Harsh Thakkar (00:01)
All right, welcome to another episode of Life Sciences 360. My guest today is Scott. Scott is somebody that I had to bring on to this show because he has tons of experience, 30 years almost, and he's worked at some amazing organizations like Novartis, Biogen, Thermo Fisher, Merck, and he truly is somebody who understands the whole landscape of

pharmaceutical drug development, how to run a facility, and how to basically integrate different technologies in making these facilities more resilient and also innovating at the same time. So I can't wait to get into this one. And I know there's a lot of challenges with adopting technology, automation, all of these things into making a state of the art manufacturing facility for life sciences.

I can't think of a better person than Scott to come and share with us what he's learned all over the years To where he is now into a very unique role at a very unique company We're gonna talk more about that and how that spun off from another big corporation So without any further ado, let's dive in and have a chat with Scott. Welcome to the show Scott

Scott Billman (01:19)
Thank you, Harsh. Glad to be here.

Harsh Thakkar (01:21)
Yeah, I want to start off by asking you how, when you first started your career and now that you look back, did you anticipate that you were going to be part of so many amazing organizations and have the opportunity to impact or oversee the global engineering and facility operations for some of the best companies in the world?

Scott Billman (01:46)
Yeah, no, it's been a great journey. know, when started out my career had no idea that this is where I would end up. You know, I started out in design engineer, but did a internship for a company that was dedicated to the pharmaceutical sector. And that really was my first entry and introduction to the type of work that the pharma and biotech industry does. And from the very beginning, seeing the technology, seeing the therapies,

I just, I was immediately all in on trying to get a career in this field.

Harsh Thakkar (02:22)
Yeah, and we might have a lot of listeners that are in pharma and that are keeping up with all the advancements in drug manufacturing and development and everything that's happening. But we also might have some listeners who are new, who are not in pharma. They're just here to learn. Based on your experience at depth and breadth of experience in this space, what have you seen in the past? What's one unexpected way that

you know, drug manufacturing has evolved since when you started and where you are today.

Scott Billman (02:59)
Yeah, it's amazing to see the technology and scientific advances in the industry. You know, if I just look or use one example of vaccines, know, nature's bioreactor is the egg, right? Flu vaccines and one of the very first manufacturing facilities that I worked in making flu vaccines in eggs. That then developed into cell culture technology.

Harsh Thakkar (03:09)
Hmm.

Scott Billman (03:25)
And now we have products in the market that are flu vaccines that are egg-free and made out of cell culture. And now you go back to the pandemic and now you have the next evolution of that technology with mRNA vaccines. And so when you just look at that one segment of our overall industry and you think about that journey over the past 20 to 30 years, you can see the technological advancement.

Harsh Thakkar (03:39)
Hmm.

Scott Billman (03:53)
and the science that's put into the therapies that the industry provides.

Harsh Thakkar (03:58)
Yeah, and those are great examples. Do you know like, what are some other factors? Why are we seeing drug manufacturing and having a manufacturing facility? Why are we seeing so much of innovation and the way companies are set up? I mean, we're seeing this in pharma. We're also seeing this on the CDMO side where they're helping biotech companies as a collaborative partner to...

know, develop and commercialize therapeutics. So what are other factors that is driving so much of innovation in how a facility is built, how it is scaled up, and how it runs to its full potential?

Scott Billman (04:41)
Yeah, the manufacturing facilities are born out of the science that comes from research and development and the pipelines of the companies. The truly innovative science is in that drug development space and over the past five to 10 years in the advancements of mRNA, cell and gene therapy.

You know, as the science develops and the therapies come out of research, it's on the engineering and technology industry and manufacturing to figure out how to make those scalable, how to make those efficiently and make them obviously safe and effective. And so really the innovation, innovation in the pipeline in the new therapies that these companies are coming up with.

Harsh Thakkar (05:16)
Mm-hmm.

Scott Billman (05:31)
drives the need for the technology to follow.

Harsh Thakkar (05:35)
Yeah, and many people may not realize this, but anytime you have a new technology, like the ones that you mentioned, you mentioned about mRNA, there's also personalized medicine. Anytime there's all these new technologies that are being adapted as like the new way of making drugs and medicines, they also come with their own.

you know, inherent challenges that maybe we know or we do not know when we implement them. So what's your take based on all the roles you've been? How have you approached in identifying what these challenges are when you implement the new technologies? And also, how do you then overcome them to make sure that they remain as efficient as possible?

