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Asembia 2025 

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Maude Schmidt is Analyst and Giovanni Saldutti is Consultant, both at ICON plc, Imperial College Innovation Hub, London.

Maude Schmidt and Giovanni Saldutti look at the intergovernmental initiatives involving joint price negotiations developed across Europe as the Beneluxa Initiative on Pharmaceutical Policy to explore the outcomes and implications from these alliances.

Emerging Collaboration in EU Drug Pricing and Reimbursement: A Beneluxa Case Study

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

As board chair-elect of the Pharmaceutical Research and Manufacturers of America (PhRMA), Paul Hudson is set to succeed Pfizer CEO Albert Bourla, PhD, in the US trade group’s top seat in 2026. Touching on the annual changeover during a recent wide-ranging sit-down with 

at Sanofi’s Washington, DC, office, the CEO of the French drug giant, a tinge of wishful thinking perhaps mixed in, wryly envisioned the possibility of a smooth entrance into the PhRMA post come February—today’s pressurized policy climate a thing of the past, “and I will come in and just relax, drink cappuccinos in the PhRMA building.”

In reality, of course, Hudson acknowledges a far more likely scenario for himself and his PhRMA colleagues: a continued steadying amid the political headwinds—unpredictable as many remain—and the readiness to contend with new and more complex dimensions sure to emerge.

“I suspect my role will be trying to execute on what has been agreed or loosely agreed with the government,” Hudson tells 

, alluding to the backdrop of several high-profile US actions this year—from pricing-centric executive orders and global tariff directives to massive health agency overhauls. But also, too, in the context of continued grappling on issues such as direct-to-consumer (DTC) engagement; Inflation Reduction Act negotiations; and fits and starts related to pharmacy benefit manager (PBM) reform.

“Or, if we’re at an impasse, which I hope we’re not, trying to help navigate,” he counters. “We will see. But I’m purpose-driven. I’m an ‘all-boats rise’ person.”

Hudson cites that mantra as a guiding principle of sorts during his tenure so far with Sanofi, which hit six years this month (he was previously CEO of Novartis Pharmaceuticals from 2016-2019). Both in its relevance to biopharma’s larger public health mandate—“me winning against another company doesn’t help a patient. All boats should rise; that’s the way it should be”—and reflected as well in Sanofi’s own journey since Hudson took the helm and crafted a path to modernize and refocus the company. The vision centered on becoming a nimbler and more innovative risk-taker—one that is, he states confidently, “R&D led, AI-powered” in its growth pursuits.

Examples of the Hudson-led pivot include Sanofi’s recent divestment of a 50% controlling stake in the company’s consumer health division, Opella, which was completed in April; decisions to double down on specialty therapy areas; and a turbocharged focus on digital transformation across its business and culture through internal integration and external collaboration.

“We chase the miracles of science to improve people’s lives,” the UK native explains. “People are looking for miracles. I get letters every day saying, ‘tell me you’re working on this disease because the doctors say there is nothing for me.’ That’s why it has to be miracles. ... As we reinvent the company, we have to be more efficient, more effective. We have to develop the next generation of leaders who can lead with a digital labor force. And they have to be chasing miracles.”

Current policy dynamics are critical to such “miracle” pursuits, as manufacturers carefully weigh the shifting tides and impacts in their strategic planning and decision-making. Signaling these efforts have been several announcements this year by Big Pharmas outlining investments to boost respective US manufacturing and research capacity—in response to prospects of US-imposed tariffs on pharma imports (various global deals have since been negotiated and formalized). 

In Sanofi’s case, in May, the company revealed its intention to invest at least $20 billion in the US through 2030. Echoing the trend as well was the French drugmaker’s decision in July to sell a New Jersey manufacturing facility to Thermo Fisher Scientific, which will continue producing a portfolio of key medicines for Sanofi at the site.

“The industry moved quickly, but not because we weren’t making those [US] investments before. I think the scale of these things in our industry is not particularly well understood,” says Hudson, while also pointing out that pharmaceuticals are Europe’s No. 1 export to the US (note: the interview with the Sanofi CEO was conducted just prior to the recently struck US-EU trade deal on a 15% tariff). “You sort of assume American companies make everything in America. That could be a leap. The global supply chain for pharma was way more sophisticated than people expected. Often, three or four countries are involved.”

