done this 10 times now. I know I'm delivering what the organization needs. I feel good about my contribution, you know, that's still positive. It's it's also really exciting to go to a new role where you're viewed as, you know, the regulatory expert and the regulatory leader. you know, there's a lot of personal satisfaction in that as well.
Conner: I know we've touched on it a little bit previously, but it's something that I discuss with hiring managers all the time, which is, you know, time served is not necessarily the same as achievement. in
Beth Weinberg: Mm.
Conner: your opinion, what should someone be able to point to before leaving a role? 'Cause I feel like that's a really important thing right now.
Beth Weinberg: Yeah. Yeah. Yeah. I I think it's important to have your own deliverables. And I really try with people, you know, who report to me or who work with me to say, like, you are responsible for this. And it may be something very simple at the beginning of someone's career. You write the cover letter, you fill out this form, you know, you QC this submission. It could be, you know, very sort of routine things, but and then sort of expanding that. You're in charge of the pediatric plan. you're in charge of you know this FDA interaction and with sort of increasing you know levels of responsibility. It's much better to have delivered on you know standalone kind of discrete projects than to say I helped with this, I helped with this, I contributed to this, you know, it it's just much better personally, it's much better for the company, for someone to to have ownership, you know, of a particular deliverable. That's what you need before you go on to a new job. If you've done the same thing and you've helped with a million things, I mean you probably learned a lot, but you've never sort of stood on your own and and so you're probably not ready for that.
Conner: Following from that directly,
Beth Weinberg: Yeah.
Conner: why would you say why would you think being able to explain one achievement from beginning to end is often more valuable than just supporting many disconnected activities? 'Cause I feel like you see like again, like you said before, people might say, I've worked here, here and here, but it's like what what did you do in all?
Beth Weinberg: Yeah. Yeah. I mean it it shows your thought process, it shows your organizational skills, it shows your you know, it it's an opportunity to highlight your experience and showcase your experience. So if you say, you know, this is how I went about this project, it's as much about the thought process. Where do you get your resources? Where do you get your inputs into that project? Well, say you're working on the pediatric plan. Okay, I looked at the regulations and then I looked at this precedent and then You know, it it helps explain how you think through things so that when you come to a new project, you have a thought process, you have a way of working that you've done before and and that's been successful, and so you know you can replicate that in your next role. And and that's, you know, satisfying and and reassuring to a hiring manager as well.
Conner: I wanna kind of flip it a little bit onto the leadership side. what can leaders do to make sure that people reporting into them leave with something tangible that they can own?
Beth Weinberg: Yeah.
Conner: and I wanna, you know, preface that with I know that we're in an environment now where we have much more smaller regulatory teams who are doing more things and sometimes it can all be funnel different areas. So it's something I'm always encouraging other people, which is try and own something so it's it's yours. You can tell that story.
Beth Weinberg: Hmm. Yeah. I mean, you have to be able to let something go. You know, I I I am a perfectionist, you know, I it's difficult for me to hand over something, but but you have to, you know, and I have to remember that every day that I have to I may not do it that exact same way. And so I do think there's a balance between like that's just not right versus that's not the way I would have done it. Right. And so as a leader and as a manager of people, you have to be able to let something go and you have to not micromanage. You have to have clear you have to set clear expectations and and make sure the person understands what what the expectations are. And and I think that means lots of check-ins along the way, at least initially, until you build that trust. but you know, you you have to be able to delegate. And and delegate at the right levels. You know, someone who if you delegate a project that's too advanced or, you know, that doesn't fit that person's experience and skill set, then you both lose because they don't do a good job at it because they don't know what they're doing. As a leader, as a manager, you're frustrated because you don't understand. Then you have to redo everything. And that's not fair to either person, right? So you have to make sure it's kind of level appropriate. as well as, you know, make sure you're giving feedback kind of early and often to make sure the project goes the way you expect.
Conner: Should a good leader prepare people for opportunities beyond the organisation they're in, as well as within it?
Beth Weinberg: I think so. I think so, yeah. you know, there's nothing wrong with taking a detour for a year or two. So you might have decided a long time ago that regulatory is your home, right? but you can go on vacation, right? You can go on vacation to other areas and you know, again, just broaden your your skill set and and learn things. So regulatory people know a lot of other people, right? Because we tend to be sort of at the spoke of the hub and spoke model often. And so making sure that that people who are in your organization have other opportunities, get exposed to other areas, I think is is one of our jobs as leaders.
