The Life Science Effect

Step into the future of pharmaceutical and medical device innovation with Steve on The Life Science Effect. In this episode, Steve explores the transformative power of Pharma 4.0 and Validation 4.0, drawing insights from two thought-provoking blog posts by Robert Perks of Performance Validation. Discover how digital-first strategies, artificial intelligence, and continuous monitoring are reshaping compliance, quality assurance, and operational efficiency in life sciences. Steve breaks down the shift from paper-based systems to predictive analytics, highlighting the importance of aligning people, processes, and technology in a highly regulated industry. Whether you're a new entrepreneur, engineer, or project manager, you'll gain actionable takeaways on embracing digital transformation, collaborating with regulators, and staying ahead of industry trends. Tune in for key lessons, expert perspectives, and a call to action for leaders ready to drive change in pharma and medical devices. Keywords: Pharma 4.0, Validation 4.0, AI in life sciences, regulatory compliance, digital transformation.

BLOG POSTS MENTIONED:

Embracing Pharma 4.0 — A Strategic Imperative for a Digital-First Future - Performance Validation

The Transformative Impact of Artificial Intelligence on Validation in Life Sciences - Performance Validation

MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

00:00:00 HOST: You are about to experience the Life Science Effect, Season 2, brought to you by our presenting sponsor, BPM Associates.

00:00:15 HOST: Extraordinary people. HOST: Relationships that matter. HOST: Important change for a better world. HOST: The joy of belonging. HOST: Life. Science. Leadership.

00:00:29 HOST (Steve): This is Steve, and it's time for another active ingredient.

00:00:33 HOST: I thought for a minute about not calling this segment "active ingredient" today because it's not just one article—it's two blog posts. But it's still off the cuff. I've read these two blog posts and I'm going to interview myself about them. Both are from the website of a great company called Performance Validation.

00:00:54 HOST: Performance Validation is a compliance company. They do validation services, commissioning qualification, building commissioning, temperature mapping, computer system validation—really involved in the nuts and bolts of our industry to ensure processes and equipment run in compliance.

00:01:24 HOST: They're a great company. Check them out at PERFVAL.com.

00:01:32 HOST: The two blog posts are by Robert Perks, Director of Digital Solutions for Performance Validation. I don't know Robert personally, but I really enjoyed these posts. Maybe I'll get to know him someday.

00:01:52 HOST: The first is "Embracing Pharma 4.0: A Strategic Imperative for a Digital First Future." The second is "The Transformative Impact of Artificial Intelligence on Validation in Life Sciences."

00:02:16 HOST: What caught my eye about these articles? If you heard a recent episode where I talked about Industry 4.0, you know I admitted I don't really know what I'm talking about there. So these posts caught my eye—maybe I can learn more about Industry 4.0 if Robert is talking about Pharma 4.0 validation. He even uses the term "Validation 4.0" in the AI article.

00:02:51 HOST: My first reaction was excitement. Pharma 4.0 aligns with Industry 4.0 by connecting resources, information, people, equipment, and software through digital systems. It aligns organizations, processes, and culture with emerging technology.

00:03:24 HOST: Pharma 4.0 is actually a trademarked term by ISPE—the International Society for Pharmaceutical Engineering. They've broadened their scope to include computer systems and medical devices, not just pharmaceuticals.

00:04:13 HOST: ISPE coined Pharma 4.0 to show how Industry 4.0 applies to pharmaceutical manufacturing, development, and distribution. At a high level, it's about aligning resources, systems, organizations, processes, and culture to fit our regulated environment, ensuring quality and compliance while breaking down silos and moving away from paper-based systems.

00:05:13 HOST: Now, we live in a paperless world. How do we align digitally enabled processes to take full advantage?

00:05:31 HOST: Is this a big deal or just noise? It's a big deal. Mr. Perks points out this isn't a future vision—it's happening now. It reminds me of the late 90s when computer systems started replacing paper, and the FDA was asked how they'd regulate digital records.

00:06:32 HOST: Now, there's more collaboration between regulators and industry, leading to optimal solutions. This is the right now, not just the future.

00:06:55 HOST: The second post is "The Transformative Impact of Artificial Intelligence on Validation in Life Sciences." So, what is validation?

00:07:09 HOST: Validation means proof that a medicine, device, or system is fit for its intended use. Proof is evidence—often test results or measurements.

00:08:17 HOST: In pharma and medical devices, validation means proving the system, process, device, or medicine is fit for its intended use—safe, effective, and reliable.

00:08:54 HOST: Historically, validation was retroactive: something happens, a report is written, signed, and filed until an auditor reviews it. If bad product was made, it might already be on the market, leading to recalls and potential harm.

00:09:54 HOST: With Validation 4.0, we're using AI and digital technologies for continuous monitoring and testing. AI can analyze data streams and alert us to issues before bad medicine is made—predictive, not just reactive.

00:10:44 HOST: My company just brought on a new consultant with high-speed manufacturing experience. Life sciences often lag in adopting advanced manufacturing technologies, but Industry 4.0, Pharma 4.0, and now Validation 4.0 are being embraced.

00:11:23 HOST: This is the future—and in some cases, it's today. The next four or five years will be transformative for our industry. I want my company at the forefront, so I'm asking folks to read, listen, try things out, and embrace technology.

00:12:18 HOST: I'd love to hear from others actually working in this space. Someone smarter than me might say it's easier than it looks, or that we could go faster if we removed obstacles.

00:12:39 HOST: Check out these blog posts—I'll link them in the show notes. Let me know what you think. Is Robert Perks onto something? If you have questions or want to see something addressed, let me know.

00:13:00 HOST: As always, you can reach me at [email protected]. Visit thelifescienceeffect.com. Find us on all podcast platforms. Like, subscribe, do all the internet things. Most importantly, take care of each other, stay strong, and thanks for listening.

In this thought-provoking Active Ingredient episode, host Steve Vinson tackles a leadership paradigm that's challenging everything he thought he knew about accountability. Inspired by Sheila Rohra's Forbes article on breaking people silos, Steve dives deep into the tension between traditional "one person accountable" thinking and the emerging concept of shared accountability across teams.

Drawing from his real-world experience designing process lane diagrams that keep spanning across departments, Steve explores why Industry 4.0 might be demanding a complete rethink of how we structure organizations. He examines the critical role of trust in making collective accountability work, the importance of baking collaboration into organizational structure rather than just talking about it, and how transparency can prevent destructive turf wars.

This episode is particularly relevant for life science leaders navigating the inflection point of the 2020s, where new generations bring fresh approaches to work and innovation. Steve challenges listeners to consider whether traditional accountability models are holding back the collaborative future that patients, healthcare providers, and the industry desperately need. It's a must-listen for anyone ready to question conventional leadership wisdom.

Why Breaking People Silos Is The Next Frontier In Leadership

MUSIC:

Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

HOST (Steve Vinson): [00:00] Testing, testing, one, two. All right, that seems good. This is Steve, and once again, we're going to do an active ingredient where I read an article and interview myself about it.

I just read "Why Breaking People Silos is the Next Frontier in Leadership" by Sheila Rohra of the Forbes Councils. This is at Forbes.com - I'll put a link in the show notes. Sheila Arora also happens to be the CEO of Hitachi Vantara.

This is not specific to life science today, by the way. I thought I would shake it up a little bit. And if you're leading a life science company or working at a life science company, it'll probably still apply. So I'll let you be the judge of that.

[01:30] Why This Article Caught My Eye

As a leader at a life science company, I'm always thinking about how we can better design the company, better enhance our culture, just be better. Because I believe that we always want to be improving. And one of the areas I've been thinking a lot about lately is organizational design.

This really caught my eye because I want to know what the latest ways of thinking are. And it talked about breaking the silos, which really caught my eye because I'm a big believer in collaboration and working together, and not having people just operate in their own little swim lane.

[02:45] My First Reaction - Challenging Traditional Thinking

My first reaction is I think I need to do more study because this article is really talking about shared accountability. And one of the things we were taught coming up as young engineers, young professionals, young managers was you cannot have shared accountability. One person needs to be accountable.

Now you can have shared responsibility - obviously teams can share responsibility - but one person needs to be accountable. One of the sayings that somebody used to say was "the best way to ensure a dog is going to be hungry is to tell two different people to feed it." Because of course, both of those two people are going to think the other one's going to take care of it.

[04:00] Current Challenges with Lane Diagrams

The other thing is lanes. When I'm designing a process right now - well, I'm not designing it, I'm on a team that's working on our processes for lead generation and lead conversion and then executing the work that we close - it's a lane diagram because I was trying to go through and say, "Who's accountable for what throughout this?"

And it was getting to shared responsibility, shared tasks. So I came up with a lane diagram and now the discussions are, "Well, that's not really one person that does that - it's a conversation that has to happen across lanes." And so I'm making these boxes on my PowerPoint span across lanes and I'm thinking that's defeating the purpose of having the lanes in the first place. This article hits at a particularly appropriate time for me.

[05:30] Industry 4.0 and the Bigger Picture

The article itself mentions something called Industry 4.0, which I haven't heard of. So I think Industry 4.0 is something I'm going to need to look into because I didn't know there was a 1.0 through 3.0. This is Forbes, so there's probably some latest thinking coming out of business schools about how best to optimize and approach these things.

Not that things didn't work well before, but a lot of the things I've learned over the course of my career, maybe it's time for a rethink. In that sense, it's probably a big deal.

[06:45] Connection to Current Times

We've been talking a lot on this program about risk and uncertainty and how this feels like a moment of change, like an inflection point. We'll look back and say 2020 was a huge inflection point, the years that followed, but then 2024, 2025 - I think we're going to look back and say the 2020s were really a big inflection point.

We have newer generations coming along with new ways of living and new ways of approaching work. So it really connects to how are we in the life science industry going to embrace new ways of working, new ways of thinking, new ways of innovating and developing products for patients, new ways of patients interacting with their healthcare providers and new ways of getting those medications prescribed to them, administered to them. We need to be thinking with a forward-looking focus.

[08:15] Key Strategies from the Article

Now, this article gave a few examples. For one thing, they said trust is absolutely critical because without trust, then it's just going to look like window dressing. So you embrace this collective accountability, this collective responsibility, but you have to have trust that says, "I know everybody's going to be contributing." And I know that the rewards or the recognition is going to be shared and not just given to one person when this was really a shared accountability.

There's also the concept of using structure to communicate the message. So this author is recommending that you don't just talk about shared accountability and shared things, but you actually bake it into the structure. And it sends the message that it really is real.

[09:30] Our Company's Approach

Our goals - I think our company does a good job of this where we're setting goals that reflect shared goals. And we actually use the word "shared" a lot, like shared goals, shared success. So the results of our goals, if we achieve them, we probably have financial success, we have opportunity success. By opportunity success, I mean if you're a project manager or a materials coordinator or some other project support person and you want to get more responsibility or do more cool projects, that is a success that can be shared as our company grows and gets more cool projects.

[10:30] Transparency and the Human Factor

Using transparency to prevent turf wars is another recommendation this author gives. So I'd like to hear more about that. Like what is it that should be shared, needs to be shared? Do we need to rethink how and what we share in terms of company performance, company profit margins, salary data, things like that?

And then finally, the future of work is human. I fully believe the future of work is human with AI and data systems and all the tools that are rapidly coming onto the scene. In order to be successful, as my COO said, it's called copilot, not autopilot. So there's a human factor here and we need to stay on top of that.

[11:45] Call to Action

If you want to get a hold of me, I'm at [email protected]. Visit our presenting sponsor, BPM Associates at BPM-associates.com. Check out thelifescienceeffect.com. Subscribe, like, comment, shoot me an email. Let's make this a conversation. And above all, stay strong out there.

Meet Raul Zavaleta, the visionary engineer whose innovations fundamentally transformed how clinical trials collect and process data. In this captivating conversation, Raul shares the incredible journey from UCLA graduate to co-founder of what became Covance - one of the world's largest clinical research organizations.

Discover how a simple frustration with keypunch cards led to revolutionary solutions that reduced clinical trial data error rates from 39% to under 2% and compressed data cleaning timelines from six months to 48 hours. Raul reveals the story behind the Zavacor system, the invention of pre-labeled clinical trial kits, and how a cardboard box pitch to FedEx helped build a global empire.