Constructs aside, there’s little doubt that broader geopolitical tensions, including the escalating US-China trade war and the ongoing conflict between Russia and Ukraine, are challenging the resilience of pharma supply chains—and the industry’s core mission statement—perhaps more than ever before.

“In a healthcare company, supplying medicines is your 

. You create them, you bring them through, you make sure people can have them,” says Hudson. “We’re always having to adjust, with one goal: How do you get medicines to patients? Here we are with a new set of criteria. [For example,] we’re adjusting to have less critical components coming out of China ... but it’s not essential that you move out of China on some of these pieces. You need to have the flexibility that you didn’t have before. That’s just good business continuity.”

On the drug pricing front, headlined by the Trump administration’s push for most-favored nation (MFN) pricing (Sanofi was one of the 17 pharmas to receive the president’s July missive on the subject), but also involving programs such as 340B, Hudson believes long-sought reform of PBM practices and rebate structures is vital to tackling the inequities—and wider fervor—clouding patient costs at the point of care.

Complicating matters for MFN, Hudson adds, is the disparity between US and European prices due to differing healthcare structures—blended pricing through commercial insurance vs. strictly government pricing. He conveyed that message, he says, in chats with members of the administration during his July visit, to help, “first of all, understand that difference.”

PBM reform has been on the Capitol Hill agenda for several years, though discussions have stalled of late. Hudson recounts one such meeting in 2023, when, amid soaring out-of-pocket costs for insulin, he testified with other large pharma CEOs at a hearing arranged by Sen. Bernie Sanders. Invited to appear during a late night call in Paris from the senator himself, Hudson had one condition for acceptance.

“I said, I’ll come if you bring the PBMs. And he brought the PBMs,” he says. “We think PBM modernization and transparency is key.”

Given these and other complexities in the broader patient access landscape, are Big Pharmas worried the impact of US policy and legislative reform could erode incentives for life sciences innovation?

“I think the AI revolution gives us the advantage in R&D, whereas the political pieces that will try and squeeze us in other elements are not, at this point, the [big] issue,” says Hudson (Sanofi officials, at the time of its Q2 earnings release, stated the company expected the impact from the 15% EU tariff to be “manageable” in the short term, 2025, and with more detail, will have a perspective on the long term).

More concerning to the prospects of future breakthroughs, most leaders agree, have been the funding and budget cuts, staff downsizing, and general volatility impacting entities such as the NIH.

“Often, large organizations or governments take an extreme view to try and pull everybody to one side. But there are consequences for that,” says Hudson. “Some innovation will be lost because studies and research will stop. The problem is nobody will ever know. The opportunity, cost, and innovation that there never was—how will you know?”

Sanofi, Hudson says, circling back to its credo of R&D-led, AI-powered,is committed to do its part to help reduce those “what-if” unknowns and contribute to the discoveries of tomorrow. The company’s recent track record and momentum may put it in good position. The world’s ninth-largest drugmaker based on the latest full-year Rx revenue figures, Sanofi has grown 10% on the top line over the last two years, the company’s fastest such spurt in its history, according to Hudson. 

Pacing efforts is Sanofi’s strong immunology franchise, led by its star monoclonal antibody, Dupixent, the industry’s third-best-selling drug, along with solid vaccine outputs. Co-developed in partnership with Regeneron, Dupixent ($14.1 billion in 2024 sales) is approved in eight indications, including as the first-ever biologic to treat chronic obstructive pulmonary disease (COPD) across the US, EU, and China.

In second-quarter earnings, unveiled in late July, Sanofi stayed the course, reporting sales of €9.9 billion ($11.4 billion), an increase of 10.1% at constant currencies vs. the same period in 2024. Dupixent revenue spiked 21.1% to €3.83 billion ($4.38 billion) in the quarter.

