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Video Transcript: Commercialization Best Practices for Small and Mid-sized Pharma

Webisode transcriptions completed by third-party vendor. AmerisourceBergen Specialty Group assumes no liability for the accuracy of the content.

Gina: Product launch planning. Increased payer influence. Logistical and operational readiness. How are small and mid-sized pharmaceutical companies approaching these issues to ensure commercial success for their products—and what can pharmaceutical companies of all sizes learn from small pharma’s best practices? Join us to find out. “In the Know” starts now.

Hello and welcome to “In the Know,” your source for insight and analysis on the issues that matter to specialty pharma. I’m your host, Gina Clark.

Today, we’re focusing on product commercialization for small and mid-sized pharmaceutical companies. We’ll examine how issues like health policy changes and industry consolidation might impact these companies differently than their larger peers. And we’ll discuss some advantages that smaller pharma companies may enjoy in the commercialization process—despite their supposed disadvantage in people and resources.

Here with us is Doug Cook, vice president of operations for ICS, one of the country’s largest providers of outsourced commercialization services for pharmaceutical manufacturers. 

Doug, thanks for joining us.

Doug: Good to be here.

What issues related to product commercialization do small and mid-size pharmaceutical companies face that large pharmaceutical companies do not?

Doug: They face a lot of the same issues, obviously, but I think they are pinched more with the capital constraints especially. And when we look at the past year, with the smaller and midsized pharmaceuticals companies that we’ve launched, they have a tougher challenge. I think even in large pharma, everybody is being more conservative and waiting maybe longer for a launch process and in general, being very careful with how they spend their dollars with just an increased air of uncertainty. The smaller companies, especially, feel that pinch. They maybe don’t have a department that they can leverage to kind of keep the ball rolling. So they just kind of feel the pinch tighter in general. 

That makes sense. In what areas might small pharmaceutical companies have an advantage over their larger industry counterparts?

Doug: Well I think that they have to be more nimble out of necessity; they learn to do more with less. So, in our case that means a lot; they’re a lot more willing to be consultative because they have to. They don’t have a large, maybe, reimbursement group helping them back at the home office or other resources to rely on, so they can, it helps us because we can be very consultative where we like to and they just have more of an appetite out of necessity, but they stay nimble because they have to. 

A number of trends continue to affect the pharmaceutical industry as a whole. I’d like to get your take on how smaller pharmaceutical companies might deal with these trends differently. Let’s start with health reform and changes to health policy.

Doug: In general, I think there is more uncertainty. So, we just see some of our partners just being more selective in terms of specific products that they’re looking at, especially when we’re talking acquisition. Just being much more selective, maybe much more due diligence, in terms of what the payer landscape might look like, just because, again, there is much more uncertainty in general.
 
How about industry consolidation? How much has that affected daily operations and strategic outlook at a smaller organization?
Doug: We’ve seen impact, we’ve seen more launches with our client base at ICS; we’re waiting longer, we’ve even launched a couple of manufacturer’s partners this year, post-approval from the FDA. So again, a more conservative approach, maybe starting later in the phase three process, and again, in some cases, starting post-FDA approval.

What about the subject of pedigree?

Doug: Pedigree, again, still a lot of uncertainty of what, ultimately, pedigree will look like. The smaller manufacturers tend to be asking a lot more questions, asking us, “What do I need to prepare for? What labeling am I going to need on my product?” Where as the large companies, in some cases, even shaping what that looks like at a legislative level, and from the launch process larger companies tend to be the ones to approach you and maybe have a beta in place of what they want to try with bar-coding or serialization, again in an overall effort of a combination to be ready or to shape the legislation. With the smaller companies, again, it’s a much more consultative approach: “Please help me understand and stay on top of the latest for what I need to be prepared for.”    
Lastly, the slowdown in FDA approvals. Again, how might smaller pharmaceutical companies be approaching their work differently in light of that trend?
Doug: Again, part of it is waiting longer, part of it is having very candid discussions about what part of the launch process do I need to do now? Maybe, what piece can I wait until I’m closer to launch and post launch and do more of a bridged launch strategy?
As a whole, how have goals and expectations among small and mid-size pharmaceutical companies changed in recent years?

Doug: I think it’s more somber, a little bit more realistic; not quite the assumed approval, they’re just being more conservative and a lot more tactical on their approach along the way, and again maybe have a plan A and plan B for if I get launched. If I don’t get launched, what an exit strategy might look like, in terms of co-marketing or partnering with a larger pharma. 