Beyond the technical innovations, this episode explores Raul's remarkable commitment to community building in Indianapolis - from transforming Marian College into a university to mentoring the next generation of life science entrepreneurs. His philosophy is simple yet powerful: understand the real problem, create significant value, and never let anyone convince you that your dream is impossible.

Whether you're an entrepreneur, scientist, or simply curious about how industries evolve, this episode delivers actionable insights wrapped in unforgettable stories.

MUSIC:

Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

Main Discussion Points:

• [02:15] From LA to Indianapolis: The five-year promise that became a lifetime commitment
• [10:20] Community transformation: Marian College to University and Hispanic Chamber consolidation
• [16:30] The keypunch card challenge that sparked a career in clinical data innovation
• [21:15] Birth of Covance: Solving the 39% clinical trial data error problem
• [32:20] Innovation breakthrough: Pre-labeled kits and foolproof design principles
• [40:30] Global expansion: From Indianapolis to Geneva and beyond
• [45:10] The ePRO revolution and eventual acquisition by Oracle
• [50:25] Entrepreneurial wisdom: Understanding problems vs. building solutions

Key Shareable Quotes:

1. "You dream it, you can achieve it. Don't let anybody talk you out of that." - Raul Zavaleta
2. "I promise you I can reduce the error rate to less than 2%. At the end of clinical trials, instead of taking six months to clean up data, we will deliver a clean dataset in 48 hours." - Raul Zavaleta
3. "The most important thing is to understand the problem - what is really the root problem? You also have to understand the value proposition." - Raul Zavaleta
4. "We have a lot of good things in Indianapolis and Central Indiana, but we're very shy about speaking about it." - Raul Zavaleta
5. "Don't be afraid to look for somebody to help you. I've been mentored and gotten a lot of good advice, and I do the same for those I mentor." - Raul Zavaleta

Call-to-Action: Ready to transform your industry like Raul? Subscribe to The Life Science Effect for more inspiring conversations with life science innovators who turned impossible dreams into billion-dollar realities. Connect with Raul Zavaleta on LinkedIn to learn more about his mentorship opportunities for entrepreneurs.

Transcript:

[00:00] Podcast Introduction

You are about to experience The Life Science Effect Season 2, brought to you by our presenting sponsor, BPM Associates. Extraordinary people, relationships that matter, important change for a better world, the joy of belonging - Life Science Leadership.

What if I told you that a single engineer's frustration with keypunch cards in 1985 would eventually revolutionize how every major pharmaceutical company in the world conducts clinical trials? That one conversation about data errors would spawn a multibillion-dollar industry transformation?

Today you'll hear the incredible story of Raul Zavaleta, co-founder of what became Covance and architect of the Zavacor system that still powers clinical research today. Raul reveals how he reduced clinical trial data error rates from 39% to under 2%, compressed six-month data cleaning cycles into 48 hours, and built a global empire starting with cardboard boxes as conference tables and a bold promise to FedEx.

Raul Zavaleta isn't just a successful entrepreneur - he's a community transformer who helped evolve Marian College into a university, brought major sporting events to Indianapolis, and continues mentoring the next generation of life science innovators. His philosophy is beautifully simple: understand the real problem, create undeniable value, and never let anyone convince you that your dream is impossible.

Whether you're building your next venture or leading innovation within an established organization, this conversation will change how you think about problems, solutions, and what's truly possible. Let's dive in.

[02:30] Host Introduction & Opening

STEVE: Hey, this is Steve. Thanks for joining. Very honored and thrilled today to have Raul Zavaleta on the show. Raul is a partner at Cogent Scientific and is an advisor, board member and all sorts of things out in the community in the life sciences community. So Raul, thank you for joining. Appreciate you being on.

RAUL ZAVALETA: Oh, glad to be here.

STEVE: Wonderful. What did I miss? You do so much in the community - tell us about how you're involved in things.

[02:15] Community Involvement Origins

RAUL ZAVALETA: Well, when we moved here in 1985, I had promised my wife that we were coming here for five years. She was born and raised in Los Angeles. We both graduated from UCLA, and Indianapolis and the Midwest was foreign to her. I said in five years we will go back. And when the time came, we had sold that first company. And she said, "You know, I really would like to stay here. I think it would be best for our kids to grow up here."

And then I said, "Well, if we're going to do that, I better get involved in the community." So I started looking at what community boards I could join and help. The first one was the Hispanic Chamber of Commerce, which at the time was very small, really not producing anything. There were two other Hispanic boards and I said to my friend Charlie Garcia, "To make an impact, you're gonna have to make something happen. These are too small. Let's put them together and make a bigger idea." And that became what is now called La Plaza.

[05:30] Expanded Community Leadership

It's much bigger, more impactful. The community supported it. Instead of the Hispanic Chamber of Commerce, we went to the Indianapolis Chamber of Commerce and said, "How about you have a chapter called the Hispanic Chamber of Commerce?" And it's been there for more than 25 years.

From that work and talking to people, I was asked to join the United Way of Central Indiana. I was on the executive committee there. I was also on the board of the Indianapolis Arts Council and Indiana Sports Corporation. I was involved in bringing the Super Bowl to Indianapolis and also the Swimming FINA World Championship at what was Conseco Fieldhouse at the time.

[08:45] Engineering Innovation in Community Projects

My role there was to bring the community into it. We came up with this idea of putting cameras where they were building the pool inside Conseco Fieldhouse, and it was fascinating. It was an engineering feat, and we brought high school students from all the various high schools to see what they were doing.

[10:20] Marian University Transformation

I was also involved with what was called Marian College at the time. I was attracted to that based on some of the things that I had done in the past, and Dan Elsener, whom I had met when he was with University of Indianapolis, had become President. He was struggling with this little college at the time. He brought some people on the board, including Jerry Semler, who just recently passed away. After about two years, it was booming. We decided to make it a university. Now look at it - it's got a medical school, an engineering school, a business school, a school of education that is outstanding and nationally recognized. And it has an endowment, which before was in debt.

[12:50] Career Origins: From Chemical Engineering to Innovation

STEVE: So how do you go from chemical engineer to founding a company and handling the informatics piece, the computer systems? How did you find yourself solving these huge problems with your chemical engineering degree?

RAUL ZAVALETA: When I graduated from UCLA, I went to the career fair and got offers from several companies. Dow Chemical came and told me they really wanted me to work for them, but they would put me first in a clinical laboratory, which at the time was called Bioscience Laboratories - the largest laboratory in the country at that time.

The first project they wanted me to do - they said, "Well, you're an engineer. We're a clinical lab and we're still using keypunch cards. Help us figure out how to get rid of that and digitize this place." I went to database classes and took several courses while coming up with the idea, interviewing all the people about what their processes were.

[16:30] The Keypunch Card Challenge

I remember talking to the lab director who had worked with the founder previously. He told me, "I don't think that's possible to do. We use those keypunch cards for a lot of things." I said to him, "We promise you we can do it, and when we finish, the last keypunch card that gets produced, we're going to frame it and put it in your office." And we did.

[18:45] Identifying the Clinical Trial Data Problem

I became the liaison to pharmaceutical companies. At the time, most of them were simply using whatever clinical lab the doctor or investigator used, and that produced a lot of problems because not all labs use the same methods. Then they started using central labs, but part of the problem was it doesn't meet the data requirements that pharmaceutical companies wanted.

After a couple of years, I went to the president of the company and said, "I have an idea. We can fix the system so that we can do clinical trial work." He said, "That may be good, but it's only 5% of our business. We're not interested."

[21:15] The Birth of Covance

At that time, Bioscience was merged with the second largest laboratory in the country and created what became Quest Diagnostics. Three of us - the lab director, VP of Operations, and the marketing person - wanted to create a lab. I said, "Let's do a lab that only does clinical trials. We don't have to worry about insurance reimbursement. We can charge a premium because we will solve the problems."

There was a 39% error rate from the data investigators provided - sometimes simple things like names or initials that computers couldn't recognize. I said, "I will build a system and I promise you I can reduce the error rate to less than 2%." The other thing was turnaround time. I promised we would deliver results in less than four hours, and most importantly, at the end of clinical trials - instead of taking six months to clean up data - we would deliver a clean dataset in 48 hours.

[25:40] Building the Revolutionary System

I wrote the business plan. I was 32 years old - what did I know? We started looking for a commercial available system that could be fixed. Nothing existed. We were gonna have to build it ourselves. I started talking to pharmaceutical companies. Lilly really loved the idea - they said, "We've been looking for something like this. Even if it saves us six months, it's millions of dollars."

They connected us with CID venture capital, which had just been started. The representative came to Los Angeles and said, "We will fund your company with one condition - you have to move to Indianapolis."

[28:50] The Move and FedEx Partnership

The four of us got together and said, "Five years, we get this company going, then we move back." I went to my wife and said, "I've got good news and bad news. Good news is we've got funding and the company is going to be a reality. Bad news? We have to move to Indianapolis."

At the same time we were moving to Indianapolis, so was FedEx putting a hub here. We went to FedEx - we didn't even have a table, we were using cardboard boxes and folding chairs - and I told this guy, "You have to believe we're going to be one of your largest clients in central Indiana."

I said, "I don't want delivery by 10:00 in the morning like you advertise. I want it there by 4:00, 6:00 in the morning." They said they'd see what they could do.

[32:20] The Innovation of Pre-Labeled Kits

We built and invented the kit because we wanted everything prepackaged. I had been to investigator sites and they had boxes of unlabeled tubes here, needles over there - it was a mess. They hated that part. They had booklets telling them what to do, which was another cause of error.

So we decided to make kits with pre-labeled tubes. All they had to do was say, "This is clinical trial ABC, this is visit one," and everything they needed was inside that kit.

[35:15] The Technology Behind Zavacor

STEVE: Was there any thought to sell Zavacor as a system as opposed to building a laboratory business around it?

RAUL ZAVALETA: No, we thought we were building a lab for clinical trials. It never occurred to us to make it commercially available because by then, other companies were trying to hire our programmers. Mayo Clinic hired one of my best programmers because they wanted to compete with us. After about 18 months, he came back and said it wasn't going to work. Quintiles also hired one of my best programmers and they couldn't do anything either.

The original system was built in MUMPS on Digital Equipment Corporation software. It was a combination of programming and database all built into one. The lasting value was that it had a very thoughtful set of datasets to accommodate flexibility from any pharmaceutical company.

[40:30] Post-Acquisition Innovation

After Corning acquired us, the CEO said, "We want to expand this globally. How do you think we should do it?" I looked around Europe and Geneva made the most sense logistically. I built that lab, starting on the top floor of a six-story building. Now they have the whole building.

When FedEx pulled out of Europe temporarily, I went to TNT and explained what I wanted to do. They said, "We will send a plane just for you to Geneva every morning." We became profitable the first year.

[45:10] The ePRO Revolution

Years later, Lilly called me to help with Cialis. They had developed software internally to collect electronic patient reporting outcomes electronically because they thought patients would be more truthful than when speaking with a nurse face-to-face.

I ran across Paul Bleicher again, who was now CEO of Phase Forward. He said, "I would like to invite you to join my team." When I pitched partnering with them, he said, "I don't want to partner. I want to buy it." Eventually, after 18 months of growth, I had five suitors for that company. Phase Forward bought it, and a month later, Oracle bought Phase Forward.

[50:25] Advice for Entrepreneurs

STEVE: What kind of advice do you have for young folks who want to innovate and transform industries?

RAUL ZAVALETA: I think the most important thing is to understand the problem - what is really the root problem? If you don't know that, you're not gonna solve the problem. You'll stay at the superficial level. But you also have to understand the value proposition. Sometimes you may solve it, but it might cost too much. It has to deliver significant value to somebody who wants to solve that problem.

[53:40] Final Inspiration

You know, when I first came up with the idea for Covance, the vice president of information technology at Bioscience said to me, "You cannot beat us. We're too large. What you're describing isn't gonna be compelling enough." About six months later, he called and said, "How are you doing this? All the other players are asking for it. We can't do it."

You dream it, you can achieve it. Don't let anybody talk you out of that.

[55:50] Closing

STEVE: Speaking of calls to action, do you have anything you want to promote?

