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1rem

 interview, Mark Bouck, chairman and CEO of PharmAlliance, a pharmaceutical and life sciences services platform, dives into:

How PharmAlliance’s acquisition of Complete Health Economics Outcomes Research Solutions (CHEORS) helps expand global reach

The platform’s biggest goal to when it comes to CHEORS and market access services

How CHEORS helps navigate cost-effectiveness and market access hurdles

Acquisitions in the space that are currently in the works

Mark Bouck discusses PharmAlliance’s latest acquisitions, while reiterating its goals surrounding health economics and outcomes research.

Navigating Market Access Hurdles

 interview, Brandon Newman, Xevant’s CEO and founder, explores:

The implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system

The role that pharmacy benefit managers (PBMs) and other intermediaries' play when it comes to determining drug costs, and how spread pricing is involved

How Xevant helps improve drug cost transparency efforts

Strategies for affordability Newman would offer the pharma industry that can be implemented immediately

Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drug price transparency. 

A Further Examination of Pharmacy Benefit Managers

The CDMO's California facility welcomes new production suites, a revamp of its development labs, and more. 

Fujifilm Completes Cell Therapy Plant Expansion Project

The 50,000 square-foot plant is expected to augment the compounding and fulfillment experience for telehealth companies. 

Strive Compounding Pharmacy Eyes Expansion, Purchases St. Louis Facility

Tips for pharmacies with the reimbursement blues.

Dusting Off One’s Cost Center Hat

Digital transformation initiatives are often complex endeavors that can significantly impact the way organizations operate. 

Navigating Digital Transformation Fatigue: The Strategy for Success in Regulated Industries

Are SDOHs associated with Medicare, Medicaid, and private insurer spending?

The Connection Between Social Determinants of Health and US Healthcare Expenditures

Key Challenges Facing the Pharma Industry in 2025

, Gaurav Gupta, managing director and head of R&D 

, discusses the regulatory pressures and rising R&D costs impacting the pharmaceutical industry as it looks toward 2025. Gupta highlighted that many regulatory challenges, such as drug pricing pressures from the Inflation Reduction Act, will persist in the coming years. Additionally, he pointed out the growing integration of real-world evidence into clinical trials and the need for regulators to keep pace with emerging technologies like AI. Gupta believes that these trends will continue to shape the industry without major new disruptions expected in the short term.

He also comments on the steps pharmaceutical leaders should take to better prepare their teams and organizations for supply chain disruptions; specific technical and "soft" skills that will be critical for pharmaceutical leaders and frontline employees to thrive in the evolving industry landscape, and how this can help when it comes to proactivity in handling talent shortages.

A transcript of Gupta’s conversation with

Looking ahead to 2025, what types of regulatory pressures and areas pertaining to rising R&D costs will impact the pharma industry, and how can companies proactively address these obstacles?

On the regulatory pressures, in many ways, it's a continuation of what we've seen over the last couple of years. Of course, there could always be something new that happens, particularly with the new administration, but I think we've already seen some of the pressures on pricing, for example, with the Inflation Reduction Act, and that's going to play out over the next couple of years in various different ways. I think that's going to continue. I think we're already seeing some new sort of thinking from regulators around things like real-world evidence and how that's being integrated into trials. We're going to continue to see that evolve.

We're going to see the evolution of regulation around emerging technologies, whether that's AI obviously being a big component of that, but also other new technologies. I think that's always a constant—as the technology develops, the regulations have to step in and keep up. I think we're going to continue to see that over the next couple of years. I don't know that there's—at least at the moment—anything significant that we can forecast that's all that different from what's already been happening. I think it's going to be a continuation of that.

On the R&D costs, it’s a similar story because the underlying dynamics haven't changed. The underlying dynamics still drive some of the same challenges probably more so around where to invest, and what’s the right sort of allocation of R&D resources, whether that's thinking about white space versus existing areas; thinking about target population, smaller target populations, which has sort of been a trend that's been going on for a little while now; thinking about even things like digital therapeutics, or AI and technology, and how much are we investing in that, versus investing in that versus investing in traditional drug development. I think that the big question will be, where do you allocate your resources? There's no question that there's going to be an increase in R&D spending. I think that's been consistent for the last 20 years at this stage.

I think that's probably where you're going to see some of the decision making, and I do think, to your question surrounding if those are connected: I think what's connected is that both of those create a level of sort of uncertainty in decision-making because we don't have all of the information that we're going to need to decide what we should be doing on the regulatory front, or what we should be doing on the R&D front. I think that the skillset around how you make decisions in an uncertain world, and how you make decisions with incomplete information is probably the key to success for most leaders and most businesses.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, details the types of regulatory pressures and factors surrounding rising R&D costs that will affect the pharmaceutical industry.

