From Design to Manufacturing: Working as One Team to Bring Medicines to Patients Faster
In an industry where everyone is chasing the next scientific breakthrough, turning these breakthroughs into advances for patients depends on much more than invention. It takes a team of chemists, engineers and many more to design a molecule and then turn it into a safe and effective medicine. Traditionally, distinct and disparate teams handle development, and then hand over to manufacturing teams for production. But to accelerate innovation and bring medicines to patients faster, the teams across this continuum—Chemistry, Manufacturing, and Controls (CMC) and Manufacturing & Supply (M&S)—must work as one, seamlessly sharing data, insights, and expertise from lab to launch.
Shawn Walker, Global Head of Synthetics, CMC Development, and Franck Leroux, Global Head of Industrial Strategy, Launches and Operational Excellence, M&S, share how they work together as one team to try to get better medicines to patients, faster.
The only reporting line that we have is with the patient. It’s not a question of authorization, department, division: we all work for the patient.
Franck Leroux
Global Head of Industrial Strategy, Launches and Operational Excellence, M&S,
One Team from Lab to Launch
Bringing a medicine from proof of concept to patient is not unlike a marathon, built as a relay from target discovery and molecule development to manufacturing of a medicine. The invention-to-delivery cycle of medicines requires teams to seamlessly transfer knowledge and move with agility across functions, and it depends just as much on effective formulation and rigorous testing of a new molecule as it does on production. Scientific innovation starts in the lab but continues to the manufacturing floor.
This kind of collaboration is made possible by M&S being engaged very early on in the development process. While the CMC team focuses on turning molecules into medicines, M&S is already starting to lay the groundwork for production. This includes mapping out the patient population size, optimizing the supply chain, and building a flexible industrial platform that is capable of rapidly scaling production to meet patient demand as soon as the medicine is approved.
Aligning CMC and M&S from the start ensures that medicines are designed for industrial-scale production and can be manufactured consistently in market. This approach also provides M&S with the flexibility to scale up or down the supply of a new medicine. “When a medicine has just been launched in market, we work closely with teams across the organization to gather data on market uptake, allowing us to make quick adjustments to our manufacturing capacity,” says Leroux. This can be anything from understanding how different groups of patients are accessing immunotherapies to tracking surges in disease outbreaks that create unexpected demand for treatment and/or prevention.
We have many different platforms of drug and vaccine development—from monoclonal antibodies, nanobodies, mRNA or gene therapies, to next-generation synthetics like targeted protein degraders. These platforms, and their combinations, give us a diverse toolkit to design new and improved medicines.
Shawn Walker
Global Head of Synthetics, CMC Development
Simplifying Collaboration with Digital Technologies
Collaboration between M&S and CMC goes beyond the physical steps of creating a medicine—it’s also about data. By sharing digital platforms, CMC can share formulation insights with M&S, and M&S can transfer real-world manufacturing performance with CMC. This bi-directional flow of information is optimized using AI to identify patterns that may impact delivery and enables teams to solve any inefficiencies or errors before production starts. The result is a faster and more efficient process to commercialization.
Digital transformation can also help make the best use of our experts across the lab and the manufacturing floor. When it comes to laboratory work, we are developing AI-enabled robotics platforms as well as digital twins of our processes. With the help of robotic arms to load protein samples or automated systems to test the solubility of newly developed synthetic molecules, as we progress these technologies, they will allow our scientists to spend less time on mundane tasks and focus even more on invention. These scientists will seamlessly move between simulations in a virtual lab and experiments in the physical lab, bringing us closer to our shared goal of delivering life-changing medicines to patients who need them most.
We design medicines with the end patient in mind, whether that’s in the development process—by formulating a medicine which is more convenient for the patient—or by enabling continuous manufacturing to maintain a steady supply of medicines.
Shawn Walker
Global Head of Synthetics, CMC Development