In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products.

They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth.

Subhi shares his personal journey in podcasting, the impact of consistent content production, and the importance of lifelong learning.

They also dive into the intricacies of combination product definitions, regulatory pathways, and trends, offering listeners a well-rounded view of the current state and future potential of this evolving industry.

Key Timestamps:

• [00:02] – Introduction of Subhi Saadeh and his background in combination products.
• [03:45] – The origin story of the Combinate Podcast and its impact on Subhi’s career.
• [12:32] – Overview of combination products and regulatory differences between the US and EU.
• [18:50] – Common misconceptions in drug-device integration.
• [28:10] – The evolving landscape of combination products and industry growth.
• [34:22] – Balancing technical and business aspects in MedTech.
• [46:15] – Notable episodes and guests from the Combinate Podcast.
• [56:30] – Final thoughts on lifelong learning and producing valuable content.

Quotes:

• Subhi Saadeh: "If I want to be a master at my craft, I need to be producing something in a way that is consistent."
• Etienne Nichols: "Teaching others is one of the best ways to instill that knowledge into yourself."
• Subhi Saadeh: "Drugs and devices aren’t as different as people think; it’s how they measure product quality that varies."

References:

• Combinate Podcast: let’s combinate.com
• Subhi Saadeh’s LinkedIn Profile: Connect with Subhi
• FDA Regulatory Guidelines for Combination Products: Important for understanding the regulatory landscape.
• Book Reference: Quality is Free by Philip Crosby - A must-read for quality management professionals.
• Book Reference: Bottle of Lifes by Katherine Eban
• Etienne Nichols’ LinkedIn Profile: Connect with Etienne

MedTech 101:

Combination Products: Products that integrate two or more regulated components (drug, device, biologic) into a single entity. Regulatory pathways for these products can vary significantly depending on the primary mode of action (PMOA), which determines which FDA center will lead the review.

Questions for the Audience:

• Poll: What do you see as the biggest challenge in the development of combination products today?
• Discussion: How do you think global harmonization of MedTech regulations will shape the future of combination products? Share your thoughts with us at podcast@greenlight.guru.

Feedback:

Enjoyed the episode? We’d love to hear from you! Leave us a review on iTunes and let us know what topics you’d like to hear about in future episodes. You can also email us at podcast@greenlight.guru.

Sponsors:

This episode is brought to you by:

Rook Quality Systems - stay ahead of the curve with Rook Quality Systems' 'Quality As A Service.' Rooks proactive approach to compliance ensures you're always prepared for the latest regulations and industry standards. Don't wait for issues to arise—be proactive with Rook. Learn more at RookQS.com!

Greenlight Guru - the only eQMS built by medical device professionals, for medical device professionals. Get to market faster with confidence. Learn more at greenlight.guru.

Etienne Nichols: Welcome to the global medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: As we're getting started here at TN, I did want to say all opinions expressed here only represent me, Subi N of one and no other organizations entities. And I'd say the one maybe major correction there is that I'm certainly not an expert and definitely not a leading expert. But I would say as part of my podcast and journey, I've talked to a lot of experts and really grateful to be on the show. Huge fan. Been a longtime listener, actually back to the John Spear days. And I'm a big fan of you as a host as well, Jeff.

Etienne Nichols: Really cool. Well, I really appreciate having you on the podcast. I'm excited to have this conversation today because you have 139 episodes. That's a lot of episodes. Curious if you could talk to us about what sparked the idea for the combinat potty podcast.

