AUDIO Epi 3 How Career Pivots Can IGNITE Growth In Your Innovation Impact!!

Welcome to the IPZO facto, Innovation: No Way But Forward podcast, where I'm thrilled that Dr. Kim Biedermann joined me. In this podcast episode, we explore how career pivots can ignite growth in your innovation impact. Learn about a medical device product, regulatory strategy, H1N1 pandemic preparedness, antimicrobials, food as medicine, risk management, and more!

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Transcript

00:00 
I felt I could take much bigger risks than I could at subsequent companies because I knew I wouldn't get fired, or at least right away. Bring the outside in and push that boulder uphill. It's a momentum that you can be more successful. 

00:16 
You're not failing. You're not pushing the boundaries hard enough for yourself. Where something was stagnant at one company gets accelerated all the way top to the CEO at another company. I respectfully disagree. 

00:31 
And if you're putting your blinders on right at the beginning, you will never see it. Not be converging. It's a divergent mode. Biology, called now pathobiology. It's biology gone bad, okay? Yeah, what could go wrong? 

00:45 
Oh, so many things. And I hit the jackpot of operations where there was some issue, some sort of fire, sometimes literally. That mean, let's talk about it. Let's break that. We gotta talk about this. 

01:00 
Right as we were doing this, that was the H1N1 pandemic. You know, before COVID, remember talking with like the DOD? Yes. Why with the dirt on his boots? First of its kind. Everything was happening in moments. 

01:16 
Literally burned to a crisp. I mean, they're just black little ashes. I mean, and that's the aha moment. It still comes up with conversations with FDA and get that dialogue. Could be very successful. 

01:29 
And then a lot of times not. FDA helped innovate with us. Isn't that crazy? It was awesome. Imagine this tomorrow. This is the gap in the problem that we're trying to solve. Here's how we're gonna solve it. 

01:47 
Unacceptable percentage of patients are actually classically malnourished. All right. We are facing a huge health crisis. For patients undergoing surgery, I cannot believe. the huge differences it makes in their outcome. 

02:02 
It's that fundamental. Surgeons on this benefit, and it's pennies on the dollar, and just the whole aspect of food is medicine, research properly can change the course of our health. Focusing on improving the human condition, how can we improve the quality of life of people? 

02:22 
Get away from chasing a dollar for our health, importance in nutrition, in medicine. I am hoping that we can really go more in that direction in the future. Well, hello. Thanks for joining this episode of It's So Facto. 

02:48 
I am so thrilled to be talking with my friend today, Kim Biedermann. Kim Biedermann, welcome to the stage. It's so great to talk with you again. I am so glad to be here. Thank you so much for inviting me on your show. 

03:02 
We had really a fantastic experience, I think, working together. So I'm really excited to bring you on this podcast in particular to kind of share our experiences and also kind of what's happened since then and learnings that we've had. 

03:18 
So what inspires you the most, Kim? And maybe do a little introduction of yourself first so everyone else can get to know you also. Yeah, sure. So I'm Kim Biedermann. As background, I have a PhD in Pathology and has spent most of my career in both healthcare and CPG companies, leading R&D, upstream R&D, innovation, product development. 

03:43 
I even did a stint in supply chain after I left GSK. Zina, I don't know if you knew that. I was VP of technical operations at what was known as the Nature's Bounty Company, who's now with Nestle. But during my time, I was able and had the opportunity to innovate on several products. 

04:04 
The main ones that are in my wheelhouse were antimicrobials, topical antimicrobials that provide physical activity on hand surfaces, masks, we'll talk about that in a little while. But also, I did a lot of work in the respiratory business. 

04:20 
Nyquil Dayquil at Procter & Gamble, at Pfizer, some of the Advil, Cold & Sinus, things like that. My most recent jobs are, I think, some of the most exciting. I was working at startup companies. So we went from, you know, huge, you know, CPG, Pfizer, PNG, to tiny, tiny little startup companies. 

04:46 
And let me tell you how it was so exciting. You had to wear multiple hats. I had to play a regulatory role, as well as R&D and in. innovation, but it was quite exciting to get some of our products out. 

05:05 
And one of my companies called MEND, M-E-N-D, is I had such passion for, and that really inspired me, being able to develop targeted nutrition. This is like food. This is like protein, amino acids, but with amazing clinical data on how it improves patient outcomes after surgery, for instance. 

05:31 
And so I've been able to work with some of the leading specialists in this area and develop some very, very effective supplements and medical foods that we're now giving to patients with fantastic results and being able to recover faster after their, like their knee surgery or hip surgery. 

05:53 
So that's what really inspires me. I think what else that really inspires me, especially now that I've had the opportunity to have all this experience, is to give back, you know, and really help the younger generation, help coach the younger generation, be a mentor. 

06:12 
In my current job, I'm currently the chief R&D officer at Nutrafol, and it gives me the opportunity to really help and coach, you know, my, especially junior members of my team, and I'm really enjoying it right now. 

06:27 
Wow. Yeah, it's quite a journey you've been on, you know, several different areas, it sounds like a lot of grounding on clinical evidence and data and how you use that data, but also you've taken some unusual, let's say, unconventional applications of products, right, that were not kind of the typical uses, but finding other uses, and that also means finding a different pathway to how you actually bring those products forward, 

07:02 
because of course it's in an unconventional way, but still valuable, right? So I think let's put a pin on that theme, we'll come back to it. So I mean, you know, as you described, your kind of your role, the journey of your roles, you also have to go on a self journey as well, right? 