Conner: And continuing to go with the theme of people's careers, obviously registered professionals build their careers through technical competence, scientific understanding, knowledge of precedent, experience submissions and agency interactions, among a ho a host of other things.
Beth Weinberg: Yeah.
Conner: as people become more senior, success increasingly depends on how they communicate, influence decisions, build trusts, and exercise judgment. at least that's something that's my opinion, is working recruitment and seeing people go through all these levels. First question on this would be why do some technically brilliant regulatory professionals eventually plateau
Beth Weinberg: Yeah, I I think that I i in the modern era there are so many ways to get information. And if you're not getting enough information and the right kind of information, if you're not using AI, you know, then then you do sort of fall behind and and you can't rely you have to rely on your previous experience, but you can't only rely on your previous experience. So you have to continue to grow, whether it's You know, I n I never used Claude at all until like a month or two ago. And now I use it every single day. And I think it makes me a better regulatory leader because I, you know, have additional insight that I could have never despite hours and hours of trying to read things on the internet, I could have never synthesized that amount of information. So you have to continue to take advantage of, you know, the the new tools that that are available to you. And if you don't, you'll plateau. And if you don't want to grow your therapeutic area, you'll plateau. If you don't want to go, I've only done FDA work. If you don't want to go beyond that, you know, then then you limit yourself. So you have to continue to kind of push yourself and and take different opportunities to to learn and to grow.
Conner: Can technical expertise become too much of a comfort zone for people?
Beth Weinberg: I think it can. I I also think we have to recognize that not everyone has aspirations to be a leader. You know, some people are very happy to be a strong individual contributor. And some people don't have the personality or the interest or, you know, just i any desire to be a manager, to to move higher up in the organization because it has too much responsibility or, you know, too much personal accountability. So I think we do have to acknowledge that there's not one pathway, right? Just like there's not one right way to do things in terms of regulatory, there's not one right way to do things in terms of career development. And we have to respect
Conner: Yeah. And I th I think it's very valid. And I think we're very much in a there's a mindset among like some of the younger generations that you always have to be going up and up and up and that you have to be going for either running your own business or I don't know, you know, you have to be going for C suite or something as soon as possible. Whereas for some people, as we talk about being comfortable when, you know, feeling established, they just want that level of I want access to this, I like doing this, and I like doing this. Anything more than that, I'm not interested. And I think We have to acknowledge that not everybody can be CEO, although there's no who's gonna who's gonna work in the companies?
Beth Weinberg: Exactly. Yeah. And and and it's fine. You know, again, it at different times in your life based on other things outside of work, you know, you may just not be able to do anything more. You know, the it you you're very comfortable in what you're doing, you're good at it, people rely on you, you know, and and that's great. That's why you're probably well compensated, you know, and pharma were well compensated and and so that's okay. In ten years that might be different. You know, your kids are now out of the house, you have more time on your own, you can devote more time. You know, there there were lots of times where all I could do was like make it to the office and make it home every day and stop at daycare on the way, right? So, you know, different times in your career give you different opportunities.
Conner: What skills become increasingly important as someone progresses from individual contributor to director to VP to further executive leadership?
Beth Weinberg: Yeah, I think it's influence. I mean, that that would be the one word I would use. Now, how you get there is is you know complicated, right? But being able to speak from experience, being able to speak credibly about your regulatory recommendation, your perspective, you know, using appropriate kind of examples and and precedents, influence, being able to think. more broadly about not just a regulatory recommendation but how that impacts the broader organization. you know, not just saying, well, this is the regulatory thing that we're going to do now. It's really, you know, this is this is our regulatory pathway. It is going to matter because of X, Y, and Z, you know, and thinking kind of two or three steps ahead. And and it's influence at different levels. It's it's influence at, you know, kind of the study team level as you're developing clinical programs. It's influence at the leadership level, it's influence at the board level, it's influence with potential partners and, you know, other sort of financial. I I've given more presentations and talked more about regulatory to bankers and investors over the last six months than I ever had in my career before. And and that's because we're in a different place, you know, with our company. And nobody cared about regulatory before, you know, it regulatory matters at certain points of development and and it matters right now. And so I've been able to use that influence and and experience to s to speak on behalf of the company and speak credibly. you know, and I I think i it it's gone a long way.
Conner: Aside from influence, what skills would you all say are the hardest to develop in those transition roles?
Beth Weinberg: I mean, I think it's the soft skills, right? It it's being able to you know, it's not just influence, it's communication, it's negotiation, it's you know, the the things that are hard to learn from a book or, you know, a class. You have to kind of live those experiences. and there's no I don't think there's a great way to to learn those other than by experience. And so back to you know something we said earlier, there is sort of a time enroll component and and
Conner: Yeah.