Etienne Nichols: Yeah, I had just had my second kid and was just in this kind of, I don't know, nebulous spot mentally, and I was thinking about like, what my values are, what I'm trying to learn. I was getting ghosted by people that I really wanted to talk to and respected. I'd always been really good at networking. But I felt like as I got to the manager level in Big Pharma and was trying to reach out to more people in like the senior director VP space, their time was more limited. And basically I wasn't getting the time of day. And it was during COVID And I'm like, for. It was, there was a lot of things going on in the background, right. I had just had my second kid. I was thinking about, well, yeah, as you have your fourth on, the way you go through, it's not like you grow in a linear progression. It's the same thing. When it comes to racing and fitness, learning is also the same way. So I was in this spot where I was just in a really reflective place, and I was thinking about, well, what do I want out of my career? What do I want to learn? And this thing, this thought that was in my head that I just couldn't get out was, if I want to be a master at my craft, I need to be producing something in a way that is consistent. I'm very good at maintaining habits. I'm disciplined. I know that. But I'm not putting myself in a situation where I'm producing almost for the sake of producing as an exercise. Said, well, I could start a blog to have that become habitual. I could. I was thinking about what I could do and I'm like, I got the gift of gab, like nobody's business. It's true. I can talk people's ear off. And so it became a two or three bird, 1 st kind of thing where I was able to produce something in a way that was consistent and challenged myself. Continue to learn. Pay yourself first in terms of learning and prioritizing that. If people are expecting an episode a week, and I've set that expectation that I need to devote at least an hour to a week to producing something. Secondary to that was my ability to connect with people and reach out, get advice on that. And I would also add, we were talking before we started recording. My father passed away when I was young. And so for a long time, I had this itch that I wanted scratched, where I would want people's advice and people's guidance and things like that as I grew older. And so that includes career, relationship, life and so on. And so that for me was very meaningful. And it's been great.

Etienne Nichols: I respect that a lot, especially the production, for production's sake. And I'm curious if you have been able to identify maybe some of the ways you've changed or the way producing this has impacted you.

Etienne Nichols: I've become a lot more efficient. So I think you said earlier that, like, oh, it takes a lot of work. I think it may be perceived as it takes a lot of work, but it doesn't take that long. Even if I'm producing a solo episode where I'm just researching a topic, putting together a script, and then recording it, like, I feel like I could turn it around in, like, 2 hours. And especially with a lot of tools that are available, it doesn't take that long. And as you. My brother is a lot faster than me in terms of racing. Right. I'm heavy and slow, but as you become more and more fit, the long runs actually take less time. And so, like, I follow people on Strava, right. And I'll see them knock out a 20 miles run in, like, 2 hours. And that's their long run for the week.

Etienne Nichols: Yeah.

Etienne Nichols: All their other runs are shorter. Right. Whereas for me to do the 20 miles, it may take me closer to 4 hours.

Etienne Nichols: Right.

Etienne Nichols: And so I think it's just the natural progression of things. As you become better and sharper, you become more efficient, and it takes a lot less time. And so that's just speaking broadly. But in terms of creative process, I've tried to automate the stuff that I can as much as possible. So, like, I typically have an intake form that I have people fill out. Like, what are the things that you definitely want to talk about? What are things you don't want to talk about? If they have a bio, they'd like to. I love the bio that you gave. Like, I need that for sure. The summary was nice. So I try and have my guest do as much of the work as possible, because this is something that I realized, too, is people are nervous about how they're talked about, and so it unnerves them if they're providing me the bio that's going to go in the show notes. Like, it's a win win where I don't have to put together the bio and they know what's going to go into the show notes. You know what I mean? Yeah. I use a tool called Descript, which really helps with my editing. I don't know if you. I don't know if you use that ten out of ten. Maybe the best money I've been, maybe the best money I've spent. And I always just look, that's like, the thought that I have is I plan on doing this forever. Okay. There's no end goal in mind, and so there's no end timeline. I should say in mind. And so from that point of view, for me to do it for the long haul, I need to make it as easy as possible so that it becomes near impossible for me to miss.

Etienne Nichols: Right. Either as easy or as pleasurable. You have to smear that, all the rough edges. For sure.

Etienne Nichols: Yeah, for sure.

Etienne Nichols: Okay. I could talk about podcasts all day, and maybe someday we're going to have to do a podcast on podcasts that gets meta. But let's focus, let's move on to the combination products topic. And I didn't ask you to do this, but I wonder if you could give maybe an overview of combination products just so that we can and level set with the audience. I don't know. We need to set up some boundaries as to what we're talking about when we talk about combination products.

