Drug Launch Success In A Changing Commercial Landscape With ACMA's William Soliman, Ph.D.

On this week's episode of the Business of Biotech, William Soliman, Founder and CEO of the Accreditation Council for Medical Affairs (ACMA), and Founder and CIO of White Manna Capital Partners, talks about why biotech drug launches so often miss expectations, and how to build an integrated commercialization plan that holds up with physicians, patients, and payers. William also describes the evolution in medical affairs, why standards and certification matter, and how AI and new media channels are reshaping how drug information reaches patients and prescribers. 

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Transcript

Welcome And Guest Background

Ben Comer 0:03

Welcome back to the business of biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Dr. William Soliman, founder and CEO of the Accreditation Council for Medical Affairs of the ACMA, and founder and CIO of White Mana Capital Partners, a life sciences-focused hedge fund. William received his PhD in pharmacology from Columbia University and has over 20 years of experience in leadership roles at companies including Merck, AbbVie, and Gilead Sciences. His experiences in commercialization and medical affairs led to the creation of the ACMA in 2015 and the establishment of the Board Certified Medical Affairs Specialist Program in 2016. And I'm thrilled to have William on the show to talk about biotech drug launches, why they so often fail to meet expectations, how the commercial landscape is changing, and what companies can do to improve their chances of launch success. William, thank you so much for being here. I think it's a really important topic.

William Soliman, Ph.D. 1:12

It is. My pleasure. Thanks for having me.

Liquor Store Lessons On People

Ben Comer 1:15

I thought we could start off with a little bit of background, uh, William, as I like to do uh on the business of biotech. And I was glancing at your LinkedIn profile uh when we decided to uh to do the show, and I noticed that you had uh Willie's liquor store listed uh at the very, very bottom of your uh list of experiences, which I thought was unique for a professional LinkedIn profile. And I I wonder if you could maybe uh explain the thinking on that.

William Soliman, Ph.D. 1:46

Well, you know, a lot of people in their LinkedIn profile, they try to keep it always um, they try to keep a certain image, you know what I mean? And I feel like it's important to be transparent and real. We have these jobs that we, you know, we do when we're young in school, and and uh a lot of times those jobs actually shape who we are as we become adults. And so one of the most valuable businesses actually I worked for uh was my dad's liquor store. My dad had a liquor store in Jersey City. Uh still there if you go there, for those of you interested on Central Avenue. He sold it now years ago, but it uh it's still there. And um it was valuable uh to work there. I learned a lot of lessons because you deal with every personality type. And uh looking back, it was probably like my first real forte in terms of dealing with just different personalities, sales, psychology, a trust, honesty, how to work and deal with employees and building a team and things like that. Then I learned that drinking can be dangerous. I remember a particular customer when I was 15, his name was Nick. He came in at the time, he his face was yellow. I I didn't know that, you know, because I was a kid, I didn't know that that was Jaundice at the time. And um, I remember he purchased uh Bacardi 151 and uh he actually one of the highest proof uh in the store, probably, right?

Ben Comer 3:10

151.

William Soliman, Ph.D. 3:11

Exactly, yeah, you know, yeah. And I didn't know. And um he he drank, I guess he was he was an alcoholic, and uh and he passed away. It was a terrible situation, and uh it was a real eye-opener for me just about the dangers of alcohol, you know, the the importance of just having a support system and and and reaching out. And but it always stuck with me because and I remember his face till now, it was one of those situations where you you just you know, you guys used to come in, he was a really nice guy, but he obviously had a problem with drinking. And it taught me a lot about, like I said, about the dangers of drinking. So if you ever go out with me, you'll find that I I rarely drink. Um, people think because my dad had a bunch of liquor stores that I that I that I drank a lot or I I'm into drinking, but I actually don't drink at all. Very rarely that I drink, because I've seen some of the negative ramifications of it.

Ben Comer 4:06

Yeah, yeah. I mean, I could actually absolutely see how those experiences would make uh a big impression, especially at an early age. And and you talked about two getting a first kind of taste or or flavor for the sales profession. Was that something that you recognized at the time that, you know, is like this is something that I I like, I like dealing with people, you know, I like that kind of relationship. I mean, did that carry you all the way into you know, getting into your first jobs in sales and medical affairs, or was it not quite a uh as direct a line as that?

William Soliman, Ph.D. 4:42

You know, it's funny. In high school, if I tell you what I did very well in school, I was, you know, an honor roll, top five, all that. But if you ask me, what were you uh like you know, at the end when you leave high school, they like that's like the the person most likely to do this or the postponement person. You know what I was when I was rated? No what? The most quiet.

Ben Comer 5:05

Really?

William Soliman, Ph.D. 5:07

Isn't that funny?

Ben Comer 5:08

The most quiet. Interesting. That well, that gives you a lot of uh a lot of avenues to go down then, I guess.

William Soliman, Ph.D. 5:14

I was a very shy kid. I was very quiet. Um, and no one would have thought that I would work in sales or that I would, you know, run a company or do any of the stuff that I did. Um, and you know why I'm saying that story actually, because I hear a lot of times kids, I have my own kids, I have five kids, but I see other kids sometimes say this about themselves, or I hear parents say this, like where you box someone in. You know, oh this kid that you know they're gonna be they're definitely gonna be an entrepreneur. This kid is gonna be this type of person. And I I everybody listen out there, don't do that. Just don't do that. Because it when you box a kid in like that, it limits what they think they can do. And luckily, my parents, thank God, never did that. Uh, my parents never made any comments like that. So I never saw that as a limitation. And really what got me into sales, to be honest, was because at the time, when I got into pharmaceutical sales, I was working as a teacher. I don't I don't know if that's on my resume. I can't remember on my LinkedIn, I can't remember, but I was a teacher at Hackensack High School. And Hackensack's kind of like an inner city school. I taught chemistry and physics there. And you know, I I didn't know anything about the pharma industry. I don't know what's going on. I mean, I started as a teacher at 21. I graduated young from college, and I met a girl, and the girl, uh, I'm not gonna say her name, I think she still works in the pharmaceutical industry, but we were, you know, I was like 21, 22, she was like 22. She had just started working at a pharma company, and we went out on a date, and she's the one that told me, you know, you would be great in pharmaceutical sales. That's how I learned about it, Ben.