Beth Weinberg: that's one of those, right? You just can't one day flip a switch and all of a sudden be, you know, a stellar communicator and and be able to negotiate certain things. that does take time.
Conner: I think I'll agree from the recruitment side here of you know speaking to people as they go out. I think soft skills and just the ability to communicate are one of the hardest things to teach and learn. And they very easy you can very easily identify who has worked on them or who has them naturally and what you know, try to add to that and those who haven't. And it's hard to give people a plan to go, to get better soft skills, you need to read these two books and go to this
Beth Weinberg: Right.
Conner: many things. It's not like there's a A B C.
Beth Weinberg: Yeah.
Conner: But something we did talk about is feedback, observation, and deliberate practice.
Beth Weinberg: Yeah. Yep.
Conner: how important are those?
Beth Weinberg: I think really important. I think you have to you know, nobody likes to hear negative feedback, but you have to find someone who's gonna be brutally honest with you. And, you know, w it's a peer, it's a someone who's sitting in the room, it's someone outside of your function, w whoever that person is that's going to be like you totally misread the room there, you know, you blew it. it that's super important. And then say thinking to yourself or playing it out with that person you said deliberate practice, you know, how would you have done it differently? How should I do it differently next time? And really say those words out loud. you know, it that's the only way to get better. and and it it's not something you can learn from a book, like you said. And and even, you know, courses kind of sometimes seem a little fake and and hokey, but they make you practice Right. And they make you, you know, listen to yourself and and understand how perhaps you're being received by other people.
Conner: I also I think there's an element of good leadership as well. We when you mentioned deliberate practice, if you can give people a setting where it's a s it's a safe area, but it's not, you know, risk free and there's
Beth Weinberg: Mm-hmm.
Conner: room for them to stand on their own two feet, but for you to come in and say, Okay, you know, if it's going wrong direction to step in and you know, course correct or to review
Beth Weinberg: Yeah.
Conner: afterwards, I think giving people just the platform to stand on their own two feet a little bit. in that safe setting, I think goes a long way. And this is something I believe and something I've tried to do as a leader when I was training people in their first steps of you know being in this industry.
Beth Weinberg: Yeah, you have to know that someone has your back, right? So there is a fine line between like, boy, they are blowing this. I'm gonna jump in and save them. To they'll get there. You know, maybe it's a a kind of small correction, and and whether that's in a meeting, I say, Well, why didn't you talk about this instead of that? You know, versus just kind of jumping in and taking over the conversation. So you do have to give people opportunities that you know, you may c sort of cringe internally at times, but as long as, you know, they're not embarrassed or uncomfortable, not too uncomfortable, un a little uncomfortable is okay. but you know, making sure that the the business objective is still achieved and that the regulatory credibility isn't, you know, kind of, you know, discounted or or harmed by whatever they're doing or saying, then you're right. You have to give people the opportunity because how else do they learn?
Conner: I appreciate that for small companies this definitely
Beth Weinberg: Yeah.
Conner: won't be at the forefront. But should companies be investing more formally in development of communication, influence and leadership?
Beth Weinberg: I mean, of course, you know, the answer is always yes. I don't know i it's just hard. You know, I I really
Conner: Yeah, yeah, yeah.
Beth Weinberg: I I don't know what kind of courses are, you know, helpful in that regard. what I do think companies can do is, you know, develop a culture and and you know, advocate a culture where it's okay to make mistakes and it's okay to, you know Learn from your experiences and give that feedback so that you know people do have the opportunity to get better.
Conner: And again, I appreciate it's a leading question, but I think your response of culture is the exact thing to do because culture's free. You know, you've you developed that by
Beth Weinberg: Yeah, exactly.
Conner: how you act, you know, how you work, what your aims are, and make sure you all have a shared goal and message. And if you if you embed in your culture, it's okay to make a mistake, we're not here to crucify you because the end goal
Beth Weinberg: Right.
Conner: is this. I think that's just a nice, free, easy way to do it because end of the day, the better you train your staff, be it you know unconsciously or consciously, The better they're gonna work for you and the better it's gonna be for the company. So it's kind of a a double edged sword. if you pay for it, you don't pay for it. But I think culture's the exact response for that.
Beth Weinberg: Yep. Yep.
Conner: what to you, what is the difference between mentoring and coaching and when does someone need either or?
