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Latest Executive Roundtables

Asembia 2025 

Topic

Sales and Marketing

1rem

Authors

Iilun Murphy, MD, serves as the director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER).

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval. 

FDA Offers GDUFA III Insight 

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

What Impact will Direct-to-Consumer Sales Have on Drug Prices

One of the biggest issues Americans face is the high cost of healthcare in general. Drug prices are a particular pain point, with many medications costing Americans more than they can afford. Multiple administrations have attempted to address this issue, but it remains a major problem. The current administration is attempting multiple ways of reducing drug costs, with the promotion of direct-to-consumer drug sales being one of the proposed solutions.

Michael Grosberg, vice president of product management, spoke with 

 about direct-to-consumer sales and what impact they’ll likely have on drug prices.

Pharmaceutical Executive: How might direct-to-consumer drug models impact pricing?

I think we can all agree that access to life-saving medication is a basic human necessity. From every conversation I’ve ever had with a pharmaceutical manufacturer, they want nothing more than to get their drugs to the patients that desperately need them.

We talk a lot about lowering drug prices, but we’re not talking about lowering them at the right point. Where it matters is at the pharmacy counter. Direct-to-consumer sales can be helpful in an area where patients are uninsured or heavily under-insured. The reality, however, is that the majority of Americans are insured, either by a government plan or through a commercial plan from their employer. It’s very unlikely that insurance plans will pay for medication that we buy directly from a pharmaceutical manufacturer.

The fact that this channel exists would in no way help us obtain those medications. In the areas of drugs that are not covered or individuals with high deductibles, this might be a way to save money on medication. It will likely impact very few therapeutic areas and very few patients.

PE: Who benefits from direct-to-consumer drug sales?

 If we think generally about therapeutic areas or classes of medicine that are unlikely to be covered by insurance, some of the novel drugs may not be covered by insurance for people using them for certain indications. This could be GLP-1s, which may be covered for diabetes but not weight-loss. That could be an area where patients benefits. A lot of dermatological drugs may not covered, so patients might be able to afford those.

If you think about novel or specialty medicines that aren’t covered by insurance, those medicines carry very high price tags. Whether it’s in the US or elsewhere in the world, they’re very expensive. With-or-without insurance, patients who need them won’t be able to afford them, whether we align ourselves to other countries or not. They’re still unaffordable.

PE: What are effective ways of reducing drug prices?

 We must look at the overall gross-to-net bubble and the incentives placed throughout the distribution chain. The PBM rebates that drive formulary placement for branded medication created a tremendous amount of upward pressure on consumer prices at the pharmacy counter. The insurance and PBM and business model for generic medication creates a situation where copays for generic medicine might be more than the medicine without insurance. That copay is used to subsidize a reduction of my policy premium.

If we are serious about reducing the cost of medicine to patients, we must look at the way that the entire channel is structured.

Michael Grosberg discusses how people with insurance will be impacted by D2C drug sales.

Who Benefits from Direct-to-Consumer Drug Sales

With insured patients less likely to benefit, who actually does benefit from D2C?

How is the Obesity Medication Marketing Landscape Evolving?

Derrick Gastineau, head of marketing at Currax Pharmaceuticals, spoke with 

 about the marketing landscape for weight loss medications and how it’s a therapeutic area where its vastly important to reach patients with the best information possible.

Pharmaceutical Executive: How is the obesity medication marketing landscape evolving?


 Evolving rapidly is the short answer. I came into this space about four years ago and if I’m being honest, I don’t think I knew what a wild ride I was signing up for. In the past two years, we’ve seen such an evolution with the major pharma players joining this space with the GLP-1s and the attention that’s brought to the disease of obesity. It’s just a massively positive thing.

It also comes with challenges. For a smaller company like us, we’re trying to navigate and figure out where we can bring the most value to patients who are out there seeking solutions living with obesity and the HCPs treating the disease. We’re really just trying to make sure that people understand that these drugs have been a massive advancement in our ability to treat this disease, it’s not a one-size-fits-all solution. We want to ensure that HCPs and patients have the education, knowledge, and resources that they need to make the most informed decisions.

What roles do patient-centered strategies play in the obesity medication marketing strategies?


 Obesity as a disease state, more so than a lot of other therapeutic areas, really presents that shared decision making opportunity for HCPs and their patients. It’s more of a consumer-driven disease state. That impacts our strategy about where we bring forth information about our product by figuring out how to bring forward the benefits, safety information, and a holistic picture of the drug and what it offers.

Along the way, we’re trying to craft that message to help patients understand the risk-profile of the drug but also allows them to see how it fits into their particular life. We’re meeting them where they are to help them understand the product and how it may fit into their specific situation.

PE: Do patients respond well to story-driven campaigns?


 Across the board, humans value authenticity. With our recent campaign, we set out to focus on real patient stories. We found people who had been on the product who were willing and courageous enough to bring forward and share their story. When you do that, with the actual lived experience of the individual who lived that journey, that resonates with people. We’ve tried to be intentional with bringing forward multiple stories because the truth with obesity is that there’s a lot of heterogeneity with the disease, not only from patient to patient but also within a singular patient.

Bringing forward those multiple scenarios and stories helped connect across the spectrum of different patients and the challenges that they are facing.

PE: How can marketing teams combat misinformation in the obesity medication space?


 It’s not my job to police the information, I’ll leave that to the regulatory bodies and the elected officials. What we can do is ensure that we’re counterbalancing that with accurate information that is presented in a fair and informed way. This ensures that patients have access to fair and balanced information alongside that misinformation that they’re going to run into that can help them make the best decision.

Making sure we understand the avenues that they’re seeking information

Making sure we have a presence on those platforms

Derrick Gastineau discusses how the focus on weight loss medications has shifted in recent years.

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic treatments. Multidisciplinary approaches are essential for optimizing care, emphasizing the importance of collaboration among oncologists, radiologists, and neurosurgeons to tailor interventions based on individual patient profiles and tumor characteristics.

This whitepaper presents a structured analysis of prior authorization outcomes for RA treatments requiring medical benefit coverage. It examines real-world access barriers from the perspective of payer decision patterns, documentation requirements, site of care, and plan type. Unlike claims-based studies or survey-based research, this analysis draws from actual prior authorization cases, providing a direct window into the real-world challenges faced by prescribers and patients alike.

New Data Reveals What’s Behind Delays and Denials in RA Care 

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiotherapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and potential side effects. Ongoing research and clinical trials continue to refine these strategies.

Case study on how one mature/late stage biopharmaceutical brand leveraged SamaCare’s insights and intervention platform to decrease administrative related discontinuations of their drug and maintain market share during a biosimilar release. 

Iilun Murphy

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