The standout drug was a central piece in the Hudson-driven reshape after his arrival in 2019. Building on successful launches in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps the previous two years, he made Dupixent’s commercialization a strategic focus, setting aggressive growth targets, with an initial goal of more than €10 billion in peak annual sales. The drug has since added five indications, including, most recently, for bullous pemphigoid. 

Dupixent’s run is illustrative of Hudson’s dual mandate noted earlier: chase science that matters, while ensuring commercial traction.

Hudson is quick to credit his predecessors for acquisitions such as the 2011 mega deal for rare disease power Genzyme, which remains a “massive contributor” and “very much part of our DNA in terms of how we think of patients as people and individuals and not numbers.” When he joined the company, however, there was a need to scale back from its legacy of volume-based M&A and growth, he notes.

“Our R&D budget was around $4.5 to $5 billion [and] doing a lot of things that had already been done, that were low risk,” Hudson tells 

noting much of the investment at the time was going toward incremental therapies. “You don’t get failures, but you don’t get successes [either]. So I moved us quite sharply toward winners.”

Today, according to the CEO, 95% of Sanofi’s pipeline is comprised of hopeful first-in-class or best-in-class therapies. The R&D shift has paid off with recent launches, including Sanofi’s steady riser Altuviiio, a next-generation treatment for hemophilia A, approved in 2023.

Other such launches in recent years include the enzyme replacement therapy Nexviazyme for Pompe disease; Rezurock, which targets graft-versus-host disease; the monoclonal antibody Sarclisa for multiple myeloma; and Beyfortus, the first long-acting antibody indicated for the prevention of respiratory syncytial virus (RSV).

The latter, which has been used to protect more than 250,000 babies, achieved blockbuster status from the jump, totaling $1.8 billion in 2024 after its first full year on the market. Within one season, Beyfortus reduced ER admission rates in the US for newborns with RSV by about 90%, Hudson adds.

Just approved in late August was the company’s BTK inhibitor Wayrilz, cleared by the FDA for adults with persistent or chronic immune thrombocytopenia, a rare disease that triggers low platelet counts. Tolebrutinib, another BTK inhibitor, may follow soon for multiple sclerosis. The promising candidate, which is engineered to cross the blood-brain barrier to reduce neuroinflammation, is under priority review at the FDA.

On Sanofi’s high-risk, high-reward approach, Hudson acknowledges, “We will get failures—we’ve had failures, even this year,” referring to itepekimab, its follow-up to Dupixent, which, in results announced in May, only met the primary goal in one out of two late-stage trials in COPD. “We’re trying to do things that have never been done before—but at scale.”

Overall, Sanofi’s pipeline includes 82 clinical-stage projects, 30 of which are in Phase III clinical studies or submitted for regulatory approval. Proceeds from the mentioned Opella divestment will also be used to further bolster R&D efforts, the company says.

“We have some big readouts ahead of us,” Hudson told 

 during the sit-down. “We’re using AI and putting in people to stack the deck in favor of more wins than losses. But it’s still a roulette spin in the R&D labs because you don’t know. By definition, if you’re first, it’s never been done. It’s fraught with challenge.”

Sanofi has not shied away from such bets in its dealmaking pursuits of late—focusing largely on bolt-on and targeted opportunities. Recent deals include the acquisition of Blueprint Medicines for $9.1 billion, completed in July, expanding Sanofi’s rare disease and immunology portfolio (it adds Blueprint’s marketed drug Ayvaki for systemic mastocytosis and two early-stage assets); the $470 million buyout of Vigil Neuroscience and its Phase II investigational therapy for Alzheimer’s disease (the deal was finalized last month); and the July acquisition of Vicebio for $1.15 billion in upfront money, bringing aboard an early-stage combination vaccine candidate for RSV and human metapneumovirus.

In March, Sanofi also inked a licensing deal with Dren Bio, adding its potential first-in-class bispecific antibody that could offer promise for autoimmune diseases such as lupus.

The emergence and adoption of artificial intelligence across biopharma and healthcare has been well-documented, as more and more organizations begin to strategically integrate AI into R&D, manufacturing, and commercial operations. In fact, a July report published by Define Ventures found that 85% of Big Pharma leaders surveyed view AI as an “immediate priority.”

