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Articles

The latest dealmaking trends: Early-stage is back in favor. There's more money to be made in being acquired than in going public. And license deals are putting more on the back end.

Finance: Q&A with Annette Grimaldi

Fran Gregory, Vice President of Emerging Therapies at Cardinal Health, gives insight into:

Recent trends in the cell and gene therapy space

How CAR-T therapies have been gaining momentum and what kind of progress we can expect in the next 10 years

Personalized medicine and gene editing advances

The biggest hurdles within cell and gene therapy space and how do we begin to jump over them

The biggest foci for cell and gene therapy for the next 5 years

Fran Gregory, PharmD, MBA, is Vice President of Emerging Therapies at Cardinal Health, where she is responsible for Cell & Gene Therapies and Biosimilars. Fran’s background includes extensive clinical, HEOR, trade and commercial experience in the payer/PBM, specialty pharmacy, and biotech manufacturer spaces. Her career reflects a consistent focus on complex, innovative, high-value pharmaceuticals, and a passion for breaking down barriers to access and care. Throughout her career she has paved the way in innovation by starting two of the first and largest specialty pharmacies in the US, launching two of the first cell and gene therapies in the world, and bringing several first-to-market biosimilars to patients. As a pharmacist, she has an acute focus on patient outcomes, and is an expert in value-based care models, reimbursement and payment strategies, as well as navigating successful teams in healthcare to deliver solutions to bring advanced therapies and treatments to patients.

The editors of Pharmaceutical Executive bring you the latest commercial insights to master the science of success. Podcast episodes examine current trends, key conferences, and critical topics in the bio/pharmaceutical industry.

Podcasts

Fran Gregory, VP of Emerging Therapies, Cardinal Health discusses her career, how both CAR-T therapies and personalization have been gaining momentum and what kind of progress we expect to see from them, some of the biggest hurdles facing their section of the industry, the importance of patient advocacy and so much more. 

Cell and Gene Therapy Check-in 2024

Our milestone 100th episode includes Lisa Henderson, group editorial director; Julian Upton, European and online editor; Fran Pollaro, senior editor; and Andy Studna, associate editor discussing various industry trends they've written up for our 

You can listen and/or download the episode on SoundCloud, or directly through iTunes, GooglePlay, Stitcher, and Overcast.

Our milestone 100th episode includes Lisa Henderson, group editorial director; Julian Upton, European and online editor; Fran Pollaro, senior editor; and Andy Studna, associate editor, discussing industry trends in areas such as Chinese biotech, corporate branding, psychedelic medicines, and market access barriers.

Industry Outlook 2022

Investment includes $1.5 billion in capital expenditures to expand manufacturing and $500 million dedicated to R&D focused on high-impact innovations.

Thermo Fisher to Invest $2 Billion in US Biotech Manufacturing, R&D

With combined investments exceeding $53 billion, both companies are deepening their US presence through expanded biologics production, gene therapy capabilities, and next generation R&D centers. 

Regeneron, Roche Launch Major US Expansion Plans to Meet Growing Demand for Biologics and Innovation

Introducing a new series highlighting ways pharma companies can up their game in winning earned media—and ultimately deliver greater impact and value from their messaging. 

Improving Your Earned Media Strategy: Tips and Insights

Investment is expected to bring approximately 1,000 new jobs at Novartis and 4,000 additional roles across the United States. 

Novartis to Invest $23 Billion in US Manufacturing and R&D Over Five Years

The increasing costs and complexity of R&D in the pharmaceutical industry have necessitated the adoption of strategic portfolio management to optimize resource allocation and enhance competitive advantage. 

Applying Porter’s Five Forces to Portfolio Management in Pharmaceutical R&D: A Strategic Roadmap

Villar Summit 2

PE: Are there any new skills that generation Alpha is bringing to the workforce? Will it help strengthen the industry?