Etienne Nichols: It's really funny. You had Susan needle on before, right after she had, after she published her book. And one of the things that she's working on through ASTM is a harmonized set of definitions for combination products. And I think that's one of the challenging areas, is around just the philosophy of what is and isn't considered a combination product. So I'll just talk about the FDA and the Eudez. So, in the US, it's a combination of two entities, a drug device, biologic device, or a biologic drug. In the EU, they take a little bit of a different approach where in the EU, drugs are called medicinal products and medical devices are medical devices. And I think rather than going through the actual definitions, yes, I'll speak to the regulatory frameworks just of the two. In the US, the reason that those regulatory definitions of drug versus device matter is because you have CDRH, which is the center that focuses on devices. You have CbER, which focuses on biologics, C DER, which focuses on drugs, and you have the Office of Combination Products, which tries to work through the management of which office should be the lead reviewer. And one of the Office of Combination products main responsibilities is handling the requests for designations for is it a combination product, is it device led, is it drug led? And so on. In the EU, it's a different model where the competent authorities are responsible for the drug reviews, and EMA is the European Medicines Agency, but they farm out the notified body opinion that's required under the EumDr Article 117, and have the notified bodies do that review, and that be an input into the review of the drug as part of the competent authority review. And so from that perspective, when you look at the definitions in the regulation, you can see like, oh, this is how it's supposed to be reviewed. So the definitions start to make a little bit more sense. But I do think one thing that I think is a problem in terms of harmonization is just the recognition of is it a combination product or is it not? And so you have the US and the EU, some countries that have started to introduce definitions for combination products, but then you have countries that don't even acknowledge it conceptually and it's just drug or device.

Etienne Nichols: Yeah. And you mentioned the different branches of the FDA that will handle different sections of the combination product. And so one of the difficulties that I think some of us in the industry get into is the thinking, okay, well, okay, I have a device and I have a biologic or a drug, or maybe all three. I suppose that's the fourth option of a combination product. And it's which entity am I going to submit my, or will my submission go through? The primary mode of action is what determines that the primary mode of action as far as what part of the, the combination product is actually mitigating or diagnosing or treating the disease. What happens when for the, if you have the drug constituent as the PMOA, what happens with the device constituent and how does that get reviewed from a regulatory standpoint? Can you speak to that?

Etienne Nichols: You mean in terms of like a pre market approval?

Etienne Nichols: Yeah, pre market approval or.

Etienne Nichols: This is my understanding, and I wouldn't say it's, I'm not a regulatory, actually, if I had a nickel for every time I said I'm not a regulatory person. I say it in my industry meetings when for the international working group, I say it a lot that I'm not a regulatory person.

Etienne Nichols: What do you call yourself?

Etienne Nichols: I would say quality more than anything.

Etienne Nichols: Okay.

Etienne Nichols: So in terms of review, I should say that you submit through the, at least if it's drug led. Most of my experience has been drug led, so I can't really speak to device led. If you're following a drug led, you're using the CTD format, the common technical document format, and you're putting some of the device related elements into the CTD format. There's expectations on where those go and those sections are reviewed by the appropriate sort of device center.

Etienne Nichols: Okay.

Etienne Nichols: And there's a group within FDA that is responsible within this, within CDRH, I should say that's responsible for reviewing those, say, functional performance characteristics and that are part of a drug led combination product.

Etienne Nichols: And I'd like to know what your, what you consider to be some of the biggest misconceptions in drug device integration and so on. Or maybe what are some of the biggest difficulties when you have a combination product? I almost want to revise that question and zoom out. Do you see drug or do you see combination product, the industry as a whole growing because it feels like its growing, but I dont know what Im basing that off of.

Etienne Nichols: I think its certainly growing more and more companies investing time, energy and resources into growing it. And I think just with the move towards a lot more home use, youre seeing I think, a lot more investment there. There's a lot more manufacturing footprint in terms of the cxos. There's a lot more familiarity. So I think where you may have needed to build out a line to have a, your first combination product, that's a little bit easier to do nowadays. And so there's less say, resistance towards technical or regulatory risk, I think because of that. And I think it's just a bigger focus. Right. Like at least in the, I used to work in the generic space and they would call these kinds of technologies differentiated drug delivery. And so if you have an existing drug, how to add value to it, you differentiate its ability to how you deliver it.

Etienne Nichols: So instead of a manual syringe, maybe a button push or something, pre filter pan or. Yeah okay. When I started, first started getting interested in combination products, Washington co pact versus single pact versus single entity. I don't know if you can speak to that or if you can elucidate on that subject any.

Etienne Nichols: Yeah, and so now you're getting into sort of the second level of definitions and this is where the US and EU definitions start to differ. But I'll focus on the ones that you mentioned.