RAUL ZAVALETA: When I told my wife I'd stay here and get involved in the community, I think that's important. We have a lot of good things in Indianapolis and Central Indiana, but we're very shy about speaking about it. As I got older, my passion became mentoring young entrepreneurs. Don't be afraid to look for somebody to help you. I've been mentored and gotten a lot of good advice, and I do the same for those I mentor. If you have a good idea, pursue your dream.

In this episode, Steve reads and discusses an article by Jason Bork titled "Alzheimer's, a Disease to be Forgotten?," featured in the Indianapolis Business Journal's special supplement, Biofutures. Steve shares his off-the-cuff impressions and insights on Bork's article, which discusses the current state of Alzheimer's research, the challenges of clinical trials, and the progress made with recent FDA-approved drugs. He also reflects on the personal impact of Alzheimer's and the importance of ongoing research in Indiana. Tune in to hear Steve's thoughts and learn more about the advancements and hurdles in the fight against Alzheimer's.

By the way, Biofutures happens to be the official magazine of the Indiana LIfe Sciences Association - Indiana Life Sciences Association – Connecting Indiana's bioscience industry.

The article is on page 7 of the magazine: Indianapolis Business Journal BioFutures Magazine

Let me know what you think of the article and of my take.

MUSIC:

Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

You are about to experience the life science effect season 2 brought to you by our presenting sponsor, BPM associate. Extraordinary people's relationships that matter, important change for a better world. The joy of belonging. Life, science, leadership. Hey, everybody, it's Steve. Thanks for listening to the live science effect. And today we have another installment of active ingredient. In which I read an article and give you my off the cuff off the top of my head impressions and I interview myself. So today's article is by Jason C Bork and it's called Alzheimer's, a disease to be forgotten and it's in the special supplement in the Indianapolis Business Journal. Called BioFutures. It's the official magazine of the Indiana Life Sciences Association. I'll try to find an online version of it to link for you guys, but this came with my my hard copy issue of. The IBJ, so I'm not sure if I'll be able to get you guys an online version, but I'll try to find something. So what caught my eye? Well, first of all, it's by Jason Bork, who is actually a colleague who has been on the show before. I interviewed Jason 5 or 6 years ago. He's been very active in Alzheimer's Research as a project. Manager helping move clinical trials forward, helping to move those studies forward for W. Is. A very elusive disease to treat. It's also a mysterious disease, so from the article. So the thing that caught my eye obviously is Jason Bourque. A friend of mine, and we talked about Alzheimer's before this article is about the. Current state of affairs with Alzheimer's. So how did it hit me? So my first reaction was I was a little surprised by some of the fact. I know that Alzheimer's is a terrible, terrible disease. Anyone who has personally experienced it knows that it's it's not great. I have not personally experienced it that I know of, and I hope I don't. But if I ever do, I know it's when you're a loved one of someone or you are someone with Alzheimer's. Terrible, terrible disease and it affects over 7 million Americans, it turned out. And I I just didn't realize it was that many. And it's growing as the population gets older and. You know more and more people through modern medicine and modern healthcare, people are living longer. And if you live longer, the incidence of Alzheimer's is growing up. Does this one feel like a big deal or just noise? Well, it feels like a big deal to me because what Jason is pointing out here is it's still elusive and it has been for the last 20 or so year, but years or more, they've been trying to find any sort of treatment for the either to slow it down. Or to prevent it in the first place to reverse it to reverse the disease. All of these things have been elusive, but there have been some recent FDA approved drugs. It's showing some progress. The drugs are slowing the disease progression by targeting amyloid buildup in the brain, which is a type of plaque that tends to build up and. That that's sort of the treatment then targets that directly, right? The other thing I did not know that surprised me and and and makes this a big deal is clinical trials have major hurdles the it's high costs, a lot of costs going into drugs that don't eventually get approved or that fail the screening so screening. Sale rates are up to 95% in some of these studies, which? Means you you spend all the money to recruit and get the folks in and then they fail the screening. It makes it really tough. If it's 95%, that makes it really hard to get a good population. And Jason points out representative population folks who may be disadvantaged or don't have healthcare. They end up with Alzheimer's too, and so they are not as well represented in some of these clinical trials. How does it connect to what I'm seeing or doing well? I live in Indiana, as you all know, and Indiana really is playing a major role. Jason points out the through our universities in Indiana, Indiana University, especially hospitals. IU Health is a major. It's a teaching hospital and it's a research hospital. As well as Eli Lilly and Company and other biotech startups in town have partnerships. So it really connects to my backyard and I'm in the industry. So I'd really like to see see us be able to help get some of these treatment. What would I like to hear someone else say about this? Well, I always pay attention when Jason talks about Alzheimer's. He's way smarter than me on this stuff. We're both project managers and we both our skill set is to manage projects, but he knows so much. I talked about manufacturing capacity a lot on this show. Because that's, I know manufacturing. I've done some. Research projects, but it's very few and it's been a long time. Jason is really smart on that stuff. But what I'd like to hear is there's this ongoing debate of are these recent drugs? They have risks that come with them. Side effects are the side effects worth the slowing down of the disease? I did ask Jason that once and he said his personal view is if you get more time with the person being who The Who, you know, you know, with Alzheimer's, people end up. Forgetting people, they forget their loved ones. They become a different person in some ways. If you could get more time with that person and that person gets more time to be who they are and who they've always been, he said. That's worth it to him. But he understands the debate. It's like, but there are these side effects, you know. That and I'm. I'm not sure what the side effects are. He it was a passing conversation. I can get a chance to ask him, but maybe we'll have him back on the show and we'll talk more about Alzheimer's and progress being made and what is expected over over the next few generations. Jason ends the article by saying, hey, maybe we're only a generation or two away from Alzheimer's being a thing of the past. What a wonderful world that would be. That's my take. Let me know what you think. Send me an e-mail at [email protected]. Or go to thelifescienceeffect.com. Thank you to our presenting sponsor BPM Associates. Without them this wouldn't be possible. You can check them out at bpm-associates.com. As always, thanks for listening. Stay strong out there.

This is the second installment of Active Ingredient. I read an article and answer a few questions about it. It's shorter than the regular episodes. I try to get to the key points of the article - the active ingredient.

This episode is my off the cuff reaction to an article in the Indianapolis Business Journal by Daniel Lee, Animal-health startup BiomEdit advances poultry antibody, lands $20M in funding, grants.

Here is a link to the article:

https://www.ibj.com/articles/animal-health-startup-biomedit-advances-poultry-antibody-lands-20m-in-funding-grants

Let me know what you think of the article and of my take in Active Ingredient.

MUSIC:

Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

You are about to experience the life science effect season 2 brought to you by our presenting sponsor, BPM associate. Extraordinary people's relationships that matter, important change for a better world. The joy of belonging. Life, science, leadership. Hi, it's Steve. Welcome to the life science effect. Today we're going to do another active ingredient, the shorter form off the cuff, less formal. Less prepared feature. Regular feature that we're going to do and I'm going to do a few of these in a row. Just so you guys can get used to them and then we'll go back to some of the regular ones and then we'll mix some of these in. It's going to be fun, but hopefully this gives you more content, more frequently and helps you think just like it helps me. Think. And what we're doing here in case this is your first one of these in active ingredient, I read an article to you know I I've read the article and then I'm going to interview myself about it. So I'm not going to read the article to you. You can go look it up. The link will be in the show notes. Today's article is from the Indianapolis Business Journal and it's by. Daniel Lee. And today, by the way, July 16th, 2025, when I'm recording this and the article is animal health startup Biome edit. Advances poultry antibody lands $20 million in funding and grants. First question is what caught my eye? Well, I just read this and the thing that made me stop scrolling on this one was $20 million is a lot of money and I had been hearing from some people in that world in the startup world that some of the. Investments were kind of drying up, but you look at this one and it's like $20 million boy, that's that's pretty good. It's animal health, which means this is a drug. Well, I'm not sure if they call it a drug, you're going to learn here. One of the things that I that I wanted to get into here was I'm not as familiar with animal health things as I am with the. Human health. So you're going to find that out as I as I read through this. So what caught my eye was $20 million in in funding. That's pretty good and it's a local company. To me it's in Greenfield IN if if you're in the business, you know why Greenfield is important. Elanco Animal Health was headquartered there for a long time. They're moving their headquarters to downtown Indianapolis, but Greenfield IN is where. Eli Lilly and Company put their animal health division when they spun it off and called it Elanco BioMed. It is actually a sort of a joint venture or a a new company that was actually founded by Elenco and a Boston based company called Ginkgo Bioworks. Biome Edit I love how they they come up with these and I want to be in the room when somebody comes up with a name like Biome edit. Anyway, if you're if you work at Biome edit my apologies, but please comment below where you came up with that name. I think I get it by him at it. OK, So what does this drug do this drug which they're calling BE 101. And if it's approved, it's not approved yet. It's still in studies. Their drug will be called Opdivo Ant. And I believe the reason they got their $20 million is they got some preliminary approvals from the United States Department of Agriculture. And they're planning on launching this thing in 2026. It treats something called Clostridium perfringens toxins, which is. It it gets rid of those toxins which cause deadly, necrotic enteritis. In broiler chickens, if those are actually all words, I just read them on my phone screen and I believe what that means is and later in the article they say some flocks that are go untreated. Some as as high as 30% of the flock could die. It results in something like $6 billion in losses every year. So you could see why somebody would want to invest $20 million to help the this company get their product to market when they're addressing a $6 billion total addressable market. So how did that hit me? Well, my first reaction after I read the article was, wow, there's a lot I don't know about the animal. Health. Side of things, it surprised me because they talk about USDA approval and I was sitting here thinking, well, I thought FDA approved animal. Bugs and I'm right about that, except there's a distinction. And if your drug, if your if your treatment is more of a biological product, the USDA regulates it. If it's a sort of synthetic drug like traditional drug, then the FDA regulates it. I didn't know that until I read this. Vertical. I had to go ask my. AI friend, what's the difference? What this? This one happens to be regulated by the USDA. OK. The other thing the the next question, does this feel like a big deal or just noise? I think it's a big deal and part of the reason it's a big deal is it's again $20 million is a lot to get from investors and you know one of the investors, it's a. It was a round that included multiple investors, including Nutreco Agri 0. Z Elevate Ventures, which is an Indiana venture capital company which I've had on the show before. So they're very interesting to talk to, but but tagro bet, Agro Ventures and others. So $20 million, I think that's a big deal. I also think this is kind of a big deal because this particular treatment is different. They're actually saying it's not really an antibiotic, it's more of a probiotic and people more and more want their chicken to not have antibiotics in it. So this one could sort of shift that industry a little bit. How does it connect to what I'm seeing or doing? It might be a stretch however maybe this is one of those remedies for if the you know capital is always looking for somewhere to go, so venture capital is no different. It's looking for somewhere to put its money to increase. You know, to get a return for investors, maybe it'll go to agriculture and and I don't know. Again, I think I've said several times. This isn't my expertise. Would love to, you know, know more about the animal health side of things. But perhaps with some of the uncertainty that we're seeing. And by the way, I guess it was. It was interesting that again, how it connects to what I've been saying lately, they have engaged Diamond Animal Health, which is based in Iowa, to be their contract development manufacturing organization, which means it will be manufactured. It will be developed and manufactured in the US and you know the US is a. Huge producer of chickens so it avoids tariffs. It it's more, you know, politically it's good because it and you know it's an investment in the United States et cetera. So. What would I love to hear someone else say about this? This is huge. I would love someone who's an expert in the animal health side of things to tell me more, so I'd like somebody from either elenco or or cortiva. Maybe not cortiva. They're more on the the seeds and and that side of agriculture and things. But you know, perhaps somebody from that world, I'd love to know what they think about this new they're saying it's not really an antibiotic. Is that accurate or is it really? The A marketing ploy to say oh ours is a probiotic, not an antibiotic. I don't know. And so I would love an expert to weigh in on that. Somebody smarter than me might say $20 million is nothing in the Agri business when you have a product that's been has had these preliminary safety approvals by USDA. Maybe they would say no. It's just natural to put your. There. So if you read the article links in the show notes, tell me what you think. Tell me where I got it wrong. Fill in the gaps of my knowledge. I sure would appreciate it if you like these like and subscribe wherever you get your podcast. Go to thelivescienceeffect.com. You can e-mail me at Steven dot. [email protected] as always, thanks to BPM associates for sponsoring the show bpm-associates.com and let me know if you like. These. Active ingredient featured episodes. As always, thanks for listening. Stay strong out there.