I think generation Alpha is really bringing a lot of interesting skills to us in the way of data science, in the way of AI or digital tools that perhaps we're not comfortable with in some of our roles. I think the trick is going to be how do we harness those skills? How do we put them to use quickly because they are also ever changing. Staying on top of those skills that they've developed, continuing to evolve the skills and the person, and then putting them to best use for how we target our businesses. I think this is a exciting opportunity, really exciting time for us to think about how we can manage tools like AI in a better way that will make better medicines better innovation, and at the end of the day, hopefully better for all patients.

PE: What struggles do you believe that these incoming pharma professionals will face when adapting to common industry practices?

As I mentioned in the session, I have a 16-year-old son. I think with him, I observed that patience is not necessarily a virtue in his eyes, he likes to move quickly. If he doesn’t get an instant reaction to something, he's already moved on and forgotten about what it was. I think a lot of that has to do with the way they use data, the way they use electronic devices, etc., which is fine. But I think that on certain things, you have to not only factor in what the data are and what the right thing to do is, but the politics of the situation, or some underlying financial factors that you might have to consider, finding the patience the patience to take all of that in and try to understand the reasons that decisions are being made in a certain way. I think that could be hard. Listen, I'm not even going to say how old I am, am patience is sometimes a challenge for me. So, I know that this is something that we all could work on. I think when you're brought up in a generation where information is instantaneous, that makes it even harder to manage your own expectations and your own patience.

PE: Are there any additional comments that you would like to add?

I would just say that this is not an issue in terms of dealing with younger generations coming into the workplace that we can avoid, we have to adapt, and we have to learn how to recruit the best talent and retain them in a way that makes sense for everybody. Real human behavior is complex, and that is part of what we’re dealing with. Learning together and growing together is going to be really important, and I think that is a challenge for us as we are very used to looking for certain expertise and being loyal to that person in their expertise for a long amount of time. How do we all adapt? How do we do so in a way that continues to make us successful in in the businesses we run?

Videos

In an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Sciences discusses new skills that members of generation Alpha will bring to the pharma industry and potential struggles that they may face. 

Video Series

US Pharma and Biotech Summit 2024: Bringing the Skillset of Generation Alpha to the Pharma Industry

Getting Pharma Ready for Generation Alpha

PE: Today, you were a part of a panel titled “Getting pharma ready for Generation Alpha.” Can you discuss the key takeaways for anyone unable to attend?

It was a great panel. Luckily, we had a young MBA student on this panel as well. But it was interesting. I think the ability to be agile on both sides, meaning the young people coming into the workforce, and those of us who are hiring them potentially, in this ability to create development plans, and the opportunities for growth and understanding for the folks that are coming into pharma is a big takeaway. think that that's really important in not only how we manage our expectations, but also how we provide skills development and growth opportunities for folks who probably are not going to stay for more than a few years at any job.

PE: What are some of the challenges and trends unique to this population that need to be considered by pharma leadership into the future?

I think that one was a big one. When I think about the time commitment and effort it takes to hire somebody, and then the expectations and what we want to get out of that person as a loyal employee to any company, I think that is changing. We hear a lot about a gig economy, and what does that really mean for companies like ours or others in the industry who may be used to having employees on the payroll for 10-20 years? How do we shift and adjust? How do we be intentional about the kinds of people we're hiring, our expectations around their hire, and then their own talent development and long-term career trajectory? I think there is also this tension, especially in our industry around the need for scientific expertise. There’s also this need to sort of move on quickly and learn something else. We’re going to have to figure that out as we go, because we do need that mastery of certain expertise. That’s how we get successful clinical trials and move ahead scientifically. So, it will be something I think we'll have to work on together longer term.

PE: Every generation has different values and expectations. How do you believe the new generation of professionals in the industry will adapt to the demands and standards of the pharma industry?

Well, adaptation is not easy for humans, I think change is hard. There’s a reason why a lot of companies move slowly. Now, I think for smaller, maybe startup companies, that seems to be a little bit easier since they can be more agile. You have people that are working at those kinds of companies that can do a lot of different things. They feel very satisfied and very motivated to do a million different things every day. Again, I think we’re going to have to figure this out.

