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A seminar shares key observations and learnings from the first round of direct price negotiations.

Asembia 2025: Understanding the Inflation Reduction Act

Market access is about aligning internal strategies with external realities that often change without warning and at a frequency likely not experienced by other biopharma executive roles.

The Hardest Job in Biopharma? The Vice President of Market Access

CMS’ draft guidance on real-world data study protocols marks a significant move toward transparency and rigor in Medicare coverage decisions.

Making Real-World Evidence Work for Medicare: What CMS’ Draft Guidance Gets Right and What Needs Work 

Four tips for midsized companies when entering new global markets.


Bringing Biotech Innovation Across Borders 

How to maximize market-entry performance for new pharma products in an increasingly competitive launch environment. 

Using AI to Predict Launch Success

How Tariffs will Impact Localized Production

Pharmaceutical Executive: Will tariffs cause a shift towards more localized production?


 These days, predicitons don’t age well. Whatever I speculate may or may not still be relevant in a few months. However, assuming this global decoupling in the pharmaceutical industry continues, every company needs to look at how they are going to manufacture a product and bring it to market.

If there is a supposed trade war with China, that country was a big market for multinational companies over the last 20 years. Since 2002, when China entered the World Trade Organization, China’s emerging middle class became potential customers, not just for pharma, but for medical technology in general. This is assuming that this trend persists, and this new, decoupled world model happens, every company needs to look at what their growth ambitions are. Where they manufacture their products will be important, but where they want to grow will be more important in the long term.

Videos

Arda Ural discusses the possible impact on how companies plan for growth based on the impact of the tariffs.

Balancing Cost Control with Innovation Amidst Tariffs

Pharmaceutical Executive: How can companies balance cost control with innovation and investment in R&D?


 This is where the macro-policy meets the micro-impacts from a company perspective and how they seek to mitigate this very large potential increase in cost. It’s fascinating because in this particular sector, from a tax perspective, the predominance of companies have a very specific tax structure. It lends itself very well, from a tax-planning perspective, to not having tariffs.

When tariffs are introduced, it has an opposite effect. What we have right now is a situation where a lot of costs are built into a product’s cost. That is optimal. From a tariff perspective, it is suboptimal. We have R&A and IP that’s not in the US. We pay for that in the form of a tariff, when we have them.

When we think about innovation, what we’re seeing is two schools of thought. We’re seeing discrete modeling for short-, medium-, and long-term and there’s an umbrella of uncertainty the encapsulates all of it. We know that in this industry, you’re dead if you’re not innovating. Where do you innovate, where do you put that money, and how long will this current state of play be in focus?

Whereas R&D decisions never contemplated trade before, now they absolutely must. The key is balancing that. You can certainly be an alarmist and prepare for millions in tariffs. What about the long-term impact on the industry and businesses? Decisions are being made on potential impact to costs, the more agile companies are saying ok, putting that in the plan, but still thinking big picture.

Lynlee Brown discusses the decisions that companies must make to adjust to the tariffs while also ensuring the ongoing innovation continues.

Kimberley Chiang, vice president of biopharma commercial solutions at CoverMyMeds, discusses how the industry leverages data and technology to identify and address affordability issues before they become a barrier to patient access.

Proactively Identifying & Addressing Affordability Issues with Predictive Analytics

 video interview, Kimberley Chiang, vice president of biopharma commercial solutions at CoverMyMeds, discusses "The 2025 Medication Access Report." She highlights gaps in data-sharing and cross-functional collaboration as major bottlenecks that cause delays, rework, and increased patient burden. Chiang shares that only 3% of patients utilize support programs due to a lack of awareness. A large majority of the report's respondents plan to expand funding for patient support programs within the next 5 years due to large number of new therapies expected to come to market.

Pharmaceutical Executive: How can the industry leverage data and technology to proactively identify and address affordability issues before they become a barrier to patient access? What role does predictive analytics play in this?


 The ability to be proactive in identifying and addressing those gaps requires a centralized data system and a greater ecosystem. The ability to leverage data requires that data to be comprehensive. Predictive analytics will run on strong data models, and in order to have those, you need a seamless experience.

How do we capture data along the patient journey, and how do we ensure that predictive analytics will help us analyze that data? It all starts with the ability to streamline the data. If we don’t begin to bring data sources together in real and important ways, we will not be able to properly allocate our resources and spending in pharma. There will be some forecasting and assumptions, but with some real-world data (RWD) integrated.

Think about the addition of an integrated data model with RWD and what that could do for better predictive analytics. Our assumptions would be lowered, and our predictions would be better. We would have optimized predictability for where the funding needs to be directed.

The second piece of that is you have better clinical outcomes if you can identify in advance. You will not have patients walking away from their prescriptions, which continues to be a challenge. We are also seeing significant increases in claims denials. About 73% of claims are denied. What do we do when claims come back denied?

