The Life Science Effect

Have you ever thought about who the people are behind life-saving breakthroughs? How did they get started in their careers? Why did they choose the Life Sciences? What effect do they hope to cause? These are the questions we explore on The Life Science Effect. Gain insights straight from thought leaders, entrepreneurial game-changers, and business executives leading the Life Sciences. Host Steve Vinson explores what it really takes to be effective in this industry as a leader and innovator with a special focus on what’s happening here, in the Heartland. We aim to inspire, equip, and empower the next generation of Life Science experts through purpose-driven conversations. Join us weekly as we talk about what happens behind the science and get to know the people who make it happen

S2E8: Pharma in Flux: Navigating Regulatory Uncertainty and Manufacturing Momentum in 2025 06/26/2025

S2E8: Pharma in Flux: Navigating Regulatory Uncertainty and Manufacturing Momentum in 2025 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. /episode/index/show/thelifescienceeffect/id/37163185

S2E7: Prophetic Musings. Navigating Uncertainty in Life Sciences 02/18/2025

S2E7: Prophetic Musings. Navigating Uncertainty in Life Sciences 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. /episode/index/show/thelifescienceeffect/id/35338260

S2E6: BPM's Commitment to DEIB is Unwavering 02/07/2025

S2E6: BPM's Commitment to DEIB is Unwavering 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. /episode/index/show/thelifescienceeffect/id/35198530

S2E5: Denise Bachman, COO of BPM Associates 01/24/2025

S2E5: Denise Bachman, COO of BPM Associates 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... /episode/index/show/thelifescienceeffect/id/34996630

