In April, the US FDA approved Eli Lilly’s orforglipron (brand name Foundayo) – the second GLP-1 drug in tablet form to reach the market. The once-daily obesity pill, which can be taken without food or water restrictions, could be used by millions of patients in the coming years.

Sarah O’Keeffe leads a team of scientists working behind the scenes to bring drugs like Foundayo to market. In fact, she and her team developed a new process to synthesize orforglipron – which was roughly seven times more efficient than the original approach. “That's the kind of work that energizes our team – taking something that doesn't have a clear path and finding the ‘how,’” she says.

Ahead of HPLC 2026, where she will deliver a keynote presentation, we spoke with O’Keeffe about her team’s role in bringing new therapies to patients, the growing complexity of modern medicines, the changing role of analytical science, and why integration across disciplines is becoming increasingly important to pharmaceutical innovation.

What is your current role and career background?

I'm Group Vice President of Product Research and Development (PRD) at Lilly, where I lead a team of 1500 scientists and engineers responsible for building a molecule, through developing the right formulation, pioneering patient-friendly drug delivery systems, innovating sustainable manufacturing processes and packaging, supporting clinical trials and finally, helping to get it into the hands of patients. We are there every step of the way.

I'm a PhD organic chemist by training and transitioned from academia into industry early in my career, and have now spent almost two decades in the pharma industry.

How did you transition from a hands-on scientist to a leadership role?

It honestly wasn't on my career plan. Not even close. When I took my first step into a management role, I was genuinely unsure whether it was something I even wanted. I was passionate about being a chemist, about being the person at the bench, on the manufacturing floor, who perseveres until the problem is solved. That was my identity. And I worried that by stepping into management, I'd lose that – not just the hands-on work, but that part of me that got a kick out of figuring things out firsthand. So yes, there was a culture shock, but it wasn't really about learning new skills or navigating organizational dynamics. It was more about letting go of one version of myself and trusting that the things I loved about science – the curiosity, the rigor, the persistence – could still show up in a completely different kind of role.

Can you give an overview of your team’s role at Lilly and a preview of your HPLC 2026 presentation?

Our team is responsible for taking a molecule from the point of discovery all the way through to a medicine a patient can take. That spans process development, formulation, analytical science, device development, clinical supply – across every modality we work on. It's a big remit, but honestly, the privilege of working on medicines that could genuinely change someone's life never gets old.

And the talk at HPLC really comes from that vantage point. The medicines we're making are changing fast: antibody-drug conjugates, mRNA, oligonucleotides, cell and gene therapies molecules that are bigger, more complex, and more heterogeneous than what most of our separation science was originally built for. So the talk is really about what has to change.

I'll touch on some of the advances – multi-dimensional chromatography, novel separation techniques – but honestly, the part I'm most excited about is where this all goes next. When you start connecting separations with automation, advanced data science, and AI, you move from just analyzing a molecule to building something much more adaptive and insight-rich. That's the step change.

And I'll draw on what we're doing at the Lilly Medicine Foundry, which is a next-generation, digitally enabled facility we've built to accelerate clinical supply. It's a real-world example of what happens when you bring separation science, digital technology, and new ways of working together under one roof. Ultimately, this is about getting medicines to patients faster and with more confidence – and analytical separations are right at the heart of that.

What are your organization’s key priorities, and can you share an example – such as the development of orforglipron?

Our organization is unique in many ways at Lilly. All innovation – whether it originates internally or comes through external partnerships – funnels through PRD on the path to commercialization. We're the team that figures out how to take a promising molecule and turn it into a real medicine that can be manufactured, supplied, and delivered to patients at scale. That's true across every modality and every therapeutic area in Lilly's portfolio.

Orforglipron is a great example. The synthesis was far more complex than a typical small molecule – roughly 30 steps where we might normally deal with a dozen. Our team proposed an entirely new process, one that prioritized efficiency and sustainability by using fewer solvents and generating less waste. The result was a process roughly seven times more efficient than the original approach. That's the kind of work that energizes our team – taking something that doesn't have a clear path and finding the "how." And it's what I want us to keep doing: building the capabilities, the infrastructure, and the culture to move the most complex and impactful medicines forward, faster, for patients around the world.

What do you find most rewarding about your work in pharmaceutical R&D?

