Pharmaceutical research and development is a rapidly evolving field, and innovation is the driving force behind progress. Sanofi, a global leader in immunology, oncology, neurology, rare diseases, and vaccines, is committed to addressing unmet patient needs worldwide through groundbreaking science.

At the 2025 International Pharmaceutical Innovation Forum (IPIF), Dr. Mike Quigley, Sanofi's Chief Scientific Officer and Global Head of Research, participated in a panel discussion to share his perspectives on China's dynamic innovation ecosystem.

Ahead of the conference, Quigley had sat down for an exclusive interview to discuss several key topics. He emphasized the importance of fostering a culture that embraces both success and failure as essential drivers of innovation. Quigley highlighted the transformative role of artificial intelligence (AI) in accelerating drug discovery and shared insights into Sanofi's stategic focus on immunology. He also underscored the company's deep integration within China's vibrant research ecosystem, including plans to expand collaborations with Chinese biotech firms, noting that "Innovation happens without borders."

From Failure to Success: How Sanofi Empowers Scientists to Innovate Fearlessly

PharmaDJ: What motivated you to join Sanofi? What are your primary responsibilities?

Mike: I believe this is a truly exciting time to be part of Sanofi. Not only is Sanofi a global immunology powerhouse with a strong development pipeline, but as the Head of Research, I am particularly focused on how we sustain that innovation through collaboration.

Within Sanofi, I hold two key leadership roles: Global Head of Research and Chief Scientific Officer. As the Global Head of Research, my primary responsibility is to ensure that our global pipeline is executed effectively. While our development pipeline is already robust, my role in research is to ensure we can sustain this momentum. This is important both internally and externally, as we strive to deliver the innovative medicines to address unmet patient needs worldwide.

The role of Global Head of Research ties closely to my position as Chief Scientific Officer. As we pursue scientific innovation globally wherever it exists—including, for instance, in China—we’re committed to actively engaging with cutting-edge science and driving innovation forward. This means leveraging our internal expertise and establishing thoughtful partnerships to advance innovation.

In both roles, my focus is strengthening our position as a collaborative partner in the global innovation ecosystem. This dual responsibility is at the core of my work as Chief Scientific Officer.

PharmaDJ: There is a growing trend of large pharmaceutical companies, like Sanofi, striking deals and partnerships with smaller biotech firms, including those based in China. Some industry observers suggest that the innovation capacity of big pharma may have declined slightly in recent years. What do you think of this? What is Sanofi doing to ensure that it continues to innovate?

Mike: At Sanofi,we believe innovation should have no borders. This includes internal innovation, but more importantly, it’s about external innovation and ensuring that as a company at the forefront of science of immunology, oncology, neurology, rare diseases, and vaccines, we are well positioned to tap into global innovation.

Traditionally, the value of a pharmaceutical company has been its scale—the ability to take innovation and deliver it to the largest number of patients with unmet needs. I believe that remains true today, particularly in scaling and executing mid- to late-stage clinical trials. What drew me back to Sanofi, as you noted, is innovation. While innovation has traditionally thrived in biotechs and the venture capital community—areas I am familiar with—what attracted me to Sanofi was the opportunity to rethink how we, as a pharmaceutical company, partner with innovative biotechs and venture ecosystems while also leveraging our deep scientific expertise to drive innovation internally.

PharmaDJ: Innovation often comes with high risks and significant costs. How do you balance risk and innovation, especially when encouraging young scientists to stay innovative and not fear failure?

Mike: At Sanofi, we aim to build a culture that embraces the idea of "fail better, fail earlier." What do I mean by that? Failure is an inherent part of research and development. Developing medicines for patients is a challenging process, but it’s driven by the right reasons—addressing unmet needs. However, much of what we do in the early-stage research may not progress to the clinical trials or reach treating physicians. This is because the science is complex, and understanding human disease is difficult. But that doesn’t mean we should shy away from it.

For early-career scientists and innovators, celebrating failure is crucial. It’s about learning from setbacks and using those lessons to move forward. Failure is not the end——it’s a step toward success.

Why do I say we should celebrate failure? As Chief Scientific Officer, my role is to identify where innovation and biology are heading and determine how we can integrate them—both externally and internally. Once we identify promising biology, the key is to quickly determine whether it can translate into meaningful impact for patients. This approach saves time, effort, energy, and resources while maximizing our chances of success.

