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Unlike for individuals or entities providing or receiving services related to in vitro fertilization (IVF), the Alabama IVF Act does not grant immunity to manufacturers, but it limits damages for their violations to the cost of an IVF cycle.

The Legal Environment for IVF and Other Assistive Reproductive Technology After Alabama’s Supreme Court and Legislative Decisions

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

In a turbulent era for the life sciences, leadership demands clarity, resilience, and adaptability. In this candid podcast conversation with 

, Ken Banta, founder and CEO of The Vanguard Network, shares high-level insights on what CEOs can do to thrive amid the disruption—from regulatory agility to cultural resilience. The corporate strategy expert and author of the new book 

 explains why the best leaders are the best learners—and how prioritization, honesty, and boldness will separate those who merely survive from those who shape the industry’s future.

Navigating a “new maze” at the FDA and its personality-driven complexities

R&D bets shifting toward proven winners, leaving long-shot breakthroughs behind

Building trust and culture through transparency in uncertain times

The call for leaders to embrace continuous learning—from AI startups to lab bench innovators

 Click below to listen. View/download the transcript 

Ken Banta, founder and CEO of The Vanguard Network, reveals the mindsets and moves biopharma leaders need to not just endure—but rise above—the current age of industry disruption.

The Rx for High-Performance Leadership: Cutting Through the Chaos

Recent advancements in COPD treatments are providing patients with potential new first-line treatments. 

 spoke with AeroRx Therapeutics’ CEO Dr. Ahmet Tutuncu about new therapies in this space, along with how big pharma companies are looking to acquire companies developing these therapies.

Pharmaceutical Executive: How are delivery methods for COPD treatments changing?

 There has been a recent shift toward more personalized, convenient, and effective delivery systems including single-inhaler dry powder systems. However, nebulizers – a proven and underleveraged modality – remain essential, especially for COPD patients with physical or cognitive impairments. Novel nebulized devices will focus on enhanced drug delivery and patient usability.

PE: Should the industry expect more acquisitions of companies developing COPD treatments?

 Yes, more acquisitions should be expected as COPD remains a high-unmet medical need and incidence continues to grow and a continued need for more effective therapies. Large pharmaceutical companies such as Merck and GSK have recognized the increasing need to deliver effective medicines to COPD patients, as demonstrated by their recent multibillion dollar COPD product acquisitions. This trend reflects the high value ascribed toward effective COPD therapy and a competitive market to bring new treatments to patients.

PE: What treatments are coming next in the nebulized COPD space?

 New long-acting bronchodilators, such as nebulized glycopyrrolate and revefenacin, which show improved efficacy and reduced side effects, as well as Merck’s ensifentrine, a first-in-class dual-acting bronchodilator and anti-inflammatory recently approved by the FDA, have expanded treatment options. However, there remains a high-unmet need for maintenance therapy solutions for older and sicker COPD patients with persistent symptoms. AeroRx is developing a novel LABA/LAMA combination product, two proven monotherapies, to address these remaining treatment gaps for moderate-to-severe COPD patients.

PE: What made AeroRX decide to come out of stealth?

AeroRx recently announced Phase 2a data for its lead program AERO-007, where both low and high dose AERO-007 was well tolerated and achieved rapid and sustained 24-hour bronchodilation in COPD patients. AERO-007 is positioned to be the first LABA/LAMA combination bronchodilator drug available for nebulization delivery for moderate-to-severe COPD patients. With these exciting data, AeroRx will continue pushing forward in the clinic toward Phase 2b and beyond.

Recent advancements in COPD treatments are focusing on personalized and effective delivery systems, including single-inhaler dry powder systems and novel nebulized devices. The industry anticipates more acquisitions of companies developing COPD therapies due to the high unmet medical need and growing incidence. New treatments, such as long-acting bronchodilators and dual-acting bronchodilators, are expanding options, yet there remains a need for maintenance therapies. AeroRx's AERO-007, a LABA/LAMA combination for nebulization, shows promise in addressing treatment gaps for moderate-to-severe COPD patients.

The AeroRx Therapeutics CEO discusses new treatments and how the industry at large is reacting to them.

Creating Momentum for COPD Treatments: Q&A with Dr. Ahmet Tutuncu

It’s been a tumultuous period for the pharmaceutical industry. Over the past 5 years, the market has seen massive upswings and devastating drops due to events like a global pandemic and a chaotic regulatory environment emerging in the United States. As major events occur around the world, other markets are starting to adapt to survive the changing landscape.

What role will Saudi Arabia play in the biotech industry?

One such market is Saudi Arabia. While the country has been able to build its economy from selling oil, that market might not have a steady future. The country, actively looking to expand its industrial diversity, launched a program titled Saudi Vision 2030 which lays out a plan to achieve its goals in the coming years.