Sanofi believes the company is ahead of the pharma pack when it comes to full-tilt integration of AI across functions. Hudson, for a few years now, has been outspoken publicly about the drugmaker’s “all-in” approach, the CEO intent on positioning Sanofi as a digital- and AI-forward player, with an aim of becoming the first pharma fully “powered by AI at scale.”

But what sets Sanofi apart, Hudson says, was the organization’s foresight from the start to build its AI transversally, across the value chain, rather than in vertical silos. This has enabled 360-degree operational views across the business—resulting in real-time insights, improvements in forecasting and workforce management, and key decision-making support, from drug discovery and R&D to product launch, manufacturing and supply, and business analysis.

“You don’t have to be the Oracle to say AI is the revolution,” Hudson asserts in a nod to the wise and fate-minded guide in 

. “Our differentiated data strategy is to be transversal, end-to-end on the value chain. That’s the only way to do it. To lead from the top, not to delegate. In my experience, you do not delegate revolutions.”

To that end, Sanofi’s AI strategy, Hudson emphasizes, is to augment human capability and innovation—not supplant them.

“The jobs that go are the people that refuse to use AI,” says Hudson. “Because in our industry, you can’t let enough people go to save so much money that it would help you find new drugs faster. It’s just the opposite.”

Hence, those workforces “weaponized” or empowered with AI are uniquely positioned to create value for patients—and the business, he adds. “If people’s productivity goes up 200%, that’s a game changer.”

Some 70,000 Sanofi employees are leveraging the company’s large language model daily, according to Hudson. The model was built by its chief digital officer, Emmanuel Frenehard, who was promoted to the post in August 2023 (he also leads Sanofi’s Digital Accelerator program, first launched in 2022). The organization operates a global network of digital hubs as part of its AI center of excellence, with key locations in Paris, Boston, New York, Barcelona, and Toronto.

Sanofi arranges its AI efforts into three buckets. One is generative AI, which, for example, can automate report creation, including data collection and formatting for the company’s thousands of annual product quality reports; it can also accelerate regulatory filings. Second, is “expert AI,” a key tool for problem-solving; for instance, high-computing AI and machine learning can help target so-called “undruggable” proteins. Lastly, is “snackable” AI, which are apps that give employees access to aggregated insights in bite-sized chunks and recommendations in real-time.

, a platform developed in partnership with Aily Labs. The tool aggregates more than one billion Sanofi data points to predict value drivers such as R&D costs, clinical trial enrollment timelines, and a program’s probability of success.

Hudson points, broadly, to specific scenarios and benefits that could result, such as using AI to help reduce the long-held 90% failure rate of trials “down to 60% or 70%,” he says. Deeper, AI-optimized insights on patient selection, disease understanding, and drug design, for example, could translate, ultimately, to greater health outcomes.

Beyond Aily, other notable Sanofi AI partnerships include one with McLaren Racing, where Sanofi has tapped its advanced simulation and data techniques to speed up manufacturing efficiency and product launch (modeling an F1 pit crew operation); a pact with OpenAI and Formation Bio around drug development; and its work with the AI biotech Owkin on target identification for precision medicine pursuits.

As these AI-fueled advances and promise attest, the life sciences industry appears on the dawn of a new digital age, spawning future “new-normal” practices in R&D, manufacturing, and beyond. In turn, patient and consumer engagement models in healthcare are evolving as well, with, for example, a growing number of Big Pharmas starting to launch their own online DTC pharmacy platforms for certain products (Sanofi, for its part, is watching the space with interest, Hudson says).

In any case, when viewing across the digital health spectrum, the sentiment of leaders such as Hudson is clear: being “AI ready” has become a strategic imperative.

“I’m the last CEO of a major pharma that will not have had a significant digital or data experience on their resume,” Hudson predicts.

A belief, too, that perhaps best sums up Sanofi’s bold turn under his leadership.

