In the May 20, 2026, the Association of University Technology Managers interviewed Steve Casey for their Big Reveal Newsletter. Previously in April, Mr. Casey had conducted an educational webinar on the 505(b)(2) Pathway for association members.
We sat down with a longtime commercialization leader and consultant at Omni-HC Ltd. to talk about building winning strategies for 505(b)(2) and value-added medicines, what still motivates him after decades in the field, and the lessons he has picked up along the way.
How did you get started commercializing 505(b)(2) products?
a) My path into 505(b)(2) commercialization started before 505(b)(2)s were widely recognized as a major pathway. In the early 1990s, I moved into my first headquarters role in marketing and began working with products known as “DESI” products, older medicines considered safe and effective after many years on the market. While I was marketing them, some were later converted into 505(b)(2) products. After that, I had the opportunity to manage a joint venture and commercialize a 505(b)(2) product for a rare liver disease. That orphan product was my first true end-to-end 505(b)(2) commercialization experience—and very likely one of the first 505(b)(2) applications to receive 7-year orphan exclusivity. Because there wasn’t an existing playbook, I had to help build the joint venture using assets from both parent companies and create the full commercialization plan from the ground up. It was a challenging and exciting crash course in orphan diseases and discovering what makes 505(b)(2)s different, especially the go-to-market approach, where you often need new messaging, new tactics, and a strategy tailored to a unique regulatory and market story. That experience really shaped my understanding of the distinct commercialization challenges that come with this pathway.
After 38 years in the field, what still excites you about this work?
a) Honestly, it’s the mix of educating, advocating, and problem-solving around 505(b)(2) products. My career didn’t start right out of college—almost 40 years ago, I was venting about my job and my father said, “Maybe you should try pharmaceuticals.” I took the advice, got hired, and I still remember the early days: the company car, the leather briefcase, the nice pen. A couple months in after a long day on the road, I pulled into my apartment parking lot and thought, “I could do this for the rest of my life.” What keeps it fresh is that every day is different, sometimes challenging, sometimes rewarding, and usually both. Over the years I’ve worked across the product lifecycle: early-stage translation, development program strategy, product launch, and market growth. I’ve also built experience in regulatory and medical affairs, which gave me a clearer view of how commercialization works when it’s done well—and what breaks down when it isn’t. With 505(b)(2)’s, each asset has its own story and the market is constantly shifting, so the work stays intellectually stimulating. A lot of the time, I’m helping a team reach the next milestone in their product or company journey. That means staying current on what’s shaping the industry and translating it into practical, workable solutions. And because there’s still a lot of misunderstanding about what it really takes to commercialize 505(b)(2) products, I feel like I can help remove some of that friction, which is a big part of why I still enjoy it.
Was there a particularly challenging product or situation that shaped how you work today?
a) Yes several, but one stands out in the 505(b)(2) context. In the early 2000s, I co-founded a specialty pharma startup focused on GI products. The plan was to raise financing, build a commercial operation, and then market and reformulate a product portfolio we were developing. Over about three years, I acquired rights to three products (one of them already in market generating revenue). Along the way, I realized that if we built the company the right way, we could create multiple potential exit paths—and still generate meaningful value. After several strong financing meetings, another (already funded) company approached my co-founder and me about acquiring us. We ultimately reached terms, stopped the financing round, and closed the sale. That experience taught me to keep as many options open as possible—and to stay alert for “non-obvious” opportunities that can show up when you’re building something.
What’s the best professional advice you’ve received?
a) Easy: when my father said, “Maybe you should try pharmaceuticals.” It changed the entire direction of my career—and almost 40 years later, I can still remember that conversation vividly.
How does AUTM Membership benefit your work at Omni-HC Ltd.?
a) AUTM helps me stay connected to how technology transfer offices think about innovation, risk, and commercialization—and it gives me a chance to be a practical resource. In my work at Omni-HC Ltd., I often collaborate with teams that have strong science but are still building the commercialization roadmap. AUTM programming and member conversations help me understand the realities TTO professionals face (timelines, partnering, limited data, constrained budgets), and that context makes my advice more actionable. On the flip side, I can share lessons learned from launching and growing products, especially where value-added medicines require a different approach to positioning, access, and adoption than people expect.
What’s your “guilty pleasure” song, movie, or food?
a) Reese’s Peanut Butter Cups. That peanut butter-and-chocolate combo is hard to beat, unfortunately, they tend to “stick with me” a little longer than I’d like. I also like peanut M&M’s. I never thought of it till now but the similarity of these two candies and 505(b)(2) products is interesting. I don’t know a lot of folks that would say peanut M&Ms are the same as a peanut butter cup but sometimes in the pharmaceutical market that is the first thing you hear with a 505(b)(2). Both products have chocolate and peanut butter and they do the same thing…satisfy a desire for a sweet. 505(b)(2) products often hear this type of response, “it’s the same compound as the generic of the innovator, why would I pay more to have your product”. The challenge is overcoming those objections and helping the market understand there is a difference and what the difference is.