Ben Comer 7:00

Wow, okay.

William Soliman, Ph.D. 7:01

Because back then, you know, you're talking back in the late 90s, there was really the internet was just coming out. AOL, you know, was everybody's using AOL still, and you know, and and there was really no way to get information like there is today quickly. So I learned from her, and um, and then I got she got me an interview with the pharma company she worked at, and I didn't get the job at her company, actually. I ended up getting a job at another company, and that was my first forte into the pharmaceutical industry, and that was it. The rest is history.

Why Medical Affairs Needs Standards

Ben Comer 7:37

So, what uh what would you credit for uh I guess raising this idea of the uh accreditation council for medical affairs? You were I and I don't want to skip uh your your experience, but is there anything that happened uh or or that you just witnessed as working in medical affairs, working as a sales rep, you know, coming up to 2025 or probably a couple years before that when it first occurred to you to start this organization? You know, what was it that made you want to do that? And and what did you see or or still see as the kind of primary objective of the ACMA?

William Soliman, Ph.D. 8:15

Well, I'll start with the primary objective. The primary objective of the ACMA is to raise the bar and the standards of pharma industry professionals that are going out talking to doctors. Period. So we know, we all know, even if you don't work in the pharma industry, everybody knows that friendly pharmaceutical sales rep that goes to the doctor's office, brings lunch, talks about the drug, blah, blah, blah, blah. But what they don't know is that prior to our organization, the ACMA, being in existence, those reps, they had no standard certification or accreditation that they had to go through to do their job. That was non-existent. And you might say, well, why do you need that? The reason why you need that is because if you think about how critical the role of a pharma rep is or a medical liaison, those are people that are also hired by pharma companies that are going out, but they educate doctors, they don't have a sales goal. And also people like field reimbursement specialists we also accredited and served by those are the people that help the doctor's offices help the patients get access to the medication, like overcoming the insurance denials. Well, all those people are helping to either inform clinical practice, they're helping to provide education, they're impacting prescription behavior, or they're impacting how the company the doctor works for the insurance company. How is it that we don't have a standard for these people? How is it that we don't have a some type of uniform framework that says Will Solomon is qualified to do this job? Heck, even a barber. I have nothing against barbers, but barbers have a license. And she was explaining to me that to be a barber, you have to have a license because of all the hygiene. And the you can give people an infection, people can get sick. So you have to know how to use the instruments correctly. Um, same thing here. The the people who are medical liaisons, for example, or medical affairs professionals, they're impacting research across the country. Remember, over 65% of research in America is actually funded by the pharmaceutical industry. So, and who are the people that are driving that? A lot of times they're medical affairs professionals. People that are out there that are physicians, pharmacists, PhDs, that but they work in the pharma industry. We're the ones that certify and accredit those people. So you need that. And the people listing that say, Oh, you don't need that because you know I'm a I already been doing this for 10 years, or I'm a PhD, like I'm a PhD. Yeah, I've been doing that for a few years. That is BS. And why is it BS? The reason why it's BS is because I went to uh I got my PhD from Columbia University. I never learned how to work in the pharma industry. When I went to be a farmer up, I had a bachelor's in biochemistry. That's my background. I don't know anything about it. Yes, the company gives you internal training, but having a level set, standardized capability framework as a company is very, very, very important because you want to make sure that everybody meets the minimum benchmark of competency and it protects the patient and it makes sure the company is more compliant. Now, what led me to that whole idea was that when I started to work in the pharma industry, I saw, and I worked a lot of different companies. I saw that the standards were all over the place. Every company did something in a different way. One company expected this, another company expected that. I saw that even the people that were supposed to be running clinical trials, they didn't always have a good working knowledge of different things. For example, I worked at a company where they didn't know how to design a clinical trial, they didn't know how to do it. I worked at another company where people weren't very strong about statistics, they just didn't have that understanding of know-how. I worked at another company where they're putting out information that was biased. They didn't know how to explain the information and help people interpret the evidence objectively. And I give you a lot of stories, but the bottom line is just because you're in the position doesn't mean you're qualified to be in the position. So what we're doing is we're making sure you're qualified. And I think for every person listening out there who's a patient, you should demand that. You should make sure that people have that because they're impacting your health, they're impacting your doctor's prescribing behavior and how they think about the medication. And doctors mostly get their information and education from pharmaceutical professionals. That's just the way it is. So this is why we exist.

Ben Comer 12:58

Yeah, it's a really important point. And you know, you mentioned how impactful it is to clinical practice, to driving prescriptions. And you're talking about individuals educating physicians on potentially a brand new substance, you know, that that has never been seen in clinical practice. It's gone through clinical trials, but uh the physician has hasn't used it, may not know uh the details about how a specific mechanism uh is gonna work. And you're having to explain, you know, what's the risk, what's the benefit, and then not to mention some of the compliance issues around off-label promotion, just to name one. And so uh you the the ACMA is looking at all of those factors and providing a certification to is it sales reps and medical science liaisons, anyone who's out in the field, or is it for specific individuals? Yeah.

