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Daniel
Hey everyone. Welcome back to founder story. Today we have Dr. Mary Hames and Dr. Mary Hames. We were just chatting a little bit about what you're working on and even my experiences with people in my family. So I'm very curious. And technology advancing in the pharma space I think is probably one of the most exciting topics. So I can't wait to learn more about that. But you are the founder and CEO of Biologic Pharma Solutions, a medical affairs consultancy helping pharma and biotech companies launch products faster. So before we go into the most exciting thing is how is AI and technology helping? Before we talk about that, like, to understand why did you start this company and why this industry?
Dr. Mary Hames
Yeah. Thank you so much for having me, Daniel. I'm excited to be here. So why, why I got started with this. You know, I've been in pharma for a number of years and launched a lot of really neat products and, and had a, had a great time with that. I love that building phase. But, you know, as we were talking, there's a lot of volatility in pharma. It's hard for the pharma companies because they don't always know if the product's going to get approved. They don't know what's going to happen with it. And so it, there's, there's a lot of turnover. There's a lot of companies that have to let whole teams go. And then, you know, there's, it's, it's hard on the company and hard on the people. So what we're doing is we're offering a flexible, scalable team that can come in during these periods of volatility and support a company through that flux. So it's very, very adaptable, very scalable, very low risk. And then for the folks in the consultancy here at Biologic, we get to enjoy several projects in parallel, which gives us more diverse work to do. And we have a bit more stability because we're prepared for that turmoil. We're happy to be in that turmoil. And when we see it coming, it's, it's, it's easier because we always have additional projects lined up.
Daniel
I see that you specialize in things like rare diseases, neurology. Why did you choose these specialties and how are you seeing the impact from when you're working with a bio company in these specific industries?
Dr. Mary Hames
Yeah, so niche, niche factions of pharma are always a little harder. So we have a lot of experience in particularly rare neurology. So rare disease is a whole other beast because there's so few patients and there, there could be gaps in the diagnostic testing markets. So it's, it's harder. And personally, how I got into neurology is, is just, you know, my, my mother had epilepsy, my sister had epilepsy. And so from a young age, you know, that it's, it's scary. And so I was, I was always a little bit interested in neurology because of that. And then, you know, when I got into Parma, I was naturally drawn to it. And then you keep doing it and that becomes kind of your, your background. So we, we do have a lot in, in rare neuro and it's, it's just particularly compelling. We're working on a project with kids with neurodevelopmental disorders. And when you can, when you can help those kids and families, it's, it's really impactful. It feels really good. And so, you know, we've, we've done a lot of that, we've done a lot of radiopharma as well. And again, you know, it's just kind of niche. And so when you're, when you're in one of those areas, it's, it's helpful to have that unique expertise if you want to enter those markets.
Daniel
Yeah, it sounds exciting. I mean, talk about some incredible breakthroughs that could significantly, positively impact the entire world. I mean, who doesn't want to be an industry where you have this massive impact? I am very excited about how AI could possibly, from what I hear, speed up, come up. We had another guest who was talking about leveraging AI to come up with possibilities for solving some of These things. So how are you seeing or leveraging AI and other emerging technologies?
Dr. Mary Hames
Yeah, great question. It's so prevalent now. Everybody has access to AI and I think what sets us apart is how we're using it and how we're implementing it into workflows. So I'll give you a couple of examples. So large language models are really good at writing and interpreting language. And so we're using a couple of different things with large language models, but one of them is in drafting a lot of medical communications. So we do a lot of writing. And when we're, when we're doing that writing, we can feed parameters into an AI system. You know, such as what are the stages of a clinical child, what information can we give and what information do we not want to provide or we can't provide because it's not publicly available? And then we can have a large language model draft, say an abstract for a publication with data. We can have AI draft for us responses to medical information queries. So when patients or families are physicians inquire. We have a system where emails come in, they're anonymized, filtered through a system, and then draft responses are automatically populated into our drafts folder in Outlook. So then we just review the question, review the answers and send it out. So it saves us a tremendous amount of time. We're also using AI in our data summaries when we attend meetings. So, you know, one of the core competencies of medical affairs is collecting information as it's breaking. You know, there's a ton of information that's, that's new scientists are out there every day, thankfully, developing new therapies and new technologies. So we'll attend these meetings and then we'll use AI to summarize that content for us in addition to, you know, our, our knowledge. So, you know, we, we still attend the meetings, we still take notes, but when you can have a system draft that summary for you, it's, it just gives us such a leg up. We like to think that we're super powered by AI. So, you know, it's not like it's not yet replacing people on the team, but it, it really, it really enhances our speed and our efficiency and, and sometimes gives us better language than, than we might have had without it. So, you know, those are some of the great things about AI. There are some definite risks and challenges. You know, AI is notorious for making things up. So, you know, if you're, if you're trying to rely on AI to do, say, a literature search or answer questions, it's really important to continue to have competent people, actual people reviewing and auditing and making sure that the information given to you, feedback fed to you by the AI is, is accurate.