Welcome to a new feature I am calling Active Ingredient. I read an article and answer a few questions about it. It's shorter than the regular episodes. I try to get to the key points of the article - the active ingredient.

This episode is my off the cuff reaction to an article in Cure by Ryan Flinn called Europe Makes Bold Bid to Attract Biotech Amid FDA Uncertainty.

Here is a link to the article:

https://wewillcure.com/insights/entrepreneurship/europe-makes-bold-bid-to-attract-biotech-amid-fda-uncertainty

Let me know what you think of the article and of my take in Active Ingredient.

MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

You are about to experience the life science effect season 2 brought to you by our presenting sponsor BPM association. Extraordinary people, relationships that matter, important change for a better. The joy of belonging. Life, science, leadership. Hello. This is Steve. Welcome to the life science effect. Starting a new feature segment today is a little more laid back. I'm calling it active ingredient and. I'm just, you know, I read about the industry and when an article catch. With my eye, I'm just going to hit record and cover some of the same things from it. This one's a little more off the cuff, a little less structured than what you may have come used to, but I will warn you ahead of time. So I hope you enjoy it. It's called active ingredient and it starts now. So I just read this piece in here. It's that we will cure.com it's a community ecosystem for life sciences, biotech in the New York City area. And it ran across my feet and it's called Europe makes bold bid to attract biotech amid FDA uncertainty. It's by Ryan Flynn. Of course there'll be. A link in the show notes. And it caught my eye. It got me to stop scrolling because if you've listened to this podcast, you know that I've been trying to follow the uncertainty at FDA and the shake ups and the differences that are happening. And this one caught my eye because my first reaction was, ah, this is what can happen. You know, FDA has led the world and led regulations in the US has LED an innovation for a long time since at least the 70s and 80's. the US has LED an innovation. And if there's uncertainty at FDA. I thought, hmm, who else in the world may you know? We've talked about China being the next big innovator in medicines and medical devices, while Europe seems like maybe they'll want to make a play as we. Well. It didn't. It sort of surprised me because Europe is known as sort of conservative on these things. Ever since, you know, kind of the thalidomide days, if you don't know about Thalidomide, Europe approved a drug before the US did, and it caused a lot of birth defects. It it was, it was to treat nausea during pregnancy. And horrifically and tragically, caused birth defects. Then that and then the US didn't approve it and they said, see, our conservative approach is better. So then Europe actually became more conservative. Part of this article is this is could be, could be a big deal or it could be just noise. I kind of think it's kind of it's kind of just noise because the FDA's talking about streamlining as well. And the thing that has led to uncertainty is just the type of people who seem to be putting politics over science sometimes right now, at HHS and at the FDA. But they are talking about streamlining and supporting innovation. So they're saying a lot of the same things that this. Medical says. But if I were in. R R&D early stage R&D if I if I were at a medical start up, I would be paying attention to this because some companies come to the US because the US is seen as more friendly to innovation. Some startups, you know, some early stage medical companies, but maybe Europe's wanting to make a play and maybe if they make a stream. If they streamline the regulatory side of it, if governments are willing to provide a more start up friendly environment, let's say. You know, it may be a more or or more science backed environment, a lot of our universities are being pressured for DI practices. For example, a lot of universities in the US are being pressured about that. And so some researchers who may have an idea for a product may want to take a look at Europe. So if I were in that kind of position. I'd I'd really be caring about that right now. And again, it's this really connects to what I'm seeing and doing because it made me think about what we've been saying about the uncertainty at FDA and how's that going to impact things moving forward. This is one of the ways, whether it's Europe or China or bricks, you know, Brazil and India and China. In in those areas. So what I'd love to. Hear. Is maybe somebody smarter than me? I would love to hear from a startup that or maybe even a VC, a venture capital firm that follows these things closely. Are they seeing more an uptick in investment in Europe or is this something that would cause them to want to? Maybe invest in Europe or European companies. In fact, I've met folks from Scotland who. I have startup companies. It makes me want to ask them now. Like what are you thinking? Are you thinking, you know, cause they told me they come to the US because it's more supportive of innovation. I wonder if this. If they're starting to think maybe that's changing, I don't know. How about you? If you read this article again, I'll put a link in the show notes. If you read it, what jumps out at you? What do you think? That's it. If you like this. Let me. Know. Shoot me an e-mail at [email protected] much shorter form. Not as big of a commitment for you as of maybe you like that better go ahead and like and subscribe wherever you get the podcast, because I will be doing the longer form ones, the more structured ones as well. Just I want to do one of these once in. A while the. Active ingredient. Thanks for listening. Go to thelifescienceeffect.com and never miss a single episode. Thank you. Stay strong out there.

In this mid-2025 update, The Life Science Effect explores the latest trends in pharma and medical devices—from regulatory upheaval under RFK Jr. and Dr. Makary to continued momentum in U.S. drug manufacturing. Learn how industry leaders are navigating clinical trial delays, FDA uncertainty, and global GLP-1 market expansion.

Full transcript:

Hey, everybody. Steve again, welcome back to the Life Science effect. If you're listening in the future, which most of you probably are, this may once again sound prophetic or maybe like a time capsule from a moment of flux. Today's updates a follow up to our episode. Earlier this year. Back then, we talked about a lot of uncertainty. A new administration in the United States. And possibly a dramatic shift in the regulatory landscape. And questions about the future. Of pharma and medical device in the United States. Well, we've got some answers now. And a few more questions. So let's get into it. First of all, Robert F Kennedy junior has been confirmed as the head of HHS. Which we were expecting last time, but we didn't have final confirmation of and we talked about some of. What we might see. With him being the head of HHS. And that by itself would have raised a lot of eyebrows in the industry, but his subsequent decisions have done more than that. What we're seeing is some reductions in basic research funding, which began with the president's executive orders and RFK Junior. Seems to be in alignment with that. He continues to do what he's done in the past, which is make false statements. About autism vaccine safety and other theories that have been. Long debunked and are just not science based. And these things are shaping public policy discourse, and some of the policy priorities. Over at the FDA, which is part of HHS, Mark doctor Martin Mccary is now at the helm. He's a surgeon from Johns Hopkins and is also a vocal critic of government health agencies. His record includes some misleading statements about COVID-19 and abortion, and. And so concerned and the food pyramid, all all sorts of. Depending on your opinion, either flat out false statements or at at least misleading. Certainly not in alignment with. Settled science. So it raises concerns that we have a science based agency being led by someone who may not follow the mainstream science. And the science based governance could take a back seat to political alignment, whether it be with RFK, junior or or President Trump, or both. So I'm just saying it plainly, this could be a volatile time for evidence based regulation. And the industry needs to be aware of that. Why does it matter? Well, like we've said before, we've got a well over a trillion dollar industry in the Pharmaceutical industry and they rely on a functional science based FDA. And when that credibility is threatened, global regulators, many of whom depend on FDA data, are also impacted. So we're already seeing ripple effects, some clinical trial timelines are slipping. Sponsors are delaying filings. Uncertainty is turning into sort of an operational pause. Yet there's reason for hope. There's momentum in the industry despite turbulence. Pharma medical device companies are continuing to invest in large scale US manufacturing projects. They're not short term bets. They're five to seven-year initiatives. 10s of billions of dollars have already been committed. A lot of these projects have already broken ground. Many announcements have been made. Canceling now would draw investor backlash and potentially delay. These drug supply expansions that are needed to meet the demand. These projects, as we said last time, are things like active pharmaceutical ingredient facilities, drug product facilities. Producing these drug substances once the API and drug substance facilities. That used to be offshore to Puerto Rico, Ireland, China, India are making their way back to the US. Full finished facilities. For those drug products complete completing the formulation and packaging sites are popping up in the US. And expansions across biologics and small molecule manufacturing. So the current administration might be, say, skeptical, skeptical of regulatory institutions, but they're eager to champion made in the USA manufacturing. And a trillion dollar industry has a lot of influence over. The politicians and government, which means the political calculus works in the favor of these projects staying funded and moving forward. I would also expect the FDA, the the FDA to be influenced by these multi billion dollar corporations. Going to them and saying if you want us to actually need these multibillion dollar. Manufacturing sites. We need a market and have a market. We need a functioning FDA that follows the science. You have to follow the science because that's what makes it predictable. We can't be subject to the whims of whatever political expediency there might be when we're making billion dollar bets. Over the course of three to five years. We can't invest that money and then three to five years from now find out. That we're not getting approval not because of the science, but because of some political alignment. I expect that industry to exert some influence, let's say, over the agency and over the politicians that oversee the agency. Another update I had the opportunity to. See a presentation by Graham Lewis, who some of you may know as the Vice president at IQ via. He's a thought. Leader he gives presentation multiple presentations every year to update industry trends and update what's going on in pharmaceuticals, medical devices, mainly pharma. And it was a fascinating presentation and I just wanted to give a few highlights from it. So shifting gears to that global picture. Here. He shared insights that other pharma leaders are watching pretty closely. One of them is there's a growing dependency on the US market with some of the large companies such as Eli Lilly. And lilies, he said, lilies. Domestic launches are really outperforming global counterparts. China, Brazil and the EU and UK remain important, but cost pressures and regulatory complexity are making them a bit tougher. The Chinese market is especially strategic because. China, as as we all know, has has more people than any other country and they their population is aging. And so those chronic disease rates are going up in China. And so they're going to need the kinds of products that are. That are making a lot of headlines these days, let's say. Specifically, obesity and other cardiometabolic issues like type 2 diabetes. Is really a global driver right now and will be for the next at least five to seven years. With GLP one medications like lagoni, Manjaro, Ozempic, Zepp bound. They're becoming available in over half the world's high population, high GDP countries. And the one exciting thing about that cardio metabolic space. Is. There are some solid dose forms of those medications that are expected to be approved later this year. Possibly early next year. Which opens up even more of a market. Especially in countries that don't have the refrigeration that's needed for the liquid form to get the shot, the the the vial. Whether you're getting a vial or a pre filled syringe, those have to be refrigerated. To be able to be kept long term. I think you can only they can only be at room temperature for like less than a few weeks before they start to go bad. And so if you think about. Countries or areas of the world that may not have that infrastructure to be able to have the refrigeration. There's an unmet need there. For people living with diabetes or obesity, and so if there's a solid dose form, those are stable at room temperature. In most cases, they will be these will be. And stable for a much longer time, which means now you can get into those markets and help those patients that need that medication or there are cultures that don't like the shot. Japan is an example. Pharma companies have found. Over the years that it's difficult to get into the Japanese market with. A drug that needs to be injected so if they can have the solid dose form that opens up the Japanese market as well. As well as persistence, that's another issue that has been found with. These. Obesity medications. Factors like you know price sensitivity, supply issues and sort of fractured care models makes it hard to keep patients on the long term treatment, which in turn. Causes the payers like Medicare, Medicaid, insurance companies. National Health Service in UK or in the EU? It makes them reluctant to pay for these medications. At first, you might think. Why wouldn't they want to pay for them? If you can get somebody to lose 15 to 25% of their body weight, a lot of other issues get taken care of. That might be costing the insurance company a lot of money. You know, we know the issues that come. Along with people living with obesity, you know, joint failure, back problems, heart problems, blood pressure, sleep apnea. The list goes on. So you would say, well, why not spend 1000 bucks a month to get the weight off and then you'll save money in the long run? Well, the issue is patients aren't staying on it long enough to get the weight loss to help realize the gains. Again with the solid dose form, it's easier to maybe I haven't heard anything about what the pricing is going to be for those pills capsules is, is how they're going to probably come out at first before they figure out a a pill, they'll have capsules. And I haven't heard what the price point is going to be, but if it could be much lower, let's say a couple 100 bucks a month. A lot more people may get on it and stay on it. I'm not an expert on 3rd party payment Medicare, Medicaid insurance. But. Graham Lewis did have some things to say about that, and he said, is it? It is interesting when a new medication comes out that may provide long term cost savings, it's interesting to see how long it takes for these third party payers to actually start covering it. He said one, you know, statins are an example. Blood pressure medication is another example. In some cases it took until there were generics available for those third party payers. Start. Somebody asked me recently when are these GLP one medications coming off patent and I still haven't looked it up, but before the next episode I'll look it up, or maybe one of you knows and you can comment down below. Or shoot me an e-mail. At [email protected]. OK, moving on. So we're also seeing another thing from Graham Lewis. We're also seeing pressure to innovate in immunology, cardiometabolic, neurology, oncology. Because we could see double digit growth in those segments, but only through innovation. Of course the challenge is with the regulatory landscape being a little bit uncertain right now. How are we going to get to that innovation? So that's the challenge. This is the prognostication part. How is the industry going to address this? My prediction is. Some of the headlines we're seeing aren't going to come to pass like. People saying that the head of the FDA, you know, doesn't believe in science. Well, he does believe in science. Maybe there's just going to be more scrutiny. Maybe there's going to need to be more clinical data. Maybe it'll take longer and they'll need to run more trials, so maybe innovation will be delayed, but it doesn't mean it's going to come to a screeching halt. Maybe. That's my prediction that this will shake out in the next few months because one of the tried and true things you can rely on is regardless of the way the political winds are blowing, when you start messing with rich people's money, they start to get upset and they start to do something about it. And one things for sure, these pharmaceutical companies are making people a lot of money and they're not going to sit back and watch their industry get slowed down or have their stock returns. Suffering. Because of some political points that somebody wants to score. So that's my. It's strange to call it hope, but that's my hope is that that system, however unfair it might be, probably will exert the kind of pressure we're going to need to make sure the FDA continues to be science based and predictable. OK, what does all this mean for BPM associates? Our presenting sponsor? Well, we're already seeing the impacts a lot of what I predicted is is happening. We're seeing an uptick in work to support these domestic manufacturing projects. Clients are looking for clarity and calm in the midst of the regulatory chaos. And teams that stay productive and engaged. Will win out in the long run and our teams are staying productive. They're staying engaged because we continue to support our folks through the uncertainty. Because our values aren't just words on a slide, people first relationships matter service to a greater cause. DI Belonging those things keep us grounded and they keep our clients coming back. That's it for today. As always, thanks for listening to the life science effect. If you found this helpful, like subscribe, follow wherever you get your podcast. Share us out on LinkedIn. You can e-mail me at [email protected] or you can visit the life science. Electric.com. 321. As always, thanks for listening to the life science effect. If you found this helpful, like subscribe or follow wherever you get your podcasts. You can e-mail me at [email protected]. Or visit thelifescienceeffect.com. Stay safe out there and keep your heads up.