“I wanted the company to allow people to take thoughtful risks in innovation, so that they could do things that people thought were impossible,” Hudson, 57, reflects. “I don’t think we’re declaring victory. I think the companies that will win, it’ll be long after me—but getting these things moving right now are completely game-changing.”

Michael Christel is the group managing editor of Pharmaceutical Executive, Pharmaceutical Commerce, and Applied Clinical Trials. He can be reached at mchristel@mjhlifesciences.com.

Paul Hudson, CEO of Sanofi, is set to become the chair of PhRMA in 2026, succeeding Pfizer's Albert Bourla. Hudson anticipates navigating complex policy challenges, including drug pricing and PBM reform, while emphasizing Sanofi's commitment to innovation and AI integration. Under his leadership, Sanofi has focused on R&D-led growth, divesting non-core assets, and enhancing digital transformation. The company has made significant investments in the US and expanded its pipeline with promising therapies. Hudson envisions AI as a transformative force in biopharma, enhancing productivity and innovation.

With healthcare at a key crossroads of policy, technology, and science, Sanofi CEO Paul Hudson shares the Big Pharma’s formula for navigating the new age of innovation, where running from risk is not an option.  

Paul Hudson: A Mindset for Miracles

Roche announced it has entered into a definitive merger agreement to acquire 89bio, along with its FGF21 analog Pegozafermin, which is currently in late-stage development for Metabolic Dysfunction-Associated Steatohepatitis (MASH).

“This acquisition further strengthens our portfolio in cardiovascular, renal, and metabolic diseases and offers opportunities to explore combinations with existing program in our pipeline,” said Thomas Schinecker, Roche Group CEO. “We are highly encouraged by Pegozafermin’s potential to become a transformative treatment option in MASH, one of the most prevalent comorbidities of obesity, and to meet diverse patient needs associated with this complex disease. With its combined anti-fibrotic and anti-inflammatory mechanism, Pegozafermin could potentially offer best-in-disease efficacy for all moderate to severe MASH patients.”

How does this acquisition effect Roche and its pipeline?

Roche’s acquisition of 89bio reflects the company’s dedication in advancing therapy treatment options for cardiovascular, renal, and metabolic disease indications, including a focus on patients diagnosed with obesity and other health challenges such as MASH. The acquisition additionally allows Roche to develop and expand its pipeline to target various causes of metabolic disease. Aside from just expanding its pipeline, Roche will also expand its workforce, as 89bio employees are expected to join the Roche Group under Roche’s pharmaceuticals division.

What are the details of the definitive merger agreement?

According to the terms of the agreement, Roche will provide its tender offer to acquire all outstanding shares of 89bio at a price of $14.50-per-share in cash. Roche will also provide a non-tradable CVR, allowing Roche to receive select milestone payments upwards of $6-per-share through a second-step merger.

The non-tradable CVR’swill entitle holders to receive $2-per-share following Pegozafermin’s first commercial sale, $1.50-per-share if Pegozafermin reaches annual global net sales of$3 billion in any year, and $2.50-per-share if Pegozafermin reaches $4 billion in annual global net sales in any year. If all CVR conditions are met it will represent upwards of $1 billion in additional cash consideration for 89bio.

The transaction is anticipated to close in the fourth quarter later this year, and is subject to standard closing conditions, which includes a tender of outstanding shares of 89bio’s common stock, along with the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Pegozafermin is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21) designed to address critical unmet needs in MASH.

With its anti-fibrotic and anti-inflammatory mechanism of action, along with its favorable safety profile, Pegozafermin is positioned to potentially deliver best-in-disease efficacy for patients suffering from moderate to severe liver fibrosis and cirrhotic MASH.

Pegozafermin also employs a unique mechanism of action holding the potential to improve efficacy and tolerability, along with unlocking opportunities for future combination development with incretins.