William Soliman, Ph.D. 13:50

Yeah, so it's medical affairs professionals, medical liaisons, the sales reps, the field reimbursement professionals. We have we have other certifications too for people that want to build a career in the industry, like for nurses. What we found after COVID was a lot of nurses were moving from traditional settings into the industry. So we have a program for them as well, for regulatory affairs professionals. And and the difference with ACMA is we all we ourselves are accredited. We're accredited through the International Accreditors for Continuing Education and Training under the American National Standards Institute. So very credible, very reputable organization. We also have accreditation through the Accreditation Council for Continuing Medical Education and the Accreditation Council for Pharmacy Education. So some of our programs, you can actually get CE credits if you're a U.S. licensed physician or a pharmacist. So I think that speaks a lot to credibility. And we're the only ones in the industry that do this. Um, so I think, you know, for people listening out there, it's important to know that the pharmaceutical industry, especially today, like you said, especially with all the more complex drugs and mechanisms of action, you need to have people that really understand this stuff when they're explaining it, they're providing accurate, reliable information, and that they're quite again, they're qualified to do it.

Ben Comer 15:08

Has the industry largely embraced this certification? Uh, do you have a sense of like, you know, uh maybe just thinking about big pharma, like what percentage of those companies are are are, you know, having their field forces certified?

William Soliman, Ph.D. 15:24

So we over the last decade have worked with over 1,000 pharmaceutical and biotech companies. So we work with many, many, many uh companies. So, yes, by and large, most people now are moving in that direction. Because most people too, they you know, in the pharmaceutical industry, they don't want to work anymore with these fragmented vendors. They really want to move towards having more of a relationship with a strategic partner like the ACMA, who's been there, done that, lives, breathes, eats medical affairs, reimbursement, prior auth, that type of thing. So, yes, at a matter of fact, one of our certifications, the PAC certification, which is the prior authorization certified specialist certification for people that are processing these prior authors when you go to the doctor's office to overcome insurance denials. That's the de facto standard. And not only do people in pharma do it, but people even in the hospital systems. Just this morning, I was having a meeting with a company about this. All the people in the healthcare systems, they actually have their medical coding, billing, prior off people go through our program.

Investing With An Operator’s Lens

Ben Comer 16:26

Excellent. I want to get to our main topic uh of biotech drug launches. Uh, but before I do, I I want to ask just quickly about white mana capital partners. You I think were a founder or co-founder of this group uh in 2025. It's a hedge fund focused on on life sciences companies. Is that correct? Can you give me a sense of um you know what what the the motive was behind you know forming that group and and maybe what your kind of investment model and focus area is?

William Soliman, Ph.D. 16:58

Sure. So White Man of Capital Partners, I'm the sole founder. It's a long, short, healthcare-focused hedge fund with a particular interest in metabolic diseases, obesity, women's health, et cetera. As you know, in the area of obesity, we're just starting. I was on television talking about this two weeks ago with the uh Rita True Tide data from Eli Lilly. That's just the beginning. I foresee over the next decade there's going to be a significant evolution in the treatment of obesity. So, this is an area I'm particularly interested in. Also, this is a quick uh trivia. I was one of the first medical directors for obesity in the pharma industry back, you know, over 12, 13 years ago for a little known drug called Belvik, Larcasserin is the drug name, taken off the market. It wasn't taken off the market when I was there, just so you know, it was taken off the market after I left. Um, but I actually headed up the medical team there, uh, you know, as medical director for that product. So obesity is very near and dear to my heart. I think it's the cause of a lot of diseases, not just cardiovascular, kidney, so forth, but even brain diseases and issues like Alzheimer's, dementia, you know, the neurodegenerative disorders that come about due to obesity are tremendous. And I think they're still, you know, very um misunderstood or not understood as much as we need to. So the idea behind White Man at Capital is this. Okay, most people who are, you know, working in these healthcare hedge funds who are who founded these healthcare hedge funds, they focus mainly on the finance, the money. They they're looking at the pharmabotic industry from the outside. Don't get me wrong, we're focused on you know bringing good uh ROI back to investors. But the whole idea here is that we're incorporating deeper operational and scientific understanding at a broader level. We're looking at things like not just clinical differentiation, safety and efficacy, but things like regulatory dynamics, payer pressure, uh, launch readiness, a lot of the commercialization strategies. Remember, um, because of my position as founder of the ACMA, I have a unique perspective, in addition to the fact that I worked in pharma for almost two decades. So I come at this very differently. I give you an example: Pralluin, which is a drug with a PCSK9 inhibitor by Sanafri Regeneron, people overrated that drug in terms of its uh success in the market. They said it's gonna be very successful commercially, but didn't get the success it was supposed to get. And if you look, what was the reason?

Ben Comer 19:27

Because it was a daily, was it a daily medication? Or what was the reason?

William Soliman, Ph.D. 19:31

The the reason really was if you look at the data, Ben, it was payers didn't want to cover it.

Ben Comer 19:35

Yeah, right. It was very expensive, yeah.

William Soliman, Ph.D. 19:37

Yeah, yeah, and I'm sure that the adherence with the daily injection is not great, but the issue was if you're a payer and you're not gonna cover the drug, it doesn't matter how good it is, the people can't get it. If you can't get it at the pharmacy counter, what are you gonna do? And that's very important to know that prior authorization is the number one reason for care delay in the United States. The number one reason. And doctors hate it. It's a big mess. This is why they come to us, because at the end of the day, our program, the PACS program, actually reduces denials by over 50%. We even cut down the time in dealing with insurance companies by about two days on average. If you're a doctor's office and and Will works for you in the doctor's office, and now I have two days back on average, that's a big deal. If I can cut down your denials by over 50%, that's a big deal. I can save you a tremendous amount of money and time. You could use my resources elsewhere. So, you know, white man of capital is very distinct in that way. And I think in the end of the day, that's really critical too. This whole issue of commercialization is related to the ability to be successful in the payer landscape.

