Paul Hudson: A Mindset for Miracles

Paul Hudson, CEO, Sanofi

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 Pharmaceutical Executive 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 Pharm Exec, 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.”

Broad disruption

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 raison d’etre. 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 Julymissive 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?”

R&D reimagined

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 Pharm Exec, 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 Pharm Exec 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.

Ascending in AI

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 The Matrix. “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.

An example of the latter is plai, 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.

A digital legacy

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.