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Asembia 2025 

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Sales and Marketing

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In an era where business-critical information is exchanged instantly, unsecured communication channels are a significant risk.

Protecting the Pipeline: Secure Communications Strategies to Thwart Espionage and Safeguard Sensitive Information and Intellectual Property

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

It’s arguable that one of the most pharma successful stories from the past few years is the rise and adoption of GLP-1 medications, especially for use with weight-loss. However, as the years continue to pass, more companies are entering the space and competition is getting tighter. Cheryl Reicin spoke with 

about the market and how drug makers and investors are looking to the future.

Pharmaceutical Executive: How is the GLP-1 boom impacting deal flow, valuations, and partnership terms?

 Lily and Novo Nordisk are flush with cash and have been racing to have many shots on goal for the next generation of GLP-1 drugs. While the GLP-1 drugs initially propelled both of these companies into the number 1 and number 2 market cap position of big pharmas, both companies were well aware that one trick ponies don’t last forever in this industry and have been investing not only in the next generation of the GLP 1 drugs but in other therapeutic areas also. These developments also coincide with the patent cliff , where many blockbuster drugs will be coming off patents soon, creating the impetus behind other big pharmas seeking new therapeutic opportunities, the cash situation for Lily and Novo and the patent cliff concerns has caused big pharma to be competitive and generous with valuations but this has been tempered because the real competition to partnership, licensing and M&A for bio pharma companies are traditionally capital provided by venture capitalists and other private investors and the public markets. These sources of funding have been particularly difficult to access post COVID pandemic.

While early-stage companies are starved for cash and big pharma are starved for new product, options-to-buy have come back into vogue. This allows big pharmas to cast a wide net for potential drugs while keeping the research and development (R&D) budgets off the balance sheet. While option agreements provide needed capital and can be non-dilutive to small companies, generally if the clinical results are successful and the option to buy is exercised, the pre-determined acquisition prices will be lower than it would have been if the company had funded the R&D with capital from third party investors.

This subsector of the industry is dynamic and changes rapidly and will continue to do so. The recent announcements have focused on Lily’s new oral GLP-1 and other companies are also gunning for the best oral applications. At the same time, Novo Nordisk has announced massive layoffs, and its market value is down $490 B since its peak in 2024 while still reaping in enormous revenue.

PE: What role are cross-border transactions and foreign investments playing in capturing market opportunities?


 R&D is a cross border global game—great innovation and science wherever it is conducted is valuable. When it comes to production and supply, demand for GLP-1s materially outpaces supply, and cross-border transactions and foreign investments play a critical role in scaling production and expanding market access. Novo Holdings’ acquisition of CDMO Catalent to boost production of Ozempic and Wegovy, as well as AstraZeneca’s $50 billion investment in a new US manufacturing facility, are examples. Global and cross border deals with big pharma or regional players allow smaller companies access to market faster. Also, there is a race to access Chinese innovation which is quicker and cheaper than innovation in North American and elsewhere. The political, tariff, intellectual property protection vulnerability and other concerns that accompany partnering with China allows for an interesting and uncertain future but with that comes opportunity for those willing to take calculated risks. They also keep lawyers busy!

PE: How can smaller companies differentiate themselves in the GLP-1 market?


While Lily, Novo Nordisk, Astra Zeneca and others are conducting internal research for the next gen GLP-1s, they are in a war to be and remain at the cutting edge of this drug class. Smaller companies with innovative improvements such as those that provide oral delivery, lower dosing frequencies, broader metabolic benefits, new indications, lesser muscle loss, improved gastrointestinal tolerability and other lessor side effects and /or lower cost alternatives are most attractive, and several are garnering significant valuation premiums. Also, innovations for targeted subsectors of the current market are desirable as a way of increasing market access. Unique models for self-pay may become more important as side effects diminish and the drugs become more of lifestyle aid.

PE: What are the key deal considerations for GLP-1 companies?


The big pharma companies are entering into deals with multiple companies to address the same or similar problems. A big risk for a small company that is granting exclusivity to a big pharma is that exclusivity is likely not to be reciprocal––especially in the fast-evolving GLP-1 market. Smaller companies must focus on monetary compensation or claw back rights if a big pharma is no longer prioritizing its technology. Negotiating the right incentives and protections can be critical.