The Future Of Obesity Treatment

Ben Comer 20:45

Well, let's talk about that. But one, I have to ask one last question. Given your focus on metabolic disorder, your experience and obesity, do you think that we are going to rid ourselves of obesity in our lifetime? Or are there going to be no more obese people, you know, by the time that uh we're coming up on uh our respective ends?

William Soliman, Ph.D. 21:07

I I I think you'll never get rid of it completely, but I do think it'll go down significantly.

Ben Comer 21:14

Yeah.

William Soliman, Ph.D. 21:14

And I think there's a probably nowadays what a lot of companies are focused on is instead of just a number on the scale, they want to look at how can I improve organ systems? How can I improve you know the metabolic elements that are underlying all this that are caused by obesity? I think that's gonna be probably a bigger problem.

Ben Comer 21:35

Because here's the thing not just BMI, right? Yeah.

William Soliman, Ph.D. 21:37

Not just BMI, because you you and I both know for a lot of the the drugs that are out there, the Wagobi, the Ozempic, et cetera, Zeppam, right? These drugs, they cause you know pretty good weight loss. But the problem is one, weight maintenance. That's always been a problem with weight loss drugs. But the second problem is you lose a lot of lean muscle mass. And we know people that have been on these drugs, they they look different. They look different. Physically. And part of the problem is because they're losing a lot of lean muscle mass. So some of the newer generation drugs are trying to cause the weight loss, but also preserve lean muscle mass loss.

Ben Comer 22:11

Excellent.

When Commercialization Should Begin

Ben Comer 22:13

Let's talk about drug launches. It's a it's a huge topic of interest in the industry right now. And partially or or maybe the main reason is because it's uh it's so uncertain. It's such a risky endeavor to launch a new drug into the commercial marketplace right now. It's hard to predict how well it's going to do. Um maybe we should, you know, just start at the beginning, which is you know, when and where should commercializate commercialization begin as a function of the biotech operating model? At what stage? And we can use a specific example if you like, or we could just talk about you know, a generic biotech organization that has, you know, a single maybe it's not the single, they have one lead candidate that is, let's say it's in phase two, you know, it's like when where do you start? Where do you start with commercialization? What are the first steps you take?

William Soliman, Ph.D. 23:08

I think the first of all, in terms of timeline, you asked a good question. I would say if you're if you have a good sense of when you want to launch, go back at least 18 months. So go back 18 months, and then from there, that's where there should be the efforts to begin planning for commercialization. Really understand in the patient journey with that particular disease, one who diagnoses the disease, what barriers exist for those patients or for those health care providers and moving the patient along that journey. I think that's really, really, really important because you know there could be several health care providers, ancillary healthcare providers involved in coordinating care for that patient. I think the other one, too, is what barriers exist to treatment today? Um, and that could be a whole you know host of different things. And what if patients care about? In other words, you know, when you're when you're looking to uh that's probably even earlier, when you're looking to design your phase two, phase three studies, what are the outcomes patients actually care about that impact their daily quality of life? So you know the qualities, these quality quality of life indicators or outcomes. Because at the end of the day, that clinical development and commercial partner need to be working hand in hand so that the story makes sense, that it resonates with the healthcare providers and it resonates with patients. It's something they care about. I remember you know, I worked on a drug where it was a drug for angina, and what they focused on was how much longer could you walk? It was a treadmill test. So we we you know, I take the drug, you don't take the drug. Would I was able to walk longer without getting chest pain? That was the test. And I forgot now what it was called, it was a type of treadmill test. But what did that mean? Well, that meant if I could walk six minutes longer, that meant more time playing with my grandchild. That meant you know, I was able to go to the kitchen, get a snack, and come back, and I wasn't, you know, having chest pain or shortness of breath or dyspnea. That meant I can go up the stairs, right? So those six minutes mean a lot, right? If you think about it practically, what does that actually mean that to be able to have six minutes extra to walk without getting chest pain? Um, what do the payers care about? Right? Um that's a big one because you know, going back to like probably when there were step edits and things like that. What are the payers going to think? Is this a first-in-class, best in class drug? Is this a drug that's, you know, third drug in the same class, and the and the impact is not that much more? Um, what does that actually mean? One of the reasons why we got a lot of attention uh on the uh Retitrutide drug from Eli Lilly was that it was 30% improvement uh in in terms of weight loss in those people with the highest BMI, that's significantly higher than the current drugs in the market. Uh, side effect profile was the same. So now the question is okay, if if you have a patient and they don't need to have 30% weight loss, maybe they have to have less, and Red or TrueTat costs more than, let's say, Munjaro or Zetbound, what do you do? Right? If you're so you have to think to yourself as a as a a commercial from a commercialization and payer strategy perspective, how do you want to position that? Are you positioning it as second line? Are you gonna position it as first line de facto? You know, but if you're positioning that first line, and you know, this is more, you know, you see that type of weight loss in people that are much higher on the BMI scale, then what do you do? You know, what percentage of the market is that? Although I'll tell you, when it goes back to obesity, only I think like maybe 3% of the addressable population is actually using pharmacotherapy, which is crazy.

Ben Comer 26:51

Yeah, right.

William Soliman, Ph.D. 26:52

That's not it's not a lot. So it looks like everybody's using the weight loss drugs, but they're actually not.

Ben Comer 26:57

Although now with the you know, with Medicare coverage coming in on the oral dosage, uh, I I assume that's gonna raise that percentage up a fair amount. But um, yeah, we'll see. Yeah.