While this program has been active for almost a decade, it’s starting to make big movements into the biotech sector. Luminary Therapeutics is one of the companies that’s opened communications with the Saudis in an attempt to get a foothold in an emerging market. Luminary’s CEO and founder Jeff Liter spoke with 

 about the work it’s doing with CAR-T therapies, the current investing climate, and why the Saudi market is so appealing at the moment.

When asked about the key challenges CAR-T is facing, Liter says, “First, there’s the cost and expense of a centralized manufacturing CAR-T therapy. Most of what’s in the commercial market space is autologous. So, about 85-90% of the products cost, on average, anywhere from $180,000-210,000 just to make. Which means in the marketplace, they’re priced anywhere from $475,000 all the way up to $2 million.”

He continues, “So, I include cost and centralized manufacturing as a single problem, and that's one of the things that we at Luminary are highly focused on. We're using a mechanism called allogeneic (as opposed to autologous) CAR-T therapies, where we can bring the cost down to under $10,000 per product, and we do that by the ability to make 450 doses out of a single healthy donor. Certain allogeneic products have not fared very well in the clinical trials, with NK cells being an example that disappointed in their initial clinical trials. We use Gamma Delta cells, which makes us extremely different.”

The cost of medicine is a key talking point across the pharmaceutical industry. While the high cost of CAR-T therapies has been noted as an issue, it’s not the only problem the sector is facing. According to Liter, it’s also a matter of results.

“The second big challenge is, so far, CAR-T therapies are only showing just tiny promises, embers of hope for solid tumors,” he says. “Luminary Therapeutics has three different new approaches for solid tumors with CAR-Ts that we’re convinced that one or some combination of our three approaches will finally knock that door down. Solid tumors make up about 80% of the overall cancers out there, so these are the two big industry challenges that currently exist for oncology.”

Luminary uses its own unique platform to develop its therapies. The Gamma 2.0+ platform develops two subset solutions, which Liter explains increases the therapies’ effectiveness against cancers. He also explains that, at the moment, there’s only a handful of companies even using Gamma Delta as their chassis due to it being an under-studied immune cell. And out of that group, Luminary is still taking a unique approach.

He says, “We're the only company that we're aware of today that uses the two primary subsets of Gamma Delta cells. All the other Gamma Delta cell companies out there use one or the other. That combination of using both subsets gives us the immediate strike of shock and awe, as we like to say, where it clears out as many of those pathogenic cells as it can. And then the V Delta ones are effectively the other subset. The Gamma Delta don’t last, but the V Delta do. Not only do they last in the body up to three years, but they can also effectively hone to tissue or solid tumors. We also cloak these cells (in a fashion) to make them effectively non detectable by the recipient but still functional.”

As Liter describes it, Luminary is working in an emerging sector of another emerging sector. The goal of his approach is to bring new ideas to the space that he believes are sorely needed.

Of course, while working in a small and unique emerging sector is exciting, it comes with challenges. Mainly, finding funding can be difficult. That’s true under normal circumstances, but the modern landscape has things even more difficult for companies like Luminary. This forced the company to develop new strategies for maintaining its runway.

Liter explains, “Biotech, and cell therapy in particular, have struggled to attract the attention of investors over the last two-and-a-half years. There was a big bump of investment when first CAR-T came out for blood tumors, but that therapy hasn’t made the next to step a new therapeutic that is highly effective. As a result, investment has been lacking. We have been fortunate enough to get a combination of financing from some high net-worth individuals (not the traditional VC route) and grant dollars, which we’ve become very good at getting through some very hard work. In fact, we have four phase-one clinical trials currently going with less money than most people would take to even do one.”

Liter provided the opening remarks and keynote address at the Saudi Biotech Welcome Reception at this year’s BIO International in Boston. His Excellency Abdulaziz Hamad Al-Ramaih, vice minister of health for planning and development in Saudi Arabia. In his role, he ensures that the country’s health-sector planning aligns with the Saudi Vision 2030 goals. He plays a critical role in shaping Saudi Arabia’s growing health care industry.

According to Liter, Luminary has a strong relationship with the Saudis and plans to be a key player in the country.

“At this year’s JP Morgan conference in January 2025, we bumped into and engaged with NEOM, which is an investment group focused on bringing various technology industries, including biotech, to the Saudi region, specifically the Neom region, where a new city is being developed as part of the country’s vision for 2030.”