There are a few companies in our industry that are quite large. How do you move a huge structure like that in a way that it can adapt and be attractive to younger professionals that might be coming in? Also, I think what they're really expecting as they join us in the pharma industry is, what are we doing that’s good? What is our return to community, and how do we put a value on that and manage that with of course, the other demands of the businesses that we run?

In an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Sciences discusses the changes expected in the pharma industry that will come with the entry of younger professionals. 

Latest Conference Coverage

US Pharma and Biotech Summit 2024: Getting Pharma Ready for Generation Alpha

Ron Lanton on PBMs and Mark Cuban's Drug Plus

Pharm Exec: Recently, CVS and Express Scripts have announced plans to set up pricing models that follow Mark Cuban’s Cost Plus Drugs model. What do you think the overall implications will be for the pharmaceutical industry?

There's definitely going to be changes. I know we'll probably get into what other pair of eyes are looking at pricing when it comes to the drug industry. I think what Mark Cuban did transformed a lot of things. I still think we have to see where his vision is going because the last time I spoke about this, he had just launched, and he had a plan, but it seemed to go towards vertical integration. He was originally going to start with low cost drugs, and that's actually moved a lot of people. We've seen retail pharmacies that are doing cost plus models and it shows that he's really changed a lot of things for the industry. It's always been this struggle to try to get to the true cost of the drug. When you look at what he's done here with this cost plus company, he has 1000 generics, with 10 brand name medications in about 38 states. It's not a small operation by any means, but he's not a typical businessperson we would normally see. When you look at his interviews, and you see his philosophy of "Hey, I've made my money and I just want to make a change," he's definitely done that. 

Pharm Exec: Specifically focusing on CVS, what were the potential motivations for large PBMs to take action on drug pricing?

From an outsider looking in and seeing all the changes that are happening, it's purely monetary. With more and more retail pharmacies looking at this model and more policy maker scrutiny on what this model is and trying to get to the true cost of a drug, the out-the-door cost is usually what the industry calls it. With them being the largest pharmacy benefit manager, it's almost as if they had no choice but to start changing with the times. 

Like many, I was very surprised when they announced their plan, the cost vantage plan, which entails customers paying drug manufacturers the list price plus a markup and a dispensing fee. They're saying that it most cases, it's going to result in lower drug prices. But, I think that many of us are skeptical. Personally, I'm skeptical, because I've dealt with CVS where we were on the other side of legislation trying to get some fairness put in as far as pharmacy reimbursement. To hear what some of those arguments have been in the past, about how things have been justified or should be justified a certain way didn't hold a lot with me. I'm encouraged that they're trying to make things right, but I think that we need some additional details to understand how this is going to work. I haven't seen it yet but maybe others have. 

Pharm Exec: At this time, can you give us an update on the current state of PBM legislation in Congress? Is there anything on the horizon that you expect?

There's quite a few things. I've done my research and there were multiple bills on point. I'll give you a few that have kind of caught momentum. 

The first that made a lot of news was the Lower Cost More Transparency Act. That bill had a lot of things such as a spread pricing ban. Under their PBM transparency section, they stated that plans offered by large employers would require PBMs would have to report transparency twice a year. Some of those actions include drug selection and acquisition costs, rebates and fees, any out of pocket spending, and rationale behind formulary placement. So, these are things to really get at. 

There were also some privacy issues with that regarding HIPPA, and they also have the gag clause ban. It's currently at the senate. I think things might happen with the senate this year. Hopefully, they won't change any of the language because if they do, it has to go back to the house and they have to work that out. So, I think they want to make as little waves as possible. But, over in congress they have a lot of issues to deal with right now that we've seen in the news, so I don't know if this is going to clear before election time. 

Two more that I'm watching are the Pharmacy Benefit Manager Transparency Act, which prohibits PBMs from engaging in certain activities when managing drug benefits, and the Pharmacy Benefit Reform Act, which basically states what a PBM has to report regarding the amount of prescription drug copay assistance plans that are funded by drug manufacturers and a list of covered drugs under the plan during a certain report period. It's transparency, but it doesn't go to the same level as the other two bills that I had mentioned. 