William Soliman, Ph.D. 27:10

Yeah. Hopefully, yeah, hopefully we'll see. So that would be my advice to to biotechs. And you know that the ACMA, we work actually with pharmaceutical companies as a capability infrastructure partner. We help them in terms of figuring these things out when they're looking to launch, looking to build out capabilities for a launch. We work with medical affairs, we work with commercial on the payer side, we work with their field reimbursement teams or help them build out field reimbursement teams. And this is a lot of things that we talk about, like what makes the most sense in terms of how you want to position.

Modality Differences And Rare Disease Realities

Ben Comer 27:39

Yeah, so the it sounds like step one is get to know your customer as well as possible. That's not just the patient, that's also the payer. Uh, and understand not just, you know, the decision-making process, um, but also what's most important and you know, what's different, I guess, about your drug. So that's the first part is really understanding the nuances and the the small pieces, you know, that will make up a successful launch. Um, and that's through knowing, you know, what patients need, what payers, what questions payers are going to ask, uh, et cetera. Does it matter what drug modality it is, William, like it or therapeutic area or patient population size, if it's rare versus a uh, you know, a broader kind of primary care type audience? Um, what's what's your advice there? Uh still kind of thinking about starting up the commercial process. Uh is it kind of the same? You need to do that no matter what your product is, or are there different approaches for different types of products?

William Soliman, Ph.D. 28:44

There's different approaches for different types of products because I worked in rare disease actually, and with rare disease, you're much you're working with a much tighter KOL community, key opinion leader community. You're working more tightly with the patient advocacy groups. Sometimes it could be one patient advocate group. Um and so you need to incorporate them in the planning and the conversation to a greater degree. From the payer side, it is uh dependent on what's available. If there's nothing out there and these patients are suffering, especially if there's a high mortality rate with the particular rare disease, generally the payers aren't gonna push back too hard. But if there's a few therapies out and your therapy helps one component, and maybe it's not impacting mortality, it might be tough, especially if the if the gain isn't much. So it goes back to the gain. And I will say this, and I don't think many people say this publicly, but I will tell you this because I've been in conversations with payers when I worked in pharma over the years. Demand. Demand. What do I mean by that? If the payer sees that there is a demand for the product, that the public has a demand for it, they'll put it on the formula. So that you know, I mean, and when I say put it on, meaning put it on a higher tune on the formulary, because payers don't want people upset, they're their customers, the patients. So if they feel like, or if they if they see that there's greater demand, that actually gives the pharma company a greater leverage, which is why a lot of times the pharma companies, when they're marketing and pushing these things out, if they can get more of a demand and people more interested, they use that as like fodder to say, look, there's a big demand for this, people need this. Um the last thing is it related to HUR. We really haven't talked about that, but health economic outcomes research or pharmacal economics, that's a big component as well, in that a drug may cost a lot now, Ben. And I dealt with this at Gilead Sciences. So they had a they had a drug, hepatitis C drug, and the drug was you know like eighty thousand dollars a year or something.

Ben Comer 30:59

Yeah, Savaldi, yeah.

William Soliman, Ph.D. 31:00

Yeah, Savaldi. And I think they even went before Congress, and it was a big thing back back in the day. But the idea was well, look, if you use the drug and you're able to reduce the progression of hepatitis C, well, that means not now, but maybe in 10 years, you reduce hepaticellular carcinoma, liver cancer, and liver transplant, right? Uh surgeries. So you you're you're you're spending a lot now, but you're gonna save a lot to the healthcare system in terms of a burden on the system in 10, 20 years. And so those things have to be taken into account. So all of that comes into play here when you're working in the pharma industry and like thinking through how you can position or tell that story.

Ben Comer 31:44

So

Regulatory And Commercial Must Sync

Ben Comer 31:45

18 months out from an approval date, you you want to you know really get in earnest in terms of planning for all of this, thinking through the various issues. Uh, I wanted to ask about regulatory uh and commercial teams. And if you're a small biotech, you know, it's there's probably not going to be an entire regulatory team and a retire, entire commercial team, at least you know, not until after there's revenue coming in. It could be a single individual. Uh, and obviously in larger companies you'll you'll have bigger teams. But are there ways that the regulatory team and commercial teams should work together during that critical period of drug submission and pidufidate and you know, possible approval? Or is there anything, you know, there there?

William Soliman, Ph.D. 32:34

Yeah, it's a great question. So when I think of regulatory, I I think of pre- and post-approval regulatory. Pre-approval regulatory is where really the regulatory affairs department is getting everything ready to make sure that they can get a successful FDA approval. Um, remember, you can have an FDA approval and still fail commercially, right?

Ben Comer 32:54

We know right.

William Soliman, Ph.D. 32:55

I think what's this the data is like 40% of the drugs that actually are launched make it successfully. So I do think that what the best teams do is they integrate regulatory, medical affairs, you know, market access, uh commercial teams, they do that all early, right? A lot of times these are these these groups are siloed. But I think today, launch success really requires this cross-functional orchestration, so to speak. So, and then after the approval, you have MLR teams, which is the medical legal regulatory teams. And these teams work, and I used to be actually part of those teams in medical, these teams work very closely together to make sure that all the information that's going out, whether it's promotional or non-promotional, is aligned to the label, is not doing anything that's going and contradicting the label. So regulatory affairs plays definitely an important role. I think, again, better integration with commercial and commercial planning is key early on to help, you know, with drug launch readiness.