07:27 
Oh, yeah, definitely. Going into those different companies, and we'll maybe reflect back now, okay, years went really fast, I would say. It's great to reconnect with you here, and that's why we had so much fun talking because we are friends, and when we met each other, it was on one of those projects where we were doing something unconventional in you, but when you started your pharmaceutical, career and different companies, 

07:57 
as you mentioned, large companies, small company startups as well. And the industry was very different in my observation from when we started. I think there was more of a company culture, a more stable company culture, if I may say in that way, and by stable, I mean, you knew who you were working with. 

08:24 
They became people that you saw every day, worked with every day. You grew up with them and families as well. That's not usual now. That's the whole different kind of, shall we say, lifestyle in pharmaceutical companies now than before. 

08:44 
Observation has been, stayed the same for a long time. That also meant you had the same ethos. and the same kind of leadership principles. And when I look back, I think that helped to have alignment with what the company's purpose was, what your own purpose was. 

09:01 
Oftentimes, you join the company because you had that alignment. But I wonder if I'm looking at it from rose colored glasses. Going back now, of course, it doesn't mean there weren't challenges. What do you think? 

09:12 
What's your feeling going through these transitions? Do you think there are things that that we've lost or maybe things that we can regain? And maybe there's new things that have improved since then, that maybe there's more opportunity now to move than maybe there was before. 

09:30 
So a lot said there, but what's your observation, kid? So, Zina, you know, such a good question. And you're right, it's it's complicated reflecting back because I was at different companies. I was much younger. 

09:43 
I was in more junior positions. But with all that, I totally agree with you. With respect to innovation, I feel like it was very different. Now, I was very lucky to start my corporate career at Procter and Gamble. 

09:58 
And Procter and Gamble and I believe they still do. They they promote from within. So there was intense stability. And with that, I felt I could take really a much bigger risk than I could, you know, at subsequent companies because I knew I wouldn't get fired or at least right away. 

10:21 
And so I felt safe. It was a real safe area. It was also, you know, you got to know people, you know, working multiple years. You really got to know them and trust them. And that was the other. I think the other really good thing with innovation is because to me, innovation is really about collaboration. 

10:42 
I'm one of those people who really innovate best when I'm with a whole group of people and a whole group of people that I really trust to know. And that was a really good opportunity back in my career to be able to really do some deep thinking, use some open innovation tools that were just being developed, even the early stages of crowdsourcing, for instance, and really come up with amazing ideas. 

11:11 
A lot of patents, I'd probably gotten most of my patents during that time as well. However, later, with the, I would say, just being able to really connect more with people, the ability, like even video chatting, all the AI tools now is an fantastic opportunity to keep up that innovative type of pace. 

11:40 
And even the open innovation tools have gotten a lot more sophisticated. I'm loving using a lot of the very sophisticated crowdsourcing. opportunities to be able to get, you know, new ideas coming in, being able to reach out to academic, you know, other thought leaders in which I couldn't do. 

11:59 
There was zero chance in the past. So I think it's a both and. However, you know, as I went through my career, everybody just started jumping from one company to the other. And it just seemed to be the norm. 

12:15 
And I, you know, I'm like, you know, leading the pack in that regard, staying only a couple years, five years, maybe six years, six years at GSK when we were there. But then things changing so amazingly, and then you need to, you know, you need to start over at another company. 

12:32 
On one hand, that was very disruptive. On the other hand, though, a lot of opportunity to learn new things. And so I think in the end, I think we even have better opportunities today to be able to connect with other people and to innovate, even innovate faster and more iteratively. 

12:52 
I always have a problem with saying that word. You gotta iterate on it. You're iterating on iteratively. That really resonates. Because part of what happened in the beginning of our career, I guess, is in those days, shall we say, yeah, there was that feeling of stability, but also there were those points of stagnation, right? 

13:16 
And you only moved up as somebody left or retired. That is so true. Yeah. And that did get a little frustrating. I'm grateful in my career, I was able to change roles or have my role be expanded. Just when I was starting to get an itch or start to get bored, I had other opportunities that the company and the leadership provided for me. 

13:40 
And it takes a skill to last at a company for so long, because especially now, because change does happen and it happens a lot. So I think yeah with change comes opportunity and I do totally agree with you that there is more opportunity now for change than there was before. 

13:59 
Now with that comes a trade off of stability but I guess what this means is you have to rethink what stability actually means right. And I do agree with you. I think the the opportunity for innovating is is more than there was before because there is so much change changes is not as scary or not as well changes can always be scary but it's it's accepted as yeah we're going to change things up. 

14:32 
I think the key is from what I've learned is that had some failures with with some of some changes we brought forward but I think what when we did bring change that actually was successful. it was because it was aligned with the company's growth pillars. 

14:50 
So I think this is another thing you think, oh, we're just going to bring white space and we're going to bring in all this stuff and the company has no experience in it at all. Let's bring it, bring the outside in and kind of push that boulder uphill. 

15:05 
When I've seen that be successful, it's because the company has already embraced a certain growth pillar and what you're bringing in actually feeds into that growth pillar. So it's a momentum that you're attaching to that way and you can be more successful and change can benefit. 

15:24 
And you mentioned that too. I mean, the role you're in now, I guess you probably would have never imagined years ago that you would be in such a role or maybe you've had that aspiration. I don't know. 

15:39 
But the roles are very different and the companies are very different. So looking back, like you said, you mentor and you develop your teams and you're really looking on helping to keep things moving and keep people motivated. 

15:53 
What are things that you suggest to how to deal with uncertainty, right? Because there was a lot of uncertainty when you change roles, people when they're facing maybe a numerous amount of uncertainties today versus before. 