I think if I had to look at what were my three strongest bills right now, it would be those. 

Pharm Exec: What do you think influenced Congress to take action on PBM transparency?

I think just the business climate as a whole. It's no secret that many independents are closing for these very reasons we've been talking about. That's been an open secret for a long time. We even had a supreme court case about it where in 2020 in state legislatures, PBMs were saying "You can't pass state transparency laws." That argument was shot down. Now, it's just the aftermath of how far can a state take these things and what is their oversight when they pass a law. 

This issue has been around for awhile. I think that congress has also been watching the FTC. They've been very active in what they've been trying to figure out. I know that in 2022, the FTC launched what is called a section 6B study, and that's basically a study where they were trying to investigate PBM business practices. They were asking for some additional information from the other large PBMs specifically about what some of these contracts have. Recently, we've had a couple of senators say that something now needs to be done. 

Pharm Exec: What could be the long-term implications of the Cuban model on drug pricing?

I think it's too early to say. I think right now it moves us towards that true cost of a drug, and I think it puts more pressure on a PBM to stop putting all these other things in the pot to try and sweeten it for them. I also think that this is going to push what has long been missing from PBM oversight, which is CMS. We've had many conversations with CMS over the years about whether or not they are the actual regulator of PBM, is there a federal regulator? We think there is, but every time you ask them about PBM oversight, they point to the non-interference clause. Personally, I think with the passing of the Inflation Reduction Act, that argument is significantly weakened. But, I think over time, that's going to erode. I think that outside forces such as Mr. Cuban's cost plus model is going to help accelerate that. I don't know what the future holds, but I do know that it's working. This didn't happen overnight where PBMs just got control of everything, and it's not going to happen overnight where we kind of unwind what has happened over the last 15 to 20 years. 

Pharm Exec: Is there any other pending legislation that could impact the pharmaceutical landscape?

I think many of our changes that we're going to see will come from the state legislatures. It just seems that they're able to pass things easier. I think we should just take a look at what some of these major market states are doing, and then keep an eye on the FTC. They've finally come out with something that is decisive enough to force PBMs to move faster. 

In an interview with Pharm Exec Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's Cost Plus Drugs model. 

Ron Lanton, Partner, Lanton Law PLLC, Discusses New Drugs Plus Pricing Models

Bill Roth

Nicholas Saraceno: Do you believe the news of Eli Lilly’s digital platform will cause a shift in manufacturers bypassing middlemen to offer DTC sales of Rx drugs via telehealth options?

We talked about it across our entire company on our regular weekly meeting. We view this as more systematic of a number of different macros that are occurring in the industry. I think for me and Blue Fin, we view Lilly Direct as competing with lifestyle pharmacies. They have both the manufacturer branded product available as well as their compounded semaglutide. That's kind of a bigger issue. I think the second piece driving it is, we're looking at an industry shift relative to payer coverage and out of pocket implications. If you look at where the NDC blocks have gone for 2024, it appears we're now over 700 NDC blocks. That's a tremendous amount of growth from the 30 or 40 blocks we had in the middle of the 2010s. I think what that translate into is that it does have manufacturers contemplating whether they should go through the insurance market. You have the rise of the cash pay pharmacies, and then you have the insurance based market. It's a chokehold point on branded products in particular. From what we see, that doesn't give you preferred access. We talked about this at the Inform Trade and Channel conference back in December. For smaller companies, you pay a double digit rate for distribution. So, no surprise you have to come out with wholesale acquisition cost of $1000 a month just to pay for all the channel concessions that are required within. You look at it and say "Do I go through insurance, is it possible to go through insurance?" I think in the case of the GOPs, even if you get coverage, it doesn't mean you're going to get what the patient would consider an affordable out of pocket. There's examples out there that aren't affordable.