Failing fast and failing better are about learning from setbacks and applying those lessons to improve. It’s like the AI process——you learn, integrate insights, and refine your approach. This applies at every level: the molecule, the biology, and the portfolio. My job is akin to being a portfolio manager, whether in finance, tech, or biotech. It’s about understanding how all our scientific efforts interconnect, identifying areas that need more iteration, and accelerating those that are mature enough to reach patients faster.

Bridging Biology and Technology: Sanofi’s AI-Powered Innovation Strategy

PharmaDJ: Sanofi has been integrating AI and machine learning into its R&D processes. In what specific ways can AI-driven drug discovery (AIDD) accelerate drug discovery?

Mike: There’s no denying the significant acceleration that AI is bringing to many aspects of pharmaceutical R&D today.

In the early stages of research within Sanofi, AI—both internally and through partnerships—is accelerating the identification and optimization of compounds to develop therapeutics targeting specific pathways we aim to address.

The focus now is on leveraging AI to drive insights into the next areas of biology to explore and, more importantly, to analyze diverse and complex data sets. Over the next five years, global integration and enablement of AI will be critical to Sanofi’s R&D efforts.

Let me share some specific examples. At Sanofi, we are fully committed to AI and digital technologies, as they are integral to powering our R&D pipeline. If you’re not leveraging AI today, you’re already falling behind in the race.

One concrete example is our collaboration with BioMap, which I had the pleasure of visiting yesterday. This partnership specializes in AI-driven drug discovery (AIDD), particularly in the biologics space. AI is not only helping us predict and optimize biologics but also enabling de novo discovery—approaches that are distinct from traditional methods—to develop new binders for our multi-specific and bispecific antibody efforts. This collaboration has been incredibly valuable, and we look forward to continuing it.

AI algorithms are optimizing biologics and directly strengthening our portfolio, enhancing the design-make-test-analyze cycle. This is consistent with how we integrate AI-enabled drug discovery across all our programs, both through partnerships like BioMap and internally at Sanofi. This applies to both biologics and small-molecule drug design and development.

While others in the industry are also adopting AI, for us, AI is not just a tool—it’s a core part of our strategy for driving innovation.

From a research perspective, the most critical decision we make is target selection. While AI hasn’t fully been there yet, its future lies in synthesizing vast amounts of data—both proprietary and public—to identify the best targets. This involves leveraging large language models and, eventually, AI agents that can query and analyze data to provide insights into the most promising targets.

PharmaDJ: What are the biggest hurdles for AIDD?

Mike: For us, the key to leveraging AI effectively is incorporating a "human in the loop." AI isn’t making decisions on its own—it’s enabling decision-making by providing recommendations, aggregating data, and facilitating scenario planning that would be impossible to do manually. Traditionally, this level of analysis hasn’t been feasible, but by ensuring humans remain involved, we can validate inputs, assumptions, and recommendations. This is critical for us and aligns with regulatory expectations.

Transparency is also a top priority. We ensure that the AI algorithms and approaches used to generate recommendations are clear and understandable. This transparency is essential, especially on the regulated side of our work, where data analytics, communication, and traceability are paramount.

On the research side, the "human in the loop" is equally important, though for slightly different reasons. While regulatory considerations may be less central here, it’s crucial to ensure that portfolio decisions are grounded in sound data analytics and robust data-driven insights. This balance between AI-enabled recommendations and human oversight is central to how we operate.

PharmaDJ: How can AI be used to optimize clinical trial design, such as patient recruitment and the selection of appropriate endpoints?

Mike: In late-stage clinical development, for instance, AI is dramatically speeding up processes like site selection, optimization of development timelines, and regulatory submissions—both here in China and globally.

Today, the vast majority of our development programs include China, reflecting its role as a key part of the global innovation ecosystem and our own pipeline at Sanofi.

At Sanofi, we have an App for that—we’re already using AI in several concrete ways. One key application is site selection for clinical trials. The second is real-time site enrollment and recruitment. For site selection, AI helps us identify sites that have historically recruited the largest patient populations relevant to our trials. It also tracks how quickly these sites are recruiting, allowing us to optimize the efficiency of our clinical trial design. Ultimately, this shortens timelines.

The App aggregates a vast amount of data, and I can use it in real-time to monitor enrollment and site selection. These recommendations can impact trial execution rates, speed, efficiency, cost, and even the probability of success. The AI analyzes data from all our global trials and suggests actions, such as increasing enrollment at certain sites, reducing enrollment at others, or opening new sites to optimize our development pipeline. This is already in use at Sanofi today.