Ben Comer 33:54

You mentioned

Three Common Launch Mistakes

Ben Comer 33:55

a statistic, I believe it's from Deloitte. Uh, more than half of drugs fail to meet expectations at launch. Um, what do you what do you think some of those mistakes are that companies make? Because I know that you know, if I ask the CEO of a biotech company, you know, while they're going into phase three, you know, have you considered the patient and like what the patient needs, they're gonna say, oh yeah, absolutely. You know, we've talked to these patient advocacy groups, we understand, you know, exactly what the patient needs, you know, we're bringing this drug, or you know, maybe even we're modifying our development plan to capture some of these factors that that patients really care about, only to come out, you know, uh six months after launch or a year after launch, and you didn't do nearly as well as you thought you did. And and maybe that's for a variety, I'm sure it is probably for a variety of different reasons and different companies and different circumstances. But are there any kind of common mistakes that you've seen or things that you could warn, you know, the business of biotech's audience off of, you know, who are maybe in that stage of getting close to late stage trials?

William Soliman, Ph.D. 35:04

There's three things I would say. The first is they don't engage medical affairs early enough. And and the problem there, and I'll say this again and again and again and again you need to kind of till the seed, if you will, in the medical community. Meaning you got to go out there and start talking to the K Well community about your particular mechanism, not the drug, right? We can't do that prior to the to the launch, but trying to get into the disease state and how you you want them to see it, right? So if you're an SGLT2 company, you know how you want them to see the role of SGLT2 and diabetes, right? Or if you're a GLP1 company, the role of GLP1 and diabetes at the time, right before it was for just obesity or for just diabetes. So you need to begin to engage the physician community and educate them so that they're comfortable with the whatever it is that the concept that you're trying to um to put out there. So I think that's not true.

Ben Comer 36:11

And I and before you go on, I just want to say that that you know that strikes me as a really distinct skill. Like you said earlier, you know, you may have a PhD. It doesn't mean that you're a good educator. Yes. Uh being, you know, being able to go in and explain to a physician a specific uh mechanism in the body and you know, why this particular uh drug, not a drug yet in this space, but why, you know, this particular channel, this particular mechanism is going to improve disease like that. That's not just a simple thing that that anybody with the knowledge can do.

William Soliman, Ph.D. 36:45

A hundred percent. You spot on. You know, I couldn't have said it better myself.

Ben Comer 36:49

Absolutely. I know that because my wife is a science teacher.

William Soliman, Ph.D. 36:52

Oh, really?

Ben Comer 36:53

Well, great high school, yeah.

William Soliman, Ph.D. 36:55

Oh, very nice. Very nice. Yeah, I I miss those days sometimes, I gotta tell you. Sometimes I miss it. The second thing is the payer strategy, the reimbursement strategy, pricing strategy is off. So not taking into account how you're gonna price the drug, how you're gonna make sure it gets reimbursed, putting it in a preferred formulary status. That's also, I think, very, very important. So that's number two. And the third one is a lot of times they fail to generate uh real-world evidence, making sure that there is data out there to support the drug early on, um, and a good pharmacal vigilance program, too, in case they catch any safety signals early on. But to me, that's the biggest thing, right? Medical pair data, having that, and I would say a good data, you know, uh publication strategy, you know, because you, you know, like anything else, the drug is a product, and you want to get a lot of buzz out about the drug, a lot of information out there, a lot of excitement out there. So you got to have a good publication plan, an awareness plan, you know, or which conferences you're gonna go to, which journals you're gonna publish in, what kind of review articles you're gonna put out, you know, all that type of stuff. Um, so to me, those three things are critical.

Building Real-World Evidence Early

Ben Comer 38:15

On the last one on data collection, pharmacovigilance programs, uh, I'm thinking of a company that, you know, uh uh early mid-stage biotech, uh exclusively focused on developing this great product that they have that's super promising. You know, they're they're spending every waking moment, you know, trying to progress this asset into late-stage clinical trials. Maybe they're not thinking yet about uh capturing that real world data on the other end after approval, fully just sort of gunning for approval at this point. Um, are there are there kind of like uh easy ways to set like once you get to that point where you think, yes, I think this drug is going to be approved, we need a pharmacovigilance program. We need to be able to capture real world data to show that this drug is impacting patients in a positive way in the commercial space. Um, how do companies, I guess, think about that or set that up?

William Soliman, Ph.D. 39:14

It's a really good question. That goes back to what I said in the beginning about the launch with your medical affairs teams, because the medical affairs teams, they're engaging KOL's where at these sites, which are most of the time they're clinical trial sites in these academic centers. So having that relationship early on so that you can have things set up in place to collect that data is critical. So that's to me, that's that would be part of the goal is you're building the relationship there with all these different academic centers of excellence around the country so that you can have a robust real-world evidence program, right? You can collect that data. Um, even even for rare disease, for example. I remember in one disease I worked on, rare disease, collecting natural history data, you know, being able to go to physicians and they had their notes and this and that, and you compile all that information and you try to get like a natural history uh study or data that's compiled, and maybe you use data historical controls for future studies, or for current data, and you like you have like historical control matched, you know, uh patients. So that relationship building early on and that awareness early on with clinical trial sites, which is where a lot of the KOLs are, I think that's really that's it. That's the key because that's how you're gonna collect that data, finding where these patients go.

Medical Affairs Expands And Meets AI

Ben Comer 40:36

Um because of your expertise in medical affairs uh and you know your your long work and and the certification process, I want to ask you just how that role is changing. The medical affairs, medical science liaison role uh is changing. We've heard you know for years now that uh there's more and more restrictions at physicians' offices in terms of like sales detailing. I don't know if it's similarly the case with medical science liaisons, although I do think that they have a little bit more of a free path into you know communicate uh about products and maybe not quite as clamped down as as sales reps uh have become. But um maybe how that role of the medical science liaison has changed and um and also how the engagement with like a pharmacy and therapeutics committee at a payer has changed because it's a lot of the same people involved. But can you speak to like what you see, like maybe how it's changed in the recent past and like how you see it shaking out going forward?