The last issue is the biggest issue. That is the challenge with branded products in retail pharmacy. The retail pharmacies making 100% or more of their margins on generics imply that it's all generics or they're massively subsidizing the losses associated with branded prescriptions. From there, 92% of the units or the prescriptions that are going out the door are generic. All of your operational workflows are going to be built around those products. I think the piece that wasn't obvious for me until the latter half of 2023 was that of the remaining 8%, roughly 80% of that 8% is tied up in the top 50 products. That means that less than 2% of all the other products that are flowing out of the pharmacy are brands. If you're new to market or on the tail end of your lifecycle, the chance of them using another generic is really high. We expect more of this to happen moving forward.

Saraceno: Do you envision access being expanded in the future to drugs like Zepbound with growing momentum in the medical community to treat obesity as a medical condition?

I do see the weight management products as being novel therapies and in a relatively unmet need perspective. There are obviously a lot of weight management options already. But, to approach it from an inhibitor perspective is a bit of a novel approach to the class and it sounds like the ethicacy rates are strong. There's a relatively low overall risk profile against a relatively effective clinical profile. There's a need in the market and the question is whether its been priced in an accessible way. I think that's where the cash PAP peice comes into play. We're working with other manufacturers right now, and I would say that the way that they're looking at the cash price of the product, they're going to look at what the best price is and they're going to say that's their cash price. That kind of ties it back into the $35 insulins as well. The reality is that the classic retail pharmacies are not built up to handle a cash market. They're geared and structured to focus on insurance. Cash market has come in another way. One of the question that popped up from my team this morning was why wouldn't the manufacturer just work with a cost plus out there that already has the infrastructure, the marketing, and the support to hand these types of things. I think that's where maybe the whole insurance based cash based model comes into play. You never really know why a company does what they're doing. We're all making some presumptions, but maybe this is a learning experience. Maybe the want to understand firsthand how to navigate this from a payer perspective, a cash pay perspective, where exactly do those price sensitivities lie? I think it's a good example of not seeing new products come out in this type of model before. We've seen direct models that are at the end of their lifecycle. Here, we have new science in a very large disease state, large unmet need, large patient population, and more so, it would make sense to the payers to put these products on because they have to make up for lost rebate dollars that are occurring right now because of the reductions on insulins. We thought that they were good coverage for the GOPs to earn those rebate dollars back, but the payers still had high out of pocket copays and there's high deductible plans. That brings us back to what Coherus did. They went to Cost Plus and they priced it out to go against those high end deductibles. 

Saraceno: Does this create ethical concerns, especially with weight loss drugs, with these telehealth providers more likely to offer prescriptions to patients who may not necessarily need them because of their close ties to the manufacturer?

From the point of view of the manufacturer, if you've ever spoken behind closed doors with a brand manager, they really have two main focuses. They actually do care about the patients that they want their drug to get to. I haven't met a brand manager in my 30+ year career that isn't forwardly altruistic about the reason that they have their product on the market to begin with. I think the second objective is that it is a business model. You have to find enough patients at the right price point to be able to justify the product coming to market. This is a commercial market, and you have to find that right balance. I think where the ethics play in is whether or not the payers have placed the product in a realistic position for affordable access. That's a broad topic we're hitting across the spectrum. The reality is that the plan sponsors want to make sure that the patients have access to products. The patients want affordable access to those products. The challenge is that when you're facing aggressive rebate scenarios the various discounts and statutory rebates that manufacturers are required to pay to the government, how do you pay for those economics and still have something positive at the end of the day? There's a specific number of drugs on the market right now that have hundreds of millions of dollars of sales and they can't make money on the product. The commercial payers have taken the incentive away from price increases. So, you really have to negotiate the price at the beginning of your launch and you can't come to terms with what that price looks like. I can say confidently that there is no more black checkbook by any payer. Medicare has now used national coverage determination multiple times. I think there's a question of value of the product, value of the profile. The problem is that there's no money left here to pay for those novel pieces of science. We knew that this was coming to the industry at some point and the question on our team's mind is "If the manufacturers have an altruistic need, how how do they get the product to the patient?" 

In an interview with Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses changes that will come with the pharma giant's new platform. 

The Impact of Eli Lilly's New DTC Platform on Rx Drug Sales and Patient Access: An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group

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