Daniel
I can imagine. Yeah. I mean, if I'm writing a story and AI hallucinates, it's not that big of a deal versus when it's doing something medical. I imagine it could be detrimental. How are you seeing these companies like pharma companies, are they open to, to when you come in leveraging and using technology alongside?
Dr. Mary Hames
Yeah, I think again, it is variable. I think everybody has their own level of comfort. I think people do understand that AI is now ubiquitous. You know, it's there, it's staying. So it's really more of how can we use this compliantly, what can we do with this that's going to be safe? That's within our comfort levels. So, you know, none of the companies that we're working with would be comfortable with, with AI sending out responses without anybody looking at them. You know, I wouldn't recommend it either. You know, I think that that's somewhere that we could envision trying to go. But we're, we're, we're pretty far from it. We've also seen, we've had some experiences with tools in, you know, in zoom, summarizing and, and we've, we've seen that go, go wrong a couple of, a couple of times. So, you know, if, if data is summarized and are transcribed and then emailed out and it's inaccurate, that can be a big problem for, for a pharma company because that's, you know, that's been in their database, the emails that have sent, you know, that this was the summary. So it's really, really critically important that, that all those things are, are accurate at the same time. Everybody wants that edge. You know, everybody wants to be as efficient and as on top of things as they can. So if, if there's a tool that they can use in a low risk way that's going to speed their, their progress, they, they want to know about it.
Daniel
Well, I'm very interested in this fractional model where it's fractional medical team. I know there's, you know, fractional CEO, fractional cmo. We've had different guests that, that fit in those, those buckets. I've never seen, seen or heard of the fractional medical team, but it makes total sense. So how do you create success around this? And are you one of the few doing it? Did you, you know, did you really create this sort of, you know, part of the industry.
Dr. Mary Hames
I think we did. We've, we're working on a patent, so we're patent pending on Fractional Medical. It looks like we're the only ones doing this. But basically what Fractional medical is, is, is, you know, you, you mentioned it, it is in other industries. But you know, what we've seen over and over is pharma companies will either a new pharma company launching their first product or you'll have a company that's, you know, that's got something new and different. They're in a, in a, in a difficult place. They'll bring in a VP of Medical affairs that, that's got, you know, 10 or 20 years of strategic experience, has led teams and launched tons of products and then they can't immediately hire a full team. And so that VP of Medical affairs ends up with their 20 years of strategy, you know, sending emails and booking flights and, you know, booking hotel reservations. And it's terribly inefficient. So one of the things that we'll do is offer when somebody's at that stage where they, where they have a medical need, but maybe they're not ready to build out a full team or like I said, they're in flux or maybe they're not sure their product's going to get approved. They can bring on a fractional team and then they can have say 2/10 of a VP that's really just doing strategy and then they'll have say, half an MSL that's out of the field and you know, two tenths of an operations person and an administrative person, things that they really need to be effective in their jobs. So then importantly, that can ship that over time. So let's say quarter one, you know, we need a whole lot of strategy. Then quarter two, we need Congress coverage.
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Dr. Mary Hames
You can scale up or down the different types of people that you need depending on that fluctuating need of the company. And we find that this is really useful for pharma companies that, that have, that their, their situation in 18 months is going to look very, very different than it does today. So it gives them that ability to be dynamic because you know when you hire just one person or you hire a specific skill set, they can't always quickly adapt and do a whole other job. You know, your person that's in the field summarizing congresses is likely not going to be your medical writer and it's certainly not going to be a marketing person or an operations person. But pharma companies need, need it all. So when we can give them a little bit of a lot of different people, it again really just increases their efficiency and productivity.
Daniel
Talk about working in a rapidly evolving, fast moving industry and coming in to help. I mean I could see there's a lot of complexities here that you, you've solved. So what advice would you give to other founders who just like you, they, they see a need in the environment of their industry, they see a problem that they have to solve. Maybe something fractional is, is the answer. But just in the general sense, how does one get started when they see these? Because I think we, you know, most founders are solving some sort of problem, but I think it's always challenging to get started.
Dr. Mary Hames
Yeah, I agree, it's, it's really scary. I think the best advice I have is to, is to act as if you cannot fail. Just jump and, and you know, look back at your successes. Think of all the things that you've done right and, and go for it. You know, it's, it's going to be scary. There's going to be ups and downs. But ultimately when you get that itch, when you get that, you know, when you see that need and you want to do it and you know that there's a market for, it's not just going to go away. You know, the only way to, to satisfy that, it just to jump in, you just have to go for it and, and you have to be ready. You know, maybe it won't work out. That's all right. You got to try. So I'd say just jump.
Daniel
Yeah. Act as if, I mean, if you never think you're going to fail, all the amazing things we could do if we're stuck always thinking about failure, we would never move and act on anything. So many things in this world would probably not exist if those people went out. That is amazing advice. Dr. Mary Hames, if people want to get in touch with you, they want to find out more information, they want to find out about your company. How can they do so?
Dr. Mary Hames
Yeah. So you can check us out online. BiologicPharmaSolutions.com we're on LinkedIn. We've got an office here in, in Grand Haven, Michigan. So we, we'd love to talk.
