“Those foundational experiences shaped who I became as a scientist. I truly believe that early exposure matters. It sets the tone for how your career unfolds. I might have gone in a completely different direction if those experiences had been negative. I’m grateful they weren’t.”
Subas Sakya is Chief Scientific Officer at BioDuro, a contract research, development and manufacturing organization with sites in the US and China. Here, we ask about his early career, including a love of planes that eventually became a love for chemistry, and find out about the latest trends affecting drug development, from RNA to AI, and new solutions in solubility.
What did you want to be when growing up?
I grew up in Nepal and later moved to Thailand because of my dad’s job – and I wanted to be a pilot! The first time I saw an airplane in Nepal – a jet – it completely fascinated me. The airport was quite far from where we lived, but you could still see the planes landing. I’d play around pretending to be a pilot.
What changed things for me was when I moved to Thailand. In high school, I had two incredible teachers – one in biology and one in chemistry. They showed me how to look at science in a different way.
Later, I got a scholarship offer from Coe College and I started taking a broad range of courses. I was interested in computers, chemistry, and even economics. But again, it was the chemistry professor who really inspired me. The way he taught the subject so deeply and passionately made me want to learn more.
What have been some of the most memorable milestones in your career to date?
I’ve been quite lucky in life. As I was finishing up my doctorate, I landed my first job at a small company called Lederle Laboratoy. It was part of the American Cyanamide Company, which no longer exists, but it was an exciting place to begin.
We were a small team, working on a novel project: developing an oral carbapenem. At the time, there was only one carbapenem drug on the market, which was an injectable: thienamycin from MSD. So here we were, a tiny team going head-to-head with MSD! It was intense and exhilarating.
This is where I learned how to read patent literature and think creatively about new ideas. My group leader gave me the freedom to explore, to dig into the literature, and to come back to the lab and test what I’d found. There were five of us working closely. We came up with a prodrug approach and eventually identified a clinical candidate.
That experience laid the foundation for everything: how I understood medicinal chemistry, how to collaborate in a team, and how to use the literature to drive innovation. Back then before everything went online, we were using STN Express to search databases, and the lab still relied on physical libraries. The experience taught me some essential lessons about drug discovery that have stuck with me ever since.
Another moment that stands out from that time was mentoring an intern in my lab. We had to come up with a novel idea, and she carried out the lab work and ran the reactions. It all came together, and we published the work. It was deeply satisfying to teach her how to do research and see it turn into a real scientific contribution.
Later, I joined Pfizer and learned so much more there.
Those foundational experiences shaped who I became as a scientist. I truly believe that early exposure matters. It sets the tone for how your career unfolds. I might have gone in a completely different direction if those experiences had been negative. I’m grateful they weren’t.
How did you get involved with the CDMO industry and BioDuro?
In everyone’s life, there are certain moments that really shape where you end up. For me, that moment came in early 2013.
My dad had a serious accident. He fell, hit his head, and developed a hematoma. We had to rush from the US to Thailand – an 18 hour journey. He was hospitalized for six months.
Later that same year, after having spent 16 years in the company, I was let go from Pfizer. I took a step back and asked myself, “Where do I need to be right now?” The answer was clear. I needed to be closer to family, so I made the decision to move to Asia.
I didn’t have any real connections in India, but in China, I had two friends who had worked at BioDuro. I was already quite familiar with the company. At the time, BioDuro was seen as an up-and-coming powerhouse in contract research focusing on early drug discovery. I also knew Pfizer had started working with them, so that gave me a sense of confidence in the organization.
What are the big trends in drug development that you see from clients?
One of the biggest shifts we’re seeing is in novel modalities. Early discovery is expanding into exciting spaces like peptides and RNA-targeted therapeutics. And of course, AI-driven drug discovery is huge right now.
In silico profiling has become a powerful tool, especially as more companies pivot toward precision medicine. Large clinical trials aren’t always delivering the best results anymore, but when you focus on specific subpopulations, the outcomes tend to improve. So, there’s a big push toward personalized approaches – precision medicine, AI integration, and compressing timelines in both drug discovery and IND-enabling studies.
Clients today are looking for integrated, end-to-end solutions. There’s enormous demand for accelerating drug development and pushing compounds into human trials as fast and efficiently as possible.
We’re also seeing increased need for phase-appropriate formulation development. You want the right formulation early on, so it performs well in the clinic. In silico modelling helps optimize at the early stage, which is incredibly valuable.