16:10 
Yeah. Well, there's a lot to impact there, Zina. Let me start off with, I had a reaction to you when you were speaking about failure and I got the sense that you were sad about it. I've had a number of failures in my life, which I was initially sad. 

16:27 
But looking back, I think failures make you a better person. What doesn't kill you makes you stronger. And if you're not failing, you're not pushing the boundaries hard enough for yourself. And that's the way I tried to explain it when there's been several times that I've been laid off. 

16:46 
off at GSK, for instance, and you can't think of that as a failure. And in fact, reflecting back, it was the best thing that ever, ever could happen. So to answer your question of, you know, of people in similar situations or they're facing uncertainty is that, you know, really reflect on exactly what your situation is, are you just trying to hold on just for safety purposes? 

17:11 
Are you just trying to hold on just because you need the money? Let me tell you that there's a lot of opportunity. You have to have that confidence. That's the biggest thing. Confidently take one step and look in your future and really see what your opportunities are. 

17:30 
And I was surprised to find such great opportunities after, you know, some, you know, some tough decisions I had to make or after, you know, involuntarily. just because of all the uncertainty going on at different companies. 

17:47 
It had nothing to do with me or my performance. You know, I was laid off with many people, many great people, and I ended up in better places. I ended up being promoted. And so when you look at change, it is stressful. 

18:03 
Don't get me wrong, it is exquisitely stressful. But in the end, reflecting back, it was for me the best thing. And so I wanted to tell people in the throes of some uncertainty and thinking you're gonna get laid off or whatever, embrace it as a potential opportunity, which it is. 

18:25 
Yeah, I think that's a wonderful point. And you're right. Regarding innovation, it is helpful. It is so much more helpful when you're going to different companies. Take, for example, my technology, antimicrobial technologies. 

18:48 
I was able to transfer that from the essence of it from P&G, build off of it at GSK. I even did a little bit more work at other companies. And so you talk about innovation, being able to build off of a foundation like that and then bringing it into a whole new environment with, as you said, Zina, new priority pillars and opportunities where something was stagnant and one company gets accelerated all the way top to the CEO at another company with great resources to build it further. 

19:28 
That's the other advantage of change. Yeah, absolutely. You bring forward some really important concepts. And definitely I've learned from failures. Failures where it's like getting a degree, right? I see the experience is like getting another degree. 

19:45 
You get that currency from that experience that you can then build on. And if you haven't been challenged or meet challenging circumstances, whatever that may be, whether it's a difficult team or challenging leadership or just something brand new that you've never done before, how you deal with that is an education in and of itself. 

20:10 
And certainly, yeah, I think why I feel sad sometimes about the so-called failures is because knowing what I know now, I would have done things a little different and I would have tried to position it differently. 

20:25 
And maybe it would have gotten a bit more traction that way. Yeah, I respectfully disagree. So, I think, you know, people ask me, you know, would you do, do, you know, things differently they asked me that like on an interview and I always love to say no I do things exactly the way that I would do them and in one respect you want to look back just to learn you know if you did make a mistake but a lot of times these these influences in fact most of the time it's sort of out out of your control and in that regard it's best not to ruminate on what could have been different what you could have done on a certain day back in a certain year and maybe it would have made a difference to tell you the truth probably not okay yeah it wasn't the right time for you know the innovation it wasn't in the right place you know there's all sorts of other intangible explanations and you just have to move on confident even if it's um the sort of deceptive but confident that you've you you did what you could do at that time and that there's opportunities in the future yeah absolutely I think I think I was saying a bit a bit of the same but maybe differently I think when I look back and say you know if I could have done things differently it's that learning I got from it you know that then I apply to a new situation to try to say okay maybe if I tweak it this way will that make a difference here based on past experience and yeah I think I think you're right uh probably probably a bit too much hubris thinking that you know maybe I could actually change change the go back in a time machine and change the whole trajectory of things things happen for a reason at the time it's a result of circumstances now you show up the best you can at the time you know in those circumstances the way that I changed my outlook then then thinking I of, 

22:37 
okay, how am I innovating myself? And rather than depending on the company to represent me, how am I representing myself? It made the comment about confidence. Rather than relying on your supervisor or the leadership team or whatever it may be to give you opportunities, actually you take ownership of that, seek things, challenge things, do things differently, even in your current role. 

23:05 
There is a lot of opportunity that you can have. So something I like to think about is you have that agency within you to foster change, change that's aligned with your purpose. So I think a lot of things that have helped me through the years is saying, okay, how does this align with my purpose, my interest, my passion, and then trying to keep aligning that even as you make changes and maybe go to different companies or different roles. 

23:35 
Yeah. That's my guiding principle as well. And it really can't be overstated, Zina. You have to really have passion in your job. And that then by nature will allow you to think creatively, to be able to expand beyond what you're already doing, to be able to talk to your supervisor about other opportunities that you're thinking about in this area. 

24:05 
If you don't like your job, please get another one. Select on what you really like to do. And life is too short. Life is too short to just, you know, have a ball and chain on you, you know, during work. 

24:23 
Go out and really understand really who you are and what really drives that passion. And then, you know, you'll be so much happier. And and also we talked about offline, we talked about the fun. Yeah. 

24:38 
Put the fun in your job. I think part of innovation, and whenever I'm doing innovation, it is so funny because we will get Play-Doh or Legos or whatever. I actually enjoy it, you know, it is, you know, you want to make it fun. 

24:55 
And with that fun comes the creativity. Okay, the creativity starts coming out. If you're not liking it and you're not having fun, you're literally blocking yourself from innovation. So that is a necessary component in order to get you in the right frame of mind. 