Production Note: Since this episode was recorded, Robert F. Kennedy, Jr. was confirmed as the head of HHS. Steve didn't know that at the time but it was a pretty good bet, so the analysis holds up.

In this topical episode of The Life Science Effect, Steve explores the uncertainties facing the life sciences industry under the new U.S. administration. He discusses the potential impact of leadership changes at HHS and the FDA, industry perspectives from Eli Lilly CEO Dave Ricks, and the significance of multi-billion dollar pharmaceutical manufacturing investments in the U.S. Through analysis, anecdotes, and even a Breaking Bad analogy, Steve considers how these factors shape the future of life sciences and BPM Associates' strategic positioning. Will his predictions hold up? Tune in to find out.

Link to Dave Ricks interview: https://www.statnews.com/2025/01/15/readout-loud-podcast-eli-lilly-dave-ricks-obesity-trump-jpm/

MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

You are about to experience the life science effect season 2 brought to you by our presenting sponsor, BPM Associates. Extraordinary people. Relationships that matter. Important change for a better world. The joy of belonging. Life, science, leadership.

Welcome to the next episode of Season 2 of the Life Science Effect. Hey everybody, it's Steve. And this is another topical episode. I'm going to be talking about some current events and how current events may impact our industry and may impact our company specifically. So I'm either going to sound really prophetic if you're listening to this in the future, or you're going to be sitting there going. What was he thinking? Either way, what we're seeing right now is quite a bit of uncertainty. We have a new administration in the US and there's always uncertainty when there's a new administration. They bring in their way of doing things and they appoint new heads of agencies and things like that. So we're used to seeing some some uncertainty when there's a new. This one, probably more than most, because the strategy seems to be somewhat fast-paced, faster paced than we're used to. Weigh in on the idea of being outsiders and coming in and shaking things up. And so that creates even more sort of uncertainty than we're used to, but we can handle it. Can handle. We'll talk about. I do talk about it with multiple people in the industry. Try to consume as much. Information as I can from. That may even know more than me have more access to the administration, etc. So that I can formulate some ideas and talk with my fellow leaders and make sure that our strategies are aligned with. What we think might happen, and so that we can have strategies to mitigate risk moving forward since we don't know what's going to happen. So I mentioned the new US administration. Fact I'm sitting here. The confirmation hearings for the nominee for the director of HHS for the Secretary of Health and Human Services is Robert F Kennedy. We don't know yet if he's going to be confirmed. But this is a chance for us to sort of see what the administrations priorities might be going forward. And if Robert F Kennedy junior gets confirmed, we're getting a chance to see how he might govern. In that post. HHS, as you may know, and as a reminder, overseas, the Food and Drug Administration, they oversee the Centers for Medicare and Medicaid Services, National Institutes of Health Centers for Disease Control and some other agencies. Those are the ones I pulled off just to those those have the biggest impact on the pharmaceutical medical device industry, probably the biggest one well in our line of work. The FDA has the biggest direct impact. The other ones, Medicare, Medicaid have impacts on pricing and the economics of the industry. The NANIH and CDC, of course, do research and direct programs. That impact the industry, but the FDA is by and large the the biggest impact on us. I'll explain that in a minute. Regardless of who ends up being the secretary of HHS, if it's RFK, junior or someone else. This current US administrations focus seems to be on smaller government fewer. They're already trying to cut staffing and things of various agencies and certainly reduced funding with some of the executive orders and memos that are coming out. We can see they're looking for ways to cut funding rather quickly. And they're looking for ways to cut staff. So we'll keep an eye on those things. We also know if RFK junior happens to be happens to be confirmed as the nominee for HHS, which again overseas FDA. We know that his attitude toward the pharma industry has been. Let's say somewhat negative. He has not been a fan of the industries, not been a fan of the FDA, how Medicare Medicaid is. Handled CDC, NIH, all those in all those agencies, he has made remarks in the past that indicate he may not be the biggest fan of those agencies. So we don't know what he'll do. If he if he is confirmed as the as the secretary, there could be big shake ups in those agencies, so we'll see. So why does any of this matter to? Well, obviously as CEO, it's my job. Part of my job is to track these industry trends and work with leadership to make sure our strategies are aligned accordingly. Obviously that gets harder when it's uncertain, and we know that there might be changes coming, so we tend to position ourselves somewhat conservatively so that we can, you know, stay viable. As things change, our responsibility is to stay as profitable as we can, make sure our revenue stays up and by profitable I really mean. Make sure revenue can pay our folks 1st and then have money leftover to invest and to grow, and we're in a pretty strong position to do that. We've managed our finances relatively conservatively, so we're in a pretty good position to handle sudden changes and risks with small company like any small business, there's risk. We have done our best and we continue to do our best to manage things so that we can handle wide swings in the industry. That's why it matters to. So what about what's happening in the industry? I listened recently to an interview. With Dave Ricks, who's the CEO of Eli Lilly and Company large pharma medical device company in in central India. And he was at the JP Morgan Health. I'll put a link to the one I listened to in the show notes. It's called the readout or the readout loud, and they had a great interview with him. Dave Rex talked about how he and other CE OS from the pharma medical device industry met with the transition team. Interview was done before January. So it was before the new administration took. But you could already start to tell what some of their priorities were going to be. And Rick Scott, to meet with the transition. He was there, along with representatives from the industry group called Pharma PHRMA, and they were able to get some of their points across as well as listen to the administration now. I'm OK with. I mean a lot of. Well, every time there's a new administration CE OS try to get access with the transition team. Try to get. Their priorities clarified and how things might affect their business and then try to understand what the new administration might do. Only unusual thing from this, and he pointed out, is like the setting was unusual. It's like in Washington, DC, somewhere. In a an office building, it's usually not at a Country Club in Florida. But that's what it was. Where they went. And he had some insights. So Rick's perspective was. He's hopeful about the new administrations. He believes this new administration is probusiness and is receptive to industry needs, and he emphasized that the Pharmaceutical industry. Medical device industry is sort of unusual in that they want a really good, well functioning regulator. Most industries you kind of hear a lot of industries. Here they see the regulators as kind of in their way, and if it worked for these regulations, we could do a lot of other stuff. The pharmaceutical medical device industry is one that wants to get the point across to the administration that no, we need and want. A good well functioning regulator because that's how we get safe and effective medicines to the market. That's our mechanism. And he made that point several times. The other point and why FDA is so. The United States FDA is a lot of countries in the world don't do what he called primary data review was. The FDA does primary data review. And if there's not a well functioning FDA? If it is defunded or de staffed or or disrupted in some way, then global regulation would suffer and getting safe effective medicines and medical devices to patients would suffer. And that doesn't do anybody any good, no matter whether you you mean politically or economically. This would disrupt the business operations, so the Pharmaceutical industry through their CE OS through their trade organizations are going to be pushing hard for a while, functioning well funded. I encourage you to listen to the interview with the CEO, Dave Ricks of Eli Lilly, because he is one of its the biggest and one of the biggest, not the biggest I'd have. Pharmaceutical companies in the world right now, and they're growing like crazy. Have a pretty strong pipeline they have. Really. Well, selling drugs out on the market now. And met and devices and they. Have a strong interest, let's say, in a functioning industry so. It was an interesting interview and I learned a lot. Go check out the show notes for a link. To give you another perspective and some more considerations. I was having a conversation with a potential collaborator recently. Exploring joint efforts on some large upcoming projects. And we were sharing. We keep hearing about several multi billion dollar drug manufacturing facilities being announced in the US including bulk drug substance or API facilities. Still finished facilities, biologics, small molecule and. We're really encouraged by these really large investment announcements. So one in particular that I'll zoom in on here is the bulk drug substance. Or API facility. These API stands for active pharmaceutical ingredient API. And that simply means the active ingredient in the medicine that you take. If you pick up a bottle of Tylenol. Say you'll see in the little box that says active ingredient. Acetaminophen, 500 milligrams. That means there's 500 milligrams of the active pharmaceutical ingredient in that pill or capsule or liquid, or however you're taking it. The rest of the stuff is inactive ingredients because if it's a liquid, it's probably some syrup and water. If it's a pill, there's probably cellulose and some other caking agents to make it form into a pill. So the active pharmaceutical ingredient, bulk drug substance are these big factories that make the actual? Active medicine. I worked in. That's why I started my career back in the early 90s. I started making bulk drug substance as giant chemical factories. A chemical engineering. I became a process. That's where I started my career. And around the mid to late 90s, company started outsourcing that not outsourcing is the wrong word but started building factories outside of the continental US. In Puerto Rico, in the United States and in Ireland and other areas of the world, it is to save on labor costs taxes. Etcetera. These are large. Required a lot of Labor and the island of Puerto Rico and the in the country of Ireland were given big tax incentives to build these things. So they started moving out now. These announcements that we're starting to hear multi billions of dollars to build these factories here in the US and bring that manufacturing back into the US that's going to be something I believe that the current administration is going to want to see happen. To give you another idea, before we move on, what is what might one of these API facilities look like? Well, if you've ever seen breaking. Bad. The Nice facility where they cooked meth down and underneath that laundry. That's what it kind of looks. An API facility, different equipment, maybe it would be a little bigger, but on a smaller scale. You know, you see some tanks, you see some dryers, you see some other pieces of equipment and pumps and things like that. Are gowned up and their hazmat suits. That's kind of what an API facility might look like. Nice one. If you think about though. When they took Jesse down to Mexico. And showed him that. And they were going to have him cook there and the guy with the lab coat shows up, thinks he knows what he's doing. And Jesse says their place is filthy. It's awful. Got to clean everything. That's about what the one looked like where I worked in the early 90s. So I look like the my the facility where I work looked like the Mexican cartel. Dirty, nasty looking one. And then nowadays they look more like the one underneath the laundry that guts frame built. Now don't come at me. I'm not advocating for cooking meth. I'm just saying that's kind of what they look like. All right, back to the show. So the other thing that's happening is is new new technology. For making what's called biologics or large molecule. And small molecule or synthetic route, traditional drugs. These biologics are really expensive to make and. They don't sell as many of them, so they're higher risk, but they are investing in these facilities now, also investing in the. What they call small molecule facilities as well. OK, why did I spend so much time on these investments that they matter? Because these are long term projects. Not like you announced $8 billion and you get it spent in the next few months. Five to seven-year projects. It's really hard to cancel. The longer that project goes on, the harder it's going to get to cancel. Now these are the kind of projects you see like from the highway where you see all the bulldozers and the trucks and they're putting in new roads and. You see steel going up and things like that. Not talking about a warehouse though. Warehouse you can put up. Takes six 8-9 months to put up this warehouse and you get it functioning and running with these highly complex, technologically advanced API facilities. It takes a lot longer putting up the shell is one thing, but then you have to put in the equipment, the information systems, the automation and who knows what techn. Going to bring over the next few years, it's going to take a while to get these put in and after the first couple of years you've spent a few billion dollars already. It's going to get really hard to cancel those for one. Aceo that tries to cancel one of these multi billion dollar projects would have to answer to the stock market. It might backlash and say what's going on. Why are you cancelling? Are you going to? Do you not predict you're going to need the capacity for your drugs? To sell or what is happening now, the current administration, they would face backlash from them if they said we're going to try moving them outside the US. This current administration, more than all administrations, wanna brag about jobs they've created. But this one has made it a central point of their administration, so I would expect government support of these projects rather than disruption, so strategically. We're well positioned if we can help our clients get these projects done, help get them done on time, under budget without leaving a trail of carnage, and make sure that there's. Lasting change there build up their teams. With people first approach, we think we can be a huge benefit from that point of view. And so we think we're strategically positioned. So to summarize, our sort of key strategic considerations as we look at this. Long term nature of the pharma projects. Not short projects. Hard to stop multi billion dollar investments. The industry needs a functioning FDA so that they can get these facilities approved, get their new drugs approved and support getting safe and effective. Medicines and devices to market political optics are favoring US manufacturing. With government incentives and support for the projects, we see that continuing. Now uncertainties, always a factor, but our values are carry us through people first. Service to a greater cause. Diversity, equity, inclusion and belonging as long as we stay true to those values. Believe that the business will remain. Strong thanks for listening to another episode. If you're listening in the future. I got it. Let me know in the comments if I got it right. Let me know that if you're listening closer to the President. Hey, tell me where you what you're hearing, what you're seeing, who you're listening to. And especially if you disagree, like if you're seeing something different, if you're seeing more doom and gloom than I am, please let me know about that. Have a conversation. You can send me an e-mail at Steven dot Vinson at BPM dash Associates.com you can go to the live science effect com you subscribe follow.