Scott Billman (06:26)
It all starts in that scale up and development process after it comes out of R and D, you know, bringing together the right group of folks across the scientists, as well as the engineering and manufacturing folks to look at what technology is out there that's available to make it scalable and commercial, right? To provide the number of patients that need the therapy. And then working across the industry, you know, what's great about the overall pharmaceutical industry is there's so many

vendors, technology providers that are there along for the journey of developing these drugs. And so as you come out of the innovative pharmaceutical companies that are discovering them, there's a whole ecosystem of technology companies and engineers to drive the advancement of the manufacturing side of the business.

Harsh Thakkar (07:24)
Yeah, and you, you as I mentioned at the start of the episode, you worked at some really amazing companies and also have had the chance to be at the forefront of, you know, managing all aspects of engineering or the facility and technology at those facilities. So when you look at all the stuff that you've done,

Is there one specific facility layout or structure? Is there a technology? Is there something that you reflect upon that you feel is like a major advancement, not just in the company where you were, but for the entire industry?

Scott Billman (08:07)
For me, the life cycle of the technologies, whether you're looking at small molecule, you're looking at large molecule, proteins, monoclonal antibodies, or now with cell and gene therapies. Each of those delivery systems has its life cycle of coming out, small processes, making sure that you can make safe and effective therapies. And then a journey of technology and equipment.

Harsh Thakkar (08:12)
Mm-hmm.

Yeah.

Scott Billman (08:37)
and processes catching up to make them larger scale manufacturing processes, which really helps drive the efficiency and drive down the cost to make it more available for more patients globally. And so when you look at each of those technology, they have that evolution. have that cycle, obviously, small molecule, much longer known technology, a lot of efficient processes out there.

Biotech, when I first got involved in the industry, were many processes that were still very small scale, a of manual processes that through the 80s and 90s and into the 2000s scaled up to scales of 10,000, 20,000 liter bioreactors, higher titers, better output, again, making more product and making it efficiently. Cell and gene therapy is in that same journey.

Harsh Thakkar (09:29)
Hmm.

Scott Billman (09:30)
You

know, there are smaller batches. You mentioned personalized medicine, right? A batch of one batch equals one patient. You know, it's in its infancy now and the technology is going to catch up just like it did in the other modalities.

Harsh Thakkar (09:46)
Right, yeah. I feel really fortunate to have got the chance to work in the cell and gene therapy space in the past five years or seven years. And then also, since I started consulting two years ago, our team has got a chance to work with so many cell and gene therapy companies. And it's always exciting to go work with a new client. Yes.

we do help them on quality management, regulatory affairs, regulatory compliance, software validation, these kinds of projects, but understanding that technology, understanding, you know, how their product is made, who is it made for, you know, how does it work? This whole cell and gene therapy areas is very interesting. First of all, and I've been like, every time I get a new client, it's the way they're

they're doing it, the way they're running the trials and managing all aspects of manufacturing for these specific cell and gene therapy, it always seems to amaze me because I'm always learning something new in this space.

Scott Billman (11:00)
Yeah, you know, we're when you think about it where we are in the infancy of this modality even though we have approved therapies and People have been working on it for many years. There's still a lot to come in this technology

Harsh Thakkar (11:16)
Yeah, so not many people know this, but you're currently at a company called Solventum. And as I was researching about the company and your role, there's a lot of interesting tidbits as to how it was born. Do you want to share with our listeners who maybe are not aware of all that development?

Scott Billman (11:36)
Yeah, absolutely. Not many people have heard of Solventum. We are now six months old as an independent company. But really we're a company that's a new company that has 70 plus years of innovation behind us. So Solventum was born off of the 3M healthcare sector and we spun off as an independent company in April of this year. And so we provide solutions

for our patients in many different areas, in the medical, surgical, and wound prevention, infection prevention areas, in the dental solutions area, whether it's corrective or restorative solutions in dental, with purification and filtration, everything from industrial and water filtration to sterile filtration for the biotech and pharma industry. And then we have a health information services division

where doctors and hospitals can more efficiently control the data for their patients. And so it's been an exciting time at the company to separate from 3M and start this journey to be a new healthcare company.

Harsh Thakkar (12:50)
Okay. are you, so in your, your role is similar to what you did in the past. Is that correct? You're still like heading up the technology facilities, engineering group.

Scott Billman (13:00)
Correct, yeah, for Solventum I head up global engineering, process technology, and then real estate and facilities for our full portfolio footprint of manufacturing, R &D, and other facilities.

Harsh Thakkar (13:02)
Yeah.

Okay, okay, that's great. And I know that you're not just, this is also another thing that many people may not know about you, which I, you know, as I was researching, I saw you're not just doing stuff within your roles, within your, you know, within the life sciences, you are also contributing a lot with external organizations like ISP. So when did you first...

