ISPE's Role in Advancing Pharmaceutical Manufacturing

May 2025

Mike Martin, President and CEO of ISPE, joins ISPE’s podcast host Robert Chew for this first episode to discuss the current pharmaceutical landscape, how the industry is responding to new challenges and opportunities, where he sees the industry going in the next five years, and more.

• Guest

  

  Mike Martin

  President and CEO

  ISPE

• Transcript

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  Welcome to the ISPE podcast, Shaping the Future of Pharma, where ISPE supports you on your journey.

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  fueling innovation, sharing insights, thought leadership, and empowering a global community

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  to reimagine what's possible. Hello and welcome to the very first episode of the ISPE podcast.

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  We're so glad you're tuning in. My name is Bob Chew and I'm honored to be your host for the ISPE

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  podcast, Shaping the Future of Pharma. I'm excited to kick off this new journey where we'll share

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  the latest insights and thought leadership on manufacturing, technology, and regulatory trends

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  impacting the pharmaceutical industry. We'll hear that directly from the innovators, experts,

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  and professionals driving progress and shaping the future. For those of you who may be new to ISPE,

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  the International Society for Pharmaceutical Engineering is a global not- for-profit

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  association that connects more than 22,000 professionals across 120 countries. We are

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  committed to advancing scientific, technical, and regulatory best practices throughout the entire

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  pharmaceutical life cycle. ISPE was founded 45 years ago by a group of pharmaceutical engineering

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  professionals. Whether you're working on the ground in operations, pushing the boundaries

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  in R&D, or guiding the next generation of pharmaceutical leaders, ISPE is here to support

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  and connect you through knowledge sharing, professional development, and a strong community

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  of experts and peers. We're excited to launch this podcast as another platform to inspire meaningful

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  conversations, share cutting-edge developments, and spotlight the people behind the progress in

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  pharma. Thank you again for joining us and now let's dive into today's podcast. To help us launch

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  this exciting new chapter of the ISPE podcast, I'm honored to welcome a very special guest and friend

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  Mike Martin, the newly appointed CEO of ISPE. Mike brings a wealth of industry and leadership

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  experience and a deep passion for advancing the pharmaceutical industry. As he steps into this

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  new role, he's focused on building on ISPE's strong foundation while driving innovation,

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  expanding global impact, and strengthening the value that we bring to our members and the broader

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  pharmaceutical industry. In today's conversation, we'll get to know Mike a little better, his

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  background, his vision for ISPE's future, and what he sees as the biggest opportunities and challenges

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  facing our industry today. Mike, welcome to this podcast. We're so glad to have you with us.

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  And Bob, it's good to see you again and connect with you. I appreciate the chance to speak with

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  you on all these subjects. I'm very happy to help kick this ISPE broadcast off and thank you for

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  being the podcast moderator for us at ISPE. It's always a pleasure to talk to you and you've been

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  an innovator in this industry for a long time and I've admired that and been proud of you for that

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  and all your contributions over the years. Good to be here. Thanks. Well, thank you, Mike. You know, as

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  I think back over almost 35 years that I've been with ISPE, I remember a couple of specific events,

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  but I also look to the current and the future that ISPE is going to be able to contribute

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  to this industry. I got my start back around 91-ish, I think. Helped getting the Great Lakes

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  Chapter of ISPE up and going. I was one of its first officers. Fast forward about 15 years or so

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  and it's 2004. It's an ISPE board meeting and three gentlemen from FDA came in

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  to meet with the ISPE International Board of Directors and they basically issued a set of

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  challenges to ISPE, some specific tasks that they wanted us to do to help move industry forward

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  and advance pharmaceutical engineering and science. And, of course, one of those six

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  eventually became the ASTM E2500 standard. So, it was actually FDA that said,

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  please write a standard on how to better do equipment qualification based on process science

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  and quality risk management. Go forward a few more years and there is an international gathering

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  of regulators through PICS in Kiev, Ukraine in 2012. And they asked ISPE to send a representative

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  to sit on the panels and discuss ISPE's view of risk-based validation, which we did.

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  But that's the past, today, and the future. You know, I really get excited and jazzed

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  every annual meeting at the Facilities of the Future banquet where we all sit together and we

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  hear about projects across the globe and awards get handed out and awards have been given to

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  projects in Asia, in Europe, in South America, and in North America, and a whole spectrum of

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  companies from big to small. And I think it's just great the innovation that we see and how

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  we're able to bring new therapies and new technologies to patient populations across

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  the globe. Mike, perhaps you would share a story or two from your experience with ISPE.