Don't miss a single episode. Keep your head up. Stay safe out there.

In this timely and thought-provoking episode, Steve Vinson discusses the current landscape of diversity, equity, and inclusion (DEI) in the corporate world amid increasing political and business pushback. He reflects on recent headlines about major corporations rolling back DEI initiatives and contrasts that with companies like Costco and JP Morgan Chase, which are standing firm in their commitment to inclusiveness.

Steve also shares BPM Associates' perspective, reaffirming that DEI is more than just an initiative - it is a core value embedded in the company's culture. He highlights how BPM's intentional DEI efforts have coincided with record growth and emphasizes that diverse teams contribute to stronger business outcomes. Citing data and expert insights, he underscores why successful companies recognize the long-term benefits of embracing diversity, even in the face of external pressures.

MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

Hello. It's Steve here. I wanted to jump in before this week's episode just to say a few words about it real quick. First of all, it's very topical and timely, so by the time you hear. It some more things may have happened in the. So if you're wondering why I don't address a certain thing like target, for example, has come out and said they're going to roll back some of their DEI efforts, and I don't mention. Target in this episode. By the time you're listening, smaller companies may have backpedaled on dei, and yet other companies may have backpedaled on their backpedal. So see it as just. The other thing I wanted to point out is. While I am reflecting the values of BPM as much as I can, these are my opinions and if something may not be the opinion of every single person at BPM, I just wanted to point. That out, I'm not trying to represent everybody's opinions, indeed. L but I am trying to reflect the values that we're committed to. So hope you. The show, let's get into it. Let me know what you think. You are about to experience the life science effect season 2 brought to you by our presenting sponsor, BPM Associates.

Extraordinary people. Relationships that matter. Important change for a better world. The joy of belonging. Life, science, leadership. I'm Steve Vincent and we are continuing season 2 of the life science effect. I was sitting and reading the paper this morning. It's been kind of cold here in Indiana, but the sun shining today it's supposed to warm up this weekend. While I was sitting in my living room reading the paper this morning, yes, I still read a newspaper. The sun shining over my shoulder through the. I'm sipping coffee, my cats sitting right behind me on the back of the couch. It's very Norman Rockwell around my house. No photos because I was sitting in my robe. Anyway, I was checking out the IBJ Indianapolis Business Journal and reading Allison Bell's column on the need for diversity in the tech workforce, and also Kate Charen's article. On diversity and Indiana universities and I was thinking, wow, this is great. You know, I. Continues focusing on diversity even as recent executive orders are crushing dei efforts within the government. But then I noticed I was reading an issue from January 10th, 10 days before the Trump administration took office. Now I know that it started in corporations before January 20th, with companies like Walmart announcing scaling back their dei efforts. And other companies, but it seems like it's accelerating a little bit here in the US since the elections. And since the new administration took office and the bandwagon effect seems to really be taking hold. Reset headlines have been awash with the anti dei news, with the US president and the Indiana governor issuing executive orders forbidding di work. That government agencies, many companies, are ending their dei. Companies like Meta, which owns a lot of platforms like Facebook, Instagram and others. Amazon, Walmart, McDonald's, Lowe's and there are others in the headlines every day of companies walking back their dei effort. Well, at my company BPM Associates, we are seeing these headlines too. And so we sent a communication to our employees reaffirming our commitment to dei. You see, a BPM dei is just an initiative or even a strategy. Of course it. Those things, too, it's a strategy. An initiative with. It's a journey, but it really is more than that. At the core of who we are. It's in fact a core value that we publish on our website and we train everybody on it's part of who we are as a people first organization. I really wanted to reaffirm that with our folks and our partners and other stakeholders and not everybody's jumping on the anti dei bandwagon. You know Costco? Board successfully pushed back here recently. Push back a right wing activist push to do away with their dei practices, and Costco is one of the big business successes of the past decade or so. Like, why would you want to mess that up? And in fact, a lot of people are quoted as saying, hey, things are going great at Costco right now. Whatever they're doing is. Why would you want to mess with that and Costco saying, hey, it's part of who we are too. Inclusiveness is part of who we are. JP Morgan Chase is another one that's being that is pushing back against this reactionary push. To eliminate their inclusiveness initiatives. And they're kind of saying the same thing, which is, hey, we want everybody to feel welcome at work. Want everybody to feel like they. We want to make sure we're building a diverse workforce to serve our diverse customer base. Why wouldn't we want to do these things? So what are these like, really successful companies? See, that would have them take like this really risky, stand in an increasingly conservative sort of anti BEI environment. Like I've already said, we do it because it's part of who we are. No headline, there's no. Social, societal change that's going to cause us to stop being people first. And push you for diversity, equity, inclusion and belonging and at the same time. You know, so in other words, it's the right thing to do, at least in our opinion. At the same time, though, you can objectively look at the data. Now our dei efforts have coincided with the biggest and fastest growth in our company's history since we started in earnest on our journey. Like I say, it's always been a part of who we are, but we we really double down and got super intentional a few years back. And since we did that, our revenue has almost doubled. If we continue on the current trajectory, it will have tripled our quadrupled in. Next year or two? And you know, we have a team of superstars out there managing projects and doing technical work on projects, making a difference in our clients to get medicine and medical devices to the market to make patients lives better. And they're doing it while making everybody on the team, whether it's a BPM person, a client person, another contract person. Every person feels like they fully and openly can belong within that team environment. So back to Allison Bells column and IBJ that I was reading with the sun shining in my nice cup of coffee. It sort of bears it out too. Not just us. She cites statistics that tech companies who embrace diversity. Are much more likely to outperform their competitors financially. I knew this data. Before we. But it's not why we did it. But we also knew it would not be a bad business decision, right? Mean it makes sense and you can see it in costcos leaderships statements. JP Morgan chases leadership statement. The products and services that we and other tech companies support are sold to a diverse range of customers, patients, the customer base is diverse, right? Doesn't it seem logical that a diverse workforce would contribute to products and services? That are better suited to and would appeal to this diverse customer base seems. The data seems to bear it out. Some of the smartest businesses in the world are recognizing. Even in the face of the relentless pressure from politicians and right wing activists. I'm not saying I'm among the smartest, but I do have the courage of my convictions and I'm delighted to work for a company that has my back and I hope everyone at BPM knows that I have their back too. And guess what? I have your back, so send me an e-mail. Me know how I can help. Thank you for listening to season. Of the life science. Don't forget, do all the Internet things you know, like the subscribe. Comment go to the life science effect com to figure out how to listen to this thing on your favorite platforms and subscribe so you don't miss a single episode. You want to learn more about BPM and our diversity efforts. Go to bpm-associates.com. And continue listening to the life science effect.

I.

In this episode of the Life Science Effect, host Steve Vinson interviews Denise Bachman, Chief Operating Officer of BPM Associates. Denise shares insights into BPM Associates, a life sciences consultancy known for its unique approach and core values. She discusses her journey as a project manager and the importance of building a supportive company culture. Denise emphasizes the significance of high-trust relationships and effective teamwork in achieving project success. She also recounts a challenging project experience, highlighting the impact of leadership and resistance to change on project outcomes

MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License

TRANSCRIPT:

00:00:01 Steve Vinson

You are about to experience the life science effect season 2 brought to you by our presenting sponsor, BPM associate.

00:00:15 Steve Vinson

Extraordinary people. Relationships that matter.

00:00:18 Steve Vinson

Important change for a better world.

00:00:21 Steve Vinson

The joy of belonging. Life, science, leadership.

00:00:32 Steve Vinson

This is season 2, episode 5 of the Life Science Effect, and another special episode.

00:00:35

I.

00:00:40 Steve Vinson

Promised we have Denise Bachman on the show today.

00:00:45 Steve Vinson

Is a great project manager.

00:00:48 Steve Vinson

And also, is the Chief operating officer of a wonderful company.

00:00:54 Steve Vinson

Bpm Associates welcome to the show, Denise.

00:00:57 Steve Vinson

Anything else you want to say about yourself by way of introduction?

00:01:01 Denise Bachman

No, that's that's.

00:01:03 Denise Bachman

Let's just have a conversation and.

00:01:05 Steve Vinson

Fantastic. Yeah.

00:01:07 Denise Bachman

OK.

00:01:07 Steve Vinson

Well, let's just start with your story. You know, talk about BPM associates, what the company stands for, what they do.

00:01:15 Steve Vinson

What does BPM do?

00:01:18 Denise Bachman

So BPM Associates is a life sciences consultancy.

00:01:24 Denise Bachman

That's not anything particularly unique, but what makes us unique is that we are different by design. And when I say that I talk about we took the time to really think about building a company that was going to be different. We defined our core purpose, our core values.

00:01:39 Denise Bachman

We defined a shared success program which is really a heavy reinvestment into our employees.

00:01:46 Denise Bachman

All of this comes together to make us.

00:01:48 Denise Bachman

Exceptional project managers and deliver great service to our clients.

00:01:54 Steve Vinson

Right. I 100% agree with that.

00:01:58 Steve Vinson

As as will be no surprise to you or anyone who listens to the show.

00:01:58 Denise Bachman

Judge.

00:02:02 Steve Vinson

So what about before?

00:02:04 Steve Vinson

What led up to you deciding to join in on this journey, and maybe some tidbits from your past life that would that led up to joining the company?

00:02:16 Denise Bachman

Sure. So I.

00:02:18 Denise Bachman

You've already mentioned I've been a project manager practising many years, pretty much the bulk of my career and it's been in life sciences, but from very early on I just always had a desire to be in a position where I could.

00:02:31 Denise Bachman

Help mold and shape the culture of a company and structure it so that people could always be learning, working to become the best version of themselves they'd ever like to be, supporting them and making sure that they were aligned with work that they would.

00:02:48 Denise Bachman

Really sell.