Honestly, it's hard to pick one moment. But there's something about finding a solution where one didn't exist and doing that alongside the smartest people around you. That's what gets me up in the morning. Finding new ways, better ways, of making medicines, and speeding them to patients in the clinic. My team and I have been working on innovative approaches to making medicines at Lilly for a long time now: from continuous manufacturing of small molecules, and peptides and solid orals. On the bioproduct side, innovation on our cell lines has quadrupled yields for our investigational medicines. On devices, our autoinjectors have defined an injection experience for millions of patients being treated for diseases including type 2 diabetes, obesity, ulcerative colitis and Crohn's disease.

We are also bringing a facility like the Lilly Medicine Foundry to life that can help enable the next wave of that innovation. Seeing all of those threads come together in one place is pretty special.

And then there's the moment you see promising clinical results come through. That never gets old. When you look at Lilly’s recently approved medicines, and you know your team played a part in making that medicine real, that's deeply rewarding.

But if I'm being really honest, the moments that hit hardest are the personal ones. I have family and friends who work with patients who are taking medicines I had a hand in making. That connection, from the lab to someone's treatment, is something no career plan could have predicted, and it's probably the thing I'm most grateful for.

How has pharmaceutical R&D changed over the past decade?

The patient has always been at the center of what we do – that's a given, and I'd assume the same is true for our peers across the industry. What's changed is the how. The tools, the science, the way teams work together to translate that patient focus into something tangible.

Take product design. At Lilly, we've long had frameworks for designing medicines around how patients actually use them – whether that's an oral tablet or a device. For example, for patients with rheumatoid arthritis their hands are often swollen, stiff, and painful. So we designed a tablet with recessed areas for easier grip, and a coating that won't slip from affected fingers. With our autoinjector platform we built in hidden needles, single push-button injection, and automatic retraction.

That kind of thinking was always there. What's evolved is our ability to act on it faster and across more complex modalities.

What key scientific, technological, and regulatory factors are driving this transformation?

A few things. The science got harder, we moved beyond traditional small molecules and monoclonal antibodies into ADCs and other bioconjugates, and gene therapies. These are fundamentally more complex to develop and manufacture, and require expertise across many experts and that forced a different way of working. You can't hand things off sequentially anymore. It demands integrated, cross-functional collaboration from the very beginning.

At the same time, technology has advanced significantly, and with it, regulatory expectations. What agencies expect in terms of process understanding, characterization, and control strategy is far more sophisticated than it was a decade ago. That's a good thing. It pushes us to be more rigorous, more data-driven, and ultimately to deliver better medicines. But it also means the bar for what "development excellence" looks like keeps rising.

And there's been a broader mindset shift, too. There's a growing recognition that creating a medicine and getting it approved isn't enough. You've got to make it available and accessible to people around the world. That means thinking about scalable manufacturing, flexible supply chains, multiple dosage forms, and cost-effective processes from the start – not as an afterthought. It changes how you design the entire development program.

The next chapter is about convergence. We're working with modalities that barely existed a decade ago –  mRNA, bioconjugates, AAV gene therapies – and each one requires new manufacturing platforms, new delivery approaches, and new ways of thinking. The organizations that will lead are the ones building flexible infrastructure and teams that can invent solutions to problems they haven't seen before. It's less about following a known playbook and more about writing a new one – finding a "how" where one doesn't yet exist.

How is PRD structured, and how do different disciplines come together to support drug development?

PRD brings together scientists, engineers, and problem-solvers across a wide range of disciplines – process chemistry, formulation science, engineering, manufacturing, clinical supply, analytical science, data science, modeling and simulation, and more. What we value is scientific integration – leveraging the expertise we have in different corners of the organization to follow the science, follow the work. It's not about rigid structure; it's about making sure the right people are connected to the right problems at the right time.

How do you manage different cultures and disciplines within one team?

When you have that breadth of expertise, people who think in code sitting next to people who think in chromatograms, the cultural challenge is real. The key is creating an environment where every discipline understands its value in the bigger picture. An analytical scientist isn't just running assays in service of someone else's project, they're shaping development strategy, flagging risks early, and accelerating decisions.