S2E4: Jeremy Opperman, Founder and Beating Heart of BPM Associates 11/18/2024

S2E3: What Do We Do? 10/31/2024

S2E3: What Do We Do? In Season 2, Episode 3 of *The Life Science Effect*, Steve Vinson discusses BPM Associates' work. He explains BPM’s core purpose and values—supporting people, fostering teamwork, and reducing turnover in the life sciences industry. Through personal stories, Steve illustrates the challenge of defining “what we do” in simple terms and describes BPM’s approach to managing projects in pharmaceuticals, including combination product scaling, regulatory compliance, and facility expansions. Emphasizing people-centered project management, BPM seeks to avoid burnout while meeting timelines and budgets. Future episodes will feature BPM employees sharing insights on their project experiences. MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License FULL 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. I'm Steve Vincent and this is season 2 episode 3. Finally, after many weeks of waiting, we're going to talk about what we do, so you'll remember Episode 1 was start with. Why? And we talked about our core purpose about extraordinary people working together in a great environment to accomplish important lasting change. And then in episode 2 of season 2, we talked about how we go about doing that, starting with our core values of people first. Relationships matter. Service to a greater cause than DEIB, and we put structures and systems in place so that our folks can be extraordinary. As exemplified by my hospital visit and the demonstration that if you take care of your folks, your folks will take care of your customers. So that's starting with Y and we got the concentric circles start with. Why then how finally we get to the outermost concentric circle? What the heck do we do? So first I'm gonna tell you a little story from a few years back. Went to a networking event and you know when you go to these networking events, somebody's always asking what do you do? And this one was no different. Had gone to this event. It was at the Columbia club in downtown Indianapolis, which is this kind of ritzy, beautiful building. They have nice art hanging on the walls. And so it was a nice place. And I practiced my, what we call the elevator pitch. The whole way there, because I had to drive there from from my house and the elevator pitch for those of you that may not know what I'm talking about there, it's that 10 seconds or so of an answer. When somebody says, what do you do? So you go to a networking event, you get on the elevator to go somewhere. You've got between 3 and 10 floors. To tell this person in that elevator what you do. That's your elevator pitch, so I'm practicing it the whole way over. It doesn't come natural for me, and answering that question, what do you do? It used to be really hard for me. You know what? What do I say? Project management. I'm a project manager. Yeah, well, me too. Everybody's a project manager these days. What does that mean? What do you? What kind of projects do you manage? And then I'm I'm talking about pharmaceutical projects. And medical device projects. Next thing I know, their eyes are glazed over and they're like, why couldn't you just say lawyer or doctor or something? My knows what that is. And I'm like. I just always had trouble with it, so I would practice these elevator pitches and this day was no different the entire way there. I'm practicing behind the wheel and then I get to the parking garage, which, by the way, paying for parking is is not easy like there's usually like an app where you got to text somebody or. And it's really expensive. So anyway, that sort of interrupted my train of thought. Then I couldn't figure out how to get out of the parking garage. I go down like three flights of stairs and then I find myself. Of trapped on the 2nd floor, I had to ask like this this one dude that was like directing people where to go was like how do I get out of here? He's like out that door and turn left. So I did. I find my way out. I finally get to the networking event and take the elevator. Ironically, nobody was in the elevator. Just me. So I'm still giving my elevator pitch to myself. I breeze out of the elevator straight into the networking event, head straight for the coffee bar, because that's what the networking books tell you to do. They say go to the refreshment area. If it's in the evening, it's where they serve the drinks anyway. I go over to the coffee thing and where people are and I'm making my coffee, there's another person making her coffee. She probably read the same books. She looks at me and I look at her. We're like, here we go, right? We're about to network. Networking is about to begin and she's about to ask me what I do. I'm ready for this, she goes. So tell me about yourself. I I I was. What? That's exactly what I said. She's like. Well, well, tell me about yourself, man. I was ready for what do you do? I wasn't ready for. Tell me about yourself in my head. I'm like, let's see. I was born in Northwest Indiana. No, wait. That's too far back. Chemical engineering degree. No, she doesn't want my resume and I was like, OK, I just. I stopped. They said. I practiced this elevator pitch. I was ready. And now I'm just frozen. I'm thrown off. She was apologizing to me, and I'm like, no, I'm the one that should be apologizing to you. And I said, can I just start over? She's like, please do. I said cool. Hi, I'm Steve Vinson. I'm a project manager and pharmaceutical and medical devices. I help clients get their projects done. Faster, better under budget. And she looks at me and she goes. Real estate. What? No. What did I say anything about real estate? She's like, yeah, in the beginning, I said Steve Vinson. No, it was after that, projects. No. Before that, I don't think I. So now we got this awkwardness hanging in the air. Right. And I finally was just like. There's somebody over there I want to talk to you. So this. What do you do? Question. The bottom line is didn't always come naturally to me. Right. And you have to recognize in some ways that the purpose of the question, it's not what she asked. It's just she