Beth Weinberg: Yeah. I mean, coaching I think is day-to-day, right? It's it's, you know, this week we're going to do this. And, you know, let me give you some feedback on that particular activity, that deliverable, that document that you wrote, whatever. mentoring is bigger, you know, so mentoring should encompass, you know, a broader scope and think about your future career goals as well as just how to get better in your day to day job. a mentor can be a peer, it can be someone in a different function. you know, your coach is pretty much your day-to-day, you know, likely your supervisor or, you know, someone more senior. but, you know, mentoring should be more personal, you know, certainly, and and take into account your career goals and and, you know, what what you want what you're good at, what you wanna do. I think you should know your mentor better than you should know your coach. I mean, it it should be a a mutual relationship. I do think it's also okay to sometimes you outgrow your mentor, right? Sometimes a mentor for today is not a mentor for long term. And and you know, you may develop in different areas and and now you need more than one mentor. You know, you need someone who's more technical, you need someone who's a better communicator, you need someone who's better at influence. You know, there are you can have lots of different mentors. You probably have one coach, otherwise you'd probably go crazy day to day, right?
Conner: Well, I was gonna say and y you you kind of answered it a little bit anyway, but can a line manager effectively provide both?
Beth Weinberg: I mean I mean at times, yes, but I certainly don't think that your line manager should be your only mentor, right? I think that,
Conner: Yeah, yeah.
Beth Weinberg: you know, they could provide mentoring perhaps in some areas. I also think that often, once you leave that role and go to a new role, your line manager can be a really good mentor because they've worked with you day to day and they've seen what what you're good at and what you can do and and you know can can offer some insight into your performance i as a former boss, right? You know, not
Conner: Yeah, yeah, yeah.
Beth Weinberg: necessarily in the moment.
Conner: How does influence differ between a large company and a small biotech?
Beth Weinberg: Yeah, it's really the scope, right? So so i in a big company your influence is probably more narrow, regardless of what, you know, unless you're really at a, you know, quite executive level. But you know, you influence your team, you influence, you know, whether it's like the regulatory team and then it's the broader team, and then it's perhaps, you know, the therapeutic area team or whatever. The the scope I think is just different. in i you you also tend to influence people who are more closely aligned with both your mission and your day-to-day work. So it's easier. You know, you you you really all are working on exactly the same thing. In biotech, you might have to influence the commercial team one day and the alliance team one day and the business team another day. And so the scope is bigger and their level of understanding of regulatory or you know the specific issues varies as well. So you have to tailor that discussion and and that conversation to to different audiences. And and that tends not to be the case, I think, in a bigger organization where your scope is more
Conner: Going back to your Raps presentation, there was a line from it that really stuck with me, which is there's a difference between getting a seat at the table and earning one. What
Beth Weinberg: Yeah.
Conner: is the difference?
Beth Weinberg: I mean it it's pretty easy for someone to say, here are the list of people you need to invite to this meeting, right? And regulatory is on that list. it it's very different when it's a small conversation or, you know, someone who's walking around looking for input or, you know, virtually or or in person walking around and saying, I let's ask Beth, you know, she has some good insight in that, or you know, let's make sure that at the next meeting, you know, Beth is there. and And I earn that because again, I've lots of opinions about lots of different things and I say those things. I also sometimes sit quietly, believe it or not, in the corner and listen and absorb and and have an opportunity to interject here and there. so I sit through a lot of meetings that probably have nothing to do with me and I may very well be multitasking, but I show up. Right. So I show up in the finance meeting, even though I hardly understand anything that they're talking about. and so they know that I'm part of the team and that I I think more broadly. you it's it really is something you earned because you know, the again, someone can have a list of people and regulatory is the last on the list, but when they think of you first, when someone in a in a team says, We need to invite Beth. And let's see who else, you know, we need to round out that conversation. that's when you know you've done a good job.
Conner: How can regulatory bring solutions and communicate risk without becoming known as the person who just says no to everything?
Beth Weinberg: Yeah, yeah. I I think it's important to have a solution, right? So you can say, here's the issue, you know, here's the risk, here's what we can do about it. If you can't get to that third part, and and that's what your experience brings over time, if you just point out the problems, then you're right. Then regulatory just becomes like the bad cop. but when you say, Here's the issue, here's the risk, but here's how we can mitigate that risk, or here's some things we could do to to change the trajectory of of the risk or whatever, you know, then then you've really brought value. You you've brought value to the team, you've brought value to the process. and it until you can get there, it it really is hard to to keep communicating just the negative things. and so, you know, I was in a meeting the other day and and someone didn't like my recommendation. I said, Okay, what would you do? Right? If you were just gonna criticize me, what would you do? and and he didn't have an answer. And so I'm like, Okay, so unless someone else has a better answer, then this is the plan, right? And and again, you have to be at a certain level and you have to have earned a certain level of trust and and respect to be able to say those kinds of things.