Before I go and ask you about bunch of questions there, which I have, when you look back at your career, when did you first feel like, okay, you know, I need to do more on the outside. Like I need to work with different organizations. I need to work with other professionals and maybe make a bigger impact than just what's in my job description.

Scott Billman (14:06)
Yeah, thanks. That's a great question. You know, early in my career, when I decided to get into the pharmaceutical and biotech area, was actually with a consulting firm. And one of the owners of that firm was a founding member of this professional organization, International Society for Pharmaceutical Engineering, right, ISPE. And so when I started there and I said, look, I need to learn more about pharma and biotech. How can I?

Harsh Thakkar (14:16)
Hmm.

Scott Billman (14:34)
be a quick study, how can I learn more about the technologies and the therapies? And he immediately said, well, that's an easy answer. You need to join ISPE and you need to get engaged outside of work in these forums. And it was a great experience, right? For anyone in any profession, there's typically a professional network or society or organization out there that deals with training and knowledge sharing.

and has trade shows and forums, right? There's lots of organizations and, you know, doing that outside of work really helped accelerate not only my knowledge of the industry, but my connections within the industry and understanding where the industry was going.

Harsh Thakkar (15:20)
Yeah, I haven't really been involved much with ISP other than you know what I do on a consulting side of things because I'm involved in a lot of technology and software validation projects people who are in life sciences might be familiar with ISP GAMP 5 which is the the guidance that Pretty much every consultant every company I know uses for software validation. So I've attended a few events and stuff, but I'm not

Maybe after this episode, I'll reach out to you of how I can do Yes Yeah, I definitely want to do more. I've done it for a few other organizations. I'm not gonna name them here. But yeah, so so I also saw that you are involved in the Fest within ISP there's this You know identifying facility of the year and you're involved with them in figuring out so

Scott Billman (15:52)
That's right. need to get you signed up as a member.

Harsh Thakkar (16:18)
What do you look for when you get the nominations or when you and the ISP team have to give the award or designation for an award-winning facility? What are some things that you're looking for before you identify some site as an award-winning facility?

Scott Billman (16:37)
Yeah, thanks for the question. know, facilities, the facility of the year award is something that's been going on for many years at ISP. And it's really a way for the pharmaceutical manufacturing companies, as well as the equipment suppliers and technology engineering firms to showcase the great work that they do every year in industry.

Harsh Thakkar (16:43)
Mm.

Scott Billman (17:00)
And so we open up submissions on a yearly basis. There's several categories around innovation and technologies and project execution. And it's a way to showcase the great work that the entire industry is doing. And so as judges, you know, there's some criteria, just baseline criteria of the facility has to meet and be producing, you know, material or meeting its intended purpose.

But every year the bar gets raised. And so to win an award, we're looking for

that new innovation either in a technology, in the science, in a solution to a problem that others couldn't solve. Sometimes it's innovative ways of executing a project, Thinking of how to do things faster, cheaper, but still at the same quality. And so every year we look at the different categories, we read the submissions, and we really look for game changing.

Harsh Thakkar (17:46)
Hmm.

Scott Billman (17:59)
methodologies or innovations and things that have not been done before. So every year it builds on itself and people just keep raising the bar and it's amazing to see some of the facilities that have been built in our industry over the past several years.

Harsh Thakkar (18:17)
So are these, is there like a geographical criteria for where this facility can be or because it's ISP is international, like is it just US or it could be outside US?

Scott Billman (18:33)
No, it's totally global. Anywhere in the world. You know, the criteria is around that it's life sciences related. So it could be an R &D facility, small molecule, large molecule, cell and gene therapy. Also the criteria doesn't matter how large the project is. We've had projects that are just one room renovations and an equipment installation that have won awards for their innovative thinking to, you know, brand new greenfield biotechnology facilities winning awards.

Harsh Thakkar (18:35)
Global, okay.

Hmm.

Nice.

Scott Billman (19:02)
And so we have different categories to make sure we acknowledge the good work across the globe and across the various sizes of projects. Over the last couple of years, I think most of our award-winning submissions have been outside the US.

Harsh Thakkar (19:11)
Are you yeah

Interesting, Are you seeing a specific region that you maybe weren't seeing before and you're like, we're getting like so many companies filing for or submitting themselves for this award or we're suddenly seeing too many companies in this one region. Do you have any insights on that? Have you seen anything as you're getting all these nominations?

Scott Billman (19:44)
You know, I think coming out of the pandemic, we saw over the past four years a larger submission set from countries that we traditionally did not get submissions from. And I believe that's because of the country investments for COVID vaccines, but also...