00:02:49 Denise Bachman

As you know, Steve, I'm always saying a happy.

00:02:51 Denise Bachman

I want to see people be in their happy place and they get to find they get to define what that.

00:02:56 Denise Bachman

That's not something I defined for them, but I'm certainly happy to help coach them and guide them and mentor them to get there.

00:03:02 Denise Bachman

So for years and years and years, I've wanted to do this all the years that I've been invested in being a project manager and delivering to clients, that certainly helped me refine my vision and my skills and my experiences all come together to land me where I am.

00:03:18 Steve Vinson

Any particular stories that come to mind are that you like to tell that illustrate. Illustrate all that.

00:03:27 Denise Bachman

Well, that's a great question. I can think of 1 project in particular that was not a good experience. Unfortunately in my long career, I really only have that one that always stands out. There were a lot of things that didn't go well.

00:03:38

Mm.

00:03:41 Denise Bachman

Was working for a small consulting company that.

00:03:45 Denise Bachman

Leadership would.

00:03:47 Denise Bachman

Was not supportive when things weren't going well, they weren't supportive.

00:03:50 Denise Bachman

You were left on your own and I always thought that that was just unprofessional and an inappropriate way to treat your employees.

00:03:57 Denise Bachman

That always stuck with me.

00:03:59 Denise Bachman

The other thing that stuck with me consistently across my projects is how often I've been told.

00:04:07 Denise Bachman

I've developed high trust relationships and it's really about working with people, so you can have the best tools, the best schedule, the best, everything, all the funding in the world. But if you don't have people and you don't treat them well, you don't have a good outcome.

00:04:23 Denise Bachman

So I always invested heavily in relationships and getting teams to come together.

00:04:28 Denise Bachman

To get stuff done, that's always been my elevator speech.

00:04:32 Denise Bachman

So I think the combination of those two things is really representative of what I do.

00:04:33

What's it?

00:04:36 Steve Vinson

For sure.

00:04:38 Steve Vinson

Yeah, and it shows in your in your work. When you say get stuff done, anything you can share like what is that stuff?

00:04:44 Steve Vinson

Know it's interesting about this.

00:04:47 Steve Vinson

A lot of people that listen are project managers and some of them aren't even in life sciences, which kind of surprised me.

00:04:54 Steve Vinson

But they're like people that want to learn, you know.

00:04:57 Steve Vinson

So when you say get stuff done, what kind of stuff?

00:05:01 Steve Vinson

Either from a project that went well or didn't go well in your in your prior career.

00:05:05 Denise Bachman

Yeah.

00:05:06 Steve Vinson

Career.

00:05:07 Denise Bachman

So that's a really good question and thanks for allowing me to.

00:05:08

Run.

00:05:11 Denise Bachman

When I say get stuff done, it can vary from project to project. But again my key focus was always on bringing a team of people together.

00:05:19 Denise Bachman

Usually, to alleviate work that they were doing, that they weren't trained to.

00:05:24 Denise Bachman

So my scientists were often working with scientists, healthcare professionals of all kinds, and then they're tasked with being responsible for managing a project.

00:05:34 Denise Bachman

Well, Project management is a an industry and a a methodology of its own.

00:05:38 Denise Bachman

You can't expect somebody who's not.

00:05:40 Denise Bachman

To do it to do.

00:05:41 Denise Bachman

Well, when I step into that role, I take over.

00:05:45 Denise Bachman

That is my area of expertise when I'm working on a project, they become the space to do what they really are trained to do and things start working well.

00:05:54 Denise Bachman

So when I say get stuff done, the project could vary greatly from whatever the deliverable is, whether it's a new software system.

00:06:03 Denise Bachman

A remediation project or transformation project.

00:06:07 Denise Bachman

The list goes on and on, so that's the output, but for me it was getting everybody working together to get that output where it needed to go. You have to do it.

00:06:18 Denise Bachman

Without causing a lot of harm or any harm really to anybody.

00:06:22 Steve Vinson

On that project you were talking about where management wasn't supportive.

00:06:26 Steve Vinson

Are you able to share what that what the product of that project was?

00:06:31 Denise Bachman

So that was a.

00:06:34 Denise Bachman

That was I was working in drug safety for a company and they were going through a transformation change, bringing together a couple of different organizations that needed to go from manual paper processing to something electronic.

00:06:49 Denise Bachman

There was a lot of resistance in different groups in the organization.

00:06:54 Denise Bachman

Actually, the most resistance came from the sponsoring organization itself. So.

00:06:59 Denise Bachman

Just.

00:07:00 Denise Bachman

Just challenged with people that didn't want to make the change that weren't interested.

00:07:04 Denise Bachman

And affecting any change delaying things because that company culture.

00:07:10 Denise Bachman

Believed that.

00:07:13 Denise Bachman

Consensus meant 100% agreement and really you want to define that ahead of time because 100% gives one person the power to stall a project.

00:07:16

Hmm.

00:07:22 Denise Bachman

That's exactly what happened.

00:07:24 Denise Bachman

We were delayed by several weeks because one person just simply didn't want to do what needed to be done.

00:07:30 Denise Bachman

Well, that created a lot of problems that caused.

00:07:35 Denise Bachman

Delays to the project.

00:07:37 Denise Bachman

Things got escalated and there was a lot of.

00:07:42 Denise Bachman

Harm caused to people who were getting ready to.

00:07:46 Denise Bachman

Who really weren't sponsoring the project the way they should have, and it just wasn't handled well.

00:07:54 Steve Vinson

Yeah, you and I have the pleasure of being at the, you know, having the amount of experience that we were there when people were transitioning from paper to electronic.

00:08:06 Steve Vinson

Records and that was that was a pretty common theme, wasn't it?

00:08:09 Steve Vinson

Were resistant to change.

00:08:12

They.

00:08:12 Steve Vinson

Didn't understand the electronic records.

00:08:15 Steve Vinson

Didn't.

00:08:16 Steve Vinson

They were comfortable with their paper, but you know that's a.

00:08:19 Steve Vinson

I'm glad you were the project manager in that one, cuz I'm sure that you even though there was harm and things didn't go.

00:08:27 Steve Vinson

The way you wanted to, I'll bet there was less harm because of your approach.

00:08:33 Denise Bachman

Well, I appreciate that it did get done, but you know the the point about paper to electronic over the life of my.

00:08:36

Yeah.

00:08:40 Denise Bachman

I've always said that making that switch is always one of the hardest for people, because once you're on an electronic system, you understand it.

00:08:46 Denise Bachman

Easier to transition to another one or to upgrade, but going paper to electronic is very difficult so.

00:08:50 Steve Vinson

Needle.

00:08:53 Steve Vinson

Yeah. Yeah, it's a great point.

00:08:55 Steve Vinson

So then you you have this stellar career.

00:08:58 Steve Vinson

There's a hot shot project manager.

00:09:02 Steve Vinson

And you find your way to BPM. What's that?

00:09:04 Steve Vinson

Tell folks that story how you found your way.

00:09:07 Steve Vinson

Bpm and.

00:09:08 Denise Bachman

You know well.

00:09:08 Steve Vinson

Why you decided to to jump on board here?

00:09:11 Denise Bachman

Yes, I did something highly.

00:09:14 Denise Bachman

I stepped outside of the life sciences industry for a few months and really regretted it.

00:09:19 Denise Bachman

Was not where I.

00:09:20 Denise Bachman

I was a fish out of water and I missed all the structure and the compliance and the regulatory requirements.

00:09:28 Denise Bachman

And the skills of the people that you work with.

00:09:32 Denise Bachman

But also the whole idea of getting products to patients, it just was so much more meaningful to me. 'cause I'd been doing it for such a long time.

00:09:38 Denise Bachman

So a mutual friend of ours, Steve, referred me to you and did and had a conversation.

00:09:46 Denise Bachman

I met with.

00:09:47 Denise Bachman

Talk to him. We thought it would be awhile before something came up.

00:09:51 Denise Bachman

And a few weeks later, he called me and had a project.

00:09:54 Denise Bachman

So I left what I was doing and drove from South Carolina up to Indianapolis and joined BP.

00:10:02 Steve Vinson

Yeah, but I was glad you did too.

00:10:05 Steve Vinson

That mutual.

00:10:06 Steve Vinson

Another great project manager and educator, project management teachers.

00:10:09 Denise Bachman

Yes.

00:10:10 Steve Vinson

So I don't have her permission to to give her name out over over the podcast, or I would. Maybe she'll comment down below if you're listening.

00:10:18 Denise Bachman

And that would, yeah, yes.

00:10:19 Steve Vinson

You know who you are.

00:10:21 Steve Vinson

So ever grateful to her for for introducing you. And I thought that was interesting too, that you and I met.

00:10:29 Steve Vinson

And you went to a project that I had left that we both ended up deciding was not was not a great environment, although you found a place in even in a company where.

00:10:40 Steve Vinson

Where I didn't feel like good project management was valued, you found.

00:10:44 Steve Vinson

Found a part of that company where you were able to thrive. I think, right?

00:10:50 Denise Bachman

Yeah, I actually worked for them. Left and when I left, I left on good terms.

00:10:54 Denise Bachman

I said you're not using me to the best of my.

00:10:56 Denise Bachman

So if you make these changes, I'm happy to come back and I did. And I I was able to help them further along with what they were doing.

00:11:04 Steve Vinson

Which is awesome.

00:11:05 Denise Bachman

Yeah.

00:11:07 Steve Vinson

So now you have BPM and that was.

00:11:09 Steve Vinson

We're so, you know, I know everybody at BP, miss. Glad you're here.

00:11:13 Steve Vinson

What's it? We've grown like crazy in the last few years.

00:11:17 Steve Vinson

What's that been like?

00:11:19 Steve Vinson

You know, being finally getting to do what you always wanted to do, help build and shape a culture, and now it's growing.

00:11:26 Steve Vinson

So what's that been like?

00:11:29 Denise Bachman

It's been.

00:11:31 Denise Bachman

It's been challenging, exhausting, exhilarating.

00:11:36 Denise Bachman

Because as you know, when we were growing this company together, you were on the same journey as.

00:11:40 Denise Bachman

But you know we're doing client billable work and trying to grow a company and recruiting the right kind of people and defining those core values and core purpose and putting all the infrastructure in place you need.

00:11:54 Denise Bachman

To grow a company.

00:11:57 Denise Bachman

In talking to other small business owners, we learned that they did the infrastructure after the fact and that it was very, very difficult for them.

00:12:04 Denise Bachman

So I think that's one of the reasons that we're different by design, because we were thoughtful about how we wanted to approach us defining those core values and core purpose in particular.

00:12:13 Denise Bachman

Key I think to where we are today.

00:12:16 Denise Bachman

We're able to attract the right kind of talent.

00:12:19 Denise Bachman

People that are invested in the desire to do all the things I've already talked about and commit to it now.

00:12:26 Denise Bachman

Not easy, but we've been able to find committed, passionate people who are willing to work hard, grow and learn.

00:12:34 Denise Bachman

And reap the rewards of being in their happy place.

00:12:39 Steve Vinson

Yeah. And to your point.

00:12:43

You know.

00:12:44 Steve Vinson

It's something I know you and I thought about throughout our.

00:12:47 Steve Vinson

Like, why do these small to mid sized consulting companies not practice what they preach?

00:12:52 Steve Vinson

You know, we go into a client and we say you need a process for this.

00:12:56 Steve Vinson

Need better.

00:12:57 Steve Vinson

You need. You know what is your?

00:13:00 Steve Vinson

What is your mission? What you know and the answer?

00:13:04 Steve Vinson

With the smaller companies was always either.

00:13:06 Steve Vinson

Me anyway was.

00:13:08 Steve Vinson

Well, we know what we're doing.

00:13:10 Steve Vinson

All know why we're.

00:13:11 Steve Vinson

We we aren't big enough yet and and even the companies that you and I have networked with.

00:13:16 Steve Vinson

With Dave.

00:13:18 Steve Vinson

Boy, we wish we had done it sooner, 'cause. We grew like crazy, and now we're trying to play catch up.

00:13:23 Steve Vinson

We're building the the train tracks. You know, after we've already passed over the ground.

00:13:28 Steve Vinson

I don't know.

00:13:29 Steve Vinson

Probably mixing metaphors there, but so yeah, I'm so glad we've done it.