Conner: This angle is framed more at, you know, people who are like in head of regulatory or they're on that pathway. how important is business acumen for re a regulatory leader?
Beth Weinberg: It it's certainly a skill that you have to know enough about, right? It's certainly something that that is increasingly important with increasing responsibility. it's surprisingly i what I think regulatory leaders need to know is not that deep. You know, you certainly don't have to understand the financial statements. You certainly but but you have to understand at a big enough level, you know, sort of the The marketing strategy, the commercial strategy, the the cash position of the company, right? The you know, what kind of partnerships you have that are important and and contribute to the business side of the world. I've learned more about business and finance in this job than I ever have in anything else. part of it's just because of where we are in the, you know, financial. process and and we have an IPO and so I've learned a lot over the last several months about that. but if you don't understand it, you're really missing a big component. Because then it becomes a an academic exercise. And again, at the end of the day, the companies want to make money and the companies, you know, to be able to reinvest and and then you know have important new treatments for patients. If you don't understand that at its basics, I think you have a deficit.
Conner: A few closing questions for you, Beth. first one being: what is one piece of career advice you wish you'd received earlier?
Beth Weinberg: I think the biggest thing is, you know, kind of not being afraid to get outside of your comfort zone, right? Someone said once in a presentation, like, be yourself, because it's too hard to be anybody else, right? but I I think that only goes to a certain extent. You know, I think you do have to be uncomfortable at times. and I think that, you know, the culture, back to culture, the culture of a company. should allow for that, should allow for it to be a safe space. I wish someone said, hey, you could be good at X, Y, and Z. You know, here are three other things because I think I had a fairly traditional path in mind. You know, I would be in clinical research, then I would be a manager, then I would be the next level. And and until someone said to me, you know, hey, here's another opportunity, here's another way you could look at the business, here's another way you could, you know, have an impact. You know, I I mean I I value that and and I was I I welcomed that opportunity, but I didn't do anything different for a long, long time.
Conner: If we were to have this conversation again in ten years, what do you think would have changed the most in regulatory affairs?
Beth Weinberg: I mean I gotta say AI. I think AI is gonna make a big difference in in everything and I think in regulatory. I was trying to write a cover letter, like something that's pretty simple, but it had you know, a few kind of difficult components, and I probably would have spent, you know, an hour on it and and instead I put it in Claude and I got ninety percent of the way there, you know, in in a minute. and so that's that's really valuable. It changes your whole perspective. I I don't know what's gonna happen with FDA in ten years, right? We've seen a lot of turmoil in the last couple of years and and I hope that it's settling down. I used to say, like, you know, my crystal ball is broken when people would say what now I don't even think I have a crystal ball because I I couldn't have possibly imagined or, you know, thought that these things that are happening now would happen. So until there's more stability there, I think it's really generally uncertain. But again, there's always change. And so we just have to be able to adapt.
Conner: And what part of regulatory affairs do you still enjoy the most?
Beth Weinberg: I mean I still it's weird to say I still love going to an FDA meeting and running an FDA meeting, you know, because I think the the preparation and and the thought exercise that you go through to prepare for that meeting and thinking about contingencies and thinking about that's where the strategy comes in. You know, if FDA says this, we could say this and we can live with this. You know, that's the kind of regulatory strategy that I love thinking about. and and I still love putting together an NDA and I still, you know, it's still very exciting at the end of the day to get your drug approved. That's where that's where we're going, right? And it's still fun. I still love ad promo. Like I st I've done a lot of ad promo in the last year and a half where I hadn't really done very much, you know, in the several years before that. And I still love it. And I realize now what drew me to regulatory and and I could see myself you know, in my retirement years doing some ad promo work. I think it would be fun.
Conner: Thank you very much for joining me. It's been an absolute pleasure speaking with you. Hope you've enjoyed it.
Beth Weinberg: Yeah, thank you so much. It's been a great conversation, Connor. Thanks.
Conner: For anybody who'd be interested in engaging more on any of these topics or any questions, feel free to comment on LinkedIn or connect with Beth directly, and maybe she can help you out on things as well. But for now, we'll see you on the next episode.
Beth Weinberg: Okay.