could have said give me your elevator pitch. Or she could have said the truth. Which is, hey, we're both at this. Event let's tell each other what we got going on so we can figure out if you can help me or if I can help you or if I know somebody that can help you or if you know somebody that you can introduce me to. That's all we're doing here. We're not trying to get each other's life stories. This isn't Life magazine. Just give me the 10 seconds so that I know whether do I need to move on to the next. So now Fast forward to today. And as I've said, I'm the CEO of a company and I represent the company at events. I'm no longer just representing me, so I need to stay on message no matter what the question is, you know, tell me about your company. Tell me about you. Tell me about yourself. What do you do? I need to be ready with those few messages. That I want to communicate. On behalf of the company. So that's what these podcasts have sort of been about. It gives me an opportunity to practice, but it also steps you through the process too, maybe for your company or you know, maybe by getting reintroduced to our company, we can find ways to help each other. So here's some messaging for you. Speaking of what we do, I saw a statistic recently. About a million people in the US work in pharmaceuticals and medical devices. And most of those are working on. Projects. 90%, I would say are more of the people of the professionals working in pharmaceuticals are working on. Projects turnover rate for those folks year over year is about 25 to 30%. That's like one out of every three or four people you're working with on a project is going to leave that job this year. And think about the impact that has on your project team. You got to really go through the storming, norming, performing, norming, storming and performing stuff. You got to reteach people. What the projects about get them back up to speed, hugely disruptive, not to mention the reason they're leaving is they're frustrated there. They don't see the connection of their project to the world or to. Making a difference for patients and so if we can figure out a way to run projects better, then we can reduce that turnover rate first of all. But more importantly, we can have people instead of feeling like they're going to a job and they're stressed out about getting their projects done, they can thrive in their career. Be happier at home and just leads to a better world. And again, not to mention patients get their medicines faster, they get their devices faster. So at BPM that's what we believe we believe in managing projects differently. Yeah, we get projects done on time and under budget by the way, if you meet somebody that works at a company and they claim they. Leverage project management or specialized in project management, but they're not telling you. They'll get their projects done on time and under budget. They probably shouldn't be in the business of project management. It's kind of like table stakes. You getting projects done on time and under budget. But I digress. Yes, BPM gets projects done on time and under budget. That's always our goal. But we also focus on not leaving behind a trail of burnout and frustration. We prioritize people. We want the people working on our projects to feel like they've grown. They've learned something new and they look forward to coming. Work because when people feel valued, they stay and the project thrives. That's all well and good, but you know, that wasn't 10 seconds. That wasn't an elevator ride. That was like, I had to capture you for a good 5 minutes to tell you all that. So how would I answer that question today if I were to go to a networking event? I end up in the elevator. Now. I'm not perfect. None of us are. Perfect. But the difference here is I believe in this message, and this isn't just some slogan to me. And the more I practice it, the more natural it's going to sound. So somebody asked me tell you, tell me about yourself. What do you do? Hi, I'm Steve Benson. I'm the CEO of BPM associates. We're a life science consulting. Firm that overseas client projects. So our consultants and experts, they get complex projects done on time, within budget and most important to us, we don't leave behind a trail of carnage. So there you go. Our approach is all about creating an environment where teams aren't just completing tasks, they are thriving by now. If I'm at the networking event, they'll be like OK. I I still don't quite get it. I get you guys do projects. I get you lead client teams, but like what? Actually kinds of projects are you doing? So what I thought I'd do today is I'll give you 3 different examples of some projects we've done and what kind of difference we've made for the client and this should give you a little bit more of a concrete feeling for what we do. So the first one. Comes from a large pharmaceutical company that had recently gotten approval for a drug that comes with a device. So we call those combination products. It's the drug is already pre loaded into the into the syringe. And the drug took off in the market place and they had to suddenly make a lot more of it than they had capacity for. So we had a number of projects where we helped them install the equipment that manufacturers these combination devices. So our project managers and in some cases project experts were involved with helping the team specify what kind of equipment they. Created. Get that equipment on order and it's multiple pieces of equipment, so a lot of moving parts. The people who manufacture this equipment, they have questions you have to make sure you're communicating. Getting those questions answered to keep that piece of it on track. Then, when the equipment shows up at the client site, it has to be installed bolted to the floor, plugged in to the electricity has to be plugged into the IT systems. It's remarkable how much these manufacture. Lines are integrated with IT systems, so knowing something about those IT systems is important for the project manager. Keep in mind our project managers aren't usually the expert on the technology, but they know enough about the technology to be able to talk to