He continues, “They were highly discerning and looking for disruptive technologies that they felt had promise. Further conversations have suggested that Luminary is a fit, so we took the extra step to visit with the hospitals, clinicians, the Ministry of Health, and the Saudi NIH. We are currently going to be meeting with the Saudi FDA. There's potentially a process where we could actually create a business there and not necessarily feel that we couldn't compete against the Novartis, BMS, and Gileads of the world. We see an opportunity where we could build a franchise and a business right in the kingdom of Saudi Arabia.”

According to Liter, biotech is one of the sectors that the Saudis are very interested in bringing into their country. The plan is to localize it and then build it out to part of the country’s diversified revenue stream. Aside from moving the country beyond oil, the goals of the program are to bring new types of jobs to its citizens and expand its export offerings.

This provides a big opportunity for Luminary.

“Given the lack of interest of investment in the US and in Europe for new, disruptive CAR-T therapies that are beyond CD19 and BCMA, single target CAR-T therapies are not being appropriately capitalized,” Liter says. “The fact that the Saudi region is willing to embrace these new disruptive technologies will bring benefits to the entire industry, well beyond Saudi Arabia.”

He continues, “We're certainly hopeful that once we get our products into the clinic for both the allogeneic-cost component and the solid-tumor component, that will advance the entire cell therapy industry in multiple ways. Now, both solid tumor and allogeneic Gamma Delta cells must be proven in the clinic. This affords us that opportunity to do that, and if our hypothesis is right with new novel targets, then I think the entire field will advance. Given that we have an allogeneic product, we could ship to anywhere in the world from a single manufacturing site.”

Saudi Arabia is diversifying its economy beyond oil through its Vision 2030 initiative, with a focus on the biotech sector. Luminary Therapeutics is exploring opportunities in this emerging market, particularly with its cost-effective allogeneic CAR-T therapies. These therapies aim to address the high costs and limited efficacy of current CAR-T treatments, especially for solid tumors. Despite funding challenges, Luminary is leveraging relationships with Saudi entities to establish a presence in the region. This collaboration could advance the cell therapy industry and contribute to Saudi Arabia's economic diversification.

Jeff Liter, CEO of Luminary, discusses his company’s approach to CAR-T therapies and why the developing Saudi market has potential.

Developing the CAR-T Sector in Saudi Arabia

Despite the often extremely high cost of drugs for orphan diseases, the tendency among health plans is to avoid risk arrangements, particularly for treatments requiring ongoing administration. There are multiple reasons, including:

Patient volume limiting savings potential

In addition, if products for orphan conditions are considered clinically comparable and cost roughly plus/minus 5% of each other, the philosophy is to let physicians make the decision.

Consequently, if one product is administered weekly and one every six months, or one is provider-administered and another patient-administered, or even if one has more versus less tolerability issues, the payer point of view is generally to maintain equal access and let the market decide.

These factors individually are impactful but collectively present a powerful barrier to risk contracting.

However, as the number of new agents gaining FDA approval for the same orphan indication increases, the suggestion here is that later entrants may begin to find a receptive ear to a risk contract offer.

Between 2020 and 2024, approximately 20-25 orphan drugs per year gained FDA approval. Estimates for 2025-2030 point to between 160-200 on a path toward FDA review. Given this pipeline, while many orphan conditions are likely to see gene or cell therapies, monoclonal antibodies, other biologics, or extremely high-cost small molecules for the first time, some can be expected to see three, four, or more of these high-cost treatments available for the same indication.

The signs for this growing competition may be reflected in a 2025 Evaluate Pharma Orphan Drug Trends Report. Globally, its research suggests that from 2025-2030, the compound annual growth rate (CAGR) for orphan products will be 10% versus 7.5% for non-orphan; but the orphan product “growth advantage looks set to slip to just 1% by the end of the decade, potentially marking the end of an extraordinary run.”

Consistent with this, other data suggests that between 2020-2024, the CAGR for US orphan products was in the 10%-11% range, with 6.3% projected for 2029-2030.

One likely reason is that pricing for new treatments where there are existing options will likely need to fit in with prevailing prices, causing the growth rate in future pricing to decline. Right now, for example, there are four prophylactic agents approved to treat hereditary angioedema and there may be another seven aiming for FDA review by 2030. Similarly, there are three agents approved to treat transthyretin amyloid cardiomyopathy, with signs of another five moving toward FDA review by 2030.

Absent significant gains in clinical benefit, it is hard to imagine new entrants pricing their treatment outside the higher end of the prevailing range since any added access barrier makes the challenge of overcoming prescriber experience with current treatments even more difficult.

While there is no reason for the first agent in an orphan space—nor probably the second and third, to offer a risk contract—they can always discount if necessary; for later entrants intent on premium pricing, there could be a business case.