Etienne Nichols: Sure.

Etienne Nichols: Single entity is integrated where like a pre filled syringe, you have a primary container that includes a device. And once you open the package, you take the product out. It's all there. So pre filled syringe, auto injector, pen injector, those are single entity, co packaged are things like kits where you open up the box and it has maybe the vial, it could be a vial of lyophilized drug, another vial of diluent, a syringe, a vial adapter, whatever, a needle and a set of instructions on how to use the product. It could just be a vial and syringe. That's a really simple copac, but everything you need to do, you need to use in the bot is in the box and you're effectively being told use this component with this drug, use this device with this drug. And the third one is cross labeled, where you're told, use this product specifically with this other standalone device. This is intended for use with this only. And I've seen that I used to work in medical devices only. My background is all medical device, basically. And you'd see that with devices where you have a hardware and it says only use with the disposables. And so that's similar to cross labeled, where they both say use with each other.

Etienne Nichols: You mentioned the different layers of definitions within the combination products, and I do think definitions is one of the biggest hurdles to overcome when it comes to a new person coming into the combination product industry. I'm sure there's a lot more. There's some technical difficulties to overcome as well. But definitions is certainly one of those hurdles. How many layers of would we need to go to fully understand?

Etienne Nichols: I don't think this is. I don't think that this is like a for. This is just how I think about it. And there is no, like, level one combo product definition, level two, it's just when I think drug led, device led, that's your saying one characteristic about the combination product. And when you say single integral, or you're saying integrated versus cross labeled versus co packaged, you're saying something else.

Etienne Nichols: Yeah.

Etienne Nichols: And so that's all I was trying to say.

Etienne Nichols: No, that makes sense. What do you think are some of the biggest misconceptions or the biggest pitfalls that someone needs to overcome when it comes to entering this industry?

Etienne Nichols: When it comes to combination products specifically? Yeah, I don't know that I'd call it a misconception. I think that there's a. As part of my podcast, I've gotten to get a lot of different perspectives. One of the things that I don't like is that sometimes device people are used to a certain way and they go into pharma and things are done a little bit differently. And they think that because they do things differently, they don't know how to do devices. And I see this where people who are legacy devices will come into a pharma company and they will try to be understood before they understand. And I think that one of the misconceptions, in my opinion, and of one, this opinion only represents me, is that drugs and device are super different. And one of the people that I love that I've gotten to meet through my podcast is Larry Mager. He was actually on your show a while back where I think you guys talked about management review or management responsibility. He. He's a quality guy, and he was, after he. He got introduced into combination products in the last couple of years. And he said this on my podcast. He said, combination drugs are not really a lot different than devices. What's different is how they measure product quality. And I really like that because we get into the part four and the nuances between the QMS differences and stuff like that. And the reality is that's the framework that was set up because of how the regulations were written. So you have a set of pharma regulations, you have a set of device regulations. This is how they were bridged in the current situation. Right. And that's a regulatory legislation concern. It's not a product quality concern. There are differences in terms of how you measure devices and drugs, but I don't think that entering it from it, it's a product.

Etienne Nichols: They might not have been philosophically different had they been allowed to evolve on their own in the industry without regulatory oversight to a certain extent. Statistical samples.

Etienne Nichols: No, no. Well, that. Well, that's not what I was saying. I was saying more that the way that the. And I really like par four, actually. But the way that's set up is against the backdrop of what was set up before.

Etienne Nichols: Yeah. And I'm not saying it's a bad thing.

Etienne Nichols: It's not. It's not because drugs and devices are inherently different. It's, in my opinion, because of how the drug and device regulations and system was set up.

Etienne Nichols: I did a whole solo episode on qmsr. Just, just. And so actually, I put out another episode recently on a couple of the guidances that came out through EMA and another one through FDA on platforms I found personally. So going back to learning.

Etienne Nichols: Well, links in the show notes, by the way.

Etienne Nichols: Yeah.

Etienne Nichols: Episodes of people.

Etienne Nichols: Yeah. So basically, there's one where I just go through the QMSR just to read it and some of the observations. Basically, I wanted to have a few guests on to talk through QMSR, but I didn't want to just ask them what's changing. Right. Without actually reading it in detail. And so I did an episode where I did read it in detail and use that to prep for those. And so there's maybe three or four episodes just focused on QMSR that folks can check out. And the difference is all this, all the, but all of these things are in the weeds, right? So I wouldn't want to speak to.