What separates a good commercialization strategy from a great one?
a) For me, the difference is whether the strategy drives the outcome you actually need. “Success” is what separates good from great, but success has to be defined in the context of the specific asset. For example, if you’re commercializing into a $150M market, many large pharma companies won’t view that as meaningful because they’re oriented toward multi-billion-dollar opportunities. But if you enter that market and capture $100M, that’s an outstanding result for the product and the organization behind it. But reduce success to revenue alone is misguided. Yes, you need an appropriate return on investment, but revenue is a proxy for something more important: whether you got the product from the clinic to the patients who need it, when they need it, where they need it, and how they need it.
Where do you see the biggest opportunities in value-added medicines right now?
a) One of the biggest opportunities is taking an already marketed compound with a strong scientific rationale for use in a new indication and then building real differentiation around it. Often, early studies start with the existing on-market dosage form, but the asset can be much better protected (and more compelling clinically) when you change the mechanics of the drug: a new dosage form, a new delivery mechanism, or another meaningful improvement. Looking ahead, I also think we’ll see a growing wave of combination products that “marry” drugs and technology. Sometimes that technology is a device or delivery platform but increasingly it could be software, digital engagement tools, or even AI-enabled components that improve outcomes, support adherence, and deepen HCP and patient engagement.
What is your favorite way to recharge outside of work?
a) Anything outdoors. I’m happy in every season landscape work, skiing, boating, hiking, stargazing, or just being in a hammock. Growing up, my mom used to tell my brothers and me, “Go outside and play, just be home when the streetlights come on.” I never had trouble finding something to do outside, and that’s still my favorite way to reset.
What’s something people often misunderstand about value-added medicines?
a) The biggest misunderstanding is that value-added medicines are basically generics—or that they’re just smaller versions of innovator drugs. They’re neither. They’re unique assets with their own commercialization “rules.” Unlike generics, value-added medicines typically require true branding and a clear plan for access through distribution and reimbursement. They can also require significant upfront investment, often millions of dollars, to demonstrate efficacy in a new indication or to prove another differentiating benefit (versus a single bioequivalence study that might cost roughly $0.5 - $1M). And unlike many innovator launches, value-added medicines don’t always need a traditional, large-scale go-to-market playbook. What they do need is a precise understanding of what will actually drive awareness and adoption for that specific product—and just as importantly, what won’t.
How did you get started commercializing 505(b)(2) products?
a) My path into 505(b)(2) commercialization started before 505(b)(2)s were widely recognized as a major pathway. In the early 1990s, I moved into my first headquarters role in marketing and began working with products known as “DESI” products, older medicines considered safe and effective after many years on the market. While I was marketing them, some were later converted into 505(b)(2) products. After that, I had the opportunity to manage a joint venture and commercialize a 505(b)(2) product for a rare liver disease. That orphan product was my first true end-to-end 505(b)(2) commercialization experience—and very likely one of the first 505(b)(2) applications to receive 7-year orphan exclusivity. Because there wasn’t an existing playbook, I had to help build the joint venture using assets from both parent companies and create the full commercialization plan from the ground up. It was a challenging and exciting crash course in orphan diseases and discovering what makes 505(b)(2)s different, especially the go-to-market approach, where you often need new messaging, new tactics, and a strategy tailored to a unique regulatory and market story. That experience really shaped my understanding of the distinct commercialization challenges that come with this pathway.
After 38 years in the field, what still excites you about this work?
a) Honestly, it’s the mix of educating, advocating, and problem-solving around 505(b)(2) products. My career didn’t start right out of college—almost 40 years ago, I was venting about my job and my father said, “Maybe you should try pharmaceuticals.” I took the advice, got hired, and I still remember the early days: the company car, the leather briefcase, the nice pen. A couple months in after a long day on the road, I pulled into my apartment parking lot and thought, “I could do this for the rest of my life.” What keeps it fresh is that every day is different, sometimes challenging, sometimes rewarding, and usually both. Over the years I’ve worked across the product lifecycle: early-stage translation, development program strategy, product launch, and market growth. I’ve also built experience in regulatory and medical affairs, which gave me a clearer view of how commercialization works when it’s done well—and what breaks down when it isn’t. With 505(b)(2)’s, each asset has its own story and the market is constantly shifting, so the work stays intellectually stimulating. A lot of the time, I’m helping a team reach the next milestone in their product or company journey. That means staying current on what’s shaping the industry and translating it into practical, workable solutions. And because there’s still a lot of misunderstanding about what it really takes to commercialize 505(b)(2) products, I feel like I can help remove some of that friction, which is a big part of why I still enjoy it.