Another area where AI is making a significant impact is in decision-making. We are integrating AI-enabled decision-making into our portfolio execution and governance processes. All our initiatives will follow a similar framework, which focuses on understanding—as precisely as possible—what the data for each program is telling us. This helps us assess the probability of success and make informed decisions about whether to advance or adjust our efforts.

PharmaDJ: As AI becomes more prevalent in pharmaceutical R&D, how will it affect the collaboration between data scientists, researchers, and clinicians, and what skills will be needed for effective teamwork?

Mike: At Sanofi, we’ve elevated the role of digital and AI within the company to ensure they are integrated into our R&D efforts. Digital and R&D now sit as peers within the global organization, working together to bring the best capabilities in digital and AI to enable R&D decision-making, portfolio execution, and efficiency.

Within R&D, we have embedded key partners from our digital organization into all our teams. While we collaborate with many external partners, we also have our own internal digital team. Their role is to identify current opportunities with AI, anticipate where the field is headed, and work closely with R&D teams to understand how these advancements can enable and enhance our work. We operate as one team, bridging the gap between digital, AI, and R&D.

On the talent side, upskilling is critical. Traditional R&D scientists may not yet be fully aware of how AI can enhance their work. Part of our focus is teaching them how to integrate AI into their daily workflows to improve efficiency and decision-making. At the same time, we’re actively hiring bilingual scientists—those with both AI and clinical expertise. This is a growing trend in the "tech-bio" space (not just biotech), and we’re committed to increasing hiring, integration, and collaboration in this area.

I often say that AI will not replace biologists, but biologists who know how to use AI will replace those who don’t. AI is an enabler, and we are thoughtfully integrating it into our processes to ensure we stay ahead. From a talent perspective, just as we are committed to developing talent in China, we are equally committed to fostering talent globally. We aim to cultivate bilingual scientists who can bridge the gap between the tech world—AI and digital tools—and traditional biological sciences.

Innovation, in my view, happens at the intersection of disciplines—in this case, biology and technology. By bringing these fields together, we can drive advances in a more efficient and effective way, both internally and through partnerships with tech-bio companies.

From Lab to Clinic: Sanofi’s Approach to Tackling Immunology’s Unmet Needs

PharmaDJ: Immunological diseases represent a significant unmet medical need globally. Can you elaborate on why Sanofi places such a strong emphasis on this area?

Mike: Our interest spans multiple therapeutic areas, including rare diseases, oncology, neurology, vaccines, and areas like respiratory infections. However, we are particularly focused on strengthening our position as an immunology powerhouse because immunology plays a role in a wide range of diseases across these areas.

Traditionally, within pharma, immunology, and inflammatory diseases have been centered on autoimmune conditions, which, as we’ve discussed, represent a growing unmet need. But we view immunology—or what we call "immunoscience"—more broadly. It’s not just about autoimmune diseases; immunology intersects with many other conditions. For example, neurodegeneration, oncology, and rare diseases often have significant inflammatory or immunological components that drive disease progression, even if they haven’t traditionally been viewed through that lens.

By leveraging our deep expertise in immunology, we take a pan-therapeutic approach to identify diseases driven by key immunological pathways. This uniquely positions us to address these conditions using immunological targets in innovative ways. Our focus on immunoscience is guided by our commitment to addressing unmet patient needs and delivering innovative medicines.

PharmaDJ: Can you provide any insights into Sanofi's immunology pipeline or early-stage discoveries? What key clinical trials are currently underway globally, including in China?

Mike: We’ve made significant progress and continue to advance rapidly, with bi- and multispecific biologics. One example in our pipeline is Lunsekimig, a bispecific nanobody that targets TSLP and IL-13. These are two cytokine targets that have individually been shown to drive diseases like asthma and COPD. The idea is that by combining these two targets, we can potentially increase both the efficacy and durability of response for patients with conditions like asthma, etc.

Similarly, Brivekimig is another bispecific nanobody from our Nanobody®  platform. It targets TNF-α and OX40L and is being studied for diseases such as hidradenitis suppurativa (HS), a devastating dermatologic condition with significant unmet need. We believe this combination approach could enhance efficacy and improve outcomes for patients with HS.

These examples highlight how combination therapies can potentially address complex diseases more effectively.

PharmaDJ: What are the biggest challenges Sanofi faces in translating immunology discoveries from the lab to clinical trials?

Mike: We refer to this approach as reverse translation. Historically, many targets, even in immunologic diseases, were discovered in isolation—through preclinical models like mouse experiments or in vitro studies—without a clear evidence of whether those pathways were relevant to human disease.