Daniel
Well, thank you so much for joining us today on Founder Story and all the inspiration that you've done to really carve, you know, something, carve a niche of your own, which is not common for founders, but always amazing and inspirational. I'm sure there's tons of people out there that are going to watch this and they're going to think the same thing, that they can do it, too. And that's what we're all about here at FounderStory is the impact that we can all have. So thank you again for joining us.
Dr. Mary Hames
Thanks so much, Daniel.
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Podcast Summary: Founder's Story
Episode: Leading with Heart and Hustle: Dr. Mary Hames on Turning Pharma Challenges into Triumphs | Ep. 194
Release Date: March 31, 2025
Host: IBH Media
In Episode 194 of Founder's Story, hosted by Daniel from IBH Media, listeners are introduced to Dr. Mary Hames, the Founder and CEO of Biologic Pharma Solutions. This episode delves into Dr. Hames' journey in the pharmaceutical industry, her innovative approach to medical affairs consultancy, and how she leverages artificial intelligence (AI) to navigate and overcome challenges in the pharma sector.
Daniel initiates the conversation by exploring Dr. Hames' motivations for starting her company and her choice of industry focus.
Dr. Mary Hames [01:51]:
"There's a lot of volatility in pharma. It's hard for the pharma companies because they don't always know if the product's going to get approved. They don't know what's going to happen with it... So what we're doing is we're offering a flexible, scalable team that can come in during these periods of volatility and support a company through that flux."
Dr. Hames emphasizes the unpredictable nature of the pharmaceutical industry, highlighting high turnover and the challenges companies face in maintaining stability. Biologic Pharma Solutions was founded to provide adaptable and scalable support to pharma and biotech companies, enabling them to navigate uncertainties without the overhead of maintaining a full in-house team.
The discussion shifts to Dr. Hames' specialization in rare diseases and neurology, areas that are inherently more challenging due to limited patient populations and diagnostic complexities.
Dr. Mary Hames [03:28]:
"Rare disease is a whole other beast because there's so few patients and there could be gaps in the diagnostic testing markets... When you can help those kids and families, it's really impactful."
Her personal connection to neurology, stemming from her family's experiences with epilepsy, fuels her passion and expertise in this field. Dr. Hames underscores the importance of specialized knowledge in addressing the unique challenges of rare diseases, enabling her team to make meaningful impacts on patients' lives.
A significant portion of the episode is dedicated to how Biologic Pharma Solutions integrates AI into their workflows to enhance efficiency and effectiveness.
Dr. Mary Hames [05:16]:
"Large language models are really good at writing and interpreting language. We're using AI to draft abstracts, respond to medical queries, and summarize data from meetings... It really enhances our speed and efficiency."
Key applications of AI in her company include:
Dr. Hames also addresses the challenges associated with AI, notably the risk of "hallucinations" or inaccuracies, emphasizing the necessity of human oversight to ensure the reliability of AI-generated content.
Dr. Mary Hames [08:28]:
"None of the companies we're working with would be comfortable with AI sending out responses without anybody looking at them. It's critically important that all those things are accurate."
Dr. Hames introduces an innovative concept she and her team are developing: the Fractional Medical Team. This model provides pharma companies with part-time, specialized medical professionals instead of a full-time staff, offering flexibility and cost-efficiency.
Dr. Mary Hames [10:34]:
"Fractional Medical is... where you have a medical need but maybe you're not ready to build out a full team... you can bring on a fractional team and have portions of various roles as needed."
This approach allows companies to scale their medical affairs capabilities dynamically, adjusting resources based on project demands and strategic priorities without the long-term commitments and costs associated with full-time hires.
Towards the end of the episode, Daniel seeks Dr. Hames' insights for entrepreneurs looking to carve out their niche in their respective industries.
Dr. Mary Hames [17:34]:
"Act as if you cannot fail. Just jump and look back at your successes... It's going to be scary, but when you get that itch and see that need, you just have to go for it."
Dr. Hames encourages founders to embrace courage and resilience, emphasizing the importance of taking decisive action despite uncertainties. Her advice underscores the value of passion and determination in overcoming challenges and achieving entrepreneurial success.
Daniel wraps up the conversation by commending Dr. Hames for her innovative contributions to the pharmaceutical industry and her inspirational entrepreneurial journey.
Daniel [19:27]:
"Thank you so much for joining us today on Founder Story and all the inspiration that you've done to really carve something of your own... It's amazing and inspirational."
Listeners are directed to Biologic Pharma Solutions’ website and LinkedIn page for more information, highlighting the company's commitment to supporting pharma and biotech companies through adaptive and technology-driven solutions.
Dr. Mary Hames [05:16]:
"We like to think that we're super powered by AI... it really enhances our speed and our efficiency."
Dr. Mary Hames [10:34]:
"Fractional Medical gives pharma companies that ability to be dynamic because when you hire just one person or a specific skill set, they can't always quickly adapt and do a whole other job."
Dr. Mary Hames [17:34]:
"Act as if you cannot fail. Just jump and go for it."
Founder's Story continues to bring forward inspiring narratives from visionary leaders, showcasing the heart and hustle that drive entrepreneurial success across various industries.