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Asembia 2025 

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An examination of proactive preparedness and readiness review for future enrollment in the agency’s QMM program—now in the pilot stage as an effort to incentivize pharma manufacturers to achieve a more mature state of quality culture.

Going Beyond Compliance: Early Adoption of FDA’s Quality Management Maturity Program—and the Practical Considerations for Executives

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

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.

Rethinking Market Access in CEE: Time to Bust the Myths

Although the pace of innovation has been strong for both pharmaceutical and biotechnology companies and the rate of US and European drug approvals continues to be solid, the financing, M&A, and stock market developments in the first half of 2025 for the pharma and biotech sectors have broken from past trends in certain categories—both positively and negatively. Many of these trends would seem not to make sense on the surface, but they are logical if you carefully examine the underlying drivers.

In this article, we will look at the major stock market, financing, and M&A trends for pharma and biotech in the first half of 2025, the outlook going forward, and the implications for industry executives.

There are also major strategic issues that will impact the future, such as the unusually large volume of patent expirations facing pharma companies, the trajectory and nature of the Trump administration actions, and the emergence of Chinese companies and research organizations as a source of innovative drugs and treatments, especially in cancer research.

By the end of the first half of 2025, the S&P 500 had increased by 5.5% and the S&P Euro 350 rose by 21%. This was a significant change, with much of the volatility in the S&P 500 driven by economic and US tariff uncertainties.

The pharma industry underperformed in the first half of 2025.

The Young & Partners (Y&P) US BioPharma index increased by only 0.05%, the Y&P European BioPharma index grew by just 1.4%, and the Y&P Generic Pharma index dropped by 19.1%.

Dollar volume of equity issuance through the first six months of 2025 was $9.2 billion versus $13.3 billion during the same period in 2024, an increase on an annualized basis.

The number of offerings in the pharma space was dramatically lower, however, with only 28 offerings in the first half of 2025 versus 69 the previous-year period.

The performance of biotech industry stock market indices was mixed in 1H2025. The broader NBI index decreased by 2.6% and the Y&P Biotech Mid-Small Cap index rose by 22.7%.

Biotech equity offerings pulled back in the first half of 2025, with only 80 such instances completed versus 371 during the same period last year. The dollar volume also declined, with $10.7 billion completed in the first half of 2025 versus $38.1 billion in 2024.

The IPO market volume softened further. Only eight IPOs were completed in the first six months of this year, worth $1.3 billion, compared to 23 IPOs, worth $3.8 billion, in all of 2024.

Many biotechs with plans to go public have been facing serious funding problems, as the IPO market has been an important source of very attractive equity funds to extend these companies’ research and regulatory runways.

The drop in biotech stock market valuations has also pushed down the private equity funding valuations and availability. Venture capital (VC) firms have taken big paper losses on their existing ownership positions in private and public biotech/biopharma companies and dramatically slowed funding new companies, except in the hot areas of technology.

Their focus has been on defending their existing portfolio companies to make sure they survive the funding and IPO drought. However, there are signs that investing activity is picking up as VCs take advantage of lower valuations and because they really cannot stop investing entirely.

With many of the private biotechs running out of money, we will continue to see downsizing announcements on a regular basis. Some biotech companies will not survive and will have to shut down. This down cycle has impacted the biotech sector many times historically, so this is not a new development for the industry.

Acquisitions by pharma companies have traditionally been a regular part of the landscape. Although Big Pharma organizations have revived their ability to invent new drugs, they still need to supplement their own efforts with acquisitions of and collaborations with pharma and biotech companies. With many pharma manufacturers facing patent cliffs on their major products, the need to acquire drugs and drug candidates continues to be high.

However, only four deals, worth $16.2 billion, were completed in the first half of 2025 versus 32 deals completed, worth $19.2 billion, for all last year. This represents a massive decrease in the number of deals and an increase in the dollar volume of M&A agreements in the pharma space. Johnson & Johnson’s $14 billion acquisition of Intra-Cellular Therapeutics, which closed in April, drove the dollar volume up in the first half.

Why have the number of pharma acquisitions declined? Pharma companies in general, with some exceptions, are focusing on strategic small-to-medium-sized acquisitions.