With predictive analytics, there are affordability and co-pay types of expansion. There’s also focus and energy around overturning claim denials. How do we ensure that the claim was denied for righteous reasons? The ability to have all of the data integrated and run it through predictive analytics alongside RWD would help us improve clinical outcomes. Those patients will not be denied medication that they need and rightfully deserve.

Doing all of this more efficiently will remove costs from the ecosystem. There is significant fragmentation in all of the processes. To bring all of that data together to understand the market access for a single brand launch, bio-pharmas must piece together all of that information. Bringing data together and using predictive analytics with strong data models will help these companies do so more efficiently. It will take costs out of the system and speed patients onto the right medications. Healthcare providers will also spend less time waiting for the patient to get approved.

Peter Ax, Founder & CEO of UpScriptHealth, explores ways that digital health platforms can assist pharma companies seeking to maintain accessibility and manage cost pressures. 

Digital Health Platforms as Strategic Partners for Pharma Companies

 Video Interview, Peter Ax, Founder & CEO of UpScriptHealth, discusses the impact of tariffs on the pharmaceutical industry, highlighting that tariffs will initially affect pharmaceutical companies, particularly those dealing with branded medications and generics. He notes that tariffs could lead to strategic supply chain changes, including potential US manufacturing shifts. Digital health platforms like UpScriptHealth aim to reduce friction and costs in healthcare, potentially offsetting tariff impacts. Ax emphasizes the importance of telehealth in ensuring medication availability and the strategic partnerships between digital health platforms and pharma companies to improve patient care and access. He also praises Pfizer's approach to delivering comprehensive care rather than just selling medications.

How can digital health platforms become strategic partners for pharma companies seeking to maintain accessibility and manage cost pressures?

The light bulb has gone off in pharma, right? Every single pharma company we're aware of is we're in some level of discussion with about the platform that works for them, the direct to patient solution that works. And what we've seen is a massive shift from sort of simple prescribing of a medication when someone has a migraine headache, letting them try, letting that patient try a new medication, perhaps, or shifting them to a different medication, to what is a really complex ecosystem of healthcare. We're now involved in platforms for pharma companies where we will send patients to injection centers or to infusion care centers. And so the level of care and the complexity of the of the patient flow is really evolving to a to a much more complex world that's sort of digital health 2.0

For us, the way we think about it, and the way that really helps pharma, if you think about all the problems we have in the current model for the delivery of care, right? Patients can't get appointments very quickly. Patients don't know what that cost of appointment is going to be for them. They don't know what their co pay is. They don't know what insurance is going to cover. They don't know if it's in network out of network. They oftentimes don't know where the fulfillment is coming from, and whether or not there's a supply of the medication that they need or the treatment that they need. We can solve all those problems by working with our pharma partners.

So, when a pharma company decides to be on the UpScriptHealth platform, it's not just a simple discussion of, we're going to put a button on your website. Patients will click on that button and see a telehealth provider. It's a much more complicated discussion about what is the patient journey, and how do we really make that patient journey a good experience, a positive experience, literally changing the paradigm of healthcare. I think, by the way, that's why Pharma is so interested in these platforms, because they realize they have to help be an instigation for the changing of how healthcare is delivered.

In this Pharmaceutical Executive Video Interview, Peter Ax, Founder & CEO of UpScriptHealth, explores ways that digital health platforms can assist pharma companies seeking to maintain accessibility and manage cost pressures. 

Peter Ax, Founder & CEO of UpScriptHealth, explores how tariffs could affect the availability and accessibility of specific medications, particularly for patients relying on direct-to-patient telehealth.

Potential Tariff Impact on Availability & Accessibility of Medications for Telehealth Patients

Beyond cost, how might tariffs affect the availability and accessibility of specific medications, particularly for patients relying on direct-to-patient telehealth?

If you think about the way direct-to-patient telehealth works, is we allow a consumer to go on the web and talk to a clinician right away, assuming they're prescribed some medication, then we have to somehow assure availability, or at least have some insight into availability.

One of the real benefits of our platform is that we're able to partner with pharmaceutical companies to be sure that we have supply available, or that they've partnered with a fulfillment partner that is assured to have supply available. In a lot of ways, we can solve kind of nuances in the market that makes supply difficult because of tariffs. Think about a pharma company that enlists engages with UpScript to develop a platform. We end up partnering with a fulfillment partner, and we can assure the supply through that fulfillment partner, because we're dealing with the manufacturer, and the manufacturer can help make sure that medications are accessible. So, in a lot of ways, telehealth can mitigate the impact of tariffs and the and the changes in supply that may occur.

I think only time will tell which medications it impacts and how it impacts, whether it impacts generic drugs more than it does branded drugs. There will, of course, be some level of impact, but it won't be across the board. It's going to be in different pockets, for example. It will be easier to get medication in New York City than it is in Des Moines, Iowa, for example, and so telehealth can help sort of mitigate those differences.

In this Pharmaceutical Executive Video Interview, Peter Ax, Founder & CEO of UpScriptHealth, explores how tariffs could affect the availability and accessibility of specific medications, particularly for patients relying on direct-to-patient telehealth.