William Soliman, Ph.D. 41:43

That's a great question. Very, very good question. I would say the biggest thing is back when I was a medical science liaison in the early 2000s, you could have a narrower set of skills and your job was narrower in terms of the things that you did. Today it's much broader. So, today, to be an effective medical affairs professional or medical science liaison professional, you need to have a broader skill set. And I and actually ironically, this is one of the things that we uh credit people on is this this greater skill set to make sure that they have all these different areas of knowledge and skills to be able to hit the ground running. Where I see it going forward is really with AI literacy. I think that AI is it's transforming the format industry, transforming a lot of industries, but it's transforming commercialization faster than most people realize, to be honest. And so the companies that can leverage AI effectively but compliantly with good governance and good guardrails, I think that's gonna be key. So, and we're already seeing this, right? People are using AI for medical affairs automation, medical information center automation, MSL coaching, you know, forecasting, whatever it is. So I think the other thing that I'll I would predict in the next five or ten years is you're gonna be expected to have a high level of AI literacy, how to use the models, which models to use, how to prompt the models, when not to use the models, um, ways to validate the models. I think all that's gonna be very, very important. And I foresee that what's going to happen, and I we're already actually getting a lot of interest from companies coming to us about this, where companies are saying, look, you know, I have an AI model, but I want ACMA to validate the model. Right? So this is an interesting thing.

Ben Comer 43:35

Are you guys doing that? Are you mod are you validating models at this point?

William Soliman, Ph.D. 43:38

Yeah, so right, yeah, we're in the midst now, actually, of a little with a lot of companies with discussions on how to begin to do that. Because the thing is, right, ACMA, we've collected data for over a decade. We know what it takes, like in the example of an MSL. We know what the effective MSL looks like in terms of the metrics. We've collected that data. So since we have that data, could you use that data to fine tune a model? So this way, if you're going to use a virtual AI MSL, that MSL, that chatbot or AI bot is as most possible representative of an actual human MSL. But to do that, you have to have data. You see what I mean?

Ben Comer 44:13

Yeah.

William Soliman, Ph.D. 44:14

So I foresee a future where that's going to be something people expect. You know, like you're using an AI. The first question is, is that AI accredited? Is that AI validated? Because if it's not, then you know, you're not really sure what you're using. So that validation piece. You know what it reminds me of? It reminds me of when you go get a car, a used car, and the car is you know certified, right? It's a certified uh pre-owned car.

Ben Comer 44:40

Yeah.

William Soliman, Ph.D. 44:40

That that has a that has it gives you reassurance and it means it has to meet certain standards, right?

Ben Comer 44:45

So yeah, you look at the Carfax Report or something. Exactly.

William Soliman, Ph.D. 44:48

Yeah, exactly.

Ben Comer 44:49

So yeah, that's uh

Omnichannel Media And Misinformation

Ben Comer 44:52

that's really interesting. And I think a related question um uh that I wanted to ask is just about how the media environment is changing. AI is obviously changing search results, you know, dramatically almost daily. Uh that that is changing, just something that I notice, you know, in my own professional and and personal life using the internet. But what, you know, I guess in the context of consumer marketing and and professional marketing, um, how is the media environment uh changing? And you know, what what can companies do to kind of think about that and create strategies for this changing media environment?

William Soliman, Ph.D. 45:30

That's a really good question. I mean, a lot of the people that I talked to in form, one of the big buzzwords is omnichannel, right? And and thinking about how do you put information out on these different social media platforms. The other day I was with someone, and uh, you know, this person's a big leader within medical affairs, and they were telling me they had a podcast on behalf of the company. They had, I saw them, you know, on on TikTok, you know, putting out videos about what happened at a recent conference. Back in the day, that that wasn't even an idea, right? Like you can't even think of doing something like that. So I think that what's happening today is that the information that people are getting is much faster. There's a much faster, you know, uh exchange of information, it's uh less filtered. Um, but the problem that I see with it is that again, when you're a journalist, you have to do your due diligence and make sure the story is accurate before you put it out there. I remember I can't remember the name of the anchor. Uh I don't know who is Dan Dan uh who's the guy on CBT. Dan Rather. Dan Rather. Remember there was some story, I forgot that he broke, and then he had to go back and correct it. He did him getting fired. I can't remember which story.

Ben Comer 46:46

Yeah, I do remember I'm trying to remember what that story was, but I absolutely do remember that. Yeah, he was a beloved newscaster, too.

William Soliman, Ph.D. 46:54

Yes. And think about it, someone at his level, right? He made a mistake and then you know it ruined his career. But the the thing, why is that? Because we hold the journalist to a higher standard. They had there's you expect that the information that's coming out's been vetted, right? It's been validated, it's been whatever. But with a person, you know, I can go on my phone, right, and and do a TikTok video and tell you something, and you don't know, is it true, is it not? You'd have to go verify it. So that's the negative that I see. Like, for example, on my podcast, I had about a month or two ago um the folks that run the vaccine guidelines in the country. And I asked them, okay, does vaccine do the vaccines cause autism? That's a big thing. You hear that all the time, right, on the news. And you know, celebrities come out and say, you know, I put my my gave my kids a vaccine, they got autism, they uh automatically assume it's a vaccine. And they said, you know, no, that's not the case. And that's misinformation. And they're they went through and explained the data. So I do think everybody nowadays is an expert about everything, and that is that that is dangerous, you know, when you see people that, you know, I'm not gonna say who, but like you see a guy who's like, you know, a psychologist, but now is he a theologian, you know, or a theologian who's now a scientist. I think those are dangerous situations.