How have these needs for services evolved, and where do you see that trend headed?

Doug: The small to midsize pharma company, compared to the bigger, there is much more appetite for looking at everything we have to offer. So for us, it’s much more of an opportunity to provide a turnkey solution, which is great, and also much more willingness to be consultative, whereas a large pharma may already have a way or an SAP or a process in way. So smaller pharma has much more appetite in general to come and say, hey, look, you know, you’ve done that, this is what I pay you for, help me not do something that is going to be detrimental to my launch process, maybe that’s even in terms of a commercial, a returns policy. What’s going to work here, what’s not going to work? And that’s great for us, because that’s where we’re most effective, when we can be very consultative like that. 
 
Excellent. Doug, in what ways have smaller pharmaceutical companies gotten it right, compared to the commercialization activities of their larger peers? What are they doing better than the larger companies?

Doug: The smaller companies tend to not have a heavy IT data-to-data interface in the beginning. A lot of times with the larger pharma companies you’ll be in pre-launch talking about maybe having an SAP or a pre-launch or another system on the back end that they want to integrate data. A lot of times with the smaller companies, that’s a post-launch discussion, let’s get going, let’s get cash flowing. Then, six months, a year into it, we’ll talk about what other data needs we might have. And that’s a smart strategy across the board.    

Doug, in what areas are small and mid-sized pharmaceutical companies still not devoting enough attention, due to time or resource constraints? What can be done to address that?

Doug: Well, I don’t know. They’re in a tough situation in many cases. We’ve been talking a little bit this morning about how they might have to wait a little longer because more of the uncertainty coming out of the FDA. In other cases though, state licensing has been interesting, over the past year our senior counsel at Amerisource Specialty Group spends a lot of time on the licensing aspect; in individual states it’s got to be a tougher process, not the other way, so while smaller and midsize pharma companies are trying to wait until later, I can’t tell you that as an example, they need to, in many cases, start earlier when it comes to putting the logistics of their licensing in place, they’ve really been squeezed. So, I don’t know if they could do anything better, they’re in a tough spot, as much as they can focus their areas on not completely holding up the launch maybe, but maybe just addressing certain things that they’re going to need in the launch scenario, maybe being smart about what can wait and what needs to be started on earlier in the process.        

Are the relationships that smaller pharmaceutical companies have with key stakeholders—like prescribers, patients and payers—any different than among larger companies? In what ways might this affect commercialization strategies?

Doug: I think in general, certainly there are differences, one thing that comes to mind when you talk about prescribers, we’ve had a number of interesting conversations, I’ve heard a number of times this past year about smaller to midsize companies as they’re looking for products to commercialize. Some of them are specifically looking for drugs that don’t require the use of a sales force and dictate a completely different way of interacting with a prescriber. So maybe it’s not sales force, but they’re looking for peer education opportunities, more telemarketing-type opportunities. So it changes how they interact with transcribers, in that case.   

Despite the industry issues they face, why does this remain a positive time to be a small or mid-sized pharmaceutical company?

Doug: It is an exciting time because you do have more of that entrepreneurial culture, we like it, it’s a lot of the client base that we deal with, ICS. But, you certainly own a lot more; it’s a lot more typical where you’ve got a small focused team that can sit back at the end of the day and say, hey, we launched and I pretty much, with my core team, had everything to do with and touched every aspect of the launch. So it’s still exciting.
 
Are there any other best practices you can share relating to preparing for product launch, ensuring patient adherence or protecting products against competitive threats?

Doug: Even though you may have more limited resources, the ones that seem to have the most success, although, maybe a smaller team, they do develop a core team, a core launch team, that’s involved in every facet of it, there is still a lot of planning that goes on, just because you have to maybe hold off certain things until later in the commercialization process, doesn’t mean you have to hold off the process all together. So maybe it’s just a little bit more disciplined and organized approach, but still keeping track of what I need to be working on six months, nine months, prior, what can wait, still planning, just maybe a little less spending along the planning process. 

I see we are about out of time, Doug. But thank you for a great discussion today.

Doug: Thanks for having me.  

And thank you for joining us—we’ll be back soon with another, all-new webisode. Until then, if it’s on your mind, it’s In the Know.

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