Etienne Nichols: Are there any specific episodes or specific guests that really stand out that you've learned that maybe you wouldn't have come across had you not interviewed that person? When you think about your podcast and what you've, what you've done.

Etienne Nichols: Yeah. And so that's the. You and I have actually talked about this before. I think one of the beauties of combination products, why I love it so much, is you can focus on pharma topics and be under the, within the folder of combination products. You can focus on device topics, be within the same folder of device, be under combination products, and you can focus on combination products and still be. And so there's a lot that, I was just going through the list of episodes, I know, yesterday or a couple of days ago, and I was like, what are some things that I would have not really been able to learn if I was just focused on the, the day to day work? So I did an episode with Michelle Lott on Foia, and basically, I'm not FoiA. Freedom of Information act.

Etienne Nichols: Oh, okay.

Etienne Nichols: Yeah, yeah. And what is accessible? What's not accessible? What. What to expect? What is the timeline? What is the. And so that was something that I would have never really needed to, but I remember being in a conversation and hearing, like, an issue with FOIA requests. And so I'm like, I know Michelle posts a lot about FOIA and some of the stuff that, um, she's gathered through that. And so I did an episode on that that I, that's one of those, like, oddball things that I would have never spent time on temperature mapping. Another one, I've done four or maybe five episodes on sterilization methods. And so I did one on steam sterilization, one on irradiation, one on gas sterilization, and one on novel sterilization methods, waste management, how to deal with a lot of the kind of lab waste that happens and what the regulations are with that market access. Yeah, I've done a handful of episodes on that. Something that I would have never needed to really get scientific, non scientific speech. And one thing that's talked about a lot is the drug marketing, the different laws and approaches internationally. And so I've done two episodes on that, one on scientific speech, one on non scientific speech. And, yeah, I think it's basically, whenever I hear of a topic, I just put a pin in it and I will spend a few minutes on LinkedIn and be like, hey, who can teach me about this?

Etienne Nichols: And I love that approach. And I love the broad range of topics that you've covered. It's pretty impressive.

Etienne Nichols: Yeah, well, like I said, I don't really, there's no real, like, method to it. I'm not like, here are the topics that I'm going to cover. It's usually just based on curiosity. I find that to be really interesting because we get so focused on the technical, and I think it's like, in every quality manual, there's the pyramid. You know what I'm talking about, how a bill becomes a law kind of thing, starts with regulation, then standards, then internal standards, or, excuse me, then internal policies and so on and so forth, down to sops and work instructions and that. I think there's another pyramid that's on top of that. Yeah, and regulations come from somewhere.

Etienne Nichols: Its really interesting, and I think its funny. Theres one episode I did with someone I really look up to. Her name is Jane True, and she talked about the Minto method in terms of how she puts together presentations. She was a management consultant, I think, for a part of her career, and ive seen her present and her presentations are amazing. And so she introduced me to this concept of Minto. And Minto uses pyramids. And so I kind of joke because I'm Middle Eastern, that whenever I present, you'll probably see a pyramid. And so a lot of times I write on an iPad, and so a lot of times I'll have like a hand drawn pyramid in a lot of my presentations. But I think when you talk about the differences in terms of being able to influence, there's the sort of bottom rung of the ladder where you do advocacy, where you're trying to influence, for example, guidances and things like that. And then you go up the chain into trying to influence policy in terms of regulation, lobbying and so on, as you go up the chain all the way up to legislation.

Etienne Nichols: Yeah, well, I'm going to put a link in the show notes to that as well. We're going to have a lot of links in the show notes of those listening. This is your jumping off point into both combination product and subies podcast. So one other question I might have, because you do a lot of endurance training, it seems like, and I love your office setup and the things that you've got going on. I'm curious how you balance technical and business aspects. I don't know if you have any suggestions or secrets for advice.