Complex biologics and RNA therapeutics are gaining ground fast, which has led to growing demand in bioanalytical services and specialized formulation techniques, such as hot melt extrusion and solid dispersion technologies. Many new drugs are highly insoluble, so advanced formulation approaches are essential and in very high demand.
There’s also a lot happening in the Drug Metabolism and Pharmacokinetics (DMPK) space, particularly with PK modelling, to ensure that in vivo results translate effectively to humans. That translational step is critical.
And let’s not forget peptide drugs. These require unique formulation strategies, especially for oral delivery. This is another area where we’re seeing a lot of momentum.
What is your approach to overcoming solubility issues and developing phase-appropriate formulations for IND filing?
Many of the compounds being developed today tend to be highly insoluble – largely because drug developers are targeting complex biological mechanisms. For instance, many of the protein binding sites being explored are deeply embedded and inherently hydrophobic. That makes solubility a persistent issue for small molecules.
Then there are peptides. Their challenge isn’t necessarily solubility in the traditional sense, but rather their large size and structural complexity. They often require specialized formulation strategies to help them reach their targets effectively.
The good news is that with the advanced formulation technologies we have now, it’s entirely possible to move even difficult compounds into the clinic. These newer, more tailored approaches allow us to overcome a lot of the limitations that used to hold projects back.
For instance, we’ve developed a data-driven approach based around hot melt extrusion and solid dispersion technologies, which are particularly effective for improving solubility. Even at the discovery stage, we incorporate in silico modelling to analyse the physicochemical properties of each molecule. Computational tools can be used to predict which types of formulations might work best, with high-throughput screening used to then test those hypotheses.
Once we identify promising formulations, we quickly move into PK studies to evaluate how the compound behaves in vivo. This real-time integration of PK data allows for formulations to be fine-tuned to ensure strong bioavailability and alignment with clinical goals.
What are the big challenges you see, both as a business and across the industry?
One of the biggest challenges right now is cost. The expense of drug development continues to rise across the industry, which puts pressure on everyone to compress timelines and work more efficiently. The question we’re all grappling with is: how do we discover and develop drugs in a cost-effective way – and deliver them to patients affordably?
That’s a huge challenge, and it's not getting any easier. But I’m also excited about some of the advances we’re seeing, especially the rise of AI technologies. There's a lot of enthusiasm around AI's potential to speed up early discovery and identify novel drug candidates more quickly.
That said, we’re still in the early stages. Translating AI insights into real-world drugs takes time, and we’re still figuring out the best ways to integrate these tools. It’s not a magic bullet – it requires the right people, the right processes, and careful validation.
At the end of the day, the core issue remains: how do we move drugs forward as quickly and efficiently as possible? That’s still the toughest part.
There are so many new ways to target disease these days. Some are working well, others not so much. We are still in a learning phase. There is no one-size-fits-all solution and drug discovery remains very much a trial-and-error process, even with AI in the mix.
From my perspective, the central challenge is still about managing cost while pushing compounds through the pipeline faster.
How has BioDuro grown over the years?
BioDuro has been growing steadily, but like many companies we’ve had to be responsive to the market. One area I’m especially excited about is our peptide platform. It’s working really well and has helped several clients develop peptide-based drugs that are now moving toward the clinic.
We also have a smaller, but fast-growing, nucleotide therapeutics capability that we’re investing in and, recently, we opened our new Bengbu site. It’s focused on intermediate-scale process development and scale-up, which gives our clients more flexibility. We now also have an OEB-5 lab, allowing us to work with highly potent compounds – including antibody-drug conjugates.
One last point I’d like to emphasize: in today’s competitive environment, cost is everything – especially for biotech companies trying to raise funding. CROs really can play a critical role here by helping to reduce the cost of research while still delivering high-quality science.
What keeps you motivated day to day?
It really comes down to the people; it’s just a fantastic group to work with, day in and day out. I’ve also had the chance to help build BioDuro from the ground up. Seeing the company grow and thrive has been incredibly rewarding.
Now, with my new role as Chief Scientific Officer based in the US, things have evolved. I’m much more client-facing, which is exciting in a different way. I get to meet a lot of people and visit different sites, which lets me really dig into what they need and how we can support them.
At the end of the day, our role is to help our clients turn their ideas and drug designs into clinical reality. We’re in a very competitive space, so helping our clients reach that next milestone more quickly than they could elsewhere is a goal that motivates me. It’s incredibly rewarding to see our clients succeed. Whether they’re a biotech getting ready to sell their asset to a pharma partner, or moving it into clinical trials, it’s exciting to know we played a part in that journey.