Our approach to target identification and target credentialing starts with the patient. Leveraging our AI capabilities, we synthesize diverse datasets, including human genetics, omics, transcriptomics, and proteomics, from both diseased tissues and clinical outcomes. These datasets come from public sources or our proprietary research. We aggregate these data and reverse translate them into our research labs.

Target selection begins with clinical data, and from there, we move into the traditional process of identifying the right molecules to target specific pathways and optimizing them. This creates a feedback loop akin to how we use AI, ensuring that our target identification and credentialing are grounded in human biology. By prioritizing genetics and human biology, we aim to increase the probability of success and ensure that the targets we select are truly relevant to human disease, not just preclinical models.

PharmaDJ: How do multi-specific biologics function and what advantages do they offer over traditional biologics?

Mike: Let me illustrate with Lunsekimig as an example. This molecule was developed on our Nanobody®  platform and targets TSLP and IL-13. You can think of Lunsekimig as "beads on a string," with binding sites for both TSLP and IL-13—two for each target. The goal is to simultaneously block both pathways, which we knew from early research were important in human disease.

To optimize the molecule, we used AI and scaled our efforts to fine-tune the binding affinity (how tightly it binds to each target) and the geometry (how flexible the molecule is to bind both targets simultaneously). This process is supported by robotics, automation, and high-throughput data analytics, which enable us to refine the molecule efficiently and precisely.  

Once optimized, we tested Lunsekimig in preclinical models that replicate the lungs of asthmatic patients. This step is crucial because it allows us to validate our assumptions and ensure the molecule effectively blocks both pathways in an environment that resembles human disease.

In early clinical development, particularly in Phase 1B trials, we’ve observed improved activity compared to individual agents targeting TSLP or IL-13 alone. This suggests that simultaneously blocking both pathways enhances efficacy, validating our reverse translation approach and the potential of combination therapies.

PharmaDJ: Does Sanofi's Nanobody® platform generate a lot of new modalities? Tell us about this platform?

Mike: The Nanobody® platform became part of Sanofi through the acquisition of Ablynx, a company based in Ghent, Belgium. This aligns with our philosophy of innovation without borders, as it was the right platform to enable our multi-specific approaches.

Nanobodies are unique because they originate from camelids like alpacas and llamas. Unlike traditional antibodies, which have two chains, Nanobodies consist of a single domain called a VHH. This makes the platform highly modular, allowing us to explore combination therapies more effectively. As we discussed earlier, this modularity enables us to optimize binding affinity, geometry, and even target multiple pathways—not just two, but potentially three or four targets. This is key to advancing the next wave of innovation in combination therapies, ensuring we achieve the right pharmacology and therapeutic impact for patients.

Another critical aspect is that everything we do in research aims to deliver medicines to patients. The Nanobody®  platform has already proven its value by advancing molecules into mid-stage clinical development and beyond. We plan to continue leveraging this platform to develop the next generation of multi-specific therapies within our portfolio.

China as a Hub for Innovation: Sanofi’s Strategic R&D Expansion and Partnerships

PharmaDJ: What role does China play in Sanofi’s R&D, particularly in drug discovery? What are Sanofi’s plans for establishing and expanding its discovery team in China in the future?

Mike: China holds a critical position for Sanofi as it’s our second-largest market. We’ve been operating in China for decades and currently have four key sites: Beijing, Shanghai, Chengdu, and Suzhou. When it comes to clinical development, we’re proud to have collaborated with over 1,100 clinical trials centers and more than 300 hospitals across China. These efforts are focused on enhancing the efficiency and effectiveness in our clinical development pipeline and organization.

We’re also deeply dedicated to nurturing talent. To that end, we’ve supported over 320 early-career investigators through partnerships with institutions like the Chinese Academy of Sciences and the Center for Excellence in Molecular Cell Science. This initiative not only fortifies the ecosystem for development but also fosters early talent.

In 2021, we opened our first research site in China, located in Suzhou—the Sanofi Institute for Biomedical Research (SIBR). The goal of this site is to embed ourselves into the local innovation ecosystem, enabling us to better deeper understand and leverage both assets and platform technologies available in China. This supports not only local research, drug discovery, and early clinical development but also contributes to the establishment and expansion of our global pipeline and portfolio.

Our commitment in China, particularly through our research efforts at SIBR, is to capitalize on this space and expand not only within the local ecosystem but also in how we engage in early research across China. This means supporting academic investigators and early-stage biotechs while aligning with our global research strategy and integrating those valuable insights back into our work.