Roche enters into a definitive merger agreement to acquire 89bio, and its phase 3 FGF21 analog for the therapy of moderate to severe MASH 

https://www.globenewswire.com/news-release/2025/09/18/3152141/0/en/Roche-enters-into-a-definitive-merger-agreement-to-acquire-89bio-and-its-phase-3-FGF21-analog-for-the-therapy-of-moderate-to-severe-MASH.html

Roche has announced a definitive merger agreement to acquire 89bio, including its FGF21 analog, Pegozafermin, which is in late-stage development for Metabolic Dysfunction-Associated Steatohepatitis (MASH). This acquisition aims to enhance Roche's portfolio in cardiovascular, renal, and metabolic diseases, particularly addressing obesity-related comorbidities. The merger agreement includes a $14.50-per-share cash offer and a non-tradable CVR with milestone payments. Pegozafermin, with its anti-fibrotic and anti-inflammatory properties, is expected to offer significant efficacy for moderate to severe MASH patients.

Roche strengthens its pipeline by acquiring 89bio and its promising MASH treatment, Pegozafermin, enhancing options for metabolic disease therapies.

Roche Announces Acquisition of 89bio and Its FGF21 Analog Pegozafermin 

Market access is one of the key issues for the pharmaceutical industry. It’s important to innovate, but it’s significantly more important to make sure that those innovations make it to patients. Putnam’s CEO Matt Riordan spoke with 

 about how this is playing out in the oncology space.

Pharmaceutical Executive: How can the industry bridge the gap between innovation and access in community oncology?


 Innovation is moving at an incredible pace in oncology. There are several new technology platforms that are emerging in clinical practice, including CAR-Ts, antibody-drug conjugates, bispecifics, and radioligand therapies. And the list keeps growing, including dual PDL1/VEGF inhibitors, trispecific antibodies, and targeted protein degraders. Making sure those advances reach the full spectrum of practicing oncologists, not just those at major academic centers, can be challenging.

Community oncology is where the majority of patients are treated in the United States, and the community setting faces unique barriers when it comes to adopting new modalities. This includes:

Investing in community-level medical affairs engagement so physicians in non-academic settings are equipped to use cutting-edge therapies with confidence

Thoughtful design of product ordering, administration, and monitoring that is easily onboarded into the community care environment

Simplifying diagnostics and embedding biomarker testing into standard workflows to ensure appropriate patients are identified without delay

Developing tailored hub services that support insurance approvals, accelerated product delivery, and patient access

Educating patient and their families about the available options in the critical “micro-moments” where there is an opportunity to influence treatment direction

Overall, the way we will be successful in bridging this gap starts with decentralized clinical trials and community research networks that ensure that the latest science reaches beyond major cancer centers, creating equity in access to innovation and providing key insights to pharmaceutical developers on what it takes to make these innovations work in the community setting. Bringing together development, marketing, medical, market access, and regulatory functions to all have a shared vision of success in the community makes an enormous difference. If we can shorten that lag between breakthrough and standard of care, even by a few years, we can change outcomes for thousands of patients.

PE: What are some ways the industry can improve access to complex therapies?

 Access to complex therapies is never just one problem to solve; it’s a chain of challenges that all have to be addressed in parallel. This includes considerations of proper and prompt insurance access, placement of medical innovations on appropriate protocols and pathways within clinics and physical access to products in a convenient and timely manner. At ASCO this year, you could see how rapidly these new technologies are advancing through clinical trials, but also how operational realities such as manufacturing timelines, site capabilities and reimbursement models can slow that progress.

Improving access starts with forward planning. As an industry, we need to be thinking about infrastructure and education well before launch. That means developing rapidly scalable solutions that ensure that treatment sites, especially in the community, having the right training and protocols in place to handle the therapy safely and effectively. It also means aligning payer engagement and evidence generation early, so the reimbursement conversation is ready at the point of FDA approval.

One of the key learnings from launches we’ve supported is that you need to remove as much friction as possible from referral pathways. That might mean creating digital platforms that guide clinicians and patients through eligibility, scheduling and follow-up, or equipping community providers with clear, accessible decision tools.

Finally, the message has to be consistent across the organization. Commercial teams, medical affairs, market access, and regulatory all have to be working from the same blueprint, so that what’s promised in the clinic is supported by what’s delivered in the field. When that alignment is there, you can take what might otherwise be a slow, selective rollout and turn it into something that scales quickly and equitably.