They are also focused on biotech companies via acquisitions, strategic partnerships, and in-licensing to achieve pipeline growth. Biotech M&A volume is not reflected in the numbers mentioned.

As of June 30, 2025, the dollar value and number of deals announced but not closed was low at $15.6 billion (16 deals).

Looking into the future, there may be one or two larger deals, but those deals will not be the strategic focus of the pharma organizations. Pharma M&A will continue to be moderately active in terms of the number of deals, with a focus on small-to-medium-sized transactions but modest dollar volumes.

Deals with a strong strategic rationale or a theme around adding new and growing technologies and products will continue to be pursued. Although the Trump administration is threatening to change drug pricing and impose large tariffs on imports of pharmaceuticals, there is still, as of this writing, much uncertainty about what will actually be implemented that dealmakers have not adjusted their approach to the market yet.

In the first half of 2025, 12 biotech deals, worth $12.6 billion, were completed versus 73 deals, worth $109 billion, finalized in all of 2024. On an annualized basis, this represents a major decline in both the total dollar volume and the number of deals completed. Transactions in the US dominated relative to the rest of the world.

Biotech M&A dollar volume and number of deals totaled a record high in 2024, driven by the combination of the ongoing strategic acquisition interests of large pharma and the plunge in biotech IPOs that reduced the options for private biotechs.

The drop in the first half of this year is a reflection of the flurry of uncertainties that have hit the biotech and pharma sectors.

The dollar value of the pipeline of biotech deals announced but not closed as of June 30, 2025, was in line with the first-half trends, at $15.1 billion (26 deals).

What is driving this trend? The surge in activity in 2024 was sparked by pharma companies aggressively looking to build their pipelines and revenues. This was aided by the collapse of the IPO market, the severe reduction in equity funding, and a dramatic drop in the share prices of biotechs, which resulted in these companies being more willing to consider a sale of their organization. There are also a number of specific therapies and markets that are a high priority for the strategic buyers.

The slowdown in the first half of this year has been driven by the dramatic increase in uncertainty in the US due to the major federal funding overhauls at the NIH and university research centers and the severe cutbacks at the FDA.

What is the outlook for biotech M&A? We expect more of the same in the future, driven by the same factors, with a moderate number and dollar volume of biotech deals being completed over the next couple of years, along with partnering, licensing, and royalty monetization for funding and for shareholder liquidity.

Pharma will be heavily focused on M&A where there is a compelling strategic rationale and where the same results cannot be obtained internally or through licensing and strategic partnerships. However, it will continue to be challenging to determine what the right valuations are for each deal. The use of earn-outs and contingent payment structures remains a third or more of the market, which reflects the challenge of bridging buyer and seller valuation expectations.

Private biotechs with assets that appeal to pharma should consider selling now, given the moribund IPO market, steady M&A valuations, and the high demand for deals in attractive segments.

The big unknown for the future is the impact that the ongoing Trump administration actions will have on healthcare regulation, drug prices, etc. However, predicting what will actually happen is very difficult at this stage.

Barring major disruptions, pharma companies will continue to enjoy relatively attractive stock market valuations and access to the financing markets, which will continue to be a stabilizing force on the industry. Although biotech stock market valuations are down and are taking some time to recover, existing public biotech companies are able to sell equity, and there are small signs that the IPO market for biotech companies will begin a slow recovery.

This overall picture is positive for the pharma companies because there is a large supply of biotech companies available for M&A transactions, licensing, and strategic partnerships at valuations that are lower than two years ago.

For biotechs, the key will be the quality and the maturity of their drug candidate pipeline and their cash needs. If a biotech company is in a therapeutic area that is the subject of high strategic interest and/or they are at a viable financing point, the outlook will be positive. The rest will have to forge a path that is sized properly relative to how long of a runway the organization will need to reach a viable financing or M&A point.

For many biotechs, it will be a matter of survival versus success.