Etienne Nichols: I'd say I have almost no business acumen and little technical, but I just, I'm good at following a plan. I don't think I remember once I was sitting down with someone that has had a lot of life experience, and it was after I had my first kid and she was going through a sleep regression and I was just asking him how he balances things because he has five or six kids, right. And he goes, balance is not like this. Balance is like this. And so basically get this idea out of your head that it's going to be, if I give everything equal time, then ill be good money. And basically what I started to try to do a little bit more, and Im not amazing at it by any means, is just focusing on is this something that gives me energy or is it something that doesnt? And so, for example, ill record a podcast for a half hour or 45 minutes and ill be ultra productive that day. Like if Im recording in the morning, Im like, I got juice for the whole day.

Etienne Nichols: Yeah.

Etienne Nichols: And then another day it may not be so and so I find that for me, like running or lifting or something like that, it's a green activity. I'm usually more buzzed and excited after doing it.

Etienne Nichols: Yeah.

Etienne Nichols: And I just try and do that. I will say, for me, what's been just tremendously helpful is having a coach. And I try and have coaching mentors because it's one thing to try and go and do something, it's another thing to try and figure out the appropriate course of action, program it and then go and do it. You know what I mean?

Etienne Nichols: I've had different types of coaches over the years, but I'm curious what your approach is and do you mean to coach more than just from a physical standpoint, from a career standpoint or how do you. Can you elaborate a little bit?

Etienne Nichols: I think generally, like, the coaching is just paid advice. Right. So whether it's podcast coaching, I hired a podcast coach for a couple of months and they were really helpful in just helping me optimize. I have a coach for endurance training that helped me do my Ironman last year and I brought him back because I just found that I was spending a lot of time trying to figure out how to program things. And is it three days this and four days that? And it was just a lot of mental energy that was unnecessarily spent. And so now what I'm working with him on is just figuring out for the long haul, what does a good system look like that I can just plug and play. And then eventually I think the goal of any coach is to work themselves out of themselves out of your life. And sometimes you need to coach for a year, sometimes you only need them for a couple months. But I think, broadly speaking, I think it's great to have coaching, paid or unpaid guidance in any area that you can like. It's a balance, right, between trying on your own, but at least in my own life progression, I spent a lot of time trying on my own and running in place before I got to the point where I'm like, I know I'm a hard worker, I know I'm disciplined. And so those two things combined with getting guidance and coaching, and that is really helpful. I think I have seen with some people where they are so into the idea of getting guidance and coaching that it may be the opposite where it's stopping. I'm usually in the position where I know I'm going to be doing something and if I find myself running in place for a long time, I think it's time for guidance because it's not working.

Etienne Nichols: Yeah. Reach that ceiling before you hire someone to help you break out.

Etienne Nichols: Exactly. Yeah, I like that. Yeah, exactly.

Etienne Nichols: Okay, let's go back to combination products. Just briefly, I want to ask you a question to see if there's anything we should be thinking about. Are there any trends or thing that that would be helpful for people to know about that you've just seen or been aware of?

Etienne Nichols: I don't know that I would call it a trend. It's maybe more of a hope. One of the companies that I worked at started getting to this point where they realized that having standalone device groups within a pharma company was an inefficient way to manage combination product development. And it's not that you don't need those device experts, but setting them up in a way where, oh, they're this different group and not doing a full mapping into the organization, full mapping into your product development process, full mapping into your qms, where it's just integrated. They are no different than anyone else. I think that my hope is that the attitude will change to be a little bit more holistic. But I think just given how growing pains naturally happen, you need to have them be separate before you can mend them together.

Etienne Nichols: I like that. That is a good hope. I respect that. And having worked in a combination product company myself, I can see the different perspectives and so they're very valuable, but if they are by themselves, they don't really get that crossover pollination to think about, I guess. One more show note link that I'd like to have. Is there an episode that you look back on over all of the 139 episodes you've done and you think, hey, if you're going to listen to one of my episodes, check this one out because, man, this one was good.

Etienne Nichols: I won't say an interview because it's like trying to pick who's your favorite kid. So I would say all of the guests have had an impact on me for sure. And so I won't say that. I will say this quality is free is maybe one of, maybe the best book I've ever read. One. One for sure. Yeah. Phil Crosby. It's, I would say it's top three, including things like, really just books and things like, it's one of my favorite books ever. And so I did an episode on quality is free. And so I think people, if I were to say one episode to check out, I'd say that. And just because I would hope that it would inspire you to read the book, because I think it's a great book. I like what is it called the Victor Franco book.