Also, as the GLP-1 boom continues to accelerate, dealmakers are navigating a complex set of considerations that go beyond clinical promise. Supply chain vulnerabilities are front and center: GLP-1 manufacturing is intricate, with many therapies relying on materials from many different and sometimes less stable regions. As a result, thorough supply chain due diligence is crucial in deals for GLP-1 companies.

Regulatory hurdles are another key factor. Strict aseptic manufacturing requirements for injection-based GLP-1s come with steep production costs. Dealmakers must also anticipate potential increased regulation that could further impact margins. Skyrocketing valuations for developers of early-stage GLP-1s without strong clinical backing also raise concerns about overpayment.

Competition in the GLP-1 market is intensifying as well. Biosimilars for first-generation GLP-1s like semaglutide are expected in Canada and Brazil by 2026. Compounding pharmacies also add pressure, making lifecycle management a critical deal consideration. Limited insurance coverage for GLP-1s and the resulting prevalence of self-pay channels in this market mean that dealmakers targeting GLP-1 companies must take into account their pricing strategies, distribution channels, and cost efficiency. Deals covering international markets also face unique challenges, including slower regulatory approvals and the absence of e-prescription infrastructure, which can complicate commercialization strategies.

The GLP-1 market is experiencing significant growth, driven by companies like Lily and Novo Nordisk, who are investing in next-generation drugs and other therapeutic areas. The competitive landscape is shaped by patent cliffs, venture capital challenges, and the resurgence of options-to-buy agreements. Cross-border transactions and foreign investments are crucial for scaling production and market access, with China emerging as a key player. Smaller companies can differentiate through innovative delivery methods and cost-effective alternatives. Key deal considerations include supply chain vulnerabilities, regulatory hurdles, and the intensifying competition from biosimilars and compounding pharmacies.

As the GLP market begins to settle, pharma companies and investors are looking to predict what comes next.

The Future of GLP-1 Investment: Q&A with Cheryl Reicin

What Diagnostic Areas are Investors Focusing On?

Pharmaceutical Executive: How have recent developments in genomic research transformed cancer care?

 There’s been a lot of change in diagnostics in general, but particularly in oncology over the last five years. It’s clear that next gen sequencing has created a new paradigm that has enabled us to come up with new tests and put them in clinical use. The way that the industry has transformed has gone from a model driven by volume (even if the test was painful) to a more responsible model that generates evidence in a way that ensure durable ongoing reimbursement for a test, having it released to the marketplace, and having it adopted by physicians.

 Diagnostics 2.0 is responsible launching of molecular diagnostic tests that focuses on strong, robust scientific evidence that demonstrates not just the clinical validity of a test, but that it has use for physicians. It changes the way that physicians practice. We’re very focused on physicians as our allies and the people we’re enabling to do their job the way they need to do it.

Diagnostics 2.0 is a focus on developing evidence very early on.

PE: What are the core tenets of diagnostics 2.0?

 The core are robust science supported by machine learning and AI technology. It is robustly completely clinical studies and ensuring that those studies are focused on the patient population for which the test is intended. It’s also about making sure that the data demonstrates clear patient and physician benefit in the treatment path and an ongoing commitment to generate evidence during the life of the test.

PE: What diagnostic areas are investors focusing on?

 There’s a few areas that investors have been focused on for several years. Some of them have come and gone. Early detection was getting a lot of focus, and it hasn’t gone away. It’s still getting a lot of attention from investors and companies. Today, however, in oncology, areas like prognostic and predictive diagnostic clinical tests that fit into the physician workflow and provide additional insights are clearly getting attention.

Another area is minimum residual disease (MRD), which is getting a lot of traction for a number of reasons. It’s very helpful for patients who have been treated, whether by therapy or surgery, and you’re looking for residual disease state or recurrence. This test can be used at multiple time points after the treatment. It’s an interesting new area and getting a lot of attention.

One thing we’re seeing is that the existence of MRD could be a potential endpoint in clinical studies because it’s proving to be a good indicator.

Marc Stapley, CEO of Verasyte, explains how investors are reacting to recent advancements in cancer care.

Understanding Drug Launches and the Forces that Dictate Pricing

Jason O’Neill, author of 'The Secrets of Successful Drug Launches' and former Dendreon CEO, discusses the current state of the pharma industry and the factors that are impacting its growth potential.

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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.

Don Sortor

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