25:13 
It's a frame of mind that's really important. So yeah. Yeah, really good call out. I mean, mindset is everything, right? What's the saying? You change your thoughts, you change your life. I mean, it's just so true. 

25:29 
And we have that agency in whatever role we're in. like to suggest that people coming into innovation roles just have an open mind, you know, don't, don't try to judge anything too early, just try to figure out what is it that we're actually trying to accomplish. 

25:47 
So my background, as you know, is regulatory affairs, and oftentimes people come to me and say, Oh, what's the regulatory pathway? What is it this, is it that, you know, will it be approval, blah, blah, blah, blah, blah? 

25:58 
It's like, you know, let's pause for a second. What are we actually trying to create? Let's talk about that. You know, let's talk about what what we're trying to bring forward. And what will be the most benefit for the target user, or the service or whatever it may be? 

26:16 
What are we actually trying to create? And to your point, you know, really lean into that creativity and ideation moment, and figure out what we're trying to shape. Don't try to put it into a box too early because if you haven't thought it all the way through, you might be putting it in the wrong box. 

26:35 
And you know, ultimately, it's not going to get the full benefit that you had initially imagined. I totally agree. And if you're putting your blinders on right at the beginning, you will never see it. 

26:49 
You know, like the discovery of penicillin. Okay, you know, it's a typical one as an example. And so it I think if you were going with we're going to find, you know, the best antibiotic, you wouldn't find it, you know, it was purely luck that it happened to grow on a Petri dish. 

27:07 
It was pure luck that you know, the conditions there, they didn't throw things away when they should have were able to find and then discover what it truly was just have to, you know, not put your blinders on, not be, you know, converging, it's a divergent mode. 

27:27 
You open to all possibilities. And that's where I think most of the true innovations, the huge ones, you know, then can occur. Yeah, totally resonates. Kevin, you know, what this reminds me of is kind of that, that growth, you know, s curve, that oftentimes, you know, innovations can be cut too early, just before you get to that inflection point to take off. 

27:54 
And my observation has been, you know, again, if you're aligning with the growth pillars of the company, so you you've already got, you know, acceptance, so then you have permission to ideate, right? 

28:07 
And you have that permission to ideate, you have that permission to create, and totally, like you said, just let it unfold, focus on what you're trying to do, but then let be open to wherever it may take you. 

28:21 
And I think there is a sense of over planning is not necessarily good, right? Just just go. There's oftentimes right in the past, it used to be, what's the five year growth plan? It's like, like, heck, we're working on an innovation. 

28:34 
Nobody knows what's happening six months from now. What are you talking about? Five years. So, but what you can have is an idea of a target, but also be able to adapt as you get more data. So you have data-driven adaptation and be open. 

28:52 
You want to accept things from all areas, from all types of people, even unconventional ideas. And so when you go back to that growth curve, if something that I found is that when you kind of think of assumptions about what you're making when you're early innovation idea and you have assumptions, now you go out and test those assumptions, maybe in a rank-ordered way. 

29:20 
And if you're doing that in an open way, you could give yourself permission to actually, keep working on that point where maybe you have a better chance to get to that inflection point rather than cutting it off too early, right? 

29:35 
And that means oftentimes it could be an entirely different business model. Exactly. It could go off in all wild ways. And it's hard. It is really, really difficult because you've got probably stakeholders and senior management funding this and they want results. 

29:57 
It's a business. They want an ROI. What's their return on their investment? And if you go year after year with really no progress, it is highly likely that that program will be cut. And so it's a balance of being able to be open and free to do whatever it is you want to do, but also know that you need to, you're beholden to the company that's employing you. 

30:25 
And so it is a balance where you need to say, hey, we're meeting certain milestones, this is what we're doing, and also allocating only a portion of your resources to open innovation or open ideas. And that can help then sustain this program until you get the light bulb and the amazing opportunities from it. 

30:53 
Yeah, absolutely. And I think that's where kind of having a conversation about what assumptions are we making and what are kind of go, no, go, kind of top, top, and so that you can test those assumptions early on. 

31:11 
Yes. Okay. Does this mean we have to adapt or pivot our direction or do we have to shift to something completely new? Yes. And I think that's a good way of having those conversations with leaders. on kind of are we allocating the funds in the right way? 

31:32 
Because as we say, you're also leaders when you're leading that project and you're responsible for how you're using that funding. So how are you gonna best use that funding to get to the best outcome that's possible and also generating the evidence but also being transparent about the timing of what you expect to do by when? 

31:54 
Exactly. Hello again. If the content of this video resonates with you, join the InnoPathways wait list for early access to new content, offers, and our founder's bundle for new programming. We'd love to have you join the community. 

32:11 
The link's below in the notes. So we talked about a lot of change and a lot of shifting that's happened and a lot of different roles. So when you go back to thinking of your education, right? how you started off, what you were going to study in your area of study. 

32:31 
And now there is so much opportunity I think with different degrees and combination of degrees that can lead you on so many different paths. So I have a pharmacy, a series of pharmacy degrees that I achieved and certainly I have not led that conventional pathway in my career. 

32:56 
And now there is so much more that's available. But that comes back to I think you can actually drive your trajectory on where you're going. So you have to also always kind of align back. But when you're talking to maybe your kids or your team members who are seeking advanced education in your own path, how have you connected your education with the path that you ended up taking professionally? 

33:30 
And have you had to skill up or kind of adapt your education in a different way than what you expected? And what's been your experience? Yeah, it's, you know, I think it's a great question for me, and everybody has a different path. 

33:50 
But for me, believe it or not, you may not know this, but I always from when I was like eight years old, wanted to be a biologist and wanted to do research. And so I was lucky in one regard and going through high school and college, it was just I knew what I wanted to do. 