For us, institutions like SIBR are critical contributors to global innovation from China. It’s essential that there’s no separation between the work we do at SIBR in Suzhou and our global efforts. Our research strategy in China is fully integrated with our global strategy—they are one and the same. This connectivity is vital to driving innovation, combining our global expertise with the strengths of China’s local innovation ecosystem. This aligns with our philosophy of innovation without borders, which is a key priority for us.

It’s inspiring to see the potential for China to become a hub of innovation for big pharmaceutical companies, moving beyond just leveraging its patient population for clinical trials. We aim to fully integrate China’s capabilities into the broader innovation landscape.

PharmaDJ: As of the first half of 2024, there are 100 ongoing and planned clinical trials in China, including 15 early-stage trials spanning multiple therapeutic areas such as immunology, oncology, neurology, and rare diseases. What are the criteria for selecting the most appropriate therapeutic areas and modalities for Sanofi’s R&D efforts in China?

Mike: It starts with identifying where Sanofi can make a meaningful impact, leveraging our expertise and capabilities to address clear unmet patient needs. For example, in immunology, there are around 100 inflammatory and immunological diseases globally, affecting approximately 7 to 9% of the world’s population. Unfortunately, this number is growing at a rate of 3 to 9% annually, including in China. Of these 100 diseases, only about 30 have approved treatments today. This highlights a significant gap in addressing these conditions and underscores the need for innovative solutions to meet this unmet need.

As a leader in immunology, we believe we are well-positioned to bring our global expertise to bear while also tapping into local ecosystems to identify the right modalities to address these challenges. Immunology is complex. Diseases often involve multiple pathways, and treating them effectively requires combination therapies. At Sanofi, including at our SIBR site in Suzhou, we are exploring innovative approaches such as bispecific antibodies that target two pathways simultaneously, as well as combining therapies with oral, bioavailable agents.

Our strategy is rooted in our deep immunology expertise and our ability to target multiple disease mechanisms. When making decisions, we focus on areas where we can contribute meaningfully—both scientifically and in drug discovery and development. If we don’t have the necessary capabilities internally, we seek collaborations to bring in the right medicines, technologies, or platforms to drive the next wave of innovation.

Ultimately, our goal is to address unmet patient needs, both in China and globally, as we advance our research pipeline and portfolio.

PharmaDJ: What are your expectations for Sanofi’s future in China?

Mike: I’m excited to be here for the first time and look forward to the rest of my trip. From an integration perspective, we have a deeply rooted presence in China’s ecosystem , including collaborations with over 1,100 clinical centers and 300 hospitals. These are deeply ingrained in what we do today.

The vast majority of our programs are already integrated from a regulatory and clinical development standpoint, working closely with regulatory authorities and hospital systems. This will continue, and we are committed to further strengthening these efforts. As we design our global program development strategies, China will remain a pivotal part of that approach. 

On the research side, we have established a Translational Medicine Unit, led by my colleague Karin Wåhlander. Karin and I work closely together—not only to discover early-stage medicines that address unmet needs but also to drive early human target validation and proof-of-concept studies. This two-pronged approach is important because it allows us to collaborate closely with investigators in China on early clinical biomarker efforts, as well as the selection of indications for downstream late-stage development, which is already well-established in China.

Suzhou is one example of our integration within the local ecosystem, but we plan to broaden this further through academic collaborations and continued partnerships with clinical development centers and regulators. We are very pleased with the evolution of China’s regulatory environment, which is increasingly aligning with global standards, in our view,this alignment drives further innovation.

PharmaDJ: Will Sanofi collaborate with Chinese biotech companies in early-phase research endeavors or pursue deals for early-stage assets with biotech firms?

Mike: Our perspective is that China has progressed remarkably and rapidly from being a hub for established CROs to driving genuine innovation—not just in assets, which many multinational companies have been focusing on, but also in fostering a dynamic ecosystem. We are determined to be deeply integrated into this local innovation landscape. While assets are important to us, we view them through a global lens, ensuring they contribute to both our Chinese and global portfolios.

To your point, we are also focused on how we can support the local ecosystem, including new biotech startups and facilitating venture capital investments in emerging companies. For example, in Suzhou, we are exploring opportunities to host new companies within our facilities.

Our commitment is to remain deeply connected to the local ecosystem, complementing the innovation happening in China with our global expertise. As we’ve discussed earlier, our strategy is unified—there is no separation between our global R&D strategy and our strategy in China. This is something we are wholehearted considering and will continue to develop over time as we refine our approach to integration.

Dr. Mike Quigley and Mao Donglei, the editor-in-chief of PharmaDJ