Peter Young is CEO and president of Young & Partners, and a member of Pharm Exec’s Editorial Advisory Board. He can be reached at pyoung@youngandpartners.com

The first half of 2025 saw significant shifts in the pharma and biotech sectors, with mixed stock market performances and a decline in M&A activity. Despite a strong innovation pace, the pharma industry underperformed, and biotech faced funding challenges due to a weakened IPO market. M&A activity decreased, with a focus on strategic small-to-medium-sized acquisitions. The Trump administration's potential regulatory changes add uncertainty. Pharma companies benefit from stable valuations and financing access, while biotechs must navigate funding challenges, with survival dependent on strategic interest and financial viability.

Despite steady innovation and solid new drug approvals, the first half of 2025 was marked by a break from historical norms in financing, stock performance, and M&A for the pharma and biotech sectors.

Navigating Divergent Currents: Biopharma Review and Outlook

The biopharma industry is at an inflection point. Scientific advances are yielding more targeted therapies and a proliferation of assets in late-stage development across nearly every therapeutic category. This hypercompetitive environment, combined with accelerated development timelines and the insurgence of technology across the entire healthcare system, is making it increasingly challenging to drive new product adoption and sustain market position over time.

 and an expected loss of $236 billion in revenue, pharmaceutical leaders are rethinking how they manage their portfolios. As major pharma organizations work to advance more than 250 late-stage assets, unpredictable M&A activity and enhanced technical capabilities have resulted in a resurgence of small molecules and more nimble biotech companies launching on their own—changing the rules of the game. Brand teams no longer have the luxury of taking five years to reach peak sales; they need to find new ways to accelerate product adoption to drive sustainable revenues.

This all comes at a time in which the larger healthcare ecosystem has become increasingly complex, and leaders seek out new ways to drive efficiency and value through technology. For life sciences, payers, and providers alike, AI is making it easier for brands to put patients at the center and individualize their care. At the same time, agile competition and shifts in policy are fundamentally reshaping profitability models. 

Why traditional launch models are no longer enough

In this environment, even the most promising new product innovations risk falling into “launch black holes,” in which products fail to gain rapid adoption and fall short of achieving full potential, despite having strong value for patients. The culprit? A launch model that has not kept pace with the speed of change and advances in technology in an increasingly connected healthcare ecosystem.

Innovative leaders should ask themselves these questions:

Has the order-of-entry model become obsolete?

Are traditional go-to-market models more of a habit than a necessity?

Can we rely on our proven return-on-investment models in this new era?

For those who dare to think differently, an opportunity exists to examine the role technology and AI play in the transformation of launch strategy, planning, and execution. In this new era, success will belong to those who can pivot from static planning to dynamic orchestration, from mass messaging to micro-targeting, and from siloed functions to agile, AI-augmented teams. 

Avoid the black hole – what you can do now

For those looking to future-proof their launch and improve effectiveness, we offer the following tenets:

Reimagine new product planning and launch operating models

: Identify processes, reporting, and decision tools that can be automated—and reallocate staff to critical strategic thinking, external market development, and stakeholder engagement.

Invest in data and AI infrastructure where it matters most

: Integrate data across siloed departments to drive better insights and improved alignment across teams.

: Integrate real-world evidence into clinical and early go-to-market strategy prior to entering pivotal trials using large language models (LLMs) to achieve scale.

Model value proposition and access scenarios

: Leverage AI to simulate health technology assessments and payer response to potential clinical profiles and evidence beyond primary and secondary clinical trial endpoints.

Consider how AI can help predict launchperformance relative to pre-launch investment scenarios to remove product and market infrastructure barriers and ensure optimal uptake in the context of the product, competition, and market development.

Next-generation launches will be led by those who embrace technology, efficiency, and ecosystem-centricity at the core. The future of launch excellence is not just digital — it’s data-driven, dynamic, and decisively different.

Guidehouse is a global AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in healthcare, financial services, energy, infrastructure, and national security markets.

The biopharma industry is experiencing a pivotal shift due to scientific advancements, increased competition, and expiring drug patents. This environment necessitates a reevaluation of traditional product launch models, which are becoming obsolete in the face of rapid technological integration and evolving market dynamics. Companies must adopt agile, AI-driven strategies to avoid "launch black holes" and ensure sustainable revenue. Emphasizing data integration, real-world evidence, and AI-enhanced planning can enhance product adoption and market positioning. Success will favor those who embrace technology and ecosystem-centric approaches in their launch strategies.

Sarah Akers

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