34:09 
And I think that's somewhat rare. But I was like that eight to 10 years old that was doing all these experiments in my basement and wild stuff. And it was funny how my parents tolerated it. So I guess the point for me is I knew my passion early on and happily, you know, a lot of times it will change and that's totally fine. 

34:36 
For me, it didn't. For me, I got more motivated. The more I learned about biology, the more motivated I became. And then it was really easy for me to think about grad school. Grad school is crazy because you're not making any money. 

34:51 
You're not in the workforce. Let me tell you, though, I had a ton of fun. So in California, not only, you know, being in grad school, but also skiing and backpacking and doing all these outdoor activities have motivated me as well. 

35:09 
But my point being is that I purely went after my passion. And back in the day, biologists were like very poor cousins to the rest of the life science, like the chemists or industry. inferior, quite frankly, to engineers. 

35:28 
And so it was frustrating on one side to have peers, you know, that are not PhDs, but at my same level. But on the other side, really, really enjoying what I what I do. I love my degree in my degree was in pathology. 

35:46 
I think it's called now things. And so it was part of the med school, too. So it was a big connection. My degree was majorly connected to diseases and then obviously the research to, you know, go after therapeutic targets and things like that. 

36:10 
And I actually spent many years in cancer research at Stanford University before going into industry. On one hand, early my career started out with pure passion, and I hit the jackpot because right as I was going in was the renaissance of biologists, molecular biology, genetics, and all of a sudden, the plethora of new tools and targets for not only the pharmaceutical industry, but also for the supplement business and cosmetic business of which I look forward to talking to you about in the future. 

36:49 
And so I just happened to be really lucky to ride that wave. And all of a sudden, everybody wanted my background. So I was able to stay in my area, you know, for the longest time. And even, you know, tangentially getting the PhD, you learn how to problem solve, you learn how to collaborate. 

37:09 
The problem solving came into play when I was when I was in supply chain and in the in the in the plant and technical operations, where there was some issue, some sort of fire, sometimes literally. That means you know, and it was so satisfying to be able to problem solve on the spot and see that then being resolved and then see the immediate consequence, you know, of being able to get, you know, get money back or recover your, 

37:41 
you know, your product or whatever. So that part, you know, I got very curious and I was, I was very excited about doing that crazy job as well. In terms of, you know, being able to really dictate your own plan, I think it's really rare to a person be able to do that. 

38:02 
I personally had a lot of headwinds. You know, I had a family. I had all these other things going on. I had, as we, you know, I get laid off where that would, you know, all of a sudden you need to find a new job. 

38:15 
You know, all these things going on in my life that would, and I had my, my husband. who also had his career. So we were a dual-career family, and that was hard. And so there was all this negotiation and compromise going on every time I would think about a new job opportunity. 

38:38 
So I also had to flex a lot. And I felt that if I could keep the nuggets of my passion intact, like I just said, the problem-solving, I could go to a completely different area and be very happy and productive. 

38:55 
So maybe that helps some people listening to this in their career and their opportunities. Yeah, I'm so glad you highlighted that, Kim, because I found this name for myself. And actually, it's been on reflection. 

39:12 
It wasn't something that I was doing. I mean, I didn't know it was a difference. Yeah, you're just kind of going through the moments, right, and trying to shift here and there. But as I look back, I have a similar reflection of, I really loved to create. 

39:32 
Now, that might be a little bit unusual for a regulatory person to say, but I love the creation. And my personal interests were law, was medicine, was diplomacy. So these three things really came together with regulatory affairs. 

39:53 
So what I love then is not looking up a rule book and telling you yes or no, but actually, how do we negotiate and understand what the framework is from a regulatory standpoint to bring forward a new idea, right? 

40:12 
How can we create that new idea within this framework? And how do we solve that problem or actually bring an opportunity and If we're doing something first to world, you're creating a new process. So there is that chance to do that because in our experience together, we had dial-ups with FDA, something we were doing that was completely different. 

40:37 
Okay, let's just, here's what we're trying to do. And you know, everyone is a person. You know, everyone's trying to do the best that they can. And I think the key thing is if you've found a problem and an unmet need that you're serving, and it can have a benefit, if you're really aligned on what that benefit is and what you're trying to create, it goes back to this ipso facto, no way but forward, 

41:07 
you just kind of find that pathway and keep ideating and creating and shifting, adapting as much as you can to kind of bring that forward. But the overarching thing there is problem solving, right? And I think that that has been a lot of fun when you create and you actually accomplish and solve a problem, how much fun that is, the thrill and actually the process, that journey. 

41:35 
So we went on a journey together, Kim, and you. And actually I met you. My most intense experience in my career. It was so awesome. You and I were lovers. It was an awesome experience, Kim. I, whenever I think about it, I just smile, right? 

42:01 
Let's talk about it. Let's break that. We got to talk about this. What we're talking about is when we were both at GSK, I was in, I was actually on special assignment in our DAU and regulatory. And we together were tasked with how we can develop some physical barriers to compliment a pandemic preparedness plan. 

42:28 
And it was along the orders of like a mask or a respirator. And I had talked to earlier about my anti-microbial technologies. And so we were bringing that in to make a coded mask. And Zina, the, I think first of all, just the benefit was very interesting because this is what FDA really wanted to understand is what is that benefit above and beyond what a mask could do on its own. 

43:01 
But it came at a time where it couldn't have come at a better time. You talk about a good time and place. This was right as we were doing this, that was the H1N1 pandemic for COVID. But it was all of a sudden the pandemic came by. 