Was there a particularly challenging product or situation that shaped how you work today?
a) Yes several, but one stands out in the 505(b)(2) context. In the early 2000s, I co-founded a specialty pharma startup focused on GI products. The plan was to raise financing, build a commercial operation, and then market and reformulate a product portfolio we were developing. Over about three years, I acquired rights to three products (one of them already in market generating revenue). Along the way, I realized that if we built the company the right way, we could create multiple potential exit paths—and still generate meaningful value. After several strong financing meetings, another (already funded) company approached my co-founder and me about acquiring us. We ultimately reached terms, stopped the financing round, and closed the sale. That experience taught me to keep as many options open as possible—and to stay alert for “non-obvious” opportunities that can show up when you’re building something.
What’s the best professional advice you’ve received?
a) Easy: when my father said, “Maybe you should try pharmaceuticals.” It changed the entire direction of my career—and almost 40 years later, I can still remember that conversation vividly.
How does AUTM Membership benefit your work at Omni-HC Ltd.?
a) AUTM helps me stay connected to how technology transfer offices think about innovation, risk, and commercialization—and it gives me a chance to be a practical resource. In my work at Omni-HC Ltd., I often collaborate with teams that have strong science but are still building the commercialization roadmap. AUTM programming and member conversations help me understand the realities TTO professionals face (timelines, partnering, limited data, constrained budgets), and that context makes my advice more actionable. On the flip side, I can share lessons learned from launching and growing products, especially where value-added medicines require a different approach to positioning, access, and adoption than people expect.
What’s your “guilty pleasure” song, movie, or food?
a) Reese’s Peanut Butter Cups. That peanut butter-and-chocolate combo is hard to beat, unfortunately, they tend to “stick with me” a little longer than I’d like. I also like peanut M&M’s. I never thought of it till now but the similarity of these two candies and 505(b)(2) products is interesting. I don’t know a lot of folks that would say peanut M&Ms are the same as a peanut butter cup but sometimes in the pharmaceutical market that is the first thing you hear with a 505(b)(2). Both products have chocolate and peanut butter and they do the same thing…satisfy a desire for a sweet. 505(b)(2) products often hear this type of response, “it’s the same compound as the generic of the innovator, why would I pay more to have your product”. The challenge is overcoming those objections and helping the market understand there is a difference and what the difference is.
What separates a good commercialization strategy from a great one?
a) For me, the difference is whether the strategy drives the outcome you actually need. “Success” is what separates good from great, but success has to be defined in the context of the specific asset. For example, if you’re commercializing into a $150M market, many large pharma companies won’t view that as meaningful because they’re oriented toward multi-billion-dollar opportunities. But if you enter that market and capture $100M, that’s an outstanding result for the product and the organization behind it. But reduce success to revenue alone is misguided. Yes, you need an appropriate return on investment, but revenue is a proxy for something more important: whether you got the product from the clinic to the patients who need it, when they need it, where they need it, and how they need it.
Where do you see the biggest opportunities in value-added medicines right now?
a) One of the biggest opportunities is taking an already marketed compound with a strong scientific rationale for use in a new indication and then building real differentiation around it. Often, early studies start with the existing on-market dosage form, but the asset can be much better protected (and more compelling clinically) when you change the mechanics of the drug: a new dosage form, a new delivery mechanism, or another meaningful improvement. Looking ahead, I also think we’ll see a growing wave of combination products that “marry” drugs and technology. Sometimes that technology is a device or delivery platform but increasingly it could be software, digital engagement tools, or even AI-enabled components that improve outcomes, support adherence, and deepen HCP and patient engagement.
What is your favorite way to recharge outside of work?
a) Anything outdoors. I’m happy in every season landscape work, skiing, boating, hiking, stargazing, or just being in a hammock. Growing up, my mom used to tell my brothers and me, “Go outside and play, just be home when the streetlights come on.” I never had trouble finding something to do outside, and that’s still my favorite way to reset.
What’s something people often misunderstand about value-added medicines?
a) The biggest misunderstanding is that value-added medicines are basically generics—or that they’re just smaller versions of innovator drugs. They’re neither. They’re unique assets with their own commercialization “rules.” Unlike generics, value-added medicines typically require true branding and a clear plan for access through distribution and reimbursement. They can also require significant upfront investment, often millions of dollars, to demonstrate efficacy in a new indication or to prove another differentiating benefit (versus a single bioequivalence study that might cost roughly $0.5 - $1M). And unlike many innovator launches, value-added medicines don’t always need a traditional, large-scale go-to-market playbook. What they do need is a precise understanding of what will actually drive awareness and adoption for that specific product—and just as importantly, what won’t.