the engineers and technicians who are the experts on the technology to identify risks. Risks help them resolve issues, remove obstacles out of the way, etcetera. So now that the equipment's on site, both the down plugged in to the electricity into the data. Systems. Now it has to be turned on and tested everything. All this equipment, the process, everything has to be tested so that we know that every single device that comes off of this manufacturing line is safe. It's effective. It's not going to hurt somebody. It's not going to be broken. When when you get it from your pharmacy and get it home and open it up, it's going to be a good one. We can't test. Each and every one of the devices, so we test the equipment and the process that make the devices so that you can know that it's still going to be a good device. That's our project and we've done a number of these. We've gotten the capacity up to the point where the market is filled fulfilled with the medicines that people need. And by the way, all the people that worked on these projects, they have really enjoyed their work. They knew why it was important. And at the end of the day, they want to do another one and they want to work with, they want to work on a project where BPM person is running the project. So next example is a lot different kind of project, but it's still a project and then we'll call it a quality system. Improvement project and that's where a regulatory body like the FDA or one of the international bodies maybe comes in. And and finds some deficiencies at a pharmaceutical manufacturer or a medical device manufacturer, and by deficiencies, I mean they're not following the regulations perfectly. They have some issues and their processes that create risk that they might be making bad product. They aren't necessarily making bad product. But there's the risk there because they're not following the regulations completely as they should be, so our project has been, would go in, we take a look at what the findings were from what they call the audit, where the the regulatory body came in and looked at their systems, gave them some. Sessions and we work with the client. We form a team of both client folks and experts in the industry. Experts on those regulations and we figure out where those deficiencies are. We get to the root cause of those deficiencies with the client so that we're not just putting band aids on the issues. We're actually addressing the underlying cultural or underlying root causes. Of the problems that they've had, in some cases that involves rewriting procedures, it may very well include identifying product that possibly is bad, that may need to be recalled, and then we'll help them through that process as well. So again we. They. Aren't necessarily the expert on FDA regulations. We know an awful lot about FDA regulations, but we have a network of experts and sometimes the client is an expert, but they don't know how to take their expertise and turn it into actual strategic and tactical actions to get these procedures. Rewritten or get these deficiencies remediated so the project becomes organizing that team and organizing the effort to get things rewritten and redone so that the FDA or whatever regulatory body can come back in, take another look at the. System and in every single case in the projects I've been involved with, the FDA comes back and says, OK, everything's fixed, you're out of trouble now or whatever the whatever the case may be. So that's quality system projects. The third one is maybe more standard of what you would think of a project and that is facility expansion. And that is just straight up somebody's building a building or they're changing something inside of a building. They're renovating a building or they're building a new building. So those of you who maybe didn't know about pharmaceutical manufacturing or didn't know about the quality system type projects, this is the kind of project where you're like, ohh yeah, I know what a building is. I know how that works, a lot of the facility expansions we do or the facility renovations now it's happening within a pharmaceutical or medical device company. So it has to follow those regulations as well. And some of these end up being a much bigger too. So we our project managers, we would put us more senior person. On a project like that, because now they're overseeing a team of hundreds of people that are doing wildly different things, you know, some of them are the experts on what does this facility need to accomplish, what kind of air handling units, what kind. Of floor finishes, wall finishes need to be in here. So you got those experts all the way to the experts on construction. So you might be working with a large. General contractor concrete people. So that's a really those are fun projects because you're working with a wide range of people and when we're on those projects again by understanding what's this building for, who's it for, what does it need to do? Why do you need this building? What happens if you don't build this building by understanding those things? Our project managers can really motivate and inspire A-Team to do their best work. Those are my three case studies for the day. I've got a lot more I think now that we've gotten through the why. The how and we're on to the what we're going to do a few more. What's so? I'm going to bring in voices of our employees to tell you about the projects they're working on. Because. You can hear it from me and you get my perspective. But boy, when you maybe hear from a project manager who's still out there every day running these projects, it it brings a different perspective. So we'll probably do a few of those in the future as well, but that's it for today. Thank you for listening. Don't forget, do all the Internet things you know like subscribe. Comment Send me an e-mail, go to thelifescienceeffect.com to figure out how to listen to this thing on all your favorite platforms and subscribe so you don't miss a single episode. You want to learn more about BPM? Go to bpm-associates.com. And continue listening to the life science effect. /episode/index/show/thelifescienceeffect/id/33698387