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  Yeah, I'm happy to do that, Bob. You know, inside of me as an engineer always has been.

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  Engineering is a part of me, my soul. My dad's an engineer. My grandfather was a math and science

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  type teacher. And I've been inside of ISPE for about 25 years, not quite as long as you,

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  but considerable time. And more recently, I led or was the head of the committee that

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  does conference planning for Facilities of the Future. So I took that role over from,

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  you know, you handed that off to me at one point, and I became the chair of that committee.

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  And for four or five years, I helped drive that. I became a member of the board of directors,

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  International Board of Directors for ISPE, served a couple of years there, got elected to

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  the executive committee about the time that ISPE selected me to be CEO. So I had to set those things

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  aside and step into a new adventure as the CEO here at ISPE. I started my connection to ISPE with

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  a need to learn something. I was driving a project in Indianapolis for Lily, who I used to work for.

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  And we were struggling with the concepts of commissioning and qualification and validation.

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  And I took a chance to go to an annual meeting, I think it was, and it was in Washington, D.C.

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  And I sat in different programs and heard about the CQB concepts that are included in the baseline

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  guide for CQB. And light bulbs went off for me all over the place. I'm like, this is what we

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  need to do different. And it solved all sorts of problems that I met people who were working

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  on the same kinds of things that I was and built a network from that. That, for me, was kind of a

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  foundational or formative experience for me and my connection to ISPE. And it changed the direction

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  of the project that I was on in a really great way. And so I built over the years connections

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  and friendships, a feeling of belonging, a sense of community. And it carried that with me into my

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  current role as the CEO here. It's a pleasure to have been a part of ISPE as a volunteer and now

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  serving as the leader of the organization. That's a great story. And I'm sure many of our listeners

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  have their own stories as to how ISPE has contributed to their professional success,

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  their career development, and opened doors for new opportunities. So speaking of opportunities,

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  the global COVID pandemic was a period of huge challenges and triumph for the pharmaceutical

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  industry. The vaccine and all the associated supply chain elements were created and received

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  regulatory approvals quickly and efficiently from rapid startup of aseptic processing

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  to those special cold chain shipping containers that innovators within our companies basically

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  created out of nothing. And then, of course, the mutual regulatory recognition happened literally

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  overnight. Now, going forward, our industry continues to respond to new challenges

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  and opportunities. Those challenges and opportunities come in the form of new science

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  that's advancing so quickly, technologies that not just our industry but many, many industries

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  are adopting. And, of course, our industry really has to be careful on how we adopt those

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  technologies. The supply chain challenges that came about from COVID and from various other forces

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  at play today, regulatory opportunities, regulatory harmonization, how regulators are

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  thinking about how we build facilities, how we copy and paste facilities, what does that mean

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  for licensing, talent acquisition, talent development, a big challenge for probably all

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  of our organizations, regardless as to whether you're an end manufacturer, an equipment

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  supplier, or a service provider. We have environmental challenges, both with effluent,

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  liquid effluent, but also CO2 emissions. We have geopolitical challenges. And finally,

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  we really want to make global accessibility and affordability central to our goals and objectives.

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  We want those scientific advancements, the new therapies, to be readily available

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  regardless of what country you live in or what corner of the globe you live in.

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  Mike, from your decades of industry experience and now your new role as CEO of ISPE,

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  how do you see these forces changing industry to better serve a global patient population?

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  Yeah, Bob, that's a big question, right? There's a big box and all the things that you mentioned,

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  and all those things are real. They're all forces that we all interact with in our roles

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  in various companies. I'm going to try to unpack those, maybe not all of them, but one by one.

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  And let me talk a little bit about the things that I've experienced in each one of those,

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  and then how I think ISPE is placed to help influence solutions and help make the world

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  a better place. But let's start with science. So the science advancements, when I was a young

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  engineer starting out at Lilly, and a lot of pharmaceutical companies and pharmaceutical

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  companies at that time were small molecule based. So these are chemical reactions that produced a

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  drug product that helped improve the lives of people. And that was widespread in industry,

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  the whole small molecule concept. And that evolved as I came into Lilly, it started moving towards

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  biotech. And this idea of taking an E. coli cell and making an insulin granule in that,

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  and then purifying that and making human insulin, whereas before that it was made from beef and pork

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  pancreas glands. And so that transformation, it carries on to today. It's vastly different than

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  it was in the late 80s. And now we're moving towards molecular medicine, things where we can

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  influence the way a cell works in the human body. And personalized medicine,

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  where the treatment is really set uniquely for the patient and what they're suffering from.