Analyzing Branded and Generic Pharmaceuticals

managing director, global operations & supply chain practice at UST, discussed how the East and Gulf Coast port strikes highlighted the contrasting dynamics between branded and generic pharmaceuticals. Branded drugs, which offer higher profit margins, are produced at limited manufacturing sites, creating potential vulnerabilities. In contrast, generics have multiple supply sources but operate with tighter margins, leading to less robust business controls and raising concerns about safety. This disparity underscores the complex challenges faced by both sectors in the pharmaceutical industry. Colehower also spoke on the valuable in pharma supply chain transparency and visibility.

A transcript of Colehower’s conversation with

How did the East and Gulf Coast port strikes bring to light the differences between branded and generic pharmaceuticals?

I think it’s a fascinating space because of the differences, and when I say the differences, there are a couple things that I'm talking about. One is just the difference between brand and generic pharmaceuticals. It's feast or famine. The brands have lots of margin that they can throw at the problem, but at the same time, they're so proprietary, it's restricted, so you may only have one manufacturing operation that's producing that brand. That's a point of failure that has to be managed.

On the other hand, there’re the generics, where you may have lots of sources of supply, but they don't have the margin. Because they don't have the margin, they don't have some of the same business controls that in other cases might be a luxury, so you then start worrying about things like safety.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, describes how events such as the East and Gulf Coast port strikes have brought to light the differences between branded and generic pharmaceuticals. 

The Value of Retail Consumerism 

, Albert Thigpen, co-founder, Talentwise Consulting, discussed how the panel on “Playing the Chess Endgame–Healthcare Policies Targeting Drug Commercialization” underscored the complexities of implementing the Inflation Reduction Act (IRA), predicting significant challenges for stakeholders like retail pharmacies, payers, and pharmacy benefit managers. They highlighted concerns about the unintended consequences of negotiated maximum fair prices (MFPs), particularly on the generics industry and oncology drug distribution, which could complicate decisions for companies and affect in-office dispensing practices. Overall, the panelists noted that the IRA's intricate framework might lead to unforeseen difficulties in the healthcare landscape.

Thigpen also emphasized the importance of taking a long-term and measured perspective for manufacturers when it comes to strategic approaches to pricing and commercialization in light of future US. healthcare policies. He noted that, similar to the evolving landscape of Medicare Part D over the past 20 years, the Inflation Reduction Act (IRA) will also undergo significant changes. Manufacturers should prepare for initial challenges and be ready to reassess their strategies annually, adapting to new rules and market dynamics as they emerge. This approach may involve delaying product launches or adjusting commercialization tactics based on negotiated MFPs and market conditions, akin to the strategies seen with AbbVie and Humira. Beyond that, Thigpen dove into key trends impacting the pharmacy benefit management and specialty pharmacy spaces, while providing a crash course on retail consumerism. 

A transcript of Thigpen’s conversation with

What is retail consumerism, and why is it so valuable?

I think about retail consumerism as it pertains to healthcare and pharmacy in general. The consumer today is incredibly empowered to make their own decisions as it relates to consumer choices in general. Let's go through a few of them.

The first one is the music industry. I'm old enough to know that I remember vinyl records, eight-track tapes, and being able to go to a record store. Now, seeing that entire industry evolve into digitized music and streaming services like Spotify or Apple Music, I get to pick and choose my music. I can pay for it on a subscription basis. I have complete control over that. The entire vinyl digital music marketplace has gone by the wayside in favor of a digital consumerism model. The travel industry—I don't care if you're talking airlines or hotels, it is in the hands of the consumer.

The consumer can choose what hotels they want to use. I can choose what airlines I want to use. I can choose multiple portals that allow me to find the cheapest price across the board, like an Expedia or a Kayak, or anything under the sun. I can negotiate with them, find deeper prices across the board, but the need to go and coordinate a vacation through a travel agent is far by the wayside. So that is retail consumerism in the travel industry in general. It’s the same way with the auto industry—I don't have to go to even see a retail agent anymore. Everything's on my phone. I can just pick and choose my car, what I want. Pick my car when I land, figure out how to return it, change it. That's retail consumerism at its best.