S2E2: How Do We Do It? 10/11/2024

S2E2: How Do We Do It? Host Steve Vinson continues exploring BPM Associates' core philosophy, following up on Simon Sinek’s idea of starting with "why." In Episode 1, Steve shared why BPM does what it does—now, he turns to "how" they do it. Before diving into the business side, Steve shares a humorous and mostly true story about his recovery from outpatient surgery, which highlights the value of a great work environment and how it can translate into better outcomes for patients, employees, and even clients. Steve emphasizes that BPM’s approach centers on strong leadership, effective project management, and living out their core values. These principles, coupled with rigorous internal processes, help BPM drive successful, lasting change for pharma and medical device companies. Tune in for insights on how BPM nurtures its people, ensures client satisfaction, and continually strives for improvement—ultimately creating a workplace where change is embraced and employees are empowered to excel. MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License FULL TRANSCRIPT: I'm Steve Vinson, and this is Season 2, Episode 2. If you watched the Simon Sinek TED Talk, or if you listened to Episode 1 of Season 2, you know that Sinek asks us to begin our communications with why, then how, then what. In Episode 1, I talked about why BPM does what it does. Today, I'll talk about how we actually do it. Then in future episodes, we'll get into what we actually do, but first, a story about that time I was recovering from outpatient surgery. Now it involves anesthesia, and I didn't get permission from the nurse to tell this story, so I'm changing some of the details to protect their privacy and maybe my fragile ego, but the gist of the story aligns with many of the conversations I've had with several folks at that same hospital. I'd say this story is mostly true, true enough, we'll say. You'll get the idea. I was walking down the hall of the hospital in my very fashionable hospital gown, in my grippy socks, and the nurse was there, of course, to make sure I didn't fall over. If I did fall over, it wouldn't hit my head. It was all part of the anesthesia recovery process, of course. I asked them how they liked working there. I have a habit of doing that at this hospital system, and you'll see why later. But they answered me, and they said they love it. They love working there. They said the administration listens to the employees, and they implement things that'll make nurse lives better and also make for better patient outcomes. They said they wish they'd started there sooner. See, they used to work at another hospital that's farther away that I've been to. I don't particularly care for it, the times I've had to use it. They lived near the hospital where I was, and they would drive past this hospital every day on their way to work for many years. They would think, you know, my commute could be a lot shorter if I'd just work at this hospital since I live closer, but we all know how that kind of goes. You get an inertia, and it takes hold, and it's hard to leave a job. As long as you feel like you're making a fair wage and things aren't too bad, folks tend to stay, even if something else might be better. It might be better. It might be worse or even the same, and if it's no better or no worse, then you went to all that trouble and the stress of changing jobs, maybe leaving work friends, not knowing where the coffee pot is. You might be right back to a job that's no better than the job you left, so we tend to stay with the devil we know because changing jobs is hard. A number of years ago, this particular nurse finally reached the tipping point at the other hospital. The specific reason or the reasons they left aren't that important. We've all been there. There's a proverbial straw, a bad day. The dam finally bursts, whatever that metaphor is, and they finally decided to leave the old job and take a job at this hospital, and now their only regret is they should have done it sooner. It's not about whether the pay or the benefits are better. I didn't ask about that. The pay and benefits might be better, but it's really the working environment is better, and the staff gets what they need to do their jobs well, and the administration truly listens at this hospital. If something will make the patient experience better, they listen and they take action. If a procedure can be changed to improve patient outcomes, they listen and they take action. If something can be changed to help the nurses have a better working environment, they listen and they make that change. I told this particular nurse that their story sounded the same as the other stories I've heard when I've talked with folks at this hospital system. I have a habit of asking them how they like working there, even when I'm not under anesthesia wearing a very flattering hospital gown. Now, I happen to love this hospital system. I really don't want to have to use it much, but when I do need it, this is where I try to go. If I need a doctor, if I need a procedure done, if I need anything, this is where I start. Thankfully, they're covered by my insurance. I feel safer there. I feel more comfortable there. Their systems are patient-friendly. It's easy to schedule there. The staff seems to like their job. The billing always seems to work out okay. I've had disputes, but they haven't been contentious. It's just like we've got to figure this out, and we fix it, and we move on. I just feel like I'm going to have better outcomes, like the procedure is going to go better, the treatment is going to go better. If the administration listens and acts on their staff's suggestions and thoughts and feelings, well, their staff is going to listen to me, and the doctors and their nurses are going to listen to me, which confirms my belief that if you focus on people first and work to create a great environment, the customer will notice, and the customer will have a better experience. What does any of that have to do with how BPM does business? That's what you came here for, right? Let's get back to Cynic's advice first and try it out with BPM's why, how, and what. As you know, our why is we believe in the power of extraordinary people working together in a great environment to accomplish important, lasting change. How do we do that? We leverage strong leadership, effective project management, and a commitment to our core values. What we do is we lead teams to deliver complex technical projects at pharma and medical device companies. Typically, we lead teams that have client experts, contract resources, other BPM experts. The projects range from R&D to manufacturing, asset delivery, to quality improvement and business process excellence. Let's try that out in Cynic's style. When he was talking about Apple, if you watch the videos, it's really compelling when he talks about Apple. Everything we do, we believe in the power of extraordinary people working together in a great environment to accomplish important, lasting change. We do this by leveraging strong leadership, effective project management, and a commitment to our core values. We happen to lead complex technical projects at pharma and medical device companies. Want to buy some? Maybe I have a future as a TED talker. We'll see. Important, lasting change. Change, as we know, is essential for business. The right people working together is essential for change to be successful and lasting. If it's important, you want it to be successful and lasting, right? We're talking about a world where change isn't scary. It's a world where change is welcome and we look forward to change, where people cannot wait to wake up and get to work on solving the most important challenges of our time. And people do change the right way, a way that leads to job satisfaction and lasting impact. At BPM, we believe a strong, skilled leader makes all the difference to completing projects on time at the right cost. A strong, skilled project manager leading a good team is going to leverage the principles of project management and organizational change management to ensure the project's done on time and at the right cost. And team members will feel like they gained something in the process. In short, they will