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  And so we're moving from broad range types of therapies that, you know, chemo that affects the

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  whole human body and really is rugged treatment for cancer, but that's the way it has been done,

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  and in some cases still done. Moving towards pinpointed therapies where the cancer cell is

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  targeted and not the whole body, that's fantastic stuff that science has brought to light.

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  Science is always advancing, sometimes advances and then retreats a little bit as we learn

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  something because it doesn't work as like we thought. It's complicated and then advances

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  further. And so over time, it's always advancing, but always with the patient in mind.

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  All the things that I talked about have been evolving, trying to help patients to survive,

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  to thrive with the whole idea of improving the quality of human life. And I think that's what

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  ISPE helps provide. It's a place for sharing and learning about these advancements in science,

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  solving problems, collaborating together, growing together as individuals as we together advance

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  science and help people. I don't know if that's been your experience, Bob, but in science,

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  those are the stories I would share with you. We've got many variations on that. You know,

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  someday they're going to genotype you and then AI is going to scratch its head a little bit

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  and there'll be a little thing over there in the corner on a Star Trek Enterprise and out pops

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  the drug. And a needleless injector gives it to you by some guy named Dr. McCoy.

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  Right? That's how it'll work. But I mean, today we've got combo products with

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  radionucleotides that kind of pinpoint where it needs to go. And then that same

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  drug transport mechanism takes the therapy to attack the cancer. So those are just a couple

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  of little examples of the vision. Vast number of those examples out there. And I think that's

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  great for industry. And ISPE is a place to share and learn about those things. Let's talk about

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  technology for a moment in that big box of forces that you talked about. This also constantly

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  changes across time. The decades that I've been involved, I remember designing, and this is going

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  to embarrass myself, but I remember designing HVAC control systems that were pneumatic in nature.

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  And some of the younger folks are like, what? What's that? So that migrated to digital. And then

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  we ended up with smart precision types of instruments, smart control systems, a constant

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  kind of change in pursuit of efficiency and manufacturing, being able to do more and more with

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  less people, with less resources. All that stuff, I think, is a fantastic aspect of technology and

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  its advancement in industry. The basis of knowledge, if it's left in silos and not shared,

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  I don't think that serves the world in the best way. So I think sharing that kind of knowledge,

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  I'll say don't give away your trade secrets, but sharing the basic knowledge is very important.

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  Innovation, in my belief, is really a series of advancements. Sometimes they're very large leaps,

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  but more often they're tiny steps. And somebody else might take the step before, and then you

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  stand in that place and take a further step. And it's interesting to watch how that

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  moves along over a period of years. And if you've lived long enough and you've been fortunate to be

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  come my age, you've seen a lot of those things. And the people that are younger now, they'll see

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  even more of those going into the future. And I think building on previous learning

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  is a core tenet of innovation and tech advancement. And ISPE tries to be a place for sharing that

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  kind of information, a place that where learning can create innovation. You'll learn about something

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  and say, oh, I know how to use that to solve my problem. And that small step advances tech

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  even further. And it gets us outside of our own heads. That was the problem I described that I

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  learned by going to the ISPE conference. I was inside my own head. And as soon as I heard how

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  this could be done, I was like, hmm, I'm not sure I would have thought of that on my own.

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  And I'm glad to have learned from someone else. It really widens our perspectives.

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  Well, and I appreciate ISPE launching this podcast because this can be another channel

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  whereby people can hear the latest ideas, but also the latest applications of those ideas.

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  So talking about technology for a minute, I'm a big fan of the digital twin. And I heard case

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  studies at ISPE conferences over the last year, year and a quarter that are just fantastic.

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  Everything from a little assembly step to a complete aseptic filling line. And then I know

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  of companies out there that have digital twins of processes. And all of this clearly facilitate

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  operational excellence opportunities and hopefully drive down cost of goods sold,

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  drive up the manufacturing yields, the batches, and make that

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  availability of therapies to patients across the globe much more achievable.