Harsh Thakkar (19:55)
Mm.

Scott Billman (20:02)
coming out of that experience, these countries are looking forward and saying, you know, we need pharmaceutical manufacturing within our borders. And so that is, yeah, that has really spawned some additional investment globally from countries. And so we are seeing some submissions that would come from countries that, you we never received submissions from before.

Harsh Thakkar (20:11)
Interesting.

Interesting. And how, so I know we could potentially have a whole episode just on ISP and what you're doing there, but for people who are not in life sciences, who don't know what ISP is, can you share, you know, maybe in a few sentences, how does exactly ISP help, you know, with the collaboration between organizations and collaboration between

companies and other external partners and consultants and so on.

Scott Billman (20:59)
Sure, absolutely. Yeah, so ISPE is a not-for-profit professional organization, and we look to share pharmaceutical knowledge across the globe. And that's for all modalities, all companies, all nationalities. And so we do that through many different forums. We're very much a membership-led organization. And so we've created

Harsh Thakkar (21:08)
Hmm.

Scott Billman (21:24)
these communities of practice that are centered around certain topics or technologies. And these communities of practice are all things that our membership is asking for. They say, we want to get together as a community and talk about this and talk about, you know, what's the next innovation? How are our peers in industry tackling certain problems? And it's really through those communities of practice that we get a lot of our engagement. Coming out of those communities of practice, then

Harsh Thakkar (21:26)
Mm.

Scott Billman (21:54)
they identify certain knowledge articles, whether it be an article in our pharmaceutical engineering magazine or a baseline guide, you know, leading to things like you mentioned, GAMP, right? GAMP came out of that process. And so based on the topic, based on the industry need,

We will then also have volunteers that will draft our baseline guides and our guidance documents and our best practice documents, which are available to everyone.

really drive that foundation and common way of approaching different systems, different technologies to try to create a standard for the globe of expectations when building a new pharmaceutical or biotech manufacturing facility.

We then also have, we have meetings that are focused on certain topics. Every year we have a meeting that's focused on facilities of the future, right? And bringing in speakers and presentations on what is that next innovation that manufacturers are bringing to the table or that equipment suppliers are working on. We have one dedicated to industry and pharma 4.0.

Harsh Thakkar (22:46)
Yeah.

Scott Billman (23:11)
in our digital journey as we all go down that road. And so we have a biotech focused conference. And so we have very specific conferences focused throughout the year from the international organization that brings like-minded professionals together to learn and knowledge share with each other.

Harsh Thakkar (23:30)
Right. And I think there's also like regional chapters or communities, right? Like there's one, San Francisco has one. I know North Carolina has one. Yeah.

Scott Billman (23:41)
Yes, correct. And that is

a huge part of the ISP community. One part is the global programs that we put on, but most of our members are located in regions and work in the region where they live. And so we have a chapter and affiliate network across the globe that puts on their own local training, seminars, meetings as well. And so...

Harsh Thakkar (23:44)
Hmm.

Scott Billman (24:06)
Through ISP, there's engagement at all levels from the local level, getting those local regional, the Boston area chapter, the Raleigh, North Carolina chapter, even you mentioned that, San Francisco, these are traditionally life sciences, biotech hubs. And so those very strong chapters in those areas integrate community of ISP members that get together locally as well.

Harsh Thakkar (24:30)
Yeah, with all the stuff you're doing with ISP, I'm getting a feel that you are getting a ton of exposure to going to different events, conferences, interacting with different companies, different professionals. Then when you come back to work, let's say at Solventum, where you are currently in your role, how do you absorb all of this? Because there's so much information I go to.

one conference and it's like I come back with you know a bag full of pamphlets and information and I'm researching every website for the next week. How do you figure out? I guess my question is how do you absorb all of that and say you know what this all this stuff is a bunch of noise but this right here is something I really need to look into.

Scott Billman (25:26)
Yeah. And, you know, sometimes the information you get out of these seminars or these, these shows isn't something you needed right then, but in a year you're going to remember, I went to that ISP conference. They talked about that. And what's, what's great about ISP is it's not just about the technical content. It's about building your network, right? Meeting your peers in industry, making those personal connections and having those discussions. And so what I've found.

Harsh Thakkar (25:34)
Mm.

right.

Hmm.

Scott Billman (25:56)
probably the most valuable in my, my gosh, I'm probably 30 years at ISP almost here at this point, is that network. And that when I run into an issue at work or problem we're trying to solve, or even just a benchmark, hey, how are other people doing this? I now have a great network of people. I can just pick up the phone and call them, email them and say, hey, how's your company dealing with this? What solutions are you seeing? Here's what we're looking at. you know, having that network.