43:21 
And all of a sudden we were in the limelight, we were talking with the CEO. We had, you know, we're talking about this as the biggest opportunity for GSK. Holy crap, I had never been under the limelight so much as we were during that time. 

43:40 
And then all of a sudden, remember talking with like the DOD? Yeah, with the dirt on his boots. And HHS and FDA and multiple times taking the Acela train down to D.C., working overnight in a parking lot when our hotel got on the car. 

44:05 
Yeah, on the top of the hood of a car. Yeah, on the top of another car that wasn't ours, the owner said, go ahead. I can't use my car anyway, the fire trucks are in the way. It was crazy, it was absolutely crazy. 

44:23 
And yet I love, I mean, working with number one, our pharmaceutical, like the vaccine team who made things happen for us, GSK paved the way, do whatever you need to do in order to, you know, work and answer not only FDA's questions, it was totally, totally new. 

44:45 
It was the first of its kind. And so that was really exciting. It wasn't as exciting when we got, you know, so many responses, you know, in requirements from the FDA. In the end, it made a very high quality product and I was very, very proud of the result. 

45:06 
Your thoughts on that? Yeah, it's one of my proudest moments also because as you say, everything was happening in moments, right, there was just shifting moments here and there, here and there. And we kept having to think differently, right? 

45:26 
So as you say, it was an exciting time to work with the full company resources, right? Not just in one area, but the full company resources and pulling on that. And as you say, making things happen, getting the results, getting the access to the viruses for testing and all of these things. 

45:49 
I mean, there was a numerous amount of collaboration and choreography that went into that and working with various different experts to kind of pull that all in together as we were kind of finding our way and going off and let's not forget the structure of the mask and testing, you know, making sure that the integrity of the mask, which was PPE, which everyone knows what that is now. 

46:20 
is that that function was not going to be impacted in any way. Well, I found it to be extremely fun because all the conversations we had with various team members and trying to figure out what type of testing we would do and trying things ourselves and it was certainly a wonderful opportunity. 

46:42 
And what was key there was also advocacy, right? So now as we think about it, we were actually doing a lot all at once. We were generating the evidence, we were producing, we were formulating, we were manufacturing, we were getting partners together to deliver different aspects of it. 

47:02 
We had the different parts of the company that we had to bring in and collaborate with to actually enhance what we were doing. And at the same time, overcoming doubts and challenges along the way, contended use. 

47:19 
of the formula, we were able to put it in squarely as a medical device. And this was something completely different at the time and different. But yeah, I mean, it was even our conversations with FDA, I think we had a lot of a lot of fun with that, because in the meeting itself, we would be asking questions, they were raising tech, you know, technology, technical questions, you're saying, okay, so how would we approach that? 

47:49 
These are our options. And we were actually talking live and trying to figure out because what's really key to a meeting is getting that information that we can, along with the potential users, we talked about Department of Defense and HHS more broadly and pandemic preparedness, what are they looking for? 

48:07 
So there were different stakeholders involved that we were also trying to deliver to. Correct. There's so much to learn from that, both good and both constructive. One of the things I wanted to point out that you may not have been aware or remember, is the innovation that went on. 

48:26 
And I said, you know, we need to lower the temperature, literally burn to a crisp. I mean, they're just black little ashes that came through the lot. You have to reduce the temperature. You know, we've been doing this for almost 100 years and we know exactly the optimal temperature and there's no way that, you know, we can change it. 

48:49 
And I said, well, can you just try it? Let's just see what it looks like. And with a little tweaking was able to lower that temperature by a major amount, you know, over 20 degrees and got perfect. Everybody was stunned. 

49:05 
This has saved us probably millions of dollars just in the savings, you know, of that energy. I mean, and that's the aha moment, you know, just these little things. What didn't work. We, you know, we, you know, we, you know, we, you know, we, you know, You know, consumers at that time and users, we literally couldn't get people to wear masks. 

49:25 
And we did not build in comfort. And so, comfort is now that we know through the pandemic, oh my goodness, we've learned so much with the pandemic. But comfort, if you're not wearing the mask, it's not working. 

49:44 
And so, I think even a cloth mask, you know, during COVID, is better than nothing, you know, where we finally, I could not believe that the guidelines allowed for cloth masks because they have very little filtration. 

50:00 
But my point being that we did not build that into our criteria, and as a result, it had limitations on its use. Great for stockpiling, but not as good for direct to consumer. So it was a really good learning, and I think going forward as we, you know, build new innovations is really to think about all the aspects that a person needs in order to use a product effectively. 

50:30 
Yeah, really good call out. I put together what I call an innovation strategy wheel, you know, kind of a hub and spoke kind of model. And with the user at the heart, because what we need to develop is that the user actually engage whoever that user might be whether it's a healthcare professional individual, if it's not something that's usable usable or, you know, reduced friction to implement the adoption. 

51:01 
We talked a lot about in hospitals and things about fitting into the workflow. So critical, because creating that little just a few extra steps to have to adopt something in a workflow can actually just destroy the whole adoption of that particular product and everything all the best benefits don't come if they use. 

51:28 
And you got to know those you got to really understand that consumer journey. Oh, I learned this from Procter Gable Marketing 101 is really understand what are you know how are users consumers, patients, you know, using comparable products, what are their barriers, what are the touch points, you know, what really matters to them. 

51:53 
And then not only providing that benefit, but being able, just as you say, to integrate that ideally in their normal habits, that leads to, you know, much greater adoption, you know, of the technology. 

52:07 
Yeah, and another thing that you brought up which is really I think extremely important is ask questions. Right? Like why? Why does it have to be that way? And as you pointed out, I think most of the time, we will we will discover that the answer is, well, we've just always done it this way. 