The major precondition for a later entrant to consider tying pricing to a risk contract centers on trial data pointing to a new and compelling clinically meaningful benefit.

The major reason for a risk contract is to premium price, and most likely the safest way a later entrant can price outside what payers will otherwise tolerate.

Significantly, risk contracting resonates with the “value-based” philosophy long on the ascent in managed care. Perhaps more importantly, it represents a new platform for the late entrant to be the “value-based workhorse” in a specific orphan disease space—the more the treatment is used, the greater the clinical and financial value generated.

Suffice it to say, each pipeline agent for an orphan disease will need to evaluate the opportunity for building a risk arrangement into its launch strategy.

While the business requirement is that the operational burden on payers be minimal, the business justification for carving in such arrangements appears to be growing.

Ira Studin, PhD, is President, Stellar Managed Care Consulting. He can be reached at istudin@stellarmc.com.

Health plans face challenges in risk arrangements for orphan drugs, but increasing competition may open doors for innovative pricing strategies.

Risk Contracting When Orphan Disease Space is Crowded

Central and Eastern Europe (CEE) has long been misunderstood by global pharmaceutical leaders—a region often sidelined in favor of the more “mature” Western European markets. But that view is no longer sustainable. In a robust analysis of 33 innovative therapies—including blockbusters, novel European Medicines Agency-approved drugs, and CAR-T therapies—the global consultancy Simon-Kucher challenged six persistent myths that have shaped pharma’s go-to-market strategies in CEE markets. The verdict? These myths are not just outdated—they’re holding the industry back.

 Myth 1: CEE markets have only limited market potential

While CEE accounts for just 8% of EU healthcare expenditure today, the region represents 23% of the EU population. Healthcare spending grew by an astonishing 48% between 2018 and 2022, nearly double the EU-4 rate (France, Germany, Italy, and the UK), signaling powerful structural drivers—economic growth, healthcare modernization, and urbanization—are already in motion.

CEE is no longer a marginal opportunity; it is a growth frontier.

Myth 2: CEE markets have reluctance toward pharma innovation

Despite modest healthcare budgets, countries such as the Czech Republic, Poland, and Romania reimburse up to 79%-88% of major innovative therapies—comparable to EU-4 markets. New funding schemes, such as Poland’s Medical Fund and Romania’s Health Innovation Pact, show the region’s commitment to accelerating access for innovative drugs.

CEE isn’t avoiding innovation—it’s investing in it strategically.

Myth 3: CEE markets have opaque pricing and market access processes

Far from ad hoc, most CEE countries now follow standardized health technology assessment (HTA) pathways similar to EU-4 markets. Structures such as Poland’s AOTMiT or Romania’s scorecard-based HTA prove that decision-making is rule-based, transparent, and increasingly harmonized via initiatives such as the EU Joint Clinical Assessment.

What appears opaque is often just unfamiliar.

Myth 4: CEE markets have excessive time to access

Yes, access delays exist—but they’re largely self-imposed. In markets such as Poland, the internal pricing and market access process averages just 318 days, comparable to EU peer markets. Most delays come from pharma companies themselves, who often wait to launch in CEE markets to protect international reference pricing (IRP)-sensitive dynamics in Western European markets.

The bottleneck isn’t in regulation—it’s in strategy.

Data shows that CEE markets can command equal or even higher list prices than the EU average—especially for newer therapies. Croatia, Czechia, and Poland list CAR-T treatments above average benchmarks. What’s more, confidential discounting and innovative contracting (e.g., outcome-based agreements) are now standard in most CEE markets.

CEE pricing is not a race to the bottom—it’s a negotiation table worth sitting at.

Myth 6: CEE markets have spillover threat to EU-4 pricing

The IRP cascade is one-directional: CEE markets reference EU-4, not vice versa. Germany doesn’t use IRP at all. France excludes CEE markets entirely. With two-tier pricing systems and sophisticated IRP management, the actual spillover risk is negligible.

Defensive launch delays based on spillover fears are a strategic misfire.

The data is unequivocal: CEE markets are evolving faster than industry perceptions. Companies clinging to outdated assumptions risk not just lost revenue—but also diminished impact on patient access and regional brand trust.

This isn’t just a call for market access reform. It’s a call for executive recalibration. Treating CEE as a secondary priority is no longer justifiable—neither economically nor ethically.

The message to pharma leaders: The time to act is now.

Christian Schuler is Senior Partner and Managing Partner, Global Health Sector, Simon-Kucher, Munich; Wiktor Miller is Senior Manager, Simon-Kucher, Warsaw

Challenging six misconceptions that have characterized product strategies in Central and Eastern European markets.

Elizabeth Chiarello, Julie Becker, and Rachel Rein

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