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  Yeah. So let's go back to the big box of forces and let's talk about regulatory advancements for

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  a moment. This industry and its regulation, it provides a platform, I think, for safely

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  launching new products. It allows for scientific review and adjustment. I think regulation is

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  always going to be needed in the pharma industry and the biotech industry because it helps things

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  be checked out well, tested well before it goes to market. And I respect the regulators who are

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  diligent and careful and even cautious sometimes because you do need to have lots of perspectives

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  when you're talking about the human health care. And I think the collaboration between industry

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  and regulators is a very important thing. And I think it's been done very effectively in the past.

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  And that, I think, collaboration helped us rapidly solve world problems like you mentioned about

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  COVID earlier. There was a vast collaboration between industry and regulators to help bring

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  a vaccine to the world to mitigate the COVID crisis. I think that's really important in our

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  industry. And that relationship between regulators and pharma, biotech, life sciences industry

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  is critical. Right now, I'd say there's some obstacles to that kind of collaboration, especially

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  in the U.S. where there's some restructuring of government going on. I think that'll resolve

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  over time and we'll get back to a place of collaboration. At least that's my dream and my hope.

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  And I would say ISPE's role in this, let me put a boundary condition on this first.

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  We do not lobby. We're not in there trying to influence a regulation. We're not trying to

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  change a regulation. That's not our job. That's not industry's desire through ISPE to do that.

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  So that is outside the scope of what ISPE provides. We really provide a structure for

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  helping to interpret what a regulation is and a set of guidelines so the industry can have a

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  common approach to working within the regulation. And if you can't do that very well, then you end

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  up with different approaches and regulators are trying to pick and choose. So I think ISPE is a

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  great place to make a baseline for how people should work together. I think it's crucial to

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  have that kind of practical implementation and guidance. And there's an idea that Tim Watson

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  from Gilead spoke to me. I don't think Tim invented it either. It's called pre-competitive space.

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  And if you'd like, you can Google that idea. There's lots of things about it, but it's the

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  idea of having a place where innovative companies can come and share knowledge,

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  even regulatory approaches, without giving away their secret and thereby collaborating

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  and influencing a common direction. ISPE is that. We offer a pre- competitive space for technology,

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  for science, for regulation, and more. And I think that's a great space for people to come

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  and collaborate. Well, and I know of two companies right now that are collaborating

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  and in conversation with regulators around an idea called network licensing,

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  where the companies are building cookie cutter facilities. They're going to operate exactly the

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  same way. And their goal is for regulators to allow what they call network licensing,

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  licensing the product into that network, as opposed to one site at a time. And so that's

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  an example of companies collaborating around a common goal that all of industry can benefit

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  from. And this is related to also cell and gene therapies being manufactured at healthcare

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  facilities across a wide geography. Maybe moving on here, where do you see industry in five years?

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  So in five years, if I jump to this area of our discussion, I think the kinds of things that I saw

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  evolve across the last few decades, it's not going to slow down. I think it's going to accelerate

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  even, because it has accelerated in my time in the industry. I think that the things that I saw

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  in automation, the changes in the way things are operated, automated, done more consistently,

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  that will evolve and AI will certainly play a role. That concept, if you haven't explored AI,

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  generative AI yourself, then get yourself a chat GPT instance on your phone. Don't put your company

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  information in there, but go explore what it can do for you. That's going to explode inside of

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  industry. And some parts of that will be not so good, but there's going to be a whole bunch of

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  good things that come from that. It'll drive efficiency. It'll drive things that are more

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  common and done in a more standardized way. It will improve sustainability, because if you can

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  make things with less resources or less waste, that's better for the planet. It will increase

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  collaboration. It will just advance the industry overall. And I think from treatments to cures,

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  in both small steps and huge leaps, all these things are going to lead to the improvement

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  in the quality of human life. Let me share a story with you, Bob. We were talking offline

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  about my parents. My mom and dad are suffering from various health conditions. My dad has a

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  congestive heart failure, and he's had a valve replacement, which is a miracle. I mean, it's a

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  non-invasive surgery to replace your heart aortic valve. Fantastic technology. Advancing that even

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  10 years before wasn't possible, and they'd have to open the chest of the patient, and elderly

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  patients, that's hard to recover from. It's just amazing what can be done. My mother has Alzheimer's,

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  unfortunately, and I hope and pray that there'll be some advancement in that space that will help

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  somebody in the future to not suffer from that. It's a debilitating disease that has huge family

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  and social consequences to it, and so I'm looking forward to the solutions to those kinds of

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  problems, whether in my lifetime or for the younger people in their lifetime. And for me, that's why