accomplish important, lasting change. And even if BPM is not serving as the project manager, maybe our resource is an expert on the team or some other kind of individual contributor, that's all right. We still believe in leveraging project management practices and we'll support whoever the project manager is, whether it's a client or even another contract company. Because to be a great leader, the project manager needs great team members. And we know how to do that. A good leader knows how to be a good follower as well. All of that having been said, how do we do our work? We start with our core values of people first, relationships matter, service to a greater cause, diversity, equity, inclusion, and belonging. We leverage those values and also our core traits of desire and curiosity. We express, model, reinforce all these values and traits in everything we do. We add in a set of key skills that we can round out what it means, what the definition of extraordinary people is, and what the definition of great environment is. And applying all these, whether we're recruiting for the next extraordinary person or developing our systems in the training curriculum or working with our folks to develop and grow, these values, traits, and skills are what guide us as we're doing those activities. So we're always building and strengthening our processes and tools to ensure people have what they need to be in their happy place and to do their best work. We started the journey a few years ago by focusing first on our people, the people of BPM. Because, again, by taking great care of our employees, we believe they will take great care of our customers. So we listened and we took action. We worked hundreds of hours over the past few years to improve our internal processes and expand what we can offer people. We partnered with a professional employment organization so we could offer big company benefits at our small growing firm. That's not just health insurance, by the way. It's also, well, health and dental. But it's also an employee assistance program that is normally only offered at bigger companies in which you can call and get any kind of support you want when it comes to that. And what you can call and get any kind of support you want when it comes to mental health, physical health, whatever. And it's free to employees. There's also discount programs. There's tons of training. So it's as if we were a hundreds-of-person company offering these benefits. We regularly conduct salary surveys because we want to make sure our compensation is fair and equitable. BPM employees take advantage of our PTO program, which is take as much PTO as you need. In fact, we encourage folks to take PTO because they're such hard workers. We sometimes have to remind folks, hey, you haven't taken any PTO in a while. Let's get somebody to cover your project so you can take a week or so off. If they need to take a day off to take care of something in their family or they have to run a particular errand or go vote, they can take that time. And it's not tracked. It's not limited. We have involved everyone in our DEIB strategy development and training. Every employee at BPM is part of a task force that works on a particular element of our program, of our strategy. And these task forces work on assessing and developing our practices using global benchmarks that we evaluate in conjunction with our DEIB consultant. And we have monthly recurring meetings that we call culture development meetings where everyone comes together. We focus solely on ways to build and improve our people-first culture. It's anything but a typical staff meeting. We can inform folks of what's going on with an email or whatever. I love the mug, the coffee mug that says, I just survived a meeting that could have been an email. We really take that to heart. I mean, if we're just trying to convey some information, we'll send an email. If you have questions about that email and you want to discuss it in a group setting, especially if it's a way to move our culture forward, let's do that in a culture development meeting. Or anybody at any time can access leadership and have a heart-to-heart conversation. One-on-one or in small groups. We apply the same rigor to how we serve our clients. So now that we had spent several years working on our internal processes, we turned our focus on, we continue working and building our internal processes, but we also, for the last couple of years, have been focusing on our client delivery practices. So our project methodology and delivery process is comprehensive, and it balances the needs of a diverse client base, the needs of specific projects, and a standard approach to project management and change management. Our resource management process and tools allow us to quickly identify any resource capacity issues, any problems that might be coming up, and identify those potential problems and opportunities well before we get to them. We've streamlined our recruiting process and we have partnered with a staffing firm, actually, so that we can bring well-qualified resources to clients two or three months faster than we were able to do it before. This allows us to respond quickly and to bring the right resources on board at the right time for our clients. The faster we can find someone when we've identified a need at the client, the quicker we can find a well-qualified resource. Because we're small, we don't have a bench at the moment, so we knew we needed to compress the time it took to find a well-qualified resource to bring them on board. Speaking of onboarding, we have worked on that process quite a bit as well to make sure that one thing that clients tell us all the time is to bring on new folks because they don't have the time to train them or to bring them on board or to tell them what it's like around here to bring them on to the client culture. We have built that process and really built that up and strengthened it so that we are the ones, our program directors are the ones doing that training. We have enough experience at our clients that we could say, you don't need to do that part. Some things have to be done by the client employee, but the things that don't, showing them where the coffee machine is, telling them what the etiquette is on when you have to make the next pot, but more importantly, what is it like around here? What's it like doing work here? What are the different processes and procedures at this client? We take care of that so the client doesn't have to. Our program directors provide oversight and experience and expertise to make sure resources are successful. We strive to identify any issues well before the client even notices. We want to ensure project success even if we didn't bring on the right resource. We don't always get it right. Stop. Nobody gets it right every single time and we recognize that. We do our best to get it right the first time, but if we don't, we try to notice that before the client does so that we can work on making a change, help that person be extraordinary someplace else maybe. Even if we don't notice it and the client notices it, we don't like that situation, but we make sure we quickly jump in to make sure the project is successful and we make a personnel change if we need to. Our account managers are able to help the program directors and the client sponsors always be monitoring for what's important and how are we doing? Are we meeting your needs? Do you have any other needs that we can take care of? In all, we think focusing on strong leadership, effective project management, and a commitment to those core values are not just embracing change, we're driving it. Together we can create a world where change is welcomed and leads to lasting positive impact. From a story about me in my flattering hospital gown talking with the nurse as we walked down the hallway together to truly building an organization that values people and the belief that if we value our folks, our folks will take care of the client. Make sure you like, subscribe, comment. Let's engage together, reach out. I'm at stephen.benson at bpm-associates.com Go to bpm-associates.com or thelifescienceeffect.com to see more and hope to see you next time. /episode/index/show/thelifescienceeffect/id/33424952