Healthcare, unfortunately, Nico, has been the last to convert on retail consumerism, and it's for a lot of different reasons. What I would like to see is a world where the retail consumer and healthcare had their ability and functionality to do what they do in those other industries. I can pick and see my doctor when I want to see my doctor. I can pick the generic when I want the generic drug. I can take if I want to deliver from Amazon pharmacy or Walgreens or CVS or my mail order. I can pick this specialty pharmacy. I can pick this drug or convert this drug. I can pick this lab test when I want it. I can pick this urgent care when I want it.

Having that type of flexibility is how I think about retail consumerism. I think some of the evolution is just like turning the Titanic in healthcare. It's just really slow, methodical changes that are getting there, but companies in the cash marketplace are the ones that are driving a lot of the consumerism by being able to take control their benefit, make the right economical choices that's best for them, choose what pharmacies they want to go to, what coupons are applied or which ones aren't applied. Empowering the consumer to make the choices is basically the under-arching thesis.

Albert Thigpen, co-founder, Talentwise Consulting, shares how today’s consumer is empowered to make their own decisions as it relates to consumer choices in general, while outlining how the concept can be applicable to the healthcare and pharma industry.

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Access Insights 2024: The Value of Retail Consumerism 

The Growth of Specialty Pharmacy

Thigpen also emphasized the importance of taking a long-term and measured perspective for manufacturers when it comes to strategic approaches to pricing and commercialization in light of future US. healthcare policies. He noted that, similar to the evolving landscape of Medicare Part D over the past 20 years, the Inflation Reduction Act (IRA) will also undergo significant changes. Manufacturers should prepare for initial challenges and be ready to reassess their strategies annually, adapting to new rules and market dynamics as they emerge. This approach may involve delaying product launches or adjusting commercialization tactics based on negotiated MFPs and market conditions, akin to the strategies seen with AbbVie and Humira. Beyond that, Thigpen dove into key trends impacting the pharmacy benefit management and specialty pharmacy spaces, while providing a crash course on retail consumerism.

How has the specialty pharmacy industry grown and evolved over the years?

Specialty pharmacy, by itself, has been subject to a lot of what retail has been in the past, which is that specialty pharmacy is approaching and getting closer to a commoditized market, just as retail brand drugs were in general. Those are for specialty drugs that have a lot of competition, maybe some biosimilars and generics in the space, but it's starting to commoditize. In some cases, it has commoditized in certain classes. There's this whole other evolution of biosimilars—what do we do with them? Are biosimilars as clinically effective and equal as an innovator brand? In some cases, yes, some cases may be unknown at this point in time.

We like to use the Humira and the biosimilars that support Humira as a proxy for that one. But still, the brand innovator still holds a pretty significant share of the marketplace. I think the trend is that companies want to embrace biosimilars and actually be able to manage biosimilars, but in reality, it hasn't quite gotten there just yet for a multitude of reasons. I think maybe one of the bigger issues in specialty in some of the evolution is that the drugs that are being launched today by the FDA are more complex and much more expensive and difficult to manage.

Think about drugs that are coming out for the cell and gene therapy-type models that are uber expensive, very personalized in nature, difficult to dispense and get to the patient at the right time; a lot of coordination of that across the board is one thing. We still have a really broad pipeline of rare, orphan, and ultra-orphan that could Eclipse a couple million dollars per patient per year, and very selective patient services and things that specialty pharmacies will need to offer and provide, of which not every specialty pharmacy can do.

We're seeing differentiation of services. We're seeing much more complex disease molecules being approved by the FDA in specialty, and we've got this quasi bio, similar model that needs to be managed in general, all of which are good problems to have if you're a specialty pharmacy.

Albert Thigpen, co-founder, Talentwise Consulting, explains how the specialty pharmacy sector has evolved over the years.

Access Insights 2024: The Growth of Specialty Pharmacy

Reassessing Pricing and Commercialization Approaches

How can one strategically reassess pricing and commercialization approaches in order to anticipate the future US healthcare policy environment?

I think it's a couple things. If I were in a manufacturer’s shoes, you have to take the long game here. You’ve got to remember that in 2026, we would have 20 years of experience of the Medicare Part D benefit underneath our belts of expertise, and how it was originally intended to roll out is not how it looks in 2026 today, and that is because every year, the federal government allows for rule changes, business model changes, and open comment periods, and that is a fluid dynamic that evolves the program over time. I say that as context, because the IRA [Inflation Reduction Act] today is going to look like a one-year snapshot in time—it's not going to be the greatest implementation out of the gate, and it will continue to evolve.