00:13:33 Steve Vinson

Was against conventional wisdom even.

00:13:37 Steve Vinson

And you know.

00:13:38 Steve Vinson

I've always wondered why companies didn't do.

00:13:41 Steve Vinson

Like why the smaller to mid size companies didn't define their their visions and their.

00:13:48 Steve Vinson

Values and put structure in place.

00:13:50 Steve Vinson

I know why it's hard.

00:13:53 Steve Vinson

It's really, really difficult.

00:13:55 Steve Vinson

And it takes investment.

00:13:59 Steve Vinson

So you know you and I working on this stuff is a huge investment that the company's making. If our founder wanted to just take the money, you know, he could not have a Denise or not have a Steve and still kind of have a company, it would.

00:14:13 Steve Vinson

Not run as well.

00:14:15 Steve Vinson

But it's.

00:14:16 Steve Vinson

Big investment so and I'm glad we've done it.

00:14:20 Denise Bachman

Oh I am.

00:14:21 Denise Bachman

And I think we're seeing the.

00:14:23 Denise Bachman

You know, people are happy with what they're doing and we're growing and our clients are happy with what we're doing.

00:14:30 Denise Bachman

Have great relationships with our clients because our values and our core purpose align well with them.

00:14:36 Denise Bachman

But we actually live up to what we say we're going to do and we respect our values and our vision and our purpose and make sure that we assign people to the right projects so that everybody thrives.

00:14:48 Steve Vinson

Do you have a story?

00:14:49 Steve Vinson

And I may ask for two stories.

00:14:51 Steve Vinson

1 is when you.

00:14:55 Steve Vinson

When you knew that we that the company should not do something because we didn't have aligned values either with the client or with the potential.

00:15:07 Steve Vinson

Employee or even an existing employee like like you had to make a decision that maybe from a pure business and profit point of view would not have been the decision to make, but from a values perspective, do you have any stories you can share about that?

00:15:24 Denise Bachman

I think we've encountered that before and I I actually, as I'm recruiting people, tell them that we will turn work away if it doesn't align with our values because we are that serious about it.

00:15:34 Denise Bachman

It's well worth the investment to do it and do it right.

00:15:37 Denise Bachman

Do what you believe in doing, not just say it.

00:15:40 Denise Bachman

But yes, we've had.

00:15:41 Denise Bachman

We've had some folks in the past who really didn't buy into our values and it became apparent as their.

00:15:49 Denise Bachman

With us went on and I don't think they were in a happy place and it was showing, so making the decision to end that relationship, yes, there's a price that comes with it to the business because you may have just lost that if you couldn't replace it.

00:16:05 Denise Bachman

But in the end, you're better off.

00:16:07 Denise Bachman

I think everybody's better and I hope all the folks that may have left us are much happier with where they are.

00:16:14 Steve Vinson

Yeah, that last bit is is another thing that sets you apart.

00:16:19 Steve Vinson

From a lot of people I've worked with, is that yeah, you don't just think of it as OK. They're gone.

00:16:26 Steve Vinson

They weren't a good fit here. They left.

00:16:28 Steve Vinson

And then out of sight, out of mind, you're like, oh, and by the way, they're probably happier too now.

00:16:35 Steve Vinson

And you just don't hear that much. And that's one of the things I love about the way you approach things.

00:16:35 Denise Bachman

Mm.

00:16:41 Steve Vinson

What about the other side? Any recent stories?

00:16:44 Steve Vinson

That say like that, you would you would point to and go see it works and this is proof that it works.

00:16:51 Denise Bachman

Wow, right.

00:16:54 Denise Bachman

Well, we've grown a lot this.

00:16:56 Denise Bachman

We've had several new hires and it's really refreshing for the people who are coming in new and seeing a small company grow for the first time in their careers and telling me, wow, you really do.

00:17:08 Denise Bachman

Act on the values and the core purpose.

00:17:11 Denise Bachman

Actually do what you say you do.

00:17:13 Denise Bachman

I've had people nearly in tears because they're so happy.

00:17:18 Denise Bachman

I've had people affecting changes in their personal life and their health and their relationships because they've been learning so much about a better way to work and a better way to live. And when I hear those stories just about weekly, I am so humbled by it.

00:17:35 Denise Bachman

That to me is proof of our.

00:17:39 Denise Bachman

But what we've done is working.

00:17:41 Steve Vinson

Man, why wouldn't anybody want to come work for BPM?

00:17:46 Steve Vinson

And or work with me VM as a client.

00:17:46 Denise Bachman

A lot of people would like that.

00:17:51 Steve Vinson

What about the?

00:17:52 Steve Vinson

So, OK, we've got, you know, the company has grown to this point and there's always growing pains and and things getting from.

00:17:59 Steve Vinson

You know, if when I was talking to Jeremy the founder, you know, getting going from one employee to two was a huge step change and then going from 2:00 to 20 is another, you know, two. Well, two to five was another one. And then you and I come.

00:18:15 Steve Vinson

And we go from.

00:18:17 Steve Vinson

5 or 6 to 20.

00:18:18 Steve Vinson

Now we're looking to the future from 20 to, you know, whatever the future holds.

00:18:24 Steve Vinson

What do you see happening to the professional project management?

00:18:29 Steve Vinson

The you know our business, BP, Ms. business specifically, what does the next 5 or so years hold for for this whole thing?

00:18:39 Denise Bachman

That's a great question. I'd like to see that we can continue doing what we're doing.

00:18:44 Denise Bachman

That means we have.

00:18:45 Denise Bachman

We have growing pains, you know, sometimes you get overloaded with.

00:18:49 Denise Bachman

So now we're looking to how do we readjust workloads. We can accommodate the growth.

00:18:54 Denise Bachman

Till everything catches up.

00:18:57 Denise Bachman

I think Project management is in a field that's going to be around for a long, long time.

00:19:01 Denise Bachman

I do think as we're starting to learn how to work with AI and project management, I think AI is going to be a great tool.

00:19:08 Denise Bachman

But it's just that a tool you still need people.

00:19:12 Denise Bachman

Projects don't run themselves.

00:19:14 Denise Bachman

AI can't do it for.

00:19:15 Denise Bachman

They it can assist and it can make things easier, but it's not going to replace.

00:19:20 Denise Bachman

So my belief is still that as long as we always invest in our people and make sure that they're growing and developing the way they want to, we can keep that foundation going.

00:19:30 Denise Bachman

Don't see why that has to be limited by.

00:19:33 Denise Bachman

Size. It just means that our internal growth in the way we structure things will change as time goes.

00:19:39 Denise Bachman

But our core beliefs and our culture should remain the same so that we can continue deliver great service to our clients.

00:19:47 Steve Vinson

One of my favorite recent Denise quotes, for those of you that don't know AI is a AI.

00:19:54 Steve Vinson

AI is entering every aspect of work in one Microsoft version is called copilot in Denise recently said.

00:20:02 Steve Vinson

Hey, it's called copilot, not autopilot.

00:20:05 Steve Vinson

Always going to need people.

00:20:07

So.

00:20:07 Steve Vinson

To which to which Jeremy?

00:20:09 Steve Vinson

That's going to end up on LinkedIn, to which I said you're both right.

00:20:15 Denise Bachman

But it's true, a lot of people think that AI is going to replace people, but not in our industry, not for what I'm doing, not not what any of us are doing right now.

00:20:16

It is.

00:20:25 Denise Bachman

I think it'll be helpful for the years to come, but I don't think we're close to having it replace people.

00:20:30 Denise Bachman

So people to me, are still the key.

00:20:33 Steve Vinson

Yeah. And I think the key is figuring out how to work with AI to to do better, to do faster, to do, you know, cheaper.

00:20:45 Steve Vinson

And not not assume that AI is going to replace us, but assume.

00:20:48 Steve Vinson

That it's gonna.

00:20:50 Steve Vinson

It's gonna be something we could work with as a tool, so I completely agree with that.

00:20:56 Steve Vinson

So, Denise, thank you for all of.

00:20:59 Steve Vinson

Is there anything you were hoping to get to?

00:21:01 Steve Vinson

I just didn't ask the right question.

00:21:04 Denise Bachman

No, it was nice to be able to talk about BPM and what makes us different and why we're special.

00:21:10 Denise Bachman

I do believe we are.

00:21:12 Denise Bachman

So I think we covered a lot.

00:21:14 Steve Vinson

Awesome.

00:21:15 Steve Vinson

So what if somebody wants to learn from the same place you?

00:21:20 Steve Vinson

Like, do you have an online resource or a book or something that that you think might benefit the listeners?

00:21:27 Denise Bachman

Great.

00:21:28 Denise Bachman

So I would say it's lifelong learning, not just not just formal education or my certifications from PMI.

00:21:35 Denise Bachman

You certainly can learn from those.

00:21:38 Denise Bachman

The experience that you get from watching people working with people and learning from them, learning how to give feedback, learning how to take feedback, paying attention to what works well for you, and knowing that it could be different for somebody else.

00:21:51 Denise Bachman

I think all of that is really important.

00:21:53 Denise Bachman

Important. And then you know, reading and reading.

00:21:58 Denise Bachman

Books can.

00:21:59 Denise Bachman

They can be all kinds of books, different kinds of books that make sense for you and for the role that you're in or where you are in your life.

00:22:08 Denise Bachman

I.

00:22:08 Denise Bachman

This might be.

00:22:09 Denise Bachman

I don't do a lot of reading of business books, but I do like to read things that are more people focused, so I just finished a book the other day called Big Panda and Tiny Dragon by James Norbury.

00:22:23 Denise Bachman

The beautifully illustrated book.

00:22:26 Denise Bachman

An artist and.

00:22:27 Denise Bachman

Writer and that just really.

00:22:30 Denise Bachman

So like I say, books from all different kinds of areas are interesting to me.

00:22:36 Denise Bachman

Helped me develop those people relationships.

00:22:41 Steve Vinson

Big Panda and Tiny Dragon by James Norberry.

00:22:44 Steve Vinson

We'll put a link to that in the in the show notes.

00:22:44

Yeah.

00:22:48 Steve Vinson

I love that because I've learned I I've been lately the last few years reading a lot of science fiction, and I've learned a awful lot about, you know, dealing with people and technology and and that kind of thing, just from science fiction, which.

00:23:04 Steve Vinson

Is, you know, it's interesting, right?

00:23:05 Steve Vinson

And history books and everything. I just.

00:23:08 Steve Vinson

I love it when people talk about like, you know, I.

00:23:11 Steve Vinson

I haven't read the latest business book, but here's a great work of fiction or art.

00:23:16 Steve Vinson

About art or biography, that really informs who you are as a person.

00:23:20 Steve Vinson

Awesome.

00:23:22 Steve Vinson

Big Panda and Tiny dragon.

00:23:23 Steve Vinson

Can't.

00:23:23 Steve Vinson

I have to check that one out.

00:23:26 Steve Vinson

All.

00:23:27 Steve Vinson

What if somebody wants to get a hold of you? Are you?

00:23:30 Steve Vinson

You're active on LinkedIn, right?

00:23:32 Denise Bachman

Yes, I.

00:23:33 Denise Bachman

You can find me on LinkedIn. VPN has a website as well, so you probably want to put that in and.

00:23:42 Denise Bachman

Wants to reach.

00:23:43 Denise Bachman

I'd love to hear from him.

00:23:46 Steve Vinson

Well, thanks very much.

00:23:46

Replay.

00:23:47 Steve Vinson

This has been delightful and look forward to.

00:23:53 Steve Vinson

Getting us out there so people can hear your story.

00:23:55 Denise Bachman

Well, thank you, Steve.

00:23:56 Denise Bachman

Appreciate it.

00:23:58 Steve Vinson

For those of you who do want more information about BPM, it's bpm-associates.com.

00:24:05 Steve Vinson

And obviously, we're also on LinkedIn and if you want to subscribe to the show, which I encourage you to do, it's the life science effect.com where you can find it on all the podcast things. And don't forget, if you enjoyed this, do all those Internet things.

00:24:20 Steve Vinson

Like subscribe.

00:24:21 Denise Bachman

Movie.

00:24:22 Steve Vinson

Share it with a friend.

00:24:24 Steve Vinson

Because we don't want you to miss a single.

00:24:26 Steve Vinson

Thank you for listening and we'll talk to you next time.