S2E1: BPM's "Why" 09/25/2024

Season 2 Trailer (re)introducing BPM Associates 09/13/2024

035: Steve Vinson | Leaders Reinforce Culture 06/26/2019

034: Steve Vinson | What does it take to be a Biomedical Entrepreneur? 06/06/2019

033: Steve Vinson | From Academia to Pharma CEO (Graham Kelly) 05/24/2019

032: Theratome Bio | Regenerative Breakthroughs with Michael Coleman and Karen Momper 04/30/2019

032: Theratome Bio | Regenerative Breakthroughs with Michael Coleman and Karen Momper What if a cutting edge technology saved your life? And then what if you got to be part of a startup company that is working on similar technology to save others' lives? Karen Momper, of Theratome Bio is living that story. This week, Micheal Coleman, PhD, and Karen tell the story of Theratorm Bio and the exciting platform they are working on. Learn about how Theratome Bio is developing a portfolio of products derived from adult stem cell secretions. The future includes exciting potential therapies like stroke treatment and organ preservation during transport. Learn Michael's and Karen's inspiring stories. Resources in this episode: About Michael Coleman, PhD: Michael brings a wealth of research and new drug development experience to Theratome Bio. He directed multidisciplinary teams at GeneMedicine and Valentis in Houston, Texas, prior to accepting a role with Centelion (a subsidiary of Sanofi-Aventis) as Vice President of R&D. He there led a team of scientists in discovery, process & clinical development, and regulatory affairs. Most recently, Michael was President and CEO of InGeneron, a medical device firm committed to driving personal regenerative medicine therapies. During his tenure InGeneron attained several regulatory approvals in Europe and initiated clinical trials in the US under FDA approval. Michael has dedicated his career to developing new therapies, ushering these innovations through regulatory paths, and ultimately seeing new therapies transitioned into the clinic. He has also continued to publish research in peer-reviewed journals and maintain a close relationship with leading researchers and clinicians in academia. He earned his BS and MS degrees from Texas A&M, his PhD from Penn State, and completed post-doctoral work at the Baylor College of Medicine. Michael has a passion for the regenerative medicine space. He’s long thought that a cell-free option is where the future of regenerative therapy is headed, and believes that TheratomeTM technology provides the key attributes of product consistency and ease of handling and administration necessary to achieve widespread clinical application. In his own words, “TheratomeTM technology solves the key issues limiting clinical application of stem cell based therapies. I am excited for the opportunity to be part of developing this technology that will provide life changing benefits patients and disrupt the field of regenerative medicine.” Karen earned a B.A. in Chemistry with a minor in Marketing from the University of Dayton. She completed an Undergraduate Thesis while there, worked for the Office of Admission leading campus tours, and was hired as a new grad to work as a Traveling Student Recruiter. Karen began her career with the Bristol-Myers Squibb Company shortly thereafter. During her ten years of employment, she served Primary Care and Hospital Sales roles, sold in multiple outpatient and inpatient therapeutic areas, negotiated formulary contracts, earned district, region, and national recognition for sales, and was selected to serve in leadership roles within her district. Since then, Karen has taken on several non-profit initiatives whereby she has initiated a group, raised funding, and marketed and maintained a leadership role in organizations. She has also used her public speaking abilities to fund-raise. In one such effort, she contributed to the establishment of an in-house Therapeutic Massage Therapy Program to treat Oncology Patients at Oregon Health and Science University (OHSU) Hospital in Portland, Oregon, a cause that was previously only filled by intermittent volunteers. Karen is happily married, and proud mother to two sons. In addition to multiple volunteer roles at her Parish and children’s schools, Karen reads live broadcasts for IRIS Radio, a free service that provides audio news and literature for the visually impaired. Karen is also the survivor of a stem cell transplant (2009), and an autologous stem cell procedure to her hip to reduce the likelihood for need of replacement. These experiences fuel her unique passion for furthering regenerative medicine innovation. /episode/index/show/thelifescienceeffect/id/9592421

031: Podcast Swap | Angela Demaree Interviews Steve about Trends in Life Sciences 04/25/2019

030: Kyle Keeney | Part 2 A Bright Future for Your Community and for Your Family 04/11/2019

029: Kyle Keeney | Part 1 How to Get the Resources You Need for your Startup 04/05/2019

028: Bob Coy | 16 Tech 03/28/2019

028: Bob Coy | 16 Tech 16 Tech is the future of collaboration in downtown Indianapolis. It will bring together the talent, capital, and technology to make innovation happen. Robert Coy is President and CEO of 16 Tech Community Corporation Inc., the entity overseeing the development of the 16 Tech innovation community. As President, Coy leads the development of 16 Tech into a major hub for scientific research, technology innovation, entrepreneurial activity and talent development, retention and attraction.Prior to 16 Tech, Coy was President and CEO of CincyTech, a venture development organization that accelerated the growth of start-up bioscience, healthcare, technology and advanced manufacturing companies in Southwest Ohio. Under Coy’s leadership for more than 11 years, CincyTech invested in 70 startups that raised more than $680 million in seed, early and late stage capital and that today employ nearly 1,000 people.Coy has held entrepreneurial and economic development leadership positions with public and private institutions over the past 32 years in Ohio, Missouri, Delaware and Pennsylvania.Prior to joining CincyTech, Coy was senior vice president for entrepreneurial development and of economic development at the St. Louis Regional Chamber and Growth Association, where he co-founded the St. Louis Arch Angels, a group of individuals who invest in early-stage companies in the St. Louis region.In Delaware, Coy served as the principal economic adviser to the governor, established a seed fund to invest in technology start-up companies and developed initiatives to promote technology partnerships between universities and businesses. In Pennsylvania, he served as executive director of the Ben Franklin Partnership Program, the state’s premier technology development program that invests in start-up companies.Coy earned a master’s degree from University of Notre Dame and a bachelor of arts degree from Pennsylvania State University. /episode/index/show/thelifescienceeffect/id/9168590