We invest a lot in helping people see the connection between their work and the patient. When someone understands that their analysis is what gives us confidence to advance a medicine into clinical trials, it deepens their understanding of their role in medicine development and their impact on people's lives. It also makes us more attractive to top talent because the best scientists don't just want to run instruments; they want to solve problems that matter, work across modalities they can't access anywhere else, and see their work make a real difference.

How does working in the pharmaceutical industry differ from academia in terms of collaboration, scope, and impact?

I haven't worked in academia. But I can speak to what the transition felt like coming out of a PhD in organic chemistry and into industry.

The biggest shift for me was going from largely individual contribution to deeply collaborative work. In a PhD, your success is mostly tied to your own research, your own thesis, your own publications. In pharma, the work is inherently team-based. No one person takes a medicine from molecule to patient – it takes chemists, engineers, analytical scientists, formulation experts, regulatory strategists, all working together. You learn very quickly that your ability to collaborate across disciplines matters just as much as your technical depth.

The second thing that struck me was breadth. In academia, you go very deep on a narrow question, and that's valuable, it builds real expertise. But in industry, you're constantly exposed to disciplines and problems you never encountered during your PhD. One week you're solving a synthesis challenge, the next you're in a conversation about formulation or device design or supply chain. That breadth is energizing. It stretches you in ways that a single research lab simply can't.

And then there's purpose. In academia, impact can feel distant – you publish, you hope it advances the field, but the connection between your work and a real person's life is often abstract. In pharma, that connection is tangible. You can draw a direct line from the problem you solved in the lab to a medicine that a patient is using – whether it's in a clinical trial or commercially. That changes your relationship with the work in a profound way.

I have to be honest, it's not always seamless. The pace and demands in industry are real – timelines are driven by patients waiting for medicines. You have to be comfortable with ambiguity, with shifting priorities, and with the fact that not every project will succeed. And for people coming from academia, the adjustment from being the sole expert on your topic to being one voice in a cross-functional team can take some getting used to. But for me, that's also what makes it rewarding, you trade some individual autonomy for collective impact, and I think that's a trade worth making.

What role do industry-academic collaborations play in your work, and can you share some examples of how these partnerships are evolving?

Yes, I've been involved in academic partnerships for many years, and they've always been important at Lilly. I'm a strong believer in what happens when you bring industry and academia together, you get different ways of thinking about problems, you build a talent pipeline, and you advance science that neither side could do alone.

A great example is our collaboration with Purdue University, which dates back to 2017. Earlier this year, we announced an expansion of up to $250 million over eight years through the Lilly-Purdue 360 Initiative, potentially the largest industry-academic research agreement in American history. The goals span the entire pharmaceutical pipeline: accelerating the delivery of medicines to patients, bridging the gap between lab discoveries and clinical applications, building more resilient supply chains, and developing the workforce of the future. There are already hundreds of graduate students actively engaged in the research, and areas like genetic medicine, nanoparticle drug delivery, and intrathecal delivery are all part of the program.

We've also expanded our partnership with Indiana University, with a $40 million collaboration to build AI-supported clinical trial infrastructure across the state. It's about widening patient access to cutting-edge trials, but also about creating programs that prepare students and professionals for careers in pharmaceutical research.

And personally, I was closely involved in our collaboration with University College Cork in Ireland and the SSPC research centre, where Lilly and academic researchers co-developed novel process chemistry and directly translated into more efficient, safer manufacturing at scale.

What message would you share with young scientists considering a career in drug development?

Drug development is hard work. There's no shortcut around that. The science is complex, the timelines are long, and there will be moments where things don't go the way you expected – where a process fails, a result surprises you, or a path you believed in hits a wall. You have to be willing to persevere when everyone else is ready to give up. You have to learn fast, adapt, and keep going.

But it is truly rewarding. There's something unique about this work that I don't think you can fully appreciate until you're in it. The first time you learn that a family member or a friend is relying on a medicine you helped develop, scale, and ultimately supply. That changes you. It makes the late nights and the hard problems worth it in a way that's difficult to put into words. You realize you're not just solving scientific puzzles. You're making something that matters to real people.

I'd encourage any young scientist who's curious about this field to lean into that. Bring your expertise, bring your curiosity, but also bring your resilience, because the problems worth solving are never the easy ones.

Of course, my six-year-old daughter reminds me of this every day. She proudly tells people that her mum makes medicine to help people feel better. And at the end of the day, I'm doing work that makes my daughter proud.

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