PE: What challenges are emerging in the CAR-T in solid tumors space?

 CAR-T therapy has reshaped the treatment paradigm for several hematologic malignancies, offering long-term remission for patients with otherwise limited options. However, translating this success into solid tumors has proven far more complex. The scientific, clinical, operational, and economic challenges form a multi-layered barrier that the industry must confront with urgency and creativity.

Significant scientific and biological challenges exist. This starts with the tumor micro-environment, which is not just a hurdle – it’s an active defense system that neutralizes CAR-T activity. Cracking that code is the key to success in solid tumors. The next challenge is antigen heterogeneity in solid tumors; without a universal target like CD19, we must innovate around multi-antigen and personalized approaches. A final biological challenge is cell trafficking and tumor penetration, as CAR-T cells often struggle to traffic efficiently to solid tumors and penetrate dense stromal barriers.

Manufacturing also remains a challenge; autologous CAR-T therapies are costly, time-intensive, and logistically complex, which is particularly problematic when treating patients with rapidly progressing solid tumors. Moreover, safety concerns, including cytokine release syndrome and off-tumor, on-target toxicity, are magnified in solid tumors.

While the path forward is fraught with complexity, the stakes are too high to retreat. Solid tumors represent the vast majority of cancer cases worldwide, and if CAR-T therapies can be successfully translated, they could redefine the standard of care for millions of patients.

PE: How will precision medicine play a role in this area?

 Precision medicine has been a pillar of oncology treatment for more than two decades. As precision medicine advances in new and exciting ways, it will help us overcome the barriers of both access and efficacy in oncology. By integrating comprehensive genomic profiling into routine care, clinicians can identify patients most likely to benefit from advanced therapies, ensuring resources are deployed where they will have the greatest impact. In CAR-T and other cell therapies, precision medicine enables the development of tailored constructs targeting specific tumor antigens, while predictive biomarkers can help stratify patients for whom risks outweigh benefits. Beyond biology, precision medicine also opens doors to adaptive trial designs, reducing time-to-market for innovative therapies. Importantly, embedding precision approaches in community oncology settings ensures equitable access, allowing patients outside major centers to benefit from cutting-edge science.

For the industry, this has two major implications. First, it improves the clinical value proposition by increasing the likelihood of durable benefit, critical for payer confidence and adoption. Second, it makes the delivery model more sustainable, because resources can be concentrated on the patients who stand to gain the most, easing some of the capacity constraints that come with complex therapies

An exciting frontier in oncology today is how precision diagnostics may change who we treat and who we do not. Biomarker-driven selection and tools like circulating tumor DNA (ctDNA) can refine patient cohorts, improving both efficacy and quality of life. For example, peri-operative durvalumab in muscle-invasive bladder cancer showed benefit across all patients, but the strongest results were in those who were ctDNA-positive, suggesting it’s possible to focus high-intensity treatments where they’re most likely to have an impact. Monitoring the emergence of ESR1 mutational clones in the ctDNA of advanced breast cancer patients has now shown us who can benefit from treatment interventions before disease progression occurs. The holy grail of precision diagnostics remains routine panel-based monitoring of large populations of healthy individuals to identify the first signs of cancer when it is early enough to intervene with curative intent – we’re getting closer and closer to accessing that grail.

The end goal is clear: every patient should have access to a therapy that’s designed for the specifics of their disease biology, delivered at the right time and supported by a system ready to manage it.

Innovation in oncology is advancing rapidly, with new therapies like CAR-Ts and bispecifics emerging. However, ensuring these innovations reach community oncologists is crucial, as most patients are treated outside major centers. Addressing barriers in community settings, such as insurance approvals and diagnostics, is essential. Precision medicine plays a pivotal role by integrating genomic profiling and adaptive trial designs, enhancing access and efficacy. Overcoming challenges in CAR-T for solid tumors requires addressing scientific, operational, and economic barriers. Aligning industry functions and forward planning are vital for improving access to complex therapies.

Putnam’s CEO discusses advancements in oncology and how companies are working to ensure patients have access to these new treatments.

Maude Schmidt and Giovanni Saldutti

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