Addressing Challenges to Access and Advancement of Myeloma Therapies

PE: Are there any particular therapies that have been historically challenging regarding access?

As I noted, myeloma is in many ways an exciting disease in the sense that when I started as a myeloma doctor over 20 years ago, the average patient lived maybe one or two years with this disease, and sadly, the disease damages people's bones. It affects their immune system, so patients are often in a lot of pain. They can be in kidney failure, and they can have repeated infections. While it still remains a terrible disease, we've had a huge improvement over the last 20 years, where now the majority of our patients are going to live more than a decade. So, it's really been a success story and sometimes I summarize the success with four different treatments that all start with the letter T, and that's an easy way for me to remember them and to describe them. 

Things that have really helped patients are what we call triplets or three drug combinations. Myeloma is a complicated disease, so it isn't one drug that overcomes it, it's that right combination. The second advancement was what we call transplants, or autologous stem cell transplantation, where we use people's own stem cells. We harvest them, we give them a big dose of chemotherapy, and then give them their stem cells back. The third has been clinical trials, because we know that trials have investigated new therapies and have given so many patients an opportunity to respond to something that works so well, even before it is formally approved. And then most recently, something called Car-T cell therapy, where we could actually take T cells from a patient, kind of like a soldier cell that we can train, train it against their own myeloma and give it back. When I started, that would have sounded like a Star Trek movie, but this is actually what we do now.

So, we look at these four T's, triplets, transplants, trials and Car-T cell therapy. They've really moved the needle in myeloma. However, the sad reality is that many patients have had less access to that internationally. Here in the United States, in particular, within the African American and Latino American populations, we've seen that disparity, and that's one of the reasons why we've created the M-Power program that I described to ensure that we do everything that we can to reduce that disparity.

When I look at what is happening now, what we're doing with these four therapies and more, I really do think we're moving closer and closer to a cure, and indeed, closer and closer to controlling it in the vast majority of our patients.

PE: What are the significant challenges hindering the advancement of multiple myeloma research?

There are a lot of things that make us humbled in what we do when we study a disease like multiple myeloma. The biology of myeloma is complicated, and so it takes complex approaches to overcome it. In a disease that is not as well-known and is not as common, there tends not to be as large a funding mechanism or awareness of it, and that's one of the reasons why we do programs like our Iceland expedition to raise awareness.

Lastly, I would say that it's so important that we collaborate together. No one place can see enough of a rare condition to fully grasp it, and that, I think to some degree, has been the superpower of the IMF. We created something called the International Myeloma Working Group. This is now almost 300 individuals around the world who are true experts in myeloma, and it brings them together in a unique way to think together, to strategize together, and to collaborate and research. Everyone has their own affinity to their institution, but together, we can do more, and we can do better. Part of the huge improvement of myeloma has been because of this group. As we work towards the future, we want to continue that. We want to work ourselves out of a job. We want to find a way that we can genuinely have patients cured of this disease, and if not cured of it, as I often say, we haven't cured diabetes, we haven't cured high blood pressure, we can try and control it. I do think we can do even better than that in myeloma with time, but it is an uphill battle, although we've had some tremendous successes of late, and I feel the enthusiasm of the myeloma community as we look into the future.

In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of access and advancement of myeloma therapies. 

Video Series

Addressing Challenges to Access, Advancement of Myeloma Therapies

Making a big change mid-career is no small feat, which is something Elizabeth (Beth) Garner, chief scientific officer for Ferring Pharmaceuticals, knows from experience. In this exclusive interview with 

®, Garner reveals what it was like transitioning from working as a gynecologic oncologist and seeing patients to working in pharma, specifically in clinical trials.

Enjoy this video and want to watch more? Check out the full Pharm Exec Podcast episode.

Elizabeth (Beth) Garner, chief scientific officer for Ferring Pharmaceuticals, is responsible for US clinical development, medical affairs, pharmacovigilance, project planning, and regulatory affairs at Ferring Pharmaceuticals US. Garner has nearly 30 years of experience in the medical industry. Prior to joining Ferring in 2022, she held chief medical officer roles for ObsEva, a biotechnology company focused on women’s health, and Agile Therapeutics, a women’s healthcare company. Earlier, she held leadership roles in medical affairs at Myriad Genetics Laboratories and clinical development at Abbott Laboratories and Merck Research Laboratories. Garner also holds a medical degree from Harvard Medical School and has practiced in obstetrics, gynecology, gynecologic oncology, and internal medicine at Brigham and Women’s Hospital and Massachusetts General Hospital. In addition, she holds a master’s degree in public health from Harvard’s T.H. Chan School of Public Health and a bachelor’s degree from Mount Holyoke College in Massachusetts.

 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.

Elizabeth (Beth) Garner, chief scientific officer for Ferring Pharmaceuticals, discusses what it was like transitioning from working as a gynecologic oncologist and seeing patients to working in pharma, specifically clinical trials. 

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