Sajith Wickramasekara is the co-founder and CEO of Benchling, which offers the R&D Cloud, an informatics platform to accelerate, measure, and forecast R&D from discovery through bioprocessing. Founded in 2012, Benchling now has more than 600 pharmaceutical and innovative biotech customers globally, nearly 100 of which are in Europe.
Speaking to Pharm Exec, Wickramasekara shares his perspectives on the R&D challenges facing the biopharma industry, and the steps needed to close the gap between research and early-stage development to accelerate scientific breakthroughs.
Pharm Exec: Can you tell us about what drew you into the world of biology and why you founded Benchling?
Sajith Wickramasekara: I’m a software engineer by background. I studied Computer Science and have had a lifelong love for programming. Along the way, I got intrigued by biology and started working in a wet lab. I loved the idea of being able to contribute to the discovery of life-saving medicines. It was the contrast between software and science that led to Benchling. Those two worlds couldn’t have been more different.
In my life as a software engineer, I had powerful, rapidly evolving tools that helped me work seamlessly with other developers. In the biology lab, where I was doing arguably more important and complex work, I had a paper notebook and Excel spreadsheets.
Software may be eating the rest of the world, but it has failed science. I felt there was something holding it back from reaching its full potential. That’s why I started Benchling, to build the software layer to power biology and help accelerate scientific discoveries.
Pharm Exec: How important is the role of technology in accelerating drug discovery?
We’re witnessing a biotechnology revolution — an explosion of new innovation in fields such as cell therapy, gene therapy, antibodies, proteins, and other new drug modalities.
Last year, Verve Therapeutics demonstrated a one-shot therapy that effectively and durably reduced LDL in primates by 61%. A single-shot cure for heart disease would change the world. Editas Medicine recently dosed the first ever patient with a CRISPR gene editing medicine, designed to correct congenital mutations that cause childhood blindness. And of course, we have seen COVID-19 antibodies delivered to the clinic in record time.
The pandemic has elevated the world’s expectations of what biology and pharma can achieve and the speed of scientific breakthroughs, especially in drug discovery.
The era of the lone scientist and the eureka moment has given way to teams of specialists around the world working in concert to develop new innovations through repeatable processes. Disparate point solutions for ELN, LIMS, and laboratory execution systems (LES) create silos that exacerbate the inherent challenges of complex collaboration. This forces scientists to spend time reconciling data between various systems instead of surfacing and sharing key insights that accelerate drug development.
Using an agile software platform built for the complexity of modern pharma is one of the highest-leverage ways to accelerate R&D timelines.
Pharm Exec: There is a close connection between the R&D process, yet there often seems to be a disconnect between the two functions. How can collaboration be improved to accelerate drug discovery?
Early development is a complex process involving hundreds of scientists and lots of workflows. At this point Process Development still starts out looking more like research — it’s very experimental and scientists need the flexibility. However, the handover process to Process Development can often see a huge loss of knowledge and data because of the siloes inside R&D organizations.
This can lead to teams redoing experiments because they don’t have access to previous research data that they may need to demonstrate anything from product safety through to information for regulatory agencies. Universally we hear that complex handoffs of data and workflows cause drag on the overall efficiency of an R&D organization.
The second challenge is that at the start of early development, scientists do all this work in a non-validated context, i.e., non-GMP or not under Good Manufacturing Practices. As the process gets closer to creating materials for the pre-clinical or early clinical studies, it needs to be locked down. The creation of that clinical supply has to be done under GMP. There are also additional document inspections (including a specific section known as Chemistry, Manufacturing, and Controls) which means that the ability to organize all the early PD work, including the entire history of runs and results, is critical not only for early development but also as we move into late development.
To accelerate this process, scientists need to move readily between being flexible and controlled, and non-validated and validated.
Ultimately, this back and forth between research and development is crucial for accelerating product development, but at the moment it is almost impossible to achieve. The more we learn in process development, the more information we need flowing back to research teams so that they can use it and improve the research that they’re doing.
Essentially, we need to bidirectionally connect research and development, so that development gets a 360-degree view of early experiments that they can be confident in, while research can learn from development’s experiments in turn.
Pharm Exec: You recently announced your expansion into the early development market. How will your new solution enable scientists to seamlessly move from research through development within a single system?
We support over 600 companies’ R&D efforts. Regardless of their size, almost all of our customers say that simplifying their R&D workflows is a systems-level challenge they feel acutely.
They need a way to look across the full R&D lifecycle to track scientific context and simplify collaboration throughout. And in particular, make tech transfer from discovery to development more manageable, alongside additional functionality to support more regimented control for sample and process management.
We recently expanded our solution so that it allows scientists to seamlessly move from research through development within a single system for the first time. Benchling accommodates both the flexibility and speed needed for research efficiency, as well as the control and compliance required for regulated processes.
This includes expanding our workflows application to support the collaborative work that takes place across specialized R&D teams. Users can now coordinate task requests and processes across teams with full traceability, including methods, samples, and inventory.
Secondly, we have introduced structured templates, meaning development teams can easily create shared, standardized processes for repeatable experiments, analytical tests, QC protocols, and more. These procedures can be locked down to meet regulatory and compliance requirements.
Pharm Exec: With better alignment between research and early development, what do you think the pharma industry can achieve in the next 5 years?
A more streamlined and efficient R&D process will be key in increasing the speed at which new drugs or treatments are researched and taken to market.
Of course, there will always be failures, and not every piece of research will lead to a breakthrough, but the more molecules we can research and test, and the less time it takes to bring them to market — and ultimately to patients — the more effective the biopharma industry will be at saving and improving lives.
Technology will also play a huge role in reducing silos and enabling better collaboration between research and development teams. But there are also big cultural shifts starting to take place, which have been accelerated by Covid, towards greater alignment, including cultures of openness and transparency.
Ultimately, these changes should allow scientists to fail fast and succeed more.