027: Angela Demaree | 21st Century Compounding Pharmacy for your Pet 03/21/2019

026: Jason Bork | Alzheimer's - How Close is a Cure? 03/14/2019

025: Nathan Glass | Nondisruptive Innovation 03/08/2019

024: Arun Giridhar | 21st Century Pharmaceuticals 02/28/2019

023: Lynn Tyler | Abbreviated Pathway for 510(k) Medical Devices 02/21/2019

022: Kurtis Sluss | How Brightlamp is Disrupting Healthcare 02/14/2019

021: Jon Speer | How to Change the Medical Device Industry 02/07/2019

020: Steve Vinson | Leading Change in Medical Devices 01/31/2019

019: John Hanak | Purdue Ventures and Purdue Foundry 01/24/2019

018: Larry Mager | Quality Systems Management 01/17/2019

018: Larry Mager | Quality Systems Management What is going on in the medical device industry right now that is driving companies and the FDA to address quality systems differently? What is the Quality Systems Management (QSM) Strategic Plan? How will it help organizations? How will it help patients? Larry Mager is an experienced medical device quality executive with success in taking quality management systems to the next level at major global medical device companies. He now is leveraging his decades of leadership and making his system available for any organization that wants or needs to improve. Quality System(s) Management (QSM) = Measure | Manage | Improve 1. A Quality System(s) Management (QSM) plan is utilized to measure, manage, and improve the ‘quality’ of an organization’s Quality Management System (QMS) 2. QSM measures what matters in regard to product and process quality, and does so in a manner that is actionable for Management 3. QSM enables the strategic understanding of product & process ‘quality’, as is expected of Management by the stakeholders 4. QSM targets issues of constraint, enabling the responsible and targeted improvement of the organization’s constraints 5. Supports EU MDR and Case for Quality initiatives (see below) EU MDR defines significant responsibilities associated with the verification of product & process ‘quality’ through the PMS & QMS surveillance activities utilized within a medical device company. The accountability for doing so resides within the designated role of Person Responsible for Regulatory Compliance (PRRC). The capability to satisfy the obligations of that role must be ‘built’ into the Quality Management System (QMS). The Case for Quality is an FDA-driven initiative, coordinated in partnership with the Medical Device Innovation Consortium (MDIC) and in collaboration with the Medical Device Industry, focused on creating “sustained predictive practices that advance medical device quality and safety.” To connect with Larry: [email protected] /episode/index/show/thelifescienceeffect/id/8286470

017: Steve Vinson | 2019 Trends in Biopharma 01/10/2019

016: Rick Ditto & Matt Dressler | Google Meets J&J and the Future of Surgery 12/20/2018

015: Dan Robertson, PhD | Applied Data Sciences Center at IBRI 12/13/2018

015: Dan Robertson, PhD | Applied Data Sciences Center at IBRI From TRS80 to artificial intelligence and big data, Dan Robertson has lived through some of the most amazing transformations in technology and life sciences. And he is at the center of the biggest disruptions yet to come. What does Apple’s ResearchKit for iOS mean for healthcare innovation? How is IBRI leading the way in the next big disruption in healthcare? Can Life Science innovate like tech? Or maybe Amazon, Google, and Uber should pay close attention to what’s happening in the medical innovation space to avoid some potential land mines as they dive into healthcare. On a personal note, Dan relates his journey from university to research-based pharma to non-profit institute and how his passion is always the same: medical innovation to make a difference for patients. Thanks to IBRI and BPM Associates for sponsoring this week's episode: www.indianabiosciences.orgwww.bpm-associates.com Daniel Robertson, PhD Research Fellow, VP of Digital Technology, and Director of the Applied Data Sciences Center Daniel H. Robertson, a proven and experienced technical leader in information technology (IT), computational science and research, is focused on defining and developing the Institute’s computational analytics, digital, and data science capabilities. Dr. Robertson originally joined the IBRI in mid-2015 as part of a loaned executive program at Eli Lilly and Company, but in mid-2017 he accepted a permanent position at the IBRI due to the opportunity at the IBRI to drive innovative research among multiple life sciences companies, academic institutions, and technology companies to advance solutions to critical problems. His most recent role at Eli Lilly and Company was Senior Director of Research IT where he led the IT team supporting discovery systems and processes across six global research sites and nine functional/therapeutic areas. During leadership role in IT at Lilly, Dr. Robertson restructured Research IT to become a leaner, more efficient organization, reset the Research IT strategy supporting the discovery functions, delivered emerging new technology and analyses through informatics, enhanced support for HPC, cloud, and internal big data storage and analysis. He also transformed the IT support for Open Innovation Drug Discovery program to be the first high-performing DevOps team, which was recognized with an InformationWeek 500 award. Throughout his 10 years in leadership roles at Lilly, Dr. Robertson developed several individuals within his organization to advance to higher level roles in other organizations within Lilly. He joined Lilly as a research scientist in Lilly Research Laboratories and performed numerous independent contributor and scientific leadership roles before transitioning to the IT organization in 2010. Dr. Robertson earned his PhD in physical chemistry from Florida State University and his Bachelor of Science degree in chemistry, graduating Summa Cum Laude, from Florida Southern College. After earning his PhD., Dr. Robertson served as an NRC/NRL Postdoctoral Research Associate at the Naval Research Laboratory in Washington, D.C., and then held several positions at Indiana University-Purdue University Indianapolis (IUPUI) from 1993 through 2000. He last served as Associate Scientist and Director of Technical and Administrative Services and Manager of the Facility for Computational Molecular Science at IUPUI before joining Eli Lilly and Company in 2000. Dr. Robertson has published 67 papers in refereed journals, authored three invited book chapters, and conducted more than 65 professional/technical presentations. He has been honored with multiple awards from Eli Lilly and Company and IUPUI, and is a member of the American Chemical Society, American Physical Society and physics and mathematics honoraries. /episode/index/show/thelifescienceeffect/id/7902869

The Life Science Effect

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