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  my career, my whole nearly 40-year career, has focused on life science aspects. I'm frankly proud

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  to be a part of it. Well, Mike, you certainly should be proud of it. I think we should all be proud of

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  the role that the pharmaceutical industry plays in improving the quality of life of people across

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  the globe. Now, maybe our last topic here. How will ISPE change to support industry as

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  industry evolves? If I were to write a vision statement or a strategic vision for ISPE,

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  it would have the words inside of it that say enhancing or improving the quality of human life,

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  and so let me start with that as that tenet, that principle, I think is really important for ISPE,

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  as it is important for the industry that ISPE serves, and so I think that ISPE helps industry

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  in three pillars, so three core concepts. The first one is knowledge, and the second one is community,

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  and the third one is innovation, and let me just briefly tell you what I mean by those.

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  So, knowledge is the collection of information that's both written, spoken, recorded, or even

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  thought in the heads of people that are members of ISPE. That's the knowledge that's represented

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  by the 22,500 people that are in ISPE. That's a vast resource, and it's really important to

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  record that, write it down, teach it, and that's part of, that's a pillar that ISPE has. The second

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  one, community. This idea of a group of people with a common interest and maybe even, you know,

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  a camaraderie, so you and I've been to university, and we know what a university experience feels

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  like, and it's not just about your math class, or your physics class, or science class, it's also

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  about the friends you made, and the fun you had, and the joy of sharing in something that you

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  commonly worked on together, and I think ISPE provides that sense of community, and the third

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  one is innovation, a place for people to practice new things, to learn about new things. I saw a

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  presentation by Kevin Trivett at the facilities of the future on just a little micro pause study

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  in an automated system for packaging that he shared. He didn't share how they did it, he just

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  shared the idea, and that inspired people to kind of fled to him after he was off stage to ask him

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  more about that. It's just amazing what that kind of innovation can do for people to grow and build

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  in there, and I think the ISPE's vision now, and how we'll keep driving to the future, is the platform

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  that creates this possibility for knowledge to be shared, for community to be built, and for

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  innovation to occur, and so I imagine through the power of volunteers, because we are a volunteer

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  organization, there's nothing I can do from the CEO seat that will change the industry in any large

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  way. It's the volunteers, the people that want to change the world, who give their time to do that,

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  that's really where the critical essence of this society is generated. So I want us to imagine,

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  imagine a database of knowledge that members have access to, that improves the way they work,

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  it improves their odds of success in their career, so they do get a personal benefit from it,

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  and ultimately those things, as we share, improve the quality of human life. That's the dream that

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  I would like to see ISPE drive towards, make that information easily accessible,

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  let it be a teaching system even, apply AI to it in the future, and let it, you know, tell Bob Chew

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  everything there is to know about steam sterilization, and, you know, he could read that

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  and query it and ask questions. That's the dream of it, and if you had that kind of community that

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  had a sense of belonging, energy, group power, a place to thrive, if you had a safe space for

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  pre-competitive discussions where people can collaborate and share ideas, that's where we're

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  going. That's what ISPE is going to be about. We're already started on that journey. We're

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  going to drive that as hard and as fast as we can. I think that's what an energized group of

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  volunteers is all about, and I think the focus for ISPE will always be about improving the quality

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  of human life. Well, that's quite a vision, Mike, and I am excited to be part of ISPE.

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  To recap and summarize our discussion, we see many factors driving change in our industry.

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  We talked about science, we talked about technology, we talked about talent, regulatory adoption,

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  affordability, and accessibility, and then your vision of ISPE as a repository of knowledge,

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  a source of community, and a wellspring of innovation. Based on my three and a half

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  decades with ISPE, I am looking forward to the many ways that ISPE can positively impact

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  the advancement of science, engineering, and regulatory expectations to ensure the availability

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  of affordable therapies to all corners of the globe. This brings us to the end of this first

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  episode of the ISPE podcast, Shaping the Future of Pharma. A very big thank you to our guest,

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  Mike Martin, for joining us and sharing his vision and leadership as ISPE's new CEO.

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  It's an exciting time for our organization and for the global pharmaceutical community,

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  and we are really looking forward to all that's ahead. If you enjoyed today's episode, be sure

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  to subscribe so you don't miss future conversations with the innovators, experts, and change makers

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  driving our industry forward. On behalf of all of us at ISPE, thank you for listening,

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  and we'll see you next time as we continue to explore the ideas, trends, and people

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  shaping the future of pharma.