52:32 
Do the experimentation. Well, after years of kind of doing something and you'll see this when you go and review SOPs again and again it's like why the heck are all of these steps here why don't we streamline it. 

52:45 
Well, because this is necessary. Why is it necessary? And nobody knows why. But the principle is why are certain things done in a certain way and also the cost impact, right? We can source things differently, just because we've always done it a different way. 

53:03 
It doesn't mean that we can't try to source it a new way. But what that means is that experimentation, just as an example that you brought up, you know, can we maintain the integrity? Sure, we can. And look at that different, that new process with such a cost savings, but nobody thought to ask that. 

53:24 
So a lot can come forward when you actually ask questions and when you're trying to create, and I think this is also part of that innovation process. When you're innovating something new, don't be afraid to ask, well, why is it this way? 

53:40 
Or why do we have to do something this way? And I think that also comes up with conversations with FDA. If you as the innovator, you're the one who is the expert on that innovation. So you can ask, well, this is this is what you're saying should be done, FDA. 

54:00 
However, we feel it can be done this way, and still maintain the criteria, but this is how we would do it and get that dialogue. And a lot of times you'll actually could be very successful. And then a lot of times not. 

54:20 
I think you learn why not, right? Yeah, I mean, sometimes it's like talk to the hand, you know, I'll give you an example that was pretty frustrating with the FDA was our testing of the safety of that mask. 

54:36 
And we wanted to really pressure test the safety. So we put the potent material right next to the skin, you know, for the, you know, the toughest tests that we could do and found that there was no, you know, it was completely safe. 

54:50 
The FDA didn't accept that because in their guidelines, you had to use it as intended. So you had to put the non-treated portion on the skin, which made no sense to me. But it was like, this is what we do. 

55:06 
There's no compromise. and you need to check the box off. And so I wanted to ask you actually, because I see that a lot. I saw that a lot with FDA. It's like we are checking off a box and it's a certain criteria and it doesn't matter if it's logical or not. 

55:25 
You just need to do it the way we said. But what's your thought on that? Yeah, I mean, I think there's some aspect on that, but one thing that's important when you look at regulatory science, right? Regulatory science is a process through which FDA can determine a repeatable model and a repeatable model in where these are, let's say standard requirements or standard ways of doing things, whereby we are assured that this will result in a safe and effective use of a product. 

56:06 
And so, Where we see now, there is multiple ways that regulatory science is advancing. And this is where FDA has invested a lot of time in recent years in doing just that. Several examples of people have said with, sadly, the leaving of Peter Marks from CBER and the advances in rare diseases and how new methods and new processes being considered on even clinical, what is clinical evidence and how do you prove that? 

56:43 
The whole thinking of risk-benefit is very different with rare diseases than it would be with a product that goes out to a general population. Because you're talking about a very different risk-benefit profile, right? 

57:01 
Because the risk of doing nothing is so worse. And so I think a lot of those standards thinking has been challenged. And so what I would say, but one key principle, I think, holds true, which is the intended use. 

57:19 
So I think it's always important to have that evidence of a product working in the condition in which it's intended. But I would say that the data that we showed them, that direct contact, gave assurance also that this is a good product. 

57:44 
So it's not alone, I think, with that direct exposure and the positive results from that gave even more assurance, a supplemental, that when it's used as intended, also we meet that so that it can be said that. 

58:07 
yeah it's used as intended whatever other aspects goes with that with the wearing of the mask and you know making sure that it fits and all of these things everything comes into play when you're looking at you know the intended use so yeah I mean there are things that will feel like a checkbox and I think we always have to look at well why why is it that way and some of the things might be a sense of a checkbox a sense of meeting a standard but I think always good to to question always good to bring supplemental evidence to bring more assurance and confidence is always there and I do think there's that opportunity for dialogue which okay we had because initially it was like this is a drug device combination full stop we have never worked on this type of product before were able to ideate in dialogue and problem solve and say, 

59:10 
okay, well, this is how it came about. I think that's the coolest thing, Zina, quite frankly, to be able to ideate with the FDA. Okay, so yeah, they had certain things, check the box, but other things they said, we're looking to you to really define what this approval slash clearance process is, for this new entity, new to the world entity, and they really worked with us. 

59:44 
I can't believe I'm saying FDA helped innovate with us. Isn't that crazy? It was awesome. I just, to this day, I just, I smile over that experience. Yeah, and we had, yeah, there was challenging technical things we had to overcome, but I think overall, the dialogue was, I mean, we enjoyed it. 

01:00:10 
We enjoyed the dialogue, I think, right? Yeah, maybe not always in the moment, but I think as we look back on things most definitely, and I even think within the teams, I remember so many laughs we had with trying to figure things out, and there's something with the class rods that we were trying to figure out, and I was like, okay, that's not this audience, you know? 

01:00:39 
Okay, that was a- That was awesome. I want to memorialize the FDA when we were talking to them about how to apply coding to the mask or whatever, and she's like, I don't care, get a glass rod. Use the glass rod, whatever, and it became like a joke, an inside joke to us, is like, whenever there was a problem, I don't care, get a glass rod. 

01:01:17 
But you're right, you remember those really long nights going over, oh my god, all the questions and the review that FDA had, and oh boy, that was daunting. But we did it. We did it. And I think others who work on regulated products, such as drugs or devices or digital products, diagnostics, so many things, key mindset to have is that you are the expert. 

01:01:46 
And when you are the expert, part of your job is to educate FDA about, or any stakeholder, like you said, we talked to. to DOD and HHS and so many different, you know, others, and also other countries as well. 