With that in mind, the manufacturers have got to take a very long view and maybe a conservative view out of the gate. They should say, “I know this isn't going to be perfect, and I know I may lose on some and win on some others, but I've got to maybe take a measured approach to the business and continually reassess it every year.” The payers are going to do the same, the PBMs are going to do the same, the retail markets and the distributors will all do the same. They can only play the cards that they're dealt in year one, then they reassess, they re-evaluate, and then wait for rule changes to occur. They kind of figured out that plan, and lo and behold, over time, we figured out somehow to make Medicare Part D successful in 20 years.

I suspect that will be some of the same cadence with the IRA and the drug manufacturers, but I do think it changes the dynamic of where the manufacturer needs to focus. For example, being fully ready to launch on day one of the PDUFA [Prescription Drug User Fee Act] date when they launch and being ready to commercialize. Then, I follow this product life cycle, and maybe, if there's an MFP [maximum fair price] tied to a drug that I'm subject to, maybe a generic doesn't launch it, maybe I need to continue to ride that out and extend that product life cycle for a period of time. It’s similar to what we've seen AbbVie and Humira exercise with biosimilars, so I think it's a measured approach. I think it is a one-year reassess every time, every year, but knowing that the rules are going to change [I would], tread lightly this year.

Albert Thigpen, co-founder, Talentwise Consulting, explains how to use these tactics in order to anticipate the future US healthcare policy environment.

Access Insights 2024: Reassessing Pricing and Commercialization Approaches

Key Nuggets Surrounding the Chess Endgame

What were the main nuggets that came out of your “Playing the Chess Endgame–Healthcare Policies Targeting Drug Commercialization” panel?

I think probably the biggest takeaway is that the IRA is complicated. The implementation of it is going to be super complex. I think the panel universally agrees that the implementation of the IRA that has implications on the retail pharmacies, the payers, the patients, the PBMs, in general, hasn't quite been architected in the way for success, and we're just planning on some train wrecks, as we had referred to it in the panel. I think that's the first thing.

The second thing is that the MFPs that have been negotiated as a result of the IRA are going to have some unintended consequences across the board to other constituents—for example, the generics industry. How does a generic company decide to launch or not launch because the MFP has already been negotiated to a very low point already, and what are the unintended consequences of that? Negotiating an MFP on an oncology drug: going forward, how much does that impact, or have an unintended consequence of a physician that does in-office dispensing? I think for the vast, high level, I would say the IRA is complex. It's not fully thought out of all the consequences that will occur. We're starting to figure out some of those solutions, but very murky waters as we know it today.

Albert Thigpen, co-founder, Talentwise Consulting, offers highlights of the drug commercialization panel that he participated in.

Access Insights 2024: Key Nuggets Surrounding the Chess Endgame

financial benefits technology

Given the technological capabilities that currently exist, how long does it take to see a reduction in annualized drug spend?

 I was talking to a health system last week, and they had sitting in current state, $1.6 million worth of savings. So just out of the gate, their perspective was, our pricing is wrong. Let's correct the pricing. That's $1.6 million savings. Then, once you get some of that low-hanging fruit of the prices that are set wrong, then you layer on.

Now the prices are changing. Do I want to make decisions about it that will change my behavior? Do I want to make some strategic changes from one drug to another? I would say that what you're typically seeing is some large fraction of a percentage savings out of the gate, and it might take you a little while to filter that through— with rebates from your wholesalers and your manufacturers—but you get to a world where you can be saving 2, 3, 4% of your drug spend in the first year, and then that continues year-over-year.

We just had one health system pass the $10 million saved mark. It’s very frequent that you're getting million-plus dollar savings in a mid-sized system within 6-12 months. It's pretty remarkable, so I'd say instantly, but you also then see that ramp up over time, and you may see different types of plays in different time horizons.

In a final part of his interview with Pharma Commerce Editor Nicholas Saraceno, Kevin MacDonald, Bluesight’s Co-founder and CEO, explains the amount of time it takes to see a reduction in annualized drug spend, and offers estimates in terms of percent savings. 

The Financial Benefits of Technology

Streamlining Pharmacy Purchasing and Procurement 

According to the latest “Hospital Pharmacy Operations Report” (HPOR) by Bluesight, 71% of hospital pharmacy participants noted that streamlining pharmacy purchasing and procurement was a priority for them this year. Why is mitigating the effect of rising costs a priority for the healthcare/pharma industry right now, and what other topics are on the docket?

 The hospital pharmacy has always been managed by drug budget, and when you zoom out to the entire health system, the drug budget has always been the second largest operational spend. It’s something to take a look at. You combine that with the rise of specialty medications and the inflation of the price of specialty medications, and it's becoming a huge part of any health system budget. Being able to understand that, control that, and understand your margin profile and cost profile is super important. I think what we're seeing is just the natural extension of as the budget goes, you put more and more focus on it. But I also think what's happening is that you're seeing consolidation in the industry—where health systems are buying other health systems—they want to be able to control that spend and understand where it's going and make decisions that are going to move the needle. The drug budget is a place where they can do that.