Ben Comer 48:09

Yeah, well, I'd I'll just put a quick plug-in for William's podcast, which is excellent. There's a sales rep on recently who was a whistleblower, which was uh a really interesting uh conversation. And and to your point, William, I know it seems like Reddit is like a primary source in Google search now, like the AI search, which uh is kind of wild uh for me to to think about when we're talking about, you know, um reliable sources, vetted sources. Uh Reddit's not the first name that comes to mind uh when I when I say those words, but um it's an interesting uh it's an interesting new world

DTC Ads: Benefits, Risks, And Oversight

Ben Comer 48:47

we're living in. I wanted to ask, uh, while we're on the subject of of advertising, what your thoughts are on the Trump administration's memorandum on DTC advertising? I think um RFK Jr. said something along the lines of uh prescription drug ads are a pipeline of deception. Um what's your what's your feeling about DTC? Uh you think we should get rid of them, or or do you have any any thoughts on uh on consumer advertising as it exists uh in 2026?

William Soliman, Ph.D. 49:20

You know, I'm on the fence about it. I think that in the positive aspect is that you put more power in the patient's hands, they can go to the doctor and they can say, Look, I saw this on television, and you know, maybe I have this ailment, or maybe this drug could be good for me. And then they have the conversation with their healthcare provider. I think this idea that you go to the doctor and say, Hey, I I saw this drug on on the on the TV on the kind of commercial, uh, please prescribe me the drug. And the doctor's like, oh, sure, I'm gonna prescribe the drug. I don't think it works that way. You know, I think most I I would give a little bit more, you know, uh credibility to the healthcare providers, give them just a little bit more trust. I think most healthcare providers, if they feel that the drug is not appropriate, they're not gonna give it to the patients. So I understand why some people feel maybe overwhelmed by healthcare advertising and you know, the industry, you know, may, you know, obviously because of its trust issues in the past, people are concerned about whether the information is, you know, reliable and objective. But I can tell you, I don't know if you know this, but I've worked on commercials for drugs. When I was in medical affairs, I would be brought in as the medical expert, and they would I would go to the studio and they'd be there with the actors and the audio and the text and all that. And you know, you have to make sure, hey, this sounds you know, uh not aligned with the label or this is misleading or whatever. And a lot goes into it, Ben. And I can tell you that we're not just putting stuff out there nilly-willy. We have a lot of recognition. Yeah, so the a lot of care goes into making sure, even every even to the point of like the actors we pick, or even if it's not an actor, even if it's like a like an image, like uh like some type of um image that we're picking that we say, you know, that image could be misleading. Someone might interpret it this way, like it's down to that level of detail. So I I don't think pharmaceutical companies are reckless in this uh, you know, whole thing with DTC. Um, but I I get it. I mean, I think it's like who us in New Zealand are the only two that do it in the world.

Ben Comer 51:27

Right.

Where Doctors Get Information Now

Ben Comer 51:28

What about unprofessional sales, thinking about the media environment? Uh, is there anything specific that you've noticed that's changed in terms of the way that physicians are receiving information about new drugs? Like where and I I know they're bombarded, you know, from every device, probably that that they own, but have you noticed, you know, something that is become a more effective channel for speaking to physicians uh in this environment?

William Soliman, Ph.D. 51:57

Yeah, I would say there's two. One of them actually, we just had we had we had a recent ACMA event uh in April, and they were actually a sponsor for our event. So I'm not plugging them, but I think they're actually a good platform, is Docsimity. Docsimity is like a social network for physicians, they provide a lot of good information, it's peer-to-peer, and also open evidence. Um, open evidence is an app that doctors now are using more and more. They can dial it's AI, you know, using a RAC system. And I think that um a lot of doctors now are going to that more and more. I also think going back to your other question, if you think about it, yeah. I don't know about you, but I rarely visit a website now. Most of the time, what I do is I go to you know AI, whether it's Claude or ChatGPT or Gemini, and I just ask a question and then I get what I need uh from AI. Right? I mean, that's what we do. Even you know, I was thinking the other day I needed a product, I forgot what it was, and I took a picture with Google Lens on my phone. I have an Android, I took a picture of Google Lens, and it gave me the product, and I just went on Amazon and I purchased the product, you know. You know, I didn't even Google it, right? So I think you know how we interface with technology is definitely changing.

Final Advice Start Early Stay Agile

Ben Comer 53:08

Uh I knew this hour was gonna fly by, uh, William. Um we're coming up on the end of our time here, but I I want to ask just a final question of you, which is the single takeaway message or advice that you would give to a biotech company who's just starting to think about building uh a commercialization group or function, maybe they're you know in phase two or thereabouts, uh, just starting to grapple with, you know, how are we gonna commercialize this drug uh if we make it through approval? You know, what what is your what is your advice to that individual?

William Soliman, Ph.D. 53:45

Start early and and not sequentially, use an agile model. Start early and not sequentially, use an agile model. Start to think about all the pieces and how they integrate and work together. That's it. Very simple. Uh, but it's simple in principle, but it's hard to execute. I'm I'm you know, I'm working with a few companies now. Some of them they're gonna launch like in you know a few months and they're trying to build a medical team. It's it's tough because you know they're trying to do a lot in a very short period of time. And you know, when you try to do a lot and the timeline's shortened, a lot of times you can make mistakes.

Ben Comer 54:21

Things drop. Yeah, it's not something you want to rush, I guess.

William Soliman, Ph.D. 54:24

Exactly, exactly. So that would be it.

Ben Comer 54:26

Well, uh, William, thank you so much for coming on the show. It's a pleasure speaking with you.

William Soliman, Ph.D. 54:31

Thanks, Ben. It was a pleasure to be here and I enjoyed it.

Ben Comer 54:34

We've been speaking with William Solomon, founder and CEO of uh the uh accreditation council for medical affairs, the ACMA, and founder and CIO of White Man of Capital Partners. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and be sure to check out our weekly video cast of these conversations every Monday under the Business of Biotech tab at life science leader.com. We'll see you next week, and thanks as always for listening.