01:02:02 
We had a conversation about it. Comes to how are you going to tell the story about what you're trying to do? Be very clear about what it is. So here's what is today. Imagine this tomorrow. This is the gap in the problem that we're trying to solve. 

01:02:20 
Now here's how we're going to solve it. A lot of how you approach stakeholders is how do you educate and describe the innovation that you're bringing forward. And you talked about earlier food for medicine, food as medicine, but now, you know, if you have an open mindset, a holistic mindset, not treating the patient or the user as being a disease, but actually being an individual who's experiencing a condition or experiencing a disease. 

01:02:49 
Now, how do we make that better? Exactly, oh my goodness, I could go on and on about this, you know, but very briefly, it is tragic that physicians in med school are not getting really good training in nutrition. 

01:03:03 
And that even patients, even in the United States, huge number of patients, huge percentage, unacceptable percentage of patients are actually classically malnourished. All right, we are facing a huge health crisis. 

01:03:19 
And so I really, you can tell my passion coming out, being able to deliver, to understand and deliver targeted nutrition for patients undergoing like surgeries, I cannot believe the huge differences it makes in their outcome. 

01:03:38 
And it's only like a three to four week course or an after, you know, that patient goes through surgery, makes all the difference in their metabolism and their preventing the muscle wasting and atrophy that goes on, it's like... 

01:03:56 
It's like a 1% a day after you get out of surgery. If you take certain proteins and amino acids, you can prevent that to a great extent. It's that fundamental. And so I am on a mission, even though I'm not at that company anymore, I'm spiritually on a mission with them to be able to just educate surgeons on this benefit. 

01:04:28 
And it's pennies on the dollar. I mean, it is just, it is amazing. And just the whole aspect of food is medicine. Research properly can change the course of our health, especially in the United States. 

01:04:44 
And so that's something I still want to do in the background and really continuing to promote that. I think it goes back to solving problems, right? Solving problems. Yeah, it's that passion behind it. 

01:04:55 
Exponential advancements of technology and data, and new insights coming every day. Now, what do we do with those insights to solve problems in very different ways now? It's at a very exciting time, but I think it's also a pivotal time. 

01:05:10 
But going back to a biggest part of treating disease, is actually preventing disease from actually fluttering, speaks to quality of life, focusing on improving the human condition. And I think that's something that will always be an opportunity. 

01:05:26 
It is amazing how COVID has created such a culture shift. Not only with remote, which offers up dramatic opportunity. I work fully remote, and it's an opportunity I wouldn't have otherwise. It's not in the main office area in New York City anymore. 

01:05:43 
But also, and maybe this is a subject for another day, but the great resignation by some of the younger generations. It really just, why am I chasing after money when my quality of life is so bad? And I really, I'm impressed with that. 

01:06:00 
And I think we should ask more questions on how can we improve quality of life with people? Get away from chasing a dollar for our health, quite frankly. The importance, let me put it in a positive way, the importance of nutrition in medicine. 

01:06:17 
I am hoping that we can really go more in that direction in the future and innovate there. Having the opportunity because of technology to actually think about things completely different. Yeah, that's why I'm still in the supplement world, quite frankly, Zina. 

01:06:32 
It's an arm of nutrition, but I'm hoping much more standardized that with using similar pharmaceuticals, tools to establish the scientific rigor and in making sure that the product is working and clinical in robust, you know, randomized controlled blinded clinical studies, which is the model for pharma, that we can begin to convince regulatory bodies that this is a great opportunity for people. 

01:07:09 
And of course, people are already buying supplements, but I would still say it's a Wild West. And I would love to see more rigor on both the, I'm going to say efficacy, and as well as safety of supplements, because I personally believe obviously that it has a huge opportunity to provide benefits and benefits in a more holistic manner, which I believe intrinsically is better for people. 

01:07:39 
Yeah, you know, I think there's parallels there when we look at digital health, right? Because there are also different approaches to digital health. There's also different, how people define digital health very differently as well. 

01:07:56 
But some companies are approaching digital as digital medicine, right? And how you can influence biomarkers through a different mechanism of action. But you're holding that same as what you just talked about, scientific rigor on how you're building that evidence and how you're proving benefit and going along that problem solving journey actually brings much more assurance in the product actually working and how it fits into the workflow, 

01:08:32 
how it fits into the overall tools that can be used for an individual and in a more holistic way. Because I mean, logically you would think biomarkers are a good thing. So if you can influence biomarkers and use it together with convergence of different technologies along with nutrition, you're really talking about holistic care and then going towards that value-based care model. 

01:09:01 
So I think now more than ever in the past, there's probably would be a lot more openness in what you're talking about, especially if you can bring forward that rigor and that same kind of research depth that goes into it. 

01:09:20 
Exactly. Summarize some key points. I think I would say follow your passion, look at problem solving in an open-minded way. Don't be afraid to ask questions even of stakeholders. I mean, so many times in our stakeholder conversations with government, you would go completely off script in the moment because, hey, this is an opportunity to learn. 

01:09:41 
Let's have the dialogue right now. but we can do that. That's possible to do in that part of creation. You know, have that open mindset and have fun doing it. Absolutely. Well, Kim, it's been so fun talking with you. 

01:10:01 
Thank you so much for inviting me. Absolutely. Thank you for joining me here in this studio and one of the inaugural episodes for this podcast. And it was also fun to reflect back on our experiences. 

01:10:17 
Thank you, Kim. Let's not keep it so long before we keep in touch again. And as you say, we will have some teacher episodes with you on completely different topics. Thank you. Thank you, Zina. Bye. Bye. 

01:10:44