by Greg Kunst, CEO
It’s said that biotech is a “team sport.” Certainly, coordination, collaboration and consistently high performance are just some of the teamwork qualities that the Aurion Biotech team displayed in the months leading up to this week’s massively significant milestone, where we had the privilege of treating our first subjects in our ABA-1 / CLARA trial.
Execution in a clinical trial requires an ever-changing mix of strategic planning, detailed project management, continuous communication and sustained efforts from multiple team members. It starts with our clinical development plan, which defines the contours of the trial: its objectives, number of subjects, primary and secondary endpoints, and dosing. Our clin-ops team is responsible for recruiting investigators, our medical affairs team has been training investigators, and both clin-ops and medical affairs are working closely with our clinical and CMC teams to ensure that doses are produced and delivered according to each investigator’s specific schedule for treating patients. In our case, our CMC team is working closely with our Quality team to ensure that our CDMO partner is producing and delivering drug product to the right location at the right time.
Of course, since humans are involved in every step of this detailed effort, things change. Constantly. So our people must communicate closely – with each other, with our CDMO partner and with our investigators – to accommodate those changes. It’s a fiendishly complex effort. There are so many places where obstacles can occur, where tempers could flare and where seemingly intractable challenges could emerge.
It’s a credit to the Aurion team that – while things haven’t always gone according to plan, where challenges have emerged – they’ve kept their “eyes on the prize:” it’s all about developing this potentially game-changing therapy, to serve millions of patients throughout the world who suffer from corneal endothelial disease. Our team is resolved to work closely and effectively with each other, and demonstrate our values of stewardship and grit to resolve issues, communicate constantly and overcome the hurdles. I am so proud of our Aurionians: because of them, we are where we are, today.
But today is just the beginning. We have many more patients to dose. Our team knows this: they’re doubling down on their efforts to continue to work effectively together. Because of their fantastic teamwork, I know that we will continue to make significant progress. Great teams get even better when faced with big, important challenges. I’m betting on the Aurion team’s continued success. I’m not the only one: we are proud to have received the Clinical Advance of the Year from Biotech Week Boston. Our future looks bright.