Harsh Thakkar (26:22)
Right.

Scott Billman (26:25)
at your fingertips is so invaluable, right? Because to your point, you're never going to remember everything you learned at a conference, but you're probably are going to remember the people you met and the people you could call and ask how they're dealing with the same challenges you are.

Harsh Thakkar (26:40)
Yeah, definitely. I think that's one of the main advantages of all these professional niche industry specific professional organizations is that you otherwise, know, when you're working in a company, you are limited to people in that company. If it's global, maybe you have a little bit more exposure and a little bit more knowledge of how employees in Europe in the same company operate versus employees in US.

But for many people, know, unless they're active on social media or they are doing a lot of speeches and going to conferences, there's also limited how much you can go, right? Like there's limits on how many conferences you can go a year. So yeah, it's I've definitely had some certifications. I've gone to some conferences, but yeah, knowing people is like you said, you may not.

You come, you know somebody, you exchange emails, you connect with them on LinkedIn or somewhere, but then six months down the line, you're like, hey, I talked to you about that. you, I'm having that problem now. Can you jump on a call or something like that? So that's very true.

What's, I have to ask you this because you've been in the industry so long and I don't take, I don't wanna butcher this word, longevity. I don't take that as, it is very serious, right? Especially for somebody who's just entering the industry or who's been just there for five years and looking at what they want in the future. What has been one guiding,

mantra or principle that you have approached everything in your career with.

Scott Billman (28:29)
You know, I think the industry that we're in has just the best mission of any job you could have, right? To wake up every morning and say, I'm going to go try to make a difference in the lives of patients who need therapies, who need help. What a great mission to have, right? And so I always just try to remember that, you know, everyone has tough days and tough weeks.

Harsh Thakkar (28:36)
Yeah.

Scott Billman (28:53)
But if you put in the context of, know, what is it that you're trying to achieve? You know, that ultimate goal is the mission of improving patients' lives through the work that we deliver. And so that's why I've stayed in this industry so long. It's a great motivator.

Especially once you start working at companies and you actually see the therapies or the products that you're working on impact the lives of your friends and your family. There's nothing that hits closer to home than having a friend or a family member using the therapy that your company is making. And it just makes it easy to come to work every day.

Harsh Thakkar (29:34)
Yeah, it's definitely, and that's a great example, knowing somebody at that personal level. But to me even, I've said this before on other, with chats with other guests here, that I used to remember when I was as an employee at some of the companies where I worked at, we used to have these lunch meetings, lunch events, or company meetings where we would have patients come on.

Scott Billman (30:02)
Yeah.

Harsh Thakkar (30:04)
And literally there would be a slide deck of, you know, before and after of whether they were in a clinical trial or whether they took a commercial product, how it changed their lives, you know, pictures with their families. They were not able to travel before and now they're going to all these places and seeing that just reshifts your, your focus. When you leave, I've seen this firsthand when people leave that room after this meeting with, and where this patient has shared their story.

the next day they come in, it's like a massive reset button in their head. And they now know why they're here.

Scott Billman (30:39)
Yeah,

right. And everywhere I've worked, they've done that, Bringing in the patient, making it personal is a great motivating factor for the whole team.

Harsh Thakkar (30:43)
Yeah.

Yeah. Scott, I know you're extremely busy. You have a lot on your plate in your new role. And I really thank you for coming on here and sharing everything about your career, what you've done, everything you're doing at ISP. Before we drop off, do you want to share with the audience how they can get in touch with you? And how can they learn more about ISP?

maybe become a member or get involved in any of the initiatives going on there.

Scott Billman (31:21)
Yeah, sure. Yeah. So I'm on LinkedIn for folks that want to connect and for ISP, isp.org is our main website. And we make all of our material available to members and non-members. Members do get certain access to other data and maybe some discounts, but there's a lot out there available to non-members as well. But so I encourage people to go look at isp.org, see all the various offerings that are out there from again, trainings to seminars to

knowledge management documents and our best practices and our baseline guides. There's a wealth of knowledge out there as folks are trying to learn about the industry. We have some what I would call basic material and trainings for folks that are just trying to learn and there's some more technical and more advanced documents as well for the more seasoned professionals.

Harsh Thakkar (32:14)
Yeah, thanks for sharing those. We'll add that in the show notes. again, once again, thanks for coming on here. It's been an amazing time having a chat with you. Wish you all the best in your role at Solventum and beyond. Thank you.

Scott Billman (32:32)
All right, thank you. was great talking to you today. Harsh.

Harsh Thakkar (32:34)
Yep.