When it comes to giving pharmacy buyers full control over their procurement landscape, what opportunities are advanced analytics tools able to provide?

 I think we've seen a step change in the past 24 months. There're still legacy products that are out there via your wholesalers and your GPOs that provide the basics of what it is offering me as the contracted best price, but in terms of the next generation of tools, we have one called CostCheck, and it provides a whole other level of analytics that allows for things like active price monitoring. If you think about the average health system, there's 50,000 NDCs where the prices change on a daily basis. And if you're a mid-size health system—if you have seven or eight sites—you're probably purchasing on 100 to 200 different accounts. And if you layer in your GPO, 340B pricing, what you’re doing with WAC purchasing—it's really complicated, and oftentimes, what's happening is a price changes on one account and not another account, and that can cost in some cases, hundreds of thousands of dollars, or millions of dollars. 

Having the ability to monitor what's going on, not just on an account-by-account basis, but system wide, is a big step change. Beyond that, just being able to understand not just I'm going to buy Brand X versus Brand Y, but what do those decisions actually mean for me? Some changes are easy. For example, buying a five-pack versus a 25-pack, if the thing that's in the pack is cheaper. There's a lot of clinician-driven changes, where you might have to go through your P&T committee or something to approve it, and understanding how easy or how difficult the changes are is an important piece. Just looking not just in the acute space, but non-acute. you know,

What are we doing for contracts? A lot of hospitals have got their GPOs that they're working with that are driving best pricing. Some hospitals additionally do things like Civica, or they'll do one-off contracts with a handful of manufacturers, so how do I know that my people, first of all, even know that I have that contract, second of all, that it's loaded properly in my systems, and third, that I'm actually purchasing and complying with all of those contracts, because it can be incredibly difficult to understand that they're there, and when you start to stack requirements on requirements, making sure that you're actually hitting your compliance metrics can also be tricky.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Kevin MacDonald, Bluesight’s Co-founder and CEO, discusses why mitigating the impact of rising costs is imperative, while explaining the benefit of advanced analytics tools.

 Editor Nicholas Saraceno, Bill Roth, SVP, Managing Partner, Blue Fin Group, discusses steps to be taken by chief commercial offers in planning for a profitable lifecycle. 

Access Insights 2023: Bill Roth Offers Insights for Chief Commercial Officers Planning a Profitable 3-5 Year Lifecycle

The first thing you have to do is think about three things: What product archetype am I working in? What therapeutic area am I in? What drug class am I in? From there, you really ask if your therapy is novel in an unmet need area or is it a commodity. So, if you're launching a cell and gene therapy, oncology, or even in a multiple sclerosis area, it's all very different. Launching in GenMed right now is a tough one. You're looking at 60% rebates to the PBM and double digit figures to the wholesaler for distribution. By the time you stack everything on, it's hard to make money. 

The hard part for chief commercial officers is how different the game is now. It's even more different than it was five years ago. Things we used to view in absolutes are not the case anymore. It's not showing up yet in the data but it is diversified. 

Blue Fin Group executive highlights how leaders can plan for immediate profitable lifecycles and beyond. 

Editor Nicholas Saraceno, Bill Roth, SVP, Managing Partner, Blue Fin Group, speaks on key takeaways from his "Fight for the Dollar" keynote speech. 

Access Insights 2023: Bill Roth Provides an Overview of his Keynote Speech, Fight for the Dollar

: The keynote was a culmination of a story that I've been working on all year long. We've always heard about the flow of the dollar. I'm getting quite tired of that one graphic that represents how brands flow. There's nine other flows. What became obvious to us over the last year and a half was this concept of the fight for the dollar. No one is really laying back and allowing the channels to basically use the manufacturers. Between 340B, the removal of the AmCap, and the addition of the IRA, price increases as we know it have been abolished. If you do it moving forward, you're going to wind up regretting the actions. The way that I open it up, I ask this question: If you put a dollar bill equidistant in a four way intersection and you put a payer pharmacy/distributor equal to that and a gun goes off, who gets to the dollar bill first and why? Traditionally, the answer has been not the manufacturer. The fight for who gets that money has created awkwardness and I think the ability to talk about that in front of a group like this is great because we're putting a problem on the table that we all need to solve. 

SVP and Managing Director for Blue Fin Group offers a synopsis of the conference opener. 

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