Etienne Nichols: Oh, yes. Man's search for meaning.

Etienne Nichols: Man's search for meaning. I love that book.

Etienne Nichols: Yeah.

Etienne Nichols: Naveen Agarwal recommended it to me. Really loved that book.

Etienne Nichols: That's a good one.

Etienne Nichols: If I can add one more book. Bottle of Lies is a good book if you work in pharma. It's a New York Times best seller written by Katherine Ebon. I actually interviewed her, and she has a whole. There's a lot of the book that's focused on this FDA inspector named Peter Baker, who I also interviewed. And that was such a cool episode, just hearing his perspective, some of the stuff that he was able to uncover in his inspections overseas. So that book is really good, and it reads like a story, even though it's all true.

Etienne Nichols: Wow. Yeah. Okay. Definitely going to include that in the show notes. So two episodes on that book, basically.

Etienne Nichols: The second one was a lot more. Also on data integrity with Peter Baker.

Etienne Nichols: Okay. Very cool. If there's one thing you'd want the audience to walk away with, what would that one thing be?

Etienne Nichols: I would say that maybe just going back to how I got started. So one of the big sort of growth spurt moments happened for me as I was starting the show, and I was working at Pfizer at the time and was trying to figure out, well, if, for example, I wanted to write an article about acceptance sampling or something, that's whatever. Or talk about a guidance document, like, what are the guardrails? And I tend to be pretty risk averse when it comes to, you actually put out an episode, you put out a couple of videos, and you talked about how you're self conscious, I think, when it comes to videos. Right? Yeah, me too, for sure. I'm exactly like that. And so one thing that was just like, pound into my head is doing things like blogging or podcasting or publishing articles or whatever. You're not doing anything wrong by doing that. And I remember meeting with the non clinical publishing team and saying, hey, I have this idea of a podcast. Like, what would I need to do? And they're like, are you going to talk about any Pfizer products? And I'm like, no. Are you going to talk about any Pfizer processes? No. And so, yeah, it was just that. And so I recorded a couple episodes, and I sent it and got it more formally clear. That talked to legal, I talked to the social media team and all of that. And it was like, across the board, if you're. That's. And actually, when I talked to the non, the non clinical publishing team that what the guy told me is like to be part of people's jobs is actually publishing. Interesting. Another way to think about it is like, for some people, this is like a requirement. Like, I'd be asking them, what have you published?

Etienne Nichols: Yeah.

Etienne Nichols: And so I would just, obviously there's. You have to be, you have to have good sense, right. But at the same time, you're not doing anything wrong by learning and publishing or posting on LinkedIn. And that, yeah.

Etienne Nichols: Being a lifelong learner is so valuable. And companies that recognize that, I think are the best companies, if they recognize their employees are striving to learn. And really teaching others is one of the best ways you can really instill that knowledge into yourself. So writing it down. I have a saying that, I don't know where I got this saying. I know it didn't come from me, but I never knew what I thought until I wrote it down. And I'm a believer in writing for that reason because I never really know exactly what I think until I write it. And I think it's similar with this publishing. So I think that's a really great piece of advice. Produce something for the sake of production and pursue your curiosity like you have. It's really cool. Where can people find you?

Etienne Nichols: LinkedIn, the podcast website is let's combinate.com. all the episodes are there. If you have any topics you'd like covered or guests that you feel like would be actually, I will say some of my best guests have actually reached out to me and, yeah, so if you feel like you'd be a great guest or have a topic that you feel like would be great, feel free to reach out.

Etienne Nichols: Yeah, and I will reemphasize what he said because it is so valuable when people reach out, even just from a listener standpoint, and say, hey, I'd love it if you cover this topic. That is really valuable feedback. So I'm sure he'd love to hear that. As a fellow podcast, I personally really appreciate it when people recommend topics. Thank you so much, Subia. Really appreciate it. This has been fun. I hope everybody will check out the show notes. In the meantime, really appreciate you all listening. We'll let you guys get back to the rest of your day and take care. We'll see you next time.

Subhi Saadeh: Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer just look for that leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only.

Etienne Nichols: Way I'm going to get better.

Subhi